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America Invents Act Referenced Items (299, 300, 301, 302, 303, 304, 305)
(302)                       DEPARTMENT OF COMMERCE
                   United States Patent and Trademark Office
                                 37 CFR Part 1
                         [Docket No. PTO-P-2011-0075]
                                 RIN 0651-AC69

       Changes To Implement the Supplemental Examination Provisions of
     the Leahy-Smith America Invents Act and To Revise Reexamination Fees

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 to implement the
supplemental examination provisions of the Leahy-Smith America Invents
Act (AIA). The supplemental examination provisions permit a patent
owner to request supplemental examination of a patent by the Office to
consider, reconsider, or correct information believed to be relevant to
the patent. These provisions could assist the patent owner in
addressing certain challenges to the enforceability of the patent
during litigation. The Office is also adjusting the fee for filing a
request for ex parte reexamination and setting a fee for petitions
filed in ex parte and inter partes reexamination proceedings to more
accurately reflect the cost of these processes.

DATES: Effective Date: The changes in this final rule take effect on
September 16, 2012.
   Applicability Date: The changes in this final rule apply to any
patent issued before, on, or after September 16, 2012.

FOR FURTHER INFORMATION CONTACT: Cynthia L. Nessler, Senior Legal
Advisor ((571) 272-7724), Pinchus M. Laufer, Senior Legal Advisor
((571) 272-7726), or Kery Fries, Senior Legal Advisor ((571) 272-7757),
Office of Patent Legal Administration, Office of the Deputy
Commissioner for Patent Examination Policy.

SUPPLEMENTARY INFORMATION:

   Executive Summary: Purpose: Section 12 of the AIA amends the patent
laws to provide that a patent owner may request supplemental
examination of a patent to consider, reconsider, or correct information
believed to be relevant to the patent. The supplemental examination
will determine whether the information presented in the request raises
a substantial new question of patentability. If the information
presented in the request raises a substantial new question of
patentability, the Office will order ex parte reexamination of the
patent. Section 12 of the AIA provides that, with certain exceptions, a
patent shall not be held unenforceable on the basis of conduct relating
to information that had not been considered, was inadequately
considered, or was incorrect in a prior examination of the patent if
the information was considered, reconsidered, or corrected during a
supplemental examination of the patent. The Office is also adjusting
the fee for filing a request for ex parte reexamination and setting a
fee for petitions filed in ex parte and inter partes reexamination
proceedings to more accurately reflect the cost of these processes.

   Summary of Major Provisions: This final rule specifies the
requirements for a request for supplemental examination and the
procedures for conducting supplemental examination.
   A request for supplemental examination must contain: (1) A list of
each item of information that is requested to be considered,
reconsidered, or corrected; (2) an identification of each claim of the
patent for which supplemental examination is requested; (3) a separate
explanation of the relevance and manner of applying each item of
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information to each claim of the patent for which it was identified;
and (4) a summary of the relevant portions of any submitted document,
other than the request, that is over fifty pages in length.
   This final rule requires the following supplemental examination
fees: (1) A fee of $5,140.00 for processing and treating a request for
supplemental examination; (2) a fee of $16,120.00 for an ex parte
reexamination ordered as a result of a supplemental examination
proceeding; and (3) for processing and treating, in a supplemental
examination proceeding, a non-patent document over 20 pages in length,
a fee of $170.00 for a document of between 21 and 50 pages, and a fee
of $280.00 for each additional 50 pages or a fraction thereof.
   This final rule also requires the following reexamination fees: (1)
$17,750.00 for filing a request for ex parte reexamination; (2)
$1,930.00 for filing a petition in an ex parte or inter partes
reexamination proceeding, except for those specifically enumerated in
37 CFR 1.550(i) and 1.937(d); and (3) $4,320.00 for a denied request
for ex parte reexamination under 37 CFR 1.510 (this amount is included
in the request for ex parte reexamination fee, and is the portion not
refunded if the request for reexamination is denied). The cost
calculations for these fees are described in "Cost Calculations for
Supplemental Examination and Reexamination", posted on the Office's
Internet Web site at www.uspto.gov.

   Costs and Benefits: This rulemaking is not economically significant
as that term is defined in Executive Order 12866 (Sept. 30, 1993).

