United States Patent and Trademark Office OG Notices: 11 Sep 2007

                            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
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
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
   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
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
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.,
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
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
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
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,
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
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
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
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
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
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,
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
(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
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
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
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
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
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,
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
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.").

   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
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).

   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"
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
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.

   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)
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
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).

   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
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
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
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
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
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
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
 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
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).

   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
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
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
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.

   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
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
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,
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
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
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
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.

   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
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
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
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
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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,
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
 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
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
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
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
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,
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
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
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
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
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
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
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
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
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
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
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.

   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
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
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
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
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
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
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
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
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
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
(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
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
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.

   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
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,
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.

   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
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
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
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.

   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
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
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
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
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
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
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
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
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
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
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
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
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,
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.

   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
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
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
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
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
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
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
indistin