Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE Print This Notice 1337 CNOG  968 

Recent Notices of Rulemaking Referenced Items (173, 174, 175, 176)
(174)			    DEPARTMENT OF COMMERCE
			  Patent and Trademark Office
				 37 CFR Part 1
		[Docket Nos.: PTO-P-2005-0022; PTO-P-2005-0023]
			   RINs 0651-AB93; 0651-AB94

	    Changes To Practice for Continued Examination Filings,
	     Patent Applications Containing Patentably Indistinct
	   Claims, and Examination of Claims in Patent Applications

AGENCY: United States Patent and Trademark Office, Commerce.

ACTION: Final rule.

SUMMARY: The United States Patent and Trademark Office (Office) is
revising the rules of practice in patent cases relating to continuing
applications and requests for continued examination practices, and for
the examination of claims in patent applications. The Office is
revising the rules of practice to require that any third or subsequent
continuing application that is a continuation application or a
continuation-in-part application, and any second or subsequent request
for continued examination in an application family, be filed to obtain
consideration of an amendment, argument, or evidence, and be supported
by a showing as to why the amendment, argument, or evidence sought to
be entered could not have been previously submitted. The Office is also
revising the rules of practice to provide that an applicant must
provide an examination support document that covers all of the claims
in an application if the application contains more than five
independent claims or more than twenty-five total claims. The Office is
also revising the rules of practice with respect to multiple
applications that have the same claimed filing or priority date,
substantial overlapping disclosure, a common inventor, and common
ownership. These changes will allow the Office to conduct a better and
more thorough and reliable examination of patent applications.

DATES: Effective Date: November 1, 2007. For applicability and
compliance dates see SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: The Office of Patent Legal
Administration, by telephone at (571) 272-7704, by mail addressed to:
Mail Stop Comments - Patents, Commissioner for Patents, P.O. Box 1450,
Alexandria, VA 22313-1450, or by facsimile to (571) 273-0100, marked to
the attention of the Office of Patent Legal Administration.

SUPPLEMENTARY INFORMATION: The Office is revising the rules of practice
in patent cases relating to continued examination filings (continuing
applications and requests for continued examination), multiple
applications containing patentably indistinct claims, and the
examination of claims in applications.

   The Office is revising the rules of practice for continuation
applications, continuation-in-part applications and requests for
continued examination. Under these revisions, an applicant may file two
continuation applications (or continuation-in-part applications), plus
a request for continued examination in the application family, without
any justification. An application family includes the initial
application and its continuation or continuation-in-part applications.
Applicant may file any additional continuation application,
continuation-in-part application, or request for continued examination
with a justification. Specifically, the Office is revising the rules of
practice to require a justification for any third or subsequent
continuing application that is a continuation application or a
continuation-in-part application, and any second or subsequent request
for continued examination in an application family. The third or
subsequent continuing application or request for continued examination
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  969 

must be filed with a petition showing why the amendment, argument, or
evidence sought to be entered could not have been previously submitted.

   The Office is also revising the rules of practice for divisional
applications. Under these revisions, an applicant is permitted to file
a divisional application of an application for the claims to a non-
elected invention that has not been examined if the application was
subject to a requirement for restriction. The divisional application
need not be filed during the pendency of the application subject to a
requirement for restriction, as long as the copendency requirement of
35 U.S.C. 120 is met. Thus, applicant may file the divisional
application during the pendency of the application that was subject to
a requirement for restriction or the pendency of any continuing
application of such an application. Applicant may also file two
continuation applications of the divisional application plus a request
for continued examination in the divisional application family, without
any justification. A divisional application family includes the
divisional application and its continuation applications. In addition,
applicant may file any additional continuation application or request
for continued examination in the divisional application family with a
petition and adequate justification.

   The Office is also revising the rules of practice for the
examination of claims in an application to provide that if the number
of independent claims is greater than five or the number of total
claims is greater than twenty-five, the Office will require the
applicant to help focus examination by providing additional information
to the Office in an examination support document covering all of the
claims (whether in independent or dependent form) in the application.

   The Office is also revising the rules of practice with respect to
multiple applications that have patentably indistinct claims and a
common assignee by either requiring that all patentably indistinct
claims in such applications be submitted in a single application or
effectively treating the multiple applications as a single application.

   These changes will mean more effective and efficient examination
for the typical applicant without any additional work on the part of
most applicants. However, in the applications that place an extensive
burden on the Office, the applicant will be required to help focus
examination by providing additional information to the Office.

   Applicability Dates: The changes to 37 CFR 1.75, 1.142(c), and
1.265 are applicable to any nonprovisional application filed under 35
U.S.C. 111(a) on or after November 1, 2007, and to any nonprovisional
application entering the national stage after compliance with 35 U.S.C.
371 on or after November 1, 2007. The changes to 37 CFR 1.75, 1.142(c),
and 1.265 are also applicable to any nonprovisional application filed
before November 1, 2007, in which a first Office action on the merits
was not mailed before November 1, 2007.

   The changes to 37 CFR 1.117 are applicable to any nonprovisional
application filed before, on, or after November 1, 2007, with respect
to any fee under 37 CFR 1.16(h), (i), or (j) or 1.492(d), (e), or (f)
paid on or after December 8, 2004.

   The changes to 37 CFR 1.78(a), 1.78(d)(1), 1.495 and 1.704(c)(11)
are applicable only to any application, including any continuing
application, filed under 35 U.S.C. 111(a) on or after November 1, 2007,
or any application entering the national stage after compliance with 35
U.S.C. 371 on or after November 1, 2007. Except as otherwise indicated
in this final rule, any application filed under 35 U.S.C. 111(a) on or
after November 1, 2007, or any application entering the national stage
after compliance with 35 U.S.C. 371 on or after November 1, 2007, seeking
to claim the benefit under 35 U.S.C. 120, 121, or 365(c) and 37 CFR 1.78
of a prior-filed nonprovisional application or international application
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  970 

must either: (1) Meet the requirements specified in one of 37 CFR
1.78(d)(1)(i) through (d)(1)(v); or (2) include a grantable petition under
37 CFR 1.78(d)(1)(vi).

   With respect to applications that claim the benefit under 35 U.S.C.
120, 121, or 365(c) only of nonprovisional applications or
international applications filed before August 21, 2007: an application
is not required to meet the requirements set forth in 37 CFR 1.78(d)(1)
if: (1) The application claims the benefit under 35 U.S.C. 120, 121, or
365(c) only of nonprovisional applications filed before August 21, 2007
or applications entering the national stage after compliance with 35
U.S.C. 371 before August 21, 2007; and (2) there is no other
application filed on or after August 21, 2007 that also claims the
benefit under 35 U.S.C. 120, 121, or 365(c) of such prior-filed
nonprovisional applications or international applications.

   The changes to 37 CFR 1.114 are applicable to any application in
which a request for continued examination is filed on or after November
1, 2007. Specifically, a petition under 37 CFR 1.114(g) must accompany
any request for continued examination filed on or after November 1,
2007, in an application in which a request for continued examination
has previously been filed, or in a continuation application or
continuation-in-part application of an application in which a request
for continued examination has previously been filed, or in an
application whose benefit is claimed in a continuation application or
continuation-in-part application in which a request for continued
examination has previously been filed.

   The changes to 37 CFR 1.17, 1.26, 1.52, 1.53, 1.76, 1.78 (except
1.78(a) and 1.78(d)(1)), 1.104, 1.105, 1.110, 1.136, 1.142(a), and
1.145 are applicable to any nonprovisional application pending on or
after November 1, 2007.

   Compliance Date: For applications filed before November 1, 2007,
applicants must comply with the requirements in 37 CFR 1.78(f)(1)
within the time periods specified in 37 CFR 1.78(f)(1)(ii), or by
February 1, 2008, whichever is later, and applicants must comply with
the requirements in 37 CFR 1.78(f)(2) within the time periods specified
in 37 CFR 1.78(f)(2)(iii), or by February 1, 2008, whichever is later.

Table of Contents

I. Background

   A. Changes to Practice for Continued Examination Filings
   B. Changes to Practice for Examination of Claims in Patent Applications
   C. Changes to Practice for Patent Applications Containing Patentably
      Indistinct Claims
   D. Retention of First Action Final Practice and Changes in Second
      Action Final Practice

II. Discussion of Specific Rules

   This final rule amends the following sections in title 37 of the
Code of Federal Regulations (CFR): §§ 1.17, 1.26, 1.52,
1.53, 1.75, 1.76, 1.78, 1.104, 1.105, 1.110, 1.114, 1.136, 1.142,
1.145, 1.495, and 1.704. This final rule adds §§ 1.117, and
1.265 to title 37 of the CFR.

III. Response to Comments

   A. Changes to Continuing Application Practice
   B. Treatment of Third and Subsequent Continuation or
      Continuation-In-Part Applications
   C. Treatment of Second and Subsequent Requests for Continued
      Examination
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  971 

   D. Petitions Related to Additional Continuation Applications,
      Continuation-In-Part Applications, and Requests for Continued
      Examination
   E. Treatment of Multiple Applications
   F. Changes to Practice for Examination of Claims
   G. Number of Independent and Total Claims Permitted Without an
      Examination Support Document
   H. Examination Support Document Requirements
   I. The Office's Authority to Promulgate the Changes in this
      Final Rule
   J. Changes to Internal Practice
   K. Suggestions Relating to Legislative Changes
   L. Effective Date of the Changes in this Final Rule
   M. Miscellaneous

IV. Rule Making Considerations

   A. Administrative Procedure Act
   B. Regulatory Flexibility Act
   C. Executive Order 13132 (Federalism)
   D. Executive Order 12866 (Regulatory Planning and Review)
   E. Executive Order 13175 (Tribal Consultation)
   F. Executive Order 13211 (Energy Effects)
   G. Executive Order 12988 (Civil Justice Reform)
   H. Executive Order 13045 (Protection of Children)
   I. Executive Order 12630 (Taking of Private Property)
   J. Congressional Review Act
   K. Unfunded Mandates Reform Act of 1995
   L. National Environmental Policy Act
   M. National Technology Transfer and Advancement Act
   N. Paperwork Reduction Act

I. Background

   In view of the need for a better focused and effective examination
process to reduce the large and growing backlog of unexamined
applications while maintaining or improving the quality of issued
patents, the Office published two notices in January of 2006 proposing
changes to the practice for continuing applications, requests for
continued examination, multiple applications containing patentably
indistinct claims, and the examination of claims in applications. See
Changes to Practice for Continuing Applications, Requests for Continued
Examination Practice, and Applications Containing Patentably Indistinct
Claims, 71 FR 48 (Jan. 3, 2006), 1302 Off. Gaz. Pat. Office 1318 (Jan.
24, 2006) (proposed rule) (hereinafter "Continuing Applications
Proposed Rule") and Changes to Practice for the Examination of Claims
in Patent Applications, 71 FR 61 (Jan. 3, 2006), 1302 Off. Gaz. Pat.
Office 1329 (Jan. 24, 2006) (proposed rule) (hereinafter "Claims
Proposed Rule").

   Both the Continuing Applications Proposed Rule and the Claims
Proposed Rule requested public comments and provided a comment period
of four months to give the public an opportunity to submit written
comments. The Office provided this extended comment period to ensure
that the public would have sufficient time to submit written comments
on the proposed changes to the rules of practice and to ensure that the
Office would receive comments from all interested persons and
organizations. In addition to the notices and requests for written
comments, the Office conducted public meetings including town hall
meetings and presentations at various locations in the United States to
discuss the proposed changes and obtain feedback from the public. The
Office received over five hundred written comments from government
agencies, universities, intellectual property organizations, industry,
law firms, individual patent practitioners, and the general public. The
Office has spent nearly one year carefully analyzing and considering
all of the written comments that were received. The comments and the
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  972 

Office's responses to the comments are provided in Section III,
Response to Comments. In response to the comments, the Office has made
appropriate modifications to the proposed changes to balance the
interests of the public, patent owners, applicants, practitioners, and
other interested parties with the need to reduce the large and growing
backlog of unexamined patent applications, improve the quality of
issued patents, and make the patent examination process more effective.

   Under the proposed changes, applicants would have been permitted
to file one of the following without any justification: A continuation
application, a continuation-in-part application, or a request for continued
examination. By contrast, this final rule permits applicants to file two
continuation applications or continuation-in-part applications, plus a
single request for continued examination in an application family, without
any justification. Applicant may file any additional continuing application
or request for continued examination with a justification. Under the
proposed changes, about eleven percent of the applications and requests for
continued examination filed in fiscal year 2006 would have required a
justification, where under the changes being adopted in this final rule
less than three percent of the applications and requests for continued
examination filed in fiscal year 2006 would have required a justification.

   The proposed changes would have permitted applicants to file a
divisional application of an application for the claims to a non-
elected invention if the application is subject to a requirement for
restriction and the divisional application is filed during the pendency
of that application. However, this final rule permits applicant to file
a divisional application of an application if the application is
subject to a requirement for restriction and the divisional application
meets the copendency requirement of 35 U.S.C. 120. Thus, this final
rule allows applicants to file divisional applications in series
whereas the proposed rule would have required applicants to file
divisional applications in parallel. This final rule also permits
applicant to file two continuation applications of a divisional
application, plus a request for continued examination in the divisional
application family, without any justification. Under the proposed
changes, about thirteen percent of divisional applications filed in
fiscal year 2006 would need to have been filed earlier, where the
changes being adopted in this final rule would not have required any of
the divisional applications filed in fiscal year 2006 to have been
filed earlier.

   The proposed changes would have required applicant to provide an
examination support document before the first Office action on the
merits if applicant designated more than ten representative claims
including all of the independent claims in the application for initial
examination. The Office received a substantial number of comments from
the public opposing this "representative claims" examination approach
and suggesting that the Office should simply adopt a threshold to
invoking the examination support document requirement based upon
whether an application contains more than a given number of independent
and total claims. The Office took those comments into consideration and
adopted a similar approach. This final rule requires an applicant to
submit an examination support document before the issuance of a first
Office action on the merits of an application to assist in the
patentability determination when the applicant presents more than five
independent claims or more than twenty-five total claims in an
application. This final rule also encourages applicant to submit all of
the claims that are patentably indistinct in one single application and
requires applicant to identify multiple applications that contain
patentably indistinct claims (same as the proposed rule). Therefore,
for each invention, an applicant is permitted to present up to fifteen
independent claims and seventy-five total claims via an initial
application and two continuation or continuation-in-part applications
without providing either an examination support document or
justification, as long as those applications are either prosecuted
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  973 

serially or contain patentably distinct claims. An examination support
document must include a preexamination search statement, a listing of
references deemed most closely related to the subject matter of each of
the claims, an identification of all of the claim limitations that are
disclosed in the references, a detailed explanation particularly
pointing out how each of the independent claims is patentable over the
cited references, and a showing of where each claim limitation finds
support under 35 U.S.C. 112, ¶ 1, in the application and any prior-
filed application. The examination support document will assist the
Office in the examination process and the determination of
patentability of the invention by providing the most relevant prior art
and other useful information.

   Under the proposed changes, about one percent of the applications
filed in fiscal year 2006 would have required either the cancellation
of one or more independent claims or an examination support document.
Furthermore, about eighty percent of the applications filed in fiscal
year 2006 would have required either a designation of dependent claims
for initial examination or an examination support document. Under the
changes being adopted in this final rule, less than eight percent of
the applications filed in fiscal year 2006 would have required either
the cancellation of one or more independent claims or an examination
support document. In addition, less than twenty-five percent of the
applications filed in fiscal year 2006 would have required either the
cancellation of one or more dependent claims or an examination support
document. However, by prosecuting an initial application and two
continuation applications serially, about ninety-five percent of the
applications filed in fiscal year 2006 would not have required either
the cancellation of any claims or an examination support document.

A. Changes to Practice for Continued Examination Filings

   The volume of continued examination filings (including both
continuing applications and requests for continued examination) and
duplicative applications that contain "conflicting" or patentably
indistinct claims, is having a crippling effect on the Office's ability
to examine "new" (i.e., non-continuing) applications. Continued
examination filings, other than divisional applications, as a
percentage of overall filings, has increased from about 11.4 percent in
fiscal year 1980, to about 18.9 percent in fiscal year 1990, to 21.9
percent in fiscal year 2000, to 29.4 percent in fiscal year 2006. The
cumulative effect of these continued examination filings is too often
to divert patent examining resources from the examination of new
applications disclosing new technology and innovations, to the
examination of applications that are a repetition of prior applications
that have already been examined and have either issued as patents or
become abandoned. In addition, when the continued examination process
fails to reach a final resolution, and when multiple applications
containing claims to patentably indistinct inventions are filed, the
public is left with an uncertainty as to what the set of patents
resulting from the initial application will cover. Thus, these
practices impose a burden on innovation both by retarding the Office's
ability to examine new applications and by undermining the function of
claims to notify the public as to what technology is or is not
available for use.

   Commentators have noted that an applicant's use of the unrestricted
continuing application and request for continued examination practices
may preclude the Office from ever finally rejecting an application or
even from ever finally allowing an application. See Mark A. Lemley and
Kimberly A. Moore, Ending Abuse of Patent Continuations, 84 B.U. L. Rev.
63, 64 (2004). The burden imposed by the repetitive filing of applications
(as continuing applications) on the Office (as well as on the public) is
not a recent predicament. See To Promote the Progress of Useful Arts,
Report of the President's Commission on the Patent System, at 17-18 (1966)
(recommending changes to prevent the repetitive filing of dependent (i.e.,
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  974 

continuing) applications). Unrestricted continued examination filings and
multiple applications containing patentably indistinct claims, however,
are now having such an impact on the Office's ability to examine new
applications that it is appropriate for the Office to clarify the
applicant's duty to advance applications to final action by placing
some conditions on the filing of multiple continuing applications,
requests for continued examination, and other multiple applications to
the same invention. See 35 U.S.C. 2(b) (authorizes the Office to
establish regulations, not inconsistent with law, which shall govern
the conduct of proceedings in the Office, and shall facilitate and
expedite the processing of patent applications). The changes in this
final rule will permit the Office to apply the patent examining
resources otherwise consumed by these applications to the examination
of new applications and thereby reduce the backlog of unexamined
applications.

   The Office also notes that not every application as filed
particularly points out and distinctly claims what the applicant
regards as his or her invention. For example, this may occur where the
applicant's attorney or agent has not adequately reviewed or revised
the application documents received from the applicant. Applicants
frequently file literal translations of foreign documents as
applications, resulting in problems with compliance with U.S. patent
law, such as the written description requirement, as well as problems
with formatting and presentation of the claims. In these situations,
examination of what applicants actually regard as their invention may
not begin until after one or more continued examination filings.
Applicants should not rely on an unlimited number of continued
examination filings to correct deficiencies in the claims and
disclosure that applicant or applicant's representative could have
corrected earlier. In addition, while only a small minority of
applications are a third or subsequent continuing application, it
appears that some applicants and practitioners have used multiple
continued examination filings as a strategy to delay the conclusion of
examination. The Office, however, considers such a strategy to be a
misuse of continued examination practice. Specifically, the Office
considers such a strategy to be inconsistent with an applicant's and
practitioner's duty under 37 CFR 10.18(b)(2)(i) not to submit an
application or other filing to cause unnecessary delay or needless
increase in the cost of prosecution before the Office. This misuse of
continued examination practice also prejudices the public by keeping
applications in pending status while awaiting developments in similar
or parallel technology and then later amending their applications to
cover these developments. The courts have permitted the addition of
claims, when supported under 35 U.S.C. 112, ¶ 1, to encompass products
or processes later discovered in the marketplace. See PIN/NIP, Inc. v.
Platt Chemical Co., 304 F.3d 1235, 1247, 64 U.S.P.Q.2d 1344, 1352 (Fed.
Cir. 2002). However, the practice of maintaining continuing
applications to delay the conclusion of examination for the purpose of
adding claims after such discoveries is inconsistent with the duty
under 37 CFR 10.18(b)(2)(i) not to submit filings to cause unnecessary
delay or needless increase in the cost of prosecution before the
Office.

   The Office, in light of its backlog and anticipated continued
increase in application filings, is making every effort to become more
efficient. Achieving greater efficiency requires the cooperation of
those who provide the input into the examination process, the
applicants and their representatives.

   In the Continuing Applications Proposed Rule, the Office proposed
to change the rules of practice to require that: (1) Any second or
subsequent continued examination filing (continuation or continuation-
in-part application or request for continued examination) include a
showing that the amendment, argument, or evidence could not have been
submitted prior to the close of prosecution after a single continuation
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  975 

or continuation-in-part application or request for continued
examination; and (2) multiple applications that have the same claimed
filing or priority date, substantial overlapping disclosure, a common
inventor, and a common assignee include either an explanation of how
the claims are patentably distinct, or a terminal disclaimer and
explanation of why patentably indistinct claims have been filed in
multiple applications.

   In response to the comments on the proposed changes to the
practices for continued examination filings, the Office has modified
these provisions relative to proposed changes. Under this final rules,
an applicant may instead file two continuation applications (or two
continuation-in-part applications, or one continuation application and
one continuation-in-part application), plus a request for continued
examination in any one of the initial application or two continuation
or continuation-in-part applications, without any justification. Any
additional continuation application, continuation-in-part application,
or request for continued examination, however, must be filed to obtain
consideration of an amendment, argument, or evidence, and be supported
by a showing as to why the amendment, argument, or evidence sought to
be entered could not have been previously submitted. This final rule
would also ease the burden of examining multiple applications that have
the same claimed filing or priority date, substantial overlapping
disclosure, a common inventor, and common assignee by requiring that
all patentably indistinct claims in such applications be submitted in a
single application absent good and sufficient reason.

   As discussed previously, the unrestricted continued examination
practice and the filing of multiple applications containing patentably
indistinct claims are impairing the Office's ability to examine new
applications without real certainty that these practices effectively
advance prosecution, improve patent quality, or serve the typical
applicant or the public. These changes to the rules in title 37 of the
CFR are intended to ensure that continued examination filings are used
efficiently to move applications forward. The Office expects that the
changes to the rules of practice in this final rule will: (1) Lead to
more focused and efficient examination, improve the quality of issued
patents, result in patents that issue faster, and give the public
earlier notice of what the patent claims cover; and (2) address the
growing practice of filing (by a common applicant or assignee) multiple
applications containing patentably indistinct claims.

   35 U.S.C. 111(a) and 120, respectively, permit an applicant to file
a nonprovisional application and to claim the benefit of a prior-filed
nonprovisional application. Similarly, 35 U.S.C. 363 and 365(c),
respectively, permit an applicant to file an international application
under Patent Cooperation Treaty (PCT) Article 11 and 35 U.S.C. 363 and,
if the international application designates the United States of
America, to claim the benefit of a prior-filed international
application designating the United States of America or a prior-filed
nonprovisional application. Similarly again, 35 U.S.C. 111(a) and
365(c) permit an applicant to file a nonprovisional application (filed
under 35 U.S.C. 111(a)) and to claim the benefit of a prior-filed
international application designating the United States of America
(under 35 U.S.C. 365(c)).

   35 U.S.C. 120 is generally considered the statutory basis for
continuing application practice. See Symbol Techs., Inc. v. Lemelson
Med., 277 F.3d 1361, 1365, 161 U.S.P.Q.2d 1515, 1518 (Fed. Cir. 2002)
(35 U.S.C. 120 and 121 form the backbone of modern continuation and
divisional application practice) (Symbol I). Nothing in 35 U.S.C. 120
or its legislative history suggests that the Office must or even should
permit an applicant to file an unlimited number of continuing
applications without any justification.

   The practice of filing "continuation applications" arose early in
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  976 

Office practice mainly as a procedural device to effectively permit the
applicant to amend an application after a rejection and receive an
examination of the "amended" (or new) application. See In re Bogese,
22 U.S.P.Q.2d 1821, 1824 (Comm'r Pats. 1991) (Bogese I). The concept of
a continuation application per se was first recognized in Godfrey v.
Eames, 68 U.S. (1 Wall.) 317, 325-26 (1864). See Bogese I, 22
U.S.P.Q.2d at 1824. 35 U.S.C. 120 is a codification of the continuation
application practice recognized in Godfrey v. Eames. See id. (citing In
re Hogan, 559 F.2d 595, 603, 194 U.S.P.Q. 527, 535 (C.C.P.A. 1977)).

   An applicant should understand, however, that he or she does not
have an unfettered right to file multiple continuing applications
without making a good faith attempt to claim the applicant's invention.
35 U.S.C. 2(b) gives the Director the inherent authority to promulgate
regulations to ensure that applicants prosecute applications in good
faith. Moreover, by assuming that an unlimited number of continuations
are available, applicants have slipped into unfocused practices in
prosecution that impede the Office's ability to conduct effective
examination. Such practices likewise cause delays in prosecution and
increase the cost of examination, both of which are contrary to an
applicant's duties under the rules of conduct before the Office set
forth in 37 CFR Part 10.

   The changes in this final rule do not set a per se limit on the
number of continuing applications. Nor are the changes intended to
address extreme cases of prosecution laches or to codify In re Bogese,
303 F.3d 1362, 1369, 64 U.S.P.Q.2d 1448, 1453 (Fed. Cir. 2002) (Bogese
II). Rather, the rules require that applicants who file multiple
continuing applications from the same initial application show that the
third and following applications, and any second or subsequent request
for continued examination in an application family, be filed to obtain
consideration of an amendment, argument, or evidence that could not
have been previously submitted.

   Likewise, the Office is putting conditions on request for continued
examination practice. 35 U.S.C. 132(b) provides for the request for
continued examination practice set forth in § 1.114. Unlike
continuation application practice, the request for continued
examination practice was recently added to title 35, United States
Code, in section 4403 of the American Inventors Protection Act of 1999
(AIPA). See Public Law 106-113, 113 Stat. 1501, 1501A-560 (1999). 35
U.S.C. 132(b) provides, inter alia, that the Office "shall prescribe
regulations to provide for the continued examination of applications
for patent at the request of the applicant." Nothing in 35 U.S.C.
132(b) or its legislative history suggests that the Office must or even
should permit an applicant to file an unlimited number of requests for
continued examination in an application. Therefore, this final rule
allows applicants to file their first request for continued examination
in an application family without any justification, but requires
applicants to justify the need for any further requests for continued
examination in light of the past prosecution.

   The Office appreciates that appropriate continued examination
practice permits an applicant to obtain further examination and advance
an application to final action. The unrestricted continued examination
practice, however, does not provide adequate incentives to assure that
the exchanges between an applicant and the examiner during the
examination process are efficient. The marginal value vis-a-vis
the patent examination process as a whole of exchanges between an
applicant and the examiner during the examination process tends to
decrease after each additional continued examination filing. The Office
resources absorbed by the examination of additional continued
examination filings are diverted away from the examination of new
applications, thus increasing the backlog of unexamined applications.

   The Office also appreciates that applicants sometimes use continued
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  977 

examination practice to obtain further examination rather than file an
appeal to avoid the delays that historically have been associated with
the appeal process. The Office, however, has taken major steps to
eliminate such delays. First, the Board of Patent Appeals and
Interferences (BPAI) has radically reduced the inventory of pending
appeals and appeal pendency during the last five fiscal years. Second,
the Office has adopted an appeal conference program to review the
rejections in applications in which an appeal brief has been filed. See
Manual of Patent Examining Procedure (MPEP) § 1207.01 (8th ed.
2001) (Rev. 5, August 2006). Third, the Office has also adopted a pre-
appeal brief conference program to permit an applicant to request that
a panel of examiners review the rejections in his or her application
prior to the filing of an appeal brief. See New Pre-Appeal Brief
Conference Program, 1296 Off. Gaz. Pat. Office 67 (July 12, 2005), and
Extension of the Pilot Pre-Appeal Brief Conference Program, 1303 Off.
Gaz. Pat. Office 21 (Feb. 7, 2006). These changes provide for a
relatively expeditious review of rejections in an application under
appeal. Thus, for an applicant faced with a rejection that he or she
feels is improper, the appeal process offers a more effective
resolution than seeking continued examination before the examiner.

   This final rule also provides that an applicant may file a
divisional application directed to each non-elected invention that has
not been examined if the prior-filed application is subject to a
requirement for restriction. The divisional application need not be
filed during the pendency of the application subject to a requirement
for restriction, as long as the copendency requirement of 35 U.S.C. 120
is met. This final rule also permits applicant to file two continuation
applications of a divisional application plus a request for continued
examination in the divisional application family, without any
justification. This final rule, however, does not permit a
"divisional" application to be filed if it is not the result of a
requirement for restriction in the prior-filed application (a so-called
"voluntary" divisional application). Such a "voluntary" divisional
application would be a continuation application, and subject to the
requirements for continuation applications, under the changes in this
final rule.

B. Changes to Practice for Examination of Claims in Patent Applications

   A number of patent applications contain a large number of claims,
which makes efficient and effective
examination of such applications problematic. The Office previously
requested comments in 1998 on a proposal to limit the number of
independent and total claims that would be examined in an application.
See Changes to Implement the Patent Business Goals, 63 FR 53497, 53506-
08 (Oct. 5, 1998), 1215 Off. Gaz. Pat. Office 87, 95-97 (Oct. 27,
1998). Specifically, in 1998, the Office requested comments on a
proposal to change the rules of practice to: (1) Limit the number of
total claims that will be examined (at one time) in an application to
forty; and (2) limit the number of independent claims that will be
examined (at one time) in an application to six. See Changes to
Implement the Patent Business Goals, 63 FR at 53506, 1215 Off. Gaz.
Pat. Office at 95. Under the 1998 proposal, if the applicant presented
more than forty total claims or six independent claims for examination
at one time, the Office would withdraw the excess claims from
consideration, and require the applicant to cancel those claims. See
id. The Office, however, ultimately decided not to proceed with a
proposed change to § 1.75 to place an absolute limit on the number
of total and independent claims that would be examined in an
application. See Changes to Implement the Patent Business Goals, 64 FR
53771, 53774-75 (Oct. 4, 1999), 1228 Off. Gaz. Pat. Office 15, 17-18
(Nov. 2, 1999).

   Applications which contain a large number of claims, however,
continue to absorb an inordinate amount of patent examining resources,
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  978 

as they are extremely difficult to properly process and examine. As a
result, contrary to the proposal under consideration in 1998, the
Claims Proposed Rule sought a change to the practice for examination of
claims that would not place a limit on the number of total or
independent claims that may be presented for examination in an
application. The Office proposed in the Claims Proposed Rule to revise
the practice for the examination of claims in an application as
follows: (1) The Office would give an initial examination only to the
representative claims, namely, all of the independent claims and only
the dependent claims that are expressly designated for initial
examination; and (2) if the number of representative claims is greater
than ten, the Office would require the applicant to help focus
examination by submitting an examination support document covering all
of the representative claims. See Changes to Practice for the
Examination of Claims in Patent Applications, 71 FR at 61-69, 1302 Off.
Gaz. Pat. Office at 1329-35.

   The Office received a substantial number of comments from the
public opposing the proposed "representative claims" examination
approach and suggesting that the Office should simply adopt a strategy
based upon whether an application contains more than a given number of
independent and total claims. As a result of the public comments on the
Claims Proposed Rule, the Office is not adopting the "representative
claims" examination approach.

   Instead, this final rule provides that if the number of independent
claims is greater than five or the number of total claims is greater
than twenty-five, the applicant must help focus examination by
providing an examination support document covering all of the claims in
the application (whether in independent or dependent form) before the
issuance of a first Office action on the merits of an application. An
applicant may present up to five independent claims and twenty-five
total claims in an initial application and each continuation or
continuation-in-part application without providing either an
examination support document or justification, as long as those
applications are either prosecuted serially or contain patentably
distinct claims. Thus, an applicant may present up to fifteen
independent claims and seventy-five total claims to a single patentably
distinct invention via an initial application and two continuation or
continuation-in-part applications that are filed and prosecuted
serially without providing either an examination support document or a
justification. Furthermore, an applicant may present up to fifteen
independent claims and seventy-five total claims via a divisional
application and its two continuation applications without providing
either an examination support document or a justification, if the
Office issues a restriction requirement in the prior-filed application.
Thus, the change to the practice for examination of claims adopted in
this final rule avoids placing a limit on the number of total or
independent claims that may be presented for examination in an
application, but does require an applicant who presents more than five
independent claims or more than twenty-five total claims in an
application to help focus examination by providing additional
information to the Office in an examination support document.

   If an applicant thinks fifteen independent claims or seventy-five
total claims to an invention is not sufficient, or if applicant wishes
to present more than five independent claims or twenty-five total
claims in any one application, then applicant has the option of
presenting as many independent and total claims as desired by providing
an examination support document. The examination support document will
assist the examiner in examining the application and determining the
patentability of a claimed invention by providing the most relevant
prior art and other useful information. Specifically, the examination
support document will assist the examiner in understanding the
invention and interpreting the claims before conducting a prior art
search. The examination support document will also assist the examiner
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  979 

in evaluating the prior art cited by the applicant and in determining
whether a claim limitation has support in the original disclosure and
in any prior-filed application. An examination support document must be
filed before the issuance of a first Office action on the merits of an
application. This is so that the information concerning the invention
will be available when the Office begins the examination process, and
thus avoids the piecemeal examination that would result if the
examination support document were not provided until after the first
Office action on the merits in the application.

C. Changes to Practice for Patent Applications Containing Patentably
Indistinct Claims

   The changes in this final rule also require that applicants provide
additional information to the Office when they file multiple
applications containing "conflicting" or patentably indistinct
claims. The rules of practice provided that "[w]here two or more
applications filed by the same applicant contain conflicting claims,
elimination of such claims from all but one application may be required
in the absence of good and sufficient reason for their retention during
pendency in more than one application." See 37 CFR 1.78(b) (2006).
   This final rule provides that an applicant must identify other
pending applications or patents that are commonly owned, have a common
inventor, and have a claimed filing or priority date within two months
of the claimed filing or priority date of the application. This
requirement does not supplant an applicant's duty to bring other
applications that are "material to patentability" of an application
(e.g., applications containing patentably indistinct claims) to the
attention of the examiner. See Dayco Prod., Inc. v. Total
Containment, Inc., 329 F.3d 1358, 1365-69, 66 U.S.P.Q.2d 1801, 1806-08
(Fed. Cir. 2003); see also MPEP § 2001.06(b). Thus, applicants are
cautioned against intentionally filing related applications outside of
this two-month window in an attempt to avoid the requirement to
identify other applications that are material to the patentability of
the application at issue. See Cargill, Inc. v. Canbra Foods, Ltd., 476
F.3d 1359, 1367-68, 81 U.S.P.Q.2d 1705, 1711 (Fed. Cir. 2007) (there is
no such thing as a good faith intent to deceive).

   This final rule provides that if there are other pending
applications or patents that are commonly owned and have a common
inventor, substantial overlapping disclosures, and the same claimed
filing or priority date, the Office will presume that the applications
contain patentably indistinct claims. In such a situation, the
applicant must either rebut this presumption by explaining how the
applications contain patentably distinct claims, or submit the
appropriate terminal disclaimers and explain why two or more pending
applications containing "conflicting" or patentably indistinct claims
should be maintained.

   The Office proposed a provision that if an application contains at
least one claim that is patentably indistinct from at least one claim
in one or more other applications or patents, the Office would (if
certain conditions were met) treat the independent claims and the
dependent claims designated for initial examination in the first
application and in each of such other applications or patents as
present in each of the applications for purposes of determining whether
the applicant would be required to submit an examination support
document. See Changes to Practice for the Examination of Claims in
Patent Applications, 71 FR at 64, 68, 1302 Off. Gaz. Pat. Office at
1331, 1334. This final rule provides that if multiple applications,
including applications having a continuity relationship, contain
patentably indistinct claims, the Office will treat the multiple
applications as a single application for purposes of determining
whether each of the multiple applications exceeds the five independent
claim and twenty-five total claim threshold. This provision is to
preclude an applicant from submitting multiple applications with claims
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  980 

that are patentably indistinct, each with five or fewer independent
claims or twenty-five or fewer total claims, for the purposes of
avoiding the requirement to submit an examination support document in
compliance with § 1.265. The Office, however, will not count the
claims in issued patents that contain patentably indistinct claims in
determining whether a pending application exceeds the five independent
claim and twenty-five total claim threshold. Nevertheless, those
patentably indistinct claims would still be subject to a double
patenting rejection.

D. Retention of First Action Final Practice and Changes in Second
Action Final Practice

   The Office has a first action final rejection practice under which
the first Office action in a continuing application, or in the
prosecution of a request for continued examination, may be made final
under certain circumstances. See MPEP § 706.07(b) and 706.07(h),
paragraph VIII. The Office proposed to eliminate this practice in
continuing applications under 35 U.S.C. 120, 121, or 365(c) and in
requests for continued examination under 35 U.S.C. 132(b) as
unnecessary in view of the proposed changes to continuing applications
and requests for continued examination practice that would permit an
applicant to file only one continuing application or request for
continued examination without any justification. See Changes to
Practice for Continuing Applications, Requests for Continued
Examination Practice, and Applications Containing Patentably Indistinct
Claims, 71 FR at 51, 1302 Off. Gaz. Pat. Office at 1321. This final
rule, however, provides that an applicant may file a request for
continued examination in either the initial application or either of
the two continuing applications without any justification. Therefore,
the Office is retaining its first action final rejection practice.
Applicants, however, are reminded that it would not be proper for the
Office to make a first Office action final in a continuing application
or after a request for continued examination if the application
contains material which was presented after final rejection or the
close of prosecution but was denied entry because: (1) new issues were
raised that required further consideration and/or search; or (2) the
issue of new matter was raised. See MPEP § 706.07(b) and 706.07(h).
Thus, applicants may guard against first action final rejection in a
continuing application or after a request for continued examination by
first seeking entry of the amendment, argument, or new evidence under
§ 1.116.

   The Office is also not changing the final action practice for the
Office action following a submission under § 1.129(a). See Changes
to the Transitional Procedures for Limited Examination After Final
Rejection in Certain Applications Filed Before June 8, 1995, 70 FR
24005 (May 6, 2005), 1295 Off. Gaz. Pat. Office 22 (Jun. 7, 2005)
(notice).

   The Office is revising second action final practice as it pertains
to second or subsequent Office actions that include a new double
patenting rejection (either statutory or obviousness-type double
patenting). Double patenting can arise when a party (or parties to a
joint research agreement under the Cooperative Research and Technology
Enhancement Act of 2004 (CREATE Act), Public Law 108-453, 118 Stat.
3596 (2004)) has filed multiple patent applications containing
patentably indistinct claims. The applicant (or the owner of the
application) is in a far better position than the Office to determine
whether there are one or more other applications or patents containing
patentably indistinct claims. For this reason, when an applicant files
multiple applications that are substantially the same, the applicant is
responsible for assisting the Office in resolving potential double
patenting situations, rather than taking no action until faced with a
double patenting rejection. Thus, if an Office action must include a
double patenting rejection, it is because the applicant has not met his
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  981 

or her responsibility to resolve the double patenting situation.
Therefore, the inclusion of a new double patenting rejection in a
second or subsequent Office action will not preclude the Office action
from being made final.

   The Office is also revising second action final practice as it
pertains to second or subsequent Office actions that include a new
ground of rejection necessitated by a showing that a claim element that
does not use the phrase "means for" or "step for" is nevertheless a
means- (or step-) plus-function claim element under 35 U.S.C. 112, ¶ 6.
The Office revised the examination guidelines for means- (or step-)
plus-function claim elements under 35 U.S.C. 112, ¶ 6, in June of 2000.
See Supplemental Examination Guidelines for Determining the
Applicability of 35 U.S.C. 112,  6, 65 FR 38510 (June 21,
2000), 1236 Off. Gaz. Pat. Office 98 (July 25, 2000) (2000 Examination
Guidelines); see also Interim Supplemental Examination Guidelines for
Determining the Applicability of 35 U.S.C. 112, ¶ 6, 64 FR
41392 (July 30, 1999). The 2000 Examination Guidelines for means- (or
step-) plus-function claim elements under 35 U.S.C. 112, ¶ 6, have been
incorporated into the MPEP. See MPEP sections 2181-2184 (8th ed. 2001)
(Rev. 5, August 2006). The 2000 Examination Guidelines set forth a
three-prong procedure for determining whether a claim element is a
means- (or step-) plus-function claim element under
35 U.S.C. 112, ¶ 6. See Supplemental Examination Guidelines for
Determining the Applicability of 35 U.S.C. 112, ¶ 6, 65 FR at
38514, 1236 Off. Gaz. Pat. Office at 101. The 2000 Examination
Guidelines provide that if a claim element does not include the phrase
"means for" or "step for" as provided in the first prong of the
Office, the applicant has two options: (1) Amend the claim to include
the phrase "means for" or "step for"; or (2) show that even though
the phrase "means for" or "step for" is not used, the claim element
is written as a function to be performed and does not recite sufficient
structure, material, or acts which would preclude application of 35
U.S.C. 112, ¶ 6. See Supplemental Examination Guidelines for
Determining the Applicability of 35 U.S.C. 112, ¶ 6, 65 FR at
38514, 1236 Off. Gaz. Pat. Office at 101. To avoid any unnecessary
delay in the prosecution of the application, an applicant who wishes to
have a claim element treated under 35 U.S.C. 112, ¶ 6, should either
use the phrase "means for" or "step for" in the claim element or
provide the necessary showing before the examination of the application
begins so that the examiner can properly interpret the claims in the
application and make a patentability determination. Furthermore,
because submitting a showing is tantamount to an amendment of the claim
to include the phrase "means for" or "step for," a showing will be
treated as an amendment of the claim for second action final purposes.
Thus, the inclusion of a new rejection in a second or subsequent Office
action necessitated by a showing submitted by applicant will not
preclude the Office from making the second or subsequent Office action
final.

   This final rule requires applicant to identify any claims in a
continuation-in-part application for which the subject matter is
disclosed in the manner provided by 35 U.S.C. 112, ¶ 1, in the prior-
filed application. See § 1.78(d)(3) and the discussion of §
1.78(d)(3). Any claim in the continuation-in-part application for which
the subject matter is not identified as being disclosed in the manner
provided by 35 U.S.C. 112, ¶ 1, in the prior-filed application will be
treated as entitled only to the actual filing date of the continuation-
in-part application, and will be subject to prior art based on the
actual filing date of the continuation-in-part application. To avoid
any unnecessary delay in the prosecution of the application, applicant
should provide the identification before the examiner begins to conduct
a prior art search. If the failure to identify the claims for which the
subject matter is disclosed in the manner provided by 35 U.S.C. 112, ¶
1, in the prior-filed application causes the examiner to include a new
prior art rejection in a second or subsequent Office action, the
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  982 

inclusion of the new prior art rejection will not preclude the Office
action from being made final.

   Therefore, the Office is revising second action final practice to
provide that a second or any subsequent Office action on the merits may
be made final, except when the Office action contains a new ground of
rejection that is not: (1) Necessitated by applicant's amendment of the
claims, including amendment of a claim to eliminate unpatentable
alternatives; (2) necessitated by applicant's providing a showing that
a claim element that does not use the phrase "means for" or "step
for" is written as a function to be performed and does not otherwise
preclude application of 35 U.S.C. 112, ¶ 6; (3) based on information
submitted in an information disclosure statement filed during the
period set forth in 37 CFR 1.97(c) with the fee set forth in 37 CFR
1.17(p); (4) based upon double patenting (statutory or obviousness-type
double patenting); or (5) necessitated by applicant's identification of
the claim or claims in a continuation-in-part application for which the
subject matter is disclosed in the manner provided by 35 U.S.C. 112, ¶
1, in the prior-filed application. The provision in MPEP § 904.02
that a search should cover the claimed subject matter and should also
cover the disclosed features which might reasonably be expected to be
claimed does not preclude an examiner from making the second or any
subsequent Office action on the merits final if the Office action
contains a new ground of rejection that was necessitated solely by
applicant's amendment of the claims to eliminate an unpatentable
alternative. An examiner cannot be expected to foresee whether or how
an applicant will amend a claim to overcome a rejection except in very
limited circumstances (e.g., where the examiner suggests how applicant
can overcome a rejection under 35 U.S.C. 112, ¶ 2).

II. Discussion of Specific Rules

   Title 37 of the Code of Federal Regulations, part 1, is amended as
follows:

   Section 1.17 (patent application and reexamination processing
fees): Section 1.17(f) is amended to include a reference to: (1)
Petitions under § 1.78(d)(1)(vi) for a continuing application not
provided for in §§ 1.78(d)(1)(i) through (d)(1)(v); and (2)
petitions under § 1.114(g) for a request for continued examination
not provided for in § 1.114(f). See discussion of §§ 1.78 and 1.114.

   Section 1.26 (refunds): Section 1.26(a) is amended to add the
phrase "[e]xcept as provided in § 1.117 or § 1.138(d)" to the
sentence "[a] change of purpose after the payment of a fee, such as
when a party desires to withdraw a patent filing for which the fee was
paid, including an application, an appeal, or a request for an oral
hearing, will not entitle a party to a refund of such fee." The
"change of purpose" provision of § 1.26(a) is directed to the
provision in 35 U.S.C. 42(d) authorizing a refund of "any fee paid by
mistake or any amount paid in excess of that required." 35 U.S.C.
42(d). Sections 1.117 and 1.138(d), however, are directed to the
provisions in 35 U.S.C. 41(a)(2) and (d)(1)(D) as amended by the
Consolidated Appropriations Act, 2005 (Consolidated Appropriations Act)
that permit the Office to develop procedures to refund search fees or
excess claims fees under certain limited conditions. See Public Law
108-447, 118 Stat. 2809 (2004). Section 1.26(b) is amended to change
"except as otherwise provided in this paragraph or in § 1.28(a)"
to "except as otherwise provided in this paragraph, or in §
1.28(a), § 1.117(b), or § 1.138(d)". This change is for
consistency with § 1.117(b) and § 1.138(d), which also specify
time periods within which certain refunds must be requested.

   Section 1.52 (language, paper, writing, margins, compact disc
specifications): Section 1.52(d)(2) is amended to refer to § 1.78(b)
concerning the requirements for claiming the benefit of a
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  983 

provisional application in a nonprovisional application. Section
1.52(d)(2) is also amended to provide that if a provisional application
is filed in a language other than English and the benefit of such
provisional application is claimed in a nonprovisional application, an
English language translation of the non-English language provisional
application will be required in the provisional application. This
change conforms § 1.52(d)(2) to the September 2005 revision to the
provisions in § 1.78 for claiming the benefit of a provisional
application. See Provisions for Claiming the Benefit of a Provisional
Application With a Non-English Specification and Other Miscellaneous
Matters, 70 FR 56119, 56121, 56128 (Sept. 26, 2005), 1299 Off. Gaz. Pat.
Office 142, 143-44, 150 (Oct. 25, 2005) (final rule). With respect to
claiming the benefit of a provisional application that was filed in a
language other than English, § 1.78(b)(5) now provides that: (1) If the
prior-filed provisional application was filed in a language other than
English and both an English-language translation of the prior-filed
provisional application and a statement that the translation is accurate
were not previously filed in the prior-filed provisional application,
applicant will be notified and given a period of time within which to file
the translation and the statement in the prior-filed provisional
application; (2) if the notice is mailed in a pending nonprovisional
application, a timely reply to such a notice must include the filing in
the nonprovisional application of either a confirmation that the
translation and statement were filed in the provisional application, or
an amendment or supplemental application data sheet withdrawing the
benefit claim, or the nonprovisional application will be abandoned; and
(3) the translation and statement may be filed in the provisional
application, even if the provisional application has become abandoned.

   Section 1.53 (application number, filing date, and completion of
application): Section 1.53(b) and (c)(4) are amended to refer to §
1.78, rather than specific paragraphs of § 1.78. Section 1.53(b)(1)
is also amended to provide that continuation or divisional applications
naming an inventor not named in the prior application must be filed
under § 1.53(b) (this provision was formerly in § 1.53(b)(2)),
and to reference § 1.78(a)(2) for the definition of a divisional
application and § 1.78(a)(3) for the definition of a continuation
application. Section 1.53(b)(2) is amended to reference §
1.78(a)(4) for the definition of a continuation-in-part application.

   Section 1.75 (claims): Section 1.75(b) is amended to provide for
the revised practice for the examination of claims in an application.
Section 1.75(b) (introductory text) provides for the requirements of a
dependent claim. Section 1.75(b)(1) provides for the five independent
claim and twenty-five total claim threshold for invoking the
examination support document requirement. Section 1.75(b)(2) provides
for claims in dependent form that are effectively independent claims.
Section 1.75(b)(3) provides for situations in which an examination
support document has not been provided in an application that exceeds
the five independent claim and twenty-five total claim threshold.
Section 1.75(b)(4) provides that the total number of claims present in
all of the copending commonly owned applications that contain
patentably indistinct claims may not exceed the five independent claim
and twenty-five total claim threshold. Section 1.75(b)(5) provides that
claims withdrawn from consideration will not, unless they are
reinstated or rejoined, be taken into account in determining whether an
application exceeds the five independent claim and twenty-five total
claim threshold. Section 1.75(c) is amended to provide that multiple
dependent claims and claims depending from a multiple dependent claim
will be considered to be that number of claims to which direct
reference is made in the multiple dependent claim for claims counting
purposes.

   Section 1.75(b) (introductory text) is amended to set forth the
existing provisions concerning dependent claims in § 1.75(c),
namely, that "[o]ne or more claims may be presented in dependent form,
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  984 

referring back to and further limiting another claim or claims in the
same application." Section 1.75(b) (introductory text) is also amended
to clarify that a dependent claim is required to incorporate by
reference all the limitations of the previous claim to which it refers
and to specify a further limitation of the subject matter of the
previous claim. See Pfizer Inc. v. Ranbaxy Labs. Ltd., 437 F.3d 1284,
1292, 79 U.S.P.Q.2d 1583, 1589-90 (Fed. Cir. 2006) (a dependent claim
is required to include all the limitations of the claim from which it
depends and the failure to incorporate by reference all the limitations
is a violation of 35 U.S.C. 112, ¶ 4, and renders the dependent claim
invalid).

   Section 1.75(b)(1) provides that an applicant must file an
examination support document in compliance with § 1.265 that covers
each claim (whether in independent or dependent form) before the
issuance of a first Office action on the merits of the application if
the application contains or is amended to contain more than five
independent claims or more than twenty-five total claims. Section
1.75(b)(1) also provides that the application may not contain or be
amended to contain more than five independent claims or more than
twenty-five total claims if an examination support document in
compliance with § 1.265 has not been filed before the issuance of a
first Office action on the merits of an application. The examination
support document in compliance with § 1.265 is required to be filed
before the issuance of the first Office action on the merits of the
application because the information provided by the applicant in the
examination support document will assist the examiner in understanding
the invention of the application, determining the effective filing date
of each claim, interpreting the claims before a prior art search,
understanding the state of the art and the most closely related prior
art cited by the applicant, and determining the patentability of the
claims. Applicant is permitted to present more than five independent
claims or more than twenty-five total claims in a continuing
application, if the applicant files an examination support document in
compliance with § 1.265 before the first Office action on the
merits of the continuing application, regardless of whether an
examination support document has been filed in the prior-filed
application.

   Claims withdrawn from consideration under §§ 1.141 through
1.146 or § 1.499 as drawn to a non-elected invention or inventions
are not taken into account in determining whether an application
exceeds this five independent claim and twenty-five total claim
threshold. See § 1.75(b)(5) and discussion of § 1.75(b)(5).

   Section 1.75(b)(2) concerns claims in dependent form that are
effectively independent claims. Section 1.75(b)(2) provides that a
claim that refers to another claim but does not incorporate by
reference all the limitations of the claim to which such claim refers
will be treated as an independent claim for fee calculation purposes
under § 1.16 (or § 1.492) and for purposes of § 1.75(b).
The Office must treat such claims as independent claims because 35
U.S.C. 112, ¶ 4, provides (inter alia) that a dependent claim "shall
be construed to incorporate by reference all the limitations of the
claim to which it refers." See 35 U.S.C. 112, ¶ 4. For examples of
such claims, see: In re Thorpe, 777 F.2d 695, 696, 227 U.S.P.Q. 964,
965 (Fed. Cir. 1985) ("product by process" claim 44); In re Kuehl,
475 F.2d 658, 659, 177 U.S.P.Q. 250, 251 (C.C.P.A. 1973) (claim 6); and
Ex parte Rao, 1995 WL 1747720, *1 (BPAI 1998) (claim 8). Section
1.75(b)(2) also provides that a claim that refers to a claim of a
different statutory class of invention will be treated as an
independent claim for fee calculation purposes under § 1.16 (or
§ 1.492) and for purposes of § 1.75(b). For examples of such
claims, see: Thorpe, 777 F.2d at 696, 227 U.S.P.Q. at 965 ("product by
process" claim 44); Ex parte Porter, 25 U.S.P.Q.2d 1144, 1145 (BPAI
1992) (claim 6); and Ex parte Blattner, 2 U.S.P.Q.2d 2047, 2047-48
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  985 

(BPAI 1987) (claim 14).

   Section 1.75(b)(3) provides that the applicant will be notified if
the application contains or is amended to contain more than five
independent claims or more than twenty-five total claims but the
applicant has not complied with the requirements set forth in §
1.75(b)(1) or 1.75(b)(4) (e.g., an examination support document in
compliance with § 1.265 has been omitted). Section 1.75(b)(3) also
provides that if the non-compliance appears to have been inadvertent,
the notice will set a two-month time period that is not extendable
under § 1.136(a) within which, to avoid abandonment of the
application, the applicant must comply with the requirements set forth
in § 1.75(b). Again, claims withdrawn from consideration under
§§ 1.141 through 1.146 or § 1.499 as drawn to a non-elected
invention or inventions are not taken into account in determining
whether an application exceeds this five independent claim and twenty-
five total claim threshold. See § 1.75(b)(5) and discussion of
§ 1.75(b)(5).

   If a notice under § 1.75(b)(3) is mailed before the first
Office action on the merits of an application and it appears that the
omission of an examination support document was inadvertent, the notice
will set a two-month time period within which the applicant must: (1)
File an examination support document in compliance with § 1.265
that covers each claim (whether in independent or dependent form); or
(2) amend the application such that it contains no more than five
independent claims and no more than twenty-five total claims. Section
1.75(b)(3) provides that this two-month time period is not extendable
under § 1.136(a) and that the failure to reply to such a notice
will result in abandonment of the application. Due to the increase in
patent pendency that would result from the routine granting of
extensions in the situation in which an application contains or is
amended to contain more than five independent claims or more than
twenty-five total claims but the applicant has not complied with the
requirements set forth in § 1.75(b)(1) or 1.75(b)(4) (e.g., an
examination support document in compliance with § 1.265 has been
omitted), the Office is limiting extensions of this two-month time
period in § 1.75(b)(3) to those for which there is sufficient cause
(§ 1.136(b)).

   Once the Office issues a notice under § 1.75(b)(3), the
applicant may not simply submit a suggested alternative requirement for
restriction under § 1.142(c), but instead must: (1) File an
examination support document in compliance with § 1.265 that covers
each claim (whether in independent or dependent form); or (2) amend the
application such that it contains no more than five independent claims
and no more than twenty-five total claims.

   If an examination support document in compliance with § 1.265
as required under § 1.75(b) was not filed before the issuance of a
first Office action on the merits of an application, an amendment that
results in the application containing more than five independent claims
or more than twenty-five total claims will be treated as non-
responsive. Specifically, if the non-compliance with § 1.75(b)
appears to have been inadvertent, the Office would give the applicant a
two-month time period that is not extendable under § 1.136(a)
within which to provide an amendment that does not result in the
application containing more than five independent claims or more than
twenty-five total claims. See § 1.135(c) ("[w]hen reply by the
applicant is a bona fide attempt to advance the application to final
action, and is substantially a complete reply to the non-final Office
action, but consideration of some matter or compliance with some
requirement has been inadvertently omitted, applicant may be given a
new time period for reply under § 1.134 to supply the omission.").

   Section 1.75(b)(4) provides for the situation in which: (1) A
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  986 

nonprovisional application contains at least one claim that is
patentably indistinct from at least one claim in one or more other
pending nonprovisional applications; and (2) the nonprovisional
application and the one or more other pending nonprovisional
applications either are owned by the same person or are subject to an
obligation of assignment to the same person. In this situation, §
1.75(b)(4) provides that the Office will treat the claims in the first
nonprovisional application and in each of such other pending
nonprovisional applications as being present in each of the pending
nonprovisional applications for purposes of § 1.75(b). That is, if
the conditions specified in § 1.75(b)(4) are present, the Office
will treat each such nonprovisional application as having the total
number of claims present in all of such applications (and not just the
claim that is patentably indistinct) for purposes of determining
whether an examination support document is required by § 1.75(b).
For example: If application "A" contains only one claim that is
patentably indistinct from the claims in application "B", application
"A" and application "B" are owned by the same company, and each
application contains three independent claims and twenty total claims,
the Office will treat each application as having six independent claims
and forty total claims in determining whether each application exceeds
the five independent claim and twenty-five total claim threshold set
forth in § 1.75(b). In this example, an examination support
document would be required in each application before the issuance of a
first Office action on the merits of the application. To avoid the
provisions of § 1.75(b)(4), applicant may present all of the
patentably indistinct claims in application "B" by canceling the
patentably indistinct claim from application "A". As discussed
previously, § 1.75(b)(4) is to preclude an applicant from
submitting multiple applications to the same subject matter (with
claims that are patentably indistinct), each with five or fewer
independent claims or twenty-five or fewer total claims, for the
purpose of avoiding the requirement to submit an examination support
document in compliance with § 1.265.

   Under § 1.75(b)(4), the Office will count the claims in the
copending nonprovisional applications containing patentably indistinct
claims (including applications having a continuity relationship) but
not in issued patents containing patentably indistinct claims, in
determining whether each such application exceeds the five independent
claim or twenty-five total claim threshold for invoking the examination
support document requirement. An applicant may present up to five
independent claims and twenty-five total claims in an initial
application and each continuing application, provided that continuing
applications that contain patentably indistinct claims are not
prosecuted in parallel with the initial application or each other.
Thus, an applicant may present up to fifteen independent claims and
seventy-five total claims to a single invention via an initial
application and two continuing applications that are filed and
prosecuted serially without providing either an examination support
document or a justification. In addition, an applicant may prosecute a
divisional application (an application containing claims that are
patentably distinct from the claims to the invention prosecuted in the
initial application) in parallel with the initial application or its
continuation or continuation-in-part applications without the claims in
the divisional application being taken into account in determining
whether the initial application or its continuation or continuation-in-
part applications exceed the five independent claim or twenty-five total
claim threshold for invoking the examination support document requirement.

   Section 1.75(b)(4) also provides that the total number of claims
present in all of such copending nonprovisional applications containing
patentably indistinct claims may not exceed five independent claims or
twenty-five total claims unless an examination support document in
compliance with § 1.265 is filed before the issuance of a first
Office action on the merits of the application containing patentably
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  987 

indistinct claims.

   The provisions of § 1.75(b)(4) do not depend upon the relative
filing dates of the nonprovisional application and the one or more
other nonprovisional applications. The provisions of § 1.75(b)(4)
apply regardless of whether the filing dates of the applications are
the same, are within two months of each other (cf. § 1.78(f)(1) and
(f)(2)), or are not within two months of each other. In other words,
the provision of § 1.75(b)(4) does not depend on the filing dates
of the respective applications. In addition, the provisions of §
1.75(b)(4) are applicable regardless of any continuity relationship
between the applications (e.g., the provision applies if a parent
application is still pending at the time the child application is under
examination). For applications having a continuity relationship, the
prior application must be pending at the time the continuing
application is filed. See 35 U.S.C. 120 (requires that a continuing
application be filed before the patenting or abandonment of or
termination of proceedings on the prior application). The Office,
however, will treat the application as no longer pending for purposes
of § 1.75(b)(4) if: (1) A notice of allowance is issued, unless the
application is withdrawn from issue (§ 1.313); (2) the Office
recognizes the application is abandoned; (3) a notice of appeal to the
U.S. Court of Appeals for the Federal Circuit under 35 U.S.C. 141 is
filed, unless the appeal is terminated; or (4) a civil action under 35
U.S.C. 145 or 146 is commenced, unless the civil action is terminated.

   Section 1.75(b)(4) as adopted in this final rule differs from
proposed § 1.75(b)(4) in that it does not provide that the Office
may require elimination of the patentably indistinct claims from all
but one of the applications. Such a provision would be a substantial
duplicate of § 1.78(f)(3) as adopted in this final rule, which
provides that if the conditions set forth in § 1.75(b)(4) exist,
the Office may require elimination of the patentably indistinct claims
from all but one of the applications in the absence of good and
sufficient reason for there being two or more such nonprovisional
applications containing patentably indistinct claims.

   Section 1.75(b)(5) provides that claims withdrawn from
consideration under §§ 1.141 through 1.146 or § 1.499 as
drawn to a non-elected invention or inventions will not, unless they
are reinstated or rejoined, be taken into account in determining
whether an application exceeds the five independent claim and twenty-
five total claim threshold set forth in §§ 1.75(b)(1), (b)(3),
and (b)(4). Thus, claims withdrawn from consideration as the result of
an Office-initiated requirement under § 1.142, 1.146, or 1.499
(regardless of whether the election is with or without traverse), or as
the result of the acceptance of a suggested restriction requirement
under § 1.142(c), are not taken into account in determining whether
an application exceeds the five independent claim and twenty-five total
claim threshold. In addition, claims withdrawn from consideration in an
application (e.g., the initial application) as the result of either an
Office-initiated requirement under § 1.142, 1.146, or 1.499, or the
acceptance of a suggested restriction requirement under § 1.142(c),
are not taken into account in determining whether a copending
application (e.g., a continuation application of the initial
application) contains a claim that is patentably indistinct from a
claim in such application for purposes of § 1.75(b)(4).

   Section 1.142(c) as adopted in this final rule provides that the
applicant may submit a suggested requirement for restriction if two or
more independent and distinct inventions are claimed in the
application. Section 1.142(c) further provides that any suggested
requirement for restriction must be filed before the earlier of the
first Office action on the merits or any Office action that contains a
requirement to comply with the requirement of unity of invention under
PCT Rule 13 or a requirement for restriction (including an election of
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  988 

species) under 35 U.S.C. 121 in the application. Section 1.142(c)
provides that any suggested requirement for restriction must also be
accompanied by an election without traverse of an invention to which
there are no more than five independent claims and no more than twenty-
five total claims, and identify the claims to the elected invention. If
the applicant submits a suggested restriction requirement, the
suggested restriction requirement is accepted, and there are five or
fewer independent claims and twenty-five or fewer total claims to the
elected invention (as required by § 1.142(c)), the Office will
simply treat the non-elected claims as withdrawn from consideration and
proceed to act on the application (assuming the application is
otherwise in condition for action). The Office action will set out the
requirement for restriction under § 1.141(a), e.g., in the manner
that an Office action on the merits would contain a written record of a
requirement for restriction previously made by telephone. See MPEP
section 810. Applicants are reminded, however, that the Office may
refund excess claims fees only for claims that are canceled prior to
the issuance of a first Office action on the merits of the application.
See 35 U.S.C. 41(a)(2) ("[t]he Director may, by regulation, provide
for a refund of any part of the fee specified in [35 U.S.C. 41(a)(2)]
for any claim that is canceled before an examination on the merits, as
prescribed by the Director, has been made of the application under [35
U.S.C.] 131").

   If the applicant files a suggested requirement for restriction in
an application containing more than five independent claims or more
than twenty-five total claims, the applicant will also be notified if
the suggested restriction requirement is not accepted. The refusal to
accept a suggested requirement for restriction may result in the
examiner making a different restriction requirement or making no
restriction requirement.

   If the examiner makes a restriction requirement (which includes an
election of species requirement) different from the suggested
restriction requirement, the applicant will be notified of the
restriction requirement. The applicant will be given a two-month time
period that is not extendable under § 1.136(a) within which the
applicant must make an election consistent with the Office-issued
restriction requirement in order to avoid abandonment of the
application. Once the Office issues a requirement for restriction, the
applicant may not simply submit a suggested alternative requirement for
restriction under § 1.142(c). Instead, the applicant must make an
election (with or without traverse) responsive to the Office-issued
requirement for restriction. If an application subject to an Office-
issued requirement for restriction contains more than five independent
claims or more than twenty-five total claims, the reply must also
either: (1) Amend the application to contain no more than five
independent claims and no more than twenty-five total claims to the
elected invention and/or species; or (2) include an examination support
document in compliance with § 1.265 that covers
each claim (whether in independent or dependent form) pending in the
application.

   If the examiner does not make a restriction requirement, the
applicant will simply be given a notice under § 1.75(b)(3). That
notice will set a two-month time period that is not extendable under
§ 1.136(a) within which, to avoid abandonment of the application,
the applicant must: (1) Amend the application to contain no more than
five independent claims and no more than twenty-five total claims; or
(2) file an examination support document in compliance with § 1.265
that covers each claim (whether in independent or dependent form)
pending in the application. See § 1.75(b)(3).

   Section 1.75(b)(5) also provides that claims reinstated (e.g., as a
result of a request for reconsideration of the requirement) or rejoined
(e.g., upon allowance of a generic claim) in the application are taken
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  989 

into account in determining whether an application exceeds the five
independent claim and twenty-five total claim threshold. As discussed
previously, unless an examination support document in compliance with
§ 1.265 was filed before the issuance of a first Office action on
the merits of an application, the application must remain at or under
the five independent claim and twenty-five total claim threshold.
Therefore, if an examination support document was not filed before the
issuance of a first Office action on the merits of the application, and
the reinstatement or rejoinder of non-elected claims results in the
application containing more than five independent claims or more than
twenty-five total claims, the Office will give the applicant a two-
month time period within which to amend the application to contain five
or fewer independent claims and twenty-five or fewer total claims. See
§ 1.75(b)(3). This two-month time period is not extendable under
§ 1.136(a). The failure to file such an amendment will result in
abandonment of the application.

   Since claims reinstated or rejoined in the application are taken
into account in determining whether an application exceeds the five
independent claim and twenty-five total claim threshold, applicants
cannot rely upon a requirement for restriction to avoid submitting an
examination support document before the issuance of a first Office
action on the merits of an application. This is especially true where:
(1) The applicant traverses the requirement for restriction; (2) the
requirement for restriction may be conditional, such as a requirement
for election of species in an application that contains a claim that is
generic to all of the claimed species (hereafter "generic claim")
(see MPEP section 809), or a requirement for restriction in an
application that contains a linking claim (e.g., a subcombination claim
linking plural combinations); or (3) the applicant plans to request
rejoinder of the claims to the non-elected invention (see MPEP §
821.04 et seq.). Thus, applicants are advised to file an examination
support document in the application before the first Office action on
the merits if they anticipate the occurrence of any of the
aforementioned three situations. Furthermore, applicants cannot rely
upon the requirement for restriction to file a divisional application
because the Office will withdraw the requirement for restriction,
including an election of species, if the non-elected claims are
reinstated or rejoined.

   Applicant is not permitted to file a divisional application of a
prior-filed application that is no longer subject to a restriction
requirement. Under § 1.78(a)(2) and 1.78(d)(1)(ii), the prior-filed
application to which a divisional application claims the benefit must
be subject to a requirement to comply with the requirement of unity of
invention under PCT Rule 13 or a requirement for restriction under 35
U.S.C. 121. Sections 1.78(a)(2) and 1.78(d)(1)(ii) also require a
divisional application to contain only claims directed to a non-elected
invention that has not been examined.

   For an application that contains a generic claim in which a
requirement for an election of species has been made, applicants should
conclude prosecution (in the initial application and its continuation
or continuation-in-part applications), including exhaustion of any
available appeals, as to the generic claim before ever filing a
divisional application to a non-elected species. If applicant no longer
wants to pursue the generic claim, applicant may file a divisional
application directed to a non-elected species. If an applicant files a
divisional application directed to a non-elected species, applicant
should: (1) Cancel the claims to the non-elected species and the
generic claim in the prior-filed application before rejoinder or
reinstatement occurs; (2) not present the non-elected claims and the
generic claim in any continuation or continuation-in-part application
of the initial application; and (3) not present the generic claim in
the divisional application or any other continuation application of the
divisional application (because the generic claim has been examined in
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  990 

the initial application and it is patentably indistinct from the claims
of the non-elected species).

   When an application contains a generic claim and the examiner makes
a provisional restriction requirement, requiring an election of species
for initial search and examination purposes, the applicant must elect a
single species. (The requirement is provisional because the restriction
will be withdrawn upon allowance of the generic claim.) The examiner
will determine the patentability of the elected species and generic
claim. Upon the allowance of the generic claim, the provisional
restriction requirement will be withdrawn, as explained above. The
claims of the non-elected species then will be rejoined. The Office
will count the rejoined claims together with the other pending claims
to determine whether the application exceeds the five independent claim
and twenty-five total claim threshold set forth § 1.75(b)(1). See
§ 1.75(b)(5). If the application contains more than five
independent claims and twenty-five total claims (counting the rejoined
claims) and the applicant did not file an examination support document
in compliance with § 1.265 before the issuance of a first Office
action on the merits in the application, then the applicant must amend
the application to contain no more than five independent claims and no
more than twenty-five total claims. See § 1.75(b)(1). Therefore,
applicants cannot rely upon a provisional requirement for restriction
to avoid submitting an examination support document before the issuance
of the first Office action on the merits in the application.

   Furthermore, upon the allowance of a claim that is generic to all
of the claimed species (either in the initial application or any
continuing application), the application is no longer subject to a
requirement to comply with the requirement of unity of invention under
PCT Rule 13 or a requirement for restriction under 35 U.S.C. 121. In
such a situation, if applicant had filed a "divisional" application
to the non-elected species following the provisional restriction in the
prior-filed application, that "divisional" application would no
longer be proper under §§ 1.78(a)(2) and 1.78(d)(1)(ii). This
is because the "divisional" application would not meet the conditions
set forth in §§ 1.78(a)(2) and 1.78(d)(1)(ii). If applicant
wishes to maintain the application, then applicant must delete or
correct the benefit claim to indicate that the application is a
continuation application, provided the requirements set forth in §
1.78(d)(1)(i) can be satisfied. In such case, the Office will treat the
application as one of the two continuation applications of the prior-filed
application permitted under § 1.78(d)(1)(i). But, if the prior-filed
application already has its benefit claimed in two other nonprovisional
applications, applicant must delete the benefit claim in the
application. See § 1.78(d)(1)(i). Therefore, applicant is cautioned
not file a divisional application drawn to a non-elected species if a
generic claim is pending in the initial application or any continuing
application of the initial application and could be found allowable.

   When an application subject to an election of species is allowed
with no claim that is generic to all of the claimed species being found
to have been allowable, the applicant will be notified that the Office
considers the requirement that the application be restricted to a
single species to be final. At that point, the applicant may cancel the
claims to the non-elected species and the generic claim in the prior-
filed application and file a divisional application in accordance with
§ 1.78(d)(1)(ii) to the non-elected species. However, if the
applicant later files a continuing application of the initial
application or the divisional application presenting one or more
generic claims in such later application, the Office will consider the
requirement that the initial application be restricted to a single
species to no longer be final. Should that occur, the "divisional"
application directed to the non-elected species would not be proper
under §§ 1.78(a)(2) and 1.78(d)(1)(ii) for the reasons
explained above. Thus, applicants should conclude prosecution,
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  991 

including exhaustion of any available appeals, as to the generic claim
before ever filing a divisional application to a non-elected species.
In other words, applicants cannot rely upon a requirement that an
application containing a generic claim will be restricted to a single
species to permit filing one or more divisional applications until the
applicant has concluded prosecution with respect to any generic claims.

   Under the Office's rejoinder practice, an applicant may request
rejoinder of claims to a non-elected invention that depend from or
otherwise require all the limitations of an allowable claim. See MPEP
§ 821.04 et seq. This "rejoinder" practice was developed in light
of the Federal Circuit's decisions in In re Ochiai, 71 F.3d 1565, 37
U.S.P.Q.2d 1127 (Fed. Cir. 1995), and In re Brouwer, 77 F.3d 422, 37
U.S.P.Q.2d 1663 (Fed. Cir. 1996), and the enactment of 35 U.S.C. 103(b)
in The Biotechnology Process Act of 1995 (Pub. L. 104-41, 109 Stat. 351
(1995)). See Guidance on Treatment of Product and Process Claims in
light of In re Ochiai, In re Brouwer, and 35 U.S.C. 103(b), 1184 Off.
Gaz. Pat. Office 86 (Mar. 26, 1996). Applicants may retain claims to a
non-elected invention in an application for possible rejoinder in the
event of the allowance of a claim to the elected invention. However, as
discussed previously, the Office will count rejoined claims towards the
five independent claim and twenty-five total claim threshold in
§ 1.75(b)(1). See § 1.75(b)(5). If applicant cancels all of the
claims directed to a non-elected invention before rejoinder occurs and
files a divisional application, the restriction requirement will not be
withdrawn and the non-elected process claims that are now canceled will
not be rejoined. This will preserve applicant's rights under 35 U.S.C.
121 and § 1.78(d)(1)(ii). See MPEP § 821.04(b).

   Section 1.75(c) is amended to provide for multiple dependent claims
only. Dependent claims are now provided for in § 1.75(b). Section
1.75(c) further provides that multiple dependent claims and claims that
depend from a multiple dependent claim will be considered to be that
number of claims to which direct reference is made in the multiple
dependent claim for purposes of § 1.75(b) (as well as § 1.16 or
1.492).

   The changes to § 1.75 are applicable to any application
(including any reissue application) filed under 35 U.S.C. 111(a) on or
after November 1, 2007, and to any nonprovisional application entering
the national stage after compliance with 35 U.S.C. 371 on or after
November 1, 2007, as well as to any application (including any reissue
application) in which a first Office action on the merits (§ 1.104)
was not mailed before November 1, 2007. The Office will provide an
applicant who filed a nonprovisional application under 35 U.S.C. 111(a)
before November 1, 2007, or a nonprovisional application that entered
the national stage after compliance with 35 U.S.C. 371 before November
1, 2007, and who would be affected by the changes in the final rule,
with an opportunity to submit: (1) An examination support document
under § 1.265; (2) a new set of claims such that the application
contains five or fewer independent claims and twenty-five or fewer
total claims; or (3) a suggested restriction requirement under §
1.142(c). Specifically, the Office will issue a notice setting a two-
month time period that is extendable under § 1.136(a) or (b) within
which the applicant must exercise one of these options in order to
avoid abandonment of the application. The Office, however, may combine
such a notice with a requirement for restriction, in which case the
applicant must make an election responsive to the restriction
requirement and, if there are more than five independent claims or more
than twenty-five total claims drawn to the elected invention, the
applicant must also: (1) File an examination support document in
compliance with § 1.265; or (2) amend the application such that it
contains five or fewer independent claims and twenty-five or fewer
total claims drawn to the elected invention. Thus, if such a notice is
combined with a requirement for restriction, the applicant does not
have the option of replying to such notice with a suggested restriction
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  992 

requirement under § 1.142(c).

   With respect to the application of the changes to § 1.75 in
this final rule to a reissue application, an examination support
document under § 1.265 will not be required pursuant to § 1.75(b)
in a reissue application if the reissue application does not
seek to change the claims in the patent being reissued. A change in the
claims in the patent being reissued is sought either by an amendment to
or addition of a claim or claims, or by an amendment to the
specification which changes a claim or claims.

   Section 1.76 (application data sheet): Section 1.76(b)(5) is
amended to refer to §§ 1.78(b)(3) and (d)(3) for consistency
with the changes to § 1.78. Section 1.76(b)(5) is also amended to
clarify that the relationship of the applications is not required for a
benefit claim under 35 U.S.C. 119(e) and to delete "the status
(including patent number if available)". Such information is not
necessary for claiming the benefit of a prior-filed application under
35 U.S.C. 119(e), 120, 121, or 365(c).

   Section 1.78 (claiming benefit of earlier filing date and cross-
references to other applications): Section 1.78 is reorganized as
follows: (1) § 1.78(a) defines "continuing application",
"continuation application", "divisional application", and
"continuation-in-part application"; (2) § 1.78(b) contains
provisions relating to claims under 35 U.S.C. 119(e) for the benefit of
a prior-filed provisional application; (3) § 1.78(c) contains
provisions relating to delayed claims under 35 U.S.C. 119(e) for the
benefit of a prior-filed provisional application; (4) § 1.78(d)
contains provisions relating to claims under 35 U.S.C. 120, 121, or
365(c) for the benefit of a prior-filed nonprovisional or international
application; (5) § 1.78(e) contains provisions relating to delayed
claims under 35 U.S.C. 120, 121, or 365(c) for
the benefit of a prior-filed nonprovisional or international
application; (6) § 1.78(f) contains provisions relating to
applications naming at least one inventor in common and containing
patentably indistinct claims; (7) § 1.78(g) contains provisions
relating to applications or patents under reexamination naming
different inventors and containing patentably indistinct claims; (8)
§ 1.78(h) contains provisions pertaining to the treatment of
parties to a joint research agreement under the CREATE Act; and §
1.78(i) provides that the time periods set forth in § 1.78 are not
extendable.

   Section 1.78(a)(1) defines a "continuing application" as a
nonprovisional application or international application designating the
United States of America that claims the benefit under 35 U.S.C. 120,
121, or 365(c) of a prior-filed nonprovisional application or
international application designating the United States of America.
Section 1.78(a)(1) provides that an application that does not claim the
benefit under 35 U.S.C. 120, 121, or 365(c) of a prior-filed
application, is not a continuing application even if the application
claims the benefit under 35 U.S.C. 119(e) of a provisional application,
claims priority under 35 U.S.C. 119(a)-(d) or 365(b) to a foreign
application, or claims priority under 35 U.S.C. 365(a) or (b) to an
international application designating at least one country other than
the United States of America. A continuing application must be a
continuation application, a divisional application, or a continuation-
in-part application. See MPEP § 201.11 ("To specify the
relationship between the applications, applicant must specify whether
the application is a continuation, divisional, or continuation-in-part
of the prior application. Note that the terms are exclusive. An
application cannot be, for example, both a continuation and a
divisional or a continuation and a continuation-in-part of the same
application.").

Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  993 

   Section 1.78(a)(2) defines a "divisional application" as a
continuing application that discloses and claims only an invention or
inventions that were disclosed and claimed in a prior-filed
application, but were subject to a requirement to comply with the
requirement of unity of invention under PCT Rule 13 or a requirement
for restriction under 35 U.S.C. 121 in the prior-filed application, and
were not elected for examination and were not examined in any prior-
filed application. This definition is more precise than the definition
of "divisional application" currently found in MPEP § 201.06.
MPEP § 201.06 defines a divisional application as an application
for an independent and distinct invention, which discloses and claims
only subject matter that was disclosed in the prior-filed
nonprovisional application. Section 1.78(a)(2), however, limits the
definition of "divisional application" to an application that claims
only an invention or inventions that were subject to a requirement to
comply with the requirement of unity of invention under PCT Rule 13 or
a requirement for restriction under 35 U.S.C. 121 in the prior-filed
application and not elected for examination and not examined in any
prior-filed application. See 35 U.S.C. 121 ("[i]f two or more
independent and distinct inventions are claimed in one application, the
Director may require the application to be restricted to one of the
inventions [and i]f the other invention is made the subject of a
divisional application which complies with the requirements of [35
U.S.C.] 120 * * *."). The Office will revise the definition of
divisional application in MPEP § 201.06 in the next revision of the
MPEP. An application that claims the benefit of a prior-filed
divisional application as defined in § 1.78(a)(2), and claims the
same patentable invention as the prior-filed divisional application,
would not be a divisional application as defined by § 1.78(a)(2).
Instead, such an application would be a continuation application.

   Section 1.78(a)(3) defines a "continuation application" as a
continuing application as defined in § 1.78(a)(1) that discloses
and claims only an invention or inventions that were disclosed in the
prior-filed application. See MPEP § 201.07 (defines a continuation
application as an application that discloses (or discloses and claims)
only subject matter that was disclosed in the prior-filed
nonprovisional application).

   Section 1.78(a)(4) defines a "continuation-in-part application"
as a continuing application as defined in § 1.78(a)(1) that
discloses subject matter that was not disclosed in the prior-filed
application. See MPEP § 201.08 (a continuation-in-part repeats some
substantial portion or all of the earlier nonprovisional application
and adds matter not disclosed in the prior-filed nonprovisional
application).

   Section 1.78(b) addresses claims under 35 U.S.C. 119(e) for the
benefit of a prior-filed provisional application. Under 35 U.S.C.
119(e)(1), a provisional application must disclose the invention
claimed in at least one claim of the later-filed application in the
manner provided by 35 U.S.C. 112, ¶ 1, for the later-filed application
to receive the benefit of the filing date of the provisional
application. See New Railhead Mfg., L.L.C. v. Vermeer Mfg. Co., 298
F.3d 1290, 1294, 63 U.S.P.Q.2d 1843, 1846 (Fed. Cir. 2002) (for a
nonprovisional application to actually receive the benefit of the
filing date of the provisional application, "the specification of the
provisional [application] must `contain a written description of the
invention and the manner and process of making and using it, in such
full, clear, concise, and exact terms,' 35 U.S.C. 112 ¶ 1, to enable an
ordinarily skilled artisan to practice the invention claimed in the
nonprovisional application"). Section 1.78(b), however, does not also
state (as did former § 1.78(a)(4)) that the provisional application
must disclose the invention claimed in at least one claim of the later-
filed application in the manner provided by 35 U.S.C. 112, ¶ 1, because
it is not necessary for the rules of practice to restate provisions of
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  994 

a statute.

   Section 1.78(b)(1) provides that the nonprovisional application or
international application designating the United States of America must
be filed not later than twelve months after the date on which the
provisional application was filed, and that this twelve-month period is
subject to 35 U.S.C. 21(b) and § 1.7(a). 35 U.S.C. 21(b) and § 1.7(a)
provide that when the day, or the last day, for taking any
action (e.g., filing a nonprovisional application within twelve months
of the date on which the provisional application was filed) or paying
any fee in the Office falls on Saturday, Sunday, or a Federal holiday
within the District of Columbia, the action may be taken, or fee paid,
on the next succeeding secular or business day. Section 1.78(b)
otherwise contains the provisions of former § 1.78(a)(4) and
(a)(5).

   Sections 1.78(b)(2) through (b)(5) contain the provisions of former
1.78(a)(4) and (a)(5). Section 1.78(c) contains provisions relating to
delayed claims under 35 U.S.C. 119(e) for benefit of prior-filed
provisional applications. Section 1.78(c) contains the provisions of
former § 1.78(a)(6).

   Section 1.78(d) contains provisions relating to claims under 35
U.S.C. 120, 121, or 365(c) for the benefit of a prior-filed
nonprovisional or international application.

   Section 1.78(d)(1) provides conditions under which an application
may claim the benefit under 35 U.S.C. 120, 121, or 365(c) and
§ 1.78 of a prior-filed nonprovisional application or international
application designating the United States of America. Section
1.78(d)(1) also provides that the Office will refuse to enter, or will
delete if present, any specific reference to a prior-filed application that
is not permitted by § 1.78(d)(1). If the claim for the benefit of a prior-
filed nonprovisional application or international application designating
the United States of America is not permitted by § 1.78(d)(1), the Office
will refuse benefit. Section 1.78(d) also provides that the entry of or
failure to delete a specific reference to a prior-filed application that is
not permitted by § 1.78(d)(1) does not constitute a waiver of the
provisions of § 1.78(d)(1). The grant of a petition under § 1.78(d)(1)(vi)
or waiver of a requirement of § 1.78(d)(1) would be only by an explicit
decision by an official who has been delegated the authority to decide such
a petition or waiver. It would not occur by implication due to the entry of
or failure to delete a specific reference to a prior-filed application that
is not permitted by § 1.78(d)(1).

   These provisions of § 1.78(d)(1) were included in the proposed
changes to § 1.78(d)(3). See Changes to Practice for Continuing
Applications, Requests for Continued Examination Practice, and
Applications Containing Patentably Indistinct Claims, 71 FR at 54, 60,
1302 Off. Gaz. Pat. Office at 1323, 1328.

   Section 1.78(d)(1)(i) provides for continuation applications or
continuation-in-part applications that do not claim the benefit of a
divisional application (either directly or indirectly). Section
1.78(d)(1)(i) permits such a continuation application or continuation-
in-part application of a prior-filed nonprovisional application or
international application designating the United States of America if:
(1) The application is a continuation application as defined in
§ 1.78(a)(3) or a continuation-in-part application as defined in
§ 1.78(a)(4) that claims the benefit under 35 U.S.C. 120, 121, or 365(c)
of no more than two prior-filed applications; and (2) any application
whose benefit is claimed under 35 U.S.C. 120, 121, or 365(c) in such
nonprovisional application has its benefit claimed in no more than one
other nonprovisional application. This does not include any
nonprovisional application that satisfies the conditions set forth in
§ 1.78(d)(1)(ii), (d)(1)(iii) or (d)(1)(vi).
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  995 


   Section 1.78(d)(1)(i) permits an applicant to continue prosecution
of an application via two continuation applications (in parallel or
serially), a continuation application and a continuation-in-part
application (in parallel or serially), or two continuation-in-part
applications (in parallel or serially). Applicants choosing to file
applications (whether continuing or non-continuing) in parallel are
reminded that § 1.75(b)(4) provides that, if certain conditions are
met, the Office will treat each such application as having the total
number of claims present in all of such applications for purposes of
determining whether an examination support document is required by
§ 1.75(b). See also § 1.78(f) concerning additional provisions
that are applicable if there are multiple applications that have the
same claimed filing or priority date, substantial overlapping
disclosure, a common inventor, and common assignee.