   Background: The AIA was enacted into law on September 16, 2011. See
Public Law 112-29, 125 Stat. 284 (2011). The Office is revising the
rules of practice in title 37 of the Code of Federal Regulations (CFR)
to implement the supplemental examination provisions of section 12 of
the AIA. These provisions permit a patent owner to request supplemental
examination of a patent by the Office to consider, reconsider, or
correct information believed to be relevant to the patent. The Office
is also setting certain fees to implement supplemental examination,
adjusting the fee for filing a request for ex parte reexamination, and
setting a fee for petitions filed in ex parte and inter partes
reexamination proceedings.
   Section 12 of the AIA amends chapter 25 of title 35, United States
Code, to add new 35 U.S.C. 257. 35 U.S.C. 257(a) provides for a
proceeding titled "supplemental examination" that may be requested by
the patent owner to consider, reconsider, or correct information
believed to be relevant to the patent in accordance with requirements
established by the Office. The information that may be presented in a
request for supplemental examination is not limited to patents and
printed publications, and may include, for example, issues of
patentability under 35 U.S.C. 101 and 112. Within three months of the
receipt of a request for supplemental examination meeting the
requirements of 35 U.S.C. 257, which include the requirements
established by the Office, the Office shall conduct supplemental
examination and shall conclude the examination (i.e., determine whether
there is a substantial new question of patentability) by the issuance
of a supplemental examination certificate. The supplemental examination
certificate shall indicate whether the items of information presented
in the request raise a substantial new question of patentability.
   If the supplemental examination certificate, which is issued under
35 U.S.C. 257(a), indicates that a substantial new question of
patentability is raised by one or more items of information in the
request for supplemental examination, the supplemental examination
certificate will indicate that ex parte reexamination will be ordered by
the Office. The resulting ex parte reexamination proceeding will be
conducted according to ex parte reexamination procedures, except that the
patent owner does not have the right to file a statement pursuant to 35
U.S.C. 304, and the basis of the ex parte reexamination is not limited to
patents and printed publications. Each substantial new question of
patentability identified during the supplemental examination proceeding
will be addressed by the Office during the resulting ex parte reexamination
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proceeding. See 35 U.S.C. 257(b).
   35 U.S.C. 257(c) specifies the effect of a supplemental examination
under 35 U.S.C. 257(a) and any resulting ex parte reexamination under
35 U.S.C. 257(b) on the enforceability of the patent. 35 U.S.C.
257(c)(1) provides that, with two exceptions, a patent shall not be
held unenforceable on the basis of conduct relating to information that
had not been considered, was inadequately considered, or was incorrect
in a prior examination of the patent if the information was considered,
reconsidered, or corrected during a supplemental examination of the
patent. The first exception is that 35 U.S.C. 257(c)(1) shall not apply
to an allegation pled with particularity in a civil action, or set
forth with particularity in a notice received by the patent owner under
section 505(j)(2)(B)(iv)(II) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(j)(2)(B)(iv)(II)), before the date of a supplemental
examination request under 35 U.S.C. 257(a) to consider, reconsider, or
correct information forming the basis for the allegation (35 U.S.C.
257(c)(2)(A)). The second exception is that in an action brought under
section 337(a) of the Tariff Act of 1930 (19 U.S.C. 1337(a)) or 35
U.S.C. 281, 35 U.S.C. 257(c)(1) shall not apply to any defense raised
in the action that is based upon information that was considered,
reconsidered, or corrected pursuant to a supplemental examination
request under 35 U.S.C. 257(a), unless the supplemental examination,
and any ex parte reexamination ordered pursuant to the request, are
concluded before the date on which the action is brought (35 U.S.C.
257(c)(2)(B)). 35 U.S.C. 257(c)(1) also provides that the making of a
request for supplemental examination under 35 U.S.C. 257(a), or the
absence thereof, shall not be relevant to enforceability of the patent
under 35 U.S.C. 282.
   35 U.S.C. 257(d)(1) provides the Director with authority to
establish fees for filing a request for supplemental examination and
for considering each item of information submitted with the request. If
ex parte reexamination is ordered under 35 U.S.C. 257(b), 35 U.S.C.
257(d)(1) also establishes that the fees applicable to ex parte
reexamination must be paid in addition to the fees for supplemental
examination. 35 U.S.C. 257(d)(2) provides the Director with authority
to establish regulations governing the requirements of a request for
supplemental examination, including its form and content.
   In accordance with 35 U.S.C. 257(e), if the Office becomes aware,
during the course of a supplemental examination or any ex parte
reexamination ordered under 35 U.S.C. 257, that a material fraud on the
Office may have been committed in connection with the patent that is
the subject of the supplemental examination, the Office shall refer the
matter to the U.S. Attorney General, in addition to any other actions
the Office is authorized to take, including the cancellation of any
claims found to be invalid under 35 U.S.C. 307 as a result of ex parte
reexamination ordered under 35 U.S.C. 257. The Office anticipates that
such instances will be rare. The Office regards the term "material
fraud" in 35 U.S.C. 257(e) to be narrower in scope than inequitable
conduct as defined by the U.S. Court of Appeals for the Federal Circuit
in Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed.
Cir. 2011).
   Section 12 of the AIA also indicates that nothing in 35 U.S.C. 257
precludes the imposition of sanctions based upon criminal or antitrust
laws (including 18 U.S.C. 1001(a)), the first section of the Clayton
Act, and section 5 of the Federal Trade Commission Act to the extent
that section relates to unfair methods of competition. See 35 U.S.C.
257(f)(1). Section 12 of the AIA sets forth rules of construction,
providing that 35 U.S.C. 257 shall not be construed to limit the
authority of the Office to investigate issues of possible misconduct
and impose sanctions for misconduct involving matters or proceedings
before the Office, or to issue regulations under 35 U.S.C. 32 or 35
U.S.C. 33 relating to sanctions for misconduct by patent practitioners.
See 35 U.S.C. 257(f)(2) and (f)(3).

   General Discussion Regarding Implementation: The Office must
determine, within three months of the filing of a request for
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supplemental examination, whether a substantial new question of
patentability affecting any claim of the patent is raised by the items
of information in the request. Unlike a request for ex parte
reexamination, the items of information presented in a request for
supplemental examination are not limited to patents and printed
publications. The items of information may include any information
which the patent owner believes to be relevant to the patent, and which
was not considered, was inadequately considered, or was incorrect
during the prior examination of the application which issued as the
patent. See 35 U.S.C. 257(a) and (c). Thus, the variety of information
that is permitted to be submitted in a request for supplemental
examination, including, for example, transcripts of audio or video
recordings, is more extensive than the information permitted to be
submitted in an ex parte reexamination proceeding. Moreover, the
information permitted in a supplemental examination is anticipated to
be more resource-intensive to process, review, and treat than the
information permitted in an ex parte reexamination, because the patent
owner may present, in supplemental examination, an item of information
that raises multiple issues and not just the issues that are permitted
to be raised in ex parte reexamination. For example, the patent owner
may present one item of information that raises patent eligible subject
matter issues under 35 U.S.C. 101 and written description or enablement
issues under 35 U.S.C. 112 with respect to the original disclosure. For
these reasons, the requirements set forth in this final rule are
designed to permit efficient processing and treatment of each request
for supplemental examination within the statutory three-month time
period, and to complete any subsequent ex parte reexamination ordered
as a result of the supplemental examination proceeding with special
dispatch.
   The Office proposed changes to the rules of practice to implement
the supplemental examination provisions in section 12 of the AIA and to
set or adjust fees in ex parte and inter partes reexamination
proceedings in a notice of proposed rulemaking published in January of
2012. See Changes to Implement the Supplemental Examination Provisions
of the Leahy-Smith America Invents Act and to Revise Reexamination
Fees, 77 FR 3666-81 (Jan. 25, 2012) (notice of proposed rulemaking).
The public submitted thirty-six comments in response to the notice of
proposed rulemaking (discussed subsequently in greater detail). In view
of the input from the public, the Office is making the following
changes to the proposed rules of practice to implement the supplemental
examination provisions of section 12 of the AIA.