   If an application is identified as a continuation-in-part
application, however, § 1.78(d)(3) provides that the applicant must
identify the claim or claims in the continuation-in-part application
for which the subject matter is disclosed in the manner provided by 35
U.S.C. 112, ¶ 1, in the prior-filed application. See discussion of
§ 1.78(d)(3). Any claims in the continuation-in-part application
that are not identified under § 1.78(d)(3) as supported by the
prior-filed application will be subject to prior art based on the
actual filing date of the continuation-in-part application.

   For a continuation-in-part application that contains one or more
claims for which the subject matter is not disclosed in the manner
provided by 35 U.S.C. 112, ¶ 1, in the prior-filed application, §
1.78(d)(1)(i) will permit an applicant to continue prosecution of the
claims that are directed solely to subject matter added in such
continuation-in-part application via two continuation applications (or
a continuation application and a continuation-in-part application, or
two continuation-in-part applications). However, the "additional"
continuation or continuation-in-part applications cannot claim the
benefit of the prior-filed application relative to the first
continuation-in-part application. The subject matter of at least one
claim of a later-filed application must be disclosed in the prior-filed
application in the manner provided by 35 U.S.C. 112, ¶ 1, for the
later-filed application to actually receive the benefit of the filing
date of the prior-filed application under 35 U.S.C. 120. See
Studiengesellschaft Kohle m.b.H. v. Shell Oil Co., 112 F.3d 1561, 1564-
65, 42 U.S.P.Q.2d 1674, 1677-78 (Fed. Cir. 1997). In addition, the term
of any resulting patent will be measured under 35 U.S.C. 154(a)(2) from
the filing date of the prior-filed application, even if the later-filed
application never receives any benefit from the prior-filed
application. See Abbott Labs. v. Novopharm Ltd., 104 F.3d 1305, 1309,
41 U.S.P.Q.2d 1535, 1537 (Fed. Cir. 1997) (rejecting patentee's
argument that it should not be bound by the filing date of the prior-
filed application because the later-filed application never received
any actual benefit from the prior-filed application). Thus, the Office
will not require that such "additional" continuation or continuation-
in-part applications contain a showing that all of the claims are
directed solely to subject matter added in the first continuation-in-
part application. Rather, § 1.78(d)(1)(i) permits the
"additional" continuation or continuation-in-part application to
claim the benefit of the first continuation-in-part application, but
does not permit the "additional" continuation or continuation-in-part
application to also claim the benefit of the prior-filed initial
application (the prior-filed application relative to the first
continuation-in-part application). For example, consider an applicant
who files: (1) An initial application "A"; (2) a first continuation-
in-part application "B" that claims the benefit of application "A";
(3) a second continuation (or continuation-in-part) application "C"
that claims the benefit of applications "B" and "A"; and (4) an
additional continuation (or continuation-in-part) application "D"
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  996 

that claims the benefit of applications "C" and "B". Under §
1.78(d)(1)(i), application "D" may claim the benefit of application
"C" and continuation-in-part application "B", but may not claim any
benefit of application "A" (except as permitted under §
1.78(d)(1)(vi)).

   Applicants are permitted to file two continuation or continuation-
in-part applications (§ 1.78(d)(1)) and one request for continued
examination (§ 1.114) without any justification. The provisions of
§ 1.78(d)(1) are independent of the provisions of § 1.114.
Therefore, the filing of a request for continued examination does not
preclude an applicant from filing two continuation or continuation-in-
part applications. In addition, an applicant may not agree to forgo a
continuation application (or continuation-in-part application) to
obtain a second or third request for continued examination, nor can an
applicant agree to forgo a request for continued examination in
exchange for a third continuation or continuation-in-part application.
For example, an applicant cannot file a second request for continued
examination without any justification instead of filing one of the two
permitted continuation applications; and an applicant cannot file three
continuation applications instead of filing a request for continued
examination. Of course, applicant may seek by petition a third or
subsequent continuation or continuation-in-part application or a second
or subsequent request for continued examination.

   The Office, however, is implementing an optional streamlined
continuation application procedure under which an applicant may request
to have a continuation application filed on or after November 1, 2007,
placed on an examiner's amended (Regular Amended) docket. The examiner
will normally pick up for action a continuation application that has
been placed on the examiner's amended (Regular Amended) docket faster
(e.g., within a few months from the date the application is docketed)
than an application placed on the examiner's new continuing application
(New Special) docket. The following conditions must be met for the
continuation application to be placed on an examiner's amended (Regular
Amended) docket rather than on the new continuing application (New
Special) docket: (1) The application must disclose and claim only an
invention or inventions that were disclosed and claimed in the prior-
filed application; (2) the applicant must agree that any election in
response to a requirement to comply with the requirement of unity of
invention under PCT Rule 13 or a requirement for restriction under 35
U.S.C. 121, including an election of species requirement, in the prior-
filed application carries over to the continuation application; (3) the
prior-filed application must be under a final Office action (§ 1.113) or
under appeal at the time of filing the continuation application;
(4) the prior-filed application must be expressly abandoned upon filing
of the continuation application, with a letter of express abandonment
under § 1.138 being concurrently filed in the prior-filed application;
and (5) applicant must request that the continuation application be placed
on an examiner's amended (Regular Amended) docket. This procedure is not
applicable to design applications because the continued prosecution
application procedures of § 1.53(d) currently provide design applicants
with an optional streamlined continuation application procedure.

   The optional streamlined continuation application procedure,
however, does require that the applicant provide a continuation
application filed under 35 U.S.C. 111(a) and § 1.53(b) (and not a
request for continued examination under 35 U.S.C. 132(b) and § 1.114
or a continued prosecution application under § 1.53(d)).
Thus, the applicant must file a continuation application that meets the
conditions set forth in 35 U.S.C. 111(a) and § 1.53(b) to be
accorded a filing date. The continuation application must also be
complete under § 1.51(b) or completed under § 1.53(f). The
Office will not docket an application for examination until the
application is complete (§§ 1.51(b) and 1.53(f)) and in
condition for publication (§ 1.211). See § 1.53(h). Thus, any
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  997 

delay in submitting the filing fee and oath or declaration (or copy of
the oath or declaration from the prior-filed application under § 1.63(d))
will delay the docketing of a continuation application even if
the applicant has requested that the continuation application be given
streamlined docketing.

   This optional streamlined continuation application procedure
concerns only the placement of the continuation application on an
examiner's amended (Regular Amended) docket. The continuation
application is otherwise treated as a new application for patent. For
example, (1) the application filing fees including the basic filing
fee, search and examination fees, and any required excess claims fees
(and not the request for continued examination fee set forth in
§ 1.17(e)) are required; (2) the continuation application will be
assigned a new application number; and (3) the continuation application
is subject to the patent term provisions of 35 U.S.C. 154(b) and
§ 1.702 et seq. as a new continuation application (and not a request
for continued examination in the prior-filed application).

   Section 1.78(d)(1)(ii) provides for divisional applications of an
application for the claims to a non-elected invention that has not been
examined if the application was subject to a requirement to comply with
the requirement of unity of invention under PCT Rule 13 or a
requirement for restriction under 35 U.S.C. 121. The divisional
application need not be filed during the pendency of the application
subject to a requirement for restriction, as long as the copendency
requirement of 35 U.S.C. 120 is met. This final rule also permits
applicant to file two continuation applications of a divisional
application plus a request for continued examination in the divisional
application family, without any justification. See §§
1.78(d)(1)(iii) and 1.114(f).

   Specifically, § 1.78(d)(1)(ii) permits a divisional application
of a prior-filed nonprovisional application or international
application designating the United States of America under the
following conditions. First, the divisional application must be a
divisional application as defined in § 1.78(a)(2) that claims the
benefit under 35 U.S.C. 120, 121, or 365(c) of a prior-filed
application that was subject to a requirement to comply with the
requirement of unity of invention under PCT Rule 13 or a requirement
for restriction under 35 U.S.C. 121. Second, the divisional application
must contain only claims directed to an invention or inventions that
were identified in the requirement to comply with the requirement of
unity of invention or requirement for restriction but were not elected
for examination and were not examined in the prior-filed application or
in any other nonprovisional application. The "not elected for
examination and were not examined in any other nonprovisional
application" requirement does not apply to any continuation
application that claims the benefit under 35 U.S.C. 120, 121, or 365(c)
of the divisional application and satisfies the conditions set forth in
§ 1.78(d)(1)(iii) or (d)(1)(vi).

   Section 1.78(d)(1)(ii)(A) permits an applicant to obtain
examination of claims that were withdrawn from consideration in the
prior-filed application due to a requirement to comply with the
requirement of unity of invention under PCT Rule 13 or a requirement
for restriction under 35 U.S.C. 121. Thus, § 1.78(d)(1)(ii)(A)
permits a divisional application filed as a result of a requirement to
comply with the requirement of unity of invention under PCT Rule 13 or
requirement for restriction under 35 U.S.C. 121 in the prior-filed
application. Section 1.78(d)(1)(ii)(A), however, does not permit a
divisional application not filed as a result of such a requirement in
the prior-filed application. Thus, § 1.78(d)(1)(ii)(A) permits so-
called "involuntary" divisional applications but does not permit so-
called "voluntary" divisional applications.

Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  998 

   Section 1.78(d)(1)(ii)(B) does not permit the filing of a set of
parallel divisional applications containing claims to the same
invention. Applicant, however, may serially prosecute up to two
continuation applications that contain claims to the same invention as
is claimed in a prior-filed divisional application if the continuation
application satisfies the conditions of § 1.78(d)(1)(iii).

   As discussed previously, applicants cannot rely upon a requirement
for restriction including an election of species to file a divisional
application in situations where: (1) The applicant traverses the
requirement for restriction; (2) the requirement for restriction may be
conditional, such as a requirement for election of species in an
application that contains a claim that is generic to all of the claimed
species (see MPEP section 809); and (3) the claims to the non-elected
invention may be rejoined at the request of the applicant (see MPEP
§ 821.04 et seq.). See the discussion of § 1.75(b)(5). This is because when
the requirement for restriction is withdrawn in the prior-filed
application, any divisional application that has been filed as the
result of the restriction requirement of the prior-filed application
will not be proper under §§ 1.78(a)(2) and 1.78(d)(1)(ii).
Applicant is not permitted to file a divisional application of a prior-
filed application that is no longer subject to a restriction
requirement. Under §§ 1.78(a)(2) and 1.78(d)(1)(ii), the prior-
filed application to which a divisional application claims the benefit
must be subject to a requirement to comply with the requirement of
unity of invention under PCT Rule 13 or a requirement for restriction
under 35 U.S.C. 121. Sections 1.78(a)(2) and 1.78(d)(1)(ii) also
require a divisional application to contain only claims directed to a
non-elected invention that has not been examined.

   For an application that contains a generic claim in which a
requirement for an election of species has been made, applicants should
conclude prosecution of the generic claim in the initial application
and its continuation or continuation-in-part applications, including
exhaustion of any available appeals, before even filing a divisional
application to a non-elected species. If applicant no longer wants to
pursue the generic claim, applicant may file a divisional application
directed to a non-elected species. If applicant files a divisional
application directed to a non-elected species, applicant must: (1)
Cancel the claims to the non-elected species and the generic claim in
the prior-filed application before a rejoinder or reinstatement occurs;
(2) not present the non-elected claims and the generic claim in any
continuation or continuation-in-part application of the initial
application; and (3) not present the generic claim in the divisional
application or any continuation application of the divisional
application.

   Under the Office's rejoinder practice, an applicant may request
rejoinder of claims to a non-elected invention that depend from or
otherwise require all the limitations of an allowable claim. See MPEP
§ 821.04 et seq. Applicants may retain claims to a non-elected
invention in an application for possible rejoinder in the event of the
allowance of a claim to the elected invention. If applicant cancels all
of the claims directed to a non-elected invention before rejoinder
occurs and files a divisional application, the restriction requirement
will not be withdrawn and the non-elected claims that are now canceled
will not be rejoined. This will preserve applicant's rights under 35
U.S.C. 121 and § 1.78(d)(1)(ii). See MPEP § 821.04(b).

   Section 1.78(d)(1)(iii) provides for continuation applications that
claim the benefit of a divisional application (either directly or
indirectly). Section 1.78(d)(1)(iii) permits such a continuation
application of a prior-filed nonprovisional application or
international application designating the United States of America if:
(1) The application is a continuation application as defined in
§ 1.78(a)(3) that claims the benefit under 35 U.S.C. 120, 121, or 365(c)
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  999 

of a divisional application that satisfies the conditions set forth in
§ 1.78(d)(1)(ii); (2) the application discloses and claims only an
invention or inventions that were disclosed and claimed in the
divisional application; (3) the application claims the benefit of only
the divisional application, any application to which such divisional
application claims benefit under 35 U.S.C. 120, 121, or 365(c) in
compliance with the conditions set forth in § 1.78(d)(1)(ii), and
no more than one intervening prior-filed nonprovisional application
(i.e., only one continuation application of the divisional application
filed between the divisional application and the second continuation
application of the divisional application); and (4) no more than one
other nonprovisional application claims the benefit of the divisional
application. This does not include any other divisional application
that satisfies the conditions set forth in § 1.78(d)(1)(ii) or any
nonprovisional application that claims the benefit of such divisional
application and satisfies the conditions set forth in § 1.78(d)(1)(iii)
or (d)(1)(vi). Section 1.78(d)(1)(iii) permits an applicant to continue
prosecution of a divisional application via two continuation applications
(in parallel or serially). The Office, however, will treat each application
prosecuted in parallel as having the total number of claims present in all
of such applications for purposes of determining whether an examination
support document is required by § 1.75(b) provided that the continuation
application contains at least one claim that is patentably indistinct from
at least one claim in the divisional application.

   Section 1.78(d)(1)(iii) does not permit a continuation-in-part of a
divisional application. Section 1.78(d)(1)(iii) is designed to permit
an applicant to complete prosecution with respect to an invention or
inventions that were disclosed and claimed in a divisional application,
and not to permit an applicant to seek patent protection for a new
invention that merely bears some relationship to an invention or
inventions that were disclosed and claimed in a divisional application.
Section 1.78(d)(1)(i) provides a mechanism for applicants to seek
patent protection for a new invention that is an improvement of an
invention or inventions that were disclosed and claimed in an initial
or continuing (including a divisional) application.

   The provisions of §§ 1.78(d)(1)(i) through (d)(1)(iii) are
illustrated with the following example: (1) There is an initial
application "A" that is subject to a restriction requirement under 35
U.S.C. 121 and § 1.141 et seq.; (2) a continuation application
"B" of application "A"; (3) a further continuation application
"C" which claims the benefit of continuation application "B" and
initial application "A"; (4) a divisional application "D" (based
upon the restriction requirement under 35 U.S.C. 121 and § 1.141 et
seq. in application "A"), which claims the benefit of continuation
application "C", continuation application "B", and initial
application "A"; (5) a continuation application "E" of divisional
application "D", which claims the benefit of divisional application
"D", continuation application "C", continuation application "B",
and initial application "A"; and (6) a further continuation
application "F" of continuation application "E", which claims the
benefit of continuation application "E", divisional application
"D", continuation application "C", continuation application "B",
and initial application "A".

   Under § 1.78(d)(1)(i), application "C" is either a
continuation application under § 1.78(a)(3) or a continuation-in-
part application under § 1.78(a)(4) that claims the benefit of no
more than two prior-filed applications "B" and "A". In addition,
applications "B" and "A" whose benefit is claimed in application
"C" have their benefit claimed in no more than one other application
(not including divisional application "D" or continuation
applications "E" and "F" of the divisional application "D"). That
is, the benefit of application "A" is claimed in only one other
application "B" (not including divisional application "D" or
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1000 

continuation applications "E" and "F" of the divisional application "D"),
and the benefit of application "B" is claimed in only one other
application "C" (not including divisional application "D" or
continuation applications "E" and "F" of the divisional application
"D").

   Under § 1.78(d)(1)(ii), nonprovisional application "D" is a
divisional application under § 1.78(a)(2) since it claims the
benefit of prior-filed application "A" that was subject to a
requirement to comply with the requirement of unity of invention under
PCT Rule 13 or a requirement for restriction under 35 U.S.C. 121.
Divisional application "D" may contain only claims directed to an
invention identified in the requirement to comply with the requirement
of unity of invention or requirement for restriction but were not
elected for examination in prior-filed application "A" or in any
other nonprovisional application (applications "B and "C"), except
for a nonprovisional application (applications "E" and "F") that
claims the benefit of divisional application "D" and satisfies the
conditions of § 1.78(d)(1)(iii). That is, divisional application
"D" may contain only claims directed to an invention or inventions
that were identified in such requirement to comply with the requirement
of unity of invention or requirement for restriction but were not
elected for examination in any other application except for its
continuation applications "E" and "F". Finally, the divisional
application "D" claims the benefit of the prior-filed applications
(applications "A", "B", and "C").

   Under § 1.78(d)(1)(iii), nonprovisional application "F" is a
continuation application under § 1.78(a)(3) that claims the benefit
of divisional application "D". Application "D" is a divisional
application that satisfies the conditions set forth in §
1.78(d)(1)(ii). The nonprovisional application "F" may disclose and
claim only an invention that was disclosed and claimed in divisional
application "D". The nonprovisional application "F" claims the
benefit of only divisional application "D", the applications to which
divisional application "D" claims benefit in compliance with the
conditions of § 1.78(d)(1)(ii) (applications "A", "B", and
"C"), and no more than one intervening prior-filed nonprovisional
application (application "E"). Divisional application "D" whose
benefit is claimed in nonprovisional application "E" and in
nonprovisional application "F" has its benefit claimed in no more
than one other nonprovisional application. That is, with respect to
application "F", divisional application "D" has its benefit claimed
in no more than one other nonprovisional application (application
"E"), and with respect to application "E", divisional application
"D" has its benefit claimed in no more than one other nonprovisional
application (application "F").

   Section 1.78(d)(1)(iv) pertains to the situation in which an
applicant files a bypass continuation (or continuation-in-part)
application rather than paying the basic national fee (entering the
national stage) in an international application in which a Demand for
international preliminary examination (PCT Article 31) has not been
filed, and the international application does not claim the benefit of
any other nonprovisional application or international application
designating the United States of America. Section 1.78(d)(1)(iv)
provides that in this situation the applicant may file "one more"
continuation application (or continuation-in-part application) without
there being a requirement for a petition and showing under §
1.78(d)(1)(vi). A "bypass" continuation (or continuation-in-part)
application is an application for patent filed under 35 U.S.C. 111(a)
that claims the benefit of the filing date of an earlier international
application designating the United States of America that did not enter
the national stage under 35 U.S.C. 371. See H.R. Rep. No. 107-685, at
222 (2002).

Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1001 

   Specifically, § 1.78(d)(1)(iv) provides that a continuation
application or continuation-in-part application is permitted if the
following conditions are met: (1) The application claims benefit under
35 U.S.C. 120 or 365(c) of a prior-filed international application
designating the United States of America, and a Demand has not been
filed and the basic national fee (§ 1.492(a)) has not been paid in
the prior-filed international application and the prior-filed
international application does not claim the benefit of any other
nonprovisional application or international application designating the
United States of America; (2) the application is a continuation
application as defined in § 1.78(a)(3) or a continuation-in-part
application as defined in § 1.78(a)(4) that claims the benefit
under 35 U.S.C. 120, 121, or 365(c) of no more than three prior-filed
applications; and (3) any application whose benefit is claimed under 35
U.S.C. 120, 121, or 365(c) in such nonprovisional application has its
benefit claimed in no more than two other nonprovisional applications.
This does not include any nonprovisional application that satisfies the
conditions set forth in § 1.78(d)(1)(ii), (d)(1)(iii) or (d)(1)(vi).

   Section 1.78(d)(1)(v) pertains to the situation in which an
applicant files a continuation (or continuation-in-part) application to
correct informalities rather than completing an application for
examination under § 1.53 (i.e., the prior-filed application became
abandoned due to the failure to timely reply to an Office notice issued
under § 1.53(f)). The prior-filed nonprovisional application,
however, must be entitled to a filing date and have paid therein the
basic filing fee within the pendency of the application. See § 1.78(d)(2).
Section 1.78(d)(1)(v) provides that in this situation the
applicant may file "one more" continuation application (or
continuation-in-part application) without there being a requirement for
a petition and showing under § 1.78(d)(1)(vi). Specifically,
§ 1.78(d)(1)(v) provides that a continuation application or continuation-
in-part application is permitted if the following conditions are met:
(1) The application claims benefit under 35 U.S.C. 120 or 365(c) of a
prior-filed nonprovisional application filed under 35 U.S.C. 111(a),
and the prior-filed nonprovisional application became abandoned
§ 1.53(f) and does not claim the benefit of any other nonprovisional
application or international application designating the United States
of America; (2) the application is a continuation application as
defined in § 1.78(a)(3) or a continuation-in-part application as
defined in § 1.78(a)(4) that claims the benefit under 35 U.S.C.
120, 121, or 365(c) of no more than three prior-filed applications; and
(3) any application whose benefit is claimed under 35 U.S.C. 120, 121,
or 365(c) in such nonprovisional application has its benefit claimed in
no more than two other nonprovisional applications. This does not
include any nonprovisional application that satisfies the conditions
set forth in § 1.78(d)(1)(ii), (d)(1)(iii) or (d)(1)(vi).

   Section 1.78(d)(1)(vi) provides that a continuing nonprovisional
application that is filed to obtain consideration of an amendment,
argument, or evidence that could not have been submitted during the
prosecution of the prior-filed application, and does not satisfy the
conditions set forth in § 1.78(d)(1)(i), (ii), (iii), (iv) or (v),
may claim the benefit under 35 U.S.C. 120, 121, or 365(c) of such
prior-filed application. Under § 1.78(d)(1)(vi), a petition must be
filed in such nonprovisional application that is accompanied by the fee
set forth in § 1.17(f) and a showing that the amendment, argument, or
evidence sought to be entered could not have been submitted during the
prosecution of the prior-filed application. This will permit an applicant
to continue prosecution of an application via a continuing application to
obtain consideration of an amendment, argument, or evidence that could not
have been submitted during the prosecution of the prior-filed application.
Section 1.78(d)(1)(vi) sets forth the time period within which such a
petition must be provided: (1) If the later-filed continuing application
is an application filed under 35 U.S.C. 111(a), within four months from the
actual filing date of the later-filed application; and (2) if the
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1002 

continuing application is a nonprovisional application which entered
the national stage from an international application after compliance
with 35 U.S.C. 371, within four months from the date on which the
national stage commenced under 35 U.S.C. 371(b) or (f) in the
international application.

   With respect to the application of the changes to § 1.78 in
this final rule to a reissue application, benefit claims under 35
U.S.C. 120, 121, or 365(c) in the application for patent that is being
reissued will not be taken into account in determining whether a
continuing reissue application claiming the benefit under 35 U.S.C.
120, 121, or 365(c) of the reissue application satisfies one or more of
the conditions set forth in §§ 1.78(d)(1)(i) through
1.78(d)(1)(vi). However, an applicant may not use the reissue process
to add to the original patent benefit claims under 35 U.S.C. 120, 121,
or 365(c) that do not satisfy one or more of the conditions set forth
in §§ 1.78(d)(1)(i) through 1.78(d)(1)(vi), if the application
for the original patent was filed on or after November 1, 2007.

   Section 1.78(d)(2) provides that each prior-filed application must
name as an inventor at least one inventor named in the later-filed
application. In addition, each prior-filed application must either be:
(1) An international application entitled to a filing date in
accordance with PCT Article 11 and designating the United States of
America; or (2) a nonprovisional application under 35 U.S.C. 111(a)
that is entitled to a filing date as set forth in § 1.53(b) or
§ 1.53(d) for which the basic filing fee set forth in § 1.16
has been paid within the pendency of the application (provisions from
former § 1.78(a)(1)).

   Section 1.78(d)(3) is amended to include the parenthetical "(i.e.,
whether the later-filed application is a continuation, divisional, or
continuation-in-part of the prior-filed nonprovisional application or
international application)" to clarify in the rules of practice what
is meant by the requirement that an applicant identify the relationship
of the applications. See MPEP § 201.11.

   Section 1.78(d)(3) also provides that if an application is
identified as a continuation-in-part application, the applicant must
identify the claim or claims in the continuation-in-part application
for which the subject matter is disclosed in the manner provided by 35
U.S.C. 112, ¶ 1, in the prior-filed application. Any claim in the
continuation-in-part application for which the subject matter is not
identified as being disclosed in the manner provided by 35 U.S.C. 112,
¶ 1, in the prior-filed application will be treated as entitled only to
the actual filing date of the continuation-in-part application, and
will be subject to prior art based on the actual filing date of the
continuation-in-part application. As discussed previously, to avoid any
unnecessary delay in the prosecution of the application, applicant
should provide the identification before the examiner begins to conduct
a prior art search. If the failure to identify the claims for which the
subject matter is disclosed in the manner provided by 35 U.S.C. 112, ¶
1, in the prior-filed application causes the examiner to include a new
prior art rejection in a second or subsequent Office action, the
inclusion of the new prior art rejection will not preclude the Office
action from being made final.

   This final rule eliminates from § 1.78(d) the provision that
the prior-filed application disclose the invention claimed in at least
one claim of the later-filed application in the manner provided by 35
U.S.C. 112, ¶ 1. For a later-filed application to receive the benefit
of the filing date of a prior-filed application, 35 U.S.C. 120 requires
that the prior-filed application must disclose the invention claimed in
at least one claim of the later-filed application in the manner
provided by 35 U.S.C. 112, ¶ 1. The Office, however, does not make a
determination as to whether a prior-filed application discloses the
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1003 

invention claimed in a claim of the later-filed application in the
manner provided by 35 U.S.C. 112, ¶ 1, unless that determination is
necessary to determine the patentability of such claim. See MPEP
§ 201.08 ("Unless the filing date of the earlier nonprovisional
application is actually needed * * *, there is no need for the Office
to make a determination as to whether the requirement of 35 U.S.C. 120,
that the earlier nonprovisional application discloses the invention of
the second application in the manner provided by 35 U.S.C. 112, ¶ 1, is
met and whether a substantial portion of all of the earlier
nonprovisional application is repeated in the second application in a
continuation-in-part situation. Accordingly, an alleged continuation-
in-part application should be permitted to claim the benefit of the
filing date of an earlier nonprovisional application if the alleged
continuation-in-part application complies with the * * * formal
requirements of 35 U.S.C. 120.").

   Section 1.78(d)(4) and (d)(5) contain the provisions of former
§ 1.78(a)(2).

   Section 1.78(d)(6) provides that cross-references to applications
for which a benefit is not claimed must be located in a paragraph
separate from the paragraph containing the references to applications
for which a benefit is claimed. Including cross-references to
applications for which a benefit is not claimed in the same paragraph
as the paragraph containing the references to applications for which a
benefit is claimed may lead to the Office inadvertently scheduling the
application for publication under 35 U.S.C. 122(b) and § 1.211 et
seq. on the basis of the cross-referenced applications having the
earliest filing date.

   Section 1.78(e) contains provisions relating to delayed claims
under 35 U.S.C. 120, 121, or 365(c) for benefit of prior-filed
nonprovisional or international applications. Section 1.78(e) contains
the provisions of former § 1.78(a)(3).

   Section 1.78(f) contains provisions relating to applications and
patents naming at least one inventor in common.

   Section 1.78(f)(1)(i) provides that the applicant in a
nonprovisional application that has not been allowed (§ 1.311) must
identify by application number (i.e., series code and serial number)
and patent number (if applicable) each other pending or patented
nonprovisional application, in a separate paper, for which the
following conditions are met: (1) The application has a filing date
that is the same as or within two months of the filing date of the
other pending or patented application, taking into account any filing
date for which a benefit is sought under title 35, United States Code;
(2) the application names at least one inventor in common with the
other pending or patented application; and (3) the application is owned
by the same person, or subject to an obligation of assignment to the
same person, as the other pending or patented application. This
identification requirement would also apply to each identified
application because the identifying application has
a filing date that is the same as or within two months of the filing
date of the identified application and vice versa.

   The phrase "taking into account any filing date for which a
benefit is sought under title 35, United States Code" in §
1.78(f)(1)(i)(A) means any filing date for which a benefit (or
priority) is sought or claimed under 35 U.S.C. 111, 119, 120, 121, 363,
or 365. Cf. 35 U.S.C. 122(b)(1)(A) (requires publication of patent
applications "promptly after the expiration of a period of 18 months
from the earliest filing date for which a benefit is sought under this
title" (emphasis added), meaning eighteen months from the earliest
filing date for which a benefit or priority is sought or claimed under
35 U.S.C. 111, 119, 120, 121, 363, or 365). Thus, if an application
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1004 

claims the benefit of or priority to other applications, "the filing
date of [the application], taking into account any filing date for
which a benefit is sought under title 35, United States Code," is the
actual filing date of the application as well as the filing date of
each application to which the application claims a benefit or priority.
For example, if an application has a filing date of December 1, 2006,
and claims the benefit of a nonprovisional application that was filed
on June 1, 2004, and claims the priority of a foreign application that
was filed on June 1, 2003, for purposes of §§ 1.78(f)(1) and
(f)(2) the filing date of the application "taking into account any
filing date for which a benefit is sought under title 35, United States
Code," is December 1, 2006, June 1, 2004, and June 1, 2003.

   The phrase "owned by the same person, or subject to an obligation
of assignment to the same person" in § 1.78(f)(1)(i)(C) (and in
§ 1.78(f)(2)(i)(C) and 1.78(f)(3)) has the same meaning as it does
in 35 U.S.C. 103(c). See MPEP § 706.02(l)(2) for a discussion of
the definition of this phrase as it is used in 35 U.S.C. 103(c).

   The phrase "has not been allowed" in § 1.78(f)(1)(i) (and in
§ 1.78(f)(2)(ii) and (iii)) means a notice of allowance under §
1.311 has not been mailed in the application, or a notice of allowance
under § 1.311 has been mailed in the application but the
application has been withdrawn from issue. Thus, the identification of
such one or more other pending or patented nonprovisional applications
under § 1.78(f)(1)(i) is not required in an application in which a
notice of allowance has been mailed, unless the application is
withdrawn from issue.

   Section 1.78(f)(1)(ii) also provides that one or more other
nonprovisional applications under § 1.78(f)(1)(i) must be
identified within the later of: (1) Four months from the actual filing
date of a nonprovisional application filed under 35 U.S.C. 111(a); (2)
four months from the date on which the national stage commenced under
35 U.S.C. 371(b) or (f) in a nonprovisional application entering the
national stage from an international application under 35 U.S.C. 371;
or (3) two months from the mailing date of the initial filing receipt
in the other nonprovisional application that is required to be
identified under § 1.78(f)(1)(i).

   Section 1.78(f)(2)(i) provides that a rebuttable presumption shall
exist that a nonprovisional application contains at least one claim
that is not patentably distinct from at least one of the claims in the
one or more other pending or patented nonprovisional applications if:
(1) The application has a filing date that is the same as the filing
date of another pending application or patent, taking into account any
filing date for which a benefit is sought; (2) the application names at
least one inventor in common with the other pending application or
patent; (3) the application is owned by the same person, or subject to
an obligation of assignment to the same person, as the other pending
application or patent; and (4) the application contains substantially
overlapping disclosure as the other pending application or patent.
Section 1.78(f)(2)(i) further provides that substantial overlapping
disclosure exists if the other pending or patented nonprovisional
application has written description support under 35 U.S.C. 112, ¶ 1,
for at least one claim in the nonprovisional application.

   If these conditions exist, the applicant must under § 1.78(f)(2)(ii)
in the nonprovisional application, unless the nonprovisional application
has been allowed (§ 1.311), within the time period specified in
§ 1.78(f)(2)(iii) either: (1) Rebut this presumption by explaining how
the application contains only claims that are patentably distinct from
the claims in each of such other pending applications or patents; or (2)
submit a terminal disclaimer in accordance with § 1.321(c). In addition,
§ 1.78(f)(2)(ii)(B) provides that where one or more other pending
nonprovisional applications containing patentably indistinct claims have
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1005 

been identified, the applicant must explain why there are two or more
pending nonprovisional applications naming at least one inventor in
common and owned by the same person, or subject to an obligation of
assignment to the same person, which contain patentably indistinct
claims. Unless applicant presents good and sufficient reasons for such
multiple applications, the Office may require elimination of the
patentably indistinct claims from all but one of the applications. See
§ 1.78(f)(3).

   As discussed previously, for applications having a continuity
relationship, the prior application must be pending at the time the
continuing application is filed. See 35 U.S.C. 120 (requires that a
continuing application be filed before the patenting or abandonment of
or termination of proceedings on the prior application). An applicant
is not required to provide an explanation under § 1.78(f)(2)(ii)(B)
for a continuation application or continuation-in-part application of a
prior-filed application that has been allowed, provided that the prior-
filed application is not withdrawn from issue. Furthermore, where the
other nonprovisional application containing patentably indistinct
claims is allowed, the Office will not count the claims of the allowed
application in determining whether the total number of claims present
in all of the copending nonprovisional applications containing
patentably indistinct claims exceeds the five independent claim and
twenty-five total claim threshold under § 1.75(b)(4). See the
discussion of § 1.75(b)(4). A terminal disclaimer in accordance
with § 1.321(c) will, however, be required in each nonprovisional
application containing patentably indistinct claims to overcome any
obviousness-type double patenting rejection.

   Under § 1.78(f)(2)(iii), the actions specified in §
1.78(f)(2)(ii) (if required) must be taken within the later of: (1)
Four months from the actual filing date of a nonprovisional application
filed under 35 U.S.C. 111(a); (2) four months from the date on which
the national stage commenced under 35 U.S.C. 371(b) or (f) in a
nonprovisional application entering the national stage from an
international application under 35 U.S.C. 371; (3) the date on which a
claim that is not patentably distinct from a claim in one or more other
pending or patented applications is presented; or (4) two months from
the mailing date of the initial filing receipt in the one or more other
pending or patented applications.

   The requirement under § 1.78(f)(2)(ii) for taking one of the
actions specified in § 1.78(f)(2)(ii) does not apply to the
applicant in the application in which a notice of allowance has been
mailed, unless the application is withdrawn from issue (§ 1.313).
For example, if an applicant filed a continuation application after a
notice of allowance has been mailed in the prior-filed application, the
applicant must either rebut the presumption under § 1.78(f)(2)(i) or
submit a terminal disclaimer in accordance with § 1.321(c) within the time
period set forth in § 1.78(f)(2)(iii) in the continuation application.
Under § 1.78(f)(2)(ii), the applicant, however, is not required to rebut
the presumption or submit a terminal disclaimer in the allowed prior-filed
application. Nevertheless, a terminal disclaimer in accordance with
§ 1.321(c) will be required in each nonprovisional application
containing patentably indistinct claims to overcome any obviousness-
type double patenting rejection.

   As discussed previously, when an applicant files multiple
applications that are substantially the same, the applicant is
responsible for assisting the Office in resolving potential double
patenting situations, rather than taking no action until faced with a
double patenting rejection. Thus, if an Office action must include a
double patenting rejection (either statutory or obviousness-type double
patenting), it is because the applicant has not met his or her
responsibility to resolve the double patenting situation. Therefore,
the inclusion of a new double patenting rejection in a second or
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1006 

subsequent Office action will not preclude the Office action from being
made final.

   Section 1.78(f)(3) applies when there are two or more commonly
owned (owned by the same person, or are subject to an obligation of
assignment to the same person) nonprovisional applications containing
patentably indistinct claims. Under § 1.78(f)(3), unless applicant
presents good and sufficient reasons for such multiple applications,
the Office may require elimination of the patentably indistinct claims
from all but one of the applications. Section 1.78(f)(3) contains
provisions similar to former § 1.78(b). The Office expects to apply
this provision primarily in situations covered by § 1.78(f)(2)(ii),
under which applicants must explain why it is necessary that there are
two or more pending nonprovisional applications naming at least one
inventor in common and owned by the same person, or subject to an
obligation of assignment to the same person, which contain patentably
indistinct claims. The Office, however, may require that an applicant
provide good and sufficient reason whenever there are two or more
pending nonprovisional applications with such common ownership or
assignment obligation and patentably indistinct claims, regardless of
the relative filing dates of the applications. Section 1.78(f)(3) does
not apply to the claims in a patent.

   The following are two examples where an applicant may have a good
and sufficient reason under § 1.78(f)(3) for there being two or
more pending nonprovisional applications that contain patentably
indistinct claims: (1) An applicant filed a continuation application
after the mailing of a notice of allowance in the prior-filed
application, but the allowance of the prior-filed application was
subsequently withdrawn by the Office; or (2) an interference was
declared in an application that contains both claims corresponding to
the count and claims not corresponding to the count, the BPAI suggests
that the claims not corresponding to the count be canceled from the
application in interference and pursued in a separate application, and
the applicant filed a continuation application to present the claims
not corresponding to the count. These examples are merely illustrative
and not exhaustive.

   Section 1.78(g) addresses applications or patents under
reexamination that name different inventors and contain patentably
indistinct claims. Section 1.78(g) contains the provisions of former
§ 1.78(c), except that "conflicting claims" is changed to
"patentably indistinct claims" for clarity and for consistency with
the language of § 1.78(f).

   Section 1.78(h) covers the situation in which parties to a joint
research agreement are treated (in essence) as a common owner for
purposes of 35 U.S.C. 103 by virtue of the CREATE Act. Section 1.78(h)
provides that if an application discloses or is amended to disclose the
names of parties to a joint research agreement under 35 U.S.C.
103(c)(2)(C), the parties to the joint research agreement are
considered to be the same person for purposes of § 1.78. The CREATE
Act amended 35 U.S.C. 103(c) to provide that subject matter developed
under a joint research agreement shall be treated as owned by the same
person or subject to an obligation of assignment to the same person for
purposes of determining obviousness if three conditions are met: (1)
The claimed invention was made by or on behalf of parties to a joint
research agreement that was in effect on or before the date the claimed
invention was made; (2) the claimed invention was made as a result of
activities undertaken within the scope of the joint research agreement;
and (3) the application for patent for the claimed invention discloses
or is amended to disclose the names of the parties to the joint
research agreement. See Changes to Implement the Cooperative Research
and Technology Enhancement Act of 2004, 70 FR 1818, 1818 (Jan. 11,
2005), 1291 Off. Gaz. Pat. Office 58, 58-59 (Feb. 8, 2005) (final
rule). Section 1.78(h) also provides that if the application is amended
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1007 

to disclose the names of parties to a joint research agreement, the
applicant must identify the one or more other nonprovisional
applications as required by § 1.78(f)(1) with the amendment unless
the applications have been identified within the four-month period
specified in § 1.78(f)(1).

   Section 1.78(i) provides that the time periods set forth in § 1.78
are not extendable.

   The changes to § 1.78 (except §§ 1.78(a) and 1.78(d)(1)) are applicable
to any nonprovisional application pending on or after November 1, 2007. The
changes to §§ 1.78(a) and 1.78(d)(1) are applicable to any application
filed on or after November 1, 2007, or any application entering the national
stage after compliance with 35 U.S.C. 371 on or after November 1, 2007.
Except as otherwise indicated in this final rule, any application filed
under 35 U.S.C. 111(a) on or after November 1, 2007, or any application
entering the national stage after compliance with 35 U.S.C. 371 on or after
November 1, 2007, seeking to claim the benefit under 35 U.S.C. 120, 121, or
365(c) and § 1.78 of a prior-filed nonprovisional application or
international application must either: (1) Meet the requirements specified
in one of §§ 1.78(d)(1)(i) through (d)(1)(v); or (2) include a grantable
petition under § 1.78(d)(1)(vi).

   With respect to applications that claim the benefit under 35 U.S.C.
120, 121, or 365(c) only of nonprovisional applications or
international applications filed before August 21, 2007: An application
is not required to meet the requirements set forth in § 1.78(d)(1)
if: (1) The application claims the benefit under 35 U.S.C. 120, 121, or
365(c) only of prior-filed nonprovisional applications filed before
August 21, 2007 or prior-filed applications entering the national stage
after compliance with 35 U.S.C. 371 before August 21, 2007; and (2)
there is no other application filed on or after the publication date of
this final rule in the Federal Register that also claims the benefit
under 35 U.S.C. 120, 121, or 365(c) of such prior-filed nonprovisional
applications or international applications. This provision will provide
applicants with "one more" continuation application or continuation-
in-part application of a second or subsequent continuing application
(continuation application or continuation-in-part application) that was
filed prior to the publication date of this final rule in the Federal
Register without a petition under § 1.78(d)(1)(vi). Thus, an applicant may
file a single continuation application or continuation-in-part
application on or after November 1, 2007, without meeting the
requirements specified in § 1.78(d)(1)(i) through (d)(1)(v), or
including a petition under § 1.78(d)(1)(vi), even if the prior-
filed application was a second or subsequent continuation or
continuation-in-part application. It should be noted that the purpose
of this provision is to ensure that an applicant may file "one more"
continuation application or continuation-in-part application of an
application that was filed prior to the publication date of this final
rule in the Federal Register without a petition and showing, and not to
provide an "extra" continuation application or continuation-in-part
application for applications filed prior to the publication date of
this final rule in the Federal Register. If an application filed before
the publication date of this final rule in the Federal Register is not
a continuing application or is only the first continuing application,
this provision will not entitle an applicant to file a third or
subsequent continuation or continuation-in-part application without a
petition under § 1.78(d)(1)(vi) showing that the amendment,
argument, or evidence sought to be entered could not have been
submitted during the prosecution of the prior-filed application.

   Section 1.104 (nature of examination): The Office proposed a number
of changes to § 1.104 to implement the "representative claims"
examination approach. See Changes to Practice for the Examination of
Claims in Patent Applications, 71 FR at 64, 68, 1302 Off. Gaz. Pat.
Office at 1131, 1332. The Office is not proceeding with the changes to
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1008 

§ 1.104 to implement the "representative claims" examination
approach, but is revising § 1.104 for consistency with current
examination practices.

   Section 1.104(a)(1) is amended to add the phrase "and other
requirements" to the phrase "the examination shall be complete with
respect both to compliance of the application or patent under
reexamination with the applicable statutes and rules" to address
situations in which the requirement is based upon Office practice as
set forth in the MPEP or in the case law. For example, the phrase
"other requirements" would address the situation in which a claim did
not comply with the requirement in MPEP § 608.01(m) that each claim
be the object of a single sentence starting with "I (or we) claim,"
"The invention claimed is," or the equivalent. See Fressola v.
Manbeck, 36 U.S.P.Q.2d 1211, 1212 (D.D.C. 1995). In addition, in the
event that there is a requirement for restriction including election of
species, or both, the provision in § 1.104(a)(1) for a "thorough
study [and] investigation of the available prior art relating to the
subject matter of the claimed invention" will continue to apply only
with respect to the invention and species elected for examination on
the merits. This provision of § 1.104 does not apply with respect
to an invention or species that has been withdrawn from consideration
as a result of a requirement for restriction, including an election of
species.

   Section 1.104(b) is also amended to delete the sentence
"[h]owever, matters of form need not be raised by the examiner until a
claim is found allowable." The Office would prefer that all matters of
form be resolved at the earliest time during the patent examination
process. Nevertheless, an Office action would not be considered
improper simply because the Office action did not raise every
applicable issue of form present in the application.

   Section 1.105 (requirements for information): Section 1.105(a)(1)
is amended to provide that an applicant may be required to set forth
where (by page and line or paragraph number) in the specification of
the application, or any application the benefit of whose filing date is
sought under title 35, United States Code, there is written description
support for the invention as defined in the claims (whether in
independent or dependent form), and of the manner and process of making
and using it, in such full, clear, concise, and exact terms as to
enable any person skilled in the art to which it pertains, or with
which it is most nearly connected, to make and use the invention, under
35 U.S.C. 112, ¶ 1. Therefore, in situations in which it is not readily
apparent where the specification of the application, or an application
for which a benefit is claimed, provides written description support
and enablement under 35 U.S.C. 112, ¶ 1, for a claim or a limitation of
a claim, the examiner may require the applicant to provide such
information. The Office considers this authority to be inherent under
the patent statute and existing rules (including § 1.105), but is
revising § 1.105 to make the authority explicit.

   Section 1.110 (inventorship and date of invention of the subject
matter of individual claims): Section 1.110 is amended to refer to
§ 1.78, rather than a specific paragraph (paragraph (c)) of § 1.78.
The first sentence of § 1.110 is also amended to relocate the
phrase "when necessary for purposes of an Office proceeding" to the
end of the sentence for clarity.

   Section 1.114 (request for continued examination): Under § 1.114,
an applicant is permitted to file a single request for continued
examination without a petition and showing in a single application
family. See § 1.114(f)(1). An application family includes the
initial application and its continuation or continuation-in-part
applications. An applicant is also permitted to file a single request
for continued examination without a petition and showing in a
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1009 

divisional application family. See §§ 1.114(f)(2) and (f)(3). A
divisional application family includes the divisional application and
its continuation applications. An applicant may file a second or
subsequent request for continued examination if the applicant files a
petition and a showing that the amendment, argument, or evidence sought
to be entered could not have been submitted earlier. See § 1.114(g).

   Section 1.114(a) is amended to make clear that an applicant may not
file an unrestricted number of requests for continued examination, that
a request for continued examination must include a petition under
§ 1.114(g) unless the conditions set forth in § 1.114(f)(1), (f)(2),
or (f)(3) are satisfied, and that a request for continued examination
must be identified as a request for continued examination. Section
1.114(a) otherwise contains the provisions of former § 1.114(a).

   Section 1.114(d) is revised to eliminate the sentence "[i]f an
applicant timely files a submission and fee set forth in § 1.17(e),
the Office will withdraw the finality of any Office action and the
submission will be entered and considered." This change is to avoid
misleading applicants into believing that the Office will pro forma
withdraw the finality of any Office action and the submission will be
pro forma entered and considered upon timely filing of a submission and
fee set forth in § 1.17(e). Under revised § 1.114, a second or
subsequent request for continued examination must also include a
petition accompanied by the fee set forth in § 1.17(f) except under
the conditions set forth in § 1.114(f).

   Section 1.114(f) provides the conditions under which an applicant
may file a request for continued examination under § 1.114 without
a petition under § 1.114(g).

   Section 1.114(f)(1) permits an applicant to file a single request
for continued examination in any one (but only one) of an initial
application or its continuation applications or
continuation-in-part applications. Section 1.114(f)(1) provides that an
applicant may file a request for continued examination under
§ 1.114 without a petition under § 1.114(g) if a request for
continued examination has not been previously been filed in any of: (1)
The application; (2) any application whose benefit is claimed in the
application under 35 U.S.C. 120, 121, or 365(c); and (3) any
application that claims the benefit under 35 U.S.C. 120, 121, or 365(c)
of the application, not including any nonprovisional application that
satisfies the conditions set forth in § 1.78(d)(1)(ii),
1.78(d)(1)(iii) or 1.78(d)(1)(vi). For example, if applicant filed one
request for continued examination in an initial application, applicant
is precluded from filing a second request for continued examination in
the initial application and in any continuation applications or
continuation-in-part applications that claim the benefit of the initial
application (not including any nonprovisional application that
satisfies the conditions set forth in § 1.78(d)(1)(ii),
1.78(d)(1)(iii) or 1.78(d)(1)(vi)), without a petition under § 1.114(g).

   Section 1.114(f)(2) permits an applicant to file a single request
for continued examination under § 1.114 in a divisional application
meeting the conditions set forth in § 1.78(d)(1)(ii) provided that
no request for continued examination has been filed in any continuation
application of the divisional application. Section 1.114(f)(2) provides
that an applicant may file a request for continued examination under
§ 1.114 in a divisional application without a petition under § 1.114(g)
if a request for continued examination has not previously been
filed in any of: (1) The divisional application; and (2) any
application that claims the benefit under 35 U.S.C. 120, 121, or 365(c)
of that divisional application, not including any nonprovisional
application that satisfies the conditions set forth in § 1.78(d)(1)(ii),
(d)(1)(iii) or (d)(1)(vi).

Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1010 

   Section 1.114(f)(3) permits an applicant to file a single request
for continued examination in a continuation application of a divisional
application meeting the conditions set forth in § 1.78(d)(1)(ii)
provided that no request for continued examination has been filed in
the divisional application or any other continuation application of the
divisional application. Section 1.114(f)(3) provides that an applicant
may file a request for continued examination under § 1.114 in a
continuation application of a divisional application without a petition
under § 1.114(g) if a request for continued examination has not
previously been filed in any of: (1) The continuation application; (2)
the divisional application; and (3) any other application that claims
the benefit under 35 U.S.C. 120, 121, or 365(c) of that divisional
application, not including any nonprovisional application that
satisfies the conditions set forth in § 1.78(d)(1)(ii), (d)(1)(iii)
or (d)(1)(vi).

   The provisions of § 1.114(f) are illustrated with the following
example (the example used to illustrate the provisions of §§
1.78(d)(1)(i) through (d)(1)(iii)): (1) There is an initial application
"A" that is subject to a restriction requirement under 35 U.S.C. 121
and § 1.141 et seq.; (2) a continuation application "B" of
application "A"; (3) a further continuation application "C" which
claims the benefit of continuation application "B" and initial
application "A"; (4) a divisional application "D" (based upon the
restriction requirement under 35 U.S.C. 121 and § 1.141 et seq. in
application "A"), which claims the benefit of continuation
application "C", continuation application "B", and initial
application "A"; (5) a continuation application "E" of divisional
application "D", which claims the benefit of divisional application
"D", continuation application "C", continuation application "B",
and initial application "A"; and (6) a further continuation
application "F" of continuation application "E", which claims the
benefit of continuation application "E", divisional application
"D", continuation application "C", continuation application "B",
and initial application "A".

   Section 1.114(f)(1) permits the filing of a single request for
continued examination without a petition under § 1.114(g) in any
one of applications "A", "B", or "C". Specifically, a request for
continued examination may be filed in application "A", if a request
for continued examination has not previously been filed in any of: (1)
application "A"; (2) any application (none) whose benefit is claimed
in application "A"; and (3) any application (applications "B" and
"C") that claims the benefit of application "A", not including
divisional application "D" and its continuation applications "E"
and "F". In addition, a request for continued examination may be
filed in application "B", if a request for continued examination has
not previously been filed in any of: (1) Application "B"; (2) any
application (application "A") whose benefit is claimed in application
"B"; and (3) any application (application "C") that claims the
benefit of application "B", not including divisional application
"D" and its continuation applications "E" and "F". Finally, a
request for continued examination may be filed in application "C", if
a request for continued examination has not previously been filed in
any of: (1) Application "C"; (2) any application (applications "A"
and "B") whose benefit is claimed in application "C"; and (3) any
application (none) that claims the benefit of application "C", not
including divisional application "D" and its continuation
applications "E" and "F".

   Section 1.114(f)(2) permits the filing of a single request for
continued examination without a petition under § 1.114(g) in
application "D", if a request for continued examination has not
previously been filed in application "E" or application "F".
Specifically, a request for continued examination may be filed in
application "D", if a request for continued examination has not
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1011 

previously been filed in any of: (1) Divisional application "D"; and
(2) any application (applications "E" and "F") that claims the
benefit of divisional application "D".

   Section 1.114(f)(3) permits the filing of a single request for
continued examination without a petition under § 1.114(g) in any
one of applications "E" or "F", if a request for continued
examination has not previously been filed in application "D".
Specifically, a request for continued examination may be filed in
continuation application "E", if a request for continued examination
has not previously been filed in any of: (1) Continuation application
"E"; (2) divisional application "D"; and (3) any other application
(application "F") that claims the benefit of divisional application
"D". In addition, a request for continued examination may be filed in
continuation application "F", if a request for continued examination
has not previously been filed in any of: (1) continuation application
"F"; (2) divisional application "D"; and (3) any other application
(application "E") that claims the benefit of divisional application "D".

   Section 1.114(g) provides that a request for continued examination
must include a petition accompanied by the fee set forth in § 1.17(f)
and a showing that the amendment, argument, or evidence sought
to be entered could not have been submitted before the close of
prosecution in the application. A petition under § 1.114(g) and the
fee set forth in § 1.17(f) are not required if the
conditions set forth in § 1.114(f) are satisfied. Since a petition
under § 1.114(g) requires a showing that there is an amendment,
argument, or evidence that could not have been submitted prior to the
close of prosecution in the application, a petition under § 1.114(g)
for a request for continued examination including only an
information disclosure statement as the submission required by
§ 1.114(c) (i.e., not including an amendment, argument, or evidence)
would not be granted.

   Thus, an applicant may file a single request for continued
examination without a petition under § 1.114(g) in any one (but
only one) of an initial application or its continuation applications or
continuation-in-part applications. An applicant may also file a single
request for continued examination without a petition under § 1.114(g)
in any one (but only one) of a divisional application (meeting
the conditions set forth in § 1.78(d)(1)(ii)) or its continuation
applications. Any second or subsequent request for continued
examination in an application or application family must include a
petition, accompanied by the fee set forth in § 1.17(f), and a
showing that the amendment, argument, or evidence sought to be entered
could not have been submitted prior to the close of prosecution in the
application.

   Section 1.114(h) provides that the filing of an improper request
for continued examination, including a request for continued
examination with a petition under § 1.114(g) that is not grantable,
will not stay any period for reply or other proceedings. This is
consistent with the current practice for requests for continued
examination. See MPEP § 706.07(h), subsection V (the mere request
for continued examination and fee will not operate to toll the running
of any time period set in the previous Office action for reply to avoid
abandonment of the application).

   The Office proposed § 1.114(f) to include: "[a]ny other
proffer of a request for continued examination in an application not on
appeal will be treated as a submission under § 1.116. Any other
proffer of a request for continued examination in an application on
appeal will be treated only as a request to withdraw the appeal." See
Changes to Practice for Continuing Applications, Requests for Continued
Examination Practice, and Applications Containing Patentably Indistinct
Claims, 71 FR at 61, 1302 Off. Gaz. Pat. Office 1329. This final rule
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1012 

does not adopt that proposed change because it is unnecessary. Section
1.116 applies only to amendments, affidavits, and other evidence filed
after the mailing of a final Office action but prior to an appeal.
However, applicants are permitted to file a request for continued
examination under § 1.114 after the mailing of a notice of
allowance or an action that otherwise closes prosecution in the
application (e.g., an Office action under Ex parte Quayle, 1935 Dec.
Comm'r Pat. 11 (1935)). See § 1.114(b). Furthermore, § 1.114(d)
already provides for the situation in which a request for continued
examination is filed in an application on appeal.

   As discussed previously, applicants are permitted to file two
continuation or continuation-in-part applications and a single request
for continued examination without any justification. The provisions of
§ 1.78(d)(1) are independent of the provisions of § 1.114.
Thus, filing a request for continued examination does not preclude an
applicant from filing a first or second continuation application (or
continuation-in-part application). In addition, an applicant may not
agree to forgo a first or second continuation application (or
continuation-in-part application) to obtain a second or third request
for continued examination, nor can applicant forgo a request for
continued examination to obtain a third continuation or continuation-
in-part application. For example, an applicant cannot file two requests
for continued examination without a petition and showing in an
application instead of filing one of the two permitted continuation
applications.

   The Office is implementing an optional streamlined continuation
application procedure under which an applicant may have a continuation
application placed on an examiner's amended (Regular Amended) docket
(see discussion of § 1.78(d)(1)(i)). Thus, an applicant may
effectively obtain the docketing benefit (i.e., being placed on an
examiner's amended (Regular Amended) docket) of a second and third
request for continued examination without a petition under § 1.114(g)
by requesting that the two continuation applications permitted
under § 1.78(d)(1)(i) be treated under the optional streamlined
continuation application procedure.

   The changes to § 1.114 apply to any application in which a
request for continued examination is filed on or after November 1,
2007. Thus, a request for continued examination filed on or after
November 1, 2007, in an application in which a request for continued
examination has previously been filed, in a continuation or
continuation-in-part application of an application in which a request
for continued examination has previously been filed, or in an
application whose benefit is claimed in any other nonprovisional
application in which a request for continued examination has previously
been filed, must include a petition under § 1.114(g). That is, an
applicant may file a request for continued examination (and not "one
more" request for continued examination) on or after November 1, 2007,
without a petition under § 1.114(g) only if the conditions set
forth in § 1.114(f)(1), (f)(2), or (f)(3) are met.

   Section 1.117 (refund due to cancellation of claim): The
Consolidated Appropriations Act provides that 35 U.S.C. 41(a), (b), and
(d) shall be administered in a manner that revises patent application
fees (35 U.S.C. 41(a)) and patent maintenance fees (35 U.S.C. 41(b)),
and provides for a separate filing fee (35 U.S.C. 41(a)), search fee
(35 U.S.C. 41(d)(1)), and examination fee (35 U.S.C. 41(a)(3)) during
fiscal years 2005 and 2006. See Public Law 108-447, 118 Stat. 2809
(2004). The Consolidated Appropriations Act also provides that the
Office may, by regulation, provide for a refund of any part of the
excess claim fee specified in 35 U.S.C. 41(a)(2) for any claim that is
canceled before an examination on the merits has been made of the
application under 35 U.S.C. 131. See 35 U.S.C. 41(a)(2) (as
administered during fiscal years 2005 and 2006 pursuant to the
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1013 

Consolidated Appropriations Act). The Revised Continuing Appropriations
Resolution, 2007 (Pub. L. 110-5, 121 Stat. 8 (2007)), keeps the patent
fee and fee structure provisions of the Consolidated Appropriations
Act, 2005, in effect during fiscal year 2007 (until September 30,
2007).

   Section 1.117 is added to implement this provision of the
Consolidated Appropriations Act. Section 1.117(a) provides that if an
amendment canceling a claim is filed before an examination on the
merits has been made of the application, the applicant may request a
refund of any fee under § 1.16(h), (i), or (j) or under § 1.492(d),
(e), or (f) paid on or after December 8, 2004, for such
claim. Thus, if an applicant decides to cancel the claims in excess of
five independent claims and in excess of twenty-five total claims
rather than provide an examination support document in compliance with
§ 1.265, the applicant may request a refund of any fee for such
claim that is paid on or after December 8, 2004. Section 1.117(a) as
adopted, however, does not require that the amendment have been filed
in reply to a notice under § 1.75(b)(3). Section 1.117(a) requires
only that the amendment have been filed before an examination on the
merits has been made of the application. The Consolidated
Appropriations Act authorizes a refund only for a claim that has been
canceled before an examination on the merits has been made of the
application under 35 U.S.C. 131. The Office thus lacks authority to
grant a refund either on the basis of: (1) The withdrawal from
consideration of a claim directed to a non-elected invention or
species; or (2) the cancellation of a claim after an examination on the
merits has been made of the application under 35 U.S.C. 131. Section
1.117(a) also provides that if an amendment adding one or more claims
is also filed before the application has been taken up for examination
on the merits, the Office may apply any refund under § 1.117 to any
excess claims fees due as a result of such an amendment. The date
indicated on any certificate of mailing or transmission under § 1.8
will not be taken into account in determining whether an amendment
canceling a claim was filed before an examination on the merits has
been made of the application.

   "[A]n examination on the merits has been made of the
application" for purposes of § 1.117(a) once a first Office action
on the merits, notice of allowability or allowance, or action under Ex
parte Quayle is shown in the Patent Application Locating and Monitoring
(PALM) system as having been counted. For purposes of § 1.117(a),
"before" means at least one day before. If an amendment canceling a
claim is filed and an Office action is counted on the same day, the
amendment canceling a claim was not filed before an examination on the
merits has been made of the application. The Patent Application
Information Retrieval (PAIR) system is a system that provides public
access to PALM for patents and applications that have been published.
The PAIR system does not provide public access to information
concerning applications that are maintained in confidence under 35
U.S.C. 122(a). Applicants, however, may use the private side of PAIR to
access confidential information about their pending application. To
access the private side of PAIR, a customer number must be associated
with the correspondence address for the application, and the user of
the system must have a digital certificate. For further information,
contact the Customer Support Center of the Electronic Business Center
at (571) 272-4100 or toll free at (866) 217-9197.

   Section 1.117(b) (§ 1.117(c) as proposed) provides that if a
request for refund under this section is not filed within two months
from the date on which the claim was canceled, the Office may retain
the excess claims fee paid in the application. This two-month period is
not extendable. If an amendment canceling a claim is not filed before
an examination on the merits, the Office will not refund any part of
the excess claims fee paid in the application except as provided in
§ 1.26.
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1014 


   The provisions of § 1.117(b) as proposed are duplicative of the
provisions of § 1.138(d) and have not been adopted as unnecessary.

   The patent fee provisions of the Consolidated Appropriations Act
expire (in the absence of additional legislation) on September 30, 2007
(at the end of fiscal year 2007). Therefore, in the absence of
subsequent legislation, the refund provision in § 1.117 will
likewise expire on September 30, 2007 (at the end of fiscal year 2007),
regardless of the date on which the excess claims fee was paid.

   Section 1.136 (extensions of time): Section 1.136(a)(1) is amended
to add "[t]he reply is to a notice requiring compliance with §
1.75(b) or § 1.265" to the enumerated list of replies to which the
extension of time provision of § 1.136(a) is not applicable. A
notice under § 1.75(b)(3) is a "notice requiring compliance with
§ 1.75(b)." A "notice requiring compliance with § 1.75(b)"
would include a notice mailed before the issuance of a first Office
action on the merits setting a two-month time period within which the
applicant must: (1) File an examination support document in compliance
with § 1.265; or (2) amend the application such that it contains no
more than five independent claims and no more than twenty-five total
claims. A "notice requiring compliance with § 1.75(b)" would also
include a notice issued after a first Office action on the merits in an
application in which the applicant is given a time period within which
the applicant must amend the application such that it contains no more
than five independent claims and no more than twenty-five total claims.
For example, if a reply to a non-final Office action on the merits
seeks to amend an application such that it contains more than five
independent claims and more than twenty-five total claims, the reply
would be held non-responsive and (if the non-compliance with § 1.75(b)
appears to have been inadvertent) the Office would give the
applicant a two-month time period that was not extendable under § 1.136(a)
within which to provide an amendment that does not result in
the application containing more than five independent claims or more
than twenty-five total claims. See § 1.135(c).

   Section 1.142 (requirement for restriction): Section 1.142(a) is
amended to state that an examiner "may" (rather than "will")
require restriction if two or more independent and distinct inventions
are claimed in a single application. The change is for consistency with
current Office practice under which a requirement that an application
containing claims to two or more independent and distinct inventions be
restricted to a single invention is discretionary (see 35 U.S.C. 121
and MPEP § 803.01). An application containing claims to two or more
independent and distinct inventions typically is not restricted to a
single invention if the search and examination of all of the claims in
the application can be made without serious burden (see MPEP section
803).

   Section 1.142(c) is added to permit applicants to suggest
requirements for restriction. Specifically, § 1.142(c) provides
that if two or more independent and distinct inventions are claimed in
a single application, the applicant may file a suggested requirement
for restriction under § 1.142(c). Any suggested requirement for
restriction must be filed before the earlier of the first Office action
on the merits or an Office action that contains a requirement to comply
with the requirement of unity of invention under PCT Rule 13 or a
requirement for restriction under 35 U.S.C. 121 in the application. It
must also be accompanied by an election without traverse of an
invention to which there are no more than five independent claims and
no more than twenty-five total claims, and must identify the claims to
the elected invention. Claims to the non-elected invention, if not
canceled, will be withdrawn from further consideration by the examiner.
If the examiner accepts the suggested restriction, then the claims to
the non-elected invention, if not canceled by the applicant, will be
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1015 

withdrawn from further consideration by the examiner. See the
discussion of §§ 1.75(b)(5) and 1.78(d)(1)(ii).

   Section 1.75(b)(3)(iii) as proposed would have permitted applicants
to reply to a notice from the Office that an application contains more
than ten representative claims (under certain conditions) by submitting
a suggested requirement for restriction accompanied by an election
without traverse of an invention to which there are no more than five
independent claims and no more than twenty-five total claims. See
Changes to Practice for the Examination of Claims in Patent Applications,
71 FR at 64, 67-68, 1302 Off. Gaz. Pat. Office 1331, 1334. However,
because the "representative claims" examination approach is not adopted in
this final rule, this proposed provision of § 1.75(b)(3)(iii) is
unnecessary. In this final rule, applicants may file a suggested
requirement for restriction accompanied by an election without traverse
(§ 1.142(c)) of an invention to which there are no more than five
independent claims and no more than twenty-five total claims without
first awaiting a notice from the Office under § 1.75(b)(3).

   Section 1.142(c) further provides that if the applicant's suggested
requirement for restriction is accepted, the restriction requirement
will be set forth in a subsequent Office action. Any claim to the non-
elected invention or inventions, if not canceled, is by the election
withdrawn from further consideration.

   If the suggested requirement for restriction is refused, the
applicant will be notified in an Office action. That Office action may
include, a notice under § 1.75(b)(3) requiring applicant to file an
examination support document or amend the application to contain no
more than five independent claims or no more than twenty-five total
claims. If an applicant's suggested restriction requirement is refused,
the examiner may make a different restriction requirement or make no
restriction requirement. 35 U.S.C. 121 authorizes, but does not compel,
the Director to require that an application containing two or more
independent and distinct inventions be restricted to one of the
inventions. A decision not to restrict an application to a single
invention is not an action or requirement within the meaning of
§ 1.181(a). Thus, any review of an examiner's requirement for restriction
that differs from a suggested restriction requirement will only concern
the appropriateness of the examiner's restriction requirement and will
not address the appropriateness of the applicant's suggested
restriction requirement or compare the examiner's restriction
requirement and the suggested restriction requirement.

   Section 1.145 (subsequent presentation of claims for different
invention): Section 1.145 is amended to state that an applicant "may"
(rather than "will") be required to restrict the claims to the
invention previously claimed if, after an Office action on an
application, the applicant presents claims directed to an invention
distinct from and independent of the invention previously claimed (see
discussion of § 1.142(a)). Section 1.145 is amended to add "on the
merits" to clarify that § 1.145 applies only after a first Office
action on the merits.

   Section 1.265 (examination support document): Section 1.265 is
added to set forth what an "examination support document" entails. An
examination support document is required under § 1.75(b)(1) when an
applicant presents more than five independent claims or more than
twenty-five total claims in an application. See § 1.75(b)(1) and
the discussion of § 1.75(b)(1). Section 1.265(a) sets forth the
requirements for an examination support document. Section 1.265(b)
provides for the requirements of the preexamination search required
under § 1.265(a)(1). Section 1.265(c) provides for the requirements
of the listing of references required under § 1.265(a)(2). Section
1.265(d) provides for certain situations in which a supplemental
examination support document is required when applicant files an
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1016 

information disclosure statement citing additional references. Section
1.265(e) provides for situations in which the examination support
document is insufficient. Section 1.265(f) provides an exemption to
applications filed by a small entity as defined by the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.). The exemption is for the
requirement in § 1.265(a)(3) that an examination support document
must include an identification of all of the claim limitations (whether
in independent or dependent form) that are disclosed by the cited
references.

   Section 1.265 contains fewer requirements than an accelerated
examination support document under the revised procedures for certain
petitions to make special (see Changes to Practice for Petitions in
Patent Applications To Make Special and for Accelerated Examination, 71
FR 36232 (June 26, 2006), 1308 Off. Gaz. Pat. Office 106 (July 18,
2006) (notice)). For example, § 1.265 does not require that the
examination support document identify any cited references that may be
disqualified as prior art under 35 U.S.C. 103(c) as amended by the
Cooperative Research and Technology Act (although applicants are
encouraged to identify any cited references that may be so
disqualified). Thus, the Office's guidelines concerning the accelerated
examination support document may be helpful to applicants who are
preparing an examination support document under § 1.265. The
guidelines under the revised accelerated examination procedure, search
templates, and samples of a preexamination search document and an
examination support document can be found on the Office's Internet Web
site at http://www.uspto.gov/web/patents/accelerated/. The Office will
provide similar guidelines for examination support document under
§ 1.265 and will post such guidelines on the Office's Internet Web site.

   Section 1.265(a)(1) provides that an examination support document
must include a statement that a preexamination search in compliance
with § 1.265(b) was conducted. The examination support document
must identify (in the manner set forth in MPEP § 719.05) the field
of search by class and subclass and the date of the search, where
applicable. For database searches, the examination support document
must identify the search logic or chemical structure or sequence used
as a query, the name of the file or files searched and the database
service, and the date of the search.

   Section 1.265(a)(2) provides that an examination support document
must include a listing in compliance with § 1.265(c) of the
reference or references deemed most closely related to the subject
matter of each of the claims (whether in independent or dependent
form). The references that would be most closely related to the subject
matter of each of the claims include: (1) A reference that discloses
the most number of limitations in an independent claim; (2) a reference
that discloses a limitation of an independent claim that is not shown
in any other reference in the listing of references required under
§ 1.265(a)(2); and (3) a reference that discloses a limitation of a
dependent claim that is not shown in any other reference in the listing
of references required under § 1.265(a)(2). References that are
only relevant to the general subject matter of the claims would not be
most closely related to the subject matter of each of the claims if
there are other references that are deemed to be more closely related
to the subject matter of the claims.

   It is envisioned that the reference or references presented as
being most closely related to the subject matter of the claims will
generally be references that result from the preexamination search
provided for in § 1.265(a)(1). The preexamination search provided
for in § 1.265(a)(1) should result in the reference or references
that are most closely related to the subject matter of the claims.
However, an applicant may not exclude a reference from an examination
support document simply because the reference was not the result of the
preexamination search provided for in § 1.265(a)(1). The reference,
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1017 

for instance, may have been brought to applicant's attention via a
foreign or PCT search report. References that have
been brought to the applicant's attention regardless of the source of
those references must be considered in identifying the reference or
references most closely related to the subject matter of each of the
claims.

   Section 1.265(a)(3) provides that an examination support document
must, for each reference in the listing of references required under
§ 1.265(a)(2), identify all of the limitations of each of the
claims (whether in independent or dependent form) that are disclosed by
the reference. Applicant may satisfy this requirement either by mapping
the limitations of each of the claims to the references or by mapping
the references to the limitations of the claims. Applicants may map the
limitations of each of the claims to the references by, for each claim,
identifying where the cited references disclose features, showings, or
teachings that are relevant to each limitation of such claim.
Applicants may map the references to the limitations of the claims by,
for each cited reference, identifying where the reference discloses
features, showings, or teachings that are relevant to the limitations
of each of the claims.

   Section 1.265(a)(3) requires the applicant to identify at least one
appearance in the reference (a representative portion) of a specific
feature, showing, or teaching for which the reference is being cited.
If the feature, showing, or teaching appears in more than one portion
of the reference, applicant would not need to specifically point out
more than one occurrence. Applicant, however, should do so where the
additional appearance may not be apparent to the examiner and may have
some additional significance over its first identified appearance. If
an applicant recognizes that a document is relevant for more than one
feature, showing, or teaching, the applicant would need to specifically
identify each additional feature, showing, or teaching and the portion
where the feature, showing, or teaching appears in the document. A mere
statement indicating that the entire reference, or substantially the
entire reference, is relevant would not comply with § 1.265(a)(3).

   Section 1.265(a)(4) provides that an examination support document
must include a detailed explanation particularly pointing out how each
of the independent claims is patentable over the references cited in
the listing of references required under § 1.265(a)(2). The
explanation required by § 1.265(a)(4) may be set forth together
with the identification required by § 1.265(a)(3) or may be
provided separately. For example, the identification required by §
1.265(a)(3) and the explanation required by § 1.265(a)(4) may be
set out in a single spreadsheet with two columns, or may be set out in
two spreadsheets. A general statement that all of the claim limitations
are not described in a single reference does not satisfy the
requirements of § 1.265(a)(4). Section 1.265(a)(4) requires that
the examination support document set out with particularity, by
reference to one or more specific claim limitations, why the claimed
subject matter is not described in the references, taken as a whole.
The applicant must explain why a person of ordinary skill in the art
would not have combined the features disclosed in one reference with
features disclosed in another reference to arrive at the claimed
subject matter. The applicant must also explain why the claim
limitations referenced render the claimed subject matter novel and non-
obvious over the cited prior art.

   Section 1.265(a)(5) provides that an examination support document
must include a showing of where each limitation of the claims (whether
in independent or dependent form) finds support under 35 U.S.C. 112, ¶
1, in the written description of the specification. If the application
claims the benefit of one or more applications under title 35, United
States Code, the showing must also include where each limitation of the
claims finds support under 35 U.S.C. 112, ¶ 1, in each such application
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1018 

in which such support exists. For means- (or step-) plus-function claim
elements under 35 U.S.C. 112, ¶ 6, this requires: (1) That the claim
limitation be identified as means- (or step-) plus-function claim
element under 35 U.S.C. 112, ¶ 6; and (2) that the structure, material,
or acts in the specification that correspond to each means- (or step-)
plus-function claim element under 35 U.S.C. 112, ¶ 6, be identified.
See Changes to Practice for Petitions in Patent Applications To Make
Special and for Accelerated Examination, 71 FR at 36325, 1308 Off. Gaz.
Pat. Office at 107.

   If the examiner, after considering the application and any
examination support document, still has questions concerning the
invention or how the claims define over the prior art or are
patentable, the examiner may request an interview before the first
Office action. If the applicant declines such a request for an
interview or if the interview does not result in the examiner obtaining
the necessary information, the examiner may issue a requirement for
information under § 1.105 to obtain such information. Section
1.133(a)(2) was amended in November of 2005 to permit an interview
before the first Office action if the examiner determines that such an
interview would advance prosecution. See Provisions for Claiming the
Benefit of a Provisional Application With a Non-English Specification
and Other Miscellaneous Matters, 70 FR at 56121, 56128, 1299 Off. Gaz.
Pat. Office at 144, 150. Applicant may request an interview before the
first Office action. Such a request is ordinarily granted in a
continuing application or if the examiner determines that the interview
would advance prosecution. See § 1.133(a)(2) and MPEP § 713.02.

   Section 1.265(b) provides that the preexamination search must
involve U.S. patents and patent application publications, foreign
patent documents, and non-patent literature, unless the applicant can
justify with reasonable certainty that no references more pertinent
than those already identified are likely to be found in the eliminated
source. That justification must be included in the statement required
by § 1.265(a)(1). Section 1.265(b) also provides that the
preexamination search must encompass all of the limitations of the
independent claims. It must also encompass all of the limitations of
the dependent claims separately from the claim or claims from which
they depend. The claims must be given the broadest reasonable
interpretation. A search report from a foreign patent office will not
automatically satisfy the requirement in § 1.265(a)(1) for a
preexamination search unless it includes the information required by
§ 1.265.

   Section 1.265(c) provides for the content requirements of the
listing of references required under § 1.265(a)(2) as part of an
examination support document. Section 1.265(c) provides the same
content requirements as those that are currently provided in §§
1.98(a) and (b). Specifically, § 1.265(c) provides that the listing
of references required under § 1.265(a)(2) as part of an
examination support document must include a list identifying each of
the cited references (§§ 1.265(c)(1) and (c)(2)), a copy of
each reference except for references that are U.S. patents or U.S.
patent application publications (§ 1.265(c)(3)), and each English
language translation if required by § 1.265(c)(4). Applicant may
use the USPTO form, "Examination Support Document Listing of
References," to submit the listing of references. The form will be
available on the Office's Internet Web site at http://www.uspto.gov/
web/forms/index.html#patent.

   Section 1.265(c)(1) provides that the list of cited references must
group U.S. patents and U.S. patent application publications (including
international applications designating the United States) in a section
separate from other references. Section 1.265(c)(1) also provides that
each page of the list of the cited references must include: (1) The
application number, if known, of the application in which the examination
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1019 

support document is being filed; (2) a column that provides a space next
to each cited reference for the examiner's initials; and (3) a heading
that clearly indicates that the list is part of an examination support
document listing of references.

   Section 1.265(c)(2) provides that the list of cited references must
identify each cited reference as follows: (1) Each U.S. patent must be
identified by first named patentee, patent number, and issue date; (2)
each U.S. patent application publication must be identified by
applicant, patent application publication number, and publication date;
(3) each U.S. application must be identified by the applicant,
application number, and filing date; (4) each foreign patent or
published foreign patent application must be identified by the country
or patent office which issued the patent or published the application,
an appropriate document number, and the publication date indicated on
the patent or published application; and (5) each publication must be
identified by publisher (e.g., name of journal), author (if any),
title, relevant pages of the publication, publication date, and place
of publication.

   Section 1.265(c)(4) provides that if a non-English language
document is being cited, any existing English language translation of
the non-English language document must be submitted if the translation
is within the possession, custody, or control of, or is readily
available to any individual identified in § 1.56(c).

   Section 1.265(d) provides for a supplemental examination support
document. If an information disclosure statement is filed in an
application in which an examination support document is required and
has been filed, the applicant must also file a supplemental examination
support document addressing the references cited in the information
disclosure statement in the manner required under §§ 1.265(a)(3) and
(a)(4), unless the information disclosure statement cites only references
that are less closely related to the subject matter of one or more claims
than the references cited in the examination support document listing of
references required under § 1.265(a)(2).

   Section 1.265(e) provides that the applicant will be notified if:
(1) The examination support document or preexamination search is deemed
to be insufficient; or (2) the claims have been amended such that the
examination support document no longer covers each claim. The notice
will give the applicant a two-month time period within which the
applicant must either file a corrected or supplemental examination
support document or amend the application such that it contains no more
than five independent claims and no more than twenty-five total claims
in order to avoid abandonment. Section 1.265(e) further provides that
this two-month period is not extendable under § 1.136(a).

   Section 1.265(f) provides an exemption from the requirement in
§ 1.265(a)(3) that an examination support document must, for each
reference cited in the listing of references required under §
1.265(a)(2), include an identification of all of the limitations of
each of the claims (whether in independent or dependent form) that are
disclosed by the reference that applies to applications by a small
entity as defined by the Regulatory Flexibility Act (5 U.S.C. 601 et
seq.). The Regulatory Flexibility Act defines a "small entity" as a
"small business" as defined in 5 U.S.C. 601(3), a "small
organization" as defined in 5 U.S.C. 601(4), and a "small
governmental jurisdiction" as defined 5 U.S.C. 601(5). See 5 U.S.C.
601(6). Section 1.265(f) specifically provides that an examination
support document, or a corrected or supplemental examination support
document, is not required to comply with the requirements set forth in
§ 1.265(a)(3) if the examination support document is accompanied by
a certification that any rights in the application have not been
assigned, granted, conveyed, or licensed, and there is no obligation
under contract or law to assign, grant, convey, or license any rights
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1020 

in the application, other than a security interest that has not been
defaulted upon, to any entity other than a business or other concern as
defined in § 1.265(f)(1), a not-for-profit enterprise as defined in
§ 1.265(f)(2), or a government as defined in § 1.265(f)(3). A
business or other concern which meets the definition set forth in
§ 1.265(f)(1), a not-for-profit enterprise that meets the definition set
forth in § 1.265(f)(2), or a government that meets the definition
set forth in § 1.265(f)(3) may make the certification provided for
in § 1.265(f) regardless of whether the business or other concern,
not-for-profit enterprise, or government is located in or operates
primarily in the United States.

   With respect to the business or other concerns defined in
§ 1.265(f)(1), the Regulatory Flexibility Act provides that "the term
`small business' has the same meaning as the term `small business
concern' under section 3 of the Small Business Act, unless an agency,
after consultation with the Office of Advocacy of the Small Business
Administration and after opportunity for public comment, establishes
one or more definitions of such term which are appropriate to the
activities of the agency and publishes such definition(s) in the
Federal Register." See 5 U.S.C. 601(3). The Office has established the
standard set forth in 13 CFR 121.802 for paying reduced patent fees as
the definition of "small business" for Regulatory Flexibility Act
purposes with respect to patent-related regulations. Therefore, a
"small business" for Regulatory Flexibility Act purposes with respect
to patent-related regulations is a business or other concern: (1) Whose
number of employees, including affiliates, does not exceed 500 persons;
and (2) which has not assigned, granted, conveyed, or licensed (and is
under no obligation to do so) any rights in the invention to any person
who made it and could not be classified as an independent inventor, or
to any concern which would not qualify as a non-profit organization or
a small business concern under this definition.

   With respect to the not-for-profit enterprises defined in
§ 1.265(f)(2), the Regulatory Flexibility Act provides that "the term
`small organization' means any not-for-profit enterprise which is
independently owned and operated and is not dominant in its field,
unless an agency establishes, after opportunity for public comment, one
or more definitions of such term which are appropriate to the
activities of the agency and publishes such definition(s) in the
Federal Register." See 5 U.S.C. 601(4). The Office has not established
any definition of "small organization" for Regulatory Flexibility Act
purposes with respect to patent-related regulations. Therefore, a
"small organization" for Regulatory Flexibility Act purposes with
respect to patent-related regulations is a not-for-profit enterprise
which is independently owned and operated and is not dominant in its
field.

   With respect to the governments defined in § 1.265(f)(3), the
Regulatory Flexibility Act provides that "the term `small governmental
jurisdiction' means governments of cities, counties, towns, townships,
villages, school districts, or special districts, with a population of
less than fifty thousand, unless an agency establishes, after opportunity
for public comment, one or more definitions of such term which are
appropriate to the activities of the agency and which are based on such
factors as location in rural or sparsely populated areas or limited
revenues due to the population of such jurisdiction, and publishes such
definition(s) in the Federal Register." See 5 U.S.C. 601(5). The Office has
not established any definition of "small governmental jurisdiction" for
Regulatory Flexibility Act purposes with respect to patent-related
regulations. Therefore, a "small governmental jurisdiction" for Regulatory
Flexibility Act purposes with respect to patent-related regulations is
a government of a city, county, town, township, village, school
district, or special district, with a population of less than fifty
thousand.

Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1021 

   An entity that meets the definition of a small entity set forth in
§ 1.27 for paying reduced patent fees may or may not meet one of
the definitions under §§ 1.265(f)(1) through (f)(3) to make a
certification under § 1.265(f). The Office will not give advisory
opinions as to whether or not a specific individual or entity meets the
definitions under §§ 1.265(f)(1) through (f)(3) to make a
certification under § 1.265(f). Questions related to standards for
small business concerns, not-for-profit enterprises, or governments may
be directed to: Small Business Administration, Size Standards Staff,
409 Third Street, SW., Washington, DC 20416.

   Section 1.495 (entering the national stage in the United States of
America): Section 1.495(g) provides that if the documents and fees
contain conflicting indications as to whether the submission is an
application under 35 U.S.C. 111 or a submission to enter the national
stage under 35 U.S.C. 371, the documents and fees will be treated as a
submission to enter the national stage under 35 U.S.C. 371. It is
Office experience that, in most cases, documents and fees that contain
such conflicting indications were intended as submissions under 35
U.S.C. 371.

   Section 1.704 (reduction of period of adjustment of patent term):
Section 1.704(c) is amended to provide the patent term adjustment
consequences of a failure to comply with § 1.75(b) (e.g., a failure
to file an examination support document in compliance with § 1.265
when necessary under § 1.75(b)). Such a failure will be considered
a circumstance that constitutes a failure of an applicant to engage in
reasonable efforts to conclude processing or examination of an
application under 35 U.S.C. 154(b)(2)(C). The failure to comply with
§ 1.75(b) will delay processing or examination of an application
because the Office must issue a notice and await the applicant's reply
before examination of the application may begin. Therefore,
§ 1.704(c) provides for a reduction of any patent term adjustment when
there is a failure to comply with § 1.75(b). Specifically, any
patent term adjustment will be reduced by the number of days in the
period between the following beginning and ending dates. The beginning
date of the period is the day after the date that is the later of: (1)
The filing date of the amendment resulting in the noncompliance with
§ 1.75(b); (2) four months from the filing date of the application
in an application under 35 U.S.C. 111(a); or (3) four months from the
date on which the national stage commenced under 35 U.S.C. 371(b) or
(f) in an application which entered the national stage from an
international application after compliance with 35 U.S.C. 371. The
ending date of the period is the filing date of: (1) An examination
support document in compliance with § 1.265; (2) an election
responsive to an Office-issued requirement for restriction including an
election of species that places the application in compliance with
§ 1.75(b) (e.g., the election of an invention that is drawn to five
or fewer independent claims and twenty-five or fewer total claims that
would obviate the need for an examination support document under
§ 1.265); (3) an amendment resulting in compliance with § 1.75(b)
(e.g., amending the application to contain five or fewer independent
claims and twenty-five or fewer total claims); (4) a suggested
requirement for restriction under § 1.142(c) accompanied by an
election without traverse of an invention to which there are no more
than five independent claims and no more than twenty-five total claims.