   Number of Items of Information Considered in a Request for
Supplemental Examination: The Office proposed to limit each request for
supplemental examination to ten items of information. See Changes to
Implement the Supplemental Examination Provisions of the Leahy-Smith
Invents Act and to Revise Reexamination Fees, 77 FR at 3667. The Office
received a number of comments requesting that there be a higher limit
or no limit on the number of items of information contained in a
request for supplemental examination. This final rule increases this
proposed limit from ten to twelve, thus permitting a request for
supplemental examination to contain up to twelve items of information.
The Office must conclude a supplemental examination within three months
of the date on which the request for supplemental examination is filed.
See 35 U.S.C. 257(b). Thus, the Office must place a limit on the number
of items of information that may be submitted with a request for
supplemental examination. Ninety-three percent of the requests for ex
parte reexamination filed in fiscal year 2011 included twelve or fewer
documents. In addition, supplemental examination is designed to preempt
allegations of inequitable conduct being raised as a defense during
patent litigation, which typically concern far fewer than twelve items
of information. Further, if twelve items of information are not
sufficient for a particular situation, more than one request for
supplemental examination of the same patent may be filed at any time.
Thus, the Office expects a limit of twelve items of information per
request to accommodate the vast majority of patent owners.
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   Content Requirements for a Request for Supplemental Examination:
The Office proposed a number of content requirements for a request for
supplemental examination. See Changes to Implement the Supplemental
Examination Provisions of the Leahy-Smith Invents Act and to Revise
Reexamination Fees, 77 FR at 3667, 3670-71. The Office received a
number of comments requesting that there be fewer and simpler content
requirements for a request for supplemental examination. Thus, this
final rule adopts content requirements for a request for supplemental
examination that are comparable to the requirements for a request for
ex parte reexamination (e.g., a list of each item of information to be
considered, reconsidered, or corrected; an identification of each claim
of the patent for which supplemental examination is requested; and a
separate, detailed explanation of the relevance and manner of applying
each item of information to each claim of the patent for which
supplemental examination is requested). See 37 CFR 1.510. In addition,
because the content requirements for a request for supplemental
examination that are comparable to the requirements for a request for
ex parte reexamination, this final rule does not implement the proposed
requirement that a request for supplemental examination contain: (1) An
identification of each item of information requiring consideration,
reconsideration, or correction, and an explanation why consideration or
reconsideration of the item of information is being requested or how
the item of information is being corrected; (2) an identification of
the structure, material, or acts in the specification that correspond
to each means-plus-function or step-plus-function element, as set forth
in 35 U.S.C. 112(f), as amended by the AIA, in any claim to be
examined; (3) an identification of each issue raised by each item of
information; (4) an explanation of the support in the specification for
each limitation of each claim identified for examination if an
identified issue involves the application of 35 U.S.C. 101 (other than
double patenting) or 35 U.S.C. 112; and (5) an explanation of how each
limitation of each claim identified for examination is met, or is not
met, by each item of information if an identified issue involves the
application of 35 U.S.C. 102, 35 U.S.C. 103, or double patenting.

   Filing Date Requirements: The Office proposed that a request for
supplemental examination must comply with the applicable regulations in
37 CFR 1.605, 1.610, and 1.615 to be entitled to a filing date. See
Changes to Implement the Supplemental Examination Provisions of the
Leahy-Smith Invents Act and to Revise Reexamination Fees, 77 FR at
3671. As discussed previously in this final rule, the Office must
conclude a supplemental examination within three months of the date on
which the request for supplemental examination was filed. However, it
would absorb a considerable portion of the three-month period for
conducting the supplemental examination for the Office to accord a
filing date to a non-compliant request for supplemental examination,
issue a notice of the defects in the request for supplemental
examination, and await a corrected request for supplemental
examination. Such a practice when applied in reexamination proceedings
repeatedly placed the Office in jeopardy of not meeting the three-month
time frame in 35 U.S.C. 303 and 312. See Clarification of Filing Date
Requirements for Ex parte and Inter Partes Reexamination Proceedings,
71 FR 44219, 44220 (Aug. 4, 2006). Therefore, the Office cannot adopt
such a procedure in supplemental examination. A request for
supplemental examination that does not comply with the requirements for
a request for supplemental examination may not be granted a filing
date. However, the Office is adopting content requirements for a
request for supplemental examination that are comparable to the
requirements for a request for ex parte reexamination, and thus has
significantly streamlined the requirements for a request for
supplemental examination to make the filing date requirements as simple
and objective as possible. The Office has also eliminated the
requirement for identification of the first-named inventor and the
issue date of the patent for which supplemental examination is
requested. Additionally, the Office has clarified that a cover sheet
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and a table of contents are not required in a request for supplemental
examination.
   A request for supplemental examination that is entitled to a filing
date will be entered into the Office image file wrapper (IFW) and
Patent Application Information Retrieval (PAIR) system, and will be
viewable by the public via the Public PAIR system. The Office, however,
is establishing a procedure in which the request, and any other papers
or information submitted as part of or accompanying the request, will
not be available in Public PAIR until the request meets the conditions
to be entitled to a filing date.
   A request for supplemental examination of a patent must be filed by
the patent owner. The request for supplemental examination must be
accompanied by the fee for filing a request for supplemental
examination, the fee for ex parte reexamination ordered as a result of
the supplemental examination proceeding under 35 U.S.C. 257, and any
applicable document size fees. The Office may hold in abeyance action
on any petition or other paper filed in a supplemental examination
proceeding until after the proceeding is concluded by the electronic
issuance of the supplemental examination certificate.
   A supplemental examination proceeding is initiated by the filing of
a request for supplemental examination that complies with 35 U.S.C. 257
and 37 CFR 1.601 et seq. and ends with the electronic issuance of the
supplemental examination certificate. See 35 U.S.C. 257(a) ("Within 3
months after the date a request for supplemental examination
meeting the requirements of this section is received, the Director
shall conduct the supplemental examination and shall conclude such
examination by issuing a certificate * * * ."). The supplemental
examination certificate will state the result of the Office's
determination as to whether any of the items of information submitted
as part of the request raises a substantial new question of
patentability. If the supplemental examination certificate states that
a substantial new question of patentability is raised by one or more
items of information in the request, ex parte reexamination of the
patent will be ordered under 35 U.S.C. 257. In other words, if the
supplemental examination certificate states that a substantial new
question of patentability is raised, an ex parte reexamination
proceeding is initiated. The electronically issued supplemental
examination certificate will remain as part of the public record for
the patent. In addition, upon the conclusion of the ex parte
reexamination proceeding, an ex parte reexamination certificate, which
will include a statement specifying that ex parte reexamination was
ordered under 35 U.S.C. 257, will be published as an attachment to the
patent. If, however, the supplemental examination certificate states
that no substantial new question of patentability is raised by one or
more items of information in the request, then the electronically
issued supplemental examination certificate, which remains as part of
the public record for the patent, will also be published in due course
as an attachment to the patent.