   The examiner's acceptance of a suggested requirement for
restriction accompanied by an election without traverse of an invention
to which there are no more than five independent claims and no more
than twenty-five total claims would be sufficient to obviate the need
for an examination support document under § 1.265. If the suggested
requirement for restriction is not accepted, the applicant will be
notified and given a time period within which the applicant must either
file an examination support document or amend the application such that
it contains no more than five independent claims and no more than
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1022 

twenty-five total claims. Failure to timely reply to such a notice
would result in the abandonment of the application. The abandonment of
an application results in the period of adjustment set forth in
§ 1.703 (if any) being reduced under § 1.704(c)(3).

III. Response to Comments

   As discussed previously, the Office published notices in January of
2006 proposing: (1) Changes to practice for continuing applications,
requests for continued examination, and applications containing
patentably indistinct claims; and (2) changes to the practice for the
examination of claims in patent applications. See Changes to Practice
for Continuing Applications, Requests for Continued Examination
Practice, and Applications Containing Patentably Indistinct Claims, 71
FR at 48-61, 1302 Off. Gaz. Pat. Office 1318-29, and Changes to
Practice for the Examination of Claims in Patent Applications, 71 FR
61-69, 1302 Off. Gaz. Pat. Office 1329-35. The Office received over
five hundred written comments (from government agencies, universities,
intellectual property organizations, industry, law firms, individual
patent practitioners, and the general public) in response to this
notice. The comments and the Office's responses to the comments follow:

A. Changes to Continuing Application Practice

   Comment 1: A number of comments stated that the changes in the
definitions of continuation, divisional, and continuation-in-part
applications set forth in § 1.78(a) are likely to confuse the
public and examiners and that the Office has not identified any value
that would result from these changes. Several comments suggested that
further guidance was needed to resolve ambiguities as to whether an
application is a divisional or continuation application. One comment
argued that the requirement to identify the relationship of the
applications could create hardship when it is unclear whether the
changes to the specification or claims make the application a
continuation, divisional, or continuation-in-part application.

   Response: The definitional changes are necessary in order to
clearly define the conditions for claiming benefit of prior-filed
applications under § 1.78(d)(1). This final rule further clarifies
the definition of a divisional application set forth in § 1.78(a)(2).
Under this final rule, an applicant may file a divisional
application directed to a non-elected invention if the prior-filed
application is subject to a requirement for restriction. The divisional
application need not be filed during the pendency of the application
subject to a requirement for restriction, as long as the copendency
requirement of 35 U.S.C. 120 is met. Thus, applicant may file a divisional
application claiming the benefit of the initial application that was
subject to the requirement for restriction and any intermediate continuing
applications.

   Furthermore, the definitions of continuation, divisional, and
continuation-in-part application set forth in § 1.78(a) are
substantially the same as the previous definitions set forth in the
MPEP, except that a divisional application is now defined more
narrowly. See the discussion of § 1.78(a). The former practice
permitted an applicant to file a continuing application and identify
the application as a "divisional" application even when the prior-
filed application was not subject to a requirement for restriction.
Such a continuing application was called a "voluntary" divisional
application. Under this final rule, a "voluntary" divisional
application would instead fall under the definition of a continuation
application. Therefore, a continuing application would be a
continuation application and not a divisional ("voluntary"
divisional) application if the prior-filed application was not subject
to a requirement for restriction. If the prior-filed application was
subject to a requirement for restriction, a continuing application
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1023 

claiming only a non-elected invention or inventions would be a
divisional application. It is noted that although the definition of
continuation application set forth in § 1.78(a)(2) uses the phrase
"invention or inventions" rather than "subject matter" (as used in
the definition of continuation application set forth in MPEP § 201.07),
no substantive difference between these terms is intended. The
requirement to identify the relationship (i.e., continuation,
divisional, or continuation-in-part) between the prior-filed
application and the continuing application is not a new requirement
under this final rule. This requirement has been provided in the former
§ 1.78(a)(2)(i). Accordingly, the definitions of continuation,
divisional, and continuation-in-part application set forth in § 1.78(a)
are not likely to confuse the public or examiners for any extended period.

   Comment 2: A number of comments observed the proposed requirement
that a divisional application may claim the benefit of only a single
application would require that all divisional applications filed as a
result of a restriction requirement in a prior-filed application be
filed before the patenting or abandonment of that application. A number
of comments suggested that the rule changes limiting divisional
applications to claim benefit to only a single prior-filed application
would result in an overall increase in application filings and
pendency, contrary to their intended purpose. The comments contended
the changes being adopted in this final rule effectively force
applicants to claim all patentably distinct inventions in the prior-
filed application or file related applications in parallel in order to
preserve potential patent rights in those inventions. The comments
suggested that since a divisional application must be filed during the
pendency of the prior-filed application, many more divisional
applications would be filed than would be filed under the current
system, as applicants will not have sufficient time and information to
determine whether the invention is worth pursuing. The comments stated
that, consequently, the Office will be forced to examine more
inventions than it would under current practice, wasting both
applicants' and the Office's resources. A number of comments also
suggested that the inability to prosecute divisional applications
sequentially, thus allowing applicants to spread filing and prosecution
costs over time and to file only those divisional applications that are
commercially valuable in view of subsequent market development, will
have a particularly negative impact on the biotechnology and
pharmaceutical industries and on small entities. The comments suggested
that patent rights will be lost due to a lack of funding and that the
increased costs will be particularly onerous in certain technologies,
e.g., biotechnology and chemical arts, where the Office routinely
issues complex restriction requirements, sometimes alleging hundreds or
thousands of independent and distinct inventions. Several comments also
suggested that the rules should be modified to account for the economic
impossibility, in many cases, of pursuing numerous divisional
applications simultaneously. One comment also suggested that the need
to file multiple stand alone applications or divisional applications at
an early stage in prosecution to cover all embodiments of the invention
will cause small companies to cut back funding on research in favor of
patent prosecution, thus hindering innovation. One comment also
suggested that the rules be revised, consistent with European Patent
Office divisional practice, to permit the serial filing of divisional
applications with the limitation that claims pursued in a continuation
of any serial divisional application must be of the same scope as, or
of a narrower scope than, the claims presented in that serial
divisional application. One comment also suggested that prior to
implementing the rule changes, the Office should conduct a study to
assess the scope of potential divisional filing problems by studying
the divisional filing habits of large and small entity applicants.

   Response: The Office notes the concerns expressed in the public
comment regarding the proposed requirement in § 1.78(d)(1)(ii) that
a divisional application be filed during the pendency of the initial
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1024 

application. In response to those concerns and suggestions,
§ 1.78(d)(ii) as adopted in this final rule does not require that a
divisional application be filed during the pendency of the initial
application. This final rule permits applicants to file a divisional
application for the claims to a non-elected invention if the initial
application is subject to a requirement for restriction, the claims to
the non-elected invention are cancelled in the initial application, and
the divisional application meets the copendency requirement of 35
U.S.C. 120. That is, an applicant may file a divisional application
during the pendency of the application that was subject to a
restriction requirement or the pendency of any continuing application
of such application. This final rule also permits applicant to file two
continuation applications of a divisional application, plus a request
for continued examination in the divisional application family, without
any justification.

   Comment 3: A number of comments suggested that the rule changes
would encourage applicants to file more petitions challenging
restriction requirements, thus further burdening the Office.

   Response: The criteria for making a restriction requirement remain
the same. Applicant may still seek review of any restriction
requirements, if appropriate. The Office, however, does not anticipate
any substantial increase in the number of petitions seeking review of
restriction requirements. As discussed previously, § 1.78(d)(1)(ii)
as adopted in this final rule does not require that a divisional
application be filed during the pendency of a single prior-filed
application. This final rule permits applicant to file a divisional
application of an application if the application is subject to a
requirement for restriction, claims to the non-elected invention are
cancelled in the prior-filed application, and the divisional
application meets the copendency requirement of 35 U.S.C. 120. That is,
applicant may file a divisional application during the pendency of the
application that was subject to a requirement for restriction or the
pendency of any continuing application of such application. Applicant
will have sufficient time to determine whether to file a divisional
application directed to a non-elected invention.

   Comment 4: Several comments stated that the rule changes do not
adequately address the situation where a restriction requirement is
made by the examiner in a continuing application. The comments
expressed concern that the rule changes appear to require applicant to
forego all but one invention. One comment stated that the applicant's
prior application, if published, may constitute prior art if benefit to
the prior application is not permitted. Another comment suggested that
concerns over prolonging patent term, abuse or bad faith are not raised
where a divisional application is filed as a result of a restriction
requirement made in the continuing application, and that such filings
may actually improve quality, as the searches performed in the initial
and first continuing application often provide significant information
and guidance to the examiner in the second continuing application.

   Response: As discussed previously, the Office has modified the
proposed § 1.78(d)(1)(ii) in this final rule such that it does not
require a divisional application to be filed during the pendency of a
single prior-filed application. Instead, this final rule permits an
applicant to file a divisional application for the claims to a non-
elected invention that was not examined if the application was subject
to a requirement for restriction, the claims to the non-elected
invention are cancelled in the prior-filed application, and the
divisional application meets the copending requirement of 35 U.S.C.
120. Therefore, applicant may file a divisional application of a
continuing application for the claims to a non-elected invention that
has not been examined if the continuing application was subject to a
requirement for restriction. Such a divisional application may claim
the benefit of the continuing application that was subject to a
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1025 

requirement for restriction and the initial application whose benefit
is claimed in the continuing application.

   Comment 5: One comment requested clarification as to whether a
divisional application can be filed if a request for continued
examination was filed in the initial application.

   Response: The filing of a request for continued examination in the
initial application does not preclude an applicant from filing a
divisional application under the proposed rule as well as under this
final rule. The condition that "no request for continued examination
under § 1.114 has been filed in the prior-filed application" as
proposed applied only to the filing of continuation and continuation-
in-part applications under proposed § 1.78(d)(1)(i). Compare
proposed §§ 1.78(d)(1)(i) and 1.78(d)(1)(ii). Furthermore,
§ 1.78(d)(1) as adopted in this final rule contains no conditions
with respect to continuation applications, divisional applications, or
continuation-in-part applications concerning whether a request for
continued examination was filed in the initial application or a prior-
filed continuing application. Therefore, the filing of a request for
continued examination does not preclude an applicant from filing two
continuation or continuation-in-part applications, and any divisional
application directed to a non-elected invention that has not been
examined if the prior-filed application was subject to a requirement
for restriction.

   Comment 6: A number of comments requested that the Office not limit
"voluntary" divisional applications. In addition, several comments
noted the importance of "voluntary" divisional applications in
protecting important inventions the significance of which could not
reasonably be anticipated when the application was filed. Another
comment indicated the importance of "voluntary" divisional
applications for obtaining quick patents to protect applicants'
products from competitors while preserving the opportunity to obtain
patent protection on other aspects of the invention. Several comments
stated that the standard under § 1.78(d)(1) makes little sense when
the objective of filing the continuing application is to obtain patents
on distinct inventions. One of the comments expressed concern that each
patent is, both by law and regulation, to be directed to a single
invention and that patent applications directed to multiple inventions
are subject to restriction under 35 U.S.C. 121.

   Response: This final rule permits applicants to file a so-called
"voluntary" divisional application as a continuation application in
compliance with § 1.78(d)(1)(i) when the prior-filed application
was not subject to a requirement for restriction. Under § 1.78(d)(1)(i),
applicant may file two such continuation applications without a petition
and showing of why the amendment, argument, or evidence sought to be
entered could not have been previously submitted. Applicant likewise may
file a third or subsequent continuation application with a petition and
showing pursuant to § 1.78(d)(1)(vi).

   Furthermore, applicant may suggest a requirement for restriction
under § 1.142(c) if the applicant believes that two or more
independent and distinct inventions are claimed in the application.
See § 1.142(c) and the discussion of § 1.142(c). In such case,
§ 1.78(d)(1)(ii) provides that an applicant may file a divisional
application directed to a non-elected invention that has not been
examined if the prior-filed application is subject to a requirement for
restriction. The divisional application is not required to be filed
during the pendency of the application subject to a requirement for
restriction, as long as the copendency requirement of 35 U.S.C. 120 is
met. Section § 1.78(d)(1)(iii) also permits an applicant to file,
without a petition and showing, two continuation applications of a
divisional application plus a request for continued examination in the
divisional application family. Therefore, applicants have sufficient
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1026 

opportunity to obtain patent protection on other aspects of the invention.

   35 U.S.C. 121 provides that "[i]f two or more independent and
distinct inventions are claimed in one application, the Director may
require the application to be restricted to one of the inventions."
(Emphasis added.) Thus, 35 U.S.C. 121 authorizes, but does not compel,
the Director to require that an application containing two or more
independent and distinct inventions be restricted to one of the
inventions. The Office typically decides whether to issue a restriction
requirement when an application contains two or more independent and
distinct inventions based upon, inter alia, the burden on the Office to
search and examine more than one invention. See MPEP § 803.

   Comment 7: Several comments suggested that the restriction on a so-
called "voluntary" divisional application would be a major divergence
from other countries and would not be favorable from the viewpoint of
promoting global harmonization of patent practices. One comment noted
that the Japan Patent Office (JPO) and the European Patent Office (EPO)
have liberal "voluntary" divisional application rules and have not
reported any evidence of abuse.

   Response: Under this final rule, applicant still has the
opportunity to file a so-called "voluntary" divisional application
except that such an application is defined in this final rule
as a continuation application. That is, as discussed previously,
applicant may file a "voluntary" divisional application as a
continuation application in compliance with § 1.78(d)(1)(i) when
the prior-filed application was not subject to a requirement for
restriction. Specifically, under § 1.78(d)(1)(i), applicant may
file two continuing applications of an initial application without a
petition and showing and then may file a third or subsequent
continuation with a petition and showing under § 1.78(d)(1)(vi).
Accordingly, this final rule is not a major divergence from the
"voluntary" divisional practice available in other countries.

   Moreover, under the PCT and the Paris Convention, the determination
of the conditions and effect of internal (domestic) priority claims is
a matter for the authority concerned. See, e.g., PCT Article 8(2)(b)
and Article 4(G)(2) of the Paris Convention. Efforts in recent years to
harmonize substantive patent law have not focused on achieving
harmonization on domestic priority. (See http://www.wipo.int/patent/
law/en/harmonization.htm for further information).

   Comment 8: Several comments suggested that eliminating "voluntary"
divisional applications violates Article 4G(2) of the Paris Convention.

   Response: Section 1.78(d) as adopted in this final rule does not
eliminate what has traditionally been referred to as a "voluntary"
divisional application. The second sentence of Article 4G(2) of the
Paris Convention provides that each country "shall have the right to
determine the conditions under which such division shall be
authorized." As discussed previously, a "voluntary" divisional
application would not meet the definition of divisional application set
forth in § 1.78(a)(2), but would instead be a continuation
application as defined in § 1.78(a)(3). If the prior-filed
application is not subject to a requirement for restriction, the
applicant may file a "voluntary" divisional application as a
continuation application under the conditions set forth in § 1.78(d)(1)(i).
Such a definition is consistent with 35 U.S.C. 121.
Furthermore, if the prior-filed application is subject to a requirement
for restriction, § 1.78(d)(1)(ii) provides that an applicant may
file an "involuntary" divisional application directed to a non-
elected invention that has not been examined. Therefore, § 1.78(d)
is consistent with Article 4G(2) of the Paris Convention.

   Comment 9: One comment suggested amending proposed § 1.78(d)(1)(ii)
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1027 

to define a divisional application as an application that only includes
claims that were non-elected in the prior-filed application to prevent
new claims from being filed in the divisional application, thus further
increasing the numbers of claims that examiners have to examine.

   Response: Such a requirement is unnecessary because applicant may
amend the non-elected claims that have been filed in the divisional
application during the course of prosecution of the divisional
applications as the prior art is developed and/or to correct formal
matters. Section § 1.78(d)(1)(ii) as adopted in this final rule
permits an applicant to file a divisional application directed to a
non-elected invention that has not been examined that was subject to a
requirement for restriction in the prior-filed application. Therefore,
applicant may present claims in the divisional application that are
different than the claims in the prior-filed application if the claims
in the divisional application are directed to the subject matter of the
non-elected invention.

   Comment 10: One comment expressed concern that the Office may
pressure examiners to limit the issuance of restrictions in order to
reduce the number of applications to be examined, thus artificially
making it look like the pendency rate has gone down. The comment
requested that the Office implement a policy mandating examiners to
issue restrictions when requested by the applicant, except in cases
where it is clear that such restrictions are not proper.

   Response: Restriction practice is set forth in Chapter 800 of the
MPEP. As discussed previously, the applicant may suggest a requirement
for restriction under § 1.142(c) if the applicant believes that two
or more independent and distinct inventions are claimed in the
application. The examiner may accept or refuse the suggested
restriction requirement. Alternatively, the examiner may issue a
different restriction. See the discussion of § 1.142(c). Either
way, it remains important from the standpoint of the public interest
that no requirements for restriction are made that might result in the
issuance of two patents for the same invention. See MPEP § 803.01.

   Comment 11: One comment questioned the status of a divisional
application if the restriction requirement is withdrawn after filing of
the divisional application.

   Response: If a restriction requirement is made and the applicant
cancels the non-elected claims (and any generic claims or other types
of linking claims if present) in the prior-filed application and files
a divisional application, the restriction requirement will not be
withdrawn. Also, as discussed previously, applicants cannot rely upon a
requirement for restriction to avoid the requirement for an examination
support document where: (1) The applicant traverses the requirement for
restriction; (2) the requirement for restriction may be conditional,
such as a requirement for election of species in an application that
contains a claim that is generic to all of the claimed species (see
MPEP § 809), or a requirement for restriction in an application
that contains a linking claim (e.g., a subcombination claim linking
plural combinations); or (3) the applicant plans to request rejoinder
of the claims to the non-elected invention (see MPEP § 821.04 et
seq.). Under §§ 1.78(a)(2) and 1.78(d)(1)(ii), the prior-filed
application to which a divisional application claims the benefit must
be subject to a requirement to comply with the requirement of unity of
invention under PCT Rule 13 or a requirement for restriction under 35
U.S.C. 121 and the invention claimed in the divisional application must
not have been elected for examination and must not have been examined
in any prior-filed application. Thus, a divisional application will be
improper when the claims to the non-elected invention have not been
cancelled and the requirement for restriction is withdrawn in the
prior-filed application (or when the invention claimed in the
divisional application has been examined in the prior-filed
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1028 

application). Furthermore, since the claims of the prior-filed
application and the divisional application would be drawn to the same
invention, both applications may be subject to a double patenting
rejection (see MPEP § 821.04) and the provisions of 1.75(b)(4)
(determining number of claims for purposes of examination support
document threshold when multiple applications contain patentably
indistinct claims).

   For example, where claims directed to a product and to a process of
making and/or using the product are presented in the same application
and subject to a requirement for restriction, the applicant may request
rejoinder of the non-elected process claims that depend from or
otherwise require all the limitations of an allowable product claim.
See MPEP § 821.04(b). Upon rejoinder of claims to a non-elected
process invention, the requirement for restriction between the elected
product and non-elected process invention is withdrawn. Thus, the
rejoinder of non-elected process claims after allowance of the elected
product claims may result in a prior or subsequently filed
"divisional" application not being a proper divisional application
under §§ 1.78(a)(2) and 1.78(d)(1)(ii) because the prior-filed
application is no longer subject to a requirement for restriction.
Applicant may avoid this problem by canceling the non-elected process
claims and claiming them in a divisional application before rejoinder
occurs. In such a situation, because the non-elected claims have been
cancelled, the restriction requirement cannot be withdrawn. This will
preserve applicant's rights under 35 U.S.C. 121 and § 1.78(d)(1)(ii).

   If the applicant chooses to retain the non-elected claims and files
a divisional application claiming the non-elected invention and then
the restriction requirement is withdrawn in the prior-filed
application, the benefit claim under § 1.78(d)(1)(ii) in the later-
filed divisional application would no longer be proper. Thus, the
later-filed application would not be entitled to the benefit of the
prior-filed application. If applicant still desires to maintain the
later-filed application, applicant must delete or correct the benefit
claim to indicate that the application is a continuation application if
the requirements set forth in § 1.78(d)(1)(i) can be met. If
applicant no longer wants to maintain the later-filed application,
applicant may abandon the application before the examination has been
made of the application and may request a refund of any previously paid
search and excess claims fees.

   Comment 12: A number of comments suggested that limiting
continuation-in-part applications was unnecessary. The comments
explained that concerns associated with continually reopening
prosecution do not apply to continuation-in-part applications, which
are usually filed as a result of the inventor having developed a
significant improvement in the invention. One comment stated that
limiting continuation-in-part applications will not reduce application
filings, but rather will simply cause applicants to file the
application as a new application without a benefit claim because the
claims of the continuation-in-part application are usually directed to
the new subject matter and thus not entitled to benefit of the parent
filing date. Several comments suggested that continuation-in-part
applications are necessary for adequate protection of improvements to
the invention and that these improvements often become the key feature
of an invention that leads to its success. One comment, however,
suggested that continuation-in-part practice be terminated, because
with the twenty-year patent term, there is no benefit to applicant or
to the Office associated with continuing this practice.

   Response: Inconsistent rules for continuation applications and
continuation-in-part applications would likely lead to confusion and
create the potential for abuse. First, there is no reason to treat
continuation applications different from continuation-in-part
applications where both fall under § 1.78 and are contemplated by
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1029 

35 U.S.C. 120. Second, there is no reason why the Office should
maintain the ability to file an unlimited string of continuation-in-
part applications without justification while proceeding with a change
to § 1.78 to require a justification for any third or subsequent
continuation application. Third, if applicants could file continuation-
in-part applications without restriction, then they could be used as a
tool to circumvent this final rule. Thus, the Office considers it
appropriate to require a justification for any third or subsequent
continuing application that is a continuation application or a
continuation-in-part application.

   The changes in this final rule do not impact applicants' ability to
protect improvements to the invention disclosed in a prior-filed
application. Section 1.78(d)(1)(i) allows an applicant to file two
continuation-in-part applications of a prior-filed application without
a petition and showing. Applicant may also file any third or subsequent
continuation-in-part application with a petition and showing. Hence,
applicants have ample opportunity to seek protection for improvements.

   Furthermore, for the continuation-in-part application to actually
receive the benefit of the filing date of the prior-filed application,
35 U.S.C. 120 requires that the subject matter of at least one claim of
the continuation-in-part application must be disclosed in the prior-
filed application in the manner provided by 35 U.S.C. 112, ¶ 1. See
Studiengesellschaft Kohle m.b.H, 112 F.3d at 1564-65, 42 U.S.P.Q.2d at
1677-78. The term of any patent resulting from the continuation-in-part
application will be measured under 35 U.S.C. 154(a)(2) from the filing
date of the prior-filed application, even if the continuation-in-part
application never receives any benefit from the prior-filed
application. See Abbott Labs., 104 F.3d at 1309, 41 U.S.P.Q.2d at 1537.
To maximize the term of any resulting patent, applicant should file the
application containing only claims directed to the improvements without
claiming the benefit of the prior-filed application rather than a
continuation-in-part application.

   Comment 13: Several comments suggested that, if the prior-filed
application is abandoned in favor of a continuation-in-part application
before examination of the prior-filed application, or is filed within a
short time of the prior-filed application, the limits on continuing
applications should not include such continuation-in-part applications.
Several comments explained that in rapidly advancing sciences,
continuation-in-part applications are often filed while abandoning the
prior application in the chain before an examination of the merits.
Thus, a continuation-in-part application is often the first in a series
to be examined as an initial application. At a minimum, the rules
should be modified to exclude from counting prior-filed applications
that are abandoned before issuance of a first action on the merits.

   Response: Section 1.78(d)(1)(v) as adopted in this final rule
addresses the situation in which an applicant files a continuation (or
continuation-in-part) application to correct informalities rather than
completing an application for examination under § 1.53. Under
§ 1.78(d)(1)(v), if the prior-filed application is abandoned due to the
failure to timely reply to an Office notice issued under § 1.53(f)),
the applicant may file "one more" continuation application
(or continuation-in-part application) without there being a requirement
for a petition and showing under § 1.78(d)(1)(vi). Specifically,
§ 1.78(d)(1)(v) provides that a continuation application or
continuation-in-part application is permitted if the following
conditions are met: (1) The application claims benefit under 35 U.S.C.
120 or 365(c) of a prior-filed nonprovisional application filed under
35 U.S.C. 111(a), and the prior-filed nonprovisional application became
abandoned due to the failure to timely reply to an Office notice issued
under § 1.53(f) and does not claim the benefit of any other
nonprovisional application or international application designating the
United States of America; (2) the application is a continuation
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1030 

application as defined in § 1.78(a)(3) or a continuation-in-part
application as defined in § 1.78(a)(4) that claims the benefit
under 35 U.S.C. 120, 121, or 365(c) of no more than three prior-filed
applications; and (3) any application whose benefit is claimed under 35
U.S.C. 120, 121, or 365(c) in such nonprovisional application has its
benefit claimed in no more than two other nonprovisional applications.
This does not include any divisional application that satisfies the
conditions set forth in § 1.78(d)(1)(ii) or continuation application that
claims the benefit of such divisional application and satisfies the
conditions set forth in § 1.78(d)(1)(iii).

   For example, applicant may file a third continuation (or
continuation-in-part) application claiming the benefit of an
intervening (second) continuation (or continuation-in-part)
application, a first continuation (or continuation-in-part)
application, and a prior-filed application without a petition under
§ 1.78(d)(1)(vi), if the prior-filed application became abandoned
due to the failure to timely reply to a Notice to File Missing Parts
mailed by the Office of Initial Patent Examination and does not claim
the benefit of any other application. The prior-filed application,
however, must be entitled to a filing date and have paid therein the
basic filing fee within the pendency of the application. See § 1.78(d)(2).

   Comment 14: One comment suggested that the rule changes encourage
applicants to file two applications, i.e., a continuation-in-part
application and a divisional application, rather than a single
continuation-in-part application, where the non-elected invention is
further developed. The comment stated that this is inefficient for both
the Office and applicants.

   Response: The Office appreciates that the changes being adopted in
this final rule do provide some incentive for applicants who seek only
to maximize the number of continuing applications and requests for
continued examination permitted without any justification to file both
a continuation-in-part application and a divisional application in this
situation. However, applicants seeking to maximize the number of
continued examination filings are not likely to file only a single
continuation-in-part application in this situation under either the
former practice or the change to continuing application practice being
adopted in this final rule. Furthermore, this final rule permits
applicant to file two continuation or continuation-in-part applications
plus one request for continued examination in an application family,
without any justification. And, this final rule permits applicant to
file two continuation applications plus one request for continued
examination in the divisional application family, without any
justification.

   Comment 15: One comment suggested that continuation-in-part
applications are an important tool for correcting errors in the initial
application (e.g., correction of test data) and this should be
encouraged, rather than discouraged.

   Response: The Office is neither encouraging nor discouraging the
filing of continuation-in-part applications. Rather, this final rule
treats continuation-in-part applications roughly the same as
continuation applications. That is, applicant is permitted to file two
continuation or continuation-in-part applications of an initial
application without a petition and showing. Applicant is also permitted
to file a third or subsequent continuation or continuation-in-part
application with a petition and showing. See § 1.78(d)(1)(i). The
only notable difference between the two, apart from their definitions,
is that an applicant may file only a continuation application of a
divisional application and not a continuation-in-part application of a
divisional application. See § 1.78(d)(1)(iii). Nevertheless,
applicants may use continuation-in-part applications to correct initial
applications under this final rule to the extent they were used for
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1031 

this purpose before this final rule. Furthermore, as previously
discussed, § 1.78(d)(1)(v) as adopted in this final rule provides
that if an applicant files a continuation (or continuation-in-part)
application to correct informalities rather than completing an
application for examination under § 1.53, the applicant may file
"one more" continuation application (or continuation-in-part
application) without there being a requirement for a petition and
showing under § 1.78(d)(1)(vi). See § 1.78(d)(1)(v).

   Comment 16: One comment suggested that the Office should require
applicants to certify that no 35 U.S.C. 102(b) bar applies for
continuation-in-part applications filed more than twelve months from
the earliest claimed date.

   Response: Under § 1.56, applicant has a duty to disclose to the
Office all information known to applicant to be material to
patentability including any prior art under 35 U.S.C. 102(b). This
includes a reference with a publication date more than one year prior
to the filing date of the continuation-in-part application if at least
one claim in the continuation-in-part application is drawn to the
subject matter not disclosed in the prior-filed application. Applicant
is required to file a newly executed oath or declaration under § 1.63
upon the filing of a continuation-in-part application. See § 1.63(e).
The oath or declaration under § 1.63 must include a statement that the
person making the oath or declaration acknowledges the duty to disclose to
the Office all information known to the person to be material to
patentability as defined in § 1.56. See § 1.63(b)(3).

   Comment 17: One comment argued that requiring applicant to identify
whether the claims are supported by the specification before the
examination is unfair and unreasonable because it is a legal issue that
should be determined during the prosecution. Another comment suggested
that the Office should, at most, require applicant to identify the
differences between the continuation-in-part application and the prior-
filed application. Another comment suggested that when a continuation-
in-part application is filed, the Office should require the applicant
to discuss whether the new matter added to the specification is
inventive or based on ordinary skill. One comment, however, supported
the requirement for a continuation-in-part applicant to identify which
claims are disclosed in the prior-filed application and thus are
entitled to the earlier filing date.

   Response: Applicants are in the best position to identify the
effective filing date of their claims. Thus, § 1.78(d)(3) provides
that if an application is identified as a continuation-in-part
application, the applicant must identify the claim or claims for which
the subject matter is disclosed in the manner provided by 35 U.S.C.
112, ¶ 1, in the prior-filed application. Any claim that is not so
identified will be treated as only being entitled to the actual filing
date of the continuation-in-part application, and subjected to prior
art based on the actual filing date of the continuation-in-part
application.

   Whether any "new matter" is inventive or based on ordinary skill
is not determinative of whether the claims of the continuation-in-part
application are entitled to the filing date of the prior-filed
application. The test is whether the original disclosure of the prior-
filed application provides adequate support and enablement for the
claimed subject matter of the continuation-in-part application in
compliance with the requirement of 35 U.S.C. 112, ¶ 1. See MPEP
§ 201.11, I, Disclosure Requirement.

   Comment 18: A number of comments suggested that the rule changes
effectively eliminate the use of "bypass" continuing applications
(i.e., an application filed under 35 U.S.C. 111(a) that claims benefit
under 35 U.S.C. 120 or 365(c) of the filing date of an earlier
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1032 

international application that did not enter the national stage under
35 U.S.C. 371). The comments argued that a bypass continuing
application would be counted as a continuing application whereas a
national stage submission under 35 U.S.C. 371 would not. The comments
indicated that there are important reasons for filing bypass applications
and suggested that it is unfair to treat bypass applications differently
than national stage applications because in both applications the examiner
will be examining the claims for compliance with U.S. national law for the
first time. Consequently, a number of comments recommended that the
international application should not be counted toward the threshold
for filing continuing applications unless the international application
enters the U.S. national stage, while other comments recommended that
the bypass application should not be counted.

   Response: The Office notes the concerns expressed in the public
comment regarding the proposed changes to § 1.78(d)(1). The Office
has modified proposed § 1.78(d)(1) in this final rule to provide
for certain "bypass" continuing applications. Under § 1.78(d)(1)(iv),
if a Demand has not been filed and the basic national
fee has not been paid in the international application, and the
international application does not claim the benefit of any other
nonprovisional application or international application designating the
United States of America, the applicant may file "one more"
continuation application (or continuation-in-part application) of such
international application without there being a requirement for a
petition and showing under § 1.78(d)(1)(vi). Specifically,
§ 1.78(d)(1)(iv) provides that a continuation application or
continuation-in-part application is permitted if the following
conditions are met: (1) The application claims benefit under 35 U.S.C.
120 or 365(c) of a prior-filed international application designating
the United States of America, and a Demand has not been filed and the
basic national fee (§ 1.492(a)) has not been paid in the prior-
filed international application and the prior-filed international
application does not claim the benefit of any other nonprovisional
application or international application designating the United States
of America; (2) the application is either a continuation application as
defined in § 1.78(a)(3) or a continuation-in-part application as
defined in § 1.78(a)(4) that claims the benefit under 35 U.S.C.
120, 121, or 365(c) of no more than three (rather than two) prior-filed
applications; and (3) any application whose benefit is claimed under 35
U.S.C. 120, 121, or 365(c) in such nonprovisional application has its
benefit claimed in no more than two (rather than one) other
nonprovisional applications. This does not include any divisional
application that satisfies the conditions set forth in
§ 1.78(d)(1)(ii) or continuation application that claims the benefit of
such divisional application and satisfies the conditions set forth in
§ 1.78(d)(1)(iii).

   For example, applicant may file a third continuation application
claiming the benefit of an intervening (second) continuation (or
continuation-in-part) application, the first "bypass" continuation
(or continuation-in-part) application, and the prior-filed
international application without a petition under § 1.78(d)(1)(vi),
if a Demand has not been filed and the basic national fee has not been
paid in the international application, and the international application
does not claim the benefit of any other nonprovisional application or
international application designating the United States of America.

   Comment 19: Several comments questioned whether an international
application that designates the United States of America and claims
benefit to a prior nonprovisional application would be treated as a
second continuation application upon entry into the U.S. national stage
if a request for continued examination is filed in the nonprovisional
application prior to entering the national stage. Another comment
questioned whether a request for continued examination could be filed
in a nonprovisional application if a U.S. national stage application
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1033 

claims benefit under 35 U.S.C. 120 or 365(c) to the nonprovisional
application. Several comments suggested that if an international
application designating the United States of America claims benefit to
a prior-filed nonprovisional application, and a request for continued
examination is filed in the nonprovisional application, then a petition
under § 1.78(d)(1)(vi) would be required, in violation of PCT Rule
51bis, in order to perfect entry of the international application into
the U.S. national stage. The comments also suggested that any refusal
to grant such a petition would violate the PCT because there is no
basis in the treaty for refusing national stage perfection on such
grounds.

   Response: The Office notes the concerns expressed in the public
comment regarding the proposed changes to §§ 1.78(d)(1) and
1.114 that would permit an applicant to file only one of the following:
A continuation application, a continuation-in-part application, or a
request for continued examination, without any justification. The
Office has made modifications to these proposed changes such that this
final rule permits an applicant to file two continuation applications
or continuation-in-part applications, plus a single request for
continued examination in an application family, without any
justification. Therefore, under this final rule, applicant is permitted
to have the national stage of an international application designating
the United States of America claim the benefit of a prior-filed
nonprovisional application in which a request for continued examination
has been filed without a petition and showing. The provisions of
§ 1.78(d)(1) are independent of the provisions of § 1.114. The filing
of a request for continued examination in a nonprovisional application
does not preclude a U.S. national stage application from claiming the
benefit of the nonprovisional application. Likewise, a U.S. national
stage application claiming the benefit under 35 U.S.C. 120 or 365(c) of
a nonprovisional application will not preclude an applicant from filing
a request for continued examination in the nonprovisional application.

   Applicant may also file any additional continuation or
continuation-in-part application or request for continued examination
with a petition and showing. If an international application that
enters the U.S. national stage contains or is amended to contain a
specific reference to a prior-filed application that is not permitted
by at least one of §§ 1.78(d)(1)(i) through (d)(1)(vi), the
Office will refuse to enter, or will delete if present, the specific
reference to the prior-filed application. See § 1.78(d)(1).
Furthermore, the national stage application will be treated as entitled
only to the actual international filing date of the national stage
application, and will be subject to prior art based on the actual
international filing date.

   Refusal to grant a petition under § 1.78(d)(1)(vi) (assuming
such a petition is necessary) would not prevent an applicant from
completing the requirements for entry into the national phase under 35
U.S.C. 371. The requirements for entry of an international application
into the national phase under 35 U.S.C. 371 are set forth in 35 U.S.C.
371(c) and § 1.495. The effect of a refusal to grant any such
petition would only be that the national stage application would not be
entitled to the benefit of the filing date of the nonprovisional
application under 35 U.S.C. 120 and 365(c). Furthermore, the necessity
to file a petition under § 1.78(d)(1)(vi) in the national stage
application to obtain benefit to the nonprovisional application would
not violate PCT Rule 51bis. PCT Rule 51bis does not govern the requirements
that a designated Office may impose for recognition of domestic benefit
claims. Rather, the ability of a designated Office to establish
conditions for, and the effect of, domestic benefit claims is expressly
provided for in PCT Article 8(2). PCT Article 8(2) states, in pertinent
part, that "[w]here, in the international application, the priority of
one or more national applications filed in or for a designated State is
claimed, or where the priority of an international application having
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1034 

designated only one State is claimed, the conditions for, and the
effect of, the priority claim in that State shall be governed by the
national law of that State."

   Comment 20: Several comments suggested that the rules create an
anomaly. The comments argued that if an application is first filed as a
nonprovisional application followed by an international application
claiming benefit to the nonprovisional application, and a request for
continued examination is subsequently filed in the nonprovisional
application, then a petition under § 1.78(d)(1)(vi) would be needed
when the international application enters the U.S. national phase. The
comments, however, further argued that if the application is first
filed as a provisional application followed by, one year later,
concurrently filed international and nonprovisional applications both
claiming benefit to the provisional application, then a petition under
§ 1.78(d)(1)(vi) would not be needed when the international
application enters the U.S. national phase even if a request for
continued examination was filed in the nonprovisional application.

   Response: The Office has made modifications to the proposed changes
to §§ 1.78(d)(1) and 1.114 such that this final rule permits an
applicant to file two continuation applications or continuation-in-part
applications, plus a single request for continued examination in an
application family, without any justification. Therefore, under this
final rule, applicant may enter the U.S. national stage in an
international application designating the United States of America
claiming the benefit of a prior-filed nonprovisional application in
which a request for continued examination has been filed without a
petition and showing. As discussed previously, the provisions of §
1.78(d)(1) are independent of the provisions of § 1.114. The filing
of a request for continued examination in a nonprovisional application
does not preclude a U.S. national stage application from claiming the
benefit of the nonprovisional application.

   Note that, in the first described application chain, the
international application claims benefit to a nonprovisional
application under 35 U.S.C. 120 or 365(c) and therefore is a
"continuing application" as defined in § 1.78(a). In the second
described application chain, the international application is not a
continuing application as it only claims benefit to the provisional
application. In any event, § 1.78(d)(1) as adopted in this final
rule would not require a petition and showing for the national stage
application to claim the benefit of a prior-filed application in which
a request for continued examination has been filed.

   Comment 21: One comment argued that applicants who first file a
nonprovisional application followed by a continuation-in-part
application would not be able to designate the United States in any
subsequently filed international application without a showing as to
why the international application could not have been filed earlier.
The comment argued that this violates the PCT.

   Response: The Office has made modifications to the proposed changes
to § 1.78(d)(1) such that this final rule permits an applicant to
file two continuation applications or continuation-in-part
applications, plus a single request for continued examination in an
application family, without any justification. Therefore, under this
final rule, applicant may file an international application designating
the United States of America claiming the benefit of two prior-filed
nonprovisional applications without a petition and showing. Applicant
may also file any additional continuation or continuation-in-part
application or request for continued examination with a petition and
showing. The petition procedure under § 1.78(d)(1)(vi) applies only
to international applications that have entered the U.S. national stage
after compliance with 35 U.S.C. 371. Thus, the rule neither requires
nor provides for the submission of such petitions in international
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1035 

applications during the international phase. It is also noted that
under PCT Rule 4.9, the designation of all states, including the United
States of America, in international applications is automatic upon
filing of the PCT request.

   Comment 22: Several comments questioned whether the limitation on
the examination of claims in nonprovisional applications under
§ 1.75(b) could be circumvented by first filing an international
application with as many claims as desired and then entering the U.S.
national phase after the claims have been searched in the international
phase. The comments suggested that the Office should examine all claims
in a national stage application that were the subject of a search and
written opinion in the international phase, particularly if the United
States Patent and Trademark Office was the international searching
authority.

   Response: The requirements of § 1.75(b) apply to national stage
applications under 35 U.S.C. 371 as well as to applications filed under
35 U.S.C. 111(a). Thus, the rule cannot be circumvented by utilizing
the PCT route. The fact that more than five independent claims or more
than twenty-five total claims may have been searched and even subjected
to international preliminary examination in the international phase
will not entitle applicants to more than five independent claims or
more than twenty-five total claims in the U.S. national phase
application without the submission of an examination support document.
This is analogous to existing practice under § 1.499, which permits
restriction of claims in a national stage application for lack of unity
notwithstanding that such claims may have been searched and subject to
international preliminary examination in the international phase.
Applying § 1.75(b) to national stage applications is appropriate
because prior art uncovered during the international search often
necessitates the need to make substantial amendments to the claims in
the national phase. Additionally, the claims would need to be examined
for compliance with all substantive requirements of U.S. national law.

   Comment 23: One comment suggested that the rules limiting
continuing applications would result in more applicants filing
international applications and entering the U.S. national stage in
order to avoid onerous restriction requirements. Another comment
suggested that the rules limiting the examination of claims might
trigger increased usage of the PCT and national stage entry into the
U.S.

   Response: Applicants are free to choose whichever route they
believe is more advantageous for obtaining patent protection in the
United States, whether through the PCT or through a direct national
filing under 35 U.S.C. 111(a).

   Comment 24: A number of comments requested that the Office should
notify the applicant in an Office action when a continuing application
is not available under any one of the first three conditions in
§ 1.78(d)(1). A number of comments stated that the refusal to enter or to
delete any references to prior-filed applications that are not permitted
under § 1.78(d)(1) would place a heavy burden on the Office.

   Response: The changes to §§ 1.78 and 1.114 in this final
rule are clearly set forth in this final rule. Applicant and his or her
representative have the duty to know the rules of practice when
prosecuting an application for patent before the Office. Applicant
should not file a continuing application without knowing whether it is
proper. The refusal to enter or to delete any references to prior-filed
applications that are not permitted under § 1.78(d)(1) would not
place any additional burden on the Office.

   Comment 25: A number of comments argued that the rule changes would
protract the examination process and divert resources from examining
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1036 

functions to administrative tasks. In particular, the comments
predicted that the rule changes would increase the number of petitions,
including petitions for filing additional continuing applications and
requests for continued examination and petitions for supervisory review
of Office actions and restriction requirements. Several other comments
argued that the delay in prosecution of an application would increase
while decisions on petitions under §§ 1.78(d)(1)(vi) and
1.114(g) were debated and reviewed. Several comments questioned whether
the Office would be adequately staffed with enough personnel to handle
the onslaught of petitions, as well as further review of decisions
dismissing the petitions. Several comments also argued that any
reduction in backlog would be insignificant given that the Office would
grant some of the petitions for additional continuing applications and
requests for continued examination. Several comments suggested that the
proposed changes to the continued examination practice will force
applicants to petition every improper procedural requirement by
examiners, including restriction requirements, finality and non-entry
of after-final amendments, in order to preserve applicant's rights. One
comment stated that applicants are likely to file petitions, such as
petitions addressing the prematureness of a final rejection under
§ 1.181, to save their one "as-matter-of-right" continuation or
continuation-in-part application or request for continued examination.
Several comments stated that applicants would petition almost all
restriction requirements, resulting in an increase in the number of
petitions filed. Another comment stated petitions seeking review of
restriction requirements would be filed in order to determine early in
the prosecution cycle the number of divisional applications that must
be filed to preserve patent rights.

   Response: One of the Office's goals is to focus its limited patent
examining resources on the examination of new applications, and thereby
increase the effectiveness of Office resources while also reducing the
backlog of unexamined patent applications. The requirements for seeking
third and subsequent continuing applications will not have an effect on
the vast majority of patent applications. The changes being adopted in
this final rule, however, will reduce the strain on the Office's patent
examining resources, which will allow for a better, more timely
examination of new applications.

   The Office recognizes the amount and type of resources needed to
implement the changes to §§ 1.78 and 1.114 being adopted in
this final rule. The authority to decide petitions under
§§ 1.78(d)(1)(vi) and 1.114(g) has been delegated to the Deputy
Commissioner for Patent Examination Policy (who may further delegate
this authority to officials under the Deputy Commissioner for Patent
Examination Policy). The Office is planning to provide sufficient staff
to handle the projected number of petitions.

   The Office provides the procedure under § 1.181 for applicants
to seek review of requirements and objections made by the examiner. If
applicant finds that a requirement or an objection made in an Office
action is procedurally wrong, applicant should request reconsideration
or file a petition under § 1.181 to review the requirement or
objection. As an example, when applicant challenges the finality of an
Office action as being premature, the applicant should focus on whether
the Office action met the appropriate standard for finality. The Office
will make every effort to decide the petitions in a timely manner.
Applicant, however, should not file a continuing application or a
request for continued examination in an effort to address improper
procedural requirements. Petitions for supervisory review of Office
actions and restriction requirements will continue to be decided by
supervisory patent examiners or other managers. Therefore, examiners
will not be diverted from the examination process by these petitions.
Finally, it should be noted that complaints about an Office action that
relate to the merits of patentability of the claims must be addressed
in an appeal to the BPAI, and not in a petition under § 1.181 for
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1037 

supervisory review, even if the issues may be phrased in procedural
terms. See Boundy v. U.S. Pat. & Trademark Office, 73 U.S.P.Q. 2d 1468,
1472 (E.D. Va. 2004).

   Comment 26: Several comments stated that any resources saved via
implementation of these final rules would be used for other filings
necessitated by the changes. Thus the rule changes, according to the
comments, would increase the backlog and pendency and add to the
administrative cost and burdens of the Office. In particular, a number
of comments predicted that the number of applications would increase
because applicants would file more of the following: (1) Provisional
applications; (2) continuation applications rather than requests for
continued examination; (3) reissue applications to perfect or broaden
claims; (4) reexamination proceedings to have prior art considered; (5)
divisional applications (because applicants are required to file all
divisional applications during the pendency of the first application);
(6) multiple parallel applications that have similar or the same
disclosures; and (7) continuing applications before the effective date.

   Response: The Office notes the concerns expressed in the public
comment and has attempted to avoid the possibility of increased filings
necessitated by modifying the proposed changes. The Office has made
modifications to the proposed changes to §§ 1.78(d)(1) and
1.114 such that this final rule permits an applicant to file two
continuation applications or continuation-in-part applications, plus a
single request for continued examination in an application family,
without any justification. Also, under this final rule, a divisional
application need not be filed during the pendency of the application
subject to a requirement for restriction, as long as the copendency
requirement of 35 U.S.C. 120 is met. This final rule also permits
applicant to file two continuation applications of a divisional
application plus a request for continued examination in the divisional
application family, without any justification. Therefore, the Office
does not expect any significant increase in filings of applications.
Specifically, the Office does not expect that the number of divisional
applications would increase in response to the changes being adopted in
this final rule because applicants should have sufficient time to
determine whether to file a divisional application for a non-elected
invention following a restriction requirement. Furthermore, an increase
in filings of provisional applications will not place additional burden
on the Office's patent examining resources because no examination is
provided in provisional applications. The Office does not expect its
examining resources to be impacted when applicants file continuation
applications rather than requests for continued examination, or when
applicants file reissue applications and reexamination proceedings rather
than continuing applications.

   The changes being adopted in this final rule do not encourage
applicants to file multiple applications with patentably indistinct
claims. Pursuant to § 1.78(f)(3), the Office may require
elimination of the patentably indistinct claims from all but one of the
nonprovisional applications. If the patentably indistinct claims are
not eliminated from all but one of the applications, the Office will
treat each application as having the total of all of the claims
(whether in independent or dependent form) for purposes of determining
whether an examination support document is required by § 1.75(b).
See § 1.75(b)(4). Moreover, when an applicant (or assignee) files
multiple applications with the same claimed filing or priority date, a
common inventor, and substantial overlapping disclosures, the Office
will presume that the applications contain patentably indistinct
claims. See § 1.78(f)(2). The applicant must either rebut this
presumption or submit the appropriate terminal disclaimers and explain
why two or more pending applications containing patentably indistinct
claims should be maintained. Once applicant recognizes that having
multiple applications that contain patentably indistinct claims is not
needed, applicant would abandon the applications or stop filing
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1038 

multiple applications that have patentably indistinct claims.

   Comment 27: One comment stated that a requirement for Director's
approval to file a second or subsequent continuing application or
request for continued examination would create a disincentive for
examiners to provide a thorough examination, leaving the burden on the
applicant to prosecute the application.

   Response: The Office modified the proposed provision that would
have limited applicant to one continuation or continuation-in-part
application or to one request for continued examination, without any
justification. This final rule allows applicant to file two
continuation or continuation-in-part applications plus a request for
continued examination in an application family, without any
justification. What is more, the Office expects that limiting the
number of continuing applications and requests for continued
examination that may be filed without justification will encourage both
applicants and examiners to engage in a more thorough prosecution and
examination earlier in the application process. Examiners are
professionals who perform their duties in compliance with patent laws,
rules of practice, and patent examining procedures set forth in the
MPEP. They are responsible for the quality of their work product. There
is no reason why examiners would provide lower quality examination in
response to the changes in this final rule. In fact, this final rule is
intended to improve the quality of examination by facilitating the
examination of applications that contain more than five independent
claims or twenty-five total claims via the examination support
document.

   Comment 28: A number of comments stated that the Office should
treat continuing applications the same as new applications and should
not limit the available protection because applicants who file
continuing applications pay the same filing fees as those who file a
new application. One comment argued that continuing applications should
not be limited because they claim "new inventions" in that they
pursue broader claims, a different invention, or an improvement, and
the purpose of patents is to protect inventions, not to facilitate
examination. One comment argued that continuation and continuation-in-
part applications are legitimate because the statutes that create and
authorize "continuation practice" do not distinguish such
applications from "new" applications in terms of their importance,
nor do they limit the resources that are committed to them.

   Response: The former unrestricted continued examination practice
was impairing the Office's ability to examine new applications. As a
result, the Office is modifying continued examination practice in this
final rule to address the backlog of unexamined new applications. Under
this final rule, therefore, if the amendments, arguments, or evidence
sought to be entered could have been previously submitted in the
initial application, two continuing applications, and a request for
continued examination, applicants are encouraged to make such
submissions early rather than wait to do so in another continuing
application or request for continued examination. That way, the
examiner would have the information earlier to make the patentability
determination. If applicant could not have submitted them earlier,
applicant may file a third continuing application with a petition and
showing under § 1.78(d)(1)(vi) or a second request for continued
examination with a petition and showing under § 1.114(g).

   Comment 29: A number of comments stated that the rule changes would
not permit applicants to file even a single continuation or
continuation-in-part application, when the applicant filed a request
for continued examination in the initial application.

   Response: The Office has made modifications to the proposed changes
to §§ 1.78(d)(1) and 1.114 such that this final rule permits an
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1039 

applicant to file two continuation applications or continuation-in-part
applications, plus a single request for continued examination in an
application family, without any justification. Applicant may also file
any additional continuation or continuation-in-part application or
request for continued examination with a petition and showing as to why
the amendment, argument, or evidence sought to be entered could not
have been submitted earlier. The provisions of § 1.78(d)(1) are
independent of the provisions of § 1.114. The filing of a request
for continued examination in the initial application does not preclude
applicant from filing a continuing application of the initial
application.

   Comment 30: Several comments objected to the Office's proposal that
a petition under § 1.78 to accept an unintentionally delayed claim
under 35 U.S.C. 120, 121, or 365(c) will not be granted in an
application in which a request for continued examination has been
filed. One comment argued that applicant would lose substantial rights
if the Office dismisses a petition to accept an unintentionally delayed
claim filed after a request for continued examination has been filed in
the prior-filed application.

   Response: The Office has made modifications to the proposed changes
to §§ 1.78 and 1.114 such that the provisions of § 1.78(d)
as adopted in this final rule are independent of the provisions of
§ 1.114. Thus, § 1.78(e) as adopted in this final rule does not
provide that a petition to accept an unintentionally delayed claim
under 35 U.S.C. 120, 121, or 365(c) will not be granted in an
application in which a request for continued examination has been
filed.

   Comment 31: A number of comments stated that the rule changes would
not permit applicants to consolidate two applications into a single
continuation-in-part application, which is contrary to the goal of
reducing the number of applications.

   Response: The Office has made modifications to the proposed changes
such that this final rule permits an applicant to file two continuation
applications or continuation-in-part applications, plus a single
request for continued examination in an application family, without any
justification. Therefore, applicant is permitted to file a
continuation-in-part application that claims the benefit of two
prior-filed applications without a petition and showing under
§ 1.78(d)(1)(vi). If applicant thinks that a third or subsequent
continuation-in-part application is necessary for consolidation
purposes, then such applicant may file a petition and showing under
§ 1.78(d)(1)(vi) to obtain the additional filing.

   Comment 32: Several comments argued that applicants need continuing
applications and requests for continued examination because the reissue
procedure does not give applicants the same flexibility.

   Response: Continuing applications and requests for continued
examination are not, by statute, available for the same purposes as
reissue applications. Continuing applications and requests for
continued examination are available to an applicant during the
prosecution of an initial application to enable an applicant to secure
protection on the full scope of an invention with the correct benefit
claim. See 35 U.S.C. 120, 121, and 365(c). By contrast, the reissue
procedure is available to an applicant after a patent has issued to
permit an applicant to correct errors made during the prosecution of
the original application without any deceptive intention and to enlarge
the scope of the claims of the original patent if the reissue
application is filed within two years from the grant of the original
patent. See 35 U.S.C. 252. Furthermore, this final rule permits
applicant to file two continuation or continuation-in-part applications
plus one request for continued examination in an application family,
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1040 

without any justification. These available filings provide sufficient
flexibility.

   Comment 33: One comment suggested that the rule changes would be
contrary to patent harmonization goals. One comment argued that the
rule changes would hurt foreign applicants because they would be
required to assess the degree of protection much earlier than they
normally would, resulting in retaliatory challenges abroad for U.S.
applicants.

   Response: The Office did not receive any comments from any foreign
patent office or authority. The Office does not expect any retaliation
from other countries or any adverse impact. Many countries do not have
flexible practices for filing continuation applications, continuation-
in-part applications, and requests for continued examination.

   Comment 34: A number of comments argued that the rule changes would
increase the cost to applicants for prosecuting each application, and
for filing more multiple parallel applications, divisional
applications, appeals, and petitions under §§ 1.78 and 1.114.
Several comments argued that the rule changes would cause applicants to
incur excessive expenses before determining whether the invention is
commercially viable. One comment argued that the Office would cause
applicants to perform patent searches in order to have a good working
knowledge of the prior art to draft claims for full coverage. One
comment argued that the rule changes would increase practitioner fees
because applicants must submit more carefully drafted claims and
replies (estimated five additional hours per case for drafting all
possible claims, at an average of 150 dollars per hour, the additional
cost would be 750 dollars per application or 200 million dollars for
317,000 applications). One comment estimated that the attorney cost in
preparing an application would at least double if not increase by a
factor of ten, which would place new applications out of reach of small
businesses. Several comments argued that it would be practically
impossible or at least much more difficult, expensive and time-
consuming to obtain patent protection for the full scope of inventions,
especially for large, complex inventions. One comment argued that the
rule changes are extremely burdensome for patent applicants and
practitioners to maintain and develop a cohesive patent strategy. One
comment stated that the rule changes were very complex and fraught with
ambiguity and would create difficulties and misunderstandings for
applicants and practitioners in the implementation, possibly resulting
in the loss of inventors' rights and an increase in practitioners'
exposure to malpractice.

   Response: The Office encourages applicants to diligently prosecute
the initial application, two continuation or continuation-in-part
applications, and one request for continued examination, without a
petition and showing, so that applicants do not need to file a petition
and showing to secure a third or subsequent continuation or
continuation-in-part application or a second or subsequent request for
continued examination and incur the costs associated with these
filings. The patent system best serves the interests of all parties,
including the public, when applicants and their representatives are
diligent in drafting the claims and replies. Applicant would get a
quality patent with desirable claim coverage. The Office would not
waste patent examining resources to examine applications that are not
diligently prepared. Even prior to the changes being adopted in this
final rule, applicants and their representatives had certain duties
when prosecuting applications in front of the Office. Applicant is
required to submit fully responsive replies to Office actions (see
§ 1.111) and to particularly point out and distinctly claim what
the applicant regards as his or her invention (see 35 U.S.C. 112, ¶ 2).
Furthermore, if applicant's lack of knowledge of the prior art (or lack
of diligence) causes unnecessary delay or needless increase in the cost
of prosecution before the Office, applicant would be violating
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1041 

§ 10.18(b)(2)(i).

   If applicants need more time to determine the aspect of the
invention for which patent protection should be sought, applicant may
file a request for deferred examination under § 1.103(d) upon
filing the initial application. Applicant should have sufficient time
to determine whether to file a divisional application for a non-elected
invention because a divisional application is not required under this
final rule to be filed during the pendency of the initial application,
as long as the copendency requirement of 35 U.S.C. 120 is met. If
applicant disagrees with the examiner's rejections, it would be more
effective to appeal the rejections than to file a continuing
application or a request for continued examination. It should not be
burdensome for applicants and their representatives to prosecute
diligently by drafting claims that particularly point out and
distinctly claim the subject matter which the applicant regards as his
or her invention, as well as replies that are fully responsive to the
Office actions.

   The requirements for seeking third and subsequent continuing
applications in this final rule will not have an effect on the vast
majority of patent applicants. Approximately 342,600 nonprovisional
patent applications (excluding plant and design applications) were
filed in the Office in fiscal year 2006. Of those applications,
approximately 32,700 were identified as continuation applications,
approximately 15,700 were identified as continuation-in-part
applications, and approximately 20,600 were identified as divisional
applications. In addition, approximately 74,700 requests for
continued examination were filed in the Office in fiscal year 2006. The
requirements for seeking a third or subsequent continuation or
continuation-in-part application or a second or subsequent request for
continued examination would only have affected 2.7 percent of these
filings (applications or requests for continued examination). As
discussed previously, the changes being adopted in this final rule do
not give any advantage to those applicants who file multiple parallel
applications containing patentably indistinct claims.
See §§ 1.75(b)(4) and 1.78(f).

   Comment 35: One comment argued that the rule changes would
encourage the courts to have a more liberal view on the doctrine of
equivalents. Another comment argued that the rule changes limiting
continuation practice takes away the right of the patentee to use
continuing applications to secure patent protection for equivalents of
the invention claimed in the prior-filed application, citing Festo
Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 344 F.3d 1359, 68
U.S.P.Q.2d 1321 (Fed. Cir. 2003) (Festo X).

   Response: The doctrine of equivalents is a patent law concept
relating to infringement which protects patentees against efforts of
copyists to evade liability for infringement by making only
insubstantial changes to a patented invention. See Festo Corp. v.
Shoketsu Kinzodu Kogyo Kabushiki Co., 535 U.S. 722, 726-27, 62
U.S.P.Q.2d 1705, 1709 (2002) (Festo VIII). The case law on the doctrine
of equivalents has been well established since Warner-Jenkinson Co. v.
Hilton Davis Chem. Co., 520 U.S. 17, 41 U.S.P.Q.2d 1865 (1997) and
Festo VIII. A concurrence in Festo X noted that the demise of the
flexible doctrine of equivalents "rule" may encourage applicants to
(inter alia) use continuation strategies to avoid the lack of
flexibility that now exists in the doctrine of equivalents. See Festo
X, 344 F.3d at 1375, 68 U.S.P.Q.2d 1332. This concurrence in Festo X,
however, was not espousing some "right" of the patentee to use
continuing applications to maintain the doctrine of equivalents, but
was simply noting that applicants now use continuing application
practice as a substitute for a flexible doctrine of equivalents.

   The Office is concerned that practitioners and applicants may
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1042 

indeed be increasingly using continuing applications not to advance
prosecution but to compensate for changes in the law of the doctrine of
equivalents. Such practices would appear to be likely to contravene
§ 10.18(b)(2)(i), under which a party presenting a paper to the
Office is certifying that the paper is not being presented to cause
unnecessary delay or needless increase in the cost of prosecution
before the Office. Under Festo X, a narrowing amendment gives rise to a
presumption that equivalents not covered by the literal language of the
claims have been foregone. Permitting two continuing applications plus
a request for continued examination in any one of the initial
application or two continuing applications as of right should in
general assure that applicants have an adequate chance to advocate to
the examiners that an amendment is unneeded. Beyond that, the Office is
concerned that applications may be continued, rather than disputes on
the need for amendment being appealed, for the purpose of delay. A
requirement that an applicant at that stage be prepared to justify his
or her need for an additional continuing application is reasonable in
these circumstances.

   Comment 36: A number of comments suggested that the rule changes
are arbitrary and capricious, premature, imprudent and ill-advised. A
number of comments argued that the Office has no rational basis for the
rule change, and has not provided sufficient explanations, data or
evidence to justify the rule changes and to show that the rule changes
will actually improve the backlog of applications, the quality of
examinations, overall examination efficiency, quality of patents, and
pendency. In addition, the comments asserted patents would be harder to
enforce and litigate because all relevant prior art may not have been
considered.

   One comment stated that the Office does not have a pendency problem
because the average pendency is within zero to three years. One comment
argued that the Office provides no studies to show that businesses are
being harmed due to delayed prosecution. One comment argued that
reducing the backlog is not an appropriate reason for limiting the
number of continuing applications and requests for continued
examination as a matter of right. Several comments argued that the
Office has not identified continuation applications as a major source
of the backlog, and therefore, the rule changes would have limited
impact on the backlog. One comment pointed out that second and
subsequent continued examination filings make up only a small
percentage of the total number of continued examination filings.
Several comments alleged that the Office's statistics are misleading
and the rule changes would only eliminate at most five to ten percent
of the continuation applications because the Office should not have
included "involuntary" divisional applications and requests for
continued examination. One comment argued that the Office provided no
statistical data showing the percentage of applicants that "misuse"
the continued examination practice as alleged. One comment also
suggested that although the Continuing Applications Proposed Rule cites
to data regarding the total number of continuations and the
consequential burdens imposed on examiners, no analysis is provided as
to the grounds for filing these applications and whether those grounds
constituted "abuse."

   Several comments argued that there is no indication that the Office
has conducted any serious analysis of how or why requests for continued
examination and continuation applications are used by applicants. The
comments suggested the following: A suitable analysis would involve
review of prosecution histories of patents that were issued from a
continuation application or a request for continued examination and
determination of whether such patents could have issued if the rule
changes were in place; and if such patents would not have issued, the
Office should explain how such a loss of rights is consistent with the
goals of the patent system. A number of comments asserted that the rule
changes should be narrowly tailored to only those few applicants who
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1043 

intentionally delay the conclusion of examination rather than adversely
impacting all applicants. A number of comments suggested that the
Office should conduct a pilot program on the changes and report the
results to the public prior to implementing the rule changes.

   Several comments further argued that the Office has not identified
any study showing that restricting applicants to a single continued
examination opportunity would satisfactorily address its problems
without causing substantial harm to the protection of innovation or the
patent examining process. Several comments alleged that the Office has
not sufficiently considered the effect of the rule changes on U.S.
applicants and the U.S. economy and suggested that further study is
needed because the ability to file multiple continuing applications
helps U.S. applicants to protect their inventions against foreign
competitors and the rule changes would cause further outsourcing of
American manufacturing and loss of American jobs.

   Several comments, however, supported the rule changes. The comments
provided the following reasons why the rule changes would be
appropriate: (1) They would improve
the Office's productivity, enhance patent quality, and eliminate
growing abuses in the patent prosecution process, which would
accelerate innovation, especially in the software and hardware
technologies that have fast technology evolution and short product life
cycle; (2) the rule changes would help the Office reduce backlog and
pendency because they would reduce the ancillary loads on the
examination process so that examiners can focus on important core
issues, and the Office could focus its limited examining resources on
faster examination of new applications; (3) the rule changes
appropriately address those few applicants who disproportionately
contribute to the backlog and provide applicants with the ability to
file appropriate continued examination filings and multiple
opportunities to present claims and arguments; (4) applicant may
correct appropriate mistakes (including by broadening claims) through
the reissue process; (5) by eliminating long chains of continued
examination filings, the rule changes would provide earlier and greater
legal certainty as to the scope of patent rights, reduce wasteful
litigation, and encourage negotiations between patent holders and
others; (6) the rule changes would likely promote confidence in U.S.
patents, stimulate innovation, enhance competition, and increase
consumer welfare; and (7) the rule changes would help to deter
applicants from strategically using the continued examination practice
to disadvantage competitors and their licensees, and would prevent
applicants from keeping continuation applications pending for extended
periods of time so that they can monitor the development of the market
and modify their claims to cover their competitors' products.

   Response: In fiscal year 2006, the average pendency to first Office
action was 22.6 months for the entire Patent Examining Corps. The
average was much higher in certain areas (e.g., in Technology Center
2100 (computer architecture, software and information security) the
average pendency to first Office action was 30.8 months, and in
Technology Centers 3620 and 3690 (electronic commerce) the average
pendency to first Office action was 43.9 months). As several comments
noted, long pendency of patent applications is problematic in some
industries (e.g., computer software and hardware technologies) where
product life cycles are short and new improvements can quickly make the
technology obsolete. The Office has the authority and responsibility to
establish regulations that shall govern the conduct of proceedings in
the Office and facilitate and expedite the processing of patent
applications. See 35 U.S.C. 2(b)(2). The Office has the responsibility
to take appropriate action to improve efficiency, patent quality and
pendency. The Office does not expect that the changes being adopted in
this final rule alone will be sufficient to address the growing backlog
of unexamined patent applications. The Office is implementing many
initiatives to improve efficiency in the examination process and
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1044 

quality of patents.

   Continued examination filings divert the Office's limited examining
resources from the examination of new applications. One of the Office's
goals is to focus the limited examining resources on the examination of
new applications. The rules do not place an absolute limit on the
number of continued examination filings. The Office recognizes there
are appropriate reasons for applicant to file a continuing application
or request for continued examination. Under this final rule, applicant
is permitted to file the initial application, two continuing
applications, and a request for continued examination in an application
family, without any justification. Thus, applicant has sufficient
opportunities to present claims, amendments, arguments, evidence, and
prior art during the prosecution of the initial application, two
continuing applications, and a request for continued examination. An
applicant who considers this to be insufficient may file a third or
subsequent continuing application or second or subsequent request for
continued examination with a petition and showing as to why the
amendment, argument, or evidence sought to be entered could not have
been previously submitted. If the amendment, argument, or evidence can
be submitted earlier in the prosecution process, applicant is required
to do so, rather than delay the prosecution and waste the Office's
patent examining resources on a prosecution that is not focused. The
examination process is more efficient when the applicant diligently
prosecutes the application so that the examiner has all of the relevant
information, including amendments, evidence, arguments, and prior art
as early as possible. Most applicants who prosecute diligently will not
need to file a third or subsequent continuing application. Reviewing
the prosecution histories of patents, conducting pilot programs,
publishing green papers, etc., would not show all of the reasons why
applicants would file multiple continued examination filings.
Applicants could have different reasons for filing continuation
applications, continuation-in-part applications and requests for
continued examination. The rules appropriately provide applicant the
opportunity to show why a third or subsequent continuing application or
second or subsequent request for continued examination is needed. The
comments do not provide any persuasive data or evidence that shows how
the rule changes, or any restrictions on the continued examination
filing practice, would have a negative impact on the quality of
patents, the U.S. economy, or innovation.

   As discussed previously, approximately 342,600 nonprovisional
patent applications (excluding plant and design applications) and
approximately 74,700 requests for continued examination were filed in
the Office in fiscal year 2006. The requirements for seeking a third or
subsequent continuation or continuation-in-part application or a second
or subsequent request for continued examination would only have
affected 2.7 percent of these filings (applications or requests for
continued examination). The Office did not include divisional
applications in this analysis. The Office included requests for
continued examination because when an applicant files a request for
continued examination, the examiner reopens the prosecution of the
application and conducts another substantive examination similar to a
continuation application.

   Comment 37: Several comments argued that the amount of resources
spent on additional continuing applications or requests for continued
examination is not as high as asserted because continuation
applications and requests for continued examination take less of the
examiner's time than new applications since the examiner is already
familiar with the prior art, issues, and subject matter of the
application.

   Response: The Office expects that limiting the number of continuing
applications and requests for continued examination that may be filed
without justification will encourage both applicants and examiners to
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1045 

focus on "getting it right the first time." In any event, examiners
are given the same amount of time to examine a continuing application
or request for continued examination as a new application. Certain
continuing applications and requests for continued examination could
have more complex issues than a new application, such as evaluating new
evidence in a biotechnology application. Any reduction in the number of
continuing applications and requests for continued examination would
increase the Office's ability to focus its patent examining resources on
the examination of new applications.

   Comment 38: Several comments asserted that the premise that
expedited examination is more important than protection of inventor's
rights is faulty.

   Response: The Office did not state such a premise. Applicants may
seek full protection of their inventions under this final rule, which
does not place any absolute limits on the number of continuing
applications and requests for continued examination. Limiting the
number of continuing applications and requests for continued
examination that may be submitted without justification is not counter
to the protection of an inventor's rights.

   Comment 39: Several comments predicted that the rule changes would
decrease the Office's revenue due to the decrease in continuing
applications and requests for continued examination.

   Response: The Office's goal is to utilize its patent examining
resources more efficiently to reduce backlog and improve pendency. In
exchange for greater efficiency, the Office expects there would be some
decrease in revenue as the number of continued examination filings
declines, as the comment indicates. But, this final rule is not being
implemented with a view toward revenue; instead, it is being
implemented to improve the patent examination process.

   Comment 40: A number of comments argued that there is no public
notice problem. The comments argued that most applications (ninety
percent) are published, the prosecution of the published applications
is open to the public, and competitors are already able to analyze a
file history to determine the broadest range of claim protection that
may be granted in a patent of a continuing application. Several
comments suggested that members of the public could prevent
infringement by identifying the novel inventions in the disclosure and
avoiding those inventions in their practices. Several comments,
however, noted that publication of applications is not sufficient to
provide public notice of what the patentee will ultimately claim
because a patent may eventually issue with broader or significantly
different claims than those published and any delays at the Office will
perpetuate uncertainty as to the scope of the eventual patent.

   Response: The Office agrees that the publication of an application
is not sufficient notice of the scope of protection afforded by an
eventual patent because the claims have not been determined to be
patentable at the time of publication. Asking the public to determine
the broadest range of claim protection and to prevent infringement
based on the publication of an application would defeat the purposes of
patent examination and 35 U.S.C. 112, ¶ 2. The patent claims provide
the public with notice of the patent protection, not the disclosure of
an application.

   Comment 41: A number of comments stated that the current patent law
already contains its own solution to the problem of long chains of
continuing applications. The comments argued that filing and
maintenance fees and the twenty-year patent term provision discourage
applicants from filing continuing applications. Several comments argued
that the Office is acting prematurely because the recent changes (e.g.,
the Office electronic filing system, the increase in hiring and fees,
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1046 

court decisions on doctrine of equivalents, the twenty-year patent term
provisions, and publication of applications) should be sufficient to
reduce the backlog and improve public notice. A number of comments
alleged that the doctrine of prosecution laches is sufficient to
address abuses. One comment argued that the Office should not be
concerned with enforcement issues and the problem with public notice
should not be a reason for the rule changes. Several comments argued
that the Office's concern over public notice is misplaced because the
notice function of claims is limited to published or patented claims
and it does not extend to any future claims that might arise. Several
comments, however, noted that even with the twenty-year patent term
provisions, unrestricted continued examination practice still gives
applicants incentives to keep continuing applications pending after the
issuance of a patent so that the applicants can monitor the industry
development and capture other companies' products by changing the scope
of the claims in the continuing applications.

   Response: The percentage of continued examination filings did not
decrease after the implementation of the twenty-year patent term
provision of the Uruguay Round Agreement Act (Pub. L. 103-465, 108
Stat. 4809 (1994)). Thus, the twenty-year patent term provisions do not
discourage applicants from filing continued examination filings. As
discussed previously, this final rule is not intended to address
extreme cases of prosecution laches or to codify Bogese II. Examiners
already have the authority (with a Technology Center Director's
approval) to make a rejection on the grounds of prosecution history
laches. See MPEP section 2190. Some of the reasons cited by the
comments as to why an indefinite number of continuing applications is
needed suggest that continuing applications may be used for purposes of
delay more commonly than could be effectively addressed by the Office's
application of its equitable prosecution history laches authority.
Moreover, even where strategies of delay are not deliberately pursued,
the lack of reasonable requirements on the use of continued examination
practice may act as a disincentive to the examiner and applicant taking
the most effective steps to reach conclusion.

   The Office did not place a per se limit on the number of continuing
applications and requests for continued examination. The rules require
applicant to show why a third or subsequent continuing application or
second or subsequent request for continued examination is necessary to
advance prosecution. The Office recognizes both the adverse effects of
unrestricted continued examination practice, and the appropriate uses
of continued examination filings. The Office has sought to draw a
reasonable balance in order not to discourage appropriate uses of
continued examination filings while providing a regulatory setting in
which unnecessary prolongation of proceedings can be avoided. The
changes being adopted in this final rule are appropriately tailored to
permit applicants to file the initial application, two continuation or
continuation-in-part applications, and a request for continued
examination in any one of these three applications without any
justification. An applicant who considers this to be insufficient may
file any additional continuation or continuation-in-part application or
request for continued examination with a petition and showing as to why
the amendment, argument, or evidence sought to be entered could not
have been submitted earlier. The changes in this final rule will also
permit the Office to focus its limited resources on examination of new
applications in order to reduce the backlog of unexamined applications.

   Comment 42: One comment argued that the Office's assertion that
multiple patents tend to defeat the public notice function of patent
claims does not justify the rule changes because the restriction
practice tends to increase the number of patents. One comment argued
that the Office is making unsupported assumptions that: (1) The
possible issuance of multiple patents arising from continuing applications
tends to defeat the public notice function of patent claims; and (2) the
public is left uncertain as to what a set of patents resulting from the
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1047 

initial application will cover when multiple applications with patentably
indistinct claims are filed.

   Response: Restriction practice encourages applicant to file a
single application for each patentably distinct invention. The public
notice function of patent claims is undermined, however, when multiple
patents together claim only one patentable invention (i.e., the patents
contain patentably indistinct claims). In such case, applicant should
file a single application claiming one patentable invention rather than
multiple applications claiming the same patentable invention. The
Office is not making unsupported assumptions that the possible issuance
of multiple patents arising from continuing applications tends to
defeat the public notice function of patent claims, and that the public
is left uncertain as to what a set of patents resulting from the
initial application will cover when multiple applications with
patentably indistinct claims are filed. See, e.g., To Promote
Innovation: The Proper Balance of Competition and Intellectual Property
Law and Policy, Ch. 4 at 26-31 (Federal Trade Commission 2003); Lemley
and Moore, Ending Abuse of Patent Continuations, 84 B.U. L. Rev. at 100
(eliminating continuing application practice would be consistent with
the policy goal of giving adequate notice about what is and is not
covered by a patent).

   Comment 43: Several comments predicted that the rule changes would
discourage public disclosure of technology, thereby hurting industrial
growth and innovation. Several comments argued that by limiting an
applicant's ability to claim everything that is disclosed in the
application, the rule changes would cause the applicant to submit more
narrow disclosures to avoid inadvertent dedication of the subject
matter to the public (citing Johnson & Johnston Associates, Inc. v.
R.E. Service Co., 304 F.2d 1235, 62 U.S.P.Q.2d 1225 (Fed. Cir. 2002)
(en banc)). Several comments noted that the rule changes would force
applicants to delay filing until all foreseeable information has been
obtained or forego continuation-in-part filings that contain additional
information. Several comments stated that small entities that have
limited resources would not disclose alternative embodiments or would
file applications with narrow disclosures to avoid restriction
requirements. Several comments averred that inventors would delay the
filing of applications until after clinical or market testing is
concluded, a potentially commercially viable product is identified, or
other refining of the invention is completed. The comments also
predicted that some inventors would keep the invention secret from the
public and/or limit the scope of the disclosure to avoid dedicating
potentially commercial embodiments to the public. One comment argued
that the Office is making an unsupported assumption that continuing
applications and multiple applications containing patentably indistinct
claims impose a burden on innovation. One comment argued that
applicants would file multiple applications having divergent subject
matter rather than a single application and applicants would omit
certain concepts from the applications. One comment stated that the
prior art complications caused by the inability to claim priority of an
earlier filed application through intermediate applications would
severely curb disclosure because applicants would avoid creating their
own prior art under 35 U.S.C. 102(b) on a possible important commercial
embodiment. One comment stated that the current continued examination
practice encourages early disclosure of multiple embodiments of
inventions developed through the iterative design process. One comment
stated that large applications that disclose everything are good and
advance the Office's mission. One comment argued that the proposed rule
changes to the examination of claims will force applicants to file
applications that incorporate secondary features into their own
separately filed application. One comment argued that the new rules
would result in omnibus filings on anything and everything.

   Response: The Office has made modifications to the proposed rules
concerning both continuing applications and examination of claims
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1048 

practices. First, this final rule permits an applicant to file two
continuation applications or continuation-in-part applications, plus a
single request for continued examination in an application family,
without any justification. Second, this final rule permits applicants
to present more than five independent claims or more than twenty-five
total claims in an application if applicant files an examination
support document before the first Office action on the merits of the
application. Taken together, the changes to continuing application and
examination of claims practices adopted in this final rule permit
applicant to file as many claims as desired in one application and give
applicant sufficient opportunity to seek appropriate protection for the
disclosed invention. Accordingly, the changes being adopted in this
final rule do not place a per se limit on the number of claims
presented in an application, nor do they place a per se limit on the
number of continuing applications and requests for continued
examination available in an application family. The changes being
adopted in this final rule likewise do not give any advantage to those
applicants who file multiple applications that contain patentably
indistinct claims because such applicants would be required to identify
the multiple applications that contain patentably indistinct claims.
See §§ 1.75(b) and 1.78(f).

   The changes adopted in this final rule will not discourage
applicants from filing patent applications because the substantive
criteria for entitlement to a patent and the basic incentives for a
patent (exclusive rights) have not changed. Whether applicants file
narrow or broad disclosures, the changes in this final rule will reduce
uncertainty with respect to what the applicant is claiming as the
invention. The Office also does not expect applicants to delay the
filing of an application because any commercial activities and public
disclosures that occurred more than one year prior to the filing of an
application would still be considered prior art under 35 U.S.C. 102(b).
The changes being adopted in this final rule simply require applicants
to prosecute their applications diligently and submit amendments,
argument, and evidence early in the prosecution of the initial
application, two continuing applications and a request for continued
examination. As previously discussed, applicant has sufficient time to
determine whether to file a divisional application. If applicant needs
more time to determine which aspect of the invention to seek protection
for, applicant may file a request for deferral of examination under
§ 1.103(d).

   Comment 44: Several comments alleged that the rule changes would
have a significant adverse impact on applicants if the first-to-file
system is adopted because applicants would need to file more continuing
applications to protect their inventions because applicants would need
to file as soon as possible with broadly conceptualized disclosures and
subsequently file continuing applications (e.g., continuation-in-part
applications) on the improvement or detailed embodiments.

   Response: The United States currently does not have a "first
inventor-to-file" standard. Other countries that have a "first
inventor-to-file" standard have less flexible continued examination
practice than the United States. For example, the Japan Patent Office does
not permit continuation-in-part applications. Under the JPO practice,
applicant may only submit an application on an improvement as a new
application. The Office will continue to consider the issues related to the
"first-to-invent" standard and the "first inventor-to-file" standard in
determining the rights to a patent in the context of international
harmonization efforts.

   Comment 45: A number of comments argued that the rule changes would
disproportionately impact small entities including universities, start-
up companies, biotechnology companies, and public health industry
because they are more likely to file continuing applications and
requests for continued examination and have less resources. The
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1049 

comments provided the following reasons: (1) The proposed rule would
require significant expenses early in the prosecution of the
application that would cause small entities and independent inventors
economic hardship; (2) the rule changes would encourage large companies
that have more financial resources to "steal" inventions from the
small entities because the increased cost of obtaining patent
protection would prevent small entities from obtaining full protection
of their inventions and cause many small entities not to seek patent
protection; (3) small entities need the flexibility to respond to
changing conditions by refining claims and they cannot afford up-front
parallel filings as large companies can; (4) independent inventors and
small entities need the ability to file multiple continued examination
filings to spread the costs; (5) the rule changes could stifle the
building of patent portfolios for small companies and cause a reduction
of capital investment in these companies and in new technologies; (6)
applicants should be permitted to get a patent on the allowed claims
and then continue to prosecute the broader or rejected claims or to
claim subject matter not previously claimed in a continuing
application, in order to bring technologies to the market sooner, which
would permit small entities to attract investors and obtain financing
for further product development and patent prosecutions; (7) continued
examination filings are more likely needed in complex fields like
biotechnology because examiners are less likely to comprehend the
invention fully in the limited time allotted for the initial search and
examination and more likely to make restriction requirements, and
applicants need additional opportunities to address technical issues
arising during prosecution and submit evidence and clinical testing
data; (8) companies in the life sciences need continued examination
filings to obtain multiple patents that protect innovations and
improvements that arise over the long time period of research and
development, clinical testing, and the Food and Drug Administration
(FDA) approval process; (9) in biotechnology, applicants may not know
at the time of filing which embodiments of the invention have
commercial value or how a competitor may attempt to copy the invention
or circumvent the patent. One comment that supports the rule changes
noted that large entities also operate within limited filing budgets,
and the effects of the rules will apply across the board because any
applicant must decide what level of filing activity it can reasonably
afford, and make filing decisions accordingly. The comment further
stated that small entities already receive a fifty percent discount on
fees and can take advantage of inexpensive provisional applications to
delay paying filing fees. Several comments argued that the rule changes
will disproportionately impact small entities and that the Office
obscures this fact by including requests for continued examination into
the analysis. The comments stated that: 32 percent of patents to the
top nineteen universities are continuation or continuation-in-part
applications; 35.2 percent of first continuations and continuation-in-
part applications are filed by small entities; and 37.9 percent of
second continuations and continuation-in-part applications are filed by
small entities.

   Response: The Office notes the concerns expressed in the public
comment particularly by small entities regarding the proposed changes
to §§ 1.78(d)(1) and 1.114 that would have permitted an
applicant to file only one of the following: A continuation
application, a continuation-in-part application, or a request for
continued examination, without any justification. The Office has made
modifications to these proposed changes such that this final rule will
permit an applicant to file two continuation applications or
continuation-in-part applications, plus a single request for continued
examination in an application family, without any justification. Under
this final rule, an applicant may file a divisional application
directed to a non-elected invention if the prior-filed application is
subject to a requirement for restriction. The divisional application
need not be filed during the pendency of the application subject to a
requirement for restriction, as long as the copendency requirement of
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1050 

35 U.S.C. 120 is met. This final rule also permits applicant to file
two continuation applications of a divisional application plus a
request for continuation examination in the divisional application
family, without any justification. Applicant may also file any third or
subsequent continuation or continuation-in-part application, or any
second or subsequent request for continued examination in an
application family, with a petition and showing. Therefore, applicants
should have sufficient time to determine whether to seek protection for
a particular aspect of an invention and should have sufficient
opportunities to present claims, amendments and evidence for that
aspect. For example, applicant is permitted to obtain a patent on the
allowed claims from the initial application, and then continue to
prosecute the broader or rejected claims in two continuation or
continuation-in-part applications, and one request for continued
examination without justification. Beyond those filings, applicant may
seek a third or subsequent continuation or continuation-in-part
application and a second or subsequent request for continued
examination with a petition and showing. As previously discussed, the
changes being adopted in this final rule do not give any advantage to
those applicants who file multiple parallel applications containing
patentably indistinct claims. See §§ 1.75(b)(4) and 1.78(f).

   Applicant should also have sufficient opportunities to spread the
cost of prosecution. Applicant has a one-year grace period under 35
U.S.C. 102(b) before filing a patent application to test the market or
obtain capital resources. Before the end of the one-year grace period,
applicant may file a provisional application to obtain a U.S. filing
date and wait up to twelve additional months to file an initial
nonprovisional application. During this two-year time period,
applicants may determine the commercial value of each aspect of the
invention before filing the initial nonprovisional application.
Applicant may also request a deferral of examination under § 1.103(d)
and defer the examination up to three years from the earliest
filing date claimed (e.g., the filing date of the provisional
application). See § 1.103(d). By requesting a deferral of examination,
applicant would have even more time to determine the commercial value of
the invention or obtain capital resources and would avoid the cost of
filing and prosecuting multiple continued examination filings.
Furthermore, divisional applications need not be filed during the
pendency of the application subject to a requirement for restriction,
as long as the copendency requirement of 35 U.S.C. 120 is met.

   The changes being adopted in this final rule do not
disproportionately impact small entities. The Office estimates that the
change would have required such a petition and showing in only 2.9
percent of the 112,210 small entity applications and requests for
continued examination filed in fiscal year 2006. The Office included
the number of requests for continued examination into the analysis
because requests for continued examination divert the Office's patent
examining resources from the examination of new applications and
contribute to the increasing backlog of unexamined applications, just
like continuation and continuation-in-part applications.

   The Office notes that, during fiscal year 2006, it appears that the
percentage of small entity continued examination filings that would
have required a petition is slightly higher than the percentage of
total continued examination filings that would have required a petition
(2.9 percent small entity as opposed to 2.7 percent for all
applicants). The Office also notes that, during fiscal year 2006, it
appears that the percentage of small entity applications that exceeded
the five independent claims and twenty-five total claim threshold is
also slightly higher than the percentage of total applications that
exceeded the five independent claim and twenty-five total claim
threshold (24.4 as opposed to 23.7). These percentages are based upon
data that is available in the Office's PALM system for applications
filed during the most recent fiscal year. The Office does not think
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1051 

these slight differences establish that the changes in this final rule
will have a disproportionate economic impact on small entities since
these differences are within the margin of error. In addition, the
comments provide no reason, and there is no apparent one for why small
entity applicants would inherently require more continued examination
filings to prosecute the applications to completion or more claims to
adequately cover their inventions. Thus, even higher differences in
these percentages could easily be explained by the fact that small
entity applicants pay only one-half of the fees that other applicants
pay for continuing applications, requests for continued examination,
and excess claims.

   Comment 46: A number of comments predicted the rule changes would
limit applicants' opportunities to present claims, which would reduce
the scope of the patent claims because applicants would be pressured to
pursue and accept narrower claims. The comments argued that inventors
would not be able to adequately protect their inventions and would in
turn lose patent protection to certain aspects of their inventions,
which would have an adverse impact on the value of patents, patent
quality, innovations, research and development, the competitiveness of
U.S. companies, and the U.S. economy and would eliminate U.S. jobs. The
comments provided the following reasons: (1) The Office has not
appropriately addressed applicants' interests in maximizing patent
protection and receiving a fair consideration of all claims submitted;
(2) the rule changes would require applicants to claim all aspects of
the disclosed invention initially, even though applicants often file
applications without knowing the value of their inventions in order to
determine which embodiment will have value and be worthy of the
investment in patent protection; (3) applicants would not be able to
identify and address all claim permutations in the initial application
and one continuation application, and complex inventions often need
more claims and more than one continuation application to protect the
invention; (4) the Office should provide applicants the flexibility to
prosecute different embodiments at a later time; (5) the applicant
should be permitted to present claims (or change the scope of the
claims) in continuing applications to cover an embodiment of the
invention disclosed in the initial application when the applicant later
determines the commercial value of the embodiment, develops the actual
product, or discovers a potential infringer's product; (6) competitors
could easily circumvent the patent claims because applicant would not
have the ability to change the scope of the claims to cover the
competitor's product in a continuing application; (7) in view of the
courts' restrictive claim interpretation, the required showing under
§§ 1.78(d)(1) and 1.114 would eliminate a vast number of
legitimate continuing applications and requests for continued
examination needed to provide coverage of alternate aspects of an
invention.

   Response: This final rule does not place any per se limits on the
number of continued examination filings that may be filed or on the
number of claims an applicant may present in an application. Applicant
is permitted to submit all of the claims that applicant desires during
the prosecution of the initial application, two continuation or
continuation-in-part applications, and a request for continued
examination. An applicant who considers this to be insufficient may
file a third or subsequent continuing application or second or
subsequent request for continued examination with a petition showing
why the amendment, argument, or evidence sought to be entered could not
have been submitted earlier. For most applicants who prosecute their
applications diligently, additional continued examination filings would
not be needed. Applicant may also file a reissue application under 35
U.S.C. 251, if appropriate, to submit claims with different scope.
Further, the use of continuation practice to circumvent statutory
requirements for reissue and reexamination proceedings is not
appropriate. In addition, the rules require an applicant to advance
prosecution and not waste the Office's resources examining an
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1052 

application when the applicant is not ready to particularly point out
and distinctly claim the subject matter which the applicant regards as
his or her invention. See also § 10.18(b)(2)(i) and Hyatt v. Dudas,
2007 U.S. App. LEXIS 15350 (Fed. Cir. Jun. 28, 2007). Applicant should
not use continued examination practice to delay the prosecution of the
application because this adversely impacts the Office's ability to
examine new applications and reduce the backlog of unexamined
applications.

   Comment 47: One comment predicted that the rule changes would
discourage first action allowances because some applicants would
intentionally file applications with at least one defect in order to
receive a rejection to drag out pendency so that they can have more
time to determine whether to file continuing applications.

   Response: There is no reason why the new changes being adopted in
this final rule will encourage an applicant to intentionally file an
application with at least one defect to delay prosecution.
Additionally, such an action by an applicant would violate
§ 10.18(b)(2)(i). By presenting to the Office any paper (including an
application), the applicant is certifying that to the best of the
applicant's knowledge, information and belief, formed after an inquiry
reasonable under the circumstances, that the paper is not being
presented to cause unnecessary delay or needless increase in the cost of
prosecution before the Office.

   Comment 48: One comment sought clarification as to whether an
applicant is permitted to amend the claims and/or file a continuation
application to claim allowable subject matter presented in dependent
claims.

   Response: Applicant may amend the claims of an initial application
to claim allowable subject matter presented in dependent claims if the
amendment complies with the rules of practice (e.g., § 1.116). For
example, applicant may submit such an amendment in the initial
application in response to a non-final Office action in the initial
application. Such an amendment, however, will not be entered in the
initial application as a matter of right after a final Office action.
Under this final rule, applicant alternatively may file two
continuation or continuation-in-part applications plus one request for
continued examination in an application family, without any
justification and pursue the amendment in one of those two applications
or in the request for continued examination.

   Comment 49: Several comments argued that the combined effect of the
limit on the number of representative claims and the limit on the
number of continuing applications and requests for continued
examination as a matter of right would increase the number of multiple
parallel applications and divisional applications because applicants
would file more multiple parallel applications with small numbers of
claims or present claim sets that would provoke restriction
requirements. Either way, the comments contended that the backlog will
increase. One comment further alleged that applicants would file more
continued examination filings and appeals because by limiting the
number of claims examined, two Office actions would be insufficient,
thus resulting in an increase in pendency and cost. One comment argued
that the rule changes would disproportionately impact inventions that
require more claims, continuing applications, or examiner time. One
comment stated that the limitations on continued examination filings
and claims would cause more litigation because they would create more
uncertainty in infringement and validity.

   Response: As discussed previously, the Office is not adopting the
"representative claims" examination approach or restricting the
number of continued examination filings to one without any
justification. Rather, this final rule permits applicant to present
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1053 

more than five independent claims or more than twenty total claims in
an application if applicant files an examination support document.
Applicant is also permitted to file two continuation or continuation-
in-part applications, plus a request for continued examination in an
application family, without any justification. The changes being
adopted in this final rule do not place per se limits on the number of
claims which applicant may present in an application or on the number
of continued examination filings. The changes being adopted in this
final rule do not encourage applicant to file multiple parallel
applications that contain patentably indistinct claims. See §§
1.75(b)(4) and 1.78(f). Applicants would obtain little benefit from
filing multiple applications that contain patentably indistinct claims
because the Office would treat each application as having the total of
all of the claims (whether in independent or dependent form) in all
such applications for purposes of determining whether an examination
support document is required by § 1.75(b)(1) (but not for purposes
of calculating the excess claims fee due in each application).
Likewise, this final rule will not cause the number of divisional
applications to increase because this final rule permits divisional
applications to be filed serially. Therefore, applicant should have
sufficient time to determine whether to file a divisional application
to claim a non-elected invention.

   Comment 50: A few comments suggested that the limits set in
§§ 1.75(b)(4) and 1.78(d)(1) are inconsistent with interference
practice under 35 U.S.C. 135 of copying claims for purposes of
preserving the right to provoke an interference. One comment suggested
that the changes to § 1.78 eliminates an applicant's right to add
claims to an application to cover a similar or parallel technology,
provided that the added claims find support in the specification,
citing PIN/NIP, Inc., v. Platt Chemical Co., 304 F.3d 1235, 1247, 64
U.S.P.Q.2d 1344, 1352 (Fed. Cir. 2002). One comment stated that
subjecting patentably indistinct claims in multiple commonly owned
applications to elimination under § 1.78(f)(3) violates case law,
for example Kingsdown Med. Consultants, Ltd. v. Hollister Inc., 863
F.2d 867, 874, 9 U.S.P.Q.2d 1384, 1390 (Fed. Cir. 1988).

   Response: The Office has modified proposed § 1.75(b)(4) and
§ 1.78(d)(1). This final rule permits an applicant to file two
continuation or continuation-in-part applications plus one request for
continued examination in an application family, without any
justification. Applicant may also file a third or subsequent
continuation or continuation-in-part application or a second or
subsequent request for continued examination with a petition and
showing. This final rule permits applicant to present up to five
independent claims or twenty-five total claims in each application,
without an explanation. Applicant may also present more than five
independent claims and more than twenty-five total claims if applicant
files an examination support document before the first Office action on
the merits of the application. Applicant may file as many claims as
necessary to claim the full scope of his or her invention. This final
rule provides sufficient opportunities for applicant to present claims
to provoke an interference during the prosecution of these
applications. Therefore, the changes to §§ 1.75(b)(4) and
1.78(d)(1) being adopted in this final rule are not inconsistent with
35 U.S.C. 135. Furthermore, applicant may also file a reissue
application under 35 U.S.C. 251, if appropriate, to submit claims for
provoking an interference. In other situations, however, applicant is
not permitted to maintain an application in pending status, without
advancing prosecution, for the sole purpose of awaiting developments in
similar or parallel technology. As previously discussed, such practice
does not advance prosecution before the Office and impairs the ability
of the Office to examine new and existing applications.

   In other situations, however, applicant is not permitted to
maintain an application in pending status, without advancing
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1054 

prosecution, for the sole purpose of awaiting developments in similar
or parallel technology. As previously discussed, such practice does not
advance prosecution before the Office and impairs the ability of the
Office to examine new and existing applications.

   The Federal Circuit noted in PIN/NIP that one may amend an
application for the purpose of encompassing devices or processes of
others, subject to compliance with the requirements of the patent
statute and regulations (the claim at issue was determined to be
invalid under 35 U.S.C. 112, ¶ 1, for lack of written description
support). See PIN/NIP, 304 F.3d at 1247, 64 U.S.P.Q.2d at 1352. As
such, PIN/NIP cannot be relied upon to support a "wait and see"
concept under which an applicant files an initial application followed
by a stream of continuation applications just to wait for any
competitor to develop and market an invention not claimed in the
initial application. PIN/NIP, 304 F.3d at 1247, 64 U.S.P.Q.2d at 1352.
Further, in Kingsdown, the Federal Circuit opined: "Nor is it in any manner
improper to amend or insert claims intended to cover a competitor's product
the applicant's attorney has learned about during the prosecution of a
patent application. Any such amendment or insertion must comply with all
statutes and regulations, of course, but, if it does, its genesis in
the marketplace is simply irrelevant." Kingsdown, 863 F.2d at 874, 9
U.S.P.Q.2d at 130. This statement does not equate to a pronouncement
that an applicant has a "right" under the patent statutes to file a
continuous stream of continuing applications to ensure that there is
always a pending application in which to present claims encompassing
devices or processes of others.

   Further continuation practice is not intended to supplant or permit
circumvention of reissue practice. The patent statute at 35 U.S.C.
chapter 25 provides for the correction of patents, and specifically
provides for the reissue of a patent in those situations in which a
"patent is, through error without any deceptive intention, deemed
wholly or partly inoperative or invalid, by reason of * * * the
patentee claiming more or less than he had a right to claim in the
patent." See 35 U.S.C. 251. See also Toro Co. v. White Consol. Indus.,
383 F.3d 1326, 1333, 72 U.S.P.Q.2d 1449, 1454 (Fed. Cir. 2004) (citing
Johnson & Johnston, 304 F.2d at 1055, 62 U.S.P.Q.2d at 1231). Nothing,
however, suggests that an applicant has a "right" under the patent
statutes to file a continuing application to avoid the requirements of
the reissue statute when seeking to correct or enlarge the scope of a
patent. There is a difference between adding claims to an application
that are otherwise pending, and deliberately prolonging prosecution in
order to be able to do so. Deliberately prolonging a proceeding before
the Office would not be consistent with the requirements of § 10.18.

   Applicant may copy claims from another application or patent that
is not commonly owned for the purposes of provoking an interference,
without triggering § 1.78(f)(3). Section 1.78(f)(3) applies only to
multiple commonly owned applications that contain patentably indistinct
claims. Section 1.78(f)(3) is a restatement of former § 1.78(b),
which previously gave the Office the same discretion to require
elimination of patentably indistinct claims in all but one of the
pending nonprovisional applications. The Office is not preventing
applicants from providing such patentably indistinct claims in a single
application, or in multiple applications if applicant submits a
terminal disclaimer in accordance with § 1.321(c) and explains why
submitting patentably indistinct claims in separate applications is
necessary.

   Comment 51: Several comments suggested that if the Office
implements the limits on continued examination filings, the limits on
the number of claims would be unnecessary.

   Response: The comment provides no explanation as to how or why
implementation of the continued examination filing changes would make
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1055 

the claims provisions unnecessary. The Office determined that the
implementation of the changes to the continued examination practice and
practice for examination of claims in patent applications are necessary
to achieve quality and efficiency in the patent examination process.

   Comment 52: A number of comments argued that applicants should be
permitted to file more than one continuation or continuation-in-part
application or request for continued examination as a matter of right
because there are many legitimate reasons for the filings. The comments
provided the following examples: (1) The process of developing the best
prior art and obtaining the broadest possible protection is a complex
process and may extend the prosecution process; (2) applicants may use
strategies that would avoid prosecution history estoppel and preserve
doctrine of equivalents protection; (3) applicants may maintain a
continuing application so that they could respond to any adverse court
decisions and associated uncertainties; (4) the quality of the
examination process may cause delays; (5) examiners would allow broader
claims in a continuation application after becoming more familiar with
the subject matter and have more time to improve the search and
analysis; (6) applicants may maintain a continuing application pending
to prevent competitors from copying the invention or circumventing the
initial patent claims because the courts are less inclined to interpret
the scope of invention beyond the literal meaning of the claims,
precluding claim scope that once was captured under the doctrine of
equivalents; (7) applicants may file continuation applications as an
"insurance policy" so that applicants can correct any defects found
in the first patent or adjust the claim coverage without surrendering
the patent (as in the reissue and reexamination practices); (8)
applicants may file continuing applications to build large patent
portfolios and attract capital investments; (9) applicants want time to
conduct testing and to reevaluate the claim scope in light of new prior
art, market experience, and technology development; (10) for complex
technologies, it may take several prosecutions to determine the bounds
of patentable subject matter; (11) applicants may want many patents on
an invention to strengthen the protection; (12) applicants may file
continuing applications to correct errors in the initial prosecution
including those made by inexperienced representatives or applicants;
and (13) applicants who are in a crowded or highly valuable field need
to keep a continuing application pending for the purposes of provoking
interference.

   Response: The Office recognizes that there are some appropriate
reasons for filing multiple continuing applications and requests for
continued examination. There are, however, a number of reasons given
for multiple continuing applications and requests for continued
examination that are not considered appropriate. The changes being
adopted in this final rule are tailored to permit applicants to file
the initial application, two continuation or continuation-in-part
applications, and a request for continued examination in an application
family, without any justification. Any applicant who considers this to
be insufficient may file an additional continuation or continuation-in-
part application or a request for continued examination with a petition
showing why the amendment, argument, or evidence sought to be entered
could not have been submitted during the prosecution of the prior
filings. Applicants are required to prosecute diligently and to
particularly point out and distinctly claim the subject matter which
the applicant regards as his or her invention, upon filing the
application. If applicant's lack of knowledge of prior art, or lack of
diligence during the prosecution of the application, causes unnecessary
delay or needless increase in the cost of prosecution before the
Office, applicant would be violating his or her duty under § 10.18.
See § 10.18(b)(2)(i).

   Comment 53: A number of comments argued that many continuing
applications and requests for continued examination are caused by
inadequate examinations, the final Office action practice, and the
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1056 

examiner production system. The comments provided the following
examples: (1) It may take several exchanges between the examiner and
applicant before the examiner appears to understand the invention; (2)
examiners' lack of experience in the art and patent law; (3) some
examiners have difficulty using the English language in oral and written
communications; (4) the Office has large turnover in examining personnel;
(5) examiners make too many restriction requirements; (6) examiners want
to obtain additional "counts"; (7) examiners make improper rejections;
(8) examiners refuse to enter any after-final replies; (9) examiners are
not given sufficient time to conduct a proper search and examination in the
initial application; (10) examiners did not read the specification and
claims; (11) examiners do not adequately consider arguments made by the
applicants; (12) examiners make premature final rejections; (13)
examiners conduct piecemeal examination; (14) examiners are being
overturned by supervisors or quality control; (15) examiners do not
indicate allowable claims; (16) examiners do not set forth the
rejections clearly in the Office actions; (17) examiners do not apply
legal standards consistently; and (18) examiners make new grounds of
rejection or cite new art in final Office actions.

   Response: The Office provides applicant with procedures to address
inadequate examination issues. Applicant should not use the continued
examination practice as a substitute for the petition or appeal
process. The practice of permitting an unlimited number of continuing
applications and requests for continued examination appears to have
created lax practices. Applicants should raise any issue of inadequate
examination before the examiner and/or the examiner's supervisor. For
example, applicants should raise any question as to prematureness of a
final rejection before the primary examiner. Applicant may seek review
of the examiner's decision on the finality of the Office action by
petition under § 1.181, if appropriate. See MPEP §§ 706.07(c) and
1002.02(c). Restriction requirements are also reviewable
by petition under § 1.181. Applicants may request an interview with
the examiner to ensure that the examiner understands the invention or
claims correctly, or to seek clarification of the rejections or Office
action. See § 1.133(a)(2). If applicant disagrees with the
examiner's rejections, applicant may appeal the rejections to the BPAI
and/or request a pre-appeal brief conference, if appropriate.

   Comment 54: A number of comments argued that filing continuing
applications and requests for continued examination is more efficient
and cost-effective in dealing with deficiencies of the examination
process (even before a "stubborn examiner") because the factual
record is fixed on appeal and the appeal process takes a longer time
and is expensive, especially for independent inventors and small
entities. The comments predicted that the rule changes would increase
the number of pre-appeal brief conferences, examiner's answers and
appeals, and force applicants to appeal applications that are not in
condition for appeal (e.g., the record has not been fully developed and
unamended claims may be appealed). Several comments pointed out that
continuing applications and requests for continued examination help
applicants to place the application in better condition for appeal
because most examiners refuse to enter the after-final amendments. One
comment stated that some applicants might file the appeal simply to
preserve pendency. Some of the comments suggested that the Office
should wait and see what effect a quicker appeal process would have on
the backlog before implementing the rule changes. The comments stated
that once applicants appreciate the appeal process changes, more
applicants would file appeals rather than continuing applications and
requests for continued examination. Furthermore, the comments noted
that a study conducted by a firm shows that out of 121 appeal briefs
(appeals from January 1, 2004 to March 23, 2006), examiners issued only
nine answers, which represents an enormous waste of applicants' time
and money. One comment predicted that the BPAI would be quickly
overwhelmed and a broken appeal process would create more damage to the
examination process than the current problems.
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1057 


   Response: If applicant disagrees with the examiner's rejections,
applicants should file an appeal rather than filing a continuation
application or a request for continued examination. The appeal process
offers a more effective resolution than the filing of a continuation
application or a request for continued examination. The pre-appeal
brief conference program provides applicant a relatively expeditious
and low cost review of rejections by a panel of examiners. If, after
the conference, the prosecution is reopened, the applicant will have a
further opportunity to prosecute in front of the examiner. Applicant
would not need to file an appeal brief. If the Office decides that the
application should remain under appeal, it would be more efficient to
appeal the rejection to the BPAI by filing an appeal brief rather than
delay the appeal by filing a continuation application or a request for
continued examination. Furthermore, the pendency of an appeal is
relatively short. The current (as of the end of the second quarter of
fiscal year 2007) pendency of a decided appeal was 5.6 months. The
pendency of an appeal is the period between the assignment of an appeal
number and the mailing date of the decision. In addition, the BPAI has
reduced the inventory of pending appeals from 9,201 at the close of
fiscal year 1997 to 1,357 at the close of fiscal year 2006.
Nevertheless, continuing applications and requests for continued
examination as a percentage of total filings have increased as BPAI
appeal pendency and inventory of pending appeals has decreased.
Applicants should have sufficient opportunity to place the application
in condition for appeal during the prosecution of the initial
application, two continuing applications, and one request for continued
examination in an application family. An applicant who considers this
to be insufficient may file any third or subsequent continuation or
continuation-in-part applications or second or subsequent requests for
continued examination with a petition showing why the amendment,
argument, or evidence sought to be entered could not have been
previously submitted.

   Comment 55: Several comments alleged that the Office has provided
no evidence for the assertion that the exchange between applicants and
examiners becomes less beneficial and suffers from diminished returns
after the initial application. A number of comments also argued that
the Office did not provide any investigation or analysis of the
frequency with which the value of exchanges between the examiner and
applicant decrease after the first continuing application or request
for continued examination. A number of comments suggested that
continuing applications and requests for continued examination permit
additional mutually beneficial interaction between the examiner and
applicant because: (1) The examiner and applicant already are familiar
with the issues in the prosecution; (2) they give the examiner more
time to examine the same subject matter and gain better understanding
of the prior art; and (3) they permit applicants multiple opportunities
to refine the claims and present additional data or evidence which
would result in better quality patents with valid claims and clearly
defined subject matter. Several comments argued that the rule changes
would not improve public notice and the exchanges between the examiner
and applicant because applicants would file multiple parallel
applications rather than one single application and the applications
would be assigned to different examiners. Several comments argued that the
exchanges between the examiner and applicant would be less efficient and
more contentious because applicants would present broader claims and argue
rejections more aggressively resulting in higher pendency. Several comments
also predicted that applicant would request more interviews which would be
more work for both the examiner and applicant. Several comments argued
that it is unclear how the exchange between examiners and applicants
will be more efficient because there is nothing in the proposal to
encourage examiners to be more reasonable and appeals are not more
efficient. One comment also argued that the Office is making
unexplained assumptions that: (1) The value of a continuing application
or a request for continued examination is less than the value of a new
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1058 

application; (2) the changes to continuing applications practice being
adopted in this final rule should improve the quality of issued
patents, making them easier to evaluate, enforce, and litigate; (3)
this small minority of applicants prejudices the public permitting
applicants to keep applications in pending status while awaiting
developments in similar or parallel technology and then later amending
the pending application to cover the developments; and (4) the changes
being adopted in this final rule will result in claims issuing faster.

   Response: Under this final rule, applicant is permitted to file two
continuation or continuation-in-part applications plus one request for
continued examination in an application family. These filings will
provide sufficient opportunities for applicants to submit amendments,
arguments, and evidence. Furthermore, the exchange between applicant
and the examiner will be more efficient because applicant can no longer
delay the submissions of amendments, argument, and evidence and the
examiner will have the information earlier to determine the
patentability of the claims. In addition, even if one could argue that
additional continuing applications and requests for continued
examination are beneficial in the particular application, the marginal
value of a third or subsequent continuing application or a second or
subsequent request for continued examination vis-a-vis the
patent examination process decreases due to the Office resources
occupied by the additional continued examination filings for
amendments, argument, and evidence that could have been presented
earlier. Nevertheless, an applicant can show on petition that an
additional filing is necessary. Finally, the changes being adopted in
this final rule require applicant to submit all of the claims that are
patentably indistinct in one single application and to identify
multiple applications that contain patentably indistinct claims. See
§§ 1.75(b) and 1.78(f).

   Comment 56: One comment argued that the Office should not impose a
limit on the number of continuing applications an applicant may file
when the Office can issue any number of rejections and improper final
rejections.

   Response: In this final rule, the Office has not placed an absolute
limit on the number of continued examination filings. Rather, applicant
is permitted to file the initial application, two continuing
applications, and a request for continued examination in an application
family, without any justification, and any third or subsequent
continuing application or second or subsequent request for continued
examination with a petition and a showing as why the amendment,
argument, or evidence sought to be entered could not have been
submitted earlier. Applicant may seek review of any improper finality
of a rejection by filing a petition under § 1.181, or of any
improper rejection by filing a notice of appeal, a request for pre-
appeal brief conference, and an appeal brief.

   Comment 57: Several comments argued that examiners will have to
review larger submissions because applicants will be forced to front-
load responses to every Office action with interviews, declarations and
other evidence when the attorney's argument alone otherwise might have
been sufficient. The comments argued that this would increase pendency.
One comment predicted that the rule changes would decrease examiners'
production because there would be "more hard cases" and "less easy
counts." Several comments stated that the rule changes would require
applicant to respond to a first Office action by preparing what would
be a de facto appeal brief with all of the arguments and evidence
because applicant would only file the one permissible continuation or
continuation-in-part application or request for continued examination
as a last resort after appeal.

   Response: Section 1.78 as adopted in this final rule permits an
applicant to file two continuing applications plus one request for
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1059 

continued examination in an application family, without any
justification. Thus, the changes adopted in this final rule do not
require applicant to respond to a first Office action by preparing what
would be a de facto appeal brief with all of the arguments and
evidence. Nevertheless, the examination will be more efficient when
applicant submits a fully responsive reply to each Office action so
that the examiner will have the information, including amendments,
arguments, and evidence, to determine the patentability sooner rather
than later. Even prior to the changes being adopted in this final rule,
applicants have been required to file a fully responsive reply to an
Office action. See §§ 1.111(b) and (c). A change to the rules
of practice that encourages applicants to submit complete, rather than
piecemeal, replies will advance prosecution to final disposition with a
minimum number of Office actions, continuing applications, and requests
for continued examination. Such change streamlines the examination
process, thereby benefiting both applicants and the Office.

   Comment 58: A number of comments argued that continuation or
continuation-in-part applications and requests for continued
examination are needed so that applicants can submit prior art that is
discovered after the prosecution is closed (e.g., through international
search reports or foreign search reports), and amend the claims in view
of late newly-discovered art. Several comments suggested that the
Office should permit applicants to file a request for continued
examination without a petition and showing to submit newly discovered
prior art, and art cited by the U.S. International Searching Authority
similar to art cited by a foreign patent office, because otherwise
applicants would be penalized due to PCT administrative backlogs. One
comment sought clarification in the situation where an applicant wishes
to withdraw an application from issue to submit new art for
consideration and a continuation application has been filed.

   Response: Applicant is not required to file a continuation or
continuation-in-part application or a request for continued examination
in order to submit prior art discovered after the prosecution is closed
or an amendment in view of the late discovered art. The Office recently
proposed changes to information disclosure statement (IDS)
requirements. See Changes To Information Disclosure Statement
Requirements and Other Related Matters, 71 FR 38808 (July 10, 2006),
1309 Off. Gaz. Pat. Office 25 (Aug. 1, 2006) (proposed rule)
(hereinafter "Information Disclosure Statement Proposed Rule"). The
proposed changes (if adopted) would permit applicant to submit an IDS
after a first Office action on the merits, but before the mailing date of
a notice of allowability or a notice of allowance under § 1.311, if
applicant files the IDS with the certification under § 1.97(e)(1) and a
copy of the foreign search report, or an explanation under proposed
§ 1.98(a)(3)(iv) and a non-cumulative description under proposed
§ 1.98(a)(3)(v). Applicant would also be permitted to submit an IDS after
allowance, but before the payment of the issue fee, if applicant files
the IDS with a patentability justification under proposed
§ 1.98(a)(3)(vi), including any appropriate amendments to the claims.
Applicant would be permitted to submit an IDS after the payment of the
issue fee if applicant files a petition to withdraw from issue pursuant
to § 1.313(c)(1), the patentability justification under proposed
§ 1.98(a)(3)(vi)(B), and an amendment to the claims. Prior to the
effective date of any final rule based upon the Information Disclosure
Statement Proposed Rule, applicant may submit an IDS after the close of
prosecution with a petition under § 1.183 if the IDS complies with
the applicable requirements set forth in the Information Disclosure
Statement Proposed Rule for such an IDS.

B. Treatment of Third and Subsequent Continuation or Continuation-In-
Part Applications

   Comment 59: Several comments supported the rule changes that permit
one continued examination filing without any justification. A number of
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1060 

comments, however, suggested that the Office should permit more than
one continued examination filing without requiring a petition and
showing. The comments suggested the following without a petition and
showing: (1) At least two continuation or continuation-in-part
applications; (2) at least three continuation or continuation-in-part
applications; (3) three to six continued examination filings; (4) three
to five applications per application family; (5) only one patent to be
issued from a chain of continuation applications; (6) unlimited number
of continuation applications coupled with a requirement for a
patentability report in the third or subsequent continuation
application or a prior art search and compliance with the requirements
under 35 U.S.C. 112; (7) two requests for continued examination, but
only one continuation or continuation-in-part application; (8) at least
one request for continued examination per application; (9) more than
one request for continued examination per application; and (10) two or
three requests for continued examination per application. Several
comments suggested that the Office should permit more than one
continuation or continuation-in-part application if the applications
are filed within a reasonable time period (e.g., one to eight years
from the earliest filing date claimed). One comment suggested that the
Office should permit requests for continued examination filed within
three years of the filing date if applicant has filed a petition to
make special for accelerated examination. One comment suggested that
the Office should permit applicant to file a request for continued
examination, but allow the examiner to refuse the request for continued
examination if the first action can be made final. One comment
suggested that the Office should eliminate all continuing applications
except for divisional applications. One comment proposed that the
Office should eliminate all continuing applications, but permit
requests for continued examination. One comment suggested that the
limitation on the number of continued examination filings should not
apply to divisional applications and requests for continued
examination.

   Response: The Office has modified the proposed provisions that
permit applicant to file one continuation or continuation-in-part
application or request for continued examination without any
justification. Under this final rule, applicant may file two
continuation or continuation-in-part applications plus one request for
continued examination in an application family, without any
justification. Applicant may also file any third or subsequent
continuation or continuation-in-part application or second or
subsequent request for continued examination with a petition and
showing. The changes being adopted in this final rule will permit the
Office to focus its patent examining resources on examining new
applications, and thus reduce the backlog of unexamined applications
and improve pendency for all applications. Permitting more than two
continuation or continuation-in-part applications and more than one
request for continued examination in an application family without any
justification would significantly decrease the effectiveness of the
changes being adopted in this final rule. These final rule requirements
for seeking a third or subsequent continuation or continuation-in-part
application will not impact the vast majority of the applications.

   A time limit requirement for filing continuing applications and
requests for continued examination would not be desirable because it
would encourage applicants to file an unlimited number of continued
examination filings before the time period expires. Furthermore, a time
limit would preclude an applicant from filing appropriate continued
examination filings after the time period expires. Additionally, this
suggested strategy would also disproportionately impact applications in
certain technologies (e.g., biotechnology) that have long prosecutions.

   Requiring a patentability report or a prior art search in a
continuation application would not increase efficiency in the
examination of the initial application. If applicant submits the
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1061 

information earlier in the initial application, applicant most likely
would not need to file a third or subsequent continuing application
because the examiner would have all of the relevant information to make
the patentability determination in the initial application.

   The Office recognizes there are appropriate reasons for filing
continued examination filings. As a result, the Office did not place an
absolute limit on the number of continued examination filings. If the
prior-filed application was subject to a requirement for restriction,
applicant may file a divisional application directed to a non-elected
invention that has not been examined. The divisional application need
not be filed during the pendency of the application subject to a
requirement for restriction, as long as the copendency requirement of
35 U.S.C. 120 is met. See § 1.78(d)(1)(ii). Therefore, the changes
being adopted in this final rule appropriately balance the need to
reduce the large and growing backlog of unexamined patent applications
and make the patent examination process more effective.

   Comment 60: Several comments expressed concerns that there would be
an added economic burden on applicants, particularly small entities, to
pursue additional continued examination filings due to the new petition
process, and that the economic burden will effectively be a bar to many
applicants. The comments stated that even when an additional continued
examination filing is completely justified, applicants will suffer
undue hardship and will likely be deterred from even attempting to
request any additional continued examination filing because of the
expense and time involved to review and prepare the petition. One
comment suggested that the petition process under §§ 1.78(d)(1)(vi)
and 1.114(g) will have a disparate effect on small entities. Several
comments suggested that the Office should provide an exception for filing
additional continued examination filings to applicants who are small
entities and those that qualify for financial hardship. One comment further
suggested that the Office should provide the exception for five years.

   Response: The Office notes the concerns expressed in the public
comment regarding the proposed changes to §§ 1.78(d) and
1.114(g) that would permit an applicant to file one continuation
application, continuation-in-part application, or request for continued
examination, without any justification. The Office has made
modifications to the proposed provisions such that this final rule
permits an applicant to file two continuation applications or
continuation-in-part applications, plus a single request for continued
examination in an application family, without any justification. Under
this final rule, an applicant may also file a divisional application of
a prior-filed application for the claims to a non-elected invention
that was not examined if the application was subject to a requirement
for restriction. The divisional application need not be filed during
the pendency of the application subject to a requirement for
restriction, as long as the copendency requirement of 35 U.S.C. 120 is
met. This final rule also permits applicant to file two continuation
applications of a divisional application plus a request for continued
examination in the divisional application family, without any
justification. Applicant may file any additional continuation
application or request for continued examination with a petition and
showing.

   The changes to §§ 1.78(d) and 1.114(g) adopted in this
final rule apply to all applicants, regardless of whether they are
individuals, small businesses or large multinational corporations.
These changes do not disproportionately affect individuals and small
businesses. Applicants who seek to file a third or subsequent
continuation or continuation-in-part application or a second or
subsequent request for continued examination are required to file a
petition under § 1.78(d)(1)(vi) or 1.114(g) regardless of their
status. The requirements for seeking a third or subsequent continuation
or continuation-in-part application or a second or subsequent request
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1062 

for continued examination would only have affected 2.9 percent of the
applications or requests for continued examination filed by a small
entity in fiscal year 2006. The Office notes that a vast majority of
applicants do not file more than two continuation or continuation-in-
part applications and more than one request for continued examination
in an application family. Therefore, the $400 petition fee and the
showing requirement will impact only a small minority of applicants.

C. Treatment of Second and Subsequent Requests for Continued
Examination

   Comment 61: Several comments supported the changes to § 1.114.
A number of comments, however, objected to the changes and suggested
that the Office should permit applicants to file requests for continued
examination without a petition and showing. The comments provided the
following reasons: (1) Requests for continued examination are different
from continuing applications because requests for continued examination
require applicant to advance prosecution and would not cause the Office
to issue multiple patents to the same invention; (2) requests for
continued examination are not continuation applications, but rather are
the same application; (3) requests for continued examination help
applicants to deal with deficiencies in the examination process and
provide a more efficient, effective and cheaper procedure to advance
prosecution and have art considered than the appeal, petition or
reissue process; (4) limiting applicants to one request for continued
examination without a petition would lead to more filings of
continuation applications and petitions; (5) due to the changes in
§ 1.75, the Office would issue more final Office actions with new
grounds of rejection, which would necessitate the filing of more
requests for continued examination; and (6) applicants would file more
appeals, and thus the pendency of applications would increase.

   Response: The Office has modified the proposed provisions to
provide that an applicant may file a request for continued examination
in an application family, without a petition and showing. An
application family includes the initial application and its
continuation or continuation-in-part applications. Under this final
rule, applicant may also file a request for continued examination in a
divisional application family, without a petition and showing. A
divisional application family includes the divisional application and
its continuation applications. The provisions of § 1.78(d)(1) are
independent of the provisions of § 1.114. Therefore, the filing of
a request for continued examination does not preclude an applicant from
filing two continuation or continuation-in-part applications.
Similarly, the filing of a continuation or continuation-in-part
application does not preclude an applicant from filing a request for
continued examination.

   When applicant files a request for continued examination, the
prosecution of the application is reopened and the examiner conducts
another substantive examination on the claims present in the
application. Consequently, similar to continuation or continuation-in-
part applications, requests for continued examination divert the
Office's patent examining resources from the examination of new
applications and contribute to the backlog of unexamined applications.
The request for continued examination practice should not be used as a
substitute for the appeal, petition or reissue process. If the
applicant disagrees with the examiner's rejections, then the applicant
should pursue the appeal process as a means to more efficiently resolve
the disagreement.

   In addition, under the Office's new optional streamlined
continuation procedure, an applicant may request that a continuation
application be placed on an examiner's amended (Regular Amended) docket
(see discussions of §§ 1.78(d)(1)(i) and 1.114) which would be
picked up for action faster than an application placed on the
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1063 

examiner's new continuing application (New Special) docket. By
requesting that the two continuation applications permitted under
§ 1.78(d)(1)(i) be treated under the optional streamlined continuation
application procedure, an applicant may obtain the benefits of faster
processing similar to having a second and third request for continued
examination without a petition under § 1.114(g).

   Comment 62: One comment sought clarification on whether the changes
to §§ 1.78 and 1.114 being adopted in this final rule apply to
reissue applications.

   Response: The changes to §§ 1.78 and 1.114 being adopted in
this final rule apply to reissue applications. Under this final rule,
applicant may file two reissue continuation applications plus a request
for continued examination in the reissue application family, without
any justification. Benefit claims under 35 U.S.C. 120, 121, or 365(c)
in the application for patent that is being reissued will not be taken
into account in determining whether a continuing reissue application
claiming the benefit under 35 U.S.C. 120, 121, or 365(c) of the reissue
application satisfies one or more of the conditions set forth in
§§ 1.78(d)(1)(i) through 1.78(d)(1)(vi). For example, even if
the application for the original patent was a second continuation
application, applicant may still file two reissue continuation
applications. However, an applicant may not use the reissue process to
add to the original patent benefit claims under 35 U.S.C. 120, 121, or
365(c) that do not satisfy one or more of the conditions set forth in
§§ 1.78(d)(1)(i) through 1.78(d)(1)(vi) to the original patent,
if the application for the original patent was filed on or after
November 1, 2007.

   Comment 63: One comment suggested that the examiner should not make
any new rejections in a request for continued examination, unless the
amendment to the claims raises new issues.

   Response: When applicant files a request for continued examination
in compliance with § 1.114, the prosecution of the application is
reopened and the examiner will consider the amendment, argument, or
evidence submitted by the applicant. The examiner will conduct another
substantive examination, consistent with providing "for the continued
examination of application" under 35 U.S.C. 132(b). Limiting the
examiner's ability to conduct a patentability determination after the
filing of a request for continued examination would not result in
efficiency in the examination process.

   Comment 64: One comment argued that it would be inconsistent to
permit the filing of a request for continued examination in a prior-
filed application after a continuation application is filed, but to not
permit the filing of a continuation application of an application that
has a request for continued examination filed therein. Another comment
suggested that the Office should permit an applicant to file a
continuation application even though a request for continued
examination had been filed in the prior-filed application.

   Response: The Office has modified the proposed provisions to
provide that an applicant may file a request for continued examination
in an application family, without a petition and showing. The
provisions of § 1.78(d)(1) are independent of the provisions of
§ 1.114. Therefore, the filing of a request for continued
examination does not preclude an applicant from first filing two
continuation or continuation-in-part applications. Likewise, the filing
of a continuation or continuation-in-part application does not preclude
an applicant from first filing a request for continued examination. Put
differently, under this final rule, applicant may file a continuation
application of an application in which a request for continued
examination has already been filed. Applicant may also file a request
for continued examination in a prior-filed application after a
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1064 

continuation application has been filed.

D. Petitions Related to Additional Continuation Applications,
Continuation-In-Part Applications, and Requests for Continued
Examination

   Comment 65: A number of comments were critical of the showing
requirement set forth in §§ 1.78(d)(1) and 1.114. One comment
argued that the required showing is a per se limit on the number of
continuation or continuation-in-part applications and requests for
continued examination. Several comments stated that the standard under
§§ 1.78(d)(1) and 1.114 is a hindsight standard. The comments
argued that except for rare instances when evidence was not in
existence prior to filing the additional continuing examination filing,
the Office could almost always conclude, in hindsight, that the
amendment, argument, or evidence sought to be entered could have been
previously submitted. One comment argued that the showing under
§§ 1.78(d)(1) and 1.114(g) is too stringent and unrealistic
given the practicalities of conventional and reasonable patent
prosecution practice and the interests of patent applicants. Several
other comments described the showing as exceptionally high, onerous,
impossible to meet, restrictive, and ambiguous. Furthermore, several
comments asserted that the rule changes required applicants to be aware
of all possible prior art. Several other comments stated that the
required showing set forth in §§ 1.78(d)(1) and 1.114 appears
difficult to meet for any amendment submitted with an application that
is not a continuation-in-part application, indicating that it is hard
to imagine how one would prove that an amendment or argument "could
not have been submitted" in the absence of new matter. One comment
objected to the required showing under §§ 1.78(d)(1) and 1.114
because the purpose of filing an additional continuation or
continuation-in-part application or a request for continued examination
may be to do something other than present a new argument, evidence or
amendment, such as protect a different aspect of the invention revealed
by research and development subsequent to an initial application
filing. One comment stated that given enough time and effort an
applicant will almost always be able to come up with some reason why
the amendment, argument, or evidence could not have been previously
submitted as required by §§ 1.78(d)(1) and 1.114 and that this
requirement merely adds a layer of bureaucracy. One comment in support
of the showing under §§ 1.78(d)(1) and 1.114 stated that it is
a sensible compromise that does not ban additional continued
examination filings, but requires applicants in essence to show good
cause for additional continued examination filings. Several comments in
support of the showing stated that the proposed rules accommodate the
legitimate uses of continuations, limit abuses that can harm the
competitive process, and promote the patent system's ability to provide
incentives to innovate by reducing pendency.

   Response: The Office notes the concerns expressed in the public
comment regarding the proposed provisions that would require a petition
and showing if an applicant files more than one continued examination
filing (a continuation application, a continuation-in-part application,
or a request for continued examination). The Office has made
modifications to these proposed changes such that this final rule
permits an applicant to file two continuation applications or
continuation-in-part applications, plus a single request for continued
examination in an application family, without any justification. Under
this final rule, an applicant may also file a divisional application of
an application for the claims to a non-elected invention that was not
examined if the application was subject to a requirement for
restriction. The divisional application need not be filed during the
pendency of the application subject to a requirement for restriction,
as long as the copendency requirement of 35 U.S.C. 120 is met. This
final rule also permits applicant to file two continuation applications
of a divisional application plus a request for continued examination in
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1065 

the divisional application family, without any justification. Applicant
may file any additional continuation application or request for
continued examination with a petition and showing. Therefore, given the
multiple opportunities for applicant to submit amendments, arguments,
or evidence, it is appropriate to require an applicant to justify why
an amendment, argument, or evidence sought to be entered could not have
been submitted earlier when filing any third or subsequent continuation
application, continuation-in-part application, or second or subsequent
request for continued examination. The Office considers the standard
set forth in §§ 1.78(d)(1)(vi) and 1.114(g) to be an
appropriate balance of the interests of applicants and the need for a
better focused and effective examination process to reduce the large and
growing backlog of unexamined applications.

   Applicants and practitioners have a duty to refrain from submitting
an application or other filing to cause unnecessary delay or needless
increase in the cost of prosecution before the Office. See
§ 10.18(b)(2). Applicants also have a duty throughout the prosecution of
an application to make a bona fide attempt to advance the application
to final agency action. See Changes to Practice for Continuing
Applications, Requests for Continued Examination Practice, and
Applications Containing Patentably Indistinct Claims, 71 FR at 49, 1302
Off. Gaz. Pat. Office at 1319. Applicant should be prepared to
particularly point out and distinctly claim what the applicant regards
as his or her invention. Furthermore, the examination process is more
efficient and the quality of the patentability determination will
improve when applicant presents the desired claims, amendments,
arguments and evidence as early as possible in the prosecution. The
changes to §§ 1.78 and 1.114 in this final rule do not require
an applicant to be aware of all possible prior art to meet the showing
under §§ 1.78(d)(1)(vi) and 1.114(g), but applicant is required
to conduct a prior art search for filing an examination support
document under § 1.265. Nor do these changes add to applicant's
existing duties under § 1.56(a) to disclose to the Office all
information known to the applicant to be material to patentability, and
under 37 CFR Part 10.

   Comment 66: One comment asserted that the Office will not achieve
its goal of reducing the number of filings of continuation applications
because an applicant could easily show why the amendment, argument, or
evidence could not have been previously submitted when the subject
matter of the claims in the continuation application is different from
the subject matter of the claims of the initial application.

   Response: The submission of an amendment to the claims or new
claims to different subject matter alone will not be sufficient to meet
the showing requirement under § 1.78(d)(1)(vi). Applicant must
provide a satisfactory showing that the amendment, argument, or
evidence sought to be entered could not have been previously submitted
during the prosecution of the initial application, two continuation
applications, and the request for continued examination.

   Comment 67: One comment stated that the required showing under
§§ 1.78(d) and 1.114 might have far-reaching implications that
extend outside the patent process. Several comments expressed concerns
that the showing may require applicants to disclose highly sensitive
business information such as business strategies, and to alert their
competitors as to how the applicants plan to gain a competitive edge.
The comments further expressed concerns that the petition procedure may
also invoke attorney-client privilege.

   Response: Applicants or patent owners often present sensitive
business information to the Office, such as a showing of unavoidable
delay in a petition to revive under § 1.137(a) or a petition to
accept late payment of a maintenance fee under § 1.378(b). The
Office has procedures in place for applicants and patent owners to
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1066 

submit trade secrets, proprietary material, and protective order
material and to prevent unnecessary public disclosure of the material.
See MPEP §§ 724-724.06. If it is necessary for an applicant to
disclose sensitive business information to the Office to meet the
showing under § 1.78(d)(1)(vi) or 1.114(g), applicant may submit
the information in compliance with the procedures set forth in MPEP
§§ 724-724.06 (e.g., the information must be clearly labeled as
such and be filed in a sealed, clearly labeled, envelope or container).

   Comment 68: One comment stated that the petitions under
§§ 1.78(d)(1) and 1.114 would be scrutinized in court, creating a
substantial increase in time and resources devoted to litigating and
enforcing otherwise valid patent rights. One comment expressed concern
that the petitions under §§ 1.78(d)(1) and 1.114 are unlikely
to be granted and are likely to be the subject of an attack in
litigation. A number of comments asserted that applicants would be
subject to a higher potential for allegations of inequitable conduct.
Additionally, one comment argued that the proposed rule changes would
increase the frequency of malpractice litigation.

   Response: The rules adopted in this final rule require applicants
to prosecute their applications with reasonable diligence and
foresight. The submission of a showing as to why an amendment, argument
or evidence sought to be entered could not have been submitted earlier
does not expose an applicant to a greater risk of inequitable conduct
or litigation. The failure to disclose material information, or an
affirmative misrepresentation of a material fact or submission of false
material information or statements, coupled with an intent to deceive
or mislead the Office, constitutes inequitable conduct. The simple
submission of a showing as to why an amendment, argument or evidence
sought to be entered could not have been submitted earlier does not by
itself raise such intent. If an applicant acts with candor and good
faith in dealing with the Office, there should be no increased risk
that the applicant will be accused of inequitable conduct. Similarly,
if patent practitioners abide by the standards of professional conduct
expected of practitioners in their relationships with their clients,
and comply with the requirements of the patent statutes and rules,
there should be no reason for increased exposure to malpractice suits.

   Comment 69: Several comments suggested that the Office should adopt
an alternate standard for additional continued examination filings in
place of the standard set forth in §§ 1.78(d)(1) and 1.114.
Some of the comments suggested the following alternatives: (1) A
reasonable diligence standard; (2) a certification by a practitioner
that it is necessary for the inventor to be adequately protected; (3)
the "unduly interferes" standard as set forth in the former §
1.111(b); (4) a requirement that the submission be a bona fide attempt
to advance prosecution; (5) an explanation of the need for the
continued examination filing; (6) a reasonable justification standard;
(7) a reasonable under the circumstances standard; or (8) a good cause
standard. One of the comments stated that a good cause standard would
not place an undue burden on the Office or prejudice the public.
Additionally, the comment requested that an application filed for good
cause should not count toward the single continued examination filing
as a matter of right.

   Response: The Office considers the standard that the amendment,
argument or evidence sought to be entered could not have been
previously submitted set forth in §§ 1.78(d)(1)(vi) and
1.114(g) appropriate for an additional continued examination filing.
The standard set forth in §§ 1.78(d)(1)(vi) and 1.114(g) as
adopted in this final rule ("a showing that the amendment, argument,
or evidence sought to be entered could not have been submitted
[earlier]") is more definite than the alternatives suggested in the
comments (e.g., "good cause" and "reasonable under the
circumstances") and other standards set forth in the patent statutes
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1067 

(see e.g., Smith v. Mossinghoff, 671 F.2d 533, 538, 213 U.S.P.Q. 977,
982 (DC Cir. 1982) (noting the absence of guidance concerning the
meaning of the term "unavoidable" in 35 U.S.C. 133)). The comments do
not provide an explanation as to why any of
these alternatives would be a more effective standard or more definite.
Furthermore, §§ 1.78(d)(1) and 1.114(g) as adopted in this
final rule do not set an absolute limit on the number of continued
examination filings. Applicants are permitted to file two continuation
or continuation-in-part applications and one request for continued
examination without any justification. Applicants are also permitted to
file any third or subsequent continuation or continuation-in-part
application or second or subsequent request for continued examination
with a petition and showing. If an amendment, argument, or evidence
could have been submitted during the prosecution of the initial
application, two continuing applications, or a request for continued
examination, applicant must present such submission earlier rather than
wait to submit it later in a third or subsequent continuation or
continuation-in-part application or in a request for continued
examination. Thus, the required showing is an appropriate standard.

   Finally, as discussed further in this final rule, the Office may
grant relief "in an extraordinary situation" in which "justice
requires" even if the situation does not technically meet the standard
that the amendment, argument or evidence sought to be entered could not
have been previously submitted. See § 1.183. The Office, however,
does not anticipate granting petitions under § 1.78(d)(1)(vi) on a
basis other than a showing that the amendment, argument or evidence
sought to be entered could not have been previously submitted.

   Comment 70: Several comments suggested that the changes to § 1.78
should only be temporary so that the Office may assess the impact
of the changes before adopting the rule. One comment also suggested
that if the Office adopts the rule changes, the Office should eliminate
the changes once the backlog decreases.

   Response: Unrestricted continued examination filings and
duplicative applications that contain patentably indistinct claims are
significantly hindering the Office's ability to examine new
applications to such an extent that it is necessary for the Office to
adopt and implement the changes to these practices. After the
implementation of the changes being adopted in this final rule, the
Office will re-evaluate the rules of practice to determine what, if
any, additional changes are necessary.

   Comment 71: Several comments suggested that §§ 1.78(d)(1)
and 1.114 should be revised from "a showing as to why the amendment,
argument, or evidence presented could not have been previously
submitted" to "a showing as to why the new claim, amendment,
argument, or evidence presented could not have been previously
submitted" to resolve any potential ambiguity in the rules.

   Response: The Office notes the comments' concern for ambiguity in
the language of the rules. The phrase, "a showing * * * that the
amendment, argument, or evidence sought to be entered could not have
been submitted" (emphasis added) inherently encompasses a showing as
to why a new claim could not have been previously submitted. A new
claim presented in a continuing application is considered to be an
amendment to the claims of the prior-filed application. Thus, by using
the word "amendment" in the standard of §§ 1.78(d)(1)(vi) and
1.114(g), the Office intended to capture new claims sought to be
introduced in a third or subsequent continuation or continuation-in-
part application or second or subsequent request for continued
examination.

   Comment 72: One comment recommended that the Office should only
require a petition and showing if the claims are presented more than
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1068 

two years after the earliest filing date claimed.

   Response: Sections 1.78(d)(1) and 1.114 as adopted in this final
rule provide applicant sufficient opportunities to present claims
during the prosecution of the initial application, two continuing
applications, and a request for continued examination in an application
family without a petition under § 1.78(d)(1)(vi) or 1.114(g). The
prosecution of these applications and the request for continued
examination, most likely, would extend more than two years from the
earliest claimed filing date. Therefore, the suggestion, if adopted,
would likely increase the number of applicants who would be required to
file a petition and showing.

   Comment 73: Several comments proposed an exception to the rule
changes to permit applicant to file a continuing application or a
request for continued examination as a matter of right, without
requiring a petition and showing, if the prior application is abandoned
prior to examination.

   Response: As suggested, the Office has made modifications to the
proposed provisions to provide that an applicant may file a
continuation or continuation-in-part application without any
justification in certain situations in which the prior-filed
application was abandoned prior to examination. Section 1.78(d)(1)(v)
as adopted in this final rule provides that if an applicant files a
continuation or continuation-in-part application to correct
informalities rather than completing an application for examination
under § 1.53 (i.e., the prior-filed application became abandoned
due to the failure to timely reply to an Office notice issued under
§ 1.53(f)), the applicant may file "one more" continuation or
continuation-in-part application without a petition and showing under
§ 1.78(d)(1)(vi). Thus, applicant may file a continuation or
continuation-in-part application to correct informalities rather than
completing an application for examination under § 1.53. The prior-
filed nonprovisional application, however, must be entitled to a filing
date and have paid therein the basic filing fee within the pendency of
the application. See § 1.78(d)(2).

   Comment 74: Several comments suggested the Office should include
exceptions to the petition requirement of §§ 1.78(d)(1) and
1.114 to permit applicant to file a continuing application or a request
for continued examination as a matter of right, without requiring a
petition and showing, in the following situations: (1) Some of the
claims in the prior-filed application have been allowed and the
continuation application contains only claims that were rejected in the
prior-filed application; (2) the continuation application contains
claims to an unclaimed invention disclosed in the prior-filed
application; (3) the continuing application is claiming an independent
and distinct invention; (4) the continuing application claims species
or subgenus that falls within a generic claim that has been allowed or
issued in one of the prior-filed applications; (5) the continued
examination filing is filed for the purposes of submitting newly
discovered prior art or amendments or evidence in view of the newly
discovered prior art; (6) the continued examination filing is filed
after an unsuccessful appeal; (7) a divisional application of an
application that was subject to a restriction requirement is filed for
the purposes of claiming the non-elected inventions; (8) the
continuation application includes claims that were canceled in the
prior-filed application; (9) the applicant certifies that the filing is
done in good faith to advance prosecution and without deceptive intent;
(10) the continued examination filing is filed for submitting evidence
or an amendment to overcome a final rejection; (11) a continuation or
continuation-in-part is filed to overcome a lack of utility rejection; (12)
the continued examination filing is filed to submit a declaration under
§ 1.131 or 1.132; (13) the continued examination filing is filed to submit
data or other evidence not available for submission in the parent
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1069 

application to obviate a rejection under 35 U.S.C. 101 or 112, ¶ 1
(e.g., for lack of utility or enablement); (14) the continued
examination filing is filed to respond to an examiner's request for
additional information; (15) the continued examination filing is filed
to respond to a new ground of rejection; (16) the prior-filed
application was abandoned in favor of a continuing application that is
filed using the Office electronic filing system; and (17) a request for
continued examination is filed via the Office electronic filing system.
One comment stated that if Congress does not eliminate 35 U.S.C.
135(b)(2), the need to copy claims from published applications should
be exempt from the limit of continued examination filings in an
application as a matter of right.

   Response: The Office notes the concerns expressed in the public
comment regarding the proposed changes to §§ 1.78(d)(1) and
1.114 that would have required applicant to file a petition and showing
for a second or subsequent continuation or continuation-in-part
application or request for continued examination. The Office has
modified these proposed changes such that this final rule permits an
applicant to file two continuation applications or continuation-in-part
applications, plus a single request for continued examination in an
application family, without any justification.

   Other than the situations provided in §§ 1.78(d)(1)(iv) and
(d)(1)(v), this final rule permits that a third or subsequent
continuing application or any second or subsequent request for
continued examination to be filed with a petition and a showing as to
why the amendment, argument, or evidence sought to be entered could not
have been previously submitted. Sections 1.78(d)(1)(iv) and (d)(1)(v)
provide that applicant may file "one more" continuation or
continuation-in-part application without a petition and showing in
certain situations. Specifically, § 1.78(d)(1)(iv) pertains to the
situation where an applicant files a bypass continuation or
continuation-in-part application rather than paying the basic national
fee (entering the national stage) in an international application in
which a Demand for international preliminary examination (PCT Article
31) has not been filed, and the international application does not
claim the benefit of any other nonprovisional application or
international application designating the United States of America. See
the discussion of § 1.78(d)(1)(iv). Section 1.78(d)(1)(v) pertains
to the situation where an applicant files a continuation or
continuation-in-part application to correct informalities rather than
completing an application for examination under § 1.53. See the
discussion of § 1.78(d)(1)(v).

   The Office will decide petitions under §§ 1.78(d)(1)(vi)
and 1.114(g) based on their substantive argument and the facts in the
record and apply the standard in a consistent manner. There are no
situations that will result in a per se or pro forma grant of a
petition under § 1.78(d)(1)(vi) or 1.114(g). Whether specific
situations would be a sufficient showing under § 1.78(d)(1)(vi) or
1.114(g) is discussed in the responses to subsequent comments.

   Comment 75: Several comments opposed the $400 fee for filing a
petition under §§ 1.78(d)(1) and 1.114. The comments indicated
that the proposed petition fee of $400 is unnecessarily high,
especially in view of the filing fees. Furthermore, the comments argued
that it is unfair to require the submission of a costly fee and a time-
consuming petition regardless of the reason for filing the continuing
application or request for continued examination. One other comment
stated that the proposed petition fee does not cover the amount of work
required to determine if applicant's showing is sufficient to meet the
requirements in §§ 1.78(d)(1) and 1.114. Another comment
questioned why an applicant must pay a petition fee of $400 when filing
an additional continuation-in-part application simply to add new
matter.
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1070 


   Response: The Office considers $400 to be an appropriate fee for
filing a petition under § 1.78(d)(1)(vi) or 1.114(g). 35 U.S.C.
41(d) authorizes the Director to establish fees to recover the
estimated average cost to the Office for handling, reviewing and
deciding petitions. The Office has determined that the average cost to
the Office for handling, reviewing and deciding the petitions under
§§ 1.78(d)(1)(vi) and 1.114(g) will be at least $400. As
previously discussed, applicants most likely will be able to avoid the
requirements for filing a petition and the required fee if applicants
diligently prosecute applications (including the continuing
applications and a request for continued examination permitted under
§§ 1.78(d)(1) and 1.114(f) without any petition). If an
applicant desires to file an application simply to claim new subject
matter, the applicant may file a new application (rather than a
continuation-in-part application) without claiming the benefit of the
prior-filed applications and avoid paying the $400 petition fee. As
discussed previously, claims to new subject matter will not be entitled
to any benefit of the prior-filed application that does not provide
support under 35 U.S.C. 112, ¶ 1, for the claimed subject matter and
the patent term of any resulting patent of the continuation-in-part
application would be measured from the filing date of the prior-filed
application.

   Comment 76: One comment requested that the Office waive the
requirement for a petition fee if applicant submits new art from a
foreign search report or related application or files an amendment in
response to new arguments made by the examiner.

   Response: A petition, the appropriate showing, and the fee set
forth in § 1.17(f) are required under § 1.78(d)(1)(vi) or
1.114(g) when applicant files a third or subsequent continuing
application or a second or subsequent request for continued examination
regardless of the reason for such a filing. In addition, a request to
submit new art from a foreign search report or related application is
not likely to be a sufficient showing under § 1.78(d)(1)(vi) or
1.114(g) (see discussion relating to the filing of continuing
applications and requests for continued examination to obtain
consideration of an information disclosure statement). Likewise, the
mere fact that the examiner made new arguments or a new ground of
rejection in a final Office action would not be considered a sufficient
showing. The Office will decide each petition on a case-by-case basis
focusing on whether the new ground of rejection in the final Office
action could have been anticipated by the applicant.

   Comment 77: Several comments stated that there is no public notice
of the criteria the Director will apply to meet the required showing
under § 1.78(d)(1) or 1.114. A number of comments sought
clarification on what type of showing under § 1.78(d)(1) or 1.114
would be necessary to permit the filing of an additional continuing
application or request for continued examination. A number of comments
specifically sought clarification of the phrase, "could not have been
previously submitted," in §§ 1.78(d)(1) and 1.114 regarding
the satisfactory showing needed to be permitted to file an additional
continuing application or request for continued examination. A number
of other comments suggested that prior to the implementation of the
final rule, the Office should publish more specific guidelines such as a
non-exclusive set of examples that would constitute a sufficient showing
under §§ 1.78(d)(1) and 1.114. In addition, several comments requested that
the Office provide an opportunity for public comment on the suggested
guidelines.

   Response: As discussed previously, the standard set forth in
§§ 1.78(d)(1)(vi) and 1.114(g) as adopted in this final rule
("a showing that the amendment, argument, or evidence sought to be
entered could not have been submitted [earlier]") is more definite
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1071 

than the alternatives suggested in the comments (e.g., "good cause"
and "reasonable under the circumstances") and other standards set
forth in the patent statutes (see e.g., Smith v. Mossinghoff, 671 F.2d
533, 538, 213 U.S.P.Q. 977, 982 (D.C. Cir. 1982) (noting the absence of
guidance concerning the meaning of the term "unavoidable" in 35
U.S.C. 133)). If an amendment, argument or evidence could be submitted
during the prosecution of the initial application, two continuing
applications, and a request for continued examination in an application
family, applicant must present such an amendment, argument or evidence
earlier rather than wait to submit it later in an additional continuing
application or request for continued examination. Applicants should not
rely upon the availability of additional continuing applications or
requests for continued examination in prosecuting an application. The
Office will determine on a case-by-case basis whether the applicant's
showing as to why the amendment, argument or evidence sought to be
entered could not have been submitted earlier is satisfactory. In
addition to the showing submitted by the applicant, the Office may
review the prosecution history of the initial application and the prior
continuing applications or require additional information from the
applicant in deciding a petition. The following are some factors that
the Office may consider when deciding whether to grant a petition under
§ 1.78(d)(1)(vi) or 1.114(g): (1) Whether applicant should file an
appeal or a petition under § 1.181 (e.g., to withdraw the finality
of an Office action) rather than a continuing application or request
for continued examination; (2) the number of applications filed in
parallel or serially with substantially identical disclosures; and (3)
whether the evidence, amendments, or arguments are being submitted with
reasonable diligence.

   With respect to the first factor (whether applicant should be
filing an appeal or a petition under § 1.181 rather than a
continuing application or request for continued examination), if the
showing under § 1.78(d)(1)(vi) or 1.114(g) relates to an issue that
should be petitioned or appealed, the Office will likely not grant the
petition for an additional continuing application or request for
continued examination. Applicant should address any issues pertaining
to inadequate examination by seeking review via a petition under §
1.181 or an appeal, rather than by filing a continuing application or
request for continued examination.

   If the disagreement between the examiner and applicant is
procedural in nature (e.g., an objection), then applicant should file a
petition under § 1.181. For example, an applicant should file a
petition under § 1.181 to request the withdrawal of the finality of
an Office action when the finality was premature, or to review the
examiner's refusal to enter an after-final amendment. The Office will
likely not grant a petition under § 1.78(d)(1)(vi) or 1.114(g) if
applicant argues only that an amendment after final rejection should
have been entered in the prior-filed application because the final was
premature. Applicant should have addressed the non-entry in the prior-
filed application and not later in a petition under § 1.78(d)(1)(vi)
or 1.114(g) for a continuing application or request for continued
examination. If the issue goes to the merits of a rejection,
applicant should file an appeal to the BPAI under 35 U.S.C. 134 and
§ 41.31.

   With respect to the second factor (the number of applications filed
in parallel or serially with substantially identical disclosures), the
higher the number of applications with identical or substantially
identical disclosures or the higher the number of applications in the
chain of prior-filed copending applications, the more opportunities
applicant had to present the amendment, argument or evidence.
Accordingly, a petition under § 1.78(d)(1)(vi) or 1.114(g) is less
likely to be granted.

   With respect to the third factor (whether the evidence, amendments,
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1072 

or arguments are being submitted with reasonable diligence), the Office
will focus on whether the evidence or data submitted with the petition
to meet the showing under § 1.78(d)(1)(vi) or 1.114(g) was
presented in a reasonably diligent manner. This will take into account
the condition of the application at the time of examination (e.g.,
whether the initial application was in proper form for examination by
the time of the first Office action in the initial application or
whether it was necessary to first issue Office actions containing
rejections under 35 U.S.C. 112 or objections to have the application
placed in proper form for examination), the consistency of the Office's
position during prosecution (e.g., whether applicant received wholly
new prior art rejections versus prior art rejections slightly modified
to address the amendments), and the earnestness of the applicant's
efforts to overcome outstanding rejections (e.g., whether replies fully
addressed all of the grounds of rejection or objection in the Office
actions, or whether amendments or evidence were submitted only when
arguments were failing to persuade the examiner).

   Comment 78: One comment sought clarification as to whether a
petition under § 1.78(d)(1) would be available for "involuntary"
divisional applications. Another comment suggested an applicant should
be permitted to file any divisional application in response to a
restriction requirement.

   Response: The Office notes the concerns expressed in the public
comment regarding the proposed changes to § 1.78(d)(1)(ii). The
Office has modified this provision relative to the proposed changes
such that § 1.78(d)(1)(ii) as adopted in this final rule does not
require a divisional application to be filed during the pendency of the
application subject to a requirement for restriction, as long as the
copendency requirement of 35 U.S.C. 120 is met. Under this final rule,
applicant may file, without any justification, a divisional application
containing only claims directed to a non-elected invention that has not
been examined if the prior-filed application was subject to a
requirement for restriction (an "involuntary" divisional
application"). Applicant may also file two continuation applications
and a request for continued examination in the divisional application
family, without any justification. Furthermore, applicant may file a
third or subsequent continuation application or a second or subsequent
request for continued examination with a petition and showing.

   Comment 79: Several comments sought clarification on whether the
Office will grant a petition under § 1.78(d)(1) for filing a
divisional application of an application that was subject to a
restriction requirement for the purposes of claiming the non-elected
inventions.

   Response: As previously discussed, the Office has modified the
provisions of § 1.78(d)(1)(ii) relative to the proposed changes. In
this final rule, § 1.78(d)(1)(ii) does not require a divisional
application to be filed during the pendency of the application subject to
a requirement for restriction, as long as the copendency requirement of
35 U.S.C. 120 is met. This final rule provides that an applicant may file
a divisional application directed to each non-elected invention that has
not been examined if the prior-filed application is subject to a
requirement for restriction. Section § 1.78(d)(1)(iii) as adopted in this
final rule also permits applicant to file two continuation applications of
a divisional application, plus a request for continued examination in the
divisional application family, without any justification. Furthermore,
applicant may file an additional continuation application or request
for continuation examination with a petition and showing. Under this
final rule, applicant should have sufficient time to file a divisional
application for claiming a non-elected invention. Therefore, the Office
will most likely not grant a petition under § 1.78(d)(1)(vi) to
permit an applicant to file a divisional application directed to a non-
elected invention.
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1073 


   Comment 80: One comment suggested a petition under § 1.78(d)(1)
should be granted when an applicant needs an additional continuing
application to partition the claims in the prior-filed application,
such that a terminal disclaimer applies only to some but not all claims
in the prior-filed application. The comment alternatively suggested
changing the regulations to allow the filing of a terminal disclaimer
for selected claims.

   Response: This final rule permits applicant to file two
continuation or continuation-in-part applications plus a request for
continued examination in an application family, without justification.
Therefore, applicant may use one of the two permitted continuation or
continuation-in-part applications to partition the claims such that a
terminal disclaimer applies to the prior-filed application but does not
apply to the continuation application. Notably, applicant may avoid
this situation by presenting all of the patentably indistinct claims in
a single application. As discussed previously, multiple applications
with patentably indistinct claims divert the Office's patent examining
resources from the examination of new applications. Applicant should
submit all patentably indistinct claims in a single application. See
§§ 1.75(b)(4) and 1.78(f). Under this final rule, applicant
must identify such multiple applications with patentably indistinct
claims to the Office and assist the Office in resolving double
patenting issues early in the prosecution. In the situation in which an
application contains at least one claim that is patentably indistinct
from at least one claim in another application, the Office will treat
the claims in both applications as being present in each of the
applications for the purposes of determining whether each application
exceeds the five independent claim and twenty-five total claim
threshold under § 1.75(b). See the discussion of § 1.75(b)(4).
Accordingly, the Office is not likely to grant a petition for the sole
purpose of partitioning claims to avoid a terminal disclaimer.

   Additionally, a disclaimer of a terminal portion of the term of an
individual claim, or individual claims, is not allowed by statute. 35
U.S.C. 253 provides that "any patentee or applicant may disclaim or
dedicate to the public * * * any terminal part of the term, of the
patent granted or to be granted." (Emphasis added.) Therefore, under
35 U.S.C. 253, a terminal disclaimer must be of a terminal portion of
the term of the entire patent and cannot be applied to selected claims
as advocated in the comment.

   Comment 81: Several comments asserted that an applicant filing an
additional continuation-in-part application would be able to argue
successfully that the amendment or argument could not have been
previously submitted because the subject matter was not present at the
time of filing the initial application. Thus, the proposed rules would
force these applicants to file a pro forma petition.

   Response: The mere fact that the subject matter was not present at
the time of filing the prior-filed application would not be a
sufficient showing under § 1.78(d)(1)(vi). The Office will decide
these petitions on a case-by-case basis based on the prosecution
history of the prior-filed application as well as the records of the
continuation-in-part application. The Office will consider the showing
of why the new subject matter sought to be entered could not have been
previously submitted in the prior-filed application. The Office will
also consider the amendment including any new claims to determine
whether the claims in the continuation-in-part application are directed
to the new subject matter or mainly to the subject matter disclosed in
the prior-filed application. For example, if the new subject matter is
not being claimed in the continuation-in-part application, but merely
being added to circumvent the rule, the Office will not grant the
petition. Furthermore, 35 U.S.C. 120 requires that the prior-filed
application disclose the subject matter of at least one claim of the
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1074 

later-filed application in the manner provided by 35 U.S.C. 112, ¶ 1,
for the later-filed application to actually receive the benefit of the
filing date of the prior-filed application. Thus, any claim in the
continuation-in-part application that is directed to the subject matter
not disclosed in the manner provided by 35 U.S.C. 112, ¶ 1, in the
prior-filed application would be entitled only to the actual filing
date of the continuation-in-part application (not the filing date of
the prior-filed application), and subject to prior art based on the
actual filing date of the continuation-in-part application. Applicant
should not claim the benefit of the prior-filed application if all of
the claims in the continuation-in-part application are directed to the
new subject matter. The continuation-in-part application would not be
entitled to the benefit of the filing date of the prior-filed
application, and the term of any patent resulting from the
continuation-in-part application will be measured under 35 U.S.C.
154(a)(2) from the filing date of the prior-filed application. That is,
applicant would not receive any benefit of the earlier application but
would have a patent term that is measured from the filing date of the
earlier application. If there are any claims in the continuation-in-
part application that are directed solely to subject matter disclosed
in the prior-filed application, applicant must submit those claims in
the prior-filed application rather than filing a continuation-in-part
application unless applicant provides a showing as to why these claims
could not have been previously submitted.

   Comment 82: Several comments requested that the Office permit an
applicant to file an additional continuing application or request for
continued examination when the applicant indicates why the new
invention could not otherwise be protected using another type of
application, such as a reissue application or a reexamination
proceeding. These comments also requested that the Office permit an
additional continuing application or an additional request for
continued examination that contains claims broader than in the previous
application to which priority is claimed and contain claims not subject
to a double patenting rejection.

   Response: The Office will likely not grant such a petition.
Applicant may file a reissue application under 35 U.S.C. 251 or a
reexamination proceeding, if appropriate, to submit claims with
different scope. A desire to avoid the requirements governing reissue
applications or reexamination proceedings would not be a sufficient
showing under § 1.78(d)(1)(vi) or 1.114(g).

   Comment 83: One comment sought clarification on whether the
required showing under §§ 1.78(d)(1) and 1.114 will preclude
explanations that are permitted when filing a reissue application. A
further comment stated the required showing under §§ 1.78(d)(1)
and 1.114 is greater than the showing required to file a reissue
application.

   Response: This final rule permits applicant to file two
continuation or continuation-in-part applications plus one request for
continued examination in an application family, without any
justification. Applicant may also file a third or subsequent
continuation or continuation-in-part application or a second or
subsequent request for continued examination with a petition and
showing that the amendment, argument, or evidence sought to be entered
could not have been submitted previously. As previously discussed, if
an amendment, argument, or evidence could have been submitted during
the prosecution of the initial application, two continuation or
continuation-in-part applications or a request for continued
examination, applicant must submit the amendment, argument or evidence
in one of these filings, rather than in a third or subsequent
continuing application or second or subsequent request for continued
examination to ensure that applicant advances the prosecution to final
action and does not impair the ability of the Office to examine new
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1075 

applications.

   Under 35 U.S.C. 251, applicant may file a reissue application to
correct an error in the patent which was made without any deceptive
intent, where, as a result of the error, the patent is deemed wholly or
partly inoperative or invalid. See MPEP section 1402. The required
showing under §§ 1.78(d)(1)(vi) and 1.114(g) is different than
the explanation required for filing a reissue application. The showing
under §§ 1.78(d)(1)(vi) and 1.114(g) does not require an error
made without any deceptive intent and does not require as a result of
the error, the patent to be deemed wholly or partly inoperative or
invalid. If it is more appropriate for applicant to file a reissue
application, applicant should file a reissue application under 35
U.S.C. 251 rather than filing a continuing application.

   Comment 84: Several comments suggested that if the Office permits
applicant to provide additional evidence of unexpected results with the
filing of an additional continued examination filing, then the
experimentation leading to the evidence must have been conducted
diligently and commenced within six months of the filing of the initial
application. Another comment further suggested evidence that an
applicant had not previously learned or known that others had developed
similar or parallel technology should not be considered as evidence
that an amendment, argument or evidence could not have been submitted
previously under § 1.78(d)(1) or 1.114.

   Response: The Office will decide petitions under § 1.78(d)(1)(vi)
or 1.114(g) on a case-by-case basis. The Office will
focus on whether the evidence or data submitted with the petition to
meet the showing under § 1.78(d)(1)(vi) or 1.114(g) was presented
in a timely manner and was diligently obtained. Any evidence or data
that petitioner did not act diligently in obtaining in response to a
rejection or requirement in an Office action will be considered
unfavorably when deciding a petition under § 1.78(d)(1)(vi) or
1.114(g). For example, the Office will likely not grant a petition if
the examiner made the rejection in the first Office action of the
initial application and maintained it in the subsequent Office actions,
but applicants responded only with arguments, instead of with evidence
or an amendment, until after the final Office action. In contrast, the
Office will likely grant a petition if, in a continuing application or
request for continued examination, the data necessary to support a
showing of unexpected results just became available to overcome a new
rejection under 35 U.S.C. 103 made in the final Office action, and the
data is the result of a lengthy experimentation that was diligently
commenced and could not have been completed earlier. Applicant should
exercise reasonable foresight to commence any appropriate
experimentation early rather than wait until the examiner makes a
rejection or finds applicant's arguments unpersuasive.

   Comment 85: Several comments sought clarification on whether an
additional continued examination filing would be permitted under
§ 1.78(d)(1) or 1.114 for submitting an information disclosure statement
or an amendment in view of an information disclosure statement in the
following situations: (1) To submit a newly discovered reference,
including a reference cited in a foreign counterpart application; (2)
to submit a new reference that was not publicly available at the time
the previous amendment was filed; (3) to submit an amendment to the
claims that is necessitated by previously cited prior art or newly
discovered prior art; and (4) to submit broadened claims after receipt
of a foreign search or examination report citing new art. One comment
argued that submissions of late discovered prior art should be
permitted because the consideration of the prior art will improve
patent quality and eliminate allegations of inequitable conduct in
obtaining patent rights.

   Response: The Office will likely not grant such a petition for
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1076 

submitting an information disclosure statement (IDS) or an amendment
necessitated by (or in view of) newly discovered prior art. The
effectiveness and quality of the examination process as well as
patentability determinations would improve if the most pertinent
information were presented early in the examination process. An
additional continued examination filing is not necessary for the
consideration of newly discovered prior art or an amendment to the
claims that is necessitated by the newly discovered prior art. See
Changes To Information Disclosure Statement Requirements and Other
Related Matters, 71 FR at 38812-16, 38820-22, 1309 Off. Gaz. Pat.
Office at 27-31, 34-36 (proposed changes to §§ 1.97 and 1.98
permit applicant to submit prior art for consideration by the examiner,
when applicant complies with specific requirements at various time
periods, including after final action, notice of allowance and payment
of the issue fee).

   The proposed IDS changes (if adopted) would permit applicant to
submit an IDS after a first Office action on the merits, but before the
mailing date of a notice of allowability or a notice of allowance under
§ 1.311, if applicant files the IDS with either: (1) The
certification under § 1.97(e)(1) and a copy of the foreign search
report, or (2) an explanation under proposed § 1.98(a)(3)(iv) as to
why each reference is being cited, and a non-cumulative description
under proposed § 1.98(a)(3)(v) as to how each reference is not
cumulative of any other reference cited. Applicant would also be
permitted to submit an IDS after allowance but before the payment of
the issue fee, if applicant files the IDS with a patentability
justification under proposed § 1.98(a)(3)(vi), including any
appropriate amendments to the claims.

   Applicant would also be permitted to submit an IDS after the
payment of the issue fee if applicant files a petition to withdraw from
issue pursuant to § 1.313(c)(1), the patentability justification
under proposed § 1.98(a)(3)(vi)(B), and an amendment to the claims.
Prior to the effective date of the final rule of the changes to IDS
requirements, applicant may submit an IDS after the close of
prosecution with a petition under § 1.183 if the IDS submission
complies with the proposed rule requirements in §§ 1.97 and
1.98.

   Comment 86: Several comments sought clarification as to whether an
additional continued examination filing would be permitted under
§§ 1.78(d)(1) and 1.114 in the following situations: (1) When
the examiner found the earlier arguments and amendments by applicants
to be unpersuasive; (2) when the examiner's interpretation of the
claims is unusual and only recently understood by the applicant; (3)
when the examiner changes his or her interpretation of claim language;
and (4) when the practitioner discovers that the examiner is under a
misunderstanding.

   Response: These circumstances alone more than likely would not be
sufficient to establish a showing under § 1.78(d)(1)(vi) or
1.114(g). Applicant should request an interview with the examiner to
resolve these types of issues during the prosecution of the initial
application, two continuation or continuation-in-part applications and
request for continued examination. In addition, applicant in each reply
to an Office action must distinctly and specifically point out the
supposed errors in the Office action and must reply to every ground of
objection and rejection raised in the Office action. See §
1.111(b). The reply must also present detailed explanations of how each
claim is patentable over any applied references. See §§
1.111(b) and (c). If applicant disagrees with the examiner's decision
to maintain a rejection on the basis that the applicant feels that the
examiner is misinterpreting the claims, applicant should seek an appeal
rather than file additional continuing applications or requests for
continued examination.
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1077 


   Comment 87: Several comments sought clarification on whether an
additional continued examination filing would be permitted under
§§ 1.78(d)(1) and 1.114 when the examiner makes a new ground of
rejection in a final Office action using a new prior art reference, a
reference already of record but not previously applied, a new basis for
the rejection (e.g., changing a rejection under 35 U.S.C. 102 to a
rejection under 35 U.S.C. 103), or a different reasoning (e.g., the
supporting arguments have changed or the rejection refers to a new
portion of the applied art). Several comments stated that permitting a
final rejection based on a new ground of rejection while not allowing
further opportunity to amend through continued examination applications
is unfair and presents an opportunity for abuse.

   Response: The Office will decide each petition for an additional
continued examination filing on a case-by-case basis, focusing on
whether the new ground of rejection in the final Office action could
have been anticipated by the applicant. For example, the Office will
likely grant a petition if the final rejection, after the two
continuing applications and request for continued examination permitted
under §§ 1.78(d)(1) and 1.114(g) without a petition, contains a
new ground of rejection that could not have been anticipated by
applicant. However, the Office will likely not grant a petition under
§ 1.78(d)(1)(vi) or 1.114(g) if the examiner only changed a
rejection under 35 U.S.C. 102 to a rejection under 35 U.S.C. 103 (or
maintained a rejection under 35 U.S.C. 103) with the addition of a new
secondary reference in response to an amendment adding a new claim
limitation because such a new rejection should have been anticipated by
the applicant. Therefore, the mere fact that the examiner made a new
ground of rejection in a final Office action probably would not
constitute a sufficient showing.

   Comment 88: Several comments sought clarification on whether an
additional continued examination filing would be permitted under
§§ 1.78(d)(1) and 1.114 in the following situations: (1) When
the examiner indicates in an advisory action that an after-final
amendment would require a new search; or (2) to submit evidence or an
amendment to overcome a final rejection.

   Response: The Office will likely not grant a petition based on the
mere showing that the examiner indicates in an advisory action that the
entry of an after-final amendment would require a new search, or that
the evidence or amendment sought to be entered will overcome a final
rejection. Applicants are permitted to submit any desired amendment,
argument, or evidence during the prosecution of the initial
application, two continuation or continuation-in-part applications and
one request for continued examination. Since numerous opportunities are
given to submit any desired amendment, argument, or evidence, the mere
fact that an amendment, argument, or evidence is refused entry because
prosecution in the prior-filed application is closed will not, by
itself, be a sufficient reason to warrant the grant of a petition under
§ 1.78(d)(1)(vi) or 1.114(g). Rather, an applicant will be expected
to demonstrate why the amendment, argument, or evidence sought to be
entered could not have been submitted prior to the close of prosecution
in the prior-filed application.

   Comment 89: Several comments sought clarification as to whether the
Office will likely grant a petition for an additional continuing
application if some of the claims in the prior application are rejected
and other claims are allowed, and applicant wishes to appeal the
rejected claims and obtain a patent on the allowed claims.

   Response: The Office is not likely to grant a petition under
§ 1.78(d)(1)(vi) in this situation in the absence of special
circumstances. Section 1.78(d)(1)(i) permits an applicant whose initial
application contains rejected claims and allowed claims to obtain a
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1078 

patent on the allowed claims, and continue prosecution of the rejected
or other claims in a continuation or continuation-in-part application.
The applicant is expected to use the two continuation or continuation-
in-part applications permitted without any petition or showing under
§ 1.78(d)(1)(i) for this purpose. The applicant needs to pursue an
appeal (or cancel the rejected claims) if the application still
contains rejected claims after a second continuing application and
request for continued examination.

   Comment 90: Several comments suggested that applicant should be
permitted to file an additional continuing application under §
1.78(d)(1) or request for continued examination under § 1.114 for
changing the scope of the claims in the following situations: (1)
Pursue claims that have the same or narrower scope as the claims in an
allowed application; (2) claim a species or subgenus that falls within
a generic claim that has been allowed or issued in one of the prior-
filed applications; (3) pursue the rejected or broader claims when
other claims are allowable; (4) file broader claims, when applicant
recently discovered a limitation in an allowed claim that was unduly
limiting; (5) pursue broader claims, or claim aspects of the invention
that are disclosed, but not claimed, in the prior-filed application
(contains claims to an unclaimed invention disclosed in the prior-filed
application); (6) pursue narrower claims; (7) claim inventions of a
different scope when the scope of new claims finds specific support in
the application as filed; (8) pursue new claims when the scope of new
claims was unintentionally omitted from the initial application; or (9)
protect a different aspect of the invention revealed by research and
development subsequent to an initial application filing.

   Response: If a claim can be submitted during the prosecution of the
initial application, two continuation or continuation-in-part
applications and one request for continued examination, applicant must
present such a claim early in these filings rather than wait to submit
it later in an additional continuing application or request for
continued examination. The situations described in the comments do not
present any reason why claims directed to claims with the same,
narrower, or broader scope could not have been submitted earlier.
Applicants may file a reissue application under 35 U.S.C. 251, if
appropriate, to submit claims with a different scope.

   Comment 91: Several comments sought clarification on whether an
additional continued examination filing would be permitted under
§§ 1.78(d)(1) and 1.114 for the following situations: (1) When
a product recently becomes commercially viable; (2) when a competing
product is newly discovered; (3) when new information is discovered
that could not have been provided in the prior application; (4) when
applicant discovered new inherent properties that he or she now wishes
to claim; (5) when applicant now has the financial resources to file
previously unclaimed inventions; (6) when clinical trials indicate the
previously unclaimed subject matter may be useful; or (7) when the
court determined that the format of a patented claim is improper and
applicant wishes to file a continuing application to seek the proper
protection.