Discussion of Specific Rules

   The following is a discussion of the amendments to Title 37 of the
Code of Federal Regulations, part 1, that are being implemented in this
final rule:

   Section 1.20: Section 1.20 is amended to set fees to implement
supplemental examination, to adjust the fee for filing a request for ex
parte reexamination, and to set a fee for petitions filed in ex parte
and inter partes reexamination proceedings.
   The authority to set fees for filing a request for supplemental
examination and to consider each item of information submitted in the
request is provided for in 35 U.S.C. 257(d)(1). See 35 U.S.C. 257(d)(1)
("[t]he Director shall, by regulation, establish fees for the
submission of a request for supplemental examination of a patent, and
to consider each item of information submitted in the request"). The
authority to set fees for filing a request for ex parte reexamination
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is provided for in 35 U.S.C. 302. See 35 U.S.C. 302 ("[t]he request
must be in writing and must be accompanied by payment of a
reexamination fee established by the Director pursuant to the
provisions of [35 U.S.C. 41]"); see also 35 U.S.C. 257(d)(1).
   Section 10(a) of the AIA provides that the Director may set or
adjust by rule any patent fee established, authorized, or charged under
title 35, United States Code, provided that such fees only recover the
aggregate estimated costs to the Office for processing, activities,
services, and materials relating to patents (including administrative
costs). See Pub. L. 112-29, 125 Stat. 283, 316 (2011).
   Sections 10(d) and (e) of the AIA set out a process that must be
followed when the Office is using its authority under section 10(a) to
set or adjust patent fees. See Pub. L. 112-29, 125 Stat. at 317-18.
This process would not feasibly permit supplemental examination and the
related ex parte and inter partes reexamination fees to be in place by
September 16, 2012 (the effective date of the supplemental examination
provisions of the AIA). Therefore, the Office is setting these fees in
this rulemaking pursuant to its authority under 35 U.S.C. 41(d)(2),
which provides that fees for all processing, services, or materials
relating to patents not specified in 35 U.S.C. 41 are to be set at
amounts to recover the estimated average cost to the Office of the
respective processing, service, or material. See 35 U.S.C. 41(d)(2).
The Office's analysis of the estimated fiscal year 2013 costs for
supplemental examination, ex parte reexamination, and petitions filed
in ex parte and inter partes reexamination proceedings is available via
the Office's Internet Web site (http://www.uspto.gov). The estimated
fiscal year 2013 cost amounts are rounded to the nearest ten dollars by
applying standard arithmetic rules so that the resulting fee amounts
will be convenient to patent users.
   The Office is in the process of separately developing a proposed
rulemaking to adjust and set patent fees under section 10 of the AIA.
The fees set or adjusted in this notice will subsequently be revisited
and may be proposed to be set or adjusted in a proposed rulemaking
under section 10 of the AIA.
   In this current rulemaking, as described further in materials
posted on the Office's Internet Web site, the Office has estimated its
fiscal year 2013 cost for processing and treating a request for
supplemental examination to be $5,180. The Office has also estimated
that the document size fees will recover an average of $40 per request
for supplemental examination (discussed subsequently). Therefore, the
Office is adding new § 1.20(k)(1) to set a fee of $5,140 for
processing and treating a request for supplemental examination (the
estimated 2013 cost amount rounded to the nearest ten dollars minus
$40).
   The Office has estimated its fiscal year 2013 cost for conducting
ex parte reexamination ordered as a result of a supplemental
examination proceeding to be $16,116. Therefore, the Office is adding
new § 1.20(k)(2) to set a fee of $16,120 for conducting ex parte
reexamination ordered as a result of a supplemental examination
proceeding (the estimated 2013 cost amount rounded to the nearest ten
dollars). The $16,120 fee for conducting an ex parte reexamination
ordered as a result of a supplemental examination proceeding will be
returned if ex parte reexamination is not ordered at the conclusion of
the supplemental examination proceeding. See § 1.26(c).
   The Office has also estimated its fiscal year 2013 cost for
processing and treating non-patent documents over 20 pages in length
that are submitted in a supplemental examination proceeding to be $166
for each document between 21 and 50 pages in length, and $282 for each
additional 50-page increment or a fraction thereof. Therefore, the
Office is also adding new § 1.20(k)(3) to provide document size
fees for any non-patent documents over 20 pages in length that are
submitted in a supplemental examination proceeding, including (1) a fee
of $170 for each document between 21 and 50 pages in length; and (2) a
fee of $280 for each additional 50-page increment or a fraction thereof
(the estimated 2013 cost amounts rounded to the nearest ten dollars).
   The decision as to whether the information submitted in a request
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for supplemental examination raises a substantial new question of
patentability is identical to the decision as to whether the
information submitted in a request for ex parte reexamination raises a
substantial new question of patentability, except that the information
submitted in a request for supplemental examination is not limited to
patents and publications, and may be directed to issues of
patentability in addition to those permitted in ex parte reexamination,
such as issues under 35 U.S.C. 101 and 112. Thus, the Office has
analyzed its ex parte and inter partes reexamination costs to estimate
the cost of supplemental examination and resulting ex parte
reexamination proceedings. The Office's analysis of the ex parte and
inter partes reexamination costs revealed that the current ex parte and
inter partes reexamination fees are not set at amounts that recover the
Office's costs for these processes or services. Thus, in addition to
setting fees for supplemental examination and resulting ex parte
reexamination proceedings, the Office is adjusting the fee for ex parte
reexamination proceedings, and setting a fee for petitions in ex parte
and inter partes reexamination proceedings.
   The Office has estimated its fiscal year 2013 cost for conducting
ex parte reexamination to be $17,747. Therefore, § 1.20(c)(1) is
amended to set a fee of $17,750 for filing a request for ex parte
reexamination under § 1.510(a) (the estimated 2013 cost amounts
rounded to the nearest ten dollars).
   The Office has estimated its fiscal year 2013 cost for the
processing and treatment of a petition in a reexamination proceeding to
be $1,932. Consequently, the Office is adding new § 1.20(c)(6) to
set a fee of $1,930 for filing a petition in an ex parte or inter
partes reexamination proceeding, except for those specifically
enumerated in §§ 1.550(i) and 1.937(d) (the estimated 2013 cost
amounts rounded to the nearest ten dollars). The fee for treating a
petition in a reexamination proceeding will apply to any petition filed
in either an ex parte or an inter partes reexamination proceeding
(except for those specifically enumerated in §§ 1.550(i) and
1.937(d)), including petitions under §§ 1.59, 1.181, 1.182, and
1.183. The petitions enumerated in §§ 1.550(i) and 1.937(d) are
petitions under §§ 1.550(c) and 1.956 to extend the period for
response by a patent owner, petitions under §§ 1.550(e) and
1.958 to accept a delayed response by a patent owner, petitions under
§ 1.78 to accept an unintentionally delayed benefit claim, and
petitions under § 1.530(l) for correction of inventorship in ex
parte or inter partes reexamination proceedings. The petitions
enumerated in §§ 1.550(i) and 1.937(d), however, remain subject
to any applicable fees other than the fee set forth in §
1.20(c)(6), including the fees required by the appropriate rule
governing each petition.
   The Office is also adding new § 1.20(c)(7) to set a fee of
$4,320 for a denied request for ex parte reexamination (discussed
below), which is included in the fee under § 1.20(c)(1) for filing
a request for ex parte reexamination. The Office has estimated that its
fiscal year 2013 cost of processing a request for ex parte
reexamination up to the issuance of a decision denying the request for
reexamination is $4,320. Under current practice, if the Office decides
not to institute an ex parte reexamination proceeding, a portion of the
ex parte reexamination filing fee paid by the reexamination requester
is refunded. This section specifies the portion of the ex parte
reexamination filing fee that is retained by the Office if the Office
decides not to institute the ex parte reexamination proceeding.
   The Office is not adjusting the inter partes reexamination filing
fee as the Office is not authorized to consider, or even accord a
filing date to, a request for inter partes reexamination filed on or
after September 16, 2012. See Revision of Standard for Granting an
Inter Partes Reexamination Request, 76 FR 59055, 59056 (Sept. 23,
2011).
   Section 1.26: Section 1.26(c) is amended to provide that if the
Director decides not to institute an ex parte reexamination proceeding
(a denied reexamination), any fee for filing an ex parte reexamination
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request paid by the reexamination requester, less the fee set forth in
§ 1.20(c)(7), will be refunded to the reexamination requester. If
the Director decides not to institute an ex parte reexamination
proceeding under § 1.625 as a result of a supplemental examination
proceeding, a refund of the fee for ex parte reexamination resulting
from a supplemental examination ($16,120), as set forth in
§ 1.20(k)(2), will be made to the patent owner who requested the
supplemental examination proceeding. The provision in § 1.26(c) for
a refund of $7,970 to the inter partes reexamination requester, where
the Director decides not to institute an inter partes reexamination
proceeding, is being retained to address any remaining instances of a
denial to institute an inter partes reexamination on or after September
16, 2012. The reexamination requester or the patent owner who requested
the supplemental examination proceeding, as appropriate, should
indicate the form in which any refund should be made (e.g., by check,
electronic funds transfer, credit to a deposit account). Generally,
refunds will be issued in the form that the original payment was
provided.
   Section 1.550: Section 1.550(i) is added to provide that a petition
in an ex parte reexamination proceeding must be accompanied by the fee
set forth in § 1.20(c)(6), except for petitions under § 1.550(c)
to extend the period for response by a patent owner, petitions
under § 1.550(e) to accept a delayed response by a patent owner,
petitions under § 1.78 to accept an unintentionally delayed benefit
claim, and petitions under § 1.530(l) for correction of
inventorship in an ex parte reexamination proceeding.
   Section 1.601: Section 1.601 et seq. is added to provide
regulations for the supplemental examination of patents. Section
1.601(a) is added to require that a request for supplemental
examination of a patent must be filed by the owner(s) of the entire
right, title, and interest in the patent. A request for supplemental
examination may result in ex parte reexamination of the patent. The
Office currently requires a patent owner requester of an ex parte
reexamination to comply with the provisions of §§ 3.71 and 3.73
for establishing an assignee's right to take action when submitting a
power of attorney. See Manual of Patent Examining Procedure §§ 2222
(Rev. 8, July 2010) (MPEP). This is because the terms of a patent
may be changed (e.g., by cancellation or amendment of the claims)
during a reexamination proceeding, and this change must be binding on
all parties having an ownership interest in the patent. Furthermore,
the Office has consistently required that all parties having an
interest in a patent are deemed "a patent owner" as a composite
entity and must act together in proceedings before the Office. See MPEP
§ 301 ("All parties having any portion of the ownership of the
patent property must act together as a composite entity in patent
matters before the Office."), and § 324 ("When an assignee seeks
to take action in a matter before the Office with respect to a patent
application, patent, or reexamination proceeding and the right, title,
and interest therein is held by more than one assignee, each partial
assignee must provide a submission under [former] 37 CFR 3.73(b). In
each submission, the extent of each assignee's interest must be set
forth so that the Office can determine whether it has obtained action
by the entirety of the right, title, and interest holders (owners).").
   Section 1.601(b) prohibits third parties from filing papers or
otherwise participating in any manner in a supplemental examination
proceeding. Section 12 of the AIA specifies that a request for
supplemental examination may be filed by the patent owner. See 35
U.S.C. 257(a). There is no provision for participation in any manner by
a third party in a supplemental examination proceeding. In addition,
because only the patent owner can file the request for supplemental
examination, third party participation is also prohibited in any ex
parte reexamination ordered under 35 U.S.C. 257 and § 1.625,
pursuant to ex parte reexamination practice.
   Section 1.601(c) provides that a request for supplemental
examination of a patent may be filed at any time during
the period of enforceability of the patent. This time period is being
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specified in this final rule because the Office believes that Congress
did not intend the Office to expend resources on the supplemental
examination of a patent which cannot be enforced. The period of
enforceability is determined by adding six years to the date that the
patent expires. It is the responsibility of the patent owner to
determine the expiration date of the patent for which supplemental
examination is requested. The patent expiration date for a utility
patent, for example, may be determined by taking into account the term
of the patent, whether maintenance fees have been paid for the patent,
whether any disclaimer was filed as to the patent to shorten its term,
any patent term extensions or adjustments for delays within the Office
under 35 U.S.C. 154, and any patent term extensions available under 35
U.S.C. 156 for premarket regulatory review. See MPEP §§ 2710
and 2750. Any other relevant information should also be taken into
account. In addition, if litigation is instituted within the period of
the statute of limitations, requests for supplemental examination may
be filed after the statute of limitations has expired, as long as the
patent is still enforceable. This policy is consistent with ex parte
reexamination practice. See § 1.510(a) and MPEP § 2211.
   Section 1.605: Section 1.605(a) is added to require that each
request for supplemental examination may include no more than twelve
items of information believed to be relevant to the patent. In other
words, the number of items of information that may be submitted as part
of each request for supplemental examination is limited to twelve (12).
As discussed previously, the amount of information that may be included
with each request is limited in order to permit full and comprehensive
treatment of each item of information within the three-month statutory
time period. Section 1.605(a) permits the filing of more than one
request for supplemental examination of the same patent at any time
during the period of enforceability of the patent. The patent owner is
not precluded from obtaining review of any item of information despite
the twelve-item limit because the patent owner may file multiple
requests for supplemental examination of the same patent at any time
during the period of enforceability of the patent.
   Section 1.605(b) provides that an "item of information" includes
a supporting document submitted as part of the request that contains
information, believed to be relevant to the patent, that the patent
owner requests the Office to consider, reconsider, or correct. Examples
include a journal article, a patent, an affidavit or declaration, or a
transcript of an audio or video recording, each of which may be
considered an item of information. If the information to be considered,
reconsidered, or corrected is not, at least in part, contained within
or based on any supporting document submitted as part of the request,
the discussion within the body of the request relative to the
information will be considered as the item of information. For example,