   Response: The Office likely will not grant such a petition in these
situations. Applicant is permitted to file two continuation or
continuation-in-part applications and a request for continued
examination without a petition and showing. Applicant should have
sufficient time to submit any desired claims. Applicant should also
know what the applicant regards as his or her invention and claim his
or her invention during the prosecution of these applications,
regardless of whether applicants have recently discovered a
commercially viable product, financial resources, useful subject
matter, a competing product, or similar or parallel technology on the
market. Applicants may file a reissue application under 35 U.S.C. 251,
if appropriate, to correct or amend any patented claims. The Office
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1079 

would not likely grant a petition to permit an applicant to end-run the
two-year filing period requirement of 35 U.S.C. 251, ¶ 4.

   Comment 92: Several comments suggested allowing an applicant to
file an additional continuing application or request for continued
examination to claim inventions related to drugs undergoing the FDA
approval process. In particular, one comment suggested two ways of
satisfying the required showing under §§ 1.78(d)(1) and 1.114:
(1) An applicant provides an affidavit or other statement to the Office
confirming that the applicant is presently engaged in obtaining
information needed for submitting an Investigational New Drug (IND)
application for that drug; or (2) an applicant provides evidence to the
Office that the applicant has already submitted an IND or a Biologics
License Application (BLA) (or an amended IND application or amended
BLA) for the particular drug.

   Response: Such evidence of ongoing FDA review for a drug allegedly
claimed in an application would not by itself be considered a
sufficient showing under § 1.78(d)(1)(vi) or 1.114(g). Applicant
should know what the applicant regards as his or her invention upon
filing an application and should claim the invention prior to, or
regardless of, any FDA approval. There is no reason why an applicant
must have FDA approval prior to deciding for which aspect(s) of the
invention or which invention(s) to seek patent protection. See In re
Brana, 51 F.3d 1560, 1568, 34 U.S.P.Q.2d 1436, 1442 (Fed. Cir. 1995)
("FDA approval * * * is not a prerequisite for finding a compound
useful within the meaning of the patent laws."). The changes adopted
in this final rule permit an applicant to file two continuation or
continuation-in-part applications and one request for continued
examination in the application family, without any justification. In
addition, applicant may file a divisional application directed to each
non-elected invention that has not been examined if the prior-filed
application was subject to a restriction requirement and the claims to
the non-elected invention are cancelled upon filing of the divisional
application. Applicant may also file two continuation applications of
the divisional application and a request for continued examination in
the divisional application family, without justification. And,
applicant may file a third of subsequent continuation application or a
second request for continued examination with a petition and showing.
If applicant is not prepared to particularly point out and distinctly
claim what the applicant regards as his or her invention during the
prosecution of the initial application, its two continuing
applications, and a request for continued examination in each
application family, applicant should consider using the deferral of
examination process. See § 1.103(d).

   The Office recognizes that, in certain unpredictable arts
(including, for example, biotechnology and certain pharmaceuticals),
there may be a need for research or testing to obtain additional
evidence or data to obviate a rejection for lack of utility under 35
U.S.C. 101 (and consequently for lack of enablement under 35 U.S.C.
112, ¶ 1). The case law, however, does not shift the burden to the
applicant to provide rebuttal evidence or data concerning the
invention's utility until the examiner "provides evidence showing that
one of ordinary skill in the art would reasonably doubt the asserted
utility." Brana, 51 F.3d at 1566, 34 U.S.P.Q.2d at 1441 (citing In re
Bundy, 642 F.2d 430, 433, 209 U.S.P.Q. 48, 51 (CCPA 1981)). Even in
situations in which a requirement for such additional evidence is
appropriate, the evidence or data that would warrant an applicant's
decision to initiate the FDA regulatory process should be sufficient to
establish utility for purposes of compliance with 35 U.S.C. 101 and
112, ¶ 1. See MPEP § 2107.03 (as a general rule, if an applicant
has initiated human clinical trials for a therapeutic product or
process, Office personnel should presume that the applicant has
established that the subject matter of that trial is reasonably
predictive of having the asserted therapeutic utility). With respect to
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1080 

situations in which it is questionable as to whether there is
sufficient enablement for the invention as claimed, evidence submitted
to the FDA to obtain approval for clinical trials may be submitted.
However, considerations made by the FDA for approving clinical trials
are different from those made by the Office in determining whether a
claim is sufficiently enabled. See MPEP § 2164.05 (citing Scott v.
Finney, 34 F.3d 1058, 1063, 32 U.S.P.Q.2d 1115, 1120 (Fed. Cir. 1994)).
Thus, situations in which it is necessary for an applicant to submit
data to the Office to demonstrate patentability using data obtained
from research or testing carried out as part of the FDA regulatory
process should be rare.

   Nevertheless, in the situation in which there is a rejection such
as lack of utility under 35 U.S.C. 101 (and/or consequently for lack of
enablement under 35 U.S.C. 112, ¶ 1) in an application claiming subject
matter in such an unpredictable art, the Office will likely grant a
petition under § 1.78(d)(1)(vi) or 1.114(f) if, in a continuing
application or request for continued examination, the evidence or data to
demonstrate utility or enablement just became available or could not have
been otherwise earlier presented, and the evidence or data resulted from
research or testing that was commenced with reasonable diligence. However,
this presupposes that the applicant has taken reasonable steps to resolve
the issue during the prosecution of the initial (or divisional)
application, its two continuing applications, and a request for
continued examination in each application family. In particular, the
Office will consider, inter alia, whether the applicant: (1) Sought
review of the rejection via an appeal that proceeded to at least the
appeal conference stage and resulted in an examiner's answer (rather
than simply filing continuing applications or a request for continued
examination without the evidence or data to again argue patentability
before the examiner); (2) initiated the research or testing promptly
(rather than waiting for a decision to initiate the FDA regulatory
review process); and (3) sought suspension of action (§ 1.103(a) or
(c)) or deferral of examination if applicable (§ 1.103(d)) in the
continuing applications or the request for continued examination and
alerted the Office of the research or testing.

   Comment 93: Several comments sought clarification whether the
Office would grant a petition for an additional continuing application
or request for continued examination to correct the inventorship of the
application due to information discovered after prosecution of the
application has closed.

   Response: The Office will likely not grant such a petition.
Applicant should make the correction early in the examination process.
Furthermore, the Office has recently proposed changes to § 1.312 to
provide that the Office may permit a correction of the inventorship
filed in compliance with § 1.48 after the mailing of a notice of
allowance if certain requirements are met, such as if the correction is
filed before or with the payment of the issue fee or if the correction
is filed with the processing fee set forth in § 1.17(i) and in
sufficient time to permit the patent to be printed with the correction.
See Changes To Information Disclosure Statement Requirements and Other
Related Matters, 71 FR at 38817-8, 38823, 1309 Off. Gaz. Pat. Office at
32, 37. Finally, after the patent has issued, applicant may correct the
inventorship by filing a reissue application under 35 U.S.C. 251 or
pursuant to 35 U.S.C. 256.

   Comment 94: One comment discussed that the limitations on
continuing applications may create due process issues because there may
be different treatment of joint inventors of an application. The
comment provided an example of an application filed naming joint
inventors, e.g., Inventors C and D, and ensuing problems caused by the
proposed rules as follows: Inventor C files a continuation application
to prosecute his or her invention. Inventor D may be deprived of filing
a continuation application on his invention because the filing by
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1081 

Inventor D would be a second or subsequent continuing application that
would require a petition under § 1.78(d)(1).

   Response: This final rule permits applicants to file two
continuation or continuation-in-part applications plus one request for
continued examination without justification. Applicants may file a
third or subsequent continuation or continuation-in-part application or
a second or subsequent request for continued examination with a
petition and showing. Under § 1.78(d)(1)(i), Inventor C is
permitted to file a continuation application (the first continuation
application) to prosecute his or her invention, and Inventor D is
permitted to file a continuation application (the second continuation
application) to prosecute his or her invention.

   Comment 95: Several comments sought clarification whether the
Office will grant a petition for an additional continuing application
or request for continued examination for the purpose of provoking an
interference.

   Response: The Office will likely not grant a petition with a
showing that the additional continuation or continuation-in-part
application or request for continued examination is solely for the
purpose of provoking an interference. In most situations, applicants
should have sufficient opportunity to provoke an interference and copy
claims in a timely manner in compliance with 35 U.S.C. 135(b)(2) in the
initial application, two continuation or continuation-in-part
applications, and one request for continued examination, all of which
are available without any justification. In any event, the Office is
likely to require that a request for a statutory invention registration
under § 1.293 be submitted as a condition of granting any petition
under § 1.78(d)(1)(vi) in the situation where a third or subsequent
continuation or continuation-in-part application or second or
subsequent request for continued examination is for the purpose of
provoking an interference. The Office, however, would likely grant a
petition under § 1.78(d)(1)(vi) (without requiring a request for a
statutory invention registration under § 1.293) in a limited
situation where an interference is declared in a second continuation or
continuation-in-part application that contains both claims
corresponding to the count and claims not corresponding to the count,
and the BPAI suggests that the claims not corresponding to the count be
canceled from the application subject to the interference and pursued
in a separate application.

   Comment 96: Several comments sought clarification as to whether the
Office will grant a petition for an additional continuing application
or request for continued examination when the Office changes the
examiner assigned to the application either on its own initiative or in
response to the applicant's request.

   Response: The Office will not grant such a petition. The mere fact
that the Office changes the examiner assigned to the application would
not be a sufficient showing under § 1.78(d)(1)(vi) or 1.114(g).

   Comment 97: Several comments sought clarification as to whether the
Office will grant a petition for an additional continuing application
or request for continued examination when applicant changes the
practitioner of record, when applicant states that the change of
practitioner was made in good faith and certifies that the applicant
was dissatisfied with the prior practitioner's claim drafting, or when
the delay in filing claims was due to practitioner's error or inaction
and was not the fault of the applicant. One comment expressed concern
that if changing the practitioner of record is an acceptable reason, it
will promote attorney swapping.

   Response: The Office will not grant such a petition for these
circumstances. A change of practitioner, or errors or delays caused by
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1082 

the practitioner, would not be considered sufficient showings. An
applicant is bound by the consequences of the acts or omissions of the
applicant's duly authorized and voluntarily chosen legal
representative. See Link v. Wabash R. Co., 370 U.S. 626, 633-34 (1962).

   Comment 98: One comment suggested that an applicant should be
permitted to file an additional continuation or continuation-in-part
application when the practitioner does not present the claims in the
prior application because of excusable neglect.

   Response: Rule 60(b) of the Federal Rules of Civil Procedure (Rule
60(b)) does provide "excusable neglect" as a basis (among others) for
relieving a party of a judgment or order. See Fed. R. Civ. P. 60(b)(1).
Rule 60(b), however, further provides that a motion based
upon "excusable neglect" must be "made within a reasonable time,"
and "not more than one year after the judgment, order, or proceeding
was entered or taken." See Fed. R. Civ. P. 60(b). Sections 1.78(d)(1)
and 1.114 as adopted in this final rule permit an applicant to file an
initial application, two continuation or continuation-in-part
applications, and a request for continued examination in any one of
these three applications without justification. Given the numerous
opportunities provided in §§ 1.78(d)(1) and 1.114 to prosecute
an application for patent, the "mistake, inadvertence, surprise, or
excusable neglect" standard set forth in Rule 60(b)(1) is not an
appropriate basis for seeking yet another opportunity to prosecute the
application. Therefore, the Office is not likely to grant a petition
under § 1.78(d)(1)(vi) or 1.114(g) solely on the basis of
"excusable neglect."

   Rule 60(b)(6), however, does provide for relief on the "catchall"
basis of "any other reason justifying relief from the operation of the
judgment." See Fed. R. Civ. P. 60(b)(6). While this language appears
to be open-ended, this provision is typically limited to exceptional or
extraordinary circumstances suggesting that a party was faultless in
the delay. See Marquip, Inc. v. Fosber Am., Inc., 198 F.3d 1363, 1370,
53 U.S.P.Q.2d 1015, 1020 (Fed. Cir. 1999) (citing Pioneer Inv. Serv.
Co. v. Brunswick Assocs. Ltd. P'ship, 507 U.S. 380, 393 (1993)). The
patent rules of practice (§ 1.183) provide that "in an
extraordinary situation" in which "justice requires," the Office may
waive or suspend any requirement of the regulations in 37 CFR part 1,
which is not a requirement of statute. The Office does not anticipate
granting petitions under § 1.78(d)(1)(vi) or 1.114(g) on a basis
other than a showing that the amendment, argument or evidence sought to
be entered could not have been previously submitted. However, in the
rare exceptional or extraordinary situation in which an applicant was
faultless in the delay, and the situation does not meet the standard
that the amendment, argument or evidence sought to be entered could not
have been previously submitted, the Office may grant relief pursuant to
§ 1.183.

   Comment 99: Several comments sought clarification as to whether the
Office will likely grant a petition for an additional continuing
application or request for continued examination if the prior-filed
application was abandoned in favor of a continuing application that was
filed using the Office electronic filing system or if the request for
continued examination was filed using the Office electronic filing
system.

   Response: The Office will likely not grant such a petition. The
mere fact that a continuing application or request for continued
examination is electronically filed via the Office electronic filing
system would not be a sufficient showing as to why the amendment,
argument or evidence sought to be entered could not have been
previously submitted.

   Comment 100: A few comments sought clarification as to whether the
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1083 

Office will likely grant a petition for an additional continuing
application or request for continued examination if the applicant
becomes disabled for a lengthy time during pendency of application.

   Response: The Office will likely not grant such a petition on the
mere showing that the applicant becomes disabled for a lengthy time
during pendency of application. The changes being adopted in this final
rule permit applicants to file two continuation or continuation-in-part
applications and a request for continued examination, without a
petition and showing. Applicant may also file a third or subsequent
continuation or continuation-in-part application or a second or
subsequent request for continued examination with a petition and
showing. Furthermore, applicant may file a petition for suspension of
action under § 1.103(a) or a request for deferral of examination
under § 1.103(d), when necessary.

   Comment 101: Several comments suggested an applicant should be
permitted to file an additional continuation or continuation-in-part
application or a request for continued examination for patent term
extension reasons.

   Response: No patent term extension benefits under 35 U.S.C. 154 and
156 will accrue to applicant by filing a third or subsequent continuing
application or a second or subsequent request for continued
examination. Therefore, a desire to obtain a patent term extension
would not be a sufficient reason to permit a third or subsequent
continuing application or a second or subsequent request for continued
examination. In fact, the filing of a continuing application or request
for continued examination may result in the loss of a patent term
adjustment under 35 U.S.C. 154(b).

   Comment 102: A number of comments expressed concern regarding an
example provided by the Office that would meet the showing under
§§ 1.78(d)(1) and 1.114 to permit the filing of an additional
continuing application or request for continued examination. This
example permits the applicant to file an additional continuing
application or request for continued examination when the applicant can
show that collection of the data necessary to demonstrate unexpected
results was started after the applicant received the rejection for the
first time, and was completed only shortly before filing the petition
for an additional filing. A number of comments stated that granting a
petition should only depend on when the information becomes available
and not when the tests begin. One other comment stated that experiments
are typically ongoing from the date of invention and that it would be
inappropriate for the Office to require experimentation to overcome an
obviousness rejection to commence only after the rejection has been
made for the first time. One comment suggested removing the language,
"could not have been anticipated by applicant," from the example
provided by the Office of an adequate showing under § 1.78(d)(1) or
1.114. The comment expressed concern that the Office's example is vague
and subjective, and that removal of the language, "could not have been
anticipated by applicant," would make the standard less arbitrary.

   Response: The example is merely one illustration of when a petition
under § 1.78(d)(1)(vi) or 1.114(g) will likely be granted. Other
appropriate showings could result in a petition under
§ 1.78(d)(1)(vi) or 1.114(g) being granted. As discussed previously, the
Office will focus on whether the evidence or data submitted was
obtained and presented in a reasonably diligent manner.

   Comment 103: One comment expressed concern regarding the
requirement under § 1.78(d)(1) that an applicant must submit a
petition within four months from the actual filing date of the later-
filed continuing application, stating that applicant may need more time
to complete the experimentation or to prepare the submission in
response to a rejection or a requirement for information. This comment
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1084 

suggested that the Office should accept an interim statement from the
applicant when more time is needed, such as a statement that the
experimentation is progressing, but is not completed.

   Response: Applicant should prepare a reply diligently upon
receiving the final Office action in the prior application, which
provides a six-month statutory period for reply. There is no reason why
an applicant should delay preparing a petition under
§ 1.78(d)(1)(vi) until a third or subsequent continuing application has
been filed. Applicants should not rely solely upon the four-month time
period under § 1.78(d)(1)(vi) to prepare and file a petition under
§ 1.78(d)(1)(vi) for a third or subsequent continuing application.
Therefore, the four-month time period from the actual filing date of a
third or subsequent continuing application is a reasonable deadline to
file a petition under § 1.78(d)(1)(vi).

   Comment 104: A number of comments requested clarification regarding
who will decide the petitions under §§ 1.78(d)(1) and 1.114.
Several comments argued that examiners should not decide the petitions
under §§ 1.78(d)(1) and 1.114. Furthermore, a number of
comments argued that there is a danger that the standard would be
applied differently in different Technology Centers. Several comments
suggested that the Office of Petitions should decide the petitions to
encourage consistency, ensure uniform interpretation of the rules, and
reduce the impact on examining resources. Yet another comment suggested
that the BPAI should review the showing required under §§ 1.78(d)(1) and
1.114. The comments further argued that there is a potential for both
disparate treatment and inconsistent application of §§ 1.78(d)(1) and
1.114 depending on who decides the petitions and that the potential of
either would violate the concept of equal protection under the law.

   Several comments requested clarification regarding the procedures
for appealing the denial of a petition under § 1.78(d)(1)(vi) or
1.114(g). Specifically, the comments questioned whether a denial of a
petition should be appealed to the BPAI or petitioned to the Director.
The comment further requested that the Office publish the decisions to
encourage consistency and understanding of the standard. One comment
sought clarification on the remedies available to an applicant if the
Office denies a petition for an additional continuing application or
request for continued examination when the examiner introduced new
prior art in a final Office action. One comment questioned whether
petitions under §§ 1.78(d)(1) and 1.114 could be decided
objectively due to the Office's desire to dramatically curtail
continuing applications and requests for continued examination.

   Response: The Office is making every effort to become more
efficient, to apply the rules and statutes uniformly, and to allocate
Office resources properly. The authority to decide petitions under
§§ 1.78(d)(1)(vi) and 1.114(g) has been delegated to the Deputy
Commissioner for Patent Examination Policy (who may further delegate
this authority to officials under the Deputy Commissioner for Patent
Examination Policy). A decision on a petition under § 1.78(d)(1)(vi) or
1.114(g) is not appealable to the BPAI. The denial of a petition under
§ 1.78(d)(1)(vi) or 1.114(g) may be viewed as a final agency action for
the purposes of judicial review under 5 U.S.C. 704. See MPEP § 1002.02.
Final decisions of the Office of the Commissioner for Patents are
accessible in the Freedom of Information Act (FOIA) section of the Office's
Internet Web site at
(http://www.uspto.gov/web/offices/com/sol/foia/comm/comm.htm).

   The Deputy Commissioner for Patent Examination Policy and officials
under the Deputy Commissioner for Patent Examination Policy will decide
petitions under §§ 1.78(d)(1)(vi) and 1.114(g) on their merits
and the facts in the record and apply the standard in a consistent
manner. The officials who will decide petitions under §§ 1.78(d)(1)(vi)
and 1.114(g) are professionals who perform their duties
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1085 

within the framework of the law, rules, and examination practice. The
Office only desires to curtail continuing applications and requests for
continued examination in situations in which the continued examination
filing is for the purpose of presenting an amendment, argument or
evidence that could have been, but was not, submitted earlier. The
Office recognizes the need for continued examination filings for
presenting an amendment, argument or evidence that truly could not have
been submitted earlier.

   Comment 105: A number of comments requested that the Office set a
time limit for rendering decisions on petitions under
§§ 1.78(d)(1) and 1.114. The comments suggested that the Office should
set up an adequately staffed office to decide the petitions promptly, and
in any event, before the close of prosecution of the parent application
so that applicants are advised of their prosecution options. The
comments further suggested that the Office should grant the petition if
it is not decided prior to the close of prosecution.

   Response: The Office is continuing to ensure prompt and consistent
decisions on petitions. It is the general policy of the Office that
petitions are decided in the order that they are filed in the Office.
Moreover, the Office will likely deny any petition under
§ 1.78(d)(1)(vi) or 1.114(g) filed before the close of prosecution
because applicant may still submit the amendment, argument, or evidence
in the application if the prosecution is open. Further, in such
situation, it is unlikely that applicants will be able to show that the
amendment, argument, or evidence sought to be entered could not have
been previously submitted.

   Comment 106: One comment sought clarification regarding the status
of an application during consideration of the petition. Specifically,
the comment questioned whether an applicant who had filed a petition
under § 1.78(d)(1) or 1.114 would be permitted to file a notice of
appeal under § 41.31(a) within the time period provided in § 1.134
to avoid abandonment of the application if the petition is dismissed.
The comment also inquired whether the notice of appeal fee would be
refunded if the petition were granted. Several other comments
suggested that the filing of a petition under § 1.78(d)(1) or 1.114
should serve as a notice of appeal if the petition is dismissed. In the
alternative, several comments suggested that the Office should allow
applicants additional time to file a notice of appeal after the
dismissal of a petition.

   Response: The Office will make every effort to decide the petitions
in a timely manner. The rules have not changed the time period for
filing a notice of appeal or an appeal brief. Pursuant to § 41.31(a)(1),
an applicant must file a notice of appeal accompanied by
the fee set forth in § 41.20(b)(1) within the time period for reply
set forth in the Office action. The notice of appeal fee is set by
statute and is non-refundable. If the Office grants the petition prior
to a decision on the merits by the BPAI, the fees paid for the notice
of appeal and the appeal brief can be applied to a later appeal on the
same application. See MPEP § 1207.04. Additionally, the filing of a
petition will not serve as a notice of appeal, and the Office will not
allow more time to file a notice of appeal. The filing of a petition,
moreover, does not toll the period for reply to any outstanding Office
action. An applicant should not use the continued examination practice
as a substitute for an appeal. Rather, an applicant should appeal the
decision if warranted.

   Comment 107: One comment sought clarification of the status of the
application if, after filing a notice of appeal under § 41.31(a),
an applicant later files a petition under § 1.114 with a request
for continued examination (with a submission and the appropriate fees),
which is dismissed. The comment questioned whether the application
would be abandoned given that the filing of a request for continued
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1086 

examination would be treated as a request to withdraw the appeal.

   Response: In the situation described in the comment, the
application would be abandoned if the application has no
allowed claims because the request for continued examination would be
treated as a request to withdraw the appeal. See MPEP § 1215.01.

   In the situation where applicant already filed a request for
continued examination in the application family, a better alternative
is for applicant to file the request for continued examination with a
petition under § 1.114(g), and then if the petition is not decided
prior to the expiration of the statutory period for reply to the final
Office action, applicant may file a notice of appeal within the period
for reply (and petition for any extension of this period under § 1.136(a)
or (b), if necessary) to avoid abandonment of the application.
If the Office subsequently dismisses the petition, the request for
continued examination will be treated as an improper request for
continued examination. However, the request for continued examination
will not be treated as a request to withdraw the appeal because the
request for continued examination was filed before the notice of appeal
(i.e., the application was not on appeal at the time of filing the
request for continued examination).

E. Treatment of Multiple Applications

   Comment 108: A number of comments suggested the four-month time
period provided in § 1.78(f)(1) for identifying to the Office
applications that meet the criteria set forth in § 1.78(f)(1) is
unreasonably short and is impractical in view of the time often
required by the Office to assign application numbers and communicate
these numbers to the applicants. One comment suggested the time period
provided in § 1.78(f)(1) for identifying to the Office applications
that meet the criteria set forth in § 1.78(f)(1) does not permit an
applicant to timely identify an international application designating
the United States of America that entered the national stage thirty
months after the filing date of a nonprovisional application filed
under 35 U.S.C. 111(a) when these two applications meet the criteria
set forth in § 1.78(f)(1).

   Response: The Office notes the concerns expressed in the public
comments concerning the proposed changes to § 1.78(f)(1). The
Office has modified this provision relative to the proposed changes
such that § 1.78(f)(1) as adopted in this final rule provides
applicant four months from the actual filing date of a nonprovisional
application filed under 35 U.S.C. 111(a), four months from the date on
which the national stage commenced under 35 U.S.C. 371(b) or (f) in a
nonprovisional application which entered the national stage from an
international application after compliance with 35 U.S.C. 371, or two
months from the mailing date of the initial filing receipt in the other
nonprovisional application, to identify other nonprovisional
applications in compliance with § 1.78(f)(1).

   Comment 109: A number of comments requested identification of any
consequences for failing to identify one or more applications that meet
the criteria set forth in § 1.78(f)(1), or for failing to identify
such applications within the time period set forth in § 1.78(f)(1).

   Response: If applicant inadvertently fails to identify the other
nonprovisional applications in compliance with § 1.78(f)(1)(i)
within the time period provided in § 1.78(f)(1)(ii), applicant
should submit the identification to the Office as soon as practical. If
the submission necessitates a new rejection based upon double patenting
(including an obviousness-type double patenting rejection) in a second
or subsequent Office action on the merits, the examiner may make such
an action final (assuming that the conditions for making a second or
subsequent action final are otherwise met). The Office may also refer
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1087 

any registered practitioner who repeatedly fails to comply with the
rule requirements to the Office of Enrollment and Discipline for
appropriate action. Applicants and practitioners are strongly
encouraged to revise their practices to ensure timely submissions of
the required identification. Applicants and registered practitioners
are reminded of their duties under § 10.18 and other professional
responsibility rules, and the consequences of any violations (e.g.,
§§ 10.18(c), 10.18(d) and 10.23).

   Comment 110: A number of comments requested clarification of
§ 1.78(f)(1) and how it interacts with § 1.56, including the
preexisting duty of an applicant to disclose similar information to the
Office under § 1.56. Several comments stated that § 1.78(f)(1)
imposes burdens on the applicants that provide a new basis for
inequitable conduct allegations.

   Response: Section 1.78(f)(1) provides that an applicant must
identify other pending applications or patents that are commonly owned,
have a common inventor, and have a claimed filing or priority date
within two months of the claimed filing or priority date of the
application. This requirement does not supplant an applicant's duty to
bring other applications that are "material to patentability" of an
application (e.g., applications containing patentably indistinct
claims) to the attention of the examiner. Section 1.78(f)(1) does not
provide a new basis for allegations of inequitable conduct when
§ 1.78(f)(1) is considered in light of the duties concurrently imposed
on applicants and practitioners by § 1.56 and the ethics rules in 37
CFR Part 10, such as § 10.18. See also Dayco, 329 F.3d at 1365-69,
66 U.S.P.Q.2d at 1806-08 (individuals covered by § 1.56 cannot
assume that the examiner of a particular application is necessarily
aware of other applications which are "material to patentability" of
the application under examination, but must instead bring such other
applications to the attention of the examiner).

   Comment 111: Several comments requested clarification regarding the
applications that must be identified pursuant to § 1.78(f)(1) when
common inventor(s) and common ownership exist.

   Response: Applicant must identify those pending nonprovisional
applications that are filed within two months of each other taking into
account any filing date for which benefit is sought, that name at least
one common inventor, and that are owned by the same person or subject
to an obligation of assignment to the same person. For example, the
applicant for application A is required to identify application B and
the applicant for application B is required to identify application A
in the following situation: The actual filing date of application A is
August 8, 2006. Application A claims priority of a foreign application
filed on August 10, 2005. The actual filing date of application B is
April 11, 2006. Application B claims the benefit of a prior-filed
nonprovisional application filed on October 4, 2005, and claims the
benefit of a prior-filed provisional application filed on January 4,
2005. Application A and application B have at least one common inventor
and common ownership. Each applicant must identify the other
application because application A has a filing date (August 10, 2005,
the foreign priority date) within two months of a filing date of
application B (October 4, 2005, the filing date of the nonprovisional
application whose benefit is claimed by application B). "Filing date"
includes the actual filing date, foreign priority date, and the filing
date of a provisional, nonprovisional, or international application
whose benefit is sought under title 35, United States Code.

   Comment 112: A number of comments objected that §§ 1.78(f)(1)
and (2) require applicants to identify and resolve a possible double
patenting issue prior to a rejection being issued by the examiner. One
comment suggested that the rebuttable presumption in § 1.78(f)(2) was akin
to saying that if an applicant submits prior art, there is a presumption of
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1088 

obviousness. One comment suggested that § 1.78(f)(2) was unnecessary because
§ 1.78(f)(1) provides the Office with sufficient information to require a
terminal disclaimer or require the cancellation of claims. One comment
stated that many applicants will attempt to circumvent § 1.78(f)(2)
by filing multiple applications that meet the criteria set forth in
§ 1.78(f)(2), but that include both patentably distinct claims and
patentably indistinct claims.

   Response: The rebuttable presumption set forth in § 1.78(f)(2)
is a procedural tool requiring the applicant to help focus and
consolidate the examination process and thus is not akin to a
presumption of obviousness. The examination is more efficient when
double patenting issues are identified and resolved early in the
process. Where an applicant chooses to file multiple applications that
are substantially the same, it will be the applicant's responsibility
to assist the Office in resolving potential double patenting situations
rather than taking no action until faced with a double patenting
rejection. Although the ultimate determination of double patenting
rests with the Office, applicants are in a far better position than the
Office to identify applications that may raise double patenting
concerns.

   Section 1.78(f)(2) requires applicant to resolve the double
patenting issues early in the prosecution by either: (1) Filing a
terminal disclaimer and an explanation as to why the multiple
applications containing patentably indistinct claims are necessary; or
(2) explaining how the application contains only claims that are
patentably distinct from the claims of other related applications.
Therefore, with the benefit of § 1.78(f)(2), double patenting
issues could be resolved more expeditiously before the first Office
action on the merits, thus saving the examiner time by eliminating the
need to search for related applications, analyze the potentially
conflicting claims, and make the rejection. Merely identifying the
other applications under § 1.78(f)(1) would not result in these
benefits.

   If the criteria set forth in § 1.78(f)(2) are met, the
rebuttable presumption would apply regardless of whether a few of the
claims are patentably distinct from the claims in the other related
applications because § 1.78(f)(2) provides that "a rebuttable
presumption shall exist that a nonprovisional application contains at
least one claim that is not patentably distinct * * * ." To rebut this
presumption, applicant must explain how the application contains only
claims that are patentably distinct. Merely explaining that some of the
claims are patentably distinct would not be sufficient to rebut this
presumption.

   Comment 113: One comment objected that § 1.78(f)(2) would
impose an undue burden on inventors because it creates a presumption
that commonly owned patent applications which share a common disclosure
and at least one inventor, are patentably indistinct. The comment
further asserted that the presumption is not in the interest of
American competitiveness as American companies often file numerous
patent applications with claims directed to different features of the
same new product. One comment suggested that § 1.78(f)(1) places an
excessive burden on applicants to anticipate all the unique claims that
could be filed at the time of filing the initial application.

   Response: Section 1.78(f)(2)(i) requires that the related
applications must have the same claimed filing or priority date in
addition to being commonly owned with one inventor in common and with
substantial overlapping disclosure. Multiple patent applications
related to the same product are not precluded by § 1.78(f)(2). In
the situation where § 1.78(f)(2)(i) actually applies and the
multiple applications relate to patentably distinct features of the
same new product, it should not be difficult to explain how the
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1089 

applications contain patentably distinct claims under
§ 1.78(f)(2)(ii)(A), and thereby rebut the presumption. Thus, the
presumption of § 1.78(f)(2)(i) does not impose an undue burden on
inventors.

   None of the criteria under § 1.78(f)(1) for identifying certain
related applications has anything to do with claims that could be filed
in the initial application as suggested by the comment. Instead,
§ 1.78(f)(1) merely requires identification of applications that meet
the identified criteria. Accordingly, there is no such burden placed on
applicants.

   Comment 114: Several comments requested clarification of the
language "taking into account any filing date for which a benefit is
sought under title 35, United States Code," in § 1.78(f)(1). Those
comments also inquired whether this language includes provisional
applications for which benefit is sought, merely the first
nonprovisional application for which benefit is sought, or every
nonprovisional application for which benefit is sought.

   Response: Section 1.78(f)(1) requires applicant to consider all
provisional, nonprovisional, international, and foreign applications
for which benefit is sought. If the filing date of an application whose
benefit is claimed in a nonprovisional application is within two months
of the filing date of another pending nonprovisional application, and
the nonprovisional applications name at least one inventor in common
and are owned by the same person or subject to an obligation of
assignment to the same person, each applicant of the nonprovisional
applications must identify the other nonprovisional application to the
Office. For example, if two nonprovisional applications claim priority
of the same foreign application (or two foreign applications filed
within two months of each other), name at least one inventor in common,
and are owned by the same person, then each applicant of the
nonprovisional applications must identify the other nonprovisional
application, no matter the difference in time between their U.S. filing
dates.

   Comment 115: A number of comments suggested that § 1.78(f)(1)
could be eliminated if the Office assigned all related applications to
the same examiner.

   Response: The Office attempts to assign related applications to the
same examiner where possible. However, applicant is in the best
position to determine and identify when applications are related, not
the Office. By meeting the provisions of § 1.78(f), applicants will
reduce the burden on the Office to identify which applications are
related and facilitate examination of the related application by the
examiner.

   Comment 116: Several comments suggested that § 1.78(f)(1) would
be burdensome to applicants who file a large number of applications in
related areas of research. These comments suggested that the examiners
working in these areas of technology will also experience a significant
burden. A number of comments suggested that the Office has not
sufficiently justified how the benefits of § 1.78(f) outweigh the
added costs for both applicants and the Office. These comments
suggested that the existing rules relating to double patenting and the
filing of terminal disclaimers are sufficient to solve the problems of
patentably distinct claims, and that the Office's searchable database
of applications makes the § 1.78(f) changes unnecessary. The
comments argued that examiners can perform common inventor searches as
easily as applicants. A number of comments doubted the Office's
reasoning that duplicative applications containing "conflicting or
patentably indistinct claims" are having a crippling effect on the
Office's ability to examine non-continuing applications. A number of
comments making such an objection stated that in fiscal year 2005,
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1090 

less than three percent of the patents granted contained a terminal
disclaimer, and accordingly there is no basis for the rebuttable
presumption of patentably indistinct claims. One comment suggested that
§ 1.78(f)(2) would not reduce examiner workloads because examiners would
still be required to make their own separate determinations regarding
whether claims are patentably distinct in order to evaluate and address
arguments made by applicants pursuant to § 1.78(f)(2).

   Response: Multiple applications with patentably indistinct claims
divert patent examining resources from the examination of new
applications. This final rule encourages applicants to submit all of
the claims that are patentably indistinct in one single application.
See §§ 1.78(f) and 1.75(b)(4). By presenting all of the
patentably indistinct claims in one application, applicants can
alleviate the Office's burden of searching for multiple applications
containing patentably indistinct claims, analyzing the applications for
double patenting issues, and requiring cancellation of the claims or a
terminal disclaimer. This will also ensure that one single examiner
will examine the same invention to provide consistent and focused
examination. Furthermore, it will preclude applicant from submitting
multiple applications to the same subject matter (with claims that are
patentably indistinct), each with five or fewer independent claims or
twenty-five or fewer total claims, for the purpose of avoiding the
requirement to submit an examination support document.

   It is envisioned that many applicants will be proactive by filing
fewer applications containing patentably indistinct claims, unless
there is a good and sufficient reason to do so. By minimizing such
filings, applicants will reduce the Office's burden of examining
multiple applications containing patentably indistinct claims.
Applicants are in a far better position than the Office to identify
related applications pursuant to § 1.78(f)(1). The Office's
searchable database is not a sufficient substitute for applicant's
knowledge of related applications, particularly in view of the fact
that ownership identification is not required when an application is
filed, and the fact that applications are often filed without executed
declarations that correctly name all of the inventors.

   The terminal disclaimer statistic cited in the comment covers all
granted patents. It does not specifically relate to the limited
situation covered by § 1.78(f)(2). Furthermore, double patenting
issues must be considered in every application where the applicant
filed another related application, not only those applications in which
applicant filed a terminal disclaimer. For example, the statistic cited
in the comment does not include applications in which the applicants
canceled the patentably indistinct claims.

   The burden on the examiner to evaluate arguments presented by
applicant is less compared to the burden of independently identifying
and reviewing each application that meets the criteria set forth in
§ 1.78(f)(2). Furthermore, the issues would be resolved earlier in
the prosecution. Without the presumption of at least one patentably
indistinct claim and applicant's assistance under § 1.78(f)(2), it
is more difficult to resolve potential double patenting situations.
   Comment 117: Several comments suggested that the two-month window
between filing dates set forth in § 1.78(f)(1) is overly burdensome
on both the Office and the applicant.

   Response: The identification requirement under § 1.78(f)(1) is
consistent with the duty to disclose information that is material to
patentability under § 1.56. The two-month window set forth in
§ 1.78(f)(1) merely provides guidance to applicants for at least those
applications that must be identified to the Office. Often, related
applications filed outside the two-month window should also be
identified to the Office under § 1.56.

Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1091 

   Comment 118: One comment stated that compliance with
§ 1.78(f)(1) would be difficult for corporations that employ multiple
law firms to handle their patent prosecution portfolios.

   Response: Each corporation typically has a person or a group of
people who oversees its outside counsel and manages its patent
portfolio. It is not unreasonable for the Office to assume that the
person(s) managing the patent portfolio is aware of the contents of the
corporation's applications being prosecuted by different law firms. In
any event, it is appropriate for the corporation to bear the burden of
tracking applications for compliance with § 1.78(f)(1).

   Comment 119: One comment suggested that some docketing systems
currently used by practitioners do not permit searching by inventor
names in a manner that would enable practitioners to identify
applications with common inventors that were filed within two months of
each other.

   Response: The fact that some practitioners do not have a docketing
system to identify applications with common inventors that were filed
within two months of each other is not a sufficient reason for the
Office to not require the information under § 1.78(f)(1) that would
assist the Office in identifying applications that potentially have
double patenting issues. Practitioners should have the required
information even though their docketing system may not keep track of
applications with common inventors. Practitioners should have more
reliable information regarding applications with common inventors than
the Office's database because many applications are filed without an
executed oath or declaration and the actual inventors are not often
identified to the Office for a number of months after the filing date.
Furthermore, ownership is not required to be identified when an
application is filed.

   Comment 120: One comment questioned whether extensions of time
would be available for applicants attempting to comply with the
requirements of § 1.78(f)(1).

   Response: Section 1.78(i) as adopted in this final rule provides
that "[t]he time periods set forth in [§ 1.78] are not extendable."

   Comment 121: A number of comments questioned why applicants would
need to identify to the Office applications with a common inventor
under § 1.78(f)(1) that contain patentably distinct claims because
those applications are not candidates for an obviousness-type double
patenting rejection.

   Response: Applicant is in the best position to identify to the
Office applications with potentially conflicting claims. By taking
responsibility for identifying such applications, applicant will be
reducing the burden on the Office so that the Office can focus its
limited examining resources on examining new applications. The ultimate
determination of obviousness-type double patenting remains with the
Office, which is why it is critical that applications that meet the
criteria of § 1.78(f)(1) be identified to the Office.

   Comment 122: A number of comments suggested that while an applicant
is in a better position to know of related applications that have been
filed, they are not in the position to determine whether the claims of
these applications are patentably distinct. This is a function of the
Office. One comment argued that the Office is making an unsupported
assumption that the applicant is in a far better position than the
Office to determine whether there are one or more other applications or
patents containing patentably indistinct claims.

   Response: The applications whose specifications possibly contain
patentably indistinct claims were made by or on behalf of the inventor
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1092 

or applicant, and not the Office or the examiner. See 35 U.S.C. 111(a).
Thus, the applicant is in a better position than the Office or examiner
to know when such related applications have been filed. While the
ultimate determinations of double patenting and patentability remain
with the Office, the Office rejects the position that the applicant has
no responsibility to facilitate those decisions. The information
provided by applicant in compliance with § 1.78(f)(1) is reasonably
necessary for the Office to determine double patenting issues. With the
information provided before the first Office action on the merits, the
Office could make the patentability determination more efficiently and
thereby reduce pendency. For example, the examiner could identify and
resolve any double patenting issues earlier in the prosecution.

   Comment 123: One comment suggested that the requirements of
§ 1.78(f)(1) would raise inventorship and ownership issues when
entities have entered into a confidential research agreement.

   Response: The identification of such applications is reasonably
necessary for an efficient and effective examination. This requirement
is similar to that imposed upon applicants having knowledge of material
prior art that became known to them via information covered by a
confidentiality agreement. In such an instance, the existence of a
confidentiality agreement does not relieve applicants from their duty
to disclose this prior art information to the Office. In any event,
§ 1.78(f)(1) requires identification of only the commonly owned
applications (if certain conditions are met), but not identification of
the owner. 35 U.S.C. 115 requires that the inventors identify
themselves.

   Comment 124: One comment suggested that § 1.78(f) will have the
greatest adverse impact on small entities.

   Response: The rules apply equally to both non-small entities and
small entities. The comment did not provide persuasive data or other
evidence supporting the conclusion. The Office's experience is that
small entities do not file a larger percentage of multiple applications
than non-small entities. Thus, it is doubtful that any impact, if
adverse, will affect small entities the most.

   Comment 125: Several comments questioned whether the Office should
even concern itself with obviousness-type double patenting rejections.
They suggested that essentially no harm at all to the public exists
through the grant of plural applications having the same, or roughly
the same, filing dates, while the technical traps for the unwary and
the undue examination burdens established by double patenting
rejections unduly complicate procurement and burden the Office.

   Response: There are two reasons why the Office still needs to make
obviousness-type double patenting rejections in applications filed on
or after June 8, 1995, and that are subject to a twenty-year term under
35 U.S.C. 154(a)(2). First, 35 U.S.C. 154 does not ensure that any
patent issuing on a utility or plant application will necessarily
expire twenty years from the earliest filing date for which a benefit
is claimed under 35 U.S.C. 120, 121, or 365(c) because 35 U.S.C. 154(b)
includes provisions for patent term extension based upon prosecution
delays during the application process. Second, § 1.321(c)(3)
requires that a terminal disclaimer filed to obviate an obviousness-
type double patenting rejection based on commonly owned patentably
indistinct claims include a provision that any patent granted on that
application be enforceable only for and during the period that the
patent is commonly owned with the application or patent which formed
the bases for the rejection. This requirement prevents the potential
for harassment of an accused infringer by multiple parties with patents
covering the same patentable invention. See MPEP § 804.02. If
applicant files all of the patentably indistinct claims in one
application, applicant could alleviate the Office's burden of searching
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1093 

for multiple applications containing patentably indistinct claims,
analyzing the applications for double patenting issues, and requiring
cancellation of the claims or a terminal disclaimer.

   Comment 126: One comment suggested that § 1.78(f)(2) prevents
an applicant from claiming different embodiments unless the embodiments
are patentably distinct.

   Response: Under this final rule, applicant may present claims
during the prosecution of an initial application and two continuation
or continuation-in-part applications plus one request for continued
examination in the application family, without any justification.
Applicant therefore should have sufficient opportunity to present
claims to different embodiments of an invention in these filings.
Furthermore, applicant is not required to provide an explanation under
§ 1.78(f)(2)(ii)(B) for a continuation application or continuation-
in-part application of a prior-filed application that has been allowed.

   Comment 127: One comment suggested that examiners would not have
any incentive to find claims patentably distinct.

   Response: Examiners are professionals who perform their duties
within the framework of the current patent laws, rules and examination
practices. No persuasive explanation was given in support of the
suggestion that examiners would be less likely to find claims
patentably distinct.

   Comment 128: One comment suggested that the rebuttable presumption
set forth in § 1.78(f)(2) was inconsistent with the Office's
restriction practice. The comment suggested that it was inconsistent to
presume that claims are patentably indistinct when, if the claims were
filed in one application, they would be found to be patentably
distinct, and subject to a restriction requirement.

   Response: The changes to § 1.78(f)(2) and restriction practice
encourage applicant to file a single application for each patentably
distinct invention. For example, if two or more independent and
distinct inventions are claimed in a single application, the examiner
may make a restriction requirement. See § 1.142. The filing of
multiple applications that together claim only one patentable invention
(i.e., the applications contain patentably indistinct claims), however,
is diverting the Office's limited examining resources from examining
new applications. Applicant should file a single application claiming
one patentable invention rather than multiple applications claiming the
same patentable invention. Applicant may rebut the presumption that
claims in multiple applications are not patentably distinct by
explaining how the application contains only claims that are patentably
distinct from the claims in each of the other applications. Similar to
the restriction practice, applicant may maintain multiple applications
if the applications contain patentably distinct claims (i.e., each
application is claiming one patentably distinct invention).

   Comment 129: One comment objected that remarks by applicants under
§ 1.78(f)(2) to rebut the double patenting presumption would create
prosecution history estoppel before the Office issued a rejection that
could impact on the certainty and quality of the patent.

   Response: First, applicant remarks under § 1.78(f)(2) would be
akin to remarks set forth in response to a double
patenting rejection. The Office does not consider the possibility of
prosecution history estoppel to be a sufficient reason to forego the
presumption built into § 1.78(f)(2). Second, such remarks would not
be required if all patentably indistinct claims are included in one
application.

   Comment 130: One comment suggested that the rebuttable presumption
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1094 

in § 1.78(f)(2) would require applicants who normally file multiple
utility applications within two months of each other, each with more
than the threshold number of claims and each claiming benefit of the
same provisional application, to now file an examination support
document for their applications. The comment suggested that this would
be especially true for those applications forming a portfolio being
developed for a new technology.

   Response: The rebuttable presumption provision of § 1.78(f)(2)
would apply only if the nonprovisional applications have the same
filing date, taking into account any filing date for which a benefit is
sought, name at least one inventor in common, are owned by the same
person or are subject to an obligation of assignment to the same
person, and contain substantial overlapping disclosure. The rebuttable
presumption provision of § 1.78(f)(2) does not apply simply because
commonly owned applications are filed within two months of each other.
In addition, § 1.78(f)(2) provides for a rebuttable presumption
that applications contain patentably indistinct claims. The
applications thus will be treated as containing patentably indistinct
claims for claim counting purposes under § 1.75(b)(4) if the
applicant does not explain how the applications do not contain
patentably indistinct claims or if the examiner does not agree with the
explanation. If an applicant files multiple applications that contain
patentably indistinct claims, there is no reason why the Office should
treat an applicant who spreads patentably indistinct claims among
multiple applications differently than an applicant who presents all of
the patentably indistinct claims in a single application.

   Comment 131: Several comments suggested that the filing of multiple
applications having at least one common inventor and specifications
with overlapping disclosures cannot be presumed to be bad faith
prosecution because these applications typically claim distinct
inventions that relate to the same product or service and such
applications are not used to delay prosecution. One such comment stated
that the rebuttable presumption under § 1.78(f)(2) represents an
overreaction to tactics engaged in by a small minority of applicants.
Another such comment took offense to § 1.78(f)(2) as appearing to
be based on underlying presumptions that applicants are gaming the
system and their representatives are acting in bad faith whenever
applications are filed meeting the criteria of the rule.

   Response: There is no presumption of bad faith on the part of
applicant. The rebuttable presumption is simply a procedural tool
requiring the applicant to help focus and consolidate the examination
process. This will help examiners to resolve double patenting issues
early in the examination process and contribute to examination
efficiency by eliminating the need to search for related applications.

   Comment 132: A number of comments stated that the § 1.78(f)(2)
criteria do not automatically lead to the conclusion the claims are
patentably indistinct and that applicants may easily maintain multiple
applications by preparing claims that are uniquely supported only in
the application in which they appear. One comment objected that the
mere presence of specifications with overlapping disclosures does not
create a prima facie case of patentably indistinct claims as evidenced
by the fact that an obviousness-type double patenting rejection
requires a comparison between the claims of the application being
examined and those of the co-owned application or patent, not a
comparison of their disclosures.

   Response: The § 1.78(f)(2) criteria lead to a rebuttable
presumption, which is rebuttable that patentably indistinct claims
exist. The rebuttable presumption is not a merits determination of
patentability, but is simply a procedural tool requiring the applicant
to help focus and consolidate the examination process. Further, an
overlapping disclosure is not the only condition for the presumption
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1095 

under § 1.78(f)(2). Section 1.78(f)(2) also specifies that the
applications must have the same claimed filing or priority date, name
at least one inventor in common, and have common ownership.
Accordingly, the presumption is limited so that it only applies to
applications that most likely contain patentably indistinct claims. The
rebuttable presumption does not equate to a prima facie case of
patentably indistinct claims. An applicant may rebut the presumption by
explaining how the application contains claims that are patentably
distinct from the claims in each of the other applications or patents.
If the applicant cannot rebut the presumption, applicant must submit a
terminal disclaimer in accordance with § 1.321(c) and explain why
there are two or more pending nonprovisional applications which contain
patentably indistinct claims.

   Comment 133: One comment suggested that the rebuttable presumption
should be provisional as the scope of the claims in question may change
during the course of prosecution.

   Response: Section 1.78(f)(2) as adopted in this final rule requires
the appropriate action within the later of: (1) Four months from the
actual filing date of an application filed under 35 U.S.C. 111(a) or
four months from the date on which the national stage commenced under
35 U.S.C. 371(b) or (f); or (2) the date on which a claim that is not
patentably distinct from at least one of the claims in the other
applications is presented. For example, if the presumption under
§ 1.78(f)(2) applies, applicant must rebut this presumption within four
months from the actual filing date of an application filed under 35
U.S.C. 111(a) for the original claims presented on the filing date of
the application. If applicant subsequently files an amendment that adds
a new claim after four months from the filing date of the application,
applicant must rebut this presumption for such a claim when applicant
files the amendment.

   Comment 134: One comment suggested that since the Office has stated
in MPEP § 804.02 that patent applications which give rise to
obviousness-type double patenting rejections are in the public
interest, it stands to reason that the rules that seek to preclude such
applications are against public interest.

   Response: The Office stated that the use of a terminal disclaimer
in overcoming an obviousness-type double patenting rejection is in the
public interest because it encourages the disclosure of additional
developments, the earlier filing of applications, and the earlier
expiration of patents whereby the inventions covered become freely
available to the public. See MPEP § 804.02. The Office did not
state that the public interest was served by all applications that
contain patentably indistinct claims.

   Comment 135: One comment questioned whether applications subject to
the requirements of § 1.78(f)(2) would increase examination
pendency or add to the Office's backlog since the rejections set forth
in applications with patentably indistinct claims are typically
overcome by a properly drafted terminal disclaimer.

   Response: The changes to § 1.78(f)(2) in this final rule are
aimed at reducing pendency and the Office's backlog. Specifically,
§ 1.78(f)(2) requires applicant to resolve the double patenting
issues early in the prosecution (e.g., four months from the actual
filing date of the application) by either: (1) Filing a terminal
disclaimer and an explanation as to why the multiple applications
containing patentably indistinct claims are necessary; or (2)
explaining how the application contains only claims that are patentably
distinct from the claims of other related applications. Therefore,
double patenting issues could be resolved before the first Office
action on the merits, thus saving the examiner time by eliminating the
need to search for related applications, analyze the potentially
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1096 

conflicting claims, and make the rejection. As a result, examination
can be more focused on prior art and other patentability issues.

   Without the rebuttable presumption of § 1.78(f)(2), it would be
harder for the examiner to identify and resolve the potential double
patenting situation. In addition, if an Office action in an application
to which the rebuttable presumption applies must include a double
patenting rejection, it is because the applicant has not helped to
resolve the double patenting situation pursuant to § 1.78(f)(2).
Accordingly, a double patenting rejection made for the first time in a
second or subsequent Office action will not preclude the Office action
from being made final (assuming that the conditions for making a second
or subsequent action final are otherwise met). Thus, applicants'
responsibility to take the initiative under § 1.78(f)(2) to resolve
double patenting situations will expedite examination, even if this
responsibility does not result in the prompt resolution of the double
patenting situation. Further, the Office envisions that many applicants
will file fewer applications containing patentably indistinct claims in
light of § 1.78(f)(2) unless there is a good and sufficient reason
to do so. Therefore, the Office expects that the requirements of §
1.78(f)(2) will not increase examination pendency or add to the Office
backlog.

   Comment 136: One comment suggested that the strategy for
circumventing the claim requirement set forth in § 1.75 by filing
multiple applications in order to receive substantive examination on
more than the threshold number of claims conflicts with § 1.78(f)(2).

   Response: As suggested by the comment, some applicants might
attempt to circumvent the requirements in § 1.75(b)(1) by filing
multiple applications. Such a strategy would be ineffective as a result
of the provisions of § 1.75(b)(4) and § 1.78(f). For the
purpose of determining whether each of the multiple applications
exceeds the five independent claim and twenty-five total claim
threshold, the Office will treat each application as having the total
number of all of the claims (whether in independent or dependent form)
from all of the multiple applications. See § 1.75(b)(4).

   Comment 137: Several comments objected that applicants are being
required to explain or justify why they are filing patent applications.
Some of the comments stated that such a requirement is unnecessarily
burdensome and forces applicants to make statements that could lead to
prosecution history estoppel issues. One of the comments questioned why
§ 1.78(f)(2)(ii) requires applicants to explain why the filing of
two applications is necessary if a terminal disclaimer has been filed.

   Response: The filing of multiple applications containing patentably
indistinct claims is impairing the Office's ability to examine new
applications. Applicant has the opportunity to avoid drafting and
filing applications that satisfy the criteria of § 1.78(f)(2) by
filing a single application containing all of the patentably indistinct
claims. Furthermore, § 1.78(f)(2)(i) gives applicant the option to
rebut the presumption of patentably indistinct claims rather than
filing a terminal disclaimer and an explanation. Also note that the
§ 1.78(f)(3) provision was similarly set forth in former § 1.78(b).

   Comment 138: Several comments were critical of § 1.78(f)(2) and
stated that the rule would merely result in applicants filing jumbo
patent applications with multiple claim sets drawn to patentably
distinct inventions in order to force the Office to issue restrictions
instead of filing multiple applications on the same day that meet the
criteria of § 1.78(f)(2).

   Response: Section 1.78(f)(2) permits applicant to file multiple
applications claiming patentably distinct inventions. Applicant may
rebut the presumption by arguing that the applications claim patentably
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1097 

distinct inventions. Applicant also has the option of filing a single
application to claim patentably distinct inventions or when applicant
is unsure whether the inventions are patentably distinct. As noted in
Berg, 140 F.3d at 1434, 46 U.S.P.Q.2d at 1231, applicants achieve no
advantage by choosing to file patentably indistinct claims in separate
applications because the claims would be subject to a rejection under
the one-way double patenting analysis. The Berg court stated that
"[i]f a potential applicant is unsure whether it has more than one
patentably distinct set of claims, the PTO advises that it file all of
the claims as one application." See id. at 1435, 46 U.S.P.Q.2d at
1232. The option presented by the Office was considered by the court to
be reasonable, notwithstanding the possibility that the examiner might
not make a restriction requirement.

   Comment 139: One comment suggested that applicants will be unfairly
disadvantaged if they fail to convince the examiner that the claims are
patentably distinct, as they will likely be simultaneously subject to a
final rejection with the probability of just a single continuation
application to gain allowance of the claims.

   Response: This final rule permits applicant to file two
continuation or continuation-in-part applications and one request for
continued examination in an application family, without any
justification. If a timely rebuttal under § 1.78(f)(2) is filed
before the application is taken up for initial examination, the
applicant will not be subject to a final rejection in the first Office
action on the merits. Only if the rebuttal is not timely filed would
the applicant be subject to a final rejection in the succeeding Office
action in the event the examiner makes a determination of patentably
indistinct claims.

   Comment 140: One comment stated that the § 1.78(f)(2)
rebuttable presumption of patentably indistinct claims is overreaching
and its burden on the applicant cannot be justified since it is very
common for an applicant to file multiple applications having a single
specification and patentably distinct claims drawn to different
inventions.

   Response: The rebuttable presumption of § 1.78(f)(2) is not
overreaching as it applies only to applications that have the same
filing date, taking into account any filing date for which a benefit is
sought, name at least one inventor in common, are owned by the same
person or are subject to an obligation of assignment to the same
person, and contain substantial overlapping disclosure. Thus, it
applies only to applications that most likely contain patentably
indistinct claims. Applicant who files multiple applications claiming
patentably distinct inventions may simply rebut the presumption.
Applicant also has the option of filing a single application to claim
patentably distinct inventions or when applicant is unsure whether the
inventions are patentably distinct. If an application claims two or more
independent and distinct inventions, the examiner may make a restriction
requirement. See § 1.142.

   Comment 141: Several comments requested clarification as to the
standard for "patentably indistinct" as the term appears in § 1.78 and
whether this applies to "same invention" double patenting under 35 U.S.C.
101, or "obviousness-type" double patenting, or something different.
Several comments requested clarification concerning what would be an
adequate explanation under § 1.78(f)(2)(i) to rebut the presumption of
patentably indistinct claims.

   Response: The standard for "patentably indistinct" as the term
appears in § 1.78 is one-way distinctness in an obviousness-type
double patenting analysis. See MPEP § 804(II)(B)(1)(a). The
presumption under § 1.78(f)(2) may be rebutted by showing that the
application claims are directed to a separate invention, or by pointing
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1098 

to a unique claim element(s) in the independent claim(s) that
patentably distinguishes them from the claims in the application(s)
that gave rise to the § 1.78(f)(2) presumption.

   Comment 142: A number of comments questioned whether all patentably
indistinct claims in multiple applications meeting the conditions of
§ 1.78(f)(2) are required to be submitted in a single application
absent good and sufficient reason.

   Response: If all patentably indistinct claims can be filed in a
single application and there is no good and sufficient reason for the
patentably indistinct claims to be filed in multiple applications, then
applicant should file the patentably indistinct claims in a single
application. Section 1.78(f)(3) provides that the Office may require
elimination of the patentably indistinct claims meeting the conditions
of § 1.78(f)(3) in all but one of the applications in the absence
of a good and sufficient reason for there being two or more
applications containing patentably indistinct claims.

   Comment 143: Several comments suggested that § 1.78(f)(2) be
changed to provide that the presumption of patentably indistinct claims
be applied to all related applications only when a double patenting
rejection is made in one of the related applications.

   Response: The suggested change would delay triggering the
presumption of patentably indistinct claims and not help reduce the
burden on examiners with respect to reviewing and analyzing related
applications with potentially conflicting claims.

   Comment 144: One comment stated that by requiring more than a
terminal disclaimer to overcome an obviousness-type double patenting
rejection, the Office is outside its authority.

   Response: No more than a terminal disclaimer is required to
overcome obviousness-type double patenting if the reference is a
patent. However, if the obviousness-type double patenting reference is
a pending application, consideration of patentably indistinct claims
can be expedited in a single application. Such a requirement is
consistent with the Office's statutory authority under 35 U.S.C.
2(b)(2). Nothing in the patent statutes requires the Office to accept
patentably indistinct claims in multiple applications absent a good and
sufficient reason.

   Comment 145: Several comments suggested eliminating the presumption
of double patenting in § 1.78(f)(2) and identification of similar
applications in § 1.78(f)(1) as such requirements are already in
the rules.

   Response: The former rules of practice did not expressly require
the identification of applications based on filing dates, inventorship
and ownership conditions. Some of the applications identified pursuant
to § 1.78(f)(1) may be applications with the potential to be
material to patentability as prosecution progresses. Section 1.78(f)(2)
as adopted in this final rule explicitly sets forth for the first time
a presumption of patentably indistinct claims among related
applications meeting certain conditions.

   Comment 146: Several comments suggested permitting "voluntary"
divisional applications instead of requiring an explanation adequate to
rebut the § 1.78(f)(2) presumption of patentably indistinct claims.

   Response: It is unclear how such a strategy would reduce pendency
and promote quality. Anytime a terminal disclaimer is filed under the
conditions of § 1.78(f)(2), the applicant would also have to file a
satisfactory explanation of why there are two or more commonly owned
pending nonprovisional applications naming at least one inventor in
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1099 

common which contain patentably indistinct claims. The alternative to
filing a terminal disclaimer with the explanation is to rebut the
§ 1.78(f)(2) presumption with a showing that the application contains
only patentably distinct claims.

   Comment 147: Several comments requested clarification as to what
constitutes "substantial overlapping disclosure" and whether it
encompasses, for example, a single common sentence or disclosed
element, or an incorporation by reference to another application.

   Response: As discussed previously, § 1.78(f)(2)(i) provides
that substantial overlapping disclosure exists if the other pending or
patented nonprovisional application has written description support
under 35 U.S.C. 112, ¶ 1, for at least one claim in the nonprovisional
application. This written description support may be either by express
disclosure or by an incorporation by reference to another application.
A single common sentence or disclosed element most likely would not, by
itself, constitute "substantial overlapping disclosure."

   Comment 148: One comment was critical that § 1.78(f)(2)(i) will
force applicants to prove a negative in order to show that there are no
patentably indistinct claims among the pending nonprovisional
applications.

   Response: To rebut the presumption under 1.78(f)(2)(i), applicant
could identify claim elements that patentably distinguish the
applications from one another. It is not required that the applicant
prove a negative.

   Comment 149: Several comments objected that § 1.78(f)(3) could
effectively promote a ban on continuation applications with patentably
indistinct claims, and may unnecessarily limit claim broadening in
continuation applications.

   Response: Section 1.78(f)(3) is a restatement of former § 1.78(b),
which previously gave the Office the same discretion to require
elimination of patentably indistinct claims in all but one of
the pending nonprovisional applications. The only difference is that
the Office will now have the benefit of § 1.78(f)(2)(i) to evaluate
when to properly exercise that discretion.

   Comment 150: A number of comments noted that § 1.78(f)(3) essentially
restates former § 1.78(b) and questioned whether § 1.78(f)(3) would achieve
anything beyond what former § 1.78(b) achieved during its existence for
over thirty-five years.

   Response: This provision will be more effectively utilized with the
other changes to § 1.78(f).

   Comment 151: A number of comments requested clarification of the
procedure for reviewing a determination of multiple applications with
patentably indistinct claims. One comment requested clarification as to
whether an adverse determination is redressed by way of appeal to the
BPAI or to a district court.

   Response: Applicants may petition the Director for review of
administrative requirements by an examiner or other Office official,
such as a requirement for an examination support document under § 1.265
when claims in multiple applications are determined to be patentably
indistinct thus causing the involved applications to exceed the five
independent claim and twenty-five total claim threshold set forth in
§§ 1.75(b)(1), (b)(3), and (b)(4), as well as a requirement that claims
in multiple applications that are determined to be patentably indistinct
be canceled from all but one application.

   The BPAI's jurisdiction and appeal procedure in general has not
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1100 

been changed as a result of this final rule. As before, applicant may
appeal the decision of the examiner to the BPAI under 35 U.S.C. 134 and
§ 41.31 if at least one claim has been twice rejected (see § 41.31(a)),
including an obviousness-type double patenting rejection.

   Comment 152: A number of comments were critical of the "may
require elimination" in § 1.78(f)(3), suggesting that the
discretion would be arbitrarily applied by individual examiners and
inconsistently applied by the Patent Examining Corps. Some comments
requested clarification of the procedure and questioned whether the
Office will make a double patenting rejection and/or require
elimination of patentably indistinct claims. Some comments questioned
whether a requirement to eliminate patentably indistinct claims would
apply to all but a single application.

   Response: Section 1.78(f)(3) provides that, in the absence of good
and sufficient reason for there being multiple commonly owned
applications that contain patentably indistinct claims, the Office may
require elimination of the patentably indistinct claims from all but
one of the applications. The term "may" provides both the Office and
applicants with the necessary discretion and flexibility either to
eliminate the identified claims found to be patentably indistinct, or
to merge multiple applications into one. Substantively, § 1.78(f)(3) is
a restatement of former § 1.78(b).

   Comment 153: A number of comments stated that requirements to
eliminate patentably indistinct claims from all but one of the
applications will lead to applicant appeals or petitions before
examination resulting in a substantial increase in pendency while
consuming Office and applicant resources. Some comments stated that
§ 1.78(f)(3) requirements will discourage applicants from
acknowledging claims that are patentably indistinct and result in
increased challenges to double patenting rejections.

   Response: As discussed previously, it is envisioned that many
applicants will file fewer applications containing patentably
indistinct claims unless there is a good and sufficient reason to do
so. Because any requirement under § 1.78(f)(3) would be made during
examination, there can be no petitions to the Director, or appeals,
filed before examination as suggested by the comment. The comment
provided no reasoning as to why § 1.78(f)(3) would have the
negative impact anticipated by the comment when § 1.78(f)(3) is a
restatement of former § 1.78(b).

   Comment 154: One comment suggested allowing multiple related
applications, keeping the requirement to identify related applications,
and adding a requirement for applicant to briefly explain the subject
matter claimed in each related application.

   Response: The proposed solution would not meet the objectives of
these rules and would not prevent the Office from unnecessarily
expending the Office's resources in the examination of multiple
applications with patentably indistinct claims.

   Comment 155: Several comments questioned whether excess claim fees
would be refunded upon elimination of patentably indistinct claims
pursuant to § 1.78(f)(3).

   Response: Applicant may request a refund of any excess claims fees
paid on or after December 8, 2004, if applicant cancels the claim
before an examination on the merits has been made of the application.
See § 1.117.

   Comment 156: Several comments questioned why there is different
language in §§ 1.78(f)(3) and 1.75(b)(4), and questioned whether the
language should be the same.
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1101 


   Response: As the comment noted, the proposed provisions that the
Office may require elimination of the patentably indistinct claims from
all but one of the applications in §§ 1.78(f)(3) and 1.75(b)(4)
were duplicative and might have appeared different. In view of the
comment, the Office did not adopt the proposed provision that the
Office may require elimination of the patentably indistinct claims from
all but one of the applications in § 1.75(b)(4). The Office adopted
this provision in § 1.78(f)(3) which is substantively a restatement
of former § 1.78(b). See the discussion of §§ 1.75(b)(4) and 1.78(f)(3).

   Comment 157: Several comments requested that implementation of
§ 1.78(f)(3) be delayed until other rule changes can be evaluated.

   Response: Section 1.78(f)(3) is a restatement of former
§ 1.78(b) which has been in effect since April 30, 1971. See Conflicting
Claims, 36 FR 7312 (April 17, 1971) (final rule).

   Comment 158: One comment stated that the patentably indistinct
claims in multiple applications are a necessary and desirable component
of United States patent law.

   Response: The comment did not provide a reason why the need for
applicants to have separate applications with patentably indistinct
claims outweighs the needs of the Office to reduce the resources
exhausted during the examination of different applications with
patentably indistinct claims.

   Comment 159: One comment stated that § 1.78(f)(3) imposes an
overly stringent standard that jeopardizes applicant's ability to
ensure patented claims will be held valid if challenged during
litigation. One comment stated that the § 1.78(f) changes are based
on the presumption that all patentably indistinct claims can be
supported and examined in the same application, but that is not always
the case.

   Response: Section 1.78(f)(3) is a restatement of former §
1.78(b), which previously gave the Office the same discretion to
require elimination of patentably indistinct claims in all but one of
the pending nonprovisional applications. Therefore, § 1.78(f)(3)
does not introduce a new standard as suggested in the comment.
Applicant may file multiple applications, but applicant must, in each
application, submit a terminal disclaimer in accordance with §
1.321(c) and explain why there are two or more pending nonprovisional
applications containing patentably indistinct claims.

   Comment 160: One comment suggested allowing applicants to add
patentably indistinct claims to an application after determination that
an original set of claims is allowable.

   Response: Patentably indistinct claims should not be added to an
application upon allowance of the original claims, but should instead
be presented earlier.

   Comment 161: One comment questioned whether it is really a burden
on the examiner to search two applications with patentably indistinct
claims versus one application with the claims of both.

   Response: It is less burdensome to the Office to have patentably
indistinct claims in a single application. A related application with
conflicting claims would have to be identified, reviewed and analyzed
for double patenting issues.

   Comment 162: One comment suggested providing for immediate and
expedited review of all decisions relating to new submissions required
by § 1.78.
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1102 


   Response: The Office will strive to promptly act on all petitions
related to the changes to § 1.78 in this final rule.

   Comment 163: One comment suggested that § 1.78(g) should be
amended to require that in response to a statutory or obviousness-type
double patenting rejection, the Office may require the assignee to
state whether the claimed inventions were commonly owned or subject to
an obligation of assignment to the same person at the time the later
invention was made, and if not to indicate which named inventor(s)
is/are the prior inventor, unless applicant traverses the rejection.

   Response: Section 1.78(g) contains the provisions of former
§ 1.78(c). The Office believes that these provisions, as well as the
information that may be required, are currently sufficient for the
Office to achieve its goals with respect to identifying commonly owned
cases that come within the provisions of 35 U.S.C. 103(c) or with respect
to determining the prior invention.

F. Changes to Practice for Examination of Claims

   Comment 164: Several comments supported the concept of
representative claims. One comment stated that the rules promote more
focused examination, reduce delay and help conserve scarce Office
resources, require little effort on the part of most applicants, and
still make certain that no patent claims will issue without a complete
examination. The comments also expressed support for limiting the
number of claims that need to be examined and encouraged the Office to
reduce overwhelming numbers of claims in favor of quality examinations.
One comment suggested that the Office should adopt a rule that only
independent claims are examined.

   A number of comments, however, argued in a variety of terms that
the "representative claims" examination approach would lead to
piecemeal examination and prolonged examination, would require
additional searching when features from non-designated dependent claims
are added to designated dependent or independent claims, and would lead
to additional filings, increased appeals, and less thorough
examination. Several comments suggested that the number of claims
examined should not be limited per se because the line of novelty in a
claim family often falls between the broad independent claims and the
narrowest dependent claim. One comment stated that the "representative
claims" examination approach may adversely affect the treatment given
to dependent claims in court. One comment argued that the Office's
statistics on applications having more than ten independent claims
ignore how many total claims had to be presented to lead to those
independent claims.

   Several comments argued that since excess claim fees have
presumably been determined based on the resources necessary to carry
out search and examination of all of the claims, it is not appropriate
for the Office to neglect to fully search and examine the entire
application for which all fees have been paid. One comment stated that
there is no basis for limiting the consideration of a dependent claim
during examination because under 35 U.S.C. 112, ¶ 4, a dependent claim
is treated as a claim that incorporates all the limitations of the
preceding claims.

   A number of comments argued that the "representative claims"
examination approach may be appropriate in other proceedings (such as
before the BPAI) or even during examination, but not before first
Office action on the merits. One comment argued that statistical data
from the appeal stage is misleading because there are fewer issues
during an appeal than during prosecution of an application before the
examiner. Several comments stated that the BPAI would be forced to
perform examination on the merits of the non-representative claims.
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1103 


   A number of comments suggested that the Office should address
excessive claiming concerns in a simple and straightforward manner by
limiting the number of claims permitted and fully examined under the
basic fee structure to, for example, six independent and thirty total
numbered claims, and allowing multiple dependent claims that depend on
other multiple dependent claims. Several comments suggested that the
Office specify that excess claims over a certain number will only be
examined if accompanied by an independent search report, rather than
burdening all applicants with the requirement to designate claims.
Several comments suggested that instead of representative claims,
applicants should be allowed to select claims that stand or fall
together.

   Finally, a number of comments also raised implementation issues,
requested clarification concerning implementation issues, or provided
suggestions concerning the implementation of the "representative
claims" examination approach.

   Response: As a result of the public comment, the Office is not
adopting the "representative claims" examination approach under which
the Office would limit the initial examination of an application to the
"representative claims" (the independent claims and the dependent
claims that are expressly designated by the applicant for initial
examination). The Office is instead making the presentation of more
than five independent claims or more than twenty-five total claims
(rather than the presentation of more than ten representative claims)
the threshold for invoking the examination support document
requirement. Thus, this final rule provides that if the number of
independent claims is greater than five or the number of total claims
is greater than twenty-five, the applicant must provide additional
information to the Office in an examination support document covering
all of the claims in the application (whether in independent or
dependent form).

   Although, the "representative claims" examination approach is not
being adopted, the Office disagrees that such an approach amounts to
piecemeal examination or that it would be less efficient than the
current examination process. Under such an approach, the Office would
have examined a claim before applicant could seek review of any
rejection of the claim on appeal, regardless of whether the claim was
designated or non-designated under the "representative claims"
examination approach.

   Regarding escalating fees, the Office previously proposed a system
of escalating fees and it was overwhelmingly opposed by user groups.
The Office has also determined that charging higher fees for large
numbers of claims would likely still not result in the desired increase
in quality since many applicants would simply pay the higher fees.
Furthermore, claim fees are set by statute, not the Office. As
discussed previously, 35 U.S.C. 112, ¶ 5, prohibits multiple dependent
claims depending on other multiple dependent claims.
   Comment 165: One comment stated that examining many claims aids in
understanding the invention.

   Response: The experience of those who actually examine applications
is that examining a large number of claims does not aid in
understanding the invention but rather obfuscates the invention. In
addition, the issuance of patents containing an excessive number of
claims has also long been considered an abuse of the courts and the
public, rather than an aid in understanding the invention. See Carlton
v. Bokee, 84 U.S. (17 Wall) 463, 471-72 (1873) (needless multiplication
of nebulous claims deemed calculated to deceive and mislead the
public); Wahpeton Canvas Co. v. Frontier, Inc., 870 F.2d 1546, 1551
n.6, 10 U.S.P.Q.2d 1201, 1206 n.6 (Fed. Cir. 1989) (presentation of the
infringement issue on an overgrown claims jungle to a jury and judge at
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1104 

trial is an unprofessional exercise in obfuscation).

   Comment 166: A number of comments argued that more claims are
needed to protect an applicant's invention adequately, especially in
light of restrictions on the doctrine of equivalents, decisions by the
Federal Circuit on unclaimed subject matter, the proposed limitations
on continuation practice, and because the complexity of some inventions
requires more claims to protect the subject matter appropriately. One
comment argued that the effects of prosecution history estoppel and the
constraints put on reissue applicants by the recapture doctrine demand
a broad range of claims. Several comments argued that the proposed
changes disproportionately affect the biotechnology and pharmaceutical
industries. One comment argued that in chemical or pharmaceutical
applications full protection requires applicant to claim a chemical
substance, a composition containing the substance, method of making the
substance, the chemical substance prepared by a claimed process and at
least one method of use, where there is varying scope within each
category of invention. The comments argued that individuals and small
businesses would be unable to afford the costs of pursuing their
inventions and may be discouraged from using the patent system due to
the financial and procedural burdens they must overcome to obtain
adequate patent protection of their invention. Several comments argued
that the proposed rules would have a disproportionate impact on small
entities. One comment stated that in the post-Festo environment,
patent-drafting techniques would suggest filing a large number of
picture claims in multiple statutory classes for easy understanding of
the invention by the Federal Circuit. One comment stated that the
primary reason why large numbers of claims are filed is that the
applicants or their representatives do not want the effort and
responsibility of determining the differences between the prior art and
the invention, and that another reason is that attorneys who are paid a
flat fee for applications attempt to induce a restriction requirement.

   Response: This final rule provides that if the number of
independent claims is greater than five or the number of total claims
is greater than twenty-five (a strategy based upon whether an
application contains more than a given number of independent and total
claims), the applicant must provide additional information to the
Office in an examination support document under § 1.265. The
overall goal of these changes is to promote early presentation of
claimed inventions, enhance quality and improve pendency. The rules do
not impose a per se limit on the number of claims which can be
presented to protect applicant's inventions. Rather, applicant may file
any desired number and scope of claims necessary to adequately protect
the applicant's invention as long as an examination support document is
provided before the issuance of the first Office action on the merits
of an application that present more than five independent claims or
twenty-five total claims.

   The Office notes that, during fiscal year 2006, the percentage of
small entity applications that exceeded the five independent claim and
twenty-five total claim threshold appeared slightly higher than the
percentage of total applications that exceeded the five independent
claim and twenty-five total claim threshold (24.4 percent as opposed to
23.7 percent). The Office does not consider this slight differential as
establishing that the changes in this final rule have a
disproportionate economic impact on small entities. While it is
possible to engage in a mathematical exercise to exaggerate the
significance of any slight differential, these percentages are based
upon data that is available in the Office's PALM system for
applications filed during the most recent fiscal year, and this slight
differential is not sufficient to establish that the changes in this
final rule have a disproportionate economic impact on small entities.
In addition, there is no apparent reason why small entity applicants
would inherently require more claims to adequately cover their
inventions. Thus, even higher differences in these percentages could
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1105 

easily be explained by the fact that small entity applicants pay only
one-half of the fees that other applicants pay for excess claims.
Moreover, the five independent claim and twenty-five total claim
threshold adopted in this final rule has a smaller differential than
other alternatives suggested in the comments. For example, in fiscal
year 2006: (1) 17.1 percent of small entity applicants exceeded a six
independent claim and thirty total claim threshold where only 15.7
percent of all applications exceeded a six independent claim and thirty
total claim threshold; (2) 10.3 percent of small entity applicants
exceeded a six independent claim and forty total claim threshold where
only 9.2 percent of all applications exceeded a six independent claim
and forty total claim threshold; and (3) 5.0 percent of small entity
applicants exceeded a ten independent claim and fifty total claim
threshold where only 4.1 percent of all applications exceeded a ten
independent claim and fifty total claim threshold.

   The remaining explanations (post-Festo patent-drafting techniques,
not wanting the responsibility of determining the differences between
the prior art and the invention, and attempts to induce a restriction
requirement) may be "reasons" why some applicants submit a large
number of claims. These reasons, however, do not justify not going
forward with a change to the rule of practice to require applicants who
place an extensive burden on the Office to help focus examination by
providing additional information in the form of an examination support
document to the Office.

   Comment 167: One comment argued that choosing dependent claims to
designate at the outset of prosecution forces applicant to make a
threshold decision regarding claim scope without the benefit of
analyzing cited prior art following an Office action. Thus, applicants
either have to guess, or perform their own prior art search prior to
filing, which puts a burden on applicant and results in the need to
file a previously unnecessary information disclosure under § 1.56.

   Response: The Office is not adopting the proposed "representative
claim" approach. Therefore, no designation is required by this final
rule. This final rule requires applicants who present more than five
independent claims or more than twenty-five total claims to file an
examination support document before the issuance of a first Office
action on the merits of an application. Applicants are encouraged to
conduct a preexamination search and review the references uncovered
from the preexamination search so applicants can better understand
where their invention fits in the overall patent landscape. Such action
would facilitate presentation of claims more likely to be patentable
over the closest prior art, thereby alleviating some of the burden on
Office resources. Nevertheless, if applicant chooses not to conduct a
preexamination search and does not submit an examination support
document before the first Office action on the merits of the
application, this does not constitute a justification for filing more
than five independent claims or more than twenty-five total claims.

   Comment 168: One comment stated that it is unclear as to whether
all claims, or only independent (or designated) claims, are counted for
the purposes of § 1.75(b)(4).

   Response: Pursuant to § 1.75(b)(4) as adopted in this final
rule, the Office will count all of the claims in copending applications
containing patentably indistinct claims (including applications having
a continuity relationship) but not in issued patents containing
patentably indistinct claims, in determining whether each such
application contains more than five independent claims or more than
twenty-five total claims and thus whether an examination support
document in compliance with § 1.265 is required. Claims withdrawn
from consideration under §§ 1.141 through 1.146 or § 1.499
as drawn to a non-elected invention or inventions, however, will not,
unless they are reinstated or rejoined, be taken into account in
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1106 

determining whether an application exceeds the five independent claim
and twenty-five total claim threshold set forth in §§ 1.75(b)(1), (b)(3),
and (b)(4). See § 1.75(b)(5). As discussed previously, this final rule
does not implement a "representative claims" examination approach.

   Comment 169: One comment stated that the rules do not provide
speedy and economical administrative relief when the Office errs in
determining whether claims are patentably indistinct, or whether there
is adequate support in an application for a claim filed in another
application.

   Response: As discussed previously, the Office already has timely
and efficient procedures in place that provide for an applicant to seek
relief with respect to matters subject to appeal (e.g., the rejection
of claims) by way of an appeal to the BPAI under 35 U.S.C. 134 and
§ 41.31 et seq., and to seek relief with respect to actions or
requirements not subject to appeal by way of a petition to the Director
under § 1.181. For example, if a double patenting rejection is made
because the claims of two applications are patentably indistinct,
applicant may seek relief by way of an appeal to the BPAI. If the
Office issues a notice under § 1.75(b) requiring an examination
support document in each of the multiple applications that contain
patentably indistinct claims, applicant may seek relief by way of a
petition to the Director under § 1.181. A grant of relief in a
petition, however, does not preclude a subsequent double patenting
rejection.

   Comment 170: One comment argued that the rule will create more work
for examiners by requiring review of all patents and applications
assigned to one assignee of an application under examination, and that
if certain examiners fail to do so, the rule will be unfairly applied
within the Office. One comment argued that implementation of the rules
will have a disproportionate effect on assignees holding small patent
portfolios because due to time constraints, examiners will be able to
review small patent portfolios more thoroughly than large ones.

   Response: The rules do not require examiners to review all patents
and applications assigned to the same assignee, but rather require
applicant to identify certain commonly assigned applications having a
common inventor. See § 1.78(f)(1). Examiners already face the
situation of having to evaluate a potentially large number of commonly
assigned patents and applications for the purpose of determining
whether a prior art or double patenting rejection is warranted. The
rules will enable the examiners to do this analysis more thoroughly and
in less time, thus enhancing quality and reducing pendency.

   Comment 171: One comment argued that implementation of the rules
will create an additional area of contention between examiners and
applicants, and an additional drain on examiners' time. The comment
further argued that the drain will be greater than that associated with
double patenting because double patenting rejections can be overcome by
filing terminal disclaimers.

   Response: No new issues between the examiner and the applicant are
introduced by the changes being adopted in this final rule. Rather, the
rules allow the examiner to identify and address issues more
thoroughly. Furthermore, as a result of the rules, applicants will be
made aware of issues earlier in the prosecution, thus giving applicants
more time to formulate appropriate responses. Terminal disclaimers will
continue to be available for use as appropriate to obviate non-statutory
double patenting rejections.

   Comment 172: One comment argued that the changes concerning claims
are superfluous in view of the rule changes concerning continuation
practice, and that a penalty for filing excessive continuations is
already provided in the continuations rules.
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1107 


   Response: The changes to the practice for examination of claims
will operate in concert with the changes to the practice for continuing
applications and requests for continued examination. The changes for
the continued examination filing practice do not by themselves act to
lessen the examiner's burden when faced with a large number of claims
for examination.

   Comment 173: One comment questioned how the Office will implement
review of two applications containing claims to the same invention.
   Response: If two or more commonly assigned applications contain
patentably indistinct claims, the Office will track the applications
via the PALM system. The applicant may explain why the claims of one
application are patentably distinct from the claims of the other(s). If
at least one claim is not patentably distinct and there are a total of
more than five independent claims or more than twenty-five total claims
in the applications, the applicant will be required to file an
examination support document before the first Office action on the
merits in each application. Applicant may file a terminal disclaimer to
obviate an obviousness-type double patenting rejection.

   Comment 174: One comment suggested that the requirement that claims
differ substantially according to § 1.75(b) should only apply to
independent claims.

   Response: The provision that "[m]ore than one claim may be
presented provided they differ substantially from each other and are
not unduly multiplied" has been set forth in § 1.75(b) even prior
to this final rule. The comment provides no reason why the requirement
that claims differ substantially from each other and not be unduly
multiplied should not also apply to dependent claims.

   Comment 175: One comment inquired about designation of claims
during reexamination. The comment stated that the rules should not
apply to reexaminations of patents granted prior to enactment of the
rules.

   Response: The changes to § 1.75 adopted in this final rule do
not apply to reexamination proceedings. Furthermore, this final rule
does not adopt the "representative claims" examination approach
(which provided for a designation of dependent claims).

   Comment 176: A number of comments argued that the changes limit the
protection paid for by applicant. One comment argued that as a result
of the limitation on the number of claims, companies that invest in
research and development could be expected to keep more inventions as
trade secrets due to the threat posed by "free riders" who make minor
modifications in an attempt to avoid infringement.

   Response: The patent statute requires that an applicant pay certain
filing fees (the filing, search, examination, excess
claims, and application size fees) on filing an application for patent.
See 35 U.S.C. 41(a). The payment of these patent filing fees does not
amount to a purchase of patent protection but are simply to help cover
the costs of examination and application processing.

   Section 1.75 does not limit the number of claims that applicant can
present in an application. Section 1.75(b)(1) permits an applicant to
present five independent claims and twenty-five total claims for
examination without the need for an examination support document. An
applicant who considers five independent claims or twenty-five total
claims to be insufficient may present more than five independent claims
or twenty-five total claims by submitting an examination support
document under § 1.265 before the first Office action on the merits
of an application.

Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1108 

   Comment 177: One comment suggested that if the rules are
implemented, the Office should reduce the examination fee and wait to
charge the excess claim fees, or refund the excess claim fees if the
application goes abandoned.