if the patent owner requests the Office to consider claim 1 of the
patent on the basis of 35 U.S.C. 101, and the discussion of any
potential application of 35 U.S.C. 101 to claim 1 is wholly contained
within the body of the request and is not based, at least in part, on
any supporting document, the discussion in the request will be
considered as the item of information. If, however, the patent owner is
presenting a copy of a supporting document within the body of the
request, such as an image of an electronic mail message or other
document, a separate copy of the supporting document must be provided,
which will be considered as an item of information. The patent owner
may not avoid the counting of an item of information by inserting the
content of the supporting document within the body of the request. As
another example, if the patent owner presents an argument in the
request regarding an issue under 35 U.S.C. 102, such as a potential
public use or sale of the claimed invention, and also submits a
supporting document with the request as possible evidence of the public
use or sale, or the lack thereof, the supporting document containing
the possible evidence will be considered as the item of information.
   Similarly, a declaration or affidavit submitted as part of a
request would be considered an item of information. If the declaration
presents two distinct items of information, such as information
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relating to a potential ground under 35 U.S.C. 101 as to patent claim 1
that was not considered during the prior examination of the patent, and
information relating to erroneous facts or data presented during the
prior examination of the patent with respect to an issue under 35
U.S.C. 103 as to patent claim 10, then each item of information
contained within the declaration will be counted separately, resulting
in two items of information. The patent owner may not avoid the
counting of multiple items of information by inserting the multiple
items within the body of a declaration or by presenting them as
exhibits accompanying the declaration. Additionally, if the declaration
presents one item of information, such as information regarding
erroneous data presented during the prior examination of the patent
with respect to an issue under 35 U.S.C. 103 as to patent claim 10, and
relies upon a single exhibit, such as a new table of data, to support
facts presented in the declaration, the Office is likely to count the
declaration, including the supporting exhibit, as a single item of
information. If, however, the declaration relies upon two separate and
distinct exhibits, such as, for example, two separate and distinct
sales receipts as evidence of a potential sale of the invention (e.g.,
a sales receipt dated March 2011 and a second, separate sales receipt
dated October 2011, which provides evidence of a second, separate sale
of the invention), then each additional sales receipt will be counted
separately, resulting in two items of information (one item consisting
of the declaration and one sales receipt, and the second item
consisting of the second sales receipt).
   Section 1.605(c) requires that an item of information must be in
writing in accordance with § 1.2. The Office does not currently
have the capability of retaining records in unwritten form. For this
reason, any audio or video recording must be submitted in the form of a
written transcript in order to be considered. A transcript of a video
may be submitted together with copies of selected images of the video,
and a discussion of the correlation between the transcript and the
copies of the video images.
   Section 1.605(d) provides that if an item of information is
combined in the request with one or more additional items of
information, each item of information of the combination may be
separately counted. If it is necessary to combine items of information
in order to raise an issue, or to explain the relevance of the items of
information to be considered, reconsidered, or corrected with respect
to the identified claims, each item of information may be separately
counted. Exceptions to this provision include the combination of a non-
English language document and its translation, and the combination of a
document that is over 50 pages in length and its summary pursuant to
§ 1.610(b)(8).
   For example, if the patent owner requests consideration of claim 1
of a patent in light of references A and B, and explains that it is the
combination of references A and B that is relevant to claim 1,
reference A and reference B will be separately counted as items of
information. Cumulative items of information will each be separately
counted. If the patent owner believes that multiple items of information
are cumulative to each other, the patent owner is encouraged to select one
or two of them as the items of information that will be submitted as part
of the request.
   If, however, a single item of information, such as a reference
patent, raises an issue under 35 U.S.C. 102 as to claim 1 and an issue
under 35 U.S.C. 103 as to claim 2, the reference patent will
nevertheless be counted as a single item of information. The Office
will count items of information, but will not count the number of
issues raised by that item.
   Section 1.610: Section 1.610 governs the content of the request for
supplemental examination. Consistent with the requirement in 35 U.S.C.
257(d) to establish fees, § 1.610(a) requires that the request be
accompanied by the fee for filing a request for supplemental
examination as set forth in § 1.20(k)(1), the fee for ex parte
reexamination ordered as a result of a supplemental examination
proceeding as set forth in § 1.20(k)(2), and any applicable
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document size fees as set forth in § 1.20(k)(3).
   Section 1.610(b) sets forth content requirements for a request for
supplemental examination. Section 1.610(b)(1) requires that the request
include an identification of the number of the patent for which
supplemental examination is requested.
   Section 1.610(b)(2) requires that the request include a list of the
items of information that are requested to be considered, reconsidered,
or corrected. Where appropriate, the list must meet the requirements of
§ 1.98(b). For example, the list must include a publication date
for each item of information, if applicable. This list must include
each of the items of information on which the request is based. If the
item of information is a discussion contained within the body of the
request, as discussed previously, the pages of the request on which the
discussion appears, and a brief description of the item of information,
such as "discussion in request of why the claims are patentable under
35 U.S.C. 101, pages 7-11," must be listed.
   Section 1.610(b)(3) requires that the request include a list
identifying any other prior or concurrent post-patent Office
proceedings involving the patent for which the current supplemental
examination is requested, including an identification of the type of
proceeding, the identifying number of any such proceeding (e.g., a
control number or a reissue application number), and the filing date of
any such proceeding. The type of proceeding may be, for example, an ex
parte or inter partes reexamination proceeding, a reissue application,
a supplemental examination proceeding, a post-grant review proceeding,
or an inter partes review proceeding.
   Section 1.610(b)(4) requires that the request include an
identification of each claim of the patent for which supplemental
examination is requested. The result of a supplemental examination is a
determination of whether any of the items of information raises a
substantial new question of patentability. Because patentability
relates to the claims of the patent, the patent owner must identify the
patent claims to be examined in order for the Office to determine
whether a substantial new question of patentability as to those claims
has been raised by an item of information. For example, if the
information raises a question as to the adequacy of the written
description portion of the specification, the substantial new question
of patentability pertains to the question of whether the specification
provides adequate support under 35 U.S.C. 112 for the identified claim.
If the information raises a question as to a foreign priority or
domestic benefit claim, the substantial new question of patentability
pertains to the question of whether the patentability the identified
claim under 35 U.S.C. 102 and 103 depends upon a foreign priority or
domestic benefit claim (e.g., where the claimed invention must be
entitled to foreign priority or domestic benefit to be patentable under
35 U.S.C. 102 and 103 because there is an intervening references).
   Section 1.610(b)(5) requires that the request include a separate,
detailed explanation of the relevance and manner of applying each item
of information to each claim of the patent for which supplemental
examination is requested. In view of the fact that patent owners filing
a request for supplemental examination may be contemplating future
litigation, the Office recommends that, in order to meet this
requirement, patent owners consider the guidance set forth in MPEP
§ 2214, which governs the content of a request for ex parte
reexamination.
   Section 1.610(b)(6) requires that the request include a copy of the
patent for which supplemental examination is requested, and a copy of
any disclaimer or certificate issued for the patent. A "certificate
issued for the patent" includes, for example, a certificate of
correction, a certificate of extension, a supplemental examination
certificate, a post-grant review certificate, an inter partes review
certificate, an ex parte reexamination certificate, and/or an inter
partes reexamination certificate issued for the patent.
   Section 1.610(b)(7) requires that the request include a copy of
each item of information listed in § 1.610(b)(2), accompanied by a
written English translation of all of the necessary and pertinent parts
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of any non-English language document. Items of information that form
part of the discussion within the body of the request as specified in
§ 1.605(b) are not required to be submitted. As discussed
previously, if the information to be considered, reconsidered, or
corrected is not, at least in part, contained within or based on any
supporting document submitted as part of the request, the discussion
within the body of the request relative to the information will be
considered as the item of information, a copy of which is not required
under § 1.610(b)(7) to be separately submitted. Copies of U.S.
patents and U.S. patent application publications are also not required,
but may be submitted.
   Section 1.610(b)(8) requires that the request include a summary of
the relevant portions of any submitted document (including patent
documents), other than the request, that is over 50 pages in length.
The summary must include citations to the particular pages containing
the relevant portions. This summary may be similar to the requirement
for information disclosure statements of a discussion of the relevant
and pertinent parts of a non-English language document. This
requirement will assist the Office in treating information presented in
lengthy documents within the statutory three-month time period. Patent
owners are encouraged to redact lengthy documents to include only the
relevant portions, unless the redaction would remove context such that
the examiner would not be provided with a full indication of the
relevance of the information.
   Section 1.610(b)(9) requires that the request must include an
identification of the owner(s) of the entire right, title, and interest
in the patent requested to be examined, and a submission by the patent
owner in compliance with § 3.73(c) establishing the entirety of the
ownership in the patent requested to be examined. As discussed
previously, § 1.601(a) requires that a request for supplemental
examination of a patent must be filed by the owner(s) of the entire
right.
   Section 1.610(c) provides that the request may optionally include
certain enumerated elements. Section 1.610(c)(1) permits the request to
include a cover sheet itemizing each component submitted as part of the
request. A "component" may be a certificate of mailing, the request,
the patent to be examined, an item of information, and any other
separate document that is deposited with or as part of the request.
Section 1.610(c)(2) permits the request to include a table of contents
for the request. Section 1.610(c)(3) provides that the request may
include an explanation of how the claims patentably distinguish over
the items of information. Section 1.610(c)(4) provides that the request
may include an explanation why each item of information does or does
not raise a substantial new question of patentability. Patent owners
are strongly encouraged to submit this explanation, which will assist
the Office in analyzing the request.
   Section 1.610(d) provides that the filing date of a request for
supplemental examination will not be granted if the request is not in
compliance with §§ 1.605, 1.610, and 1.615, subject to the
discretion of the Office. If the Office determines that the request, as
originally submitted, is not entitled to a filing date, then the patent
owner will be so notified and will be given an opportunity to complete
the request within a specified time. If the patent owner does not
timely comply with the notice, the request for supplemental examination
will not be granted a filing date and the fee for reexamination as set
forth in § 1.20(k)(2) will be refunded. If the patent owner timely
files a corrected request, in response to the notice, that properly
addresses all of the defects set forth in the notice and that otherwise
complies with all of the requirements of §§ 1.605, 1.610, and
1.615, the filing date of the supplemental examination request will be
the receipt date of the corrected request.
   Section 1.615: Section 1.615(a) requires that all papers submitted
in a supplemental examination proceeding must be formatted in
accordance with § 1.52. Section 1.615(b) provides that court
documents and non-patent literature may be redacted, but must otherwise
be identical both in content and in format to the original documents,
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and if a court document, to the document submitted in court, and must
not otherwise be reduced in size or modified, particularly in terms of
font type, font size, line spacing, and margins. Patents, patent
application publications, and third-party-generated affidavits or
declarations must not be reduced in size or otherwise modified in the
manner described in this paragraph.
   Section 1.620: Section 1.620(a) requires that, within three months
following the filing date of a request for supplemental examination,
the Office will determine whether a substantial new question of
patentability affecting any claim of the patent is raised by any of the
items of information properly presented in the request. The standard
for determining whether an item of information submitted as part of the
request raises a substantial new question of patentability will be the
standard set forth in the MPEP: i.e., whether there is a substantial
likelihood that a reasonable examiner would consider the item of
information important in determining patentability. See MPEP § 2242.
   The determination of whether an item of information submitted as
part of the request raises a substantial new question of patentability
(SNQ) will generally be limited to a review of the item(s) of
information identified in the request with respect to the identified
claim(s) of the patent. For example, a determination on a request that
includes three items of information, where each item is requested to be
considered with regard to claim 1, will generally be limited to whether
any of the three items of information raise a substantial new question
of patentability with respect to claim 1. If the patent owner is
interested in applying an item of information to multiple claims of the
patent, the request for supplemental examination must include an
identification of each claim to which the item of information is to be
applied and the required detailed explanation with respect to each
claim. For example, if the patent owner fails to request that the
Office consider certain claims in view of an item of information, then
the patent owner is not entitled to a determination for that item of
information with respect to those claims. The determination will be
based on the claims in effect at the time of the determination. The
supplemental examination certificate, which contains the determination
of whether a substantial new question of patentability was raised by
one or more of the items of information submitted as part of the