   Response: The basic filing, search, examination, and excess claims
fees are set by statute, which the Office cannot change by rule making.
The filing fees are due upon filing of the application and the excess
claims fees are due when the claims are presented. See 35 U.S.C. 41.
Applicant may request a refund of any previously paid search and excess
claims fees if applicant expressly abandons an application filed under
35 U.S.C. 111(a) on or after December 8, 2004, by filing a petition
under § 1.138(d) before an examination has been made of the
application. An "examination has been made of the application" for
purposes of § 1.138(d) once there has been a requirement for
restriction including an election of species, requirement for
information under § 1.105, first Office action on the merits,
notice of allowability or allowance, or action under Ex parte Quayle.
Applicant may also request a refund of any excess claims fees paid on
or after December 8, 2004, if an amendment canceling the excess claims
is filed before an examination on the merits has been made of the
application. See § 1.117. An "examination on the merits has been
made of the application" for purposes of § 1.117(a) once there has
been a first Office action on the merits, notice of allowability or
allowance, or action under Ex parte Quayle.

   Comment 178: One comment argued that the small number of
problematic cases with excessive claims that confuse or obscure the
invention can be adequately handled through the use of undue
multiplicity rejections.

   Response: Undue multiplicity rejections based on 35 U.S.C. 112,
¶ 2, are rare. See MPEP § 2173.05(n). The rule changes are designed
to provide a more focused quality examination of all applications. The
Office would not be able to obtain the desired gains in efficiency and
quality by merely relying on the use of undue multiplicity rejections.

   Comment 179: One comment argued that the impact of the rules on the
backlog will be minimal and referred to the Inspector General Report of
2004 which identified suboptimal incentives for examiners as the cause
of the backlogs, not the excess number of claims.

   Response: The September 2004 Inspector General Report (Final
Inspection Report No. IPE-15722), available at
http://www.oig.doc.go v/oig/reports/2004/USPTO-IPE-15722-09-04.pdf,
concluded that the Office should reevaluate patent examiner production
goals, appraisal plans, and award systems. The September 2004 Inspector
General Report was not the result of a general study of the causes of the
growing backlog of unexamined patent applications, but was the result of
a review of only patent examiner production goals, appraisal plans, and
award systems. Thus, the September 2004 Inspector General Report does not
discuss other causes of the growing backlog of unexamined patent
applications (e.g., changes in applicant filing tendencies) and does not
warrant the conclusion that the September 2004 Inspector General Report
identifies suboptimal incentives for examiners as the sole cause of the
growing backlog of unexamined patent applications. In any event, the Office
is in the process of reassessing patent examiner production goals,
appraisal plans, and award systems as recommended in the September 2004
Inspector General Report. Absent significant changes to the patent
examination process, the Office does not consider it reasonable to
expect that changes to patent examiner production goals, appraisal
plans, and award systems alone will be sufficient to address the
growing backlog of unexamined patent applications while maintaining a
sufficient level of quality.

   Comment 180: One comment argued that the Office admitted to
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1109 

previously abandoning a proposal to limit the number of total and
independent claims. The comment argued that if such a proposal was
deemed inappropriate, it is difficult to see how limiting claims before
initial examination is also not inappropriate.

   Response: The previous proposal was not abandoned because it was
deemed inappropriate; rather, it was abandoned because it was
unpopular. The Office subsequently sought increases in excess claims
fees via legislative change. There was insufficient public support for
all the fee increases that the Office considered necessary and the
current fees are not adequately addressing the problem of large numbers
of claims. The comments submitted in response to the Claims Proposed
Rule indicate that many view an approach similar to that proposed in
1998 to be preferable. The changes being adopted in this final rule (in
contrast to the changes proposed in 1998) do not place a limit on the
number of claims (independent or dependent) that may be presented in an
application. These changes adopted in this final rule simply require
the submission of an examination support document if an applicant
chooses to present more than five independent claims or more than
twenty-five total claims in an application. Furthermore, the backlog of
unexamined applications has increased from 224,446 at the end of fiscal
year 1998 to 701,147 at the end of fiscal year 2006. The Office expects
the backlog of unexamined applications to continue to increase without
significant changes to the patent examination process. In addition, the
average number of claims per application has not decreased since 1998.
Thus, the Office does not consider the fact that the changes being
adopted in this final rule may not be popular to be an adequate reason
for not going forward at this time.

   Comment 181: One comment pointed out inconsistencies between
proposed § 1.75(b)(3)(iii), which requires a suggested restriction
to be drawn to "no more than ten" claims, and the preamble to the
proposed rule, which requires the restriction to be drawn to "fewer
than ten" claims.

   Response: Proposed § 1.75(b)(3)(iii) provided that an applicant
may file a suggested requirement for restriction accompanied by an
election without traverse of an invention to which there are drawn no
more than ten independent claims and no more than ten representative
claims. This final rule did not adopt the proposed "representative
claims" examination approach, but requires applicant to file an
examination support document when the application contains more than
five independent claims or more than twenty-five total claims. Under
§ 1.142(c) as adopted in this final rule, applicant may file a suggested
requirement for restriction accompanied by an election without traverse
of an invention to which there are no more than five independent claims
and no more than twenty-five total claims.

   Comment 182: One comment argued that applicants would circumvent
the proposed rules by designating a "picture claim" in all
applications, thereby forcing the examiner to perform a complete search
and examination, thus obviating any time or effort saved through the
proposed changes.

   Response: The Office has no objection to an applicant presenting a
claim that recites in detail all of the features of an invention (i.e.,
a "picture" claim) in an application. Nevertheless, the mere fact
that a claim recites in detail all of the features of an invention is
never, in itself, justification for the allowance of such a claim. See
MPEP § 706.

   Comment 183: One comment argued that according to In re Wakefield,
422 F.2d 897, 164 U.S.P.Q. 636 (C.C.P.A. 1970), applicant should be
allowed to determine the necessary number and scope of claims.

   Response: The changes adopted in this final rule do not set a per
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1110 

se limit on the number of claims that an applicant may file in an
application. The applicant is free to file as many claims as necessary
to adequately protect the invention. Applicant may present more than
five independent claims or more than twenty-five total claims in an
application if applicant files an examination support document before
the first Office action on the merits of the application. The
information provided by the applicant in the examination support
document will assist the examiner in understanding the claimed
invention, determining the effective filing date of each claim and the
claim interpretation before the prior art search, understanding the
state of the art and the most closely related prior art cited by the
applicant, and determining the patentability of the claims. Thus, the
examiner will be able to perform a better examination on the claims.

   Comment 184: A number of comments argued that the rules would
lessen the applicant's ability to file applications due to budget
constraints and would increase costs for counseling applicants to get
the best patent protection. One comment argued that the rules will
increase applicant's costs to such an extent that individual inventors
and small companies will not be able to afford patent protection.
Furthermore, the costs to comply with the rules will cause many people
with technology that can spur innovation to be frozen out of the patent
process.

   Response: The current rules will only impact those applications
that are filed with more than five independent claims or more than
twenty-five total claims. If applicant presents more than five
independent claims or more than twenty-five total claims, then
applicant will be required to submit an examination support document
under § 1.265. If an application is so significant that the
applicant must present more than five independent claims or more than
twenty-five total claims, then the additional costs should not be a
deterrent.

   Comment 185: One comment suggested that if the Office were to
follow Muncie Gear Works v. Outboard Marine & Mfg Co., late claiming of
applications would likely decrease.

   Response: In Westphal v. Fawzi, 666 F.2d 575, 577 (C.C.P.A. 1981),
the Court of Customs and Patent Appeals discredited the idea that
Muncie Gear Works v. Outboard Marine & Mfg. Co., 315 U.S. 759 (1942)
should be read as announcing a new "late claiming" doctrine. Rather,
the Court of Customs and Patent Appeals interpreted the Muncie Gear
Works holding of invalidity as grounded in the statutory prohibition
against new matter.

   Comment 186: A number of comments suggested that claims written in
alternative form should not be treated differently from other claims,
and that the Office should use election of species practice to identify
alternatives to be used as representative claims. Several comments
stated that claims drafted using Markush or other alternative language
should be treated as single claims rather than treating each
alternative as a separate claim. One comment stated that if members of
Markush groups are counted separately, biotechnology and chemical
applicants will file more multiple parallel applications. One comment
requested clarification as to whether each element of a Markush claim
would be considered to be an independent claim. One comment stated that
Markush claims are beneficial to both the Office and applicants, and
stated that the proposed changes would unfairly disadvantage members of
the pharmaceutical community. One comment suggested that encouraging
applicants to adhere more closely to existing 35 U.S.C. 112, ¶ 1 and 35
U.S.C. 101 requirements is a better means of managing the breadth of
Markush claims than individualized claim counting schemes and required
showings. One comment suggested that the Office should treat a Markush
claim as a broad or generic claim. One comment asserted that the Office
has not provided any study or anecdotal evidence that identifies an
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1111 

abuse of Markush practice. One comment stated that the MPEP has never
required that individual elements in a Markush group be treated
separately, and that it is unfair to an applicant to use up claim
designations on the individual elements of a Markush group because a
reference teaching one element is applied to all.

   Several comments argued that the proposed rule relating to
determining the presence of separate claims in a Markush grouping will
slow down prosecution, in part due to an increased number of petitions
to review.

   Response: The Office requested comments on how claims written in
the alternative form, such as claims in an alternative form permitted
by Ex parte Markush, 1925 Dec. Comm'r Pat. 126 (1924), should be
counted for purposes of proposed § 1.75(b). See Changes to Practice
for the Examination of Claims in Patent Applications, 71 FR at 64, 1302
Off. Gaz. Pat. Office at 1331. This final rule does not change the
practice of the Office with regard to claims containing Markush or
other alternative language. That is, a claim containing Markush or
other alternative language would be considered as one claim for the
purposes of determining whether an application exceeds the five
independent claim and twenty-five total claim threshold set forth in
§ 1.75(b). However, the Office is evaluating changes to Markush
practice, which could be implemented in a separate rule making.

   The Office is also clarifying second action final practice with
respect to using alternative language (e.g., Markush claims). MPEP
§ 803.02 indicates that if an applicant amends a rejected Markush
claim to exclude species anticipated or rendered obvious by the prior
art, a second action on the rejected claims can be made final unless
the examiner introduces a new ground of rejection that is neither
necessitated by applicant's amendment of the claims nor based on
information submitted in an information disclosure statement filed
under § 1.97(c) with the fee set forth in § 1.17(p). MPEP § 803.02
provides this instruction in the context of the situation in
which the examiner has determined that the Markush claim encompasses at
least two independent or distinct inventions, has required applicant to
make a provisional election of a single species, and has rejected the
Markush claim on prior art grounds. This has led to some confusion as
to when a second action on the rejected claims can be made final when
the examiner has not found that the claim encompasses at least two
independent or distinct inventions and applicant amends a claim to exclude
unpatentable alternatives. If a Markush claim or other claim that sets
forth alternatives is rejected under 35 U.S.C. 102 or 103 on the basis
of prior art that anticipates or renders obvious the claim with respect
to any one of the alternatives or on any other basis (e.g., 35 U.S.C.
101 or 112) with respect to any one of the alternatives, a second or
any subsequent Office action on the merits may be made final. However,
such an Office action may not be made final if it contains a new ground
of rejection that is not: (1) Necessitated by applicant's amendment of
the claims (including amendment of a claim to eliminate unpatentable
alternatives); (2) necessitated by applicant's providing a showing that
a claim element that does not use the phrase "means for" or "step
for" is written as a function to be performed and does not otherwise
preclude application of 35 U.S.C. 112, ¶ 6; (3) based on information
submitted in an information disclosure statement filed during the
period set forth in § 1.97(c) with the fee set forth in § 1.17(p); or
(4) based upon double patenting (statutory or obviousness-
type double patenting). The provision in MPEP § 904.02 that a
search should cover the claimed subject matter and should also cover
the disclosed features which might reasonably be expected to be claimed
does not preclude an examiner from making the second or any subsequent
Office action on the merits final if the Office action contains a new
ground of rejection that was necessitated solely by applicant's
amendment of the claims to eliminate the unpatentable species.

Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1112 

   Comment 187: A number of comments supported the appropriate use of
the proposed requirement in § 1.105(a)(1)(ix) where this
information is needed to resolve a reasonable question which is
relevant to the determination of a patentability issue before the
examiner.

   Response: The Office is adopting the change to § 1.105.

   Comment 188: One comment argued that the provision in
§ 1.105(a)(1)(ix) serves no purpose and may be abused. The comment argued
that examiners could simply shift the burden on applicant to prove
support when there is no basis for making a rejection under 35 U.S.C.
112, ¶ 1. One comment argued that the changes to § 1.105(a)(1)(ix)
are unnecessary since examiners already have the power to request such
information.

   Response: One purpose of the provision in § 1.105(a)(1)(ix) is
to assist the examiner in properly examining the application when it is
not readily apparent where the specification of the application
provides support under 35 U.S.C. 112, ¶ 1, for a claim or a limitation
of a claim. This is information that the applicant should be aware of
and should be able to provide to the examiner. The Office considers
this authority to be inherent under the patent statute and rules
existing prior to this rule change, including the previous version of
§ 1.105, and thus there is no reason to expect such provision to be
abused. The Office agrees that examiners inherently have the authority
to request this information. See Star Fruits S.N.C. v. United States,
393 F.3d 1277, 73 USPQ2d 1409 (Fed. Cir. 2005). The Office is amending
§ 1.105 to make the authority explicit.

   Comment 189: One comment suggested that the Office should encourage
examiners to use § 1.105 to require a concise, plain-English
explanation of the invention and claim set when the application
contains large claim sets or the invention cannot be understood.

   Response: The examination support document will assist the examiner
when there are large numbers of claims. If the invention cannot be
understood, the examiner could use § 1.105 to require an
explanation.

   Comment 190: Several comments suggested that language should be added
to the rules to indicate that the information required by § 1.105(a)(1)(ix)
is not to be used to read limitations into the claims.

   Response: Such a change is not necessary. It is well established
that the meaning of the terms in the claims is to be ascertained in
light of the specification but that limitations from the specification
are not to be read into the claims. See Phillips v. AWH Corp., 415 F.3d
1301, 1316, 75 U.S.P.Q.2d 1321, 1329 (Fed. Cir. 2005); In re American
Academy of Science Tech Center, 365 F.3d 1359, 1369, 70 USPQ2d 1827,
1834 (Fed. Cir. 2004); In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320,
1322 (Fed. Cir. 1989).

   Comment 191: A number of comments supported the extension of the
Office's refund authority beyond the expiration date of the legislation
and encouraged the Office to accelerate implementation of § 1.117.

   Response: The Office is working to make the patent fee and fee
structure provisions of the Consolidated Appropriations Act, 2005 (Pub.
L. 108-447, 118 Stat. 2809 (2004)), permanent. The Revised Continuing
Appropriations Resolution, 2007 (Pub. L. 110-5, 121 Stat. 8 (2007)),
keeps the patent fee and fee structure provisions of the Consolidated
Appropriations Act, 2005, in effect during fiscal year 2007. The Office
is implementing § 1.117 in this final rule.

   Comment 192: Several comments questioned whether excess claim fees
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1113 

would be refunded if claims are eliminated pursuant to § 1.78(f)(3).

   Response: Applicant may request a refund of any excess claims fees
paid on or after December 8, 2004, if an amendment canceling the excess
claims is filed before an examination on the merits has been made of
the application. See § 1.117. Applicant may also request a refund
of any previously paid search and excess claims fees if applicant
expressly abandons an application filed under 35 U.S.C. 111(a) on or
after December 8, 2004, by filing a petition under § 1.138(d)
before an examination has been made of the application.

   Comment 193: One comment suggested that the Office should refund
eighty percent of the fees for claims that are withdrawn because of a
restriction requirement.

   Response: The Office does not have the statutory authority to
refund the excess claims fees for claims that are still pending in an
application where the fees were properly paid. The Consolidated
Appropriations Act, 2005, authorizes a refund only for a claim that has
been canceled before an examination on the merits has been made of the
application under 35 U.S.C. 131. See 35 U.S.C. 41(a)(2)(C). Claims that
are withdrawn due to a restriction requirement are still pending in the
application. Applicant may cancel the withdrawn claims prior to a first
Office action on the merits of the application and request for a refund
of any excess claims fees paid on or after December 8, 2004. See § 1.117.

   Comment 194: A number of comments noted that since very few
examination support documents are likely to be filed, there is not
likely to be any opportunity to reduce a patent term adjustment.

   Response: The Office is not adopting the changes in this final rule
for the purpose of reducing patent term adjustment. The Office simply
does not want an applicant to obtain patent term adjustment by delaying
compliance with the examination support document requirements.

   Comment 195: Several comments argued that it was unfair to reduce
patent term adjustment for not complying with the rules for applications
pending before the effective date.

   Response: Section 1.704(c)(11) as adopted in this final rule is
applicable only to applications under 35 U.S.C. 111(a) filed on or
after November 1, 2007, or international applications that have commenced
the national stage after compliance with 35 U.S.C. 371 on or after
November 1, 2007. Thus, other applications for which an examination support
document (or other appropriate action) is required would not encounter a
patent term adjustment reduction unless the applicant failed to properly
reply to an Office notice requiring an examination support document (or
other appropriate action) within three months of the date the notice was
mailed to the applicant.

   Comment 196: One comment argued that § 1.704(c)(11) is contrary
to statute because 35 U.S.C. 154(b)(2)(C)(ii) guarantees a minimum of
three months to respond before patent term adjustment is lost.

   Response: 35 U.S.C. 154(b)(2)(C)(ii) provides that "[w]ith respect
to adjustments to patent term made under the authority of [35 U.S.C.
154(b)(1)(B)], an applicant shall be deemed to have failed to engage in
reasonable efforts to conclude processing or examination of an
application for the cumulative total of any periods of time in excess
of 3 months that are taken to respond to a notice from the Office
making any rejection, objection, argument, or other request, measuring
such 3-month period from the date the notice was given or mailed to the
applicant." See 35 U.S.C. 154(b)(2)(C)(ii). The patent term adjustment
reduction provision of 35 U.S.C. 154(b)(2)(C)(ii) is applicable where
the applicant's failure to engage in reasonable efforts to conclude
processing or examination of an application involves a failure to reply
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1114 

to an Office action or notice within three months of the date the
Office action or notice is mailed or given to the applicant. 35 U.S.C.
154(b)(2)(C), however, contemplates other circumstances that may
constitute an applicant's failure to engage in reasonable efforts to
conclude processing or examination, by further providing that "[t]he
Director shall prescribe regulations establishing the circumstances
that constitute a failure of an applicant to engage in reasonable
efforts to conclude processing or examination of an application." See
35 U.S.C. 154(b)(2)(C)(iii). The provisions of § 1.704(c),
including § 1.704(c)(11), are promulgated under the Office's
authority in 35 U.S.C. 154(b)(2)(C)(iii) to prescribe regulations
establishing the circumstances that constitute a failure of an
applicant to engage in reasonable efforts to conclude processing or
examination of an application. For example, an examination support
document is required to be filed before the issuance of a first Office
action on the merits when the application contains or is amended to
contain more than five independent claims or more than twenty-five
total claims. See § 1.75(b)(1). Therefore, § 1.704(c) provides
for a reduction of any patent term adjustment when there is a failure
to comply with § 1.75(b), e.g., a failure to file an examination
support document in compliance with § 1.265 when necessary under
§ 1.75(b). The Office does not issue a notice requiring an
examination support document (or other appropriate action) until the
Office has determined that an examination support document is required
under § 1.75(b), but applicant failed to submit an examination
support document.

   Comment 197: Several comments argued that § 1.704(c)(11) would
adversely affect small businesses. One comment argued that some patents
owned by universities and small biotechnology companies have values of
one million dollars per day, and these patents often have hundreds of
days of patent term extension. The comment argued that the proposed
reductions in patent term would easily cost small businesses one
hundred million dollars per year.

   Response: An applicant can avoid a reduction in patent term
adjustment simply by providing an examination support document in
compliance with § 1.265 before the first Office action on the
merits or taking other appropriate action (if necessary) in a timely
manner.

   Comment 198: One comment questioned whether the proposed changes to
§ 1.75 (the "representative claims" examination approach) as
applied to national stage applications violate the PCT. Another comment
suggested that the proposed changes to § 1.75 are contrary to PCT
Article 17.

   Response: As discussed previously, this final rule does not
implement a "representative claims" examination approach.
Nevertheless, nothing in the PCT or the regulations under the PCT
requires a designated Office to examine all claims presented (in any
particular order or at a particular stage) in a national stage
application. Furthermore, PCT Article 27(6) provides that the national
law may require that the applicant furnish evidence in respect of any
substantive condition of patentability prescribed by such law. Under
this final rule, applicant is free to submit as many claims as he or
she chooses, as long as applicant files an examination support document
before the first Office action on the merits if there are more than
five independent claims or more than twenty-five total claims. Article
17 of the PCT concerns procedures before the international searching
authorities. The changes to § 1.75 do not apply to international
searching authorities and, accordingly, do not conflict with Article 17.

G. Number of Independent and Total Claims Permitted Without an
Examination Support Document

Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1115 

   Comment 199: A number of comments argued that the proposed change
in the definition of an independent claim for determining the number of
designated claims and calculating additional claims fees would be
complicated and confusing. A number of comments argued that the
statutory classes of invention are not necessarily mutually exclusive.
A number of comments expressed the opinion that the proposed changes to
the way claims are treated for fee purposes will further burden the
Office. One comment stated that it would cause disputes and slow down
the examination process. One comment argued that it would likely
produce inconsistent results. One comment argued that the rule change
makes it very difficult to calculate claim fees for anyone other than a
registered practitioner. Several comments opined that as a result of
the proposed rule, the fee calculation process would no longer be
merely administrative, but would involve a legal opinion. The comments
questioned whether fee calculations will be handled by examiners, and
what the process for dispute resolution will be. A number of the
comments also argued that the change would effectively increase fees.

   Response: Designation of claims for initial examination is not
required because this final rule did not adopt the "representative
claims" examination approach. This final rule, however, requires
applicant to file an examination support document in compliance with
§ 1.265 before the issuance of a first Office action on the merits
of an application that contains more than five independent claims or
twenty-five total claims, counting all of the claims in any other
copending application having a patentably indistinct claim. If an
examination support document in compliance with § 1.265 is not
filed before the issuance of a first Office action on the merits of the
application, the application may not contain or be amended to contain
more than five independent claims or more than twenty-five total
claims.

   This final rule adopts the proposed changes to § 1.75(b)(2) to
provide that a claim that refers to a claim of a different statutory
class of invention will also be treated as an independent claim for fee
calculation purposes and for purposes of determining whether an
application exceeds the five independent claim and twenty-five total
claim threshold under § 1.75(b). Section 1.75(b) (introductory
text) as adopted in this final rule clarifies that a dependent claim
must contain a reference to a claim previously set forth in the same
application, incorporate by reference all the limitations of the
previous claim to which such dependent claim refers, and specify a
further limitation of the subject matter of the previous claim. See 35
U.S.C. 112, ¶ 4; see also Pfizer, 457 F.3d at 1291-1292, 79 U.S.P.Q.2d
at 1589-1590. If a claim does not incorporate by reference all the
limitations of the previous claim to which it refers, it is not a
dependent claim under 35 U.S.C. 112, ¶ 4. It would be proper for the
Office to consider such a claim as an independent claim for fee
calculation purposes and for purposes of determining whether an
examination support document is required. The determination of whether
a claim is independent or dependent could be difficult when applicant
did not clearly draft the claim as an independent claim or a dependent
claim under 35 U.S.C. 112, ¶ 4. Applicant may minimize issues related
to fee calculation for claims by drafting claims that are in compliance
with 35 U.S.C. 112, ¶ 4, and § 1.75(b) (e.g., not presenting claims
that refer to another claim of a different statutory class of invention
or claims that refer to another previous claim but do not incorporate
by reference all of the limitations of the previous claim). Once a
determination of whether a claim is independent or dependent has been
made, the fee calculation is simple. If applicant disagrees with the
Office's determination that a claim is an independent claim, applicant
should provide a showing of how the claim is a dependent claim in
compliance with 35 U.S.C. 112, ¶ 4, and § 1.75(b) either in a reply
to a notice requiring a claim fee or a request for a refund.

   Comment 200: One comment stated that a claim that does not make
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1116 

reference to another claim is an independent claim, and a claim that
does make reference to another claim is a dependent claim. One comment
stated that the Office cannot charge independent claim fees for
dependent claims because to do so would violate statute. One comment
questioned how a claim can fail to incorporate by reference all of the
limitations of the claim to which it refers, and yet be statutory. The
comment suggested that the proposed rule is unnecessary and not
supported by the case law cited by the Office. One comment suggested
that the changes to § 1.75(b)(2) (e.g., treating a claim that
refers to a claim of a different statutory class of invention as an
independent claim for fee calculation purposes and for purposes of
determining whether an examination support document is required) might
be contrary to judicial precedent set forth in In re Ochiai, 71 F.3d
1565, 37 U.S.P.Q.2d 1127 (Fed. Cir. 1995). The comment also argued that
these changes would create a "tricky fee structure" and a "trap for
the unwary" and would increase the administrative/non-substantive
workload on the examiner.

   Response: A claim that merely refers to another claim is not a
dependent claim in compliance with 35 U.S.C. 112, ¶ 4. A proper
dependent claim must also incorporate by reference all the limitations
of the claim to which it refers and specify a further limitation of the
subject matter in the claim to which the dependent claim refers. Some
applicants present claims that refer to a previous claim, but fail to
comply with the requirements of 35 U.S.C. 112, ¶ 4. See e.g., Pfizer,
457 F.3d at 1291-1292, 79 U.S.P.Q. 2d at 1589-1590. The provisions of
§ 1.75(b)(2) are consistent with 35 U.S.C. 112, ¶ 4, and judicial
precedent including Ochiai (the use of per se rules in determining
nonobviousness under 35 U.S.C. 103). A claim that refers to a previous
claim of a different statutory class of invention could require a
separate search and patentability determination because the
patentability of such a claim might not stand or fall together with the
previous claim. For example, if claim 1 recites a specific product, a
claim for method of making the product of claim 1 in a particular
manner would require a separate patentability determination because in
accordance with Ochiai, there is no per se rule in applying the test
for obviousness under 35 U.S.C. 103. Furthermore, a claim that refers
to a previous claim of a different statutory class of invention does
not comply with 35 U.S.C. 112, ¶ 4, because such a claim does not
further limit the subject matter of the previous claim.

   Comment 201: A number of comments recommended that the Office issue
guidance for use by Office employees as well as the public in
distinguishing among statutory classes of invention. One comment stated
that it is unclear how "a different statutory class of invention"
will be applied. The comment questioned whether the last sentence of
§ 1.75(b)(2) would apply only to combination method-apparatus
claims or whether it might also be applied to regular dependent claims
which add additional limitations of a similar kind such as a method
limitation for a method claim or an apparatus limitation for an
apparatus claim. One comment stated that § 1.75(b)(2) provides
clarification that claims which refer to a claim of a different
statutory class would be regarded as independent. One comment stated
that § 1.75(b)(2) appears to be a statement of the current state of
the law.

   Response: The statutory classes of invention are set forth in 35
U.S.C. 101. If a method claim depends from another method claim,
incorporates by reference all of the limitations of the method claim
from which it depends, and adds additional method limitations, such a
claim will be considered as a dependent claim. However, if a method
claim refers to a composition claim (e.g., "A method of using the
composition of claim 1 comprising * * *"), it will be treated as an
independent claim. The Office will issue any guidance as necessary and
appropriate for the implementation of the rules.

Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1117 

   Comment 202: Several comments argued that § 1.75(b) is a
problem for software-based inventions because it is common for
applications to include claims to different classes of invention. The
comments argued that there is no reason to discourage a claim drawn to
one class of invention which depends from a claim drawn to another
class when little additional work is required of the examiner to
examine both claims, citing the example of a claim drawn to a
manufacture which depends from a claim drawn to a process for making a
manufacture.

   Response: The rule does not discourage an applicant from submitting
whatever claims may be considered desirable for protection of the
invention, and does not discourage submission of claims to any
statutory class of invention. Rather, the rule clarifies how claims
will be treated for the purposes of fee calculation and determination
whether an examination support document is required under § 1.75(b)(1).

   Comment 203: A number of comments argued that ten representative
claims are not sufficient for adequate patent protection and suggested
various numbers for the representative claim limit including at least
twenty claims, twenty-five claims, or at least thirty claims. Several
comments suggested twenty claims, with a maximum of three independent
claims, as being more consistent with the fee schedule. Several
comments suggested that the limit should be six independent and forty
total claims. One comment suggested that the limit should be twelve
independent claims and fifty total claims. One comment suggested
that the limit should be ten independent claims and sixty total claims.
Several comments suggested that there should be no limit. One comment
suggested that there should be no limit on dependent claims.

   Several comments stated that the rules affect the vast majority of
applications that contain an ordinary number of claims, rather than
targeting the small number of problem applications with excessive
claims. One comment stated that it was unclear why all applicants
should be limited to representative claims when approximately ninety
percent of all non-provisional applications currently filed contain six
or fewer independent claims and forty or fewer total claims. The
comment argued that examining forty or fewer claims does not appear to
constitute an undue examination burden. One comment suggested that the
rule changes should be more narrowly tailored with respect to the
technology areas where the inventions are not capable of being
adequately protected using only twenty claims. One comment inquired
about the need for establishing a separate procedure for examination of
claims if only 1.2 percent of applications fall within the category of
excess claims. Several comments argued that there is a lack of
statistical analysis relating to the number of applications containing
more than ten total claims.

   Response: The Office notes the concerns expressed in the public
comments concerning the proposed "representative claims" examination
approach. The Office did not adopt this approach in this final rule.
This final rule provides that if the number of independent claims is
greater than five or the number of total claims is greater than twenty-
five, the applicant must provide additional information to the Office
in an examination support document under § 1.265 covering all of
the claims in the application (whether in independent or dependent
form).

   The Office received a significant number of comments suggesting a
threshold of six independent claims and thirty total claims. The Office
also received a number of comments suggesting independent claim
thresholds ranging from three to ten and total claim thresholds ranging
from twenty to sixty (or no limit). The comments, however, provided no
justification for deeming any particular independent and total claim
threshold to be the ideal threshold or even superior to any other
possible independent and total claim threshold. The Office arrived at
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1118 

the five independent claim and twenty-five total claim threshold
primarily for the following reasons.

   First, a significant number of comments suggested a threshold of
six independent claims and thirty total claims, but did not suggest
such a threshold if it were not considered sufficient to provide
adequate patent protection for an invention.

   Second, the majority of applications contain no more than five
independent claims and no more than twenty-five total claims.
Specifically, over 92 percent of the applications filed in fiscal year
2006 contained no more than five independent claims, and over 78
percent of the applications filed in fiscal year 2006 contained no more
than twenty-five total claims. These figures do not take into account
that many applications contained claims to more than one distinct
invention, and the changes in this final rule permit an applicant to
suggest a restriction requirement and elect an invention to which there
are drawn no more than five independent and twenty-five total claims.
In addition, the majority of applications in every Technology Center
contain five or fewer independent claims and twenty-five or fewer total
claims. Therefore, there is no support for the position that there are
technology areas that are just not capable of being adequately
protected with five or fewer independent claims and twenty-five or
fewer total claims. Finally, the Office notes that the most common
number of independent claims presented in an application is three, and
the most common number of total claims presented in an application is
twenty.

   Third, an applicant may present up to fifteen independent claims
and seventy-five total claims via an initial application and two
continuation or continuation-in-part applications that are prosecuted
serially without providing either an examination support document or a
justification as discussed previously. Only about five percent of the
applications filed in fiscal year 2006 were in an application family
that contained more than fifteen independent claims or more than
seventy-five total claims.

   Finally, this final rule does not preclude an applicant from
presenting more than five independent claims or more than twenty-five
total claims. Rather, an applicant may present more than five
independent claims or more than twenty-five total claims in an
application with an examination support document in compliance with
§ 1.265 if the applicant considers it necessary or desirable in the
particular application. Specifically, this final rule requires
applicant to file an examination support document in compliance with
§ 1.265 before the issuance of a first Office action on the merits
of an application that contains more than five independent claims or
twenty-five total claims, counting all of the claims in any other
copending application having a patentably indistinct claim. If an
examination support document in compliance with § 1.265 is not
filed before the issuance of a first Office action on the merits of the
application, the application may not contain or be amended to contain
more than five independent claims or more than twenty-five total
claims.

   Comment 204: A number of comments suggested that the Office should
explore the possibility of examining multiple dependent claims that are
dependent on other multiple dependent claims to reduce examination
burden and better focus the examination process. The comments argued
that most foreign countries permit such claims and that this would
significantly reduce the number of claims. One comment argued that if
the Office adopts representative claims rules, it will move towards the
European style of claim sets, but without the benefit of multiple
dependent claims and claims stated in the alternative. Several comments
expressed the opinion that multiple dependent claims should be
encouraged because examining a multiple dependent claim is no more work
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1119 

than examining a single dependent claim.

   Response: As discussed previously, the Office did not adopt the
"representative claims" examination approach in this final rule.
Further, 35 U.S.C. 112, ¶ 5, prohibits multiple dependent claims that
are dependent on other multiple dependent claims. Moreover, the
examination of multiple dependent claims that are dependent on other
multiple dependent claims would be at least as burdensome as if these
claims were presented as a plurality of single dependent claims or as
permitted multiple dependent claims. The Office disagrees that
permitting multiple dependent claims that depend on other multiple
dependent claims would reduce the examination burden or better focus
the examination process. The Office's experience is that multiple
dependent claims are significantly more difficult to search and
evaluate than a plurality of single dependent claims. Multiple
dependent claims that depend on other multiple dependent claims would
be even more burdensome. While the use of multiple dependent claims may
be a convenient shorthand mechanism, a multiple dependent claim
is considered to be that number of claims to which direct reference is
made therein and must be considered in the same manner as a plurality
of single dependent claims. See MPEP § 608.01(n), paragraph I. The
same would be true for multiple dependent claims that are dependent on
other multiple dependent claims.

   Comment 205: One comment suggested that there should be a limit of
twenty claims in every application with no exceptions and no
requirement for an examination support document. Another comment
suggested that the Office should limit the number of claims of any
application to twenty or thirty total claims, and two or three
independent claims. One comment suggested that there should simply be a
hard cap without an option to file an examination support document to
have additional claims examined. The comment argued that this would not
take away any substantive rights, as long as applicant's right to file
continuing applications and requests for continued examination is
preserved.

   Response: This final rule appropriately balances applicants'
interests to have an adequate number of claims to protect their
inventions and the need to reduce the large and growing backlog of
unexamined patent applications, improve the quality of issued patents,
and make the patent examination process more effective. The changes to
§ 1.75 in this final rule permit an applicant to present five or
fewer independent claims and twenty-five or fewer total claims in the
application without submitting an examination support document in
compliance with § 1.265. The changes to § 1.75 in this final
rule also permit an applicant to present more than five independent
claims or more than twenty-five total claims if the applicant files an
examination support document in compliance with § 1.265.

   Comment 206: Several comments suggested that the Office should
adjust the fees if excess claims fees are insufficient to permit
examination of the claims for which they are paid. One comment
suggested that there should be higher fees for claims in excess of ten.
Several comments suggested that there should be higher fees for claims
in excess of twenty. One comment suggested higher fees for independent
claims in excess of three. One comment suggested that there should be a
higher fee for independent claims in excess of ten and total claims in
excess of fifty. Several comments suggested that there should be
escalating fees for increasing numbers of claims. One comment argued
that applicants should be permitted to designate a number of claims,
without an examination support document, that varies with the filing
fee paid. One comment suggested that applicants should be charged in
proportion to the number of designated claims, and that, optionally, an
upper bound on the number of claims (e.g., twenty-five total claims, no
more than twelve independent claims) could be established.

Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1120 

   Response: Excess claims fees are set by statute. See 35 U.S.C.
41(a). The Office sought a legislative change to increase excess claims
fees, and while some increases were made in the Consolidated
Appropriations Act, 2005, the Office did not obtain the increases that
it considered necessary. In any event, the changes adopted in this
final rule will help to focus examination and increase quality.

   Comment 207: Several comments suggested that excessive claiming
should be dealt with on a case-by-case basis, rather than by penalizing
all applicants. One comment suggested that the Office should consider
strategies under present § 1.105 to address problem applications on
a case-by-case basis. A number of comments suggested that the
requirement for an examination support document should be imposed on a
case-by-case basis, only in those situations that impose a unique
burden on the Office.

   Response: As discussed previously, the Office is not adopting the
"representative claims" examination approach under which the majority
of applicants would have been required to either designate dependent
claims for initial examination or file an examination support document.
The changes adopted in this final rule require the applicant to file an
examination support document under § 1.265 only if the applicant
presents more than five independent claims or more than twenty-five
total claims. If an examination support document in compliance with
§ 1.265 is not filed before the issuance of a first Office action
on the merits of the application, the application may not contain or be
amended to contain more than five independent claims or more than
twenty-five total claims. The majority of applications do not contain
more than five independent claims or more than twenty-five total
claims. Therefore, as a result of the public comment, this final rule
adopts an approach that avoids requiring a majority of applicants to
make the choice between designating dependent claims for initial
examination and filing an examination support document.

   Comment 208: One comment suggested that one of the representative
claims should be in Jepson format. Another comment suggested that fees
should be increased on all non-Jepson claims. One comment suggested
that the Office should charge less for claims written in Jepson format.

   Response: There is no persuasive explanation as to why Jepson
claims should be treated differently from non-Jepson claims.
Furthermore, fees are set by statute and the statute does not provide
the authority to charge higher or lower fees for Jepson claims.

   Comment 209: One comment suggested that there should be an
expedited procedure for an application with a limit of five claims, a
1200-word specification, and four drawings, (with the filing fee being
$1000 for a small entity or $3000 for a non-small entity), where the
application could issue as a patent in fifteen months or less. One
comment argued that the representative claim proposal should be an
option for applicants and those applications with ten or fewer
representative claims should be assigned a higher priority for
examination. One comment argued that the examination support document
should only be used as an optional procedure for an applicant to
advance the application out of turn.

   Response: The proposed "representative claims" examination
approach is not adopted in this final rule. Further, the Office has
revised its accelerated examination program with the goal of completing
examination within twelve months of the filing date of the application.
The application must contain three or fewer independent claims and
twenty or fewer total claims, and the applicant must provide an
accelerated examination support document and meet a number of other
requirements. See Changes to Practice for Petitions in Patent
Applications To Make Special and for Accelerated Examination, 71 FR
36323 (June 26, 2006), 1308 Off. Gaz. Pat. Office 106 (July 18, 2006)
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1121 

(notice). However, requiring an examination support or similar document
only as an optional procedure for applicant to advance the application
out of turn would not result in the desired gains in efficiency and
quality.

   Comment 210: One comment suggested that if examination is limited
to a certain number of claims, the Office should not be allowed to make
a restriction requirement that is not linked to the burden of
searching. Thus, the comment suggested that where different statutory
classes or independent claims within a class do not really impose an
additional burden,they should not be counted against the examination limit.

   Response: Under the current restriction practice, the burden of the
search and examination in an application is considered before a
requirement for restriction is made. See MPEP section 803. This
includes where there are different statutory classes of invention or
independent claims within a class that do not impose a search burden.

   Comment 211: A number of comments argued that the one-month time
period to reply to a notification of more than ten representative
claims was too short to prepare and submit an adequate examination
support document. One comment suggested that the time period should be
at least two months with extensions of time being permitted. One
comment suggested that the time period should be three months with
extensions of time being permitted.

   Response: The proposed "representative claims" examination
approach is not adopted in this final rule. Under this final rule,
applicant is required to provide an examination support document if
applicant presents more than five independent claims or more than
twenty-five total claims in an application. If an examination support
document in compliance with § 1.265 is not filed before the
issuance of a first Office action on the merits of the application, the
application may not contain or be amended to contain more than five
independent claims or more than twenty-five total claims. The time
period provided in the notice requiring an examination support document
is only applicable where it appears that the omission of an examination
support document was inadvertent. Therefore, applicant should prepare
and file an examination support document when applicant presents more
than five independent claims or more than twenty-five total claims in
an application. Applicant should not rely on the notification from the
Office and a new period within which to prepare an examination support
document. Nevertheless, the Office is revising this provision to
provide a two-month time period that is not extendable under § 1.136(a),
which should be sufficient for those situations in which an
applicant inadvertently omitted an examination support document.

   Comment 212: A number of comments argued that the notice to the
applicant under § 1.75(b)(3) would impose costs because it would
have to be generated by an examiner and another round of communications
would be needed if applicant suggests a restriction requirement and it
is not accepted by the Office.

   Response: Since the examination support document is required
whenever applicant presents more than five independent claims or more
than twenty-five total claims and the notice only applies when it
appears that the omission of the examination support document was
inadvertent, the Office expects that the number of notices would be
relatively low. Furthermore, the Office plans to have a notice under
§ 1.75(b)(3) generated by someone other than the examiner. While it
may be necessary on occasion for the examiner to communicate with the
applicant if a suggested restriction requirement is not accepted, this
additional communication is far outweighed by the benefits of focused
examination and increased quality.

   Comment 213: Several comments requested that the Office explain the
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1122 

procedures for how the Office will evaluate a suggested restriction
requirement. Some comments questioned how an examiner will approve a
suggested restriction requirement. One comment questioned what would
occur if the restriction requirement was not accepted by the examiner.

   Response: As discussed previously, if the applicant submits a
suggested restriction requirement, the suggested restriction
requirement is accepted, and there are five or fewer independent claims
and twenty-five or fewer total claims to the elected invention, the
Office will simply treat the non-elected claims as withdrawn from
consideration and proceed to act on the application (assuming the
application is otherwise ready for action). The Office action will set
out the requirement for restriction under § 1.142(a), e.g., in the
manner that an Office action on the merits would contain a written
record of a requirement for restriction previously made by telephone.
See MPEP section 810.

   The refusal to accept a suggested requirement for restriction may
result in the examiner making a different restriction requirement or
making no restriction requirement. If the examiner makes a restriction
requirement (different from the suggested restriction requirement), the
applicant will be notified (a notice under § 1.75(b)(3) coupled
with a restriction requirement) and given a time period within which
the applicant must make an election. In addition, if there are more
than five independent claims or more than twenty-five total claims to
the elected invention and/or species, the applicant must also: (1)
Amend the application such that it contains no more than five
independent claims and no more than twenty-five total claims to the
elected invention and/or species; or (2) file an examination support
document in compliance with § 1.265 that covers each claim (whether
in independent or dependent form) to the elected invention and/or
species.

   Comment 214: Several comments argued that the rules should provide
guidance on how the non-extendable deadline would be treated in the
event of a petition or appeal relating to the requirement for an
examination support document. Several comments questioned how the
notice and time period would be set when there are multiple
applications that have patentably indistinct claims that are being
considered together for purposes of determining the number of claims in
an application.

   Response: Applicant may file a petition under § 1.181 if the
applicant disagrees with a determination that an application contains
more than five independent claims or more than twenty-five total
claims, or a determination that an examination support document does
not comply with § 1.265. As stated in § 1.181(f), the mere
filing of a petition will not stay any time period that may be running
against the application. Applicant must file a reply in compliance with
§ 1.75(b)(3) within the two-month time period to avoid abandonment
even when applicant files a petition under § 1.181. If there are
multiple applications with at least one patentably indistinct claim,
the Office will issue a notice under § 1.75(b)(3) in each
application and set a separate time period in each application.

   Comment 215: Several comments argued that applicants would file
more applications in parallel with fewer claims to avoid having to file
an examination support document and this would create more work for the
Office.

   Response: This final rule provides that if multiple applications
contain at least one patentably indistinct claim, the Office will treat
the multiple applications as a single application for purposes of
determining whether each of the multiple applications exceeds the five
independent claim and twenty-five total claim threshold. See
§ 1.75(b)(4). For example, if one of the claims in an application is
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1123 

patentably indistinct from at least one of the claims in another
application, the Office will treat each application as containing the
total of all of the claims in both applications when determining
whether each application exceeds the five independent claim and twenty-
five total claim threshold. This provision is intended to prevent an
applicant from submitting multiple applications to the same subject matter,
each with five or fewer independent claims or twenty-five or fewer total
claims, for the purposes of avoiding the requirement to submit an
examination support document. Furthermore, under § 1.78(f), applicant is
required to identify such applications if they: (1) Have filing dates that
are the same as or within two months of each other, taking into account any
filing date for which a benefit is sought under title 35, United States
Code; (2) name at least one inventor in common; and (3) are owned by
the same person, or subject to an obligation of assignment to the same
person. If the applications also have the same claimed filing or
priority date and substantially overlapping disclosures, applicant must
rebut a presumption that the applications contain patentably indistinct
claims or file a terminal disclaimer and provide good and sufficient
reasons why two or more such pending applications are required rather
than one. See §§ 1.78(f)(2) and (f)(3).

   Comment 216: One comment questioned whether the Office would
require an examination support document if a parent application issues
as a patent with ten claims and a continuation application is filed
with indistinct claims.

   Response: The Office has revised § 1.75(b)(4) to provide that
if there are multiple applications containing at least one patentably
indistinct claim the Office will treat each of such applications as
containing the total of all of the claims (both independent and
dependent) present in all of the multiple applications containing
patentably indistinct claims for purposes of determining whether each
such application contains more than five independent claims or more
than twenty-five total claims. Under § 1.75(b)(4), the Office will
count the claims in copending applications containing patentably
indistinct claims (including applications having a continuity
relationship) but not in issued patents containing patentably
indistinct claims, in determining whether each such application
contains more than five independent claims or more than twenty-five
total claims and thus whether an examination support document in
compliance with § 1.265 is required. As discussed previously, this
provision is to preclude an applicant from submitting multiple
applications to the same subject matter (with claims that are
patentably indistinct), each with five or fewer independent claims or
twenty-five or fewer total claims, for the purposes of avoiding the
requirement to submit an examination support document in compliance
with § 1.265. Although claims in an issued patent are not counted
for the purposes of § 1.75(b)(4), the pending application may still
be subject to a double patenting rejection.

   Comment 217: One comment questioned how the Office would determine
when an examination support document was "inadvertently" omitted.

   Response: If the omission of an examination support document is an
isolated instance, then generally the omission would be considered
inadvertent. Where, however, a particular individual (e.g., applicant
or attorney) has a pattern of not including an examination support
document when required, then the Office would be less inclined to
consider such an omission as being inadvertent. The Office will not
generally question whether the omission of an examination support
document was inadvertent unless there is a reason to do so.

H. Examination Support Document Requirements

   Comment 218: Several comments supported the concept of an
examination support document. One comment agreed that the examination
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1124 

support document would help the Office to reduce the backlog.

   Response: The Office is adopting the concept of an examination
support document in this final rule. Under this final rule, an
examination support document is required if applicant presents more
than five independent claims or more than twenty-five total claims in
an application.

   Comment 219: A number of comments argued that the search and
analysis necessary to prepare an examination support document would add
significant cost to the preparation of an application, that the cost
would be significantly more than the $2,500 predicted by the Office,
and that this would significantly disadvantage independent inventors
and small businesses. Several comments argued that it would be
unaffordable for independent inventors and small entities. Several
comments argued that the patentability search done by most
practitioners is limited to United States patents and United States
published applications and does not generally set forth in detail the
patentability of each claim element by element. A number of comments
argued that the examination support document was more like a validity
search and opinion and included various estimates of the cost of
preparing an examination support document, which ranged from $5,000 to
$30,000. One comment argued that it would cost a minimum of $30,000 for
a biotechnology application. One comment argued that even if the
Office's estimate is accurate, it would cost a small entity applicant
$3,000 to have twenty claims examined, which would be a six hundred
percent increase over current costs and would have a significant
economic impact.

   Response: As discussed previously, the Office has modified the
proposed rules with respect to claims. Under the proposed rules,
applicants who wished to have more than ten representative claims
examined in the initial Office action would have had to file an
examination support document. Under the changes in this final rule,
applicants may have up to five independent and twenty-five total claims
examined in an application without filing an examination support
document.

   The Office was given feedback that the costs for preparing an
examination support document could be anywhere from $5,000 to $100,000.
No data to support the alleged costs were submitted. Contrary to some
of the comments, the Office is not requiring a validity search and
opinion. The pre-filing preparation of an application that contains
more than five independent claims or more than twenty-five total claims
should involve obtaining a patent novelty search, analysis and opinion.
Preparation of an examination support document requires that this
information be reduced to writing in a particular format.

   The Office commissioned a detailed analysis of the final rule's
impacts on small entities. This analysis indicated that the cost of an
examination support document is likely to be in the range of $2,563 to
$13,121. This analysis also concludes that this final rule is not
expected to result in a significant economic impact on a substantial
number of small entities. This final rule does provide an exemption
from the requirement (§ 1.265(a)(3)) that an examination support
document must, for each reference cited in the listing of the
references required under § 1.265(a)(2), include an identification
of all the limitations of each of the claims that are disclosed by the
reference that applies to applications by a small entity as defined by
the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). See § 1.265(f).

   Comment 220: Several comments argued that the examination support
document is substantially more burdensome than the current procedure
for accelerated examination because the search and examination support
document must separately address every claim for which examination is
sought, and the rule contains substantial additional burdens. One
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1125 

comment argued that the accelerated examination procedure is too
onerous as shown by the very small number of applicants who used the
procedure, and the examination support document is even more stringent.
Several comments argued that a petition to make special is voluntary,
not mandatory. Furthermore, such a petition does not foreclose
applicant's opportunity to pursue additional inventive subject matter
to protect against design-arounds, as would happen in view of the
concurrent continuation proposed rule changes.

   Response: The Office has reduced the requirements for an
examination support document under § 1.265 as adopted in this final
rule. The Office proposed to require applicants to provide a detailed
explanation of how each independent and dependent claim was patentable
over the cited art (proposed § 1.261(a)(4)). Section 1.265(a)(4) as
adopted in this final rule requires applicants to provide the same
explanation for the independent claims only. The Office also proposed
to require applicants to provide statements of utility of the invention
as defined in each independent claim (proposed § 1.261(a)(5)).
Section 1.265 as adopted in this final rule does not include such a
requirement. These changes reduce the requirements for applicants who
wish to file an examination support document while still providing
examiners with valuable information to assist in the examination of
applications.

   Furthermore, an examination support document in compliance with
§ 1.265 is required under § 1.75(b) only when an applicant
presents more than five independent claims or more than twenty-five
total claims. It is not required in applications that contain five or
fewer independent claims and twenty-five or fewer total claims. Thus,
the majority of applications would not need an examination support
document since a majority of applications contain five or fewer
independent claims and twenty-five or fewer total claims.

   In addition, the accelerated examination procedure was recently
revised. The accelerated examination procedure has more requirements
than are contained in § 1.265. See Changes to Practice for
Petitions in Patent Applications To Make Special and for Accelerated
Examination, 71 FR at 36323-27, 1308 Off. Gaz. Pat. Office 106-09. For
example, the accelerated examination support document must also
identify any cited references that may be disqualified as prior art
under 35 U.S.C. 103(c) as amended by the Cooperative Research and
Technology Enhancement (CREATE) Act (Pub. L. 108-43, 118 Stat. 3596
(2004)).

   Comment 221: Several comments argued that due to the cost and
"duty to search," the requirement for an examination support document
is tantamount to imposing a de facto limit on the number of claims in
an application.

   Response: The Office has not placed a de facto limit on the number
of claims. If an applicant wants to present more than five independent
claims or more than twenty-five total claims, the applicant simply
needs to submit an examination support document in compliance with
§ 1.265 before the first Office action on the merits. As discussed
previously, the accelerated examination procedure has more requirements
than are contained in § 1.265. However, over four hundred
applications have been filed under the revised accelerated examination
procedure in the last nine months.

   Comment 222: One comment suggested that § 1.265 should be
replaced by a requirement that applicant comply with the rules for a
petition to make special. Another comment argued that applicants will
file a petition to make special after going through the effort and
expense to prepare and file an examination support document.

   Response: As discussed previously, the Office has recently revised
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1126 

its accelerated examination program with the goal of completing
examination within twelve months of the filing date of the application.
An application containing more than five independent claims or more
than twenty-five total claims would not be eligible for the revised
accelerated examination program. Nevertheless, the Office has no
objection to every applicant filing his or her application under the
revised accelerated examination program.

   Comment 223: A number of comments argued that the requirement for
an examination support document transfers to the applicant the costs
and responsibilities of the examination process for which fees have
been paid. One comment questioned why applicant must pay a search fee
and perform a search of their own in order to prepare an examination
support document. One comment suggested that the Office should consider
eliminating the search and examination fee when an examination support
document is provided. One comment argued that the excess claims fees
that are paid are more than enough to cover the associated extra
expense and burden placed on the Office in examining the excess claims.
One comment suggested that the excess claims fee should be increased
rather than requiring applicants to submit an examination support
document.

   Response: Applications which contain a large number of claims
absorb an inordinate amount of patent examining resources, and such
applications are extremely difficult to process and examine properly.
An applicant who presents more than five independent claims or more
than twenty-five total claims will be required to assist the Office
with the examination by providing an examination support document in
compliance with § 1.265. The Office will still conduct a search and
examine an application in which an examination support document is
filed. Furthermore, the search and examination fees and excess claims
fees do not recover the costs of searching and examining an
application. The higher cost estimates provided in the comments on the
Claims Proposed Rule confirm that the cost of conducting a search and
preparing an analysis far exceeds the search and examination fees. The
Office, however, cannot increase these fees because they are set by
statute.

   Comment 224: Several comments argued that the examination support
document imposes extra burdens on the applicants that are not performed
by the Office since applicants are required to translate any foreign
documents not in the native language of the applicant and rejections by
the Office do not comply with most of the requirements imposed under
the rule.

   Response: Examiners frequently obtain translations of foreign
documents that they consider to be pertinent. Examiners must obtain a
translation of any document that is in a language other than English if
the examiner seeks to rely on that document in a rejection. See MPEP
§ 706.02. During examination, examiners cite references that are
most closely related to the subject matter of the claims, identify the
limitations of the claims that are disclosed by the references being
relied upon in a rejection, explain how each of the independent claims
are being rejected over the references being applied, and make
determinations regarding utility and 35 U.S.C. 112, ¶ 1, support and
enablement. The requirements in § 1.265 are intended to assist the
examiner with the examination process.

   Comment 225: Several comments stated that the costs and
requirements of an examination support document would encourage
applicants to seek the services of the least qualified searchers.

   Response: The Office is not encouraging applicants to seek the
services of the least qualified searchers. An applicant who decides to
file an examination support document has the option to seek the
services of any searcher he or she chooses or to conduct the
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1127 

preexamination search on his or her own. Applicant should have an
incentive to hire the most qualified searchers since a better search is
more likely to result in a more thorough examination. The requirements
of an examination support document are clearly set forth in § 1.265
and an applicant who chooses to file an examination support document
must satisfy these requirements. If the preexamination search is poor,
then applicant runs the risk that the preexamination search or the
examination support document will be deemed insufficient. If the
preexamination search or examination support document is deemed
insufficient, applicant will be given only a two-month time period that
is not extendable under § 1.136(a) in which to file a corrected
examination support document to avoid abandonment of the application.
See § 1.265(e).

   Comment 226: One comment argued that the Office's estimate that the
burden imposed by the rule change will equate to an additional one
minute and forty-eight seconds to twelve hours was unrealistic for
applications having multiple independent claims and hundreds of pieces
of prior art to be reviewed.

   Response: The one minute and forty-eight seconds to twelve hours
response time provided in the notice of proposed rule making covered
each activity that may occur during the processing of an application
for patent (OMB control number 0651-0031). The specific estimate for an
examination support document was twelve hours (which has subsequently
been increased to twenty-four hours). While the Office received
comments suggesting that the Office's cost estimate for an examination
support document was low, these comments provided only conclusory
statements and contained few facts or information.

   Comment 227: A number of comments argued that it was almost
impossible to determine the extent to which the prior art must be
searched to satisfy the preexamination search requirement. Several
comments argued that there is no way to meet the search requirements.
One comment argued that it would be impossible to prove the "non-
existence" of more pertinent art. A number of comments argued that the
search should not be required to go beyond the resources that are
publicly available in the Office's search room. One comment suggested
that the Office's search room would need to be upgraded to allow access
to all foreign patents, periodicals and publications as well as all
United States patents to meet the examination support document
requirements. Several comments argued that applicant would be required
to conduct a search that is beyond the scope of the searches performed
by examiners and that this was unfair and burdensome to the applicants.
Some comments argued that the information that must be identified is
significantly more than what the Office provides to an applicant for a
search and that a requirement for a statement that applicant has
searched on the Office's database, the resources available to
examiners, should be sufficient.

   Response: The standard for the preexamination search that is
required is the same standard that the Office uses to examine patent
applications, which is set forth in MPEP §§ 904-904.03. The
information that applicant must identify is the same information that
the examiner must record in the application file as set forth in MPEP
§ 719.05. If applicant follows the search guidelines set forth in
the MPEP, then the preexamination search should be sufficient. The
Office has published patent search templates to define the field of
search, search tools, and search methodologies that should be considered
when performing a search. The search templates are published on the Office's
Internet Web site at http://www.uspto.gov/web/patents/searchtemplates/.
The Office has requested comments on the patent search templates. See
Request for Comments on Patents Search Templates, 71 FR 94 (May 16, 2006),
1307 Off. Gaz. Pat. Office 22 (Jun. 6, 2006).

   The accelerated examination procedure has more requirements than
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1128 

are contained in § 1.265. See Changes to Practice for Petitions in
Patent Applications To Make Special and for Accelerated Examination, 71
FR 36232 (June 26, 2006), 1308 Off. Gaz. Pat. Office 106 (July 18,
2006) (notice). Thus, the information concerning the requirements for a
preexamination search document under the revised accelerated
examination procedure can be applied to fulfill the requirements for a
preexamination search under § 1.265. See samples of a
preexamination search document and an accelerated examination support
document on the Office's Internet Web site at
http://www.uspto.gov/web/patents/accelerated/.

   Finally, a statement that applicant has searched on the Office's
database and the resources available to examiners would not be
sufficient. A mere statement that the applicant has searched on the
Office's database and the resources available to examiners would not
identify the field of search, the date of the search, and, for database
searches, the search logic or chemical structure or sequence used as a
query, the name of the file or files searched and the database service,
and the date of the search. See § 1.265(a)(1).

   Comment 228: One comment argued that the fact that foreign search
reports are not sufficient for the preexamination search or examination
support document seemed at odds with the objective of promoting greater
reliance on and use of work done by other competent patent offices. One
comment questioned whether an international search report is sufficient
to satisfy the search requirement, and if it is, then why are foreign
patent office searches not sufficient.

   Response: Neither foreign search reports nor international search
reports are per se excluded. If a foreign search report or an international
search report satisfies the requirements for a preexamination search set
forth in § 1.265, then it would be accepted.

   Comment 229: One comment argued that the preexamination search
requirement that the search must cover all the features of the
designated dependent claims separately from the claim or claims from
which the dependent claim depends makes no sense. The comment argued
that if a dependent claim adds an element to the combination in an
independent claim, a search for prior art references that disclose the
additional element separately from the elements of the independent
claim is likely to produce many references that have no relation to the
invention. The comment suggested that the language of the rule be
revised to clarify that the preexamination search must include a
separate search for each independent claim and each designated
dependent claim.

   Response: As discussed previously, the Office did not adopt the
"representative claims" examination approach. Under this final rule,
if the application contains more than five independent claims or more
than twenty-five total claims, applicant is required to file an
examination support document in compliance with § 1.265 that covers
each of the claims (whether in independent or dependent form) before
the first Office action on the merits. If an examination support
document in compliance with § 1.265 is not filed before the issuance of a
first Office action on the merits of the application, the application may
not contain or be amended to contain more than five independent claims or
more than twenty-five total claims. The Office has revised § 1.265(b) to
delete the phrase "separately from the claim or claims from which the
dependent claim depends." Section 1.265(b) as adopted in this final rule
requires that the preexamination search must encompass all of the
features of the claims (whether independent or dependent), giving the
claims the broadest reasonable interpretation. For example, if
independent claim 1 recites elements ABC and dependent claim 2 depends
on claim 1, incorporates all the limitations of claim 1 and
additionally recites element D, then, even if applicant cannot find
elements ABC and believes elements ABC to be novel, applicant must
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1129 

still search for element D.

   Comment 230: One comment argued that the requirement that the
search encompass the "disclosed features that may be claimed" should
be deleted because it gives examiners carte blanche to reject
preexamination searches on essentially arbitrary grounds.

   Response: The Office notes the concerns expressed in the public
comment. The Office has modified the proposed provision such that
§ 1.265(b) as adopted in this final rule does not require that the
preexamination search must encompass the disclosed features that may be
claimed. For any amendment to the claims that is not encompassed by the
examination support document, however, applicants are required to
provide a supplemental examination support document that encompasses
the amended or new claims at the time of filing the amendment.

   Comment 231: Several comments suggested that there should be an
exemption from the limits on the number of claims for independent
inventors. One comment argued that many individual inventors lack the
skills and requisite knowledge to perform an adequate preexamination
search and prepare an examination support document.

   Response: The applicant of a patent application should have
sufficient knowledge of his or her own invention. Performing a
preexamination search and preparing an examination support document
should be no more difficult than preparing and prosecuting the patent
application. Furthermore, applicants can avoid the need to file an
examination support document by not presenting more than five
independent claims or more than twenty-five total claims in an
application. This final rule, however, provides that a small entity as
defined by the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) may
claim an exemption from the requirement in § 1.265(a)(3) for an
identification of all of the limitations of each of the claims that are
disclosed by the references cited in the listing of the references
required under § 1.265(a)(2). See § 1.265(f).

   Comment 232: One comment suggested that the Office should hire
experienced searchers to perform the searching function.

   Response: The Office has recently conducted a pilot using PCT
international applications for competitively sourcing search functions
to commercial entities, each of which had experience in providing
patent searches. The purpose of the pilot program was to demonstrate
whether searches conducted by commercial entities could meet or exceed
the standards of searches conducted and used by the Office during the
patent examination process. The pilot was not proved successful and was
concluded after six months.

   Comment 233: A number of comments argued that the rules requiring
an examination support document are fraught with dangers in the form of
inequitable conduct allegations and malpractice. One comment argued
that there would be challenges on the sufficiency of the examination
support document, the scope of the search of the examination support
document, and the timing of the search for the examination support
document. A number of comments argued that even a good faith attempt is
likely to be attacked on the grounds of inequitable conduct, and that
such a duty is contrary to Frazier v. Roessel Cine Photo Tech., Inc.,
417 F.3d 1230, 75 U.S.P.Q.2d 1822 (Fed. Cir. 2005). A number of
comments argued that the risk of inequitable conduct allegations in
litigation would effectively force applicants to file ten or fewer
claims, which would deny them the right to adequately protect their
inventions. Several comments argued that each patent that includes an
examination support document in its file history would be inherently
weak given current inequitable conduct practices. Several comments
argued that the likelihood of having to defend against inequitable
conduct would reduce perceived public confidence in the validity of
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1130 

issued patents. Several comments also argued the examination support
document will increase litigation costs. Several comments also argued
that the added costs in terms of the perceived reduction in patent
quality and the potential litigation costs would outweigh any potential
speed of examination benefit. One comment argued that forcing
applicant's representatives to limit the claims to an arbitrary number
is akin to asking them to commit what amounts to malpractice. One
comment stated that the rules put applicants in a triple-jeopardy
situation for losing patent rights. First, because examiners will not
consider all initially filed claims, applicants are put in jeopardy of
having to file continuations for unexamined claims. Second, if
applicants choose to have more than the threshold number of claims,
applicants risk inequitable conduct charges. Third, if only the
threshold number of claims is pursued, applicants will be unable to
adequately protect their inventions.

   Response: Applicants may present as many claims as they feel are
necessary to adequately protect their invention. Under this final rule,
applicant may present up to five independent claims and twenty-five
total claims for examination in an application without providing an
examination support document. As discussed previously, the Office has
also modified the proposed changes to continuing application practice
and continued examination practice to permit an applicant to file two
continuation or continuation-in-part applications plus one request for
continued examination in an application family, without any
justification. Thus, an applicant is permitted to present up to fifteen
independent claims and seventy-five total claims for each patentably
distinct invention via an initial application and two continuation or
continuation-in-part applications that are prosecuted serially without
providing either an examination support document or a justification.
Applicant may also present additional claims by submitting an
examination support document under § 1.265 before the first Office
action on the merits.

   The changes in this final rule do not force an applicant to carry
any affirmative duty that may expose him or her to a greater risk of
inequitable conduct. The submission of an examination support document
to assist the Office in gathering information for use during
examination does not expose an applicant to a greater risk of
inequitable conduct. Inequitable conduct is a doctrine based, in part,
upon "intent to deceive." See Molins PLC v. Textron, Inc., 48 F.3d
1172, 1178, 33 U.S.P.Q.2d 1823, 1826 (Fed. Cir. 1995). To establish
inequitable conduct, a party must provide clear and convincing evidence
of: (1) Affirmative misrepresentations of a material fact,
failure to disclose material information, or submission of false
material information; and (2) an intent to deceive. See, e.g., Impax
Labs., Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1374, 81 U.S.P.Q.2d
1001, 1006 (Fed. Cir. 2006) (citing Alza Corp. v. Mylan Labs., Inc.,
391 F.3d 1365, 1373, 73 U.S.P.Q.2d 1161, 1167 (Fed. Cir. 2004)). Absent
such "intent to deceive", inequitable conduct cannot be proven.
Unless the applicant has an "intent to deceive" when submitting an
examination support document, the simple submission of an examination
support document, even one containing erroneous information, to the
Office does not by itself raise an intent to deceive or mislead the
Office. See Frazier, 417 F.3d at 1236 n.1, 75 U.S.P.Q.2d at 1826 n.1
(the mere submission of erroneous information to the Office does not by
itself raise an inference of intent to deceive or mislead). Moreover,
frivolous allegations in litigation are subject to professional
responsibility rules and Rule 11 of the Federal Rules of Civil
Procedure.

   Comment 234: A number of comments argued that the Office must
create a "safe harbor" that appropriately protects the applicant from
inequitable conduct allegations when identifying and characterizing
important prior art. Several comments argued that changes to § 1.56
would need to be made to exempt examination support documents from it.
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1131 

One comment argued that legislative reform is needed. Several comments
argued that implementation of the examination support document should
be delayed until changes to inequitable conduct are made. A number of
comments suggested that more meaningful participation by applicants in
prosecution of the application requires adequate "safe-harbor"
provisions from inequitable conduct.

   Response: The Office proposed revising § 1.56 to provide a
"safe harbor" to applicants who make a reasonable good faith effort
to comply with the proposed requirements. See Changes To Information
Disclosure Statement Requirements and Other Related Matters, 71 FR at
38811-12, 38820, 1309 Off. Gaz. Pat. Office at 27, 34. Most of the
comments indicated that such a "safe harbor" at best sets out the
current state of the law of inequitable conduct, in that a "safe
harbor" is unnecessary for applicants who act in good faith (i.e.,
without an intent to deceive or mislead the Office) because an intent
to deceive or mislead the Office is a separate and essential component
of inequitable conduct. See e.g., Weatherchem Corp. v. J.L. Clark,
Inc., 163 F.3d 1326, 1336, 49 U.S.P.Q.2d 1001, 1009 (Fed. Cir. 1998) (a
finding that the patentee acted without any intent to deceive disposes
of the inequitable conduct issue), and Manville Sales Corp. v.
Paramount Systems Inc., 917 F.2d 544, 552, 16 U.S.P.Q.2d 1587, 1593
(Fed. Cir. 1990) (materiality does not presume intent, which is a
separate and essential component of inequitable conduct). The comments
also expressed concern that any "safe harbor" would possibly create
new requirements with respect to an applicant's duty of disclosure
under § 1.56. It is the Office's position that an applicant's duty
of disclosure under § 1.56 with respect to an examination support
document under § 1.265 is satisfied if an individual as defined in
§ 1.56(c) acted in good faith to comply with the requirements in
§ 1.265 for an examination support document. The Office, however,
is not adopting changes to § 1.56 in this final rule to provide a
"safe harbor" to applicants because such a provision would be
unnecessary. The Office notes that patent reform legislation is pending
in the 110th Congress before both the Senate and House of
Representatives. See Patent Reform Act of 2007, S. 1145, 110th Cong.
(2007), and H.R. 1908, 110th Cong. (2007). The Department of Commerce
submitted a letter on May 18, 2007, to the Chairman of the House
Subcommittee on Courts, the Internet, and Intellectual Property
recommending that H.R. 1908 be amended to address the doctrine of
inequitable conduct and unenforceability to ensure that patent
applicants are not discouraged from fully and fairly sharing relevant
information with the Office.

   Comment 235: A number of comments argued that the examination
support document would require the applicant to make binding admissions
as to the scope of the claims and how they relate to the prior art
references and thus force applicant to create prosecution history
estoppel and address rejections that would never have occurred during
prosecution. Several comments argued that such a requirement shows a
complete lack of understanding of the pitfalls that admissions can have
in litigation. Several comments argued that such statements can be
misinterpreted and distorted in unforeseen ways. One comment argued
that this may cause the practitioner to unintentionally and
unnecessarily narrow the claims through the effect of prosecution
history estoppel, which will decrease the commercial value and the
quality of the patent. Several comments argued that the requirement for
an examination support document places applicant in a precarious
position of having to provide as much information as possible to
support patentability of the claimed invention while avoiding
statements that can be easily manipulated in litigation. One comment
argued that applicants would be put in a position of having to make
statements against interest long before the scope of their invention is
realized. One comment argued that requiring applicant to examine his or
her own application creates a conflict of interest, which would raise a
question of concealment or understatement.
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1132 


   Response: The best way to avoid prosecution history estoppel is by
knowing what the prior art is and filing claims that initially define
patentable subject matter without having to file an amendment.
Conducting a preexamination search and preparing an examination support
document will help applicants to draft a better written disclosure and
more focused claims, thereby minimizing any prosecution history
estoppel.

   Comment 236: Several comments argued that the one-month non-
extendable time period to respond to a notice requiring a corrected or
supplemental examination support document is insufficient. Some
comments suggested that a three-month time period, which is extendable
up to six months with an extension of time, should be given. Some
comments suggested that the time period should be at least three months
or extensions of time should be permitted.

   Response: The Office notes the concerns expressed in the public
comment regarding the time period set forth in a notice requiring a
corrected or supplemental examination support document when an
examination support document is deemed to be insufficient. The Office
has revised the proposed provision such that § 1.265(e) provides a
two-month time period that is not extendable under § 1.136(a). The
two-month time period should be more than sufficient to correct any
minor deficiencies. Applicants, however, should not rely on the two-
month time period in § 1.265(e) to prepare an examination support
document or a supplemental examination support document. The
requirements for an examination support document are clearly set forth
in § 1.265. Applicant should prepare the examination support
document in compliance with the requirements before presenting more
than five independent claims or more than twenty-five total claims.
Applicant should also conduct the preexamination search to encompass all
of the disclosed features that applicant expects to claim in order to avoid
the need to update the preexamination search. Applicant should file a
supplemental examination support document at the time applicant
presents any amendment to the claims that is not covered by the
previous examination support document. Applicant also has the option of
canceling the requisite number of claims (independent or total) that
necessitate an examination support document, rather than submitting a
corrected or supplemental examination support document. Furthermore,
extensions of this two-month time period in § 1.265(e) are
available to those for which there is sufficient cause (§ 1.136(b)).

   Comment 237: One comment suggested that if applicant's examination
support document is deemed insufficient, applicant should be afforded
an opportunity to undesignate claims, and if applicant fails to
undesignate the claims or file a corrected examination support
document, then the examiner should undesignate claims and proceed with
examination, rather than holding the application abandoned.

   Response: The Office is not adopting the "representative claims"
examination approach in this final rule. Thus, designation (or
"undesignation") of dependent claims for initial examination is not
required in this final rule. Under this final rule, if applicant wants
to present more than five independent claims or more than twenty-five
total claims in an application, applicant simply needs to submit an
examination support document in compliance with § 1.265 before the
first Office action on the merits. If applicant files an examination
support document and it is insufficient, the Office will notify the
applicant and give the applicant the options of either: (1) Filing a
corrected or supplemental examination support document in compliance
with § 1.265 that covers each of the claims (whether in independent
or dependent form); or (2) amending the application such that it
contains no more than five independent claims and no more than twenty-
five total claims.

Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1133 

   Comment 238: One comment argued that applicant should be given the
options available under § 1.75(b)(3) and not be limited to
submission of a corrected or supplemental examination support document
when an examination support document is deemed to be insufficient or in
other situations under § 1.265(e) (§ 1.261(c) as proposed).

   Response: The Office notes the concerns expressed in the public
comment regarding the proposed provision that requires a corrected or
supplemental examination support document when an examination support
document is deemed insufficient. The Office has modified this proposed
provision such that § 1.265(e) provides that if an examination
support document is insufficient, the Office will notify the applicant
and give the applicant the options of either: (1) Filing a corrected or
supplemental examination support document in compliance with § 1.265 that
covers each of the claims (whether in independent or dependent form); or
(2) amending the application such that it contains no more than five
independent claims and no more than twenty-five total claims. However,
applicants will not be given the option to submit a suggested requirement
for restriction. Such an option would not be appropriate after applicant
has already submitted an examination support document.

   Comment 239: A number of comments requested clarification on how
the Office would use an examination support document. Some comments
questioned whether an independent search would be conducted and whether
the cited references would be independently evaluated by the examiner.
One comment noted that if the examiner simply adopts the results of the
search and the conclusions of patentability, there would be a wide
variation in quality and thoroughness of the searches performed, and in
the quality of analysis of the search results. The comment further
argued that if the examiner will perform further searching, then it was
difficult to understand how the objective of "sharing the burden" is
accomplished, since it would not seem to yield time or cost savings for
the Office. Several comments argued that examiners should not give any
faith and credit to the information in an examination support document.
One comment argued that if the examiner does rely on the external
search, the uncertainty of the patent will be increased. Another
comment argued that the submission of an examination support document
may motivate examiners to skip doing a thorough search, thus leading to
lower patent quality. One comment argued that requiring an examination
support document was a punitive measure because: (1) The examination
support document requires information that is rarely if ever required,
such as details regarding literal support for the claim elements; (2)
the Office does not indicate that examiners will receive additional
time to review the examination support document; and (3) the Office has
not indicated that it will rely on the external search.

   Response: Upon taking up an application for examination, the
examiner will consider the prior art submitted in an information
disclosure statement in compliance with §§ 1.97 and 1.98 (see
§ 1.97(b)) and those filed with an examination support document in
compliance with § 1.265 (required under § 1.75(b)), and make a
thorough investigation of the available prior art related to the
subject matter of the claimed invention (see § 1.104(a)(1)). The
examiner will make an independent patentability determination in view
of the prior art on the record, other information in the examination
support document, and any other relevant prior art or evidence. The
examination support document will assist the examiner in the
examination process and the determination of patentability of the
claims by providing the most relevant prior art and other useful
information. It will help the examiner in understanding the invention
and to focus on the relevant issues. The examination support document
will also assist the examiner in evaluating the prior art cited by the
applicant and in determining whether a claim limitation has support in
the original disclosure and in any prior-filed application. The
requirement for an examination support document is not a punitive
measure, nor is it a substitute for the Office's examination. The
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1134 

information required in an examination support document is to assist
the examiner with the more extensive examination of an application
having more than five independent claims or more than twenty-five total
claims.

   The Office has reduced the requirements for an examination support
document under § 1.265 as adopted in this final rule. The Office
proposed to require applicants to provide a detailed explanation of how
each independent and dependent claim was patentable over the cited art
(proposed § 1.261(a)(4)). Section 1.265(a)(4) as adopted in this
final rule requires applicants to provide the same explanation for the
independent claims only. The Office also proposed to require applicants
to provide statements of utility of the invention as defined in each
independent claim (proposed § 1.261(a)(5)). Section 1.265 as
adopted in this final rule does not include such a requirement. These
changes reduce the requirements for applicants who
wish to file an examination support document while still providing
examiners with valuable information to assist in the examination of
applications.

   Comment 240: Several comments questioned how the Office would
determine if an examination support document is insufficient. Some
comments also questioned what would happen if the Office knows of
closer prior art than that cited by applicant. One comment questioned
whether the examiner could hold the examination support document non-
compliant if the examiner objects to the search or the claim scope and
also what would be applicant's remedy. Several comments argued that
applicants currently disregard §§ 1.56, 1.97 and 1.98 and fail
to cite their own work. The comments argued that applicant will cite
generic references to comply with § 1.265 and will likely not
reveal the most pertinent art. One comment argued that the examination
support document requirements are subjective. One comment suggested
that the Office should institute a petition process for disputing the
requirement for an examination support document or the holding that an
examination support document is insufficient. The comment suggested
that the requirement should be stayed pending the outcome of the
petition, or applicants should at least be given sufficient time for
the petition to be heard.

   Response: The Office will review an examination support document to
determine if it meets all the requirements set forth in § 1.265. As
discussed previously, the accelerated examination procedure has more
requirements than are contained in § 1.265. The Office has provided
guidelines for examination support documents filed under the
accelerated examination procedure. The Office's guidelines concerning
the accelerated examination support document may be helpful to
applicants who are preparing an examination support document under
§ 1.265. The guidelines under the accelerated examination
procedure, search templates, and samples of a preexamination search
document and an examination support document are available on the Office's
Internet Web site at http://www.uspto.gov/web/patents/accelerated/.
The Office will provide similar guidelines for examination support
documents under § 1.265, including the preexamination search statement,
and will post such guidelines on the Office's Internet Web site. These
guidelines should minimize subjectivity in evaluating whether an
examination support document complies with the requirements of § 1.265.

   Section 1.265(a)(2) requires a listing of references deemed most
closely related to the subject matter of each of the claims (whether in
independent or dependent form). As discussed previously, the references
that would be most closely related to the subject matter of each of the
claims include: (1) A reference that discloses the greatest number of
limitations in an independent claim; (2) a reference that discloses a
limitation of an independent claim that is not shown in any other
reference in the listing of references required under § 1.265(a)(2);
and (3) a reference that discloses a limitation of a dependent
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1135 

claim that is not shown in any other reference in the listing
of references required under § 1.265(a)(2). References that are
only relevant to the general subject matter of the claims would not be
most closely related as long as there are other references that are
more closely related to the subject matter of the claims. Applicant may
not exclude a reference from an examination support document simply
because the reference was not the result of the preexamination search
provided for in § 1.265(a)(1). References, from whatever source,
that have been brought to the applicant's attention must be considered
in determining the references most closely related to the subject
matter of each of the claims. Accordingly, if applicant merely cites
generic references and does not cite the most pertinent art (including
applicant's own work), then the examination support document would most
likely not be compliant with § 1.265. Simply because the Office
knows of a closer prior art reference (that is not applicant's own
work) than the prior art cited by the applicant is generally not enough
to hold a preexamination search insufficient.

   An examination support document could be deemed insufficient based
on an insufficient search. If the preexamination search or examination
support document is deemed insufficient, applicant will be given only a
two-month time period that is not extendable under § 1.136(a) in
which to file a corrected examination support document or amend the
application to contain five or fewer independent claims and twenty-five
or fewer total claims to avoid abandonment of the application. See
§ 1.265(e). Any applicant who disagrees with a requirement for an
examination support document or the holding that an examination support
document or preexamination search is insufficient may file a petition
under § 1.181. As provided in § 1.181(f), the mere filing of a
petition will not stay any period for reply that may be running against
the application. The Office will make every effort to decide petitions
in a timely manner.

   Comment 241: A number of comments argued that it was unfair and
inconsistent for the Office to require applicants to produce an
examination support document when the Office is not effectively using
foreign search reports. One comment argued that since the Office is
unwilling to accept a foreign search report or use international search
reports prepared by the Office itself, the examination support document
would not reduce pendency. Another comment argued that since examiners
ignore international search reports they would not consider an
examination support document.

   Response: The Office will consider any prior art submitted by
applicant in an examination support document in compliance with
§ 1.265 (required under § 1.75(b)) and an information disclosure
statement in compliance with §§ 1.97 and 1.98 including those
that are filed with a foreign search report or an international search
report. Any relevant prior art will assist the examiner in the
determination of patentability of the claims. The examiner, however,
must make an independent determination of patentability of the claims
in the application. The examiner cannot accept the determination of
patentability by another examiner in a foreign application or an
international application because the patentability standard of a
foreign or international application is different than the standard in
a U.S. application.

   Comment 242: A number of comments argued that the requirement for
an examination support document would create more work for the examiner
since the examiner would have to determine the adequacy of the
examination support document. One comment argued that complex cases
would continue to be complex and the Office would just have the
additional tasks of determining whether or not an examination support
document should be required, and whether or not an examination support
document is sufficient. One comment argued that examiners will not have
sufficient time to review the examination support documents and that
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1136 

examiners would need more time for reviewing the examination support
documents. The comment questioned whether this would take the place of
the examiner reviewing the specification. Several
comments argued that determining the adequacy of examination support
documents would divert resources from examination and prolong pendency.
One comment argued that there would be additional burdens on the
examiner in having to impose the requirement for designation of claims,
issue communications challenging the sufficiency of the examination
support document, perform a different search after claims are amended
in response to an Office action, and search and examine the non-
designated claims after allowance of designated claims. One comment
argued that the number of petitions would increase because of petitions
regarding whether an examination support document was needed or
defective.

   Response: Under this final rule, applicant is required to file an
examination support document under § 1.75(b)(1) if applicant
presents more than five independent claims or more than twenty-five
total claims in an application. If an examination support document in
compliance with § 1.265 is not filed before the issuance of a first
Office action on the merits of the application, the application may not
contain or be amended to contain more than five independent claims or
more than twenty-five total claims. The majority of the applicants
would not need to file an examination support document. The
requirements of an examination support document are clearly set forth
in § 1.265. Applicants should comply with the requirements at the
time applicant presents more than five independent claims or more than
twenty-five total claims in an application. As discussed previously,
any relevant prior art and other information provided in an examination
support document will assist the examiner in the examination process
and in the determination of patentability of the claims. During the
examination process, the examiner will consider all relevant prior art
and information, and interpret the claims in light of the
specification. The examiner will review the specification even when
applicant files an examination support document. Thus, the benefits
obtained by the examination support document would outweigh the
Office's additional task of determining whether or not it is sufficient
or is required.

   Comment 243: One comment questioned whether the Office would give
examiners less time to examine those applications in which an
examination support document is filed and, if not, then how would the
workload be reduced.

   Response: Changes to patent examiner production goals are beyond
the scope of the proposed changes to the rules of practice. Therefore,
whether examiners should be given less time to examine certain
applications is not discussed in this final rule. The Office expects
that these rule changes will result in a more focused quality
examination. The information provided in the examination support
document will assist the examiner with the more extensive examination
of the application. This information will be available to the examiner
up front and will include the most closely related references and a
detailed explanation of how the claims are patentable over these
references. As a result, the exchanges between examiners and applicants
should be more efficient and effective, the number of Office actions
should be reduced, prosecution should be concluded faster, and the need
to file a continuation application or request for continued examination
should be reduced. Thus, the Office's workload would be reduced.

   Comment 244: Several comments argued that the requirement for the
broadest reasonable interpretation of the claims in conducting the
search for an examination support document is inconsistent with current
case law citing In re Johnston and In re Donaldson that require the
Office to interpret the claims reasonably in light of the specification.

Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1137 

   Response: The requirement in § 1.265(b) is consistent with
current case law. The current case law requires that during examination
the claims must be given their broadest reasonable interpretation
consistent with the specification. According to case law, however, the
broadest "reasonable" interpretation is necessarily one that is
consistent with the specification. See, e.g., Phillips, 415 F.3d at
1316, 75 U.S.P.Q.2d at 1329; In re Morris, 127 F.3d 1048, 1054, 44
U.S.P.Q.2d 1023, 1027 (Fed. Cir. 1997) ("Some cases state the standard
as the broadest reasonable interpretation, others include the qualifier
consistent with the specification or similar language. Since it would
be unreasonable for the PTO to ignore any interpretive guidance
afforded by the applicant's written description, either phrasing
connotes the same notion: As an initial matter, the PTO applies to the
verbiage of the proposed claims the broadest reasonable meaning of the
words in their ordinary usage as they would be understood by one of
ordinary skill in the art, taking into account whatever enlightenment
by way of definitions or otherwise that may be afforded by the written
description contained in the applicant's specification.") (citations
omitted). Therefore, the reference in § 1.265(b) to giving the
claims "the broadest reasonable interpretation" is consistent with
case law.