request, will become a part of the official record of the patent.
   Section 1.620(b) provides that the Office may hold in abeyance an
action on any petition or other paper filed in a supplemental
examination proceeding until after the proceeding is concluded by the
electronic issuance of the supplemental examination certificate as set
forth in § 1.625. The only actions by the Office on the request for
supplemental examination are: (1) a determination of whether the
request is entitled to a filing date; and (2) a determination of
whether any of the items of information submitted with the request
raises a substantial new question of patentability. The only relevant
type of petition that the Office anticipates will be filed in a
supplemental examination proceeding would involve the filing date of
the request, which is not relevant to the determination of whether any
of the items of information submitted with the request raises a
substantial new question of patentability. Holding in abeyance a
decision on such a petition will assist the Office in making the
determination regarding the substantial new question within the three-
month statutory period.
   Section 1.620(c) provides that if an unauthorized or otherwise
improper paper is filed in a supplemental examination proceeding, it
will not be entered into the official file or considered, or if
inadvertently entered, it will be expunged.
   Section 1.620(d) requires that the patent owner must, as soon as
possible upon the discovery of any other prior or concurrent post-
patent Office proceeding involving the patent for which the current
supplemental examination is requested, file a paper limited to
notifying the Office of the post-patent Office proceeding, if such
notice has not been previously provided with the request. The Office
anticipates that a patent for which supplemental examination is
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requested is likely to be involved in other post-patent Office
proceedings, including another supplemental examination proceeding.
Knowledge of other proceedings is important to ensure a quality
determination. In addition, notice is required due to the statutory
three-month period within which the Office must conclude the
supplemental examination. The notice is limited to an identification of
the post-patent Office proceeding, including the type (e.g., ex parte
or inter partes reexamination, reissue, supplemental examination, post-
grant review, or inter partes review), an identifying number, such as a
control number or reissue application number, and the filing date of
the post-patent Office proceeding. The notice may not include any
discussion of the issues present in the current supplemental
examination proceeding or in the identified post-patent Office
proceeding(s). If the paper containing the notice is not so limited,
the paper will be held to be improper, and will be processed as an
unauthorized paper pursuant to § 1.620(c).
   Section 1.620(e) prohibits interviews in a supplemental examination
proceeding. This requirement will assist the Office to process the
request for supplemental examination within the three-month statutory
period. A telephone call to the Office to confirm receipt of a request
for supplemental examination, or to discuss general procedural
questions, is not considered to be an interview for the purposes of
this provision. This prohibition against interviews applies only to
supplemental examination proceedings. Interviews conducted in
connection with any ex parte reexamination ordered under 35 U.S.C. 257
as a result of the supplemental examination proceeding are governed by
the regulations governing ex parte reexamination proceedings. See,
e.g., § 1.560.
   Section 1.620(f) provides that no amendment may be filed in a
supplemental examination proceeding. Amendments are not items of
information, and are not appropriate in a supplemental examination
proceeding. As specified in 35 U.S.C. 257(b), the patent owner does not
have the right to file a statement under 35 U.S.C. 304. See § 1.625(d)(1).
35 U.S.C. 304 permits a patent owner to file an amendment
by including the amendment with the patent owner's statement prior to
an initial Office action. However, because the ex parte reexamination
proceeding does not exist prior to the order under 35 U.S.C. 257, and
because the patent owner is precluded from filing a statement under 35
U.S.C. 304, no amendment may be filed from the time the request for
supplemental examination is filed, until after the issuance of an
initial Office action on the merits in any ex parte reexamination
proceeding ordered under 35 U.S.C. 257.
   Section 1.620(g) provides that, if the Office becomes aware, during
the course of a supplemental examination or of any ex parte
reexamination ordered under 35 U.S.C. 257 as a result of the
supplemental examination proceeding, that a material fraud on the
Office may have been committed in connection with the patent requested
to be examined, the supplemental examination proceeding or any ex parte
reexamination proceeding ordered under 35 U.S.C. 257 will continue. The
matter will be referred to the U.S. Attorney General in accordance with
35 U.S.C. 257(e), as discussed previously.
   Section 1.625: Section 1.625(a) provides that a supplemental
examination proceeding will conclude with the electronic issuance of
the supplemental examination certificate. The supplemental examination
certificate will be electronically issued in the Office IFW system and
will be visible in the Office PAIR system within three months of the
filing date of the request. Electronic issuance of the supplemental
examination certificate will permit the Office to issue the certificate
within the three-month statutory period and will permit sufficient time
to review the items of information submitted as part of the request.
The certificate will be viewable by the public in Public PAIR. The
supplemental examination certificate will indicate the result of the
determination whether any of the items of information presented in the
request raised a substantial new question of patentability.
   Section 1.625(b) provides that, if the supplemental examination
certificate indicates that a substantial new question of patentability
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is raised by one or more items of information in the request, ex parte
reexamination of the patent will be ordered under 35 U.S.C. 257. Upon
the conclusion of the ex parte reexamination proceeding, an ex parte
reexamination certificate, which will include a statement specifying
that ex parte reexamination was ordered under 35 U.S.C. 257, will be
published as an attachment to the patent by the Office's patent
publication process. The electronically issued supplemental examination
certificate will also remain as part of the public record for the
patent.
   Section 1.625(c) provides that, if the supplemental examination
certificate indicates that no substantial new question of patentability
is raised by any of the items of information in the request, and ex
parte reexamination is not ordered under 35 U.S.C. 257, the
electronically issued supplemental examination certificate will be
published in due course by the Office's patent publication process as
an attachment to the patent. The fee for reexamination ordered as a
result of supplemental examination, as set forth in § 1.20(k)(2),
will be refunded in accordance with § 1.26(c).
   Section 1.625(d) provides that any ex parte reexamination ordered
under 35 U.S.C. 257 will be conducted in accordance with §§ 1.530 through
1.570, which govern ex parte reexamination, except that:
(1) The patent owner will not have the right to file a statement
pursuant to § 1.530, and the order will not set a time period
within which to file such a statement; (2) ex parte reexamination of
any claim of the patent may be conducted on the basis of any item of
information as set forth in § 1.605, and is not limited to patents
and printed publications or to subject matter that has been added or
deleted during a reexamination proceeding, which differs from the
provisions of § 1.552(a); (3) issues in addition to those raised by
patents and printed publications and by subject matter added or deleted
during an ex parte reexamination proceeding may be considered and
resolved, which differs from § 1.552(c); and (4) information
material to patentability will be defined by § 1.56(b) for the
purposes of a supplemental examination proceeding