   Comment 245: One comment agreed that the requirements relating to
the concise statement of utility and the 35 U.S.C. 112 showing is
sharing the burden of examining all of the claims in the application,
but argued that requiring applicant to characterize the prior art goes
too far and is best left to the examiner since it is the examiner's
role to review and analyze the prior art for patentability purposes in
view of § 1.104. Several comments argued that the burden of the
examination belongs with the Office and that it is against the public
interest to shift the burden from the examiner to the applicant. One
comment argued that the examination support document requirement asks
applicant to prove that patent claims are patentable, which is
essentially impossible. One comment argued that the only purpose of an
examination support document is to force applicants to do what they
already should be doing, that is, carefully comparing their claims to
every close prior art reference and adding limitations to distinguish
the claims.

   Response: Ultimately it is the Office's responsibility to determine
patentability. Nevertheless, it is appropriate for applicants to
provide information regarding an initial review of claims to assist the
Office in determining patentability in applications where they feel
they need to have more than five independent claims or more than
twenty-five total claims. There is no reasonable explanation as to why
it is against public interest for an applicant who presents more than
five independent claims or more than twenty-five total claims to
provide additional information to the Office. The Office is not
requiring applicants to prove that their claims are patentable. The
Office is simply requiring applicants who present more than five
independent claims or more than twenty-five total claims to provide
additional information to the Office by conducting a preexamination
search and submitting an examination support document. The Office
agrees that applicants should be comparing their claims to every close
prior art reference and adding limitations to distinguish the claims.

   Comment 246: One comment stated the Office should require a showing
of precise written description (35 U.S.C. 112, ¶ 1) support for all
amendments made by applicants.

   Response: Applicant should specifically point out the support for
any amendments made to the disclosure. See e.g., MPEP § 2163.06.
Furthermore, when applicant adds a new claim limitation in an
application that contains more than five independent claims or more
than twenty-five total claims, applicant is required to submit a
supplemental examination support document that includes a showing of
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1138 

where such new claim limitation finds support under 35 U.S.C. 112, ¶ 1,
in the written description of the specification and in any parent
application. In addition, the examiner may require the applicant to
show where the specification of the application or a parent application
provides written description support under 35 U.S.C. 112, ¶ 1, for a
new limitation. See § 1.105(a)(1)(ix) (as adopted in this final rule).

   Comment 247: One comment argued that the concise statement of
utility and the 35 U.S.C. 112 showing required in an examination
support document make no sense. The comment argued that cross-
referencing each line of the claims back to the specification is a
waste of time. One comment argued that applicants should not have to
admit what is disclosed, but rather they should only have to admit what
is not disclosed.

   Response: In view of the comments, the Office is not adopting the
requirement that an examination support document contain a concise
statement of the utility of the invention as defined in each of the
independent claims. The showing of where each limitation of the claims
finds support under 35 U.S.C. 112, ¶ 1, however, would be helpful to
the examiner. The examiner is responsible for determining whether or
not there is 35 U.S.C. 112, ¶ 1, support in the written description for
claimed subject matter. If applicant provides this information, it will
assist the examiner in the examination of the application by making it
easier for the examiner to make the necessary determinations. See Hyatt
v. Dudas, 2007 U.S. App. LEXIS 15350 (Fed. Cir. Jun. 28, 2007). The
applicant should be aware of where each limitation of the claims finds
support under 35 U.S.C. 112, ¶ 1, in the written description by virtue
of having prepared the application. There is no justification for
requiring the examiner to duplicate this effort in an application that
exceeds the five independent claim and twenty-five total claim
threshold set forth in § 1.75(b).

   Comment 248: One comment argued that § 1.265(a)(2) through
(a)(4) resurrects provisions that used to be in the rules, but were
amended out of the rules in 1992 when they were found to be unworkable.

   Response: The Office proposed a number of changes to the rules of
practice around 1990 related to the duty of disclosure and the filing
of information disclosure statements. See Duty of Disclosure, 56 FR
37321 (Aug. 6, 1991), 1129 Off. Gaz. Pat. Office 52 (Aug. 27, 1991)
(proposed rule), and Duty of Disclosure and Practitioner Misconduct, 54
FR 11334 (Mar. 17, 1989), 1101 Off. Gaz. Pat. Office 12 (Apr. 4, 1989)
(proposed rule). The Office ultimately adopted changes to the duty of
disclosure provisions of § 1.56 and the information disclosure
statement provisions of §§ 1.97 and 1.98 (and deleted § 1.99) in 1992.
See Duty of Disclosure, 57 FR 2021 (Jan. 17, 1992), 1135
Off. Gaz. Pat. Office 13 (Feb. 13, 1992) (final rule). The changes
adopted in the 1992 final rule concerning the duty of disclosure
provisions of § 1.56 and the information disclosure statement
provisions of §§ 1.97 and 1.98 did not eliminate, or decline to
adopt as final, provisions similar to the provisions of § 1.265(a).

   Comment 249: One comment argued that the requirement for an
examination support document was contrary to case law (citing In re
Wilder, 736 F.2d 1516, 222 U.S.P.Q. 369 (Fed. Cir. 1984)) that
applicant is not under a duty to search.

   Response: Initially, it is noted that Wilder does not stand for the
proposition that applicant does not have a duty to search. Wilder
involved a reissue application. That case held that an attorney's
statement that his error was a misunderstanding of the scope of the
invention arose resulting from a lack of a prior art search was a
sufficient explanation to satisfy the requirements of the reissue rule
regarding how the error arose. There is some case law, however, that
indicates that applicant does not have a duty to search. See Nordberg,
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1139 

Inc. v. Telesmith, Inc., 82 F.3d 394, 397, 38 U.S.P.Q.2d 1593, 1595-96
(Fed. Cir. 1996); FMC Corp. v. Hennessy Indus., Inc., 836 F.2d 521, 526
n.6, 5 U.S.P.Q.2d 1272, 1275-76 n.6 (Fed. Cir. 1987); FMC Corp. v.
Manitowoc Co., 835 F.2d 1411, 1415, 5 U.S.P.Q.2d 1112, 1115 (Fed. Cir.
1987); Am. Hoist & Derrick Co. v. Sowa & Sons, Inc., 725 F.2d 1350,
1362, 220 U.S.P.Q. 763, 772 (Fed. Cir. 1984), cert. denied, 469 U.S.
821, 224 U.S.P.Q. 520 (1984). In view of these cases, the Office has
stated that "[a]n applicant has no duty to conduct a prior art search
as a prerequisite to filing an application for patent." See MPEP §
410. The case law, however, only discusses applicant's responsibility
under the rules in 37 CFR Part 1 that were in effect at the time that
was relevant to these particular cases. The case law does not stand for
the proposition that the Office cannot change the rules in 37 CFR Part
1 to require a preexamination search, either generally or, when an
applicant presents more than five independent claims or more than
twenty-five total claims in an application. Indeed, commentators have
suggested that, especially after Festo X, a practitioner who declines
to conduct any pre-filing search as a matter of practice may be falling
short of the responsibility under 37 CFR part 10 to perform services
with competence. See Schneck, The Duty to Search, 87 J.P.T.O.S. 689,
696-701 (2005).

   Comment 250: One comment argued that an examination support
document is not properly compared to an appeal brief since, in an
appeal brief, the focus is on the examiner's rejection and
interpretation of the references, whereas in an examination support
document, applicant is required to provide a search, interpret claims,
and identify all issues related to the search results with respect to
each element of each claim.

   Response: The Office did not compare an examination support
document to an appeal brief. The Office simply indicated that the
proposed "representative claim" examination approach was similar to
the BPAI's representative claim practice. Nevertheless, the Office is
not adopting the "representative claims" examination approach in this
final rule.

   Comment 251: One comment argued that the rule changes, especially
the requirement for an examination support document, are not rationally
related to achieving the stated goals of improving patent quality and
increasing efficiency.

   Response: The Office is requiring an examination support document
in those cases where applicants feel they need to have more than five
independent claims or more than twenty-five total claims because these
applications are the most burdensome for the Office. An examination
support document will help the Office improve quality and increase
efficiency because it will assist the examiner with the examination of
the application. It should provide the examiner with the most pertinent
prior art and an analysis of that art. Therefore, the changes being
adopted in this final rule are related to the goals of improving
quality and increasing efficiency.

   Comment 252: One comment argued that the examination support
document requirement will increase demand for public searchers and this
may drain the examining pool and worsen retention.

   Response: It is the Office's experience that only a small number of
examiners who leave the Office do so to become public searchers.

   Comment 253: One comment argued that practitioners do not draft
patent applications to claim subject matter that they believe is not
supported by the specification and thus it should be sufficient to
merely assert that the claims are supported by the "entire
specification."

Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1140 

   Response: The purpose of the requirement for a showing of where
each limitation of the claims finds support under 35 U.S.C. 112, ¶ 1,
is to assist the examiner in determining where the specification
provides written description support for each claim limitation. An
assertion by the practitioner that the claims are supported by the
entire specification would not be of any assistance to the examiner.

   Comment 254: Several comments argued that an examination support
document should not be required until after the time for issuing a
restriction requirement has passed because it is unfair to require
applicant to prepare and file an examination support document when
claims may be restricted such that fewer than ten representative claims
are pending for examination. One comment suggested that a time period
should be set in which the examiner must issue a restriction
requirement or indicate that there will be none, and then the time
period for submission of an examination support document should be set
after that.

   Response: As discussed previously, an applicant may submit a
suggested restriction requirement accompanied by an election without
traverse of an invention to which there are no more than five
independent claims and no more than twenty-five total claims. See
§ 1.142(c) and the discussion of § 1.142(c). In this situation, an
examination support document will not be required if the suggested
restriction requirement is accepted. An examination support document
will be required only if the suggested restriction requirement is not
accepted, and the application contains more than five independent
claims or more than twenty-five total claims, or more than five
independent claims or more than twenty-five total claims to the elected
invention and/or species if the examiner makes a restriction
requirement that is different from the suggested restriction
requirement.

   Comment 255: One comment suggested that the Office should give
assurances that: Like an information disclosure statement, nothing in
an examination support document is an admission of prior art; nothing
in the examination support document would be considered as affecting
the scope of the claims; and the examination support document would not
be published and examiners would make no references to it in
correspondence. One comment supported the use of a limited examination
support document that would require applicants to identify where in the
specification the corresponding structure, material or acts for
functional claim elements may be found since this would improve
examination efficiency and have minimal effects in litigation.

   Response: Providing assurances that the examination support
document would not affect the scope of the claims would not be
appropriate. The showing of where each limitation of the claims finds
support under 35 U.S.C. 112, ¶ 1, in the written description of the
specification and the showing that includes the structure, material, or
acts in the specification that correspond to each means-(or step-)
plus-function claim element that invokes consideration under 35 U.S.C.
112, ¶ 6, may affect the interpretation of the claims. The
determination on patentability is made on the entire record of the
application. In order to provide a complete application file history,
the examiner may find that it is necessary to state on the record any
agreement or disagreement with applicant's explanation of how the
claims are patentable over the references or applicant's explanation of
where each limitation of the claims finds support under 35 U.S.C. 112,
¶ 1, in the written description. The application record is available to
the public upon the publication of the application under 35 U.S.C.
122(b) and the issuance of a patent on the application.

   Comment 256: One comment suggested that the Office require
applicants to provide claim charts that illustrate the differences
between claims. The comment also suggested that applicants could be
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1141 

required to identify where support exists in the specification for the
claims, or to identify groups of claims that are similar and define
similar limitations.

   Response: There is no prohibition against applicants submitting
claim charts to illustrate the differences between claims. The Office
does not consider it necessary at this time to make claim charts a
requirement.

   Comment 257: One comment inquired why, when claims in excess of ten
are designated, a justification for all designated claims must be
supplied and not just the number in excess of ten representative
claims.

   Response: The Office is not adopting the "representative claims"
examination approach in this final rule. Under this final rule,
applicant is required to file an examination support document when
applicant presents more than five independent claims or more than
twenty-five total claims in an application. In order to best assist in
examination, the examination support document must cover all of the
claims (in independent or dependent form) in the application, and not
just the independent claims in excess of five or the total claims in
excess of twenty-five.

I. The Office's Authority To Promulgate the Changes in This Final Rule

   Comment 258: A number of comments argued that the changes to the
rules of practice being adopted in this final rule are beyond the
Office's rulemaking authority under 35 U.S.C. 2(b)(2). The comments
argued that the proposed §§ 1.75(b), 1.78(d), and 1.78(f) are
substantive and not procedural in nature because they affect an
applicant's right to receive a patent for an invention or an
applicant's ability to claim what the applicant regards as the
invention.

   Response: The Office has the authority under 35 U.S.C. 2(b)(2) to
establish regulations, not inconsistent with law, which shall govern
the conduct of proceedings in the Office. The "conduct of proceedings
in the Office" provision of 35 U.S.C. 2(b)(2) (as well as former 35
U.S.C. 6(a)), however, is not limited to what might be characterized as
"procedural" rather than "substantive" rules. See United States v.
Haggar Apparel Co., 526 U.S. 380, 387-88 (1999). Simply contending that
a regulation is "substantive and not procedural" fails to address the
issue because a regulation that relates to application processing
within the Office and that is not inconsistent with law falls within
the Office's rulemaking authority. See In re Van Ornum, 686 F.2d 937,
945, 214 U.S.P.Q.2d 761, 768 (C.C.P.A. 1982) ("Appellants say the
regulation is `invalid on its face' but they do not explain why beyond
contending it is `substantive and not procedural.' We can give no
weight to that contention. True, the rule is substantive in that it
relates to a condition under which a patent will be granted which
otherwise would have to be denied for double patenting. Much of the
content of the PTO rules is `substantive' in this respect. The
regulation clearly relates to application processing within the PTO in
a manner consistent with statutory and case law, which is its principal
business.").

   The regulations at issue in this final rule concern application
processing exclusively within the Office. The changes to § 1.75 being
adopted in this final rule govern the requirements relating to the
examination of the claims in an application, as is provided for in 35
U.S.C. 131. The changes to § 1.78(d) being adopted in this final rule
govern the conditions under which an application may contain or be amended
to contain a claim under 35 U.S.C. 120, 121, or 365(c) to the benefit of a
prior-filed application. The changes to § 1.78(f) being adopted in
this final rule govern the requirements relating to the filing and
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1142 

examination of multiple applications by a common owner. The filing of
an application for patent, amendment of an application, and the
examination of an application are proceedings that take place
exclusively within the Office. Therefore, regulations governing
requirements relating to the filing, amendment, and examination of an
application fall squarely within the Office's authority under 35 U.S.C.
2(b)(2) to establish regulations which "govern the conduct of proceedings
in the Office."

   The substantive right at issue during the patent examination
process involves whether the applicant has met the conditions and
requirements under title 35, United States Code, to be entitled to a
patent, rather than the ability to file and maintain an unlimited
number of continuing applications or requests for continued examination
or the ability to refrain from obtaining and providing information
pertinent to the examination of the application to the Office. See,
e.g., 35 U.S.C. 101 ("[w]hoever invents or discovers any new and
useful process, machine, manufacture, or composition of matter, or any
new and useful improvement thereof, may obtain a patent therefor,
subject to the conditions and requirements of this title"). The
changes in this final rule do not preclude applicants from obtaining a
patent on an invention, discourage, impede, or block an applicant's
statutory right to a patent, or stifle inventors' rights to protect
their inventions.

   The changes to continuing application practice adopted in this
final rule do not set a per se limit on the number of continuing
applications that an applicant may file. That is, applicant may
automatically file a first and second continuation application without
any justification and may file any number of additional continuation
applications as long as he or she justifies each filing by a showing as
to why the amendment, argument or evidence sought to be entered could
not have been previously presented. Therefore, the changes to the final
rule do not affect an applicant's right to receive a patent for an
invention. The modification to continuation practice simply improves
the procedures under which an applicant may file a continuation
application by focusing and consolidating the examination process.
Furthermore, as an alternative, an applicant may choose to file an
appeal when confronted with a rejection that he or she feels is
improper. The changes adopted in this final rule to the continuing
application practice prevent applicants from unnecessarily prolonging
prosecution of applications before the Office.

   The changes to the examination of claims practice adopted in this
final rule do not prevent an applicant from presenting as many claims
as are considered necessary or desirable to protect the full scope of
the invention. The changes to the examination of claims practice
adopted in this final rule simply provide that if an applicant exceeds
or contemplates exceeding a specified threshold (five independent
claims or twenty-five total claims), the applicant can provide for that
eventuality by submitting additional information to the Office in an
examination support document in order to facilitate effective
examination of the application. The submission of an examination
support document does not change the substantive criteria applied
during examination (i.e., the statutory standards of patentability set
forth in title 35, United States Code) to determine the applicant's
entitlement to a patent.

   The patentably indistinct claims provisions do not affect
applicant's patent rights because once the required explanation of
patentable indistinctness has been provided, the claimed invention is
examined on the merits and patentability is determined by the Office.
The requirement that applicant show that claims are patentably distinct
up front is simply a tool to focus and consolidate the examination of
multiple applications.

Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1143 

   Comment 259: A number of comments suggested that a requirement of a
showing to obtain an additional continuation application is contrary to
35 U.S.C. 120, 121, 365, 132(b), and other sections of title 35, United
States Code, under which an applicant has a right to file an unlimited
number of continuation applications. The comments suggested that: (1)
The proposed rules disregard case law, in particular, In re Hogan, 559
F.2d 595, 194 U.S.P.Q. 527 (C.C.P.A. 1977), and In re Henriksen, 399
F.2d 253, 158 U.S.P.Q. 224 (C.C.P.A. 1968); (2) the Office does not
have authority to limit the number of continuing applications under 35
U.S.C. 2(b)(2) because the proposed rules are inconsistent with the
law, and specifically do not "facilitate and expedite the processing
of patent applications"; (3) the changes to § 1.78 cut off
substantive rights for reasons other than patentability (as set forth
in 35 U.S.C. 102, 103 and 112 of title 35, United States Code) and
procedural misconduct, and thus are in violation of 35 U.S.C. 131; (4)
the changes to § 1.78 are inconsistent with 35 U.S.C. 131 or 132,
because the Director does not have the statutory discretion under these
provisions to refuse to examine or to reexamine any application; (5)
the requirement for a "showing" is contrary to law because the Office
has no authority to deny an applicant the right to file a continuation
application or a request for continued examination; (6) no
justification or legal basis exists for the petition requirements set
forth in the rules to get the benefit of an earlier filing date under
35 U.S.C. 120 or 365; (7) the Office has no statutory authority to
delete a claim to priority in a continuing application filed according
to the statutory provisions; and (8) applicants have a right to file a
continuation application, as long as the reason is not improper, unduly
successive or repetitive, citing Godfrey v. Eames, 68 U.S. (1 Wall.)
317, 325-26 (1864). Other comments, however, suggested that the
proposed rules are consistent with both statute and case law given
that: (1) The Office is not instituting a per se numerical limit on the
number of continuation applications that an applicant may file; and (2)
applicants are afforded an opportunity to justify by a showing the need
to file additional continuation applications.

   Response: None of the statutory provisions or case law cited by the
comments provides that an applicant may file an unlimited number of
continuing applications or requests for continued examination.
   None of the statutory provisions related to continuing applications
cited by the comment provide that an applicant may file an unlimited
number of continuing applications. 35 U.S.C. 120 simply provides that
an applicant may claim the benefit of the filing date of a prior-filed
application provided that certain conditions are satisfied. 35 U.S.C.
121 provides that if the Director requires that an application
containing claims to two or more independent and distinct inventions be
restricted to one of the inventions and a non-elected invention is made
the subject of a divisional application, the applicant in the divisional
application may claim the benefit of the filing date of prior-filed
application provided that the conditions specified in 35 U.S.C. 120 are
satisfied. 35 U.S.C. 365(c) provides that an applicant in an
international application designating the United States may claim the
benefit of the filing date of a prior-filed national application or a
prior-filed international application designating the United States,
and that an applicant in a national application may claim the benefit
of the filing date of a prior-filed international application
designating the United States, again provided that the conditions
specified in 35 U.S.C. 120 are satisfied.

   Since 35 U.S.C. 120, 121 and 365(c) all hinge upon 35 U.S.C. 120,
the response focuses on that provision. 35 U.S.C. 120 provides that:

   An application for patent for an invention disclosed in the
manner provided by the first paragraph of section 112 of this title
in an application previously filed in the United States, or as
provided by section 363 of this title, which is filed by an inventor
or inventors named in the previously filed application shall have
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1144 

the same effect, as to such invention, as though filed on the date
of the prior application, if filed before the patenting or
abandonment of or termination of proceedings on the first
application or on an application similarly entitled to the benefit
of the filing date of the first application and if it contains or is
amended to contain a specific reference to the earlier filed
application. No application shall be entitled to the benefit of an
earlier filed application under this section unless an amendment
containing the specific reference to the earlier filed application
is submitted at such time during the pendency of the application as
required by the Director. The Director may consider the failure to
submit such an amendment within that time period as a waiver of any
benefit under this section. The Director may establish procedures,
including the payment of a surcharge, to accept an unintentionally
delayed submission of an amendment under this section.

   35 U.S.C. 120 (2000).

   35 U.S.C. 120 has been revised significantly since its codification
as part of the 1952 Patent Act. 35 U.S.C. 120 as codified in the 1952
Patent Act provided that: "[a]n application for patent for an
invention disclosed in the manner provided by the first paragraph of
section 112 of this title in an application previously filed in the
United States by the same inventor shall have the same effect, as to
such invention, as though filed on the date of the prior application,
if filed before the patenting or abandonment of or termination of
proceedings on the first application or on an application similarly
entitled to the benefit of the filing date of the first application and
if it contains or is amended to contain a specific reference to the
earlier filed application." 35 U.S.C. 120 (1952). 35 U.S.C. 120 was
amended in 1975 to add "or as provided by section 363 of this title"
to provide for claims under 35 U.S.C. 120 to the benefit of an
international application filed under the PCT (i.e., international
applications filed under 35 U.S.C. 363). Pub. L. 94-131, section 9, 89
Stat. 685, 692 (1975). 35 U.S.C. 120 was amended again in 1984 to
substitute "by an inventor or inventors named in the previously filed
application" for "by the same inventor" for consistency with the
changes to the inventorship provisions of 35 U.S.C. 116. Public Law 98-
622, section 104(b), 98 Stat. 3383, 3385 (1984). 35 U.S.C. 120 was
finally amended in 1999 to give the Director greater authority with
respect to setting forth the time period within which claims to the
benefit of a prior-filed application must be submitted by adding:

   No application shall be entitled to the benefit of an earlier
filed application under this section unless an amendment containing
the specific reference to the earlier filed application is submitted
at such time during the pendency of the application as required by
the Director. The Director may consider the failure to submit such
an amendment within that time period as a waiver of any benefit
under this section. The Director may establish procedures, including
the payment of a surcharge, to accept an unintentionally delayed
submission of an amendment under this section.

   Public Law 106-113, 113 Stat. 1501, 1501A-563 through 1501A-564 (1999).
Thus, 35 U.S.C. 120 has never contained any language either expressly
or implicitly stating that an applicant may file an unlimited number of
continuing applications.

   Turning to the legislative history of the 1952 Patent Act, it does
not mention whether an applicant may file an unlimited number of
continuing applications. The Senate Report simply documents that
"[s]ections 120 and 121 express in the statute certain matters which
exist in the law today but which had not before been written into the
statute, and in so doing make some minor changes in concepts
involved." S. Rep. No. 1979, at 2400 (June 27, 1952). The House Report
contains basically the same description for 35 U.S.C. 120. The
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1145 

testimony from hearings before a Subcommittee of the Committee on the
Judiciary, House of Representatives, for the 82nd Congress, held on
June 13, 14, and 15, 1951, contains the same description for 35 U.S.C.
120 and little else of substance. For example, P.J. Federico testified:
"Sections 120 and 121 express in the statute certain things which
exist in the law today that have not been written into the statute, and
in so doing make some changes in the concepts involved." Patent Law
Codification and Revision, 82d Cong. 39 (June 13, 1951) (statement of
P.J. Federico, Examiner-In-Chief, United States Patent Office).
Additionally, as noted in the congressional record for the 1952 Patent
Act, 35 U.S.C. 120 codified existing patent practice. 98 Cong. Rec. 7,
9323 (June 28, 1952 to July 7, 1952) (statements of Senators
Saltonstall and McCarran). In particular, "[t]he provisions set out in
section 120 giving the applicant the benefit of the date of an earlier
application by him for the same invention constitute a restatement of
the former practice which was not, however, spelled out in the former
law." Charles L. Zinn, Commentary on New Title 35, U.S. Code
"Patents" 2515.

   Secondary sources providing information about 35 U.S.C. 120 also do
not offer guidance with respect to whether an applicant may file an
unlimited number of continuing applications. The 1952 Patent Act was
drafted by: (1) P.J. Federico, Examiner-In-Chief of the Patent Office;
(2) Giles S. Rich, then an attorney of some twenty years representing
the National Council of Patent Law Associations; (3) Paul Rose,
chairman of the laws and rules committee of the American Patent Law
Association; and (4) Henry Ashton, a representative of the coordinating
committee on revision and amendment of the patent laws of the National
Council of Patent Law Associations. See generally, Giles S. Rich,
Congressional Intent - Or, Who Wrote the Patent Act of 1952, Patent
Procurement and Exploitation (BNA 1963), reprinted in Nonobviousness -
The Ultimate Condition of Patentability (John F. Witherspoon ed., 1983)
(hereinafter "Rich on Congressional Intent"). Following enactment,
Federico gave a series of lectures to teach the patent bar about the
new law. Federico's lectures were transcribed, consolidated, and
reprinted for many years in title 35, United States Code Annotated. See
35 U.S.C.A. sections 1 to 110 (1954). The Federal Circuit has
considered Federico's Commentary to be "an invaluable insight into the
intentions of the drafters of the Act." Symbol I, 277 F.3d at 1366, 61
U.S.P.Q.2d at 1519.

   Federico explained that 35 U.S.C. 120 was "not specified in the
old statute but was developed by decisions of the courts beginning with
a decision of the Supreme Court of 1864, Godfrey v. Eames." P.J.
Federico, Commentary on the New Patent Act, 75 J. Pat. & Trademark Off.
Soc'y 3, 192 (Mar. 1993) (hereinafter "Federico's Commentary"). After
offering this opening statement, he then set forth the three requirements
fora continuation application required by 35 U.S.C. 120 and elaborated on
the meaning of each of these three requirements.

   Although Federico's Commentary did not expressly mention any limits
or conditions on an applicant's ability to file a continuation, it also
did not state that the drafters contemplated allowing an applicant to
file an unlimited number of continuation applications. Thus, there is
nothing which indicates that the drafters intended to permit an
applicant to file an unlimited number of continuing applications. What
is more, Federico described examples of situations where continuations
were used before the codification of the 1952 Patent Act:

   Continuing applications are utilized in a number of different
situations; for example, in the case of a requirement to restrict an
application to a single invention a second application might be
filed for the invention excluded from the the [sic] first
application as explained in connection with the next section of the
law, or a second application might be filed for a separable
invention even though no requirement was made. A continuing
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1146 

application with the disclosure the same as a first application
might sometimes be filed for procedural reasons with the first
application thereafter being abandoned. And a continuing application
with added subject matter may sometimes be filed when the inventor
has additional details relating to the invention which he wishes to
disclose in the application; in such cases the second application
would be entitled to the date of the first application only as to
the common subject matter.

   Federico's Commentary, 5 J. Pat. & Trademark Soc'y at 194.

   Federico's list, albeit not exhaustive, suggests that patent
practitioners used continuing applications in more limited
circumstances before the 1952 Patent Act than today. His first example
focuses on the divisional-type situation where a continuing
(divisional) application is pursued to protect a second invention as a
result of a restriction in the initial application. His third example
focuses on a continuation-in-part situation where a continuing
application is filed to enable an applicant to add subject matter to
the application. Only his second example contemplates anything like
current continuation practice where a continuing application is filed
to pursue protection for an invention disclosed in the initial
application. Federico nevertheless explained that the first application
to which the continuing application claims priority is abandoned after
the continuation is filed.

   Federico did not include the then-rare situation in which the first
application issued as a patent and the continuing application was filed
to pursue further protection for the invention of the patent on the
first application. At the time of the 1952 Patent Act the double
patenting doctrine did not permit a patentee to obtain more than one
patent on patentably indistinct subject matter. See e.g., Miller v.
Eagle Mfg. Co., 151 U.S. 186, 199 (1894) (the "a patent" for an
invention provision does not permit a patentee to obtain more than one
patent on patentably indistinct subject matter). Even after the 1952
Patent Act, the double patenting provision of 35 U.S.C. 101 ("a
patent" for an invention), like its predecessor, was interpreted as
precluding a patentee from obtaining more than one patent on patentably
indistinct subject matter. See, e.g., In re Ockert, 245 F.2d 467, 469,
114 U.S.P.Q. 330, 332 (C.C.P.A. 1957)). It was not until 1970 that the
Court of Customs and Patent Appeals held that the double patenting
provision of 35 U.S.C. 101 precluded only "same invention" double
patenting (i.e., two patents containing claims to identical subject
matter) and permitted the use of a terminal disclaimer to overcome
double patenting unless the application and patent were claiming
identical subject matter. See In re Vogel, 422 F.2d 438, 441, 164
U.S.P.Q. 617, 622 (C.C.P.A. 1970). Thus, applicants today frequently do
not abandon the initial application, but instead prosecute the initial
application in parallel with the continuation application. Because of
the development of terminal disclaimer practice, the authors of the
1952 Patent Act would not have contemplated a continuing application
system under which an applicant would file an unlimited number of
continuing applications.

   Moreover, both before and long after the 1952 Patent Act applicants
did not file long strings of continuation applications as is often done
today. Indeed, the Board of Patent Appeals (Board) in Henriksen
attempted to identify cases involving a series of more than three
patents from cases litigated in the courts and patents issued by the
Office during the week of April 26, 1966. Ex parte Henriksen, 154
U.S.P.Q. 53, 58-59 (Pat. Off. Bd. App. 1966). The Board in Henriksen
was unable to isolate a single case involving a priority chain longer
than three applications, with one exception that the Board nevertheless
dismissed because the case was quite old, dating to 1867, and because
the factual record was developed under different law. Id. at 58, n.2
(referring to the case as "an antique curiosity"). Based on the
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1147 

Board's research, it appears that priority chains having more than
three family members were actually uncommon, if they existed at all,
before the 1952 Patent Act. Thus, if anything, the drafters of the Act,
seeking to codify existing practice, did not envision that an applicant
would use the provisions of 35 U.S.C. 120 to file and maintain an
unlimited number of continuing applications.

   Following the enactment of the 1952 Patent Act, case law has
specifically addressed the imposition of limits or conditions on
continuation practice in the two cases cited by the comments (Henriksen
and Hogan). In Henriksen and Hogan, the Court of Customs and Patents
Appeals (C.C.P.A.) overturned rulings by the Board denying an
applicant's priority claim to earlier - filed applications. In Hogan,
the Board sought - without prior warning - to limit the number of
continuations by restricting the applicant from claiming priority where
the continuation applications covered a pendency period of twenty-four
years. In Henriksen, the Board took the position that 35 U.S.C. 120
imposed a per se limit on the number of permissible continuations.

   The changes adopted in this final rule, however, do not set a limit
on the applicant's ability to claim the benefit of a prior-filed
application regardless of the pendency period, nor do they set a per se
limit on the number of continuing applications that an applicant may
file. See Changes to Practice for Continuing Applications, Requests for
Continued Examination Practice, and Applications Containing Patentably
Indistinct Claims, 71 FR at 50, 1302 Off. Gaz. Pat. Office at 1320
("No limit is placed on the number of continuing applications.").
Applicant may automatically file a first and second continuation
application and further extend examination by filing a request for
continued examination. After these options are exhausted an applicant
may also file any number of third and subsequent continuation
applications as long as the applicant justifies each filing by a
showing that amendment, argument, or evidence sought to be entered
could not have been presented earlier. The Henriksen court objected to
the approach taken by the Board in changing continuing application
practice retroactively. The Henriksen court objected to the Board
changing the interpretation of the provisions of 35 U.S.C. 120 and
applying that interpretation to previously filed applications. The
Henriksen court specifically stated that:

   The action of the board is akin to a retroactive rule change
which may have the effect of divesting applicants of valuable rights
to which, but for the change in Patent
Office position brought about by the board's decision, they were
entitled. Nothing appears in the Patent Office Rules of Practice or
the Manual of Patent Examining Procedure which sanction such a
result.

   Henriksen, at 399 F.2d at 261-62, 158 U.S.P.Q. at 231. In Henriksen
and Hogan, the Office had not promulgated any rules, let alone given the
public notice of, or an opportunity to respond to, the ad hoc limits
imposed. By contrast, the Office here is pursuing prospective rule
making, having given the public notice of the changes to § 1.78 and
an opportunity to comment.

   Although the Court of Customs and Patent Appeals in a "post
script" mentioned congressional resolution to remedy the abuses
associated with continuation applications in both Henriksen and Hogan,
the court seemed more concerned with the openness of the process for
effecting change. Henriksen, 399 F.2d at 262, 158 U.S.P.Q. at 231.
Here, the Office is adopting the prospective and open process missing
in Hogan and Henriksen. The Office has given the public the opportunity
to participate in shaping the rules for continuing application
practice, received hundreds of comments, and has modified the proposed
rules in response to those public comments.

Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1148 

   More recent case law demonstrates that an applicant does not have
the right to file an endless stream of continuing applications. See
Symbol I, supra, In re Bogese II, 303 F.3d 1362, 64 U.S.P.Q.2d 1448
(Fed. Cir. 2002), and Symbol Techs. v. Lemelson Medical, Educ. &
Research Found., 277 F.3d 1361, 61 U.S.P.Q.2d 1515 (Fed. Cir. 2002)
(Symbol II). Symbol II, Bogese II and Symbol I suggest that the Office
has the authority to place reasonable restrictions and requirements on
the filing of continuing applications, just as it can place reasonable
restrictions and requirements on the prosecution of those applications.
In addition, the court in Bogese II expressly rejected the view that
its previous case law (e.g., Henriksen) stood for the broad proposition
that 35 U.S.C. 120 gave applicants carte blanche to prosecute
continuing applications in any desired manner. Rather, it held that,
while the statute itself provided no limit on the number of
applications that may be co-pending, "[n]owhere does [the prior case
law] suggest or imply that the PTO must allow dilatory tactics or that
the PTO lacks inherent power to prohibit unreasonable delay in
prosecution." Bogese II, 303 F.3d at 1368 n.6, 64 U.S.P.Q.2d at 1452
n.6.

   By amending the procedures under which an applicant may file
continuation applications, the Office is seeking to encourage the
prompt presentation of amendment, argument and evidence in patent
prosecution. To do so, the Office has determined that it must, at some
point, change the continuing application practice that has facilitated
the past dilatory presentation of amendment, argument and evidence that
could have been presented earlier. The changes adopted in this final
rule allow an applicant the flexibility to choose between filing a
continuing application and filing an appeal, but do not permit an
applicant to persist indefinitely before the examiner rather than seek
an appeal. Therefore, this final rule does not preclude an applicant
from obtaining a patent on an invention when requirements of title 35,
United States Code, are satisfied. As explained in the Continuing
Applications Proposed Rule, the changes to § 1.78 will "make the
exchange between examiners and applicants more efficient, get claims to
issue faster, and improve the quality of issued patents." See Changes
to Practice for Continuing Applications, Requests for Continued
Examination Practice, and Applications Containing Patentably Indistinct
Claims, 71 FR at 50, 1302 Off. Gaz. Pat. Office at 1320.

   Like the statutory provisions for continuing applications, the
statutory provision for requests for continued examination, namely, 35
U.S.C. 132(b), does not provide that an applicant may file an unlimited
number of requests for continued examination. As discussed previously,
the provisions of 35 U.S.C. 132(b) were added relatively recently by
section 4403 of the AIPA. See Public Law 106-113, 113 Stat. 1501,
1501A-560 (1999). 35 U.S.C. 132(b) provides that:

   The Director shall prescribe regulations to provide for the
continued examination of applications for patent at the request of
the applicant. The Director may establish appropriate fees for such
continued examination and shall provide a 50 percent reduction in
such fees for small entities that qualify for reduced fees under
section 41(h)(1) of this title.

   35 U.S.C. 132(b) (2000). The Office first implemented the provisions
of 35 U.S.C. 132(b) by a final rule in August of 2000 that was preceded by
an interim rule in March of 2000. See Request for Continued Examination
Practice and Changes to Provisional Application Practice, 65 FR 50092
(Aug. 16, 2000), 1238 Off. Gaz. Pat. Office 13 (Sept. 5, 2000) (final
rule), Changes to Application Examination and Provisional Application
Practice, 65 FR 14865 (Mar. 20, 2000), 1233 Off. Gaz. Pat. Office 47
(Apr. 11, 2000) (interim rule).

   The AIPA is title IV of the Intellectual Property and
Communications Omnibus Reform Act of 1999 (S. 1948), and was
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1149 

incorporated and enacted into law as part of Public Law 106-113. The
Conference Report for H.R. 3194, 106th Cong., 1st. Sess. (1999), which
resulted in Public Law 106-113, does not contain any discussion (other
than the incorporated language) of S. 1948. See H.R. Conf. Rep. No.
106-497, at 37 and 1089-174 (1999). A section-by-section analysis of S.
1948, however, was printed in the Congressional Record at the request
of Senator Lott. See 145 Cong. Rec. S14,708-26 (1999) (daily ed. Nov.
17, 1999). This section-by-section analysis of S. 1984 provides with
respect to 35 U.S.C. 132(b) that:

   Section 4403 amends section 132 of the Patent Act to permit an
applicant to request that an examiner continue the examination of an
application following a notice of "final" rejection by the
examiner. New section 132(a) authorizes the Director to prescribe
regulations for the continued examination of an application
notwithstanding a final rejection. The Director may also establish
appropriate fees for continued examination proceedings, and shall
provide a 50% fee reduction for small entities which qualify for
such treatment under section 41(h)(1) of the Patent Act.

   145 Cong. Rec. S14,718.

   35 U.S.C. 132(b) does not specify the conditions and requirements
for continued examination under 35 U.S.C. 132(b), but rather authorizes
the Director to "prescribe regulations to provide for the continued
examination of applications for patent at the request of the
applicant." See 35 U.S.C. 132(b). There is nothing in 35 U.S.C. 132(b)
that precludes the Office from promulgating regulations that provide
for no more than a single request for continued examination under 35
U.S.C. 132(b), or precludes the Office from requiring that any request
for continued examination under 35 U.S.C. 132(b) include a showing as
to why the amendment, argument or evidence could not have been
previously presented.

   Comment 260: A number of comments expressed the opinion that any
limitation on continuations should be done legislatively by
congressional action and not by the Office via rule making. Some
comments argued that the Office is usurping the legislative role of
Congress by modifying continuation practice via regulation, arguing
Congress by inaction tacitly endorses the current practice, and that
the Federal Circuit has acknowledged that limiting continuation
practice is an issue best left to Congress, citing Ricoh Co., Ltd. v.
Nashua, 185 F.3d 884 (Fed. Cir. 1999) (nonprecedential decision). Some
comments suggested that the Office should not adopt sweeping changes
unless and until Congress acts to address the issues through the
pending patent reform legislation, which would ensure consistency with
previous legislative acts. Some comments argued that questions
regarding the Office's statutory authority to make the proposed changes
would likely lead to litigation and a period of uncertainty until the
matter can be resolved either judicially or legislatively. Several
comments also suggested that the proposed changes to continuation
practice will ultimately result in an even larger backlog at the Office
should the Federal Circuit hold the proposed changes to be contrary to
law, arguing that applicants in the meantime are left in a state of
limbo until the courts finally resolve the matter. One comment argued
that the Office's stated rationale regarding the public notice function
of claims is not consistent with the law and is more appropriately
addressed by Congress or the courts. Two comments also suggested that
rules limiting the number of continuing applications are
unconstitutional because they exceed the rule making authority of the
Office, thereby suggesting that the Office should have sought these
changes via legislation, not rule making.

   Response: The Office is not usurping the legislative role of
Congress, but instead acting consistently with the authority given to
the Office by Congress. Pursuant to 35 U.S.C. 2(b)(2)(A), Congress has
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1150 

given the Office the authority to establish regulations that "govern
the conduct of proceedings in the Office." By the grant of authority
in 35 U.S.C. 2(b)(2)(A), "Congress [is understood] to have `delegated
plenary authority over PTO practice' * * * to the Office." Stevens v.
Tamai, 366 F.3d 1325, 1333, 70 U.S.P.Q.2d 1765, 1771 (Fed. Cir. 2004)
(quoting Gerritsen v. Shirai, 979 F.2d 1524, 1527 n.3, 24 U.S.P.Q.2d
1912, 1915 n.3 (Fed. Cir. 1992)). Therefore, the decision to make these
changes via rule making is not an unconstitutional exercise of the
Office's rule making authority under 35 U.S.C. 2(b)(2).

   Additionally, the provisions of § 1.78, which concern
continuing applications, govern proceedings in the Office because they
set forth the process by which an applicant can file a continuing
application. See Changes to Practice for Continuing Applications,
Requests for Continued Examination Practice, and Applications
Containing Patentably Indistinct Claims, 71 FR at 50, 1302 Off. Gaz.
Pat. Office at 1320 (noting that continuation practice is "a
procedural device that permits an applicant to amend his application
after rejection and receive examination of the `amended' (or new)
application") (citing In re Bogese I, 22 U.S.P.Q. 2d at 1824).
Specifically, under revised § 1.78, an applicant may automatically
file a first and second continuing application and then may file any
number of third and subsequent continuing applications as long as the
applicant justifies each filing by a showing as to why the amendment,
argument or evidence sought to be entered could not have been
previously presented. Furthermore, as an alternative, an applicant may
choose to file an appeal when confronted with a rejection that he or
she feels is improper. The changes adopted in this final rule do not
impede or block an applicant's statutory right to a patent.

   The Office is responsible for the granting and issuing of patents
and has the authority and responsibility to establish regulations that
govern the conduct of proceedings in the Office and facilitate and
expedite the processing of patent applications. See 35 U.S.C. 2(a)(1)
and (b)(2). The Office has the responsibility to take appropriate
action in the near term to improve patent quality and pendency issues
rather than wait for possible legislative solutions to these issues.
The Office is implementing the rule changes via the rule making
procedures set forth in 35 U.S.C. 2(b)(2)(A) and 5 U.S.C. 553 by
publishing the proposed rules in the Federal Register and giving the
public the opportunity for comment. Thus, the Office is acting under
the broad rule making authority delegated to it by Congress. Were the
Office to sit idle and not set forth procedures to govern a continuing
application practice that has become problematic, the Office would be
ignoring the responsibility imposed on it by Congress in 35 U.S.C.
2(b)(2)(A). Finally, inaction by Congress is not a tacit endorsement of
the current continuing application practice (see United States v.
Price, 361 U.S. 304, 310-11 (1960) ("nonaction by Congress affords the
most dubious foundation for drawing positive inferences")), and the
Federal Circuit has cautioned against reliance upon nonprecedential
decisions such as Ricoh Co., Ltd. v. Nashua (see Symbol I, 277 F.3d at
1368, 61 U.S.P.Q.2d at 1520, declining to consider the nonprecedential
opinions Ricoh Co., Ltd. v. Nashua and Bott v. Four Star Corp., 848
F.2d 1245 (Fed. Cir. 1988)).

   Comment 261: A few comments suggested that patent reform
legislation indicates that the Office does not have the authority to
limit the number of continuing applications, citing The Patent Reform
Act of 2005, H.R. 2795, 109th Cong. § 8 (2005). One comment
specifically suggested that Congress' decision to remove authority to
limit continuations from later patent reform legislation indicates that
Congress is still debating the issue and that the Office does not have
that authority. One comment suggested that Congress' intent is not to
limit the number of applications that an applicant may file or the
number of inventive concepts that an application may pursue, because
that would stifle inventors' rights to protect their inventions.
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1151 


   Response: The Office notes that legislation was pending before the
109th Congress (The Patent Reform Act of 2005) which, as introduced on
June 8, 2005, contained a provision (section 8) that expressly
authorized the Office to limit certain continuing applications. The
Office also notes that the House Subcommittee on Courts, the Internet,
and Intellectual Property held a hearing on September 15, 2005, on a
proposed substitute that did not contain such a provision. No further
action, however, was taken on this legislation by the 109th Congress.
The Office does not consider this course of events as constituting any
evidence of "congressional intent" because the legislation at issue
(The Patent Reform Act of 2005) was not voted on by either House of
Congress, or even a Committee or Subcommittee of either House of
Congress. Thus, this change between the legislation as introduced and
as amended is at most evidence of the intent of a drafting committee.
In any event, the 109th Congress did not enact changes to the
provisions of 35 U.S.C. 2(b), 120, 121, 131, 132, or 365. Rather, the
provisions at issue were enacted by earlier Congresses. The views of a
subsequent Congress have little relevance in determining the intent of
an earlier Congress. See United States v. Southwestern Cable Co., 392
U.S. 157, 170 (1968) ("The views of one Congress as to the
construction of a statute adopted many years before by another Congress
have very little, if any, significance."). This is especially true
when the gap is as broad as the one here, spanning more than half a
century (i.e., 1952-2005).

   Furthermore, this final rule does not stifle inventors' rights
because it provides inventors with ample opportunity to present their
claims and secure protection for their inventions. In fact, this final
rule encourages inventors to fully disclose and fully claim their
inventions promptly, on first filing. Applicants may file two
continuation or continuation-in-part applications and a
request for continued examination in an application family, without any
justification and may file additional continuing applications or
requests for continued examination on a showing that the amendment,
evidence or argument could not have been earlier presented. Finally,
this final rule does not affect the patentability requirement of title
35, United States Code.

   Comment 262: A few comments asserted that the doctrine of
prosecution laches, originally set forth by the Federal Circuit in
Bogese II, and more recently endorsed by the Federal Circuit in Symbol
II, does not extend the Office's authority to deny benefit claims to
legitimate continuing applications.

   Response: The Office is not using the doctrine of prosecution
laches as a sword to sever an applicant's priority claim. Nor are the
changes adopted in this final rule an attempt to codify Bogese II or to
combat extreme cases of prosecution laches. See Changes to Practice for
Continuing Applications, Requests for Continued Examination Practice,
and Applications Containing Patentably Indistinct Claims, 71 FR at 50,
1302 Off. Gaz. Pat. Office at 1320. Applicants and practitioners have a
duty to refrain from submitting an application or other filing to cause
unnecessary delay or needless increase in the cost of prosecution
before the Office. See § 10.18(b)(2). Applicants also have a duty
throughout prosecution of an application for patent to make a bona fide
attempt to advance the application. See Changes to Practice for
Continuing Applications, Requests for Continued Examination Practice,
and Applications Containing Patentably Indistinct Claims, 71 FR at 49,
1302 Off. Gaz. Pat. Office at 1319. In Symbol I, Symbol II, and Bogese
II, the Federal Circuit recognized that an applicant has a duty of good
faith in advancing the prosecution of an application. The Federal
Circuit likewise held that an applicant does not have the right to file
an endless stream of continuing applications in order to prolong
prosecution for the purpose of gaming the system. That is, applicants
should not rely on an unlimited number of continuing applications to
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1152 

either correct deficiencies in the claims and disclosure, or to delay
the conclusion of examination in a calculated manner. By requiring
applicants to show why the amendment, argument, or evidence sought to
be entered in a third or subsequent continuing application or second or
subsequent request for continued examination could not have been
presented earlier, the Office is ensuring that applicants are not
unnecessarily prolonging prosecution of the application before the
Office.

   The possibility that, without justification, a string of continuing
applications could last as long as two decades has created
inefficiencies and opportunities for the delay of proceedings before
the Office that, as a practical matter, can only be addressed by
general rule making. Requiring that, at a given stage in the continuing
application process, an applicant must make an affirmative showing of
need is necessary for the Office to assure an effective examination
process. Relying only on a case-by-case approach to address the most
egregious cases of abuse would not be sufficient when continued
examination filings (other than divisional applications) have grown
from less than twelve percent of total filings in 1980 to over twenty-
nine percent of total filings in fiscal year 2006. The Federal Circuit
specifically indicated in Bogese II that the Office has the inherent
authority to set reasonable deadlines and requirements for the
prosecution of patent applications. See Bogese II, 303 F.3d at 1368
n.6, 64 U.S.P.Q.2d at 1452 n.6 ("The PTO is the administrative agency
that is `responsible for the granting and issuing of patents * * *' 5
U.S.C. 2 (2000). Like other administrative agencies, the PTO may impose
reasonable deadlines and requirements on parties that appear before it.
The PTO has inherent authority to govern procedure before the PTO, and
that authority allows it to set reasonable deadlines and requirements
for the prosecution of applications."). Thus, consistent with the
Office's inherent authority to set reasonable deadlines and
requirements for the prosecution of applications, and to improve the
effectiveness of the patent examination process, the Office is revising
the rules of practice to require that an applicant make an affirmative
justification for a third or subsequent continuing application or
second or subsequent request for continued examination.

   Comment 263: Two comments argued that the proposed rules prevent an
applicant from filing even a single continuation application of an
application in which a request for continued examination was previously
filed, thereby eliminating access to the benefits conferred by 35
U.S.C. 120.

   Response: The Office has modified the proposed changes such that an
applicant is permitted under this final rule to file a first and second
continuation application or continuation-in-part application without
any justification, and is also permitted to file a request for
continued examination in any one of the initial application, the first
continuing application, or the second continuing application without
any justification. Thus, under § 1.78 as adopted in this final
rule, an applicant may file two continuation applications without any
justification, even if a request for continued examination was
previously filed in the initial application.

   Comment 264: Several comments suggested that the definition of a
"divisional application," as specified in proposed § 1.78, is
inconsistent with 35 U.S.C. 121 because, under proposed § 1.78, a
divisional application is limited to only one application, whereas 35
U.S.C. 121 permits applicants to file a divisional application for each
invention restricted out. Another comment suggested that 35 U.S.C. 121
permits applications that are both a divisional application and a
continuation-in-part application and any rule to the contrary is void.

   Response: This final rule defines a "divisional application" as
an application "that discloses and claims only an invention or
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1153 

inventions that were disclosed and claimed in a prior-filed
application, but were subject to a requirement to comply with the
requirement of unity of invention under PCT Rule 13 or a requirement
for restriction under 35 U.S.C. 121 in the prior-filed application and
not elected for examination and not examined in any prior-filed
application." See § 1.78(a)(2). This definition is consistent with
35 U.S.C. 121, which states that the divisional application resulting
from a restriction requirement is "entitled to the benefit of the
filing date of the original application," where the "original
application" within the context of 35 U.S.C. 121 is the application
from which the divisional application has been restricted.
Additionally, §§ 1.78(a)(2) and (d)(1)(ii) permit there to be
as many divisional applications as there are inventions restricted out
of the prior-filed application. Therefore, the changes adopted in this
final rule allow an applicant to file a plurality of divisional
applications resulting from a restriction requirement in the prior-
filed application so that the applicant may obtain examination of the
claims that were withdrawn from consideration in the prior-filed
application due to the requirement for restriction. Section
1.78(d)(1)(ii) as adopted in this final rule also does not require that
any divisional application be filed during the pendency of a single
prior-filed application, but permits a divisional application to be
filed as long as it meets the copendency requirement of 35 U.S.C. 120.
Therefore, the definition of divisional application set forth in
§ 1.78(a)(2) is consistent with 35 U.S.C. 121.

   This final rule also permits an applicant to file an application
that is in substance both a divisional application and a continuation-
in-part application. Specifically, § 1.78(d)(1)(i) as adopted in
this final rule permits an applicant to file an application directed
both to an invention that was disclosed and claimed, but not elected
for examination, in a prior-filed application, and an invention or
subject matter that was not described or claimed in the prior-filed
application. Such an application would be subject to the conditions
applicable to other applications that disclose subject matter that was
not disclosed in the prior-filed application (i.e., the conditions
applicable to continuation-in-part applications). This is, because such
application is not limited to inventions that were subject to a
requirement for restriction by the Office in the prior-filed
application, but instead includes subject matter not disclosed in the
prior-filed application and thus was not subject to any requirement for
restriction by the Office in any prior-filed application, it is a
continuation-in-part application rather than a divisional application.
The provisions of § 1.78(d)(1)(ii) apply to divisional applications
that disclose and claim only an invention or inventions that were
disclosed and claimed in a prior-filed application, but were subject to
a requirement to comply with the requirement of unity of invention
under PCT Rule 13 or a requirement for restriction under 35 U.S.C. 121
in the prior-filed application and not elected for examination and not
examined in any prior-filed application.

   Comment 265: A number of comments argued that requiring an
applicant to designate a limited number of (ten) representative claims
for examination is contrary to statute, specifically, 35 U.S.C. 131 and
112, as well as contrary to In re Wakefield, 422 F.2d 897, 164 U.S.P.Q.
636 (C.C.P.A. 1970), because the rules limit an applicant's ability to
claim the full scope of his or her invention and that it is the
applicant, not the Office, who should determine the proper number of
claims that particularly point out and distinctly claim the subject
matter that applicants regard as their invention. Two comments argued
that the courts have not recognized any statutory authority for
rejecting claims as being "unnecessary," citing Wakefield where the
court held that the forty claims presented in the application at issue
were not unduly multiplied. One comment also argued that Congress
intended for each claim to be examined on the merits when it enacted 35
U.S.C. 112, ¶ 2, citing In re Weber, 580 F.2d 455, 198 U.S.P.Q. 328
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1154 

(C.C.P.A. 1978), and one comment suggested that limiting the number of
claims to be examined is contrary to 35 U.S.C. 131 because the
invention is defined by all of the claims. A few comments suggested
that the Office has a duty to examine all of the claims in a patent
application when the applicant has paid the search, examination, and
claim fees because Congress has authorized dependent claims and
specified charges for those claims, and the Office is required to
examine all claims, not just the designated ones. A number of comments
argued that the Office lacks the statutory authority under 35 U.S.C.
102, 103, 131, and 132 to presume that claims are patentably indistinct
by requiring the applicant to designate representative claims from
among copending, related applications. Finally, one comment argued that
the patent statutes do not permit the Director to examine part of an
application or less than the whole invention, and that the Director
does not have statutory authority under 35 U.S.C. 2(b)(2) or 112, ¶ 2,
to cause an application to be examined only if it does not result in
too much work for the examiner, and then if it does, to shift the
burden to the applicant to do the search and the examination.

   Response: The Office notes the concerns expressed by the public
comment concerning the proposed "representative claims" examination
approach. The Office also recognizes numerous comments suggested a
claim threshold in place of representative claims. The Office took
these comments into consideration and is not implementing a
"representative claims" examination approach. Instead, this final
rule provides that if the number of independent claims is greater than
five or the number of total claims is greater than twenty-five (a
strategy based upon whether an application contains more than a given
number of independent and total claims), the applicant must provide
additional information about the claims to the Office in an examination
support document to enable the Office to efficiently and effectively
examine the application.

   Thus, the changes adopted in this final rule do not limit the
number of claims that will be examined in an application because an
applicant is always free to file as many claims as necessary to
adequately protect the invention provided that applicant files an
examination support document before the first Office action on the
merits of the application. This final rule simply provides that an
applicant who puts a disproportionate burden on examination by
presenting more than five independent claims or twenty-five total
claims must provide additional information to the Office to facilitate
effective examination of the application. The Office, in turn, will
ensure that every claim submitted in an application is examined prior
to the issuance of a patent. Neither 35 U.S.C. 112 nor 131 provides
that an applicant has an unfettered right to submit an unlimited number
of claims. In contrast to Wakefield, where the Office declined to
examine certain claims due to undue multiplicity, the changes adopted
in this final rule do not limit the number of claims that will be
examined in an application because an applicant is always free to file
as many claims as necessary to adequately protect the invention.

   While this final rule does not implement a "representative
claims" examination approach, that proposal approach was simply a
mechanism to focus the examination process and in no way impacted the
merits of the examination. Even under a "representative claims"
approach, the Office would examine and determine the patentability for
every claim in an application before issuing a patent on the
application. Thus, a "representative claims" approach would have
altered the examination process (i.e., determining when examination of
certain claims takes place), but would not have changed the merits
requirements of examination (i.e., the statutory standards of
patentability).

   Comment 266: A number of comments suggested that the rationale
presented in the Claims Proposed Rule is contrary to 35 U.S.C. 2(b),
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1155 

102, 131 and 132, in that the Office is responsible for granting and
issuing patents. These comments stated that the examiner bears the
initial burden of presenting a prima facie case of unpatentability,
that the search is not the duty of the applicant but rather is the
Office's responsibility under 35 U.S.C. 131, and the rules are
inconsistent with the new fee structure which contemplates filing of
additional claims with higher fees. A few comments suggested that the
examination support document requirement improperly shifts the burden
of assessing patentability to an applicant when that burden resides
with the Office in the first instance under 35 U.S.C. 102. A few
comments asserted that requiring an applicant to submit an examination
support document constitutes an abdication of an inherently
governmental function, moves the United States one step closer to a
registration system, and places an affirmative duty on an applicant to
perform searches, ultimately exposing the applicant to a greater risk of
an inequitable conduct challenge.

   Response: The changes adopted in this final rule do not mandate the
submission of an examination support document. That is, an examination
support document is only required if an applicant chooses to present
more than five independent claims or more than twenty-five total claims
for examination in an application. If an applicant will not present
more than five independent claims and no more than twenty-five total
claims for examination in any particular application, an examination
support document is not required.

   The requirement for submission of an examination support document
is not an abdication of the examination function, or a shifting of the
burden to applicant to make a prima facie case of entitlement to a
patent. The examination support document simply requires the applicant
to provide additional information to the Office so that the Office may
more effectively conduct a substantive examination of the application.
The Office will examine and determine patentability for every claim in
an application before issuing a patent.

   Comment 267: A few comments stated that the examination support
document requirement transfers the costs of examination to applicants
when applicants already pay filing fees.

   Response: The changes to § 1.75(b) do not impose any additional
Office fees on the applicant. The changes to § 1.75(b) may increase
costs for an applicant who presents more than five independent claims
or twenty-five total claims in an application. The Office, however,
considers it appropriate for applicants who place a disproportionate
burden on examination by presenting more than five independent claims
or twenty-five total claims to bear these additional costs to
facilitate effective examination of the application. In any event, the
Office's actual cost of examining an application for patent far exceeds
the "filing fees" (i.e., the filing, search, examination, excess
claims, and application size fees) charged to applicant. See United
States Patent and Trademark Office Performance and Accountability
Report Fiscal Year 2005 at 23 (2005) (Patent Efficiency Table).

   Comment 268: Several comments objected to the rebuttable
presumption in § 1.78(f)(2) as being contrary to the judicial
precedent in other areas of patent law such as obviousness and
enablement. One comment suggested that the patentably indistinct
presumption is contrary to 35 U.S.C. 101, which allows a "patent on an
invention." One comment objected to the rebuttable presumption as
being contrary to the patent statute that states in part that "a
person is entitled to a patent unless * * *. " The comment suggests
that these words in the patent statute evidence that the burden is on
the Office to establish a prima facie case of unpatentability. A number
of comments stated that as part of its statutory duty to determine
patentability, the Office has the burden to determine patentable
distinctness, and even under the conditions of § 1.78(f)(2), it is
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1156 

improper to shift that burden to applicants. Further, some of the
comments argued that the patentably indistinct presumption is contrary
to case law because the Federal Circuit has repeatedly held that the
burden of showing that the claims recited in copending, related
applications are patentably indistinct rests with the Office, citing In
re Kaplan, 789 F.2d 1574, 229 U.S.P.Q. 678 (Fed. Cir. 1986); In re
Longi, 759 F.2d 887, 225 U.S.P.Q. 645 (Fed. Cir. 1985); In re Epstein,
32 F.3d 1559, 31 U.S.P.Q.2d 1817 (Fed. Cir. 1994); In re Oetiker, 977
F.2d 1443, 24 U.S.P.Q.2d 1443 (Fed. Cir. 1992); and In re Piasecki, 745
F.2d 1468, 223 U.S.P.Q. 785 (Fed. Cir. 1984).

   Response: The presumption of patentably indistinct claims appearing
in multiple applications as set forth in § 1.78(f)(2) of this final
rule is not contrary to the cited statutes or case law. Even if the
applicant shows that the claims in question are patentably distinct
from each other, it does not mean that the claims are also patentable
over the prior art. That is, the rebuttable presumption is not a merits
determination of patentability. It is simply a procedural tool
requiring the applicant to help focus and consolidate the examination
process.

   When the Office is faced with multiple applications containing
overlapping subject matter, it is in the best interest of the
applicant, the Office, and the public to ensure that patentably
indistinct claims are identified early in the examination process. The
applicant is responsible for drafting the application, including the
claims, and is in the best position to identify indistinct claims
spanning across multiple applications so that they can be consolidated
in a single application, or so that the Office will at least be alerted
to evaluate them for double patenting. Further, requiring the applicant
to ferret out which claims are indistinct from each other is procedural
in nature and assists the Office with processing multiple related
applications, but should not be confused with a patentability
determination on the merits. Such a procedural requirement is not
contrary to statute or case law, but is fully within the Office's
authority to regulate the procedure of examination.

   Comment 269: One comment suggested that 35 U.S.C. 116 provides for
the filing of continuation applications and the Office does not have
the authority to make changes.

   Response: 35 U.S.C. 116 provides for joint inventorship (35 U.S.C.
116, ¶ 1), application for patent by the remaining inventors in the
absence of a joint inventor (35 U.S.C. 116, ¶ 2), and correction of
inventorship in an application for patent (35 U.S.C. 116, ¶ 3). 35
U.S.C. 116 does not pertain to continuing applications.

   Comment 270: One comment suggested that the changes to § 1.114
violate 35 U.S.C. 133 because the Office would be assuming authority to
hold an application "abandoned" even when a bona fide reply was
timely filed.

   Response: 35 U.S.C. 133 provides that: "[u]pon failure of the
applicant to prosecute the application within six months after any
action therein, of which notice has been given or mailed to the
applicant, or within such shorter time, not less than thirty days, as
fixed by the Director in such action, the application shall be regarded
as abandoned by the parties thereto, unless it be shown to the
satisfaction of the Director that such delay was unavoidable." An
applicant's reply in prosecuting an application under a final Office
action is limited to either appealing in the case of rejection of any
claim (§ 41.31 of this title), or amending the claims as specified
in § 1.114 or 1.116. See § 1.113(a). The admission of, or
refusal to admit, any amendment after final rejection (§ 1.116)
will not operate to save the application from abandonment. See § 1.135(b).
Therefore, a reply to a final Office action other than an appeal, an
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1157 

amendment after final (§ 1.116) that places the application in condition
for allowance, or a request for continued examination in compliance with
§ 1.114 (including the requirement that any second or subsequent request
for continued examination be accompanied by a grantable petition under
§ 1.114(g)) is not a bona fide reply to the final Office action.

   Comment 271: A few comments suggested that the Office has a duty to
examine all of the claims in a patent application when the applicant
has paid the search, examination, and claim fees. The comments also
argued that because Congress has authorized dependent claims and
specified charges for those claims, the Office is required to examine all
claims, not just the designated ones. One comment also argued that the
recently revised fee structure was put in place based on an allocation of
resources for search workload on the examiner and therefore the Office is
obligated to perform the search and cannot shift the burden to the
applicant.

   Response: The Office recognizes the concern expressed in the public
comments that the "representative claims" examination approach could
be perceived as allowing claims to be issued that had not been fully
examined. The Office is not adopting the "representative claims"
examination approach in this final rule. This final rule instead
provides that an applicant who puts a disproportionate burden on
examination by presenting more than five independent claims or twenty-
five total claims must provide an examination support document to the
Office before the first Office action on the merits to facilitate
effective examination of the application. An applicant who presents
five or fewer independent claims and twenty-five or fewer total claims
need not provide an examination support document or other additional
information to the Office. In either situation, the Office will ensure
that every claim submitted in an application is examined prior to the
issuance of a patent.

   Further, neither the excess claim fees nor the search fee is
directly proportional to actual agency costs. The fee provisions are
not a restriction on the agency's ability to promulgate reasonable
regulations governing the application process.

   Comment 272: A few comments stated that the rules are arbitrary,
capricious, and represent an overly aggressive interpretation of
statutes, are beyond the power of the Office permitted under 35 U.S.C.
2(b)(2), expose the Office to legal action under 5 U.S.C. 706(2)(c),
and may require the Office to reimburse attorney fees under the Equal
Access to Justice Act.

   Response: The changes adopted in this final rule are not arbitrary,
capricious, an overly aggressive interpretation of the patent statute,
or beyond the power of the Office rule making authority under 35 U.S.C.
2(b)(2) for the reasons previously discussed in detail. Concisely put,
the Office considers the changes being adopted in this final rule to be
an appropriate exercise of its rulemaking authority under 35 U.S.C.
2(b)(2). See, e.g., Lacavera v. Dudas, 441 F.3d 1380, 77 U.S.P.Q.2d
1955 (Fed. Cir. 2006), Star Fruits S.N.C. v. United States, 393 F.3d
1277, 73 U.S.P.Q.2d 1409 (Fed. Cir. 2005), and Arnold P'ship v. Dudas,
362 F.3d 1338, 70 U.S.P.Q.2d 1311 (Fed. Cir. 2004).

   J. Changes to Internal Practice

   Comment 273: A number of comments expressed support for the
elimination of the first Office action final practice, and one comment
encouraged the Office to adopt a practice of no first action final
rejection in any continuing application where the factual record has
changed. A number of comments, however, stated that a first action
final may be appropriate where no effort has been made to advance
prosecution, e.g., by adding to the factual record with additional
evidence or amendments to the claims. One comment supported developing
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1158 

rules whereby an applicant's failure to prosecute could result in the
close of prosecution unless adequate and sustained progress is being
made in the application.

   Response: This proposed change has not been adopted. As discussed
previously, this final rule, however, provides that an applicant may
file two continuing applications plus a request for continued
examination in any one of the initial application or two continuing
applications (rather than only one continuing application or request
for continued examination as proposed) without any showing. Therefore,
the Office is retaining its first action final rejection practice.

   Comment 274: Several comments recommended that the Office develop
procedures whereby an Office action could not be made final until the
examiner was applying the exact same rejection as in the previous
Office action, and/or to encourage the Office to issue non-final second
Office actions. Several comments suggested reforming examination
procedures so that the examiner does not issue a final rejection as
long as prosecution is advancing.

   Response: The practice suggested by the comments would unduly
prolong prosecution, which is counter to the Office's goal for reducing
pendency. Thus, the Office and the applicants need to be efficient to
reduce the backlog of applications and most importantly, to meet the
public notice function of patent claims as quickly as possible.
Further, as one comment recognized, a practice under which an Office
action could not be made final until the examiner was applying the
exact same rejection would result in an applicant being able to avoid a
final Office action by continually amending the claims.

   Comment 275: A number of comments proposed that the Office permit
amendments after final as matter of right, and assess a modest fee for
the added examination burden. Most of these comments are in the context
of a graduated credit system for continuation filings, with more credit
being given during the first application and fewer "counts" or less
time given in subsequent continuations. Several comments proposed that
applicants should be permitted to respond to any new ground of
rejection made in the final Office action without having to file a
continuation application. Several comments suggested that the examiner
should not make an Office action final whenever new art is applied, and
one comment suggested an examiner must explain why the new art could
not have been located during the first search.

   Response: To permit entry of amendments after final as a matter of
right would unduly delay prosecution. An applicant may file an
amendment to place the application in condition for allowance or in
better form for consideration on appeal under § 1.116. Furthermore,
a new ground of rejection is only permitted in a final Office action
under the limited circumstances. As discussed previously, in this final
rule, the Office is revising second action final practice to provide
that a second or any subsequent Office action on the merits may be made
final, except when the Office action contains a new ground of rejection
that is not: (1) Necessitated by applicant's amendment of the claims,
including amendment of a claim to eliminate unpatentable alternatives;
(2) necessitated by applicant's providing a showing that a claim
element that does not use the phrase "means for" or "step for" is
written as a function to be performed and does not otherwise preclude
application of 35 U.S.C. 112, ¶ 6; (3) based on information submitted
in an information disclosure statement filed during the period set
forth in § 1.97(c) with the fee set forth in § 1.17(p); (4)
based upon double patenting (statutory or obviousness-type double
patenting); or (5) necessitated by applicant's identification of the
claim or claims in a continuation-in-part application for which the
subject matter is disclosed in the manner provided by 35 U.S.C. 112,
¶ 1, in the prior-filed application. Since the applicant is often adding
limitations that raise new issues that would require further
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1159 

consideration and/or search, it has long been the Office practice to
make the action final at this point. Allowing an expanded practice in
this area would undermine the goal of reducing patent pendency.

   Comment 276: A number of comments suggested providing examiners
with additional time to consider replies after final rejection and
to provide a new full evaluation of the content of those replies.

   Response: No changes in after final practice are planned at this
time. Under current practice, examiners consider any requests for
reconsideration submitted after final rejection in accordance with
§ 1.116.

   Comment 277: A number of comments suggested that the Office require
a patentability review conference with others, similar to the pre-
appeal conference proceeding, prior to an Office action being made
final, in order to address the problem of improper final Office actions
and to expedite indication of allowable subject matter. One comment
noted that the statistics show that less than half of applications that
had a pre-appeal conference are going forward to appeal and indicate
that many improper finals are being made. One comment stated that a
supervisor should review all first Office actions in a second request
for continued examination to determine if prosecution is proper.

   Response: The Office recognizes that it is important to make sure
the final Office action is proper. The pre-appeal brief conference
program is still an ongoing pilot program. The results of that program
will help to determine whether the Office replaces it with, or adds, a
"pre-final conference" as suggested. Further, the pre-appeal brief
conference program is designed for situations in which the applicant
believes that the rejections of record are clearly not proper (and is
not designed for "close cases"). See New Pre-Appeal Brief Conference
Program, 1296 Off. Gaz. Pat. Office at 67. Thus, data collected during
pre-appeal brief conferences (e.g., with respect to re-opening rates)
cannot validly be extended to all applications.

   In addition, the Office has an ongoing "in process review" of
applications to identify problems and trends. Each Technology Center
develops ongoing action plans and training each year to address the
problems/trends found via the "in process reviews" and the pre-appeal
brief conferences. Additionally, the Office will reinforce, during the
training on this final rule, issues such as proper final rejection
practice, the importance of making proper final rejections, and the
importance of indicating allowable subject matter at the earliest
possible time. Furthermore, if an applicant believes a rejection was
improperly made final, applicant may seek review by filing a petition
under § 1.181.

   Comment 278: A number of comments stated that the Office should
continue and expand ongoing efforts to hire and retain patent
examiners. One comment suggested that "[h]iring should be the
centerpiece of the Office's strategy." A number of comments stated
that the Office has not provided sufficient evidence to show why the
Office could not solve the backlog problem by hiring more examiners.
One comment argued that the Office should have sufficient funding to
pay for additional resources (e.g., more examiners) needed to examine
the backlog of applications in view of the recent increase in patent
fees. One comment stated that the Office has not supported its
assertion that it cannot hire enough examiners to reduce pendency.
Another comment stated that the Office should seriously consider hiring
retired or former examiners or patent practitioners to be trainers or
to assist examiners. In particular, one comment stated retired
examiners should be hired to work on specific big applications to
reduce the burden on examiners. Another comment stated the Office
should hire "generalists" instead of "ultra specialized advanced
degree scientists and engineers" to obtain more flexibility in the
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1160 

workforce.

   Response: Hiring additional examiners remains an important
component of the Office's overall plan to reduce pendency of patent
applications. The Office is committed to the hiring of as many
examiners as resources permit. The ability to hire qualified new
examiners is affected by many components, such as budget, the economy,
the availability of scientists and engineers, and the ability to absorb
and train new employees. Furthermore, it will take many years to
develop an experienced patent examining corps of sufficient size to
address the growing backlog of unexamined patent applications. The
Office recognizes that hiring alone will not reduce the backlog of
pending applications in the near future. As a result, the Office is
actively seeking ways for retaining more employees, such as retention
bonuses. The Office continues to become more efficient by implementing
many initiatives, such as the current regulatory changes, to reduce
pendency.

   The Office plans to hire 1,200 examiners each year for the next
five fiscal years. See United States Patent and Trademark Office Fiscal
Year 2008 President's Budget at 20-21 (2007). This will result in the
number of patent examiners increasing from 4,779 at the end of fiscal
year 2006 to 7,118 at the end of fiscal year 2012 (accounting for
attrition). See id. Even with this increase in the size of the Patent
Examining Corps, the Office anticipates that average pendency to first
Office action will increase from 22.6 months in fiscal year 2006 to
28.9 months in fiscal year 2012, and that average total pendency will
increase from 31.1 months in fiscal year 2006 to 38.6 months in fiscal
year 2012. See id.

   Comment 279: A number of comments stated that the current
examiners' production system in the Office encourages the filing of
continuing applications and requests for continued examination. In
addition, several comments stated that the production system also
encourages more restrictions and unwillingness to consider any after-
final amendment. The comments suggested several alternative accounting
schemes to encourage examiners to examine more non-continuing
applications and provide more thorough first Office actions, including
giving less credit for work done in continuation applications,
divisional applications and requests for continued examination, giving
examiners more credit for first Office actions as opposed to disposals,
giving examiners credit for claims disposed as opposed to applications
disposed, or giving examiners credit based on numerous application
factors such as specification length, technology complexity, number and
complexity of the claims, and pertinence of prior art submitted. One
comment suggested only having team examination and production goals.
One comment suggested the Office should use a performance system, such
as the system recently established by the Department of Defense. One
comment suggested that examiners should not have any time constraints.
Another comment stated the hours per disposal should be decreased to
improve production. Several comments argued that timesaving for
examiners needs to be tied with an agreement with the Patent Examining
Corps to increase productivity and decrease pendency due to the amount
of time saved in light of the proposed changes to the examination of
claims. One comment argued the rule changes will likely result in less
time for the examiners and it is unclear how this will result in more
thorough and reliable examination. The comments strongly suggested that
any changes to the examiners' production system should be transparent
to the public to install public confidence in such changes.

   Response: The Office expects to gain a more focused quality
examination as a result of these rule changes. It is expected that
these rules will make the exchange between the examiner and applicants
more efficient and effective. Issued patents will be examined more
thoroughly, making them easier to evaluate, enforce and litigate.
Furthermore, the patents will issue sooner, giving the public a clearer
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1161 

understanding of what is patented. In any event, the Office is in the
process of reassessing patent examiner production goals, appraisal
plans, and award systems. Absent significant changes to the patent
examination process, the Office does not consider it reasonable to
expect that changes to patent examiner production goals, appraisal
plans, and award systems alone will be sufficient to address the
growing backlog of unexamined patent applications while maintaining a
sufficient level of quality.

   Comment 280: Several comments stated that examiners should be given
more production time for certain situations, such as for applications
with more than twenty claims, for consideration of over fifteen to
twenty cited references and for responding to after-final amendments.
One comment stated that primary examiners should be given more time to
review a junior examiner's work.

   Response: Changes to patent examiner production goals are beyond
the scope of the proposed changes to the rules of practice. Therefore,
whether examiners should be given more production time for certain
situations is not discussed in this final rule. An examination support
document in compliance with § 1.265 will assist the examiner in the
examination of an application that contains more than five independent
claims or more than twenty-five total claims, resulting in a more
effective and focused examination. For example, citing the most
relevant references and identifying all of the limitations of each of
the claims that are disclosed by the references will help the examiner
to consider the most relevant prior art more thoroughly. The Office
already provides time for training junior examiners and reviewing their
work. Furthermore, a sampling of "in process reviews" for each
Technology Center helps identify training needs in a focused manner.
The Office of Patent Training is thoroughly preparing each new examiner
in proper practice and procedure with access to a dedicated trainer for
the first eight months; after that, the examiner is placed in a
traditional setting with proper supervision and review of his or her
work.

   Comment 281: A number of comments suggested that the Office could
retain more examiners by increasing compensation and offering better
working conditions. A number of comments also suggested that if it is
necessary to increase examiner salaries, changes to Title 5 of the
United States Code should be requested by the Office. One comment
stated that the salary for starting examiners should also be doubled.
One comment stated that the Office should seek authority to increase
salaries through either existing OPM processes or through restructuring
to a quasi-government corporation. One comment suggested charging fees
for responding to an Office action and for interviews, and using this
money to hire more examiners and pay for retention initiatives. Another
comment suggested establishing a salary increase when an examiner
passes a test at a number of pay grades. One comment stated that a
bonus system should be established. Another comment has suggested
increased salary levels for art units with high backlogs. Several
comments stated that increased filing fees should go towards increased
salary for examiners. One comment explained that the Office could give
examiners better working conditions by placing less stress on the more
experienced examiners. Another comment suggested the Office should
explore more flexible work schedules, including part-time arrangements.

   Response: The Office already provides many first rate benefits to
its employees. The Office is at the forefront in government for
teleworking opportunities for the staff. The Office has also adopted a
variety of creative work schedules such as: Maxi-flex, compressed and
alternate work schedules, part-time and flex-time for all employees.
Additionally, the Office offers paid overtime, compensatory time and
credit hours programs. The Office has transitioned into a paperless
environment and deployed state-of-the art technology to its employees.
The Office has relocated to a new campus, and provides amenities such
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1162 

as a first class child-care facility, a state-of-the-art fitness center
and a cafeteria.

   The Office already provides a robust bonus system for examiners
that enables one to earn up to ten percent of one's salary per year in
bonus compensation. Examiners are already on a special pay scale, with
the most recent increase of seven percent for all patent professionals,
granted in December 2006. In addition, an examiner receives regular
salary increases upon promotions to increasing levels of
responsibilities.

   Comment 282: Several comments stated the Office should authorize
overtime to work on the backlogs. One comment specifically suggested
that overtime pay should be 125 percent of the current pay rate, and
should only be available to work on first Office actions on the merits.

   Response: Examiners who have been certified as capable of working
independently by their supervisors are currently authorized to work
overtime. The overtime pay rate is set by statute. See 5 U.S.C. 5542.
The Office has recently begun distributing laptop computers to
examiners to further encourage overtime.

   Comment 283: A number of comments encouraged the Office to consider
establishing satellite offices in different areas in the United States
to assist in recruiting and retaining of examiners. The comments
further explained that satellite offices could tap into a greater pool
of potential new examiners, as there would be multiple working
locations. In addition, the comments stated that satellite offices
could specialize in certain technologies that are prevalent in the area
of the satellite office. Another comment pointed out that a satellite
office would facilitate more personal interviews, which would expedite
prosecution. The comments also stated that salary structures could be
adjusted depending on the cost of living within the area surrounding
the satellite office.

   Response: The Office is considering establishing satellite offices
as reflected in the Office's 2007-2012 Strategic Plan.

   Comment 284: A number of comments stated that the Office should
increase training requirements for examiners in order to improve patent
quality and retain more examiners. One comment suggested using any
increase in patent fees to provide training. Several comments offered
assistance in providing technical and legal training to the examiners.
One comment suggested that examiners should receive more training on
making proper rejections under 35 U.S.C. 103, and also suggested
testing examiners periodically. Another comment stated that examiners'
prior art searching is poor, and that the Office is not making efforts
to stem poor rejections, which lead to rework. One comment suggested
that the Office should train examiners using self-training programs
utilizing videos. Another comment stated that training should be
outsourced. Several other comments suggested training potential new
examiners by creating a patent examination curriculum for universities.

   Response: The Office has redesigned the training program of new
examiners and increased technical and legal training for other
examiners and patent professionals. Currently, the first classes of new
hires have completed their training in the new Patent Training Academy
program, wherein examiners go through eight months of intensive training
prior to being assigned to an art unit. Mirroring a collegiate environment,
examiners are trained in a variety of disciplines, including technology
skills, legal skills, and procedural requirements.

   For non-first year examiners, the Office has expanded training to
include patent law and evidence. Each employee must attend a specified
number of training hours in a variety of pertinent legal and technical
subjects. Additionally, the Office also offers a Law School Tuition
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1163 

Assistance Program (LSTAP) to qualified employees as an extension of
the Office's internal training program. Reimbursements for university
technical training courses related to the technology being examined are
also available for employees. Creating a partnership between the Office
and interested universities to offer an undergraduate course in patent
law and examination practice to highlight career opportunities in the
intellectual property field is also being investigated.

   Comment 285: A number of comments stated that the Office did not
address improvements in the internal examination process. One comment
alleged that the Office did not consider any changes to address
examiners' errors that extend the prosecution. Several comments
suggested that the Office should improve the examination process before
implementing the rule changes.

   Response: The Office is implementing many initiatives including
improvements in the internal examination process as well as the rule
changes in this final rule. To realize the effectiveness of these
initiatives in the near term, the Office is implementing many of them
simultaneously. The Office seeks ways to improve internal examination
processes by providing training created as a result of internal reviews
that identify areas where challenges exist.

   Comment 286: Several comments encouraged the Office to take
additional measures to improve the quality and clarity of Office
actions, in particular first Office actions. One comment stated that
examiners should use "plain English" in explaining the rationale
behind rejections.

   Response: The Office recognizes that the quality of Office actions
is of great importance. There are several quality initiatives in place
to insure that quality continues to improve. The new Patent Training
Academy emphasizes the importance of high quality Office actions.
Current interview practice encourages the use of interviews to clarify
the examiner's position, as necessary. The Office also has writing
classes available to employees.

   Comment 287: Several comments stated that examiners should be
encouraged to allow an application, or to point out allowable subject
matter, in the first Office action, if appropriate. Several comments
also suggested requiring examiners to propose amendments when
prosecution reaches a certain point, such as the filing of a second
request for continued examination.

   Response: The Office has previously adopted, in part, these
comments. It is current Office policy to encourage examiners to suggest
allowable subject matter as early as possible in the prosecution in
order to achieve the Office's goal of compact prosecution. It has long
been a standard in the examiner's performance appraisal plan, and it is
indeed an indicia of outstanding performance, to indicate allowable
subject matter at the earliest time possible. (See also, e.g., MPEP
§ 707.07(j)(III) EARLY ALLOWANCE OF CLAIMS, "Where the examiner is
satisfied that the prior art has been fully developed and some of the
claims are clearly allowable, the allowance of such claims should not
be delayed"; MPEP § 2106 (II), "Whenever practicable, Office
personnel should indicate how rejections may be overcome and how
problems may be resolved * * * ."; and MPEP § 2164.04, "In other
words, the examiner should always look for enabled, allowable subject
matter and communicate to applicant what that subject matter is at the
earliest point possible in the prosecution of the application.").

   Comment 288: There were a number of comments pertaining to the
quality review of examiners' work product. A number of comments stated
that the Office should limit its "second-pair-of-eyes" review to the
work of examiners that have been identified as needing more review in
their annual performance appraisal. The comment further explained that
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1164 

the Office should focus more intensive review on an examiner's work if
it is the principal cause for the failure to close prosecution on an
invention (e.g., by making poor rejections). Another comment suggested
eliminating the review of allowed applications and having the
"review" examiners work on the backlog. One comment stated that
supervisors should review all Office actions for examiners that have
fewer than three years experience unless they have passed a proficiency
examination. Another comment stated the review should spot factual
issues instead of just legal issues to better improve Office action
quality.

   Response: The Office already has focused "second pair of eyes"
reviews only for those examiners and/or technology areas where it has
been determined necessary. Additionally, the Office has an ongoing "in
process review" of applications to identify problems and trends. Each
Technology Center develops ongoing action plans and training each year
to address the problems/trends found via the "in process reviews" and
other sources, such as the pre-appeal brief conferences. Supervisors,
or their designated primary examiners, currently review all the work of
examiners who do not have signatory authority. All of these reviews do
encompass both factual and legal issues.

   Comment 289: A number of comments stated that examiners should be
encouraged or required to conduct more interviews throughout the
prosecution, including preexamination interviews and after-final
interviews. Several comments suggested that all interviews should
include the supervisor of the examiner or a person with signatory
authority. Several other comments suggested giving examiners a count,
or credit, for an interview, and charging a fee for interviews. Another
comment stated that examiners should be trained to give more productive
interviews.

   Response: Interview practice is set forth in § 1.133 and MPEP
§§ 713 through 713.10. Normally, one interview after final
rejection is permitted. See MPEP § 713.09. The Office also provides
examiners extra time to conduct an interview. In June 2006, this
practice was expanded to allow extra time for telephone interviews
initiated by applicants or their representatives; it had previously
only been available for personal (face-to-face) interviews. The Office
conducted a pilot program permitting an interview before the first
Office action in applications that were assigned to certain art units
in Technology Center 3600. See Notice of Pilot Program to Permit Pre-
First Office Action Interview for Applications Assigned to Art Units
3624 and 3628 and Request for Comments on Pilot Programs, 1281 Off.
Gaz. Pat. Office 148 (Apr. 27, 2004). Section 1.133(a)(2) was amended
in November of 2005 to permit an interview before the first Office
action in any application if the examiner determines that such an
interview would advance prosecution of the application. See Provisions
for Claiming the Benefit of a Provisional Application With a Non-
English Specification and Other Miscellaneous Matters, 70 FR at
56121, 56128, 1299 Off. Gaz. Pat. Office at 144, 150. As discussed
previously, if the examiner, after considering the application and any
examination support document, still has questions concerning the
invention or how the claims define over the prior art or are
patentable, the examiner may request an interview before the first
Office action.

   Comment 290: One comment stated that the Office should encourage
the submission of more useful information disclosure statements, which
contain statements of materiality and have provisions to discourage
"dumping" of references. Such an information disclosure statement may
be filed at a reduced fee amount. Another comment questioned whether
the Office has considered a rule that states that duty of disclosure
terminates at the close of prosecution.

   Response: The Office recently published proposed changes to the
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1165 

information disclosure statement practice which will encourage the
submission of more useful information. See Changes To Information
Disclosure Statement Requirements and Other Related Matters, 71 FR at
38812-16, 38820-22, 1309 Off. Gaz. Pat. Office at 27-31, 34-36.

   Comment 291: A number of comments suggested that the Office should
make better use of search and examination reports from other
intellectual property offices and PCT search and examination
authorities. On the other hand, one comment stated that the Office
should not rely on foreign office searches. Several comments further
suggested separating the search and examination functions and
outsourcing the search function. One comment stated that U.S. and PCT
prosecution should be done at the same time.

   Response: The Office recognizes the importance of leveraging the
search results from other intellectual property offices. One of the
specific action plans of the United States Patent and Trademark Office
21st Century Strategic Plan is to share search results with other
intellectual property offices. Since the beginning of 2003, the Office,
the European Patent Office and the Japan Patent Office (the Trilateral
Offices) have participated in search exchange projects aimed at
promoting the mutual exploitation of search results. The Office
implemented the Patent Prosecution Highway pilot program in July 2006.
See Patent Prosecution Highway Pilot Program between the United States
Patent and Trademark Office and the Japan Patent Office, 1307 Off. Gaz.
Pat. Office 61 (June 13, 2006). Under the Patent Prosecution Highway
pilot program, an applicant whose claims are determined to be
patentable by the Japan Patent Office may request that the
corresponding application filed in the Office be advanced out of turn
for examination provided certain conditions are met. The Patent
Prosecution Highway pilot program allows the Office to exploit the
search and examination results of the Japan Patent Office and
applicants to obtain corresponding patents faster and more efficiently.
Additionally, whenever the Office is designated as the International
Searching Authority, both the international application and the
application filed under 35 U.S.C. 111(a) are assigned to the same
examiner, if possible.

   Comment 292: A number of comments stated that all related
applications should be assigned to the same examiner, including
applications with overlapping disclosures.

   Response: The Office will continue to make reasonable efforts to
ensure that related applications are assigned to the same examiner, if
possible. However, the Office normally assigns divisional applications
to the technology area most appropriate for the claimed subject matter.
In fact, this is in part why this final rule requires applicants to
identify certain related applications. See § 1.78(f).

   Comment 293: A number of comments suggested creating a new or
modified accelerated examination procedure. One comment requested a
procedure to permit accelerated examination for applications that enter
the national stage under the Patent Cooperation Treaty. Another comment
stated that accelerated examination could be available to applications
containing ten or fewer representative claims. Another comment
suggested allowing accelerated examination if the applicant permits an
inter partes submission of a prior art statement and applicant provides
either an examination report from either the European Patent Office or
the Japan Patent Office, or pays a high fee for a special search. One
comment stated high technology areas should be given examination
priority. Another comment suggested requiring expedited replies in
continued examination applications and not giving extensions of time
under § 1.136(a). Another comment requested accelerated examination
for independent inventors.

   Response: The Office has long provided for advancement of
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1166 

examination upon granting a petition to make special. See § 1.102
and MPEP § 708.02. The Office also announced a revised accelerated
examination procedure, and the goal is to complete examination within
twelve months of the filing date of the application under this program.
See Changes to Practice for Petitions in Patent Applications To Make
Special and for Accelerated Examination, 71 FR at 36323-27, 1308 Off.
Gaz. Pat. Office 106-09. Any applicants, including independent
inventors, may participate in the revised accelerated examination
program which provides an expedited reply procedure. As discussed
previously, under the Patent Prosecution Highway pilot program, an
applicant whose claims are determined to be patentable by the Japan
Patent Office may request that the corresponding application filed in
the Office be advanced out of turn for examination provided certain
conditions are met.

   Comment 294: Several comments suggested that examiners should
strictly follow the guidance set forth in MPEP section 708 and examine
applications with the oldest effective filing date first. On the other
hand, several comments stated the Office should promote earlier
examination of non-continuing applications by giving continuation
applications a lower priority in the examination queue.

   Response: The Office will continue to follow the guidance set forth
in MPEP section 708 pertaining to the order of examination of
applications, including that "[e]ach examiner will give priority to
that application in his or her docket, whether amended or new, which
has the oldest effective U.S. filing date." An exception to this
guideline is an application in which examination has been advanced
pursuant to § 1.102.

   Comment 295: One comment suggested examiners should not just search
the claimed invention, but also subject matter that might be reasonably
claimed at a later time.

   Response: MPEP § 904 sets forth that "[t]he first search
should cover the invention as described and claimed, including the
inventive concepts toward which the claims appear to be directed."
Additionally, MPEP § 904.02(a) states that "[t]he field of search
extends to all probable areas relevant to the claimed subject matter
and should cover the disclosed features which might reasonably be
expected to be claimed."

   Comment 296: Several comments encouraged the Office to hire
efficiency experts, or a task force, to find the best ways to improve
the quality and efficiency of examination.

   Response: The Office expects these rule changes to improve the
quality and efficiency of examination. The Office will evaluate the
effectiveness of the rule changes in partnership with the
Office's customers and employees as all gather experience in operating
under these adjustments. The Office is currently studying all
suggestions, including those in the various studies made of the Office.

   Comment 297: One comment requested that the panel involved in a
pre-appeal brief conference be required to provide legal and factual
reasoning for the decision to both the examiner and the practitioner so
as to better make the decision a teaching tool.

   Response: The Pilot Pre-Appeal Brief Conference Program has been
extended until further notice. See Extension of the Pilot Pre-Appeal
Brief Conference Program, 1303 Off. Gaz. Pat. Office 21, (February 7,
2006) (notice). Since this program is still in the pilot phase, it
would be premature to make any changes until a full evaluation of the
entire program is completed. Furthermore, the purpose of this program
is to provide a quick relief for applications that are clearly not in
condition for appeal, so that applicant does not have to go through the
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1167 

expense of preparing and filing an appeal brief. Preparing a written
decision of the conference would unduly delay the process.

   Comment 298: Several comments stated that the Office should create
an Ombudsman position to decide issues regarding examination errors by
examiners.

   Response: The Office has many effective mechanisms to decide issues
regarding alleged "examination errors" by examiners. Practitioners
have several options, including but not limited to, responding on the
record, calling a supervisor, requesting a pre-appeal brief conference,
filing a petition, and filing an appeal.

   Comment 299: One comment requested a return to the appeal rules
where the examiners are not able to make new grounds of rejection
during appeal.

   Response: The rules of practice for the appeal process were changed
in 2004 to permit a new ground of rejection in an examiner's answer.
See Rules of Practice Before the Board of Patent Appeals and
Interferences, 69 FR 49960, 1286 Off. Gaz. Pat. Office 21 (September 7,
2004) (final rule). The approval of the appropriate Technology Center
Director, or his or her designee, is needed for such a new ground of
rejection, which should be rare. In response to any new ground of
rejection made in an examiner's answer, appellant has the options to
request that prosecution be reopened and to request that the appeal be
maintained under § 41.39(b). There have been no demonstrated
problems to date, thus the Office does not plan to change this
practice.

   Comment 300: One comment suggested accepting more "variations" in
filings to reduce the number of non-compliant notices sent.

   Response: The Office waives certain requirements set forth in §
1.121(c) and may accept certain non-compliant amendments. See
Acceptance of Certain Non-Compliant Amendments Under 37 CFR 1.121(c),
1296 Off. Gaz. Pat. Office 27 (July 5, 2005). Practitioners and
applicants, however, are responsible to know the laws and rules
relating to prosecuting patent applications and to keep current with
any changes. The Office will continue to review common problems that
arise, and implement solutions as appropriate.

   Comment 301: One comment requested that the Office publish, once a
month, a projection of when a new application will be taken up for
examination so that applicants can better manage the filing of
preliminary amendments.

   Response: The Office currently publishes in each issue of the
Official Gazette the average filing date of the applications that
received a first Office action during the preceding three months for
each Technology Center Work Group.

   Comment 302: One comment suggested that the Office should allow
more documents to be filed via the Office electronic filing system.
Another comment stated the Office should require electronic filing and
that all prosecution be performed electronically.

   Response: The Office permits applicants to file many applications,
fees, and correspondence (e.g., amendments and replies) electronically
via the Office electronic filing system (EFS-Web) with a few exceptions
(e.g., Credit Card Authorization Form (PTO-2038), maintenance fees, new
plant applications and color plant drawings). There are no plans to
make electronic filing mandatory, although special programs (e.g.,
accelerated examination) do require electronic filing. See Changes to
Practice for Petitions in Patent Applications To Make Special and for
Accelerated Examination, 71 FR at 36323-27, 1308 Off. Gaz. Pat. Office
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1168 

106-09.

   Comment 303: One comment proposed requiring applicants to give an
opinion of the usefulness or commercial potential of the invention.

   Response: The Office is not adopting the requirement that an
examination support document contain a concise statement of the utility
of the invention. An opinion from the applicant on the commercial
potential of the invention is generally unnecessary in determining the
patentability of the claimed invention. However, applicant may submit
objective evidence of commercial success when applicant seeks to rebut
an obviousness rejection under 35 U.S.C. 103. See § 1.132 and MPEP
§ 716.03.

   Comment 304: One comment requested prioritizing the order of
examination based on such factors as the economic impact and value to
society, the quality of the technical description of the invention and
the quality of prior art cited. The comment also suggested requiring
applicants to state in their application how the invention will be
distributed to the public.

   Response: It would be very difficult to evaluate and assess these
subjective factors for each application filed. In addition, most of
this information would not be helpful in determining the patentability
of the claimed invention.

   Comment 305: One comment suggested creating an electronic search
tool that would automatically compare the claim language to prior art
and provide complete searches in under ten minutes.

   Response: The Office has been evaluating tools to improve the
examination practice. Although the Office is routinely seeking ways to
improve automated tools, the resources needed for implementation and
the applicability of the tools must be considered and weighed. Often,
the application of search tools is limited to specific technologies.
For example, in many biotechnology applications, the Office employs an
Automated Biotechnology Sequence Search System (ABSS) to compare
genetic sequences submitted with applications to a number of sequence
databases. The Office's Scientific and Technical Information Center
(STIC) conducts between 10,000 and 15,000 of these searches a year. Due
to the number of requests and because the search runs against multiple
databases, ABSS searches can be time-consuming. In other technologies,
such as electrical and mechanical arts, STIC provides the option of
conducting a Patent Linguistic Utility Service (PLUS) search, which
runs significant words from sections of the specification against the
full text of the United States Patent and United States Pre-Grant
Publication databases. STIC is performing over 20,000 of these searches
a year. While these searches are done quickly, limitations in key word
searching are not always reliable in finding relevant prior art.

   Comment 306: One comment stated that the Office should create a better
search engine so inventors can more easily perform better searches.

   Response: The Office continues to explore various ways to
disseminate information and improve the searching capabilities of the
public. Currently, the Office allows applicants and inventors to search
on-line using Patent Full-Text and Full-Page Image Databases
(http://www.uspto.gov/patft/index.html) and works in concert with
eighty-three Patent and Trademark Depository Libraries
(http://www.uspto.gov/go/ptdl/) throughout the United States to offer the
public extension research capabilities. The Office also has a library and
tools at the Alexandria campus for the public to use.

   Comment 307: One comment suggested that procedures for appeals and
petitions should be changed to be less costly and to result in more
timely decisions. One comment suggested the Office waive the notice of
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1169 

appeal fee and the appeal brief fee while the applicant awaits a
decision on petition to invoke supervisory authority relating to a
premature final rejection in an Office action.

   Response: Most petition fees are set by regulation. The petition
fee amounts that are set by regulation are set at an amount based upon
the resources required to handle and decide the petition. See Changes
to Support Implementation of the United States Patent and Trademark
Office 21st Century Strategic Plan, 69 FR 56482, 56491-93 (Sept. 21,
2004), 1287 Off. Gaz. Pat. Office 67, 75-76 (Oct. 12, 2004). The notice
of appeal fee and the appeal brief fee are set by statute and cannot be
waived. Additionally, the appeal fees recover only a fraction of the
Office cost of handling and deciding the appeal.

   With respect to petitions, the Office is taking the necessary steps
to minimize the backlog and to respond to petitions in a timely
fashion. Within the Technology Centers, almost all petitions for relief
from improper final rejections or restrictions are answered in a timely
fashion. The Office is working to ensure that most of the petitions for
relief from improper final rejections or restrictions are decided
within four months from when they are filed, and continues to work on
ways to make the process consistent across the different Technology
Centers. The Office has also taken major steps to eliminate delays with
the appeal process. The BPAI has radically reduced the inventory of
pending appeals during the last five fiscal years.

   The Office also recognizes that it is important to make sure that
the finality of any final Office actions is proper. It is the Office's
experience that applicants who seek review of the finality of an Office
action also request review of the merits of the rejections contained in
the final Office action. The propriety of the finality of an Office
action is purely a question of Office practice that is wholly distinct
from the merits of the rejections contained in the final Office action
rejection. See MPEP § 706.07(c). The propriety of the finality of
an Office action is properly raised in a petition under § 1.181,
and is not a proper basis for an appeal or complaint to the BPAI during
an appeal. See id. Likewise, arguments relating to the merits of the
rejections contained in the final Office action rejection are properly
raised in an appeal to the BPAI, and are not a proper basis for a
petition under § 1.181 or for contesting the propriety of the
finality of an Office action.

   The rules of practice provide that the mere filing of a petition
under § 1.181 will neither stay any period for reply that may be
running against the application, nor act as a stay of other
proceedings. See § 1.181(f). While the Office has put in place
procedures to decide the appeals and petitions in a timely manner, the
applicant is responsible to continue to prosecute the application
consistent with § 1.181(f). Thus, there may be situations in which
it is necessary for an applicant to file a notice of appeal to maintain
the pendency of an application while a petition under § 1.181
requesting review of the finality of an Office action is being decided.
The filing of a notice of appeal, however, does not moot such a
petition under § 1.181, so the Office will decide a petition under
§ 1.181 requesting review of the finality of an Office action even
if the applicant has filed a notice of appeal in the application. In
such a situation, applicants should also request a pre-appeal brief
conference with the filing of a notice of appeal. The pre-appeal brief
conference will be conducted and the applicant will be notified of the
result of the pre-appeal brief conference before the appeal brief and
appeal brief fee must be filed. This should ensure that any petition
under § 1.181 requesting review of the finality of an Office action
is decided before the applicant must file the appeal brief and appeal
brief fee. If the Office determines that the finality of the rejection
was premature, the finality of the Office action will be withdrawn and
any fees paid for the notice of appeal and the appeal brief can be
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1170 

applied to a later appeal on the same application. See MPEP § 1207.04.

   Comment 308: Several comments stated that the Office should
exercise better control over restriction practices. Several comments
stated that the Office should encourage claims of different statutory
classes to be filed in one application to improve examiner efficiency.
One comment asserted that disposal pressures on examiners in the
biotechnology area are totally unrealistic and have led to legally
ridiculous restriction requirements. Several comments suggested that
restriction reform is needed. Several comments suggested that the
Office adopt the unity of invention standard. Several comments
suggested an interim standard based on current PCT unity of invention
practice should be available at the option of the applicant as an
alternative to adopting unity of invention practice. Some comments
expressed the opinion that current restriction practice in Technology
Center 1600 (biotechnology and organic chemistry) requires applicants
to file too many continuing and divisional applications. One comment
expressed the opinion that current restriction practice is a result of
the examiners' production system. Several comments stated that
restriction is necessary to avoid abusive filing tactics by applicants
seeking to circumvent the proposed regulation of continued examination
filings. Several comments suggested that the Office eliminate
restriction practice. Another comment stated that if proposed
§ 1.78(d)(1)(ii) is adopted, the Office should be bound by an initial
restriction requirement and § 1.146, authorizing species
restrictions, should be repealed. One comment suggested that if
restriction practice must be maintained, it should be limited to
applications in which two claimed inventions are literally unrelated,
and all divisional applications should be examined by the same
examiner.

   Response: As part of the United States Patent and Trademark Office
21st Century Strategic Plan, restriction reform was studied
extensively. See Request for Comments on the Study of Changes Needed to
Implement a Unity of Invention Standard in the United States, 68 FR
27536 (May 20, 2003), 1271 Off. Gaz. Pat. Office 98 (June 17, 2003)
(notice). A revision of the study was posted in November 2003, and the
study was expanded to include four restriction reform options. See
Notice of the Availability of and Request for Comments on Green Paper
Concerning Restriction Practice, 70 FR 32761 (June 6, 2005), 1295 Off.
Gaz. Pat. Office 146 (June 28, 2005) (notice) and the extension of the
comment period announced at 70 FR 45370 (August 5,
2005) (notice). There were sixteen responders, and there was no
consensus as to which of the four options to adopt. In addition, the
restriction reform study concluded that a change to unity of invention
under PCT Rule 13 under any of the four restriction reform options
would significantly increase patent pendency. Thus, the Office is
maintaining its current practices with respect to requirements for
restriction under 35 U.S.C. 121 or unity of invention under PCT Rule
13.

   Technology Center 1600 (biotechnology and organic chemistry) has
implemented a comprehensive restriction training plan. This includes
training examiners on proper restriction practices, including proper
grouping of claims and rationale supporting the restriction
requirement, using Art Unit and Work Group specific examples. Training
has been ongoing, using materials that are published on the Office's
Internet Web site. Feedback from the training to date has been
incorporated into the initial patent examining training given to new
hires.

   Although the Office will continue to assign divisional applications
to the technology area most appropriate for the claimed subject matter,
they are not necessarily assigned to the same examiner.

   Comment 309: Several comments asserted that restriction practice
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1171 

will increase as a result of the rule changes. One comment suggested
that the Office needs to coordinate any changes in continuation
practice with restriction reform. Another comment expressed the opinion
that the proposed rule changes will exacerbate problems with the
current restriction practice. One comment suggested that divisional
application filings would likely drop in view of designating ten
representative claims because examiners usually do not bother to make
restriction requirements when they only have a few claims to examine.
Another comment stated that an increase in restrictions is a desirable
alternative to the rule changes. Another comment argued that current
restriction practice adequately limits the claims for examination. The
rules would complicate restriction practice resulting in multiple
exchanges between the examiner and applicant when designated claims are
subject to restriction.

   Response: The Office is not adopting the "representative claims"
examination approach in this final rule. As noted previously, the
Office received comments that restrictions would increase and comments
that restrictions would decrease as a result of the changes to the
rules. The changes being adopted in this final rule do not encourage
more or fewer restrictions. Thus, the Office is maintaining its current
practices with respect to requirements for restriction under 35 U.S.C. 121
or unity of invention under PCT Rule 13. See §§ 1.141, 1.142, and 1.499.

   Comment 310: One comment suggested that the Office require all
restriction requirements to be made within six months of filing, with
no excess claim fees charge until after that period. Another comment
stated that excess claims fees should only be determined after any
restriction requirement has been made.

   Response: In fiscal year 2006, the average pendency to first Office
action was 22.6 months for the entire Patent Examining Corps.
Therefore, the Office's current first Office action pendency does not
allow for an examination of the application to determine whether
restriction is appropriate within six months of filing in most
applications. Excess claims fees are required by the statutory
requirement "on filing or on presentation at any other time." See 35
U.S.C. 41(a)(2). In response to a restriction requirement, applicant
may file an amendment canceling the non-elected claims and request a
refund of any excess claims fees paid on or after December 8, 2004, for
the non-elected claims, if the amendment is filed before an examination
on the merits has been made of the application. See § 1.117.

K. Suggestions Relating to Legislative Changes

   Comment 311: A number of comments suggested that Congress should
adequately fund the Office by making the United States Patent and
Trademark Fee Modernization Act of 2005 (H.R. 2791, 109th Cong. (2005))
permanent and eliminating fee diversion. One comment also suggested
that Congress provide additional funds (outside of fees collected) to
the Office. A number of comments suggested that the fees for continued
examination filings in excess of one should be increased (e.g.,
graduated fee schedule for subsequent filings). A number of comments
suggested charging a fee for each priority claim made. One comment
suggested that the fee would be proportional to the years of benefit
requested. Several comments suggested that the current fee structure
encourages continuations since it is cheaper to file multiple
applications than to file a large number of claims (e.g., sixty total
claims with nine independent claims) in a single application, and that
the Office should revisit the fee structure if it wants to encourage
filing the claims in a single application. A number of comments
suggested that there should be higher fees on claims exceeding a
certain minimal number, which is proportionate to the increased burden
on the Office. One comment suggested permitting applicant to pay
additional search and examination fees for those who want to submit
more than ten representative claims. At least one comment suggested
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1172 

increasing fees based on complexity of the claims and art. One comment
suggested that the Office should permit an applicant to file a third or
subsequent continuing application with an appropriate higher fee. One
comment suggested a three-tiered system: The first tier would allow
three independent claims and twenty total claims; the second tier would
activate a very high surcharge; and the third tier, in applications of
more than ten independent and thirty total claims, would require a
showing as to why such additional claims are necessary. Several
comments suggested an overall general fee increase, especially for
those areas with high workloads. One comment suggested that doubling
the basic filing fee, search and examination fees would not be a
hardship for applicants. Several comments suggested a number of changes
to the fee schedule: Tripling fees for large entities; instituting a
graduated fee scale for adding new matter rather than limiting the
number of continuation-in-part applications; charging a higher filing
fee for an application with greater than five claims and more than 1200
words in the specification; raising fees if more than ten or more than
twenty claims are submitted; increasing fees for independent claims in
excess of three; increasing fees on all non-Jepson claims; and
eliminating search and examination fees if an examination support
document is submitted.

   Several comments stated that surcharges should be imposed on
independent claims in excess of three and total claims in excess of
twenty in order to address the problem of applications with excess
numbers of claims. Several comments argued that the current fees appear
to be having a significant impact in reducing the number of claims
filed, that the Office has not fully evaluated that impact, and that
the Office should give the fee increase more time to see if it will be
effective.

   Response: Patent fees are primarily set by statute, and Congress
has considerable authority in setting patent fees and funding of the
Office. See Figueroa v. United States, 466 F.3d 1023, 1031-32, 80
U.S.P.Q.2d 1437, 1443 (Fed. Cir. 2006). Thus, patent fee
and Office funding issues are beyond the scope of the proposed changes
to the rules of practice.

   In 2002, the Office proposed a patent fee structure that included a
graduated excess claims fees schedule and additional fees for
continuing applications. The House Subcommittee on Courts, the
Internet, and Intellectual Property held a hearing on July 18, 2002, at
which patent user groups expressed strenuous opposition to the Office's
2002 proposed patent fee structure. See The U.S. Patent and Trademark
Office: Fee Schedule Adjustment and Agency Reform: Oversight Hearing
Before the Subcommittee on Courts, the Internet, and Intellectual
Property of the House Committee on the Judiciary, 107th Cong., 2nd
Sess., Final Print Serial No. 92 (2002). The Office was unable to
garner public support for a patent fee structure including a graduated
excess claims fees schedule or any additional fees for continuing
applications. Therefore, the patent fee structure proposed in the
United States Patent and Trademark Fee Modernization Act of 2003
(introduced as H.R. 1561) included the former "flat" excess claims
fee schedule (with an adjustment to the fee amounts) and no additional
fees for continuing applications.

   Section 801 et seq. of Division B of the Consolidated
Appropriations Act, 2005, provided that 35 U.S.C. 41(a), (b), and (d)
shall be administered in a manner that revises patent application fees
(35 U.S.C. 41(a)) and patent maintenance fees (35 U.S.C. 41(b)) during
fiscal years 2005 and 2006. See Public Law 108-447, 118 Stat. 2809
(2004). In essence, the Consolidated Appropriations Act, 2005, made the
patent fees set forth in the United States Patent and Trademark Fee
Modernization Act effective during most of fiscal year 2005 and all of
fiscal year 2006. The Revised Continuing Appropriations Resolution,
2007 (Pub. L. 110-5, 121 Stat. 8 (2007)), kept the patent fee and fee
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1173 

structure provisions of the Consolidated Appropriations Act, 2005, in
effect during fiscal year 2007.

   Moreover, the examination fee in effect under this legislation does
not recover the entire cost of examination. The excess claims fee
structure in effect under this legislation does not provide sufficient
incentive for all applicants to keep the number of claims in an
application at a reasonable number. The application filing fees in
effect under this legislation provide no incentive for applicants to
keep the number of continuing applications to a reasonable number.
Thus, increasing fees, as suggested by many of the comments, is not, by
itself, a sufficient solution for the large and growing backlog of
unexamined applications.

   Comment 312: One comment suggested permitting applicants to pay an
additional search fee for inventions that are restricted.

   Response: The Office studied such a proposal and determined that it
would result in an unacceptable increase in patent pendency. See Green
Paper Concerning Restriction Practice at 14-18 (2005). The Green Paper
Concerning Restriction Practice is available on the Office's Internet
Web site at: http://www.uspto.gov/web/patents/greenpaper.htm. Thus, the
Office is not pursuing such a change to patent practice.

   Comment 313: One comment suggested that fees for small entities
should be maintained and that fees for others should be increased.

   Response: The Office believes that Congress has set an appropriate
discount for fees paid by small entities. 35 U.S.C. 41(h)(1) currently
provides for a fifty percent reduction in patent fees charged under 35
U.S.C. 41(a), (b), or (d)(1) for applicants who qualify as a small
entity under 35 U.S.C. 41(h)(1), and 35 U.S.C. 41(h)(3) further
provides a seventy-five percent reduction in the filing fee charged
under 35 U.S.C. 41(a)(l)(A) for small entity applicants who file their
applications electronically. The Office notes that small entity
applicants file excess claims and continuing applications at virtually
the same rate as other (non-small entity) applicants.

   Comment 314: One comment suggested that if a specification is a
poor-quality literal or machine translation of a non-English language
application, the examiner should be permitted to reject the
specification as indefinite and provide a time period for applicant to
provide a better quality translation.

   Response: The goal of the changes in this final rule is to increase
quality and decrease pendency of patent applications. To assist the
Office in meeting that goal, applicants should file applications that
are in condition for examination, or provide corrections no later than
the time they are taken up for examination. It should not be necessary
for the Office to issue an Office action rejecting or objecting to an
application due to informalities. However, if a specification is a poor
quality literal translation of a non-English application, the examiner
has the authority to object to the specification.

   Comment 315: One comment suggested that the Office adopt a
"utility model" type of patent as used in Australia in which a patent
issues without a search being done, and a search is only conducted when
the patent is enforced.

   Response: The Office is currently studying the concept of
alternative types of patents, thus allowing an applicant to select a
patent product based upon the applicant's needs. See Draft 2007-2012
Strategic Plan (Objective 2 of Goal 1). A copy of the Office's draft
proposed five-year (2007-2012) strategic plan can be found at
http://www.uspto.gov/web/offices/com/strat2007/. However, implementing
such a practice would need legislative changes.
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1174 


   Comment 316: One comment indicated that Congress recently endorsed
and expanded opportunities for double patenting via the CREATE Act
(Cooperative Research and Technology Enhancement Act (Pub. L. 108-43,
118 Stat. 3596 (2004)).

   Response: The legislative history of the CREATE Act (Cooperative
Research and Technology Enhancement Act (Pub. L. 108-43, 118 Stat. 3596
(2004)) indicates that Congress appreciated that the CREATE Act would
result in additional double patenting situations. See H.R. Rep. No.
108-425, at 6 (the Office may require a terminal disclaimer when double
patenting is determined to exist for two or more claimed inventions for
any application for which the applicant takes advantage of the "safe
harbor" provision in 35 U.S.C. 103(c) as amended by the CREATE Act).
Congress' acknowledgment of the possibility of double patenting is not,
however, an expression of support for applicants to intentionally
submit claims that would result in a double patenting situation.
Instead, it shows that the Congress is aware of the problems created by
multiple patents covering the same or substantially the same invention,
and expects the Office to address these issues.

   Comment 317: Several comments suggested eliminating the two-year
limit for filing a broadening reissue. One comment suggested amending
the "reissue" or "reexamination" statute to permit broadening of
claims at any time for a number of reasons such as: (1) To replace
continuing applications which are now being filed to avoid the two-year
statutory period for broadening patent claims; (2) to allow correction
of simple drafting mistakes which may not be caught before the patent
issues; and (3) to provide certainty to industry. The comment stated
that to encourage participation by patentee, legal (as opposed to
equitable) intervening rights should be provided that are linked to the
date of the amendment. Also, such an amendment should provide for
intervening rights after eighteen months to patent applications as well
as patents to put an end to the submarine patent situation.

   Response: The suggested changes to reissue or reexamination
practice are not consistent with the Office's goals of increasing
quality and reducing pendency. The Office, nevertheless, appreciates
that continuing application practice may currently be used improperly
to avoid the two-year bar and the broadening "error" requirement of
the reissue statute (35 U.S.C. 251). The changes to continuing
application practice in this final rule will reduce a patentee's
ability to end-run the reissue statute via continuing application
practice.

   Comment 318: One comment suggested instituting a tiered search and
examination procedure, which provides for a refund of the examination
fee if applicant decides to abandon the application after the search
but before the examination. If applicants can save money by abandoning
applications no longer deemed viable, applications will drop out of the
application process, thereby freeing up valuable Office examination
resources to focus on quality examination of the remaining
applications, as well as reducing pendency.

   Response: The current fee legislation authorizes the Office to
refund the search fee but not the examination fee if the applicant
chooses not to pursue an application after it has been filed. See 35
U.S.C. 41(d)(1)(D). This provision has been implemented in § 1.138(d).
Under § 1.138(d), applicant may file a petition for express abandonment
before an examination has been made of the application to obtain a refund
of the search fee and excess claims fee paid in the application. The
feedback received by the Office indicates that the examination fee is too
low to provide any additional incentive for an applicant to withdraw from
the examination process and seek a refund.

   Comment 319: One comment suggested charging more money for
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1175 

voluminous IDS submissions, and additional surcharges for particular
technologies where "second pair of eyes" review has had a significant
impact on examination quality at an increased cost to the Office.

   Response: The Office is addressing the problem of large IDS
submissions in a separate rule making. See Changes To Information
Disclosure Statement Requirements and Other Related Matters, 71 FR at
38812-16, 38820-22, 1309 Off. Gaz. Pat. Office at 27-31, 34-36. As for
increasing fees for particular technologies where "second pair of
eyes" review has had a significant impact on examination quality at an
increased cost to the Office, Office funding is subject to
appropriations by Congress, and charging additional fees will not
necessarily provide more funding for the Office. See Figueroa, 466 F.3d
at 1031, 80 U.S.P.Q.2d at 1442 (there is no requirement that the
revenue resulting from patent fees be appropriated to fund the Office).
Furthermore, the limitation currently facing the Office is not a lack
of funds to hire new examiners, but rather the ability to hire and
train new examiners in the numbers necessary to lower patent pendency
while maintaining patent quality.

   Comment 320: One comment suggested modifying the relevant statutes
to bar a continuing application or request for continued examination
after thirty months from the filing date (other than a divisional
application, which would be given a different period). The comment also
indicated that continuation-in-part applications filed more than thirty
months after the initial application should be barred under 35 U.S.C.
102(b) based on the eighteen-month publication of the initial application.

   Response: First, the statutes cannot be modified without
legislative action by Congress. Further, this final rule provides
applicant sufficient opportunities to present claims during the
prosecution of the initial application, two continuing applications,
and a request for continued examination without justification. The
prosecution of these applications and the request for continued
examination will most likely extend more than thirty months from the
earliest claimed filing date, particularly in certain areas such as
biotechnology. The changes as adopted in this final rule appropriately
balance an applicant's need for opportunities to present claims and the
Office's need to utilize its examining resources more efficiently to
reduce the backlog of unexamined applications and improve quality.

   Comment 321: One comment suggested developing a practice where new
matter can be added to an existing application with a request for
continued examination. The comment explained such a practice would
eliminate the need to file continuation-in-part applications, would not
take the application out of the examining queue, and would be more
efficient because the same examiner, rather than different examiners,
would examine the application, and would also avoid double patenting
issues.

   Response: A request for continued examination is not a new
application, but is instead a means to continue examination of an
existing application. Thus, such a change could not be made, because 35
U.S.C. 132(a) prohibits introduction of new matter into an application.
Furthermore, even if 35 U.S.C. 132(a) did not prohibit such a practice,
such a practice would create problems in determining the filing date of
the new matter.

   Comment 322: One comment suggested that the Office should seek the
authority from Congress to limit the number of claims in any particular
application.

   Response: The Office is not seeking to limit the number of claims
in an application. Instead, the Office aims to improve the quality of
examination. The changes to § 1.75 in this final rule permit an
applicant to present up to five independent claims and twenty-five
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1176 

total claims in the application without submitting an examination
support document in compliance with § 1.265. The changes to §
1.75 in this final rule also permit an applicant to present more than
five independent claims or more than twenty-five total claims if the
applicant submits an examination support document in compliance with
§ 1.265. If an examination support document in compliance with
§ 1.265 is not filed before the issuance of a first Office action
on the merits of the application, the application may not contain or be
amended to contain more than five independent claims or more than
twenty-five total claims. Thus, the changes being adopted in this final
rule are not placing a limit on the number of claims.

   Comment 323: One comment suggested that the Office should permit
all claims to be filed in an application without any excess claims
fees, and then after restrictions are made, calculate the needed fee
for "additional claims" so applicants are not penalized by paying
claims fees twice.

   Response: An applicant can request a refund for excess claims
canceled prior to a first action on the merits. See § 1.117. Thus,
an applicant does not need to pay claim fees twice, if applicant
cancels the non-elected claims in reply to a restriction requirement.

   Comment 324: One comment suggested providing for the addition of
dependent claims after allowance for a reduced fee with the requirement
that applicant identify support for the claims in the specification.

   Response: The comment did not provide an explanation as to how such
a strategy would reduce pendency and promote quality. Even assuming
applicant would file less claims under this suggested practice,
examination of the newly added claims after allowance would be
required. Thus, it is not clear how the suggested strategy would serve
these goals more effectively than the changes being adopted in this
final rule.

   Comment 325: One comment suggested to bar, by statute, more than
three independent claims and ten total claims, provided that amendments
may be made in the regular course of prosecution and after grant to end
claim gaming. The comment further indicated that the proposed rule
changes will be subject to administrative challenge, leading to several
years of uncertainty and chaos.

   Response: A number of comments indicated that there are situations
in which more than three independent claims and more than ten total
claims are needed. Thus, the Office recognizes that it would be
inappropriate to seek such legislation to place an absolute limit on
the number of claims at this juncture.

   Comment 326: One comment suggested that reducing the filing and
maintenance fees would reduce filings. The comment stated that the
backlog has gotten so large due to the increases in excess claims fees,
there has been a tendency among practitioners to segment applications
into multiple related filings, each having twenty or so claims. This
segmenting, the comment explains, has significantly increased the
number of filings within the Office.

   Response: It is unclear how reducing fees would reduce the number
of filings. The experience of the Office is that reducing patent fees
would not lead to reduced filings.

   Comment 327: One comment suggested including a patent term
reduction while an application remains pending.

   Response: Section 1.704 currently provides for reduction of patent
term adjustment for processing delays attributable to the applicant.

Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1177 

   Comment 328: One comment suggested moving to a first-to-file
system.

   Response: As part of global patent law harmonization efforts, the
Office has sought public comment on whether the first to invent (used
in the United States) or the first inventor to file (used in the
remainder of the world) standard in determining the right to a patent
represented a "best practice" for a harmonized global patent system.
See Request for Comments on the International Effort to Harmonize the
Substantive Requirements of Patent Laws, 66 FR 15409 (Mar. 19, 2001)
(request for comments). The Office is continuing to consider the issues
related to the first to invent versus the first inventor to file
standard in determining the right to a patent in the context of
international harmonization efforts.

   Comment 329: One comment suggested elimination of all forms of
continuing applications except divisional applications.

   Response: The changes to continuing application practice adopted in
this final rule seek a balanced approach between the needs of
applicants for patents and the goals of the Office to increase quality
and decrease pendency.

   Comment 330: One comment suggested reducing the shortened statutory
period for an applicant's response to three months without any
extension of time. One comment suggested implementing a thirty-day
reply period for both the Office and applicants.

   Response: The Office is considering whether it should change the
shortened statutory period for Office actions on the merits to less
than three months.

   Comment 331: Several comments expressed support for publication of
all applications. One comment suggested limiting secrecy of a patent
application to one month. One comment suggested that some form of
intervening rights legislation might better address the problem of
repetitive filings. One comment suggested elimination of 35 U.S.C.
135(b). One comment suggested amending 35 U.S.C. 271 so that a variety
of claim forms are not necessary for direct infringement to be found,
arguing that current 35 U.S.C. 271 is the reason why software-based
inventions require claims to different statutory classes, thus
increasing the number of claims in an application. One comment
suggested that the Office should work with Congress to legislatively
overturn Honeywell Int'l Inc. v. Hamilton Sundstrand Corp., 370 F.3d
1131, 71 U.S.P.Q.2d 1065 (Fed. Cir. 2004), to promote the use of
dependent claims and not construe the rewriting of an objected to
dependent claim in independent form narrowly under the doctrine of
equivalents. One comment suggested granting rights to regulate the use
of an Internet patent to the assignee and the enforcement of such
regulation would be based on a fee and would not include the right to
prevent others from using the invention.

   Response: The changes suggested by the comments are beyond the
scope of the proposed changes to the rules of practice. It is not
clear, however, how the changes suggested by the comments would address
the increased usage of continuing application practice or have an
appreciable impact on quality or pendency.

L. Effective Date of the Changes in This Final Rule

   Comment 332: One comment stated that the Office does not have any
authority to promulgate retroactive rules because the Administrative
Procedures Act does not confer such power on the Office. Several
comments asserted that Congress never expressly authorized the Office
to promulgate retroactive rules, citing Landgraf v. USI Film Prods.,
511 U.S. 244, 265 (1994) and Bowen v. Georgetown Univ. Hosp., 488 U.S.
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1178 

204, 208 (1988). A number of comments also suggested that the
retroactive effect of proposed rule § 1.78 is contrary to judicial
precedent, citing Henriksen and Hogan. Several comments argued that
applying the changes to § 1.75 retroactively would be unfair to the
applicants and a violation of due process because applicants were not
given sufficient notice of the changes when they filed applications.
Lastly, one comment argued that applying the rule changes to pending
applications is an unconstitutional denial of due process.

   Response: The Office is not engaging in retroactive rule making.
This final rule has a prospective effect only. The Office's decision to
grandfather only pending applications in which a first Office action on
the merits was mailed before November 1, 2007 (the effective date of
the changes in this final rule) with respect to the changes to §
1.75 does not constitute retroactive rule making. Likewise, the
Office's decision to grandfather only continuing applications and
requests for continued examination that were filed before the effective
date of the final rule with respect to §§ 1.78 and 1.114 (with
a provision that allows for at least "one more" continuation
application or continuation-in-part application of an application filed
before the publication date of this final rule) does not constitute
retroactive rule making.

   "A statute [or regulation] does not operate `retroactively' merely
because it is applied in a case arising from conduct antedating the
statute's enactment." Landgraf, 511 U.S. at 255. Rather, a statute (or
regulation) is retroactive if it takes away or impairs vested rights
acquired under existing law, creates a new obligation, imposes a new
duty, or attaches a new disability with respect to transactions already
completed. See Landgraf, 511 U.S. at 269. The filing of an application
for patent does not create a vested right or amount to a transaction
already completed. See Community TV, Inc. v. FCC, 216 F.3d 1133, 1143
(D.C. Cir. 2000) (the Federal Communications Commission is free to alter
the criteria for consideration of pending "upgrade" applications because
the mere filing of an application does not vest the applicant with a
legally cognizable expectation interest); Chadmore Communs. v. FCC, 113
F.3d 235, 240-41 (D.C. Cir. 1997) (the mere filing of an application
does not vest an applicant with a legally cognizable expectation
interest). In addition, the Office is not changing the substantive
criteria of patentability. The Office is simply revising the procedures
an applicant must follow for presenting more than five independent
claims or more than twenty-five total claims in an application, and for
seeking continued examination of an application via a continuation
application, continuation-in-part application, or a request for
continued examination. See Landgraf, 511 U.S. at 275 (changes in
procedural rules may generally be applied in actions arising before the
change without raising retroactivity concerns).

   Finally, this final rule does not raise constitutional due process
concerns. This rule change does not preclude an applicant from filing
an application or receiving a patent containing any number of claims.
Rather, the changes to § 1.75 in this final rule simply revise the
procedures for presenting more than five independent claims or more
than twenty-five total claims. As for the changes to § 1.78 in this
final rule, the filing of an application does not vest an applicant
with a due process right to obtain continued examination via a
continuation application, continuation-in-part application, or a
request for continued examination for purposes of presenting
amendments, arguments, or evidence that could have been submitted prior
to close of prosecution in the initial application (or the prior-filed
application).

   Comment 333: A number of comments suggested that the Office should
not retroactively affect any pending applications when adopting the
changes to § 1.78. Specifically, the comments disagreed with the
Office's decision to apply the changes to § 1.78 to any
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1179 

applications filed on or after the effective date of the final rule,
which would result in an applicant being able to file only one
continuation or continuation-in-part application (and not "one more"
continuation or continuation-in-part application) on or after the
effective date of the final rule without meeting the requirements
specified in § 1.78(d)(1)(i) or (d)(1)(iii) or including a petition
under § 1.78(d)(1). The comments argued that the changes would
retroactively affect the prosecution of many pending applications,
particularly those that are continued examination filings, precluding
any opportunity for subsequent continued examination filings. A number
of comments also argued that retroactively affecting the pending
applications would be unfair to applicants because it would deprive
applicants of timely notice of the rule changes and it would be a
violation of due process. Several comments argued that retroactively
affecting the pending applications would require applicants to review
the pending applications to determine whether to file additional
continuing applications to preserve the patent rights of unclaimed
subject matter or restricted inventions and to file many continuing
applications before the effective date. The comments further argued
that this would increase the cost of prosecution and the Office's
backlog of applications. One comment estimated the cost of reviewing
the pending applications to be 180 million dollars based on 600,000
pending applications. A number of the comments suggested that the
changes should be applicable only to claiming the benefit of
applications filed on or after the effective date (i.e., the changes
should be applicable only to non-continuing applications filed on or
after the effective date). One comment suggested that the changes to
§ 1.78 should apply to applications filed on or after the effective
date with an exception for any applications that have a filing date
earlier than one year from the effective date. One comment suggested
that in the determination of the number of continued examination
filings permitted without a petition and a showing, the Office should
count only the continued examination filings filed on or after January
3, 2006. One comment suggested that the Office should permit applicants
to file one more continued examination filing on or after the effective
date.

   Response: This final rule provides that an applicant is not
required to meet the requirements set forth in § 1.78(d)(1) if: (1)
The application claims the benefit under 35 U.S.C. 120, 121, or 365(c)
only of nonprovisional applications or international applications filed
before the publication date of this final rule in the Federal Register;
and (2) there is no other application filed on or after the publication
date of this final rule in the Federal Register that also claims the
benefit under 35 U.S.C. 120, 121, or 365(c) of such prior-filed
nonprovisional applications or international applications. This will
provide applicants with "one more" continuation application or
continuation-in-part application of an application that was filed prior
to the publication date of this final rule in the Federal Register
without a petition and showing. Thus, applicants are also permitted to
file a divisional application in compliance with § 1.78(d)(1)(ii)
of an application that was filed prior to the effective date of this
final rule without a petition and showing.

   The rules of practice currently provide that by presenting any
paper (including any continuation application, continuation-in-part
application, or request for continued examination) to the Office, the
party presenting the paper is certifying that to the best of the
party's knowledge, information and belief, formed after an inquiry
reasonable under the circumstances, that the paper is not being
presented for any improper purpose, such as to harass someone or to
cause unnecessary delay or to needlessly increase the cost of
prosecution before the Office. See § 10.18(b)(2)(i). Thus, as part
of the reasonable inquiry, the Office expects a party to review
applications to ensure that the desired amendments, arguments, or
evidence that can be submitted during the prosecution of the prior-
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1180 

filed (or before the close of prosecution in the) application are
submitted rather than waiting to make such submission in a later-filed
continuation application. Therefore, it is unclear why the final rule
would impose any significant additional cost on applicants.

   Comment 334: Several comments suggested that if the Office adopts
the proposed changes to § 1.78, the Office should publish the final
rule well in advance of the effective date to provide sufficient time
for applicants to adjust their prosecution strategies in any pending
applications. A few comments further suggested a time period of six
months to one year between the publication of the final rule and the
effective date. Furthermore, a few comments suggested that the changes
to § 1.78 should be implemented in phases. One of the comments
provided an example that the changes would initially apply only to non-
continuing applications filed on or after the effective date, and then
six months after the effective date, the changes would apply to
applications that have an effective filing date more than four years
before the effective date.

   Response: This final rule has been published well (more than sixty
days) in advance of the November 1, 2007, effective date of the changes
in this final rule. As previously discussed, this final rule permits
applicants to file "one more" continuation or continuation-in-part
application of an application that was filed prior to the publication
date of this final rule in the Federal Register without a petition and
showing, and to file (at least) "one more" divisional application in
compliance with § 1.78(d)(1)(ii) of an application that was filed prior to
the effective date of this final rule without a petition and showing.
The Office published the Continuing Applications Proposed Rule and the
Claims Proposed Rule in the Federal Register on January 3, 2006, which
set forth proposed changes to the practice for continued examination
filings, patent applications containing patentably indistinct claims,
and examination of claims in patent applications. Applicants have been
provided with a time period of more than one and a half years from the
publication date of the proposed rules to the effective date of this
final rule, and a time period of more than sixty days from the
publication of the final rule to the effective date. Therefore,
applicants should have sufficient advance notice of the rule changes.

   Comment 335: One comment suggested a transitional practice for
divisional applications, permitting benefit claims to be added only to
applications filed on or before the effective date in serial divisional
applications.

   Response: Section 1.78(d)(1)(ii) as adopted in this final rule
permits an applicant to file a divisional application of an application
for the claims to a non-elected invention that has not been examined if
the application was subject to a requirement for restriction. The
divisional application need not be filed during the pendency of the
application subject to a requirement for restriction, as long as the
copendency requirement of 35 U.S.C. 120 is met. Thus, applicant may
file the divisional application during the pendency of the application
that was subject to a requirement for restriction or the pendency of
any continuing application of such an application.

   Comment 336: A number of comments suggested that the changes to
§ 1.75 should apply only to applications filed on or after the
effective date. A number of comments disagreed with the Office's
decision to apply the changes to § 1.75 to applications filed
before the effective date. Several comments further argued that the
cost of "retroactively" applying the rule changes would be enormous
to applicants, especially to small entities, because most applicants
would be required to review their pending applications for compliance
with the new requirement. Several comments estimated the cost to be 100
to 120 million dollars to designate representative claims in pending
applications, and one comment estimated the cost to be 180 million
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1181 

dollars. Several comments argued that small entities are less able to
absorb expenses associated with reviewing and revising pending
applications. This could prevent small entities from prosecuting
pending applications. Several comments argued that because applicants
already paid the increased claims fees under the Consolidated
Appropriations Act, 2005, in the pending applications for the Office to
examine all of the claims, the new requirements would constitute a
taking by the Federal Government. Several comments also argued that
applicants did not anticipate the additional costs in reviewing and
amending the applications for compliance with the new requirements.

   Response: The Office has revised § 1.75 to provide that if an
application contains more than five independent claims or more than
twenty-five total claims, the applicant must submit an examination
support document in compliance with § 1.265. Of the applications
currently awaiting examination for which claim data is available in
PALM (which is over ninety percent of the applications for which
preexamination processing is complete), about thirty percent contain
more than five independent claims or more than twenty-five total
claims. Therefore, the Office's decision to grandfather only pending
applications in which a first Office action on the merits was mailed
before November 1, 2007 (the effective date of the changes in this
final rule) with respect to the changes to § 1.75 will not affect
the majority of applications that are currently pending before the
Office. In addition, the changes in this final rule do not preclude an
applicant from filing an application or obtaining a patent containing
any number of claims, but simply changes the procedures for
applications containing more than five independent claims or more than
twenty-five total claims. Therefore, there is no support for the
proposition that the changes in this final rule amount to a "taking"
by the government. Additionally, § 1.117 as adopted in this final
rule provides that if an amendment canceling a claim is filed before an
examination on the merits has been made of the application, the
applicant may request a refund of any excess claims fee paid on or
after December 8, 2004 (fees paid under the Consolidated Appropriations
Act), for such claim.

   Comment 337: One comment suggested that if the changes to
§ 1.75 are retroactively applied to applications filed before the
effective date, the Office should automatically consider certain claims
as representative when applicant fails to designate claims within the
time period set forth in a notice requiring the designation of
representative claims. One comment inquired about requiring applicants
to take action on applications in the backlog within the first month
following enactment of the proposed rules. One comment suggested that
the Office should send a notice giving applicant three months
(extendable to six months) within which to designate the representative
claims in each pending application and, if necessary, to file an
examination support document.

   Response: As discussed previously, this final rule does not adopt
the "representative claims" examination approach. Under this final
rule, applicant is permitted to present more than five independent
claims or more than twenty-five total claims if applicant files an
examination support document before a first Office action on the merits
of an application. The Office does not expect that most applicants will
need to take any action to comply with the changes to § 1.75 in
this final rule within the first month following the effective date of
this final rule because the majority of applications contain five or
fewer independent claims and twenty-five or fewer total claims. The
Office will provide an applicant who filed a nonprovisional application
under 35 U.S.C. 111(a) before November 1, 2007, or a nonprovisional
application that entered the national stage after compliance with 35
U.S.C. 37 before November 1, 2007, and who would be affected by the
changes in the final rule, with an opportunity to submit: (1) An
examination support document; (2) a new set of claims such that the
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1182 

application contains five or fewer independent claims and twenty-five
or fewer total claims; or (3) a suggested restriction requirement.
Specifically, the Office will issue a notice setting a two-month time
period that is extendable under § 1.136(a) or (b) within which the
applicant must exercise one of these options in order to avoid
abandonment of the application. The Office, however, may combine such a
notice with a requirement for restriction, in which case the applicant
must make an election responsive to the restriction requirement and, if
there are more than five independent claims or more than twenty-five
total claims drawn to the elected invention, the applicant must
also: (1) File an examination support document in compliance with
§ 1.265; or (2) amend the application such that it contains five or fewer
independent clams and twenty-five or fewer total claims drawn to the
elected invention. Thus, if such a notice is combined with a
requirement for restriction, the applicant does not have the option of
replying to such notice with a suggested restriction requirement under
§ 1.142(c).

M. Miscellaneous

   Comment 338: One comment suggested that the changes to § 1.78
are contrary to the purpose of the Bayh-Dole Act.

   Response: The Bayh-Dole University and Small Business Patent
Procedures Act (Pub. L. 96-517, 94 Stat. 3015-28 (codified at 35 U.S.C.
200 et seq.)), concerns patent rights in inventions made with federal
assistance. Specifically, 35 U.S.C. 200 provides that:

   It is the policy and objective of the Congress to use the
patent system to promote the utilization of inventions arising from
federally supported research or development; to encourage maximum
participation of small business firms in federally supported
research and development efforts; to promote collaboration between
commercial concerns and nonprofit organizations, including
universities; to ensure that inventions made by nonprofit
organizations and small business firms are used in a manner to
promote free competition and enterprise without unduly encumbering
future research and discovery; to promote the commercialization and
public availability of inventions made in the United States by
United States industry and labor; to ensure that the Government
obtains sufficient rights in federally supported inventions to meet
the needs of the Government and protect the public against nonuse or
unreasonable use of inventions; and to minimize the costs of
administering policies in this area.

   The changes to § 1.78 adopted in this final rule do not concern
patent rights in inventions made with federal assistance and do not
impinge upon any of the policies or objectives set forth in 35 U.S.C.
200. The changes in this final rule do not treat patent applications
resulting from federally supported research differently from other
patent applications. The policy objectives of the Bayh-Dole Act do not
encourage or condone more favorable treatment of patent applications
resulting from federally supported research. See Univ. of Rochester v.
G.D. Searle & Co., 358 F.3d 916, 929, 69 U.S.P.Q.2d 1886, 1896 (Fed.
Cir. 2004) (none of the eight policy objectives of the Bayh-Dole Act
encourages or condones less stringent application of the patent laws to
universities than to other entities).

   Comment 339: A number of comments suggested that to help reduce the
backlog of pending applications the Office should provide a procedure
under which an applicant may request deferral of examination of the
application.

   Response: The rules of practice currently have a procedure under
which an applicant may request deferral of examination. Specifically,
§ 1.103(d) permits deferral of examination for up to three years
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1183 

from the earliest filing date for which a benefit is claimed under
title 35, United States Code. The Office publishes any application in
which a deferral of examination under § 1.103(d) is requested. The
entire period of deferral is a reduction under § 1.704(c)(1) of any
patent term adjustment.

   Comment 340: A number of comments suggested variations of the
deferral of examination procedure under § 1.103(d), including,
inter alia, providing for automatic deferral of examination, extending
the period of deferral, allowing third party requests for examination
of deferred applications, eliminating any negative impact on patent
term adjustment resulting from deferral, adopting deferral of
examination procedures used in other countries such as Japan and
Canada, tying the period of deferral to the actual filing date of the
application rather than the claimed benefit date, and establishing
deferral fees based on the length of deferral.

   Response: The deferral of examination procedure set forth in §
1.103(d) was used in fewer than two hundred applications since November
29, 2000 (the effective date of § 1.103(d)). The Office did not
propose any changes to the deferral of examination procedure in the
notices of proposed rulemaking published on January 3, 2006, in the
Federal Register. In view of the comments received on the deferral of
examination procedure, the Office is studying whether changes (e.g.,
the maximum deferral period, third party request for examination, and
patent term adjustment) to the deferral of examination procedure would
be appropriate.

   Comment 341: Several comments opposed third party participation,
but suggested that the Office could move toward providing a post-grant
opposition period, similar to that currently offered in Europe, during
which the public could oppose issued patents and make prior art
submissions so the patent could receive a post-grant review.

   Response: Legislation regarding post-grant opposition and related
participation by third parties is currently pending before Congress. If
enacted, the Office will implement the legislation accordingly.

   Comment 342: A number of comments suggested expanding the
opportunity under § 1.99 for third parties to submit prior art
references in applications; for example, up to a first Office action.

   Response: The Office has proposed changes to § 1.99 that would
extend the period for submission of information from two months after
pre-grant publication of the application to six months after pre-grant
publication of the application, or mailing of a notice of allowance,
whichever occurs first. See Changes To Information Disclosure Statement
Requirements and Other Related Matters, 71 FR at 38816, 38822, 1309
Off. Gaz. Pat. Office at 31, 36.

   Comment 343: One comment questioned applicant's recourse if a third
party submission was filed in his or her application.

   Response: Applicant's recourse would be the same as it currently is
when a third party submits patents or publications pursuant to §
1.99 in a published patent application. Applicant will have an
opportunity to comment on any patents or publications relied upon by
the examiner in a rejection of applicant's claims. Note, however, 35
U.S.C. 122(c) prohibits third party protests.

   Comment 344: Several comments suggested that prior art submissions
by third parties should be required to conform to current information
disclosure statement rules. These comments also suggested that either
statements of relevance for each submitted document, or arguments why
the claims are unpatentable in view of the cited documents, should
accompany the submissions.
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1184 


   Response: Prior to the publication of a patent application, a third
party may file prior art submissions in compliance with the
requirements of § 1.291 in the application. After the publication
of the application, § 1.99 only permits a third party to file up to
ten patents or publications per submission. Section 1.99 does not
permit the third party to file comments regarding the documents, or
comments regarding the patentability of the claims in view of the
documents. Additionally, permitting a third party to file an
explanation of relevance would rise to the level of a protest, which is
prohibited by 35 U.S.C. 122(c).

   Comment 345: Several comments suggested allowing a third party to
request examination of an application upon paying a fee during a time
frame such as between thirty-six and forty-eight months from the
application filing date. One comment suggested permitting third parties
to request accelerated examination of long-pending applications by
submitting documents required for accelerated examination.

   Response: Under the current patent laws and regulations, it is not
proper for a third party to be involved in the examination of an
application owned by another which includes seeking to accelerate the
examination of an application that is properly awaiting its turn to be
examined. Permitting a third party to advance prosecution of an
application may be considered in the future for those instances in
which an applicant has requested deferral of the examination. However,
at this time, the Office has not elected to amend § 1.103(d) to
permit such action, in order to further study the issue and to provide
the public additional opportunity to comment.

   Comment 346: One comment suggested the use of authorized third
party prior art searches.

   Response: Patents or publications filed by a third party in
compliance with § 1.99 may be entered in the file of a published
application. Examiners may use any of these references in a rejection,
if appropriate.

   Comment 347: Several comments were critical of the Office's
position that the proposed changes to the practice for continuing
applications, request for continued examination, and applications
containing patentably indistinct claims will not create any additional
work for the applicant.

   Response: The changes being adopted in this final rule will not
require any additional submissions for the majority of patent
applications. Prosecution, however, may be more compact since the
number of continuing applications and requests for continued
examination permitted without any justification is being limited.
Nevertheless, the changes being adopted in this final rule will result
in more effective and efficient examination without any additional work
on the part of the majority of applicants.

   Comment 348: Several comments recommended that the Office should
conduct a public hearing before adopting the rule changes. One comment
suggested that the Office should issue a green paper or advance notice
of proposed rule making to receive more input and perform a cost-
benefit analysis on the rule changes. One comment recommended that the
Office should form a patent practice advisory committee, consisting of
volunteers from the patent bar, for the purpose of studying problems
experienced by the Office and proposing solutions that would be
tailored to address those problems. The comments recommended that the
Office should bring together all the relevant parties, including the
Office, patent practitioners, patentees, litigators, and judges, to
arrive at a solution that benefits all parties in the patent system.

Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1185 

   Response: 35 U.S.C. 2(b)(2)(B) directs the Office to follow the
procedures set forth in 5 U.S.C. 553 in adopting changes to the rules
of practice, and 35 U.S.C. 3(a)(2)(B) directs the Office to consult
with the Patent Public Advisory Committee when proposing or adopting
changes to the rules of practice that change user fees or are subject
to notice and comment under 5 U.S.C. 553. The Office published notices
of proposed rule making pursuant to 5 U.S.C. 553(b) in advance of this
final rule, provided an extended comment period to give interested
persons an opportunity to submit written data, views, or arguments
pursuant to 5 U.S.C. 553(c), and has published this final rule at least
thirty days in advance of its effective date pursuant to 5 U.S.C.
553(d). The Office also consulted with the Patent Public Advisory
Committee prior to publishing the notices of proposed rule making and
this final rule. The Office also conducted four public meetings to
obtain feedback from the public on the proposed changes which resulted
in the changes being adopted in this final rule: (1) The first in
Chicago, Illinois, on February 1, 2006; (2) the second in Berkeley,
California, on February 28, 2006; (3) the third in Houston, Texas, on
March 22, 2006; and (4) the fourth in Alexandria, Virginia (at the
Office's Carlyle campus) on April 25, 2006. The number of comments
submitted in response to the notices of proposed rule making indicates
that interested persons and organizations have been given ample
opportunity to provide input on the changes being adopted in this final
rule.

IV. Rule Making Considerations

A. Administrative Procedure Act

   This notice adopts changes to the rules of practice that concern
the process for applying for a patent, namely, continuing applications
and requests for continued examination practices, the treatment of
applications containing more than a set number of independent or total
claims, and the treatment of multiple applications containing
patentably indistinct claims. The changes being adopted in this notice
do not change the substantive criteria of patentability and do not
effectively foreclose the applicant's opportunity to make a case on the
merits (i.e., the changes being adopted in this final rule continue to
provide patent applicants with numerous opportunities). Therefore,
these rule changes involve interpretive rules, or rules of agency
practice and procedure. See Bachow Communs., Inc. v. FCC, 237 F.3d 683,
690 (DC Cir. 2001) (rules governing an application process are "rules
of agency organization, procedure, or practice" and exempt from the
Administrative Procedure Act's notice and comment requirement); see
also Fressola v. Manbeck, 36 USPQ2d 1211, 1215 (D.D.C. 1995) ("it is
extremely doubtful whether any of the rules formulated to govern patent
or trade-mark practice are other than `interpretive rules, general
statements of policy, * * * procedure, or practice.'") (quoting C.W.
Ooms, The United States Patent Office and the Administrative Procedure
Act, 38 Trademark Rep. 149, 153 (1948)). Accordingly, prior notice and
an opportunity for public comment were not required pursuant to 5
U.S.C. 553(b)(A) (or any other law), and thirty-day advance publication
is not required pursuant to 5 U.S.C. 553(d) (or any other law).
Nevertheless, the Office sought public comment on proposed changes to
these rules of practice to obtain the benefit of such input prior to
adopting the changes to the rules of practice in this final rule.

B. Regulatory Flexibility Act

   As prior notice and an opportunity for public comment are not
required pursuant to 5 U.S.C. 553 (or any other law), neither a
regulatory flexibility analysis nor a certification under the
Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are required. See 5
U.S.C. 603. Nevertheless, the Office published notices of proposed rule
making setting forth the factual basis for certification under the
Regulatory Flexibility Act and sought public comment on that
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1186 

certification. See Changes to Practice for the Examination of Claims in
Patent Applications, 71 FR at 66, 1302 Off. Gaz. Pat. Office at 1333,
and Changes to Practice for Continuing Applications, Requests for
Continued Examination Practice, and Applications Containing Patentably
Indistinct Claims, 71 FR at 56-57, 1302 Off. Gaz. Pat. Office at 1325.
For the reasons set forth herein, the Deputy General Counsel for
General Law of the United States Patent and Trademark Office has
certified to the Chief Counsel for Advocacy of the Small Business
Administration that the changes in this final rule will not have a
significant economic impact on a substantial number of small entities.
See 5 U.S.C. 605(b).

   This final rule provides that: (1) A third or subsequent
continuation or continuation-in-part application or any second or
subsequent request for continued examination must include a showing as
to why the amendment, argument, or evidence sought to be entered could
not have been submitted prior to the close of prosecution after a first
and second continuation or continuation-in-part application and a
request for continued examination; (2) any divisional application be
the result of a requirement to comply with the requirement of unity of
invention under PCT Rule 13 or a requirement for restriction under 35
U.S.C. 121 in the prior-filed application; (3) an application that
contains or is amended to contain more than five independent claims or
more than twenty-five total claims must include an examination support
document under 37 CFR 1.265 that covers each claim (whether in
independent or dependent form) before the first Office action on the
merits; and (4) multiple applications that have the same claimed filing
or priority date, substantial overlapping disclosure, a common
inventor, and a common assignee include either an explanation as to how
the claims are patentably distinct, or a terminal disclaimer and
explanation as to why patentably indistinct claims have been filed in
multiple applications.

   In response to the Office's certification in the notices of
proposed rule making, the Small Business Administration Office of
Advocacy (SBA-Advocacy) submitted a comment contending that the
proposed changes are likely to have a significant economic impact on a
substantial number of small entities, including small businesses and
small independent inventors. SBA-Advocacy recommended that the Office
conduct a supplemental Initial Regulatory Flexibility Analysis before
publishing a final rule.

   The Office's analysis of the proposed rules indicated that the
rules would not have a significant economic impact on a substantial
number of small entities. The Office considered all public comments
addressing small entities, including those submitted by SBA-Advocacy.
In response to these comments, this final rule incorporates a number of
revisions designed to further reduce the number of small entities
affected by the changes and the impacts on small entities. These
changes in this final rule vis-a-vis the proposed rules that
reduce small entity impacts are as follows: (1) This final rule adopts
an examination support document requirement threshold of five
independent claims or twenty-five total claims, rather than ten
representative claims; (2) this final rule provides that small entities
as defined by the Regulatory Flexibility Act are exempt from the
requirement that an examination support document must, for each cited
reference, include an identification of all of the limitations of each
of the claims that are disclosed by the reference; (3) this final rule
adopts a continued examination filing petition threshold of two
continuing applications (continuation or continuation-in-part
applications), plus a request for continued examination in any one of
the initial or two continuing applications, rather than one
continuation application, continuation-in-part application, or request
for continued examination; (4) this final rule does not require that a
divisional application be filed during pendency of initial application;
and (5) this final rule provides for at least "one more" continuation
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1187 

or continuation-in-part application after the effective date,
regardless of the number of previous continued examination filings.

   In addition, the Office commissioned a detailed analysis of the
impacts of this final rule on small entities. The analysis concludes
that this final rule is not expected to result in a significant
economic impact on a substantial number of small entities. The analysis
measured economic impact in terms of annualized incremental cost as a
percentage of revenue. The analysis indicated that the incremental cost
(not annualized) would be between $2,563 and $13,121 for an entity who
would be required to file an examination support document, a petition
for an additional continued examination filing, or both. The analysis
presumed that an economic impact greater than three percent of
annualized incremental cost as a percentage of revenue was a
significant impact. The analysis indicated that no small entities fell
into this category. The analysis also presumed that an economic impact
greater than one percent of annualized incremental cost as a percentage
of revenue was a more moderate impact. The analysis indicated that
fewer than one percent of small entities fell into this category. The
analysis also presumed that a substantial number of small entities are
affected if more than twenty percent of small entities are impacted.
The analysis indicated that about 1.0 percent of small entities would
be affected by the requirement to submit an examination support
document, that about 2.7 percent of small entities would be affected by
the requirement to submit a petition for an additional continued
examination filing, and that about 0.3 percent of small entities would
be affected by both the requirement to submit an examination support
document and the requirement to submit a petition for an additional
continued examination filing. A copy of the report containing this
analysis is available on the Office's Internet Web site at
http://www.uspto.gov.

   As a result of this analysis, the Office has determined that it is
appropriate to make a certification that the changes being adopted in
this final rule would not have a significant economic impact on a
substantial number of small entities. The Office has revised the final
rule requirements, as discussed previously, to further reduce economic
impacts on small entities.

   SBA-Advocacy commented that while the Office asserts that
preparation of the examination support document should cost about
$2,500, small entities contend that completing an examination support
document will be more costly, time consuming and restrict their ability
to prosecute patents vigorously. SBA-Advocacy also commented that small
entity representatives have provided feedback that completion of an
examination support document could cost from $25,000 to $30,000.

   The Claims Proposed Rule referenced a $2,500 figure covering a
patent novelty search, analysis, and opinion, as reported in a 2003
survey conducted by the American Intellectual Property Law Association
(AIPLA). The Office agrees with the comments that this figure is
probably less than the cost of an examination support document in most
situations. Therefore, the Office has further analyzed costs based on
the modified examination support document requirements applicable to
small entities. The analysis models cost variability based on the
number of claims the examination support document must address, and on
whether or not a prior art search was conducted when the application
was prepared. Based on this analysis, the Office estimates that the
examination support document costs for small entities will range from
$2,563 up to $13,121, although this latter figure assumes the
examination support document must address as many as fifty independent
claims or three hundred and fifty total claims. Only a small number of
small entities, however, will be required to prepare an examination
support document, and nearly all of these will incur costs towards the
lower end of the range. Thus, the Office does not expect the final rule
to result in a
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1188 

significant impact on a substantial number of small entities.

   SBA-Advocacy commented that small entity representatives have
asserted that, taken together, the two proposed changes would increase
the cost of application preparation and hinder the patent prosecution
process.

   As discussed previously, the Office commissioned a detailed
analysis of the impact of the final rule on small entities. The
analysis explicitly considered the combined cost of both proposed rules
(which have been combined into a single final rule). The analysis
concludes that the final rule is not expected to result in a
significant economic impact on a substantial number of small entities.

   SBA-Advocacy commented that small entity representatives have
raised concerns that the proposed changes will significantly impact the
most valuable and commercially viable patents because those types of
patents typically involved a higher number of continuations.

   The Office notes that there are studies espousing the position that
many commercially valuable patents are the result of a continuing
application, or of a second or subsequent continuing application.
However, these studies do not support the position that the applicants
could not have obtained these commercially valuable patents but for the
availability of an unlimited number of continuing applications. That
is, these studies do not show that these commercially valuable patents
could not have been obtained via two or fewer continuing applications
prosecuted with a reasonable amount of foresight and diligence. Thus,
these studies do not demonstrate that these commercially valuable
patents happen to be the result of a continuing application or of
multiple continuing applications for any reason other than simply
because the prosecution tactics employed in the applications underlying
these patents were based upon the availability of an unlimited number
of continuing applications.

   The analysis commissioned by the Office specifically considered the
claim that the most valuable and commercially viable patents are those
types of patents that typically involved a higher number of
continuations. The Office ultimately rejected the claim that this final
rule will preclude applicants from being able to obtain a patent on the
most valuable and commercially viable patents due to the speculative
nature of the nexus drawn between the availability of an unlimited
number of continuing applications and an applicant's ability to obtain
these commercially valuable patents.

   SBA-Advocacy commented that small entity representatives have
indicated that limiting applicants to ten representative claims would
make it very difficult to properly identify a potential patent, could
create future liability concerns, and would weaken potential patents.

   The final rule requirements apply to patent applications with more
than five independent claims or more than twenty-five total claims,
rather than ten representative claims. As discussed previously,
applicants with more than five but less than fifteen independent
claims, or more than twenty-five but less than seventy-five total
claims, to an invention are able to prosecute their application in a
manner that does not trigger the claims or continuations requirements.
Specifically, an applicant may do this by submitting an initial
application containing up to five independent claims and up to twenty-
five total claims, and then adding a similar number of claims in each
of two continuation applications (or two continuation-in-part
applications, or one continuation application and one continuation-in-
part application) permitted without a petition. Moreover, even for
those applications that will require an examination support document,
the requirement does not "limit" applicants to any particular number
of claims. Applicants may continue to submit as many claims as
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1189 

necessary to appropriately claim their inventions, even if doing so
required them to prepare and submit an examination support document.

   SBA-Advocacy commented that small entity representatives have
contended that limiting continuation applications and examinations
would inhibit their ability to enhance their applications,
significantly increase costs through new fees, and force small entities
to seek review through the very expensive appeals process. Small entity
representatives thus assert that limiting the number of continuations
could severely weaken small entities' ability to protect their patents.

   The Office analysis indicates that the continued examination filing
requirements adopted in this final rule will not lead to significant
cost increases nor will it have a significant economic impact on a
substantial number of small entities. The requirements are necessary to
ensure that patent applications are of reasonable quality and that
applicants pursue their patents in good faith. The excessive use of
continued examination filings has been a major factor in the growing
backlog of unexamined applications. With respect to having to use the
appeals process in place of additional continued examination filings,
if an applicant disagrees with the examiner's rejections, the applicant
should file an appeal rather than filing a continuation application or
a request for continued examination, for reasons discussed in detail in
the statement of considerations for the final rule. The Office believes
that applicants should have sufficient opportunity to place the
application in condition for appeal during the prosecution of the
initial application, two continuing applications, and a request for
continued examination. An applicant who considers this to be
insufficient may file a third or subsequent continuing application or
second or subsequent request for continued examination with a petition
showing why the amendment, argument, or evidence sought to be entered
could not have been previously submitted.

   SBA-Advocacy commented that the proposed changes will affect a
substantial number of small entities, and that the two proposed changes
to the rules reshape the basic rights of any small entity that files a
patent application.

   The Office agrees that the final rule places new requirements on
the current patent application process. However, the Office's analysis
indicates that the rule will not have a significant economic impact on
a substantial number of small entities. In fact, only a small
proportion of small entities will be affected by the changes in this
final rule.

   SBA-Advocacy commented that small entity representatives have
contended that the definition of small entity that the Office uses in
its certification is for calculating filing fees and excludes any small
entity that has a contractual arrangement involving the invention with
a larger company. SBA-Advocacy commented that small entity
representatives have further asserted that small business size
standards for Regulatory Flexibility Act purposes do not include this
restriction so the number of small businesses affected is likely to be
larger than stated in the certification.

   The Regulatory Flexibility Act permits an agency head to establish,
for purposes of Regulatory Flexibility Act analysis and certification,
one or more definitions of "small business concern" that are
appropriate to the activities of the agency, after consultation with
the Office of Advocacy of the Small Business Administration and after
opportunity for public comment. See 5 U.S.C. 601(3) and 13 CFR 121.903(c).
Pursuant to this authority, the Office has established the following
definition of small business concern for purposes of the Office conducting
an analysis or making a certification under the Regulatory Flexibility Act
for patent-related regulations: A small business concern for Regulatory
Flexibility Act purposes for patent-related regulations is a business or
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1190 

other concern that: (1) Meets the Small Business Administration's
definition of a "business concern or concern" set forth in 13 CFR 121.105;
and (2) meets the size standards set forth in 13 CFR 121.802 for the purpose
of paying reduced patent fees, namely, an entity: (a) Whose number of
employees, including affiliates, does not exceed 500 persons; and (b)
which has not assigned, granted, conveyed, or licensed (and is under no
obligation to do so) any rights in the invention to any person who made
it and could not be classified as an independent inventor, or to any
concern which would not qualify as a non-profit organization or a small
business concern under this definition. See Business Size Standard for
Purposes of United States Patent and Trademark Office Regulatory
Flexibility Analysis for Patent-Related Regulations, 71 FR 67109, 67112
(Nov. 20, 2006), 1313 Off. Gaz. Pat. Office 60, 63 (Dec. 12, 2006)
(notice). Prior to establishing this definition of small business
concern for purposes of the Office conducting an analysis or making a
certification under the Regulatory Flexibility Act for patent-related
regulations, the Office consulted with the Small Business
Administration Office of Advocacy and published such a definition for
public comment. See Size Standard for Purposes of United States Patent
and Trademark Office Regulatory Flexibility Analysis for Patent-Related
Regulations, 71 FR 38388 (Jul. 6, 2006), 1309 Off. Gaz. Pat. Office 37
(Aug. 1, 2006) (notice). The Small Business Administration small entity
size standards set forth in 13 CFR 121.802 excludes any business
concern that has assigned, granted, conveyed, or licensed any rights in
the invention to an entity which would not qualify for small entity
status.

   Nevertheless, in analyzing the provisions of the final rule, the
Office explicitly considered a sensitivity analysis that assumed all
patent applicants qualified as small entities. Even under this
sensitivity analysis, this final rule is not expected to result in a
significant impact on a substantial number of small entities.

   SBA-Advocacy suggested that with respect to the continued
examination filing requirements, the Office should increase the number
of permissible continuing applications.

   The final rule changes the continued examination filing petition
threshold from a single continuation application, continuation-in-part
application, or request for continued examination as proposed to two
continuing applications (continuation or continuation-in-part
applications), and a single request for continued examination in any
one of the initial or two continuing applications.

   SBA-Advocacy suggested that with respect to the continued
examination filing requirement, the Office should consider increasing
the fees for additional continuation applications.

   Currently, patent application and excess claims fees are set by
statute (35 U.S.C. 41(a)). In 2002, the Office proposed a patent fee
structure that included a graduated excess claims fees schedule and
additional fees for continued examination filings. As discussed
previously, however, the Office was unable to garner sufficient support
from patent user groups for a patent fee structure including a
graduated excess claims fees schedule or any additional fees for
continued examination filings. Therefore, the Office did not pursue
this alternative.

   SBA-Advocacy suggested that with respect to the continued
examination filing requirement, the Office should defer review of
subsequent continuation applications.

   The Office considered expanding the deferral of examination
provisions to allow a longer deferral of examination period. The Office
currently has a provision (37 CFR 1.103(d)) under which an applicant
may request deferral of examination for up to three years from the
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1191 

earliest filing date for which a benefit is claimed. As discussed
previously, the Office is studying whether changes (e.g., the maximum
deferral period, third party request for examination, and patent term
adjustment) to the deferral of examination procedure would be
appropriate.

   SBA-Advocacy suggested that with respect to the claims
requirements, the Office should expand the number of representative
claims included in initial review.

   The Office has revised the final rule to change the examination
support document threshold from ten representative claims to five
independent claims or twenty-five total claims. As discussed
previously, however, applicants with more than five but less than
fifteen independent claims, or more than twenty-five but less than
seventy-five total claims, to an invention are able to prosecute their
application in a manner that does not trigger the claims or
continuations requirements.

   SBA-Advocacy suggested that with respect to the claims
requirements, the Office should provide expedited review of
applications that contain ten or fewer representative claims. The
Office has considered the suggestion to provide expedited examination
to applications containing less than a set number of claims. As
discussed previously, the Office currently has an accelerated
examination program for applicants who limit the number of claims in
their applications (to no more than three independent claims and no
more than twenty total claims) and who also provide an accelerated
examination support document. Therefore, the Office did not pursue this
alternative in the final rule.

   SBA-Advocacy suggested that with respect to the claims requirements,
the Office should not apply the regulation to the backlog of pending
unexamined applications.

   The Office has considered not applying the claims requirement to
pending applications that have not yet been examined to minimize the
impact on small entities. The examination support document threshold
being adopted in this final rule (i.e., more than five independent
claims or more than twenty-five total claims) means that most small
entity applications will not be impacted by the final rule or the
decision to apply the final rule to the backlog of unexamined
applications. Given the current backlog of over 700,000 unexamined
applications, a decision to not apply the changes to the backlog of
unexamined applications would mean that it would be calendar year 2010
before the Office would see any benefit from the change, and that the
Office (and applicants) would be in a transition state until late
calendar year 2011. Therefore, this suggestion was not adopted in the
final rule.

   The Office also received a number of additional comments from the
public generally asserting that the Office did not comply with the
requirements of the Regulatory Flexibility Act in certifying that the
changes in this rule making will not have a significant economic impact
on a substantial number of small entities. The comments stated that:
(1) In light of the fact that several large companies support the
proposed changes it is questionable whether the rule changes are truly
neutral towards small companies and that a bias in favor of large
companies and against small entities could be in violation of the
Regulatory Flexibility Act; (2) the Office's certification did not
adequately address the impact of the proposed rules on small entities,
and the Office failed to provide a credible factual basis to justify its
certification that the proposed rules would not have a significant
economic impact on a substantial number of small entities in compliance
with 5 U.S.C. 605(b); (3) the rule changes would have a significant
economic impact on a substantial number of small entities seeking
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1192 

patents due to the additional costs associated with preparing an
application, establishing the required showing under 37 CFR
1.78(d)(1)(vi) and 1.114(g), and supplying an examination support
document in compliance with 37 CFR 1.265, and would hinder the
abilities of small entities to enhance their applications and protect
their inventions; (4) the definition of small entities used by the
Office in its certification of the proposed rules is for the purpose of
paying reduced patent fees and excludes any application from a small
business that has assigned, granted, conveyed, or licensed any rights
in the invention to an entity which would not qualify for small entity
status; (5) the Office should prepare an initial Regulatory Flexibility
Analysis and republish the proposed rules before issuing any final rule
to enable the Office to closely examine the impact on the affected
small entities, encourage small entities to comment on additional
information provided by the analysis, identify viable regulatory
alternatives to the proposed rules, and demonstrate the Office's
compliance with the Regulatory Flexibility Act; (6) the Office did not
describe any viable alternatives to the proposed rules to provide
regulatory relief to small entities as required under 5 U.S.C. 603(c);
(7) the rule changes would be invalid and vulnerable to challenges
under 5 U.S.C. 611 if the Office fails to comply with the requirements
of the Regulatory Flexibility Act; and (8) the Office should exempt
small entities from complying with the proposed rules to avoid further
scrutiny under the Regulatory Flexibility Act.

   The Office has received comments from some large entities that the
changes being adopted in this final rule have a bias against large
entities, and has received comments from small entities that the
changes being adopted in this final rule have a bias in favor of large
entities. The changes being adopted in this final rule are neutral
towards both small entities and large entities. That several large
entities support the changes being adopted in this final rule is more
likely indicative of a willingness to take a systemic view with respect
to the need to take more significant steps to address patent quality
and pendency.

   As discussed previously, the Office commissioned a detailed
analysis of the final rule's impact on small entities. As a result of
this analysis, the Office has determined that it is appropriate to make
a certification that the changes being adopted in this final rule would
not have a significant economic impact on a substantial number of small
entities. Therefore, the Office is not required to conduct a Regulatory
Flexibility Analysis.

   Pursuant to 5 U.S.C. 605(b), the requirements in 5 U.S.C. 603 and
604 for an initial and final Regulatory Flexibility Analysis (including
identification of viable regulatory alternatives to the proposed rules)
do not apply if the agency head certifies that the changes will not
have a significant economic impact on a substantial number of small
entities. In accordance with 5 U.S.C. 605(b), the Deputy General
Counsel for General Law of the United States Patent and Trademark
Office has certified to the Chief Counsel for Advocacy of the Small
Business Administration that the proposed changes would not have a
significant economic impact on a substantial number of small entities.

   The Office considers this rule making to be in compliance with the
requirements of the Regulatory Flexibility Act. Thus, the possibility
of legal action does not warrant a decision to delay proceeding with
the changes being adopted in this final rule to allow for preparation
of an initial and final Regulatory Flexibility Analysis, or to
completely exempt small entities from complying with the changes being
adopted in this final rule.

C. Executive Order 13132 (Federalism)

   This rule making does not contain policies with federalism
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1193 

implications sufficient to warrant preparation of a Federalism
Assessment under Executive Order 13132 (Aug. 4, 1999).

D. Executive Order 12866 (Regulatory Planning and Review)

   This rule making has been determined to be significant for purposes
of Executive Order 12866 (Sept. 30, 1993), as amended by Executive
Order 13258 (Feb. 26, 2002) and Executive Order 13422 (Jan. 18, 2007).

E. Executive Order 13175 (Tribal Consultation)

   This rule making will not: (1) Have substantial direct effects on
one or more Indian tribes; (2) impose substantial direct compliance
costs on Indian tribal governments; or (3) preempt tribal law.
Therefore, a tribal summary impact statement is not required under
Executive Order 13175 (Nov. 6, 2000).

F. Executive Order 13211 (Energy Effects)

   This rule making is not a significant energy action under Executive
Order 13211 because this rule making is not likely to have a
significant adverse effect on the supply, distribution, or use of
energy. Therefore, a Statement of Energy Effects is not required under
Executive Order 13211 (May 18, 2001).

G. Executive Order 12988 (Civil Justice Reform)

   This rule making meets applicable standards to minimize litigation,
eliminate ambiguity, and reduce burden as set forth in sections 3(a)
and 3(b)(2) of Executive Order 12988 (Feb. 5, 1996).

H. Executive Order 13045 (Protection of Children)

   This rule making is not an economically significant rule and does
not concern an environmental risk to health or safety that may
disproportionately affect children under Executive Order 13045 (Apr,
21, 1997).

I. Executive Order 12630 (Taking of Private Property)

   This rule making will not effect a taking of private property or
otherwise have taking implications under Executive Order 12630 (Mar.
15, 1988).

J. Congressional Review Act

   Under the Congressional Review Act provisions of the Small Business
Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), the
United States Patent and Trademark Office will submit a report
containing this final rule and other required information to the U.S.
Senate, the U.S. House of Representatives and the Comptroller General
of the Government Accountability Office. The changes in this final rule
will not result in an annual effect on the economy of 100 million
dollars or more, a major increase in costs or prices, or significant
adverse effects on competition, employment, investment, productivity,
innovation, or the ability of United States-based enterprises to
compete with foreign-based enterprises in domestic and export markets.
Therefore, this final rule is not a "major rule" as defined in 5
U.S.C. 804(2).

K. Unfunded Mandates Reform Act of 1995

   The changes in this final rule will not result in the expenditure
by State, local, and tribal governments, in the aggregate, or by the
private sector, of 100 million dollars or more in any one year, and it
will not significantly or uniquely affect small governments. Therefore,
Top of Notices Top of Notices   (174)  December 30, 2008 US PATENT AND TRADEMARK OFFICE 1337 CNOG  1194 

no actions are necessary under the provisions of the Unfunded Mandates
Reform Act of 1995. See 2 U.S.C. 1501 et seq.

L. National Environmental Policy Act

   This rule making will not have any effect on the quality of
environment and is thus categorically excluded from review under the
National Environmental Policy Act of 1969. See 42 U.S.C. 4321 et seq.

M. National Technology Transfer and Advancement Act

   The requirements of section 12(d) of the National Technology
Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) are
inapplicable because this rule making does not contain provisions which
involve the use of technical standards.

N. Paperwork Reduction Act

   This final rule involves information collection requirements which
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). The
collection of information involved in this final rule has been reviewed
and approved by OMB under OMB control number 0651-0031. This final rule
provides that: (1) A third or subsequent continuation or continuation-
in-part application or any second or subsequent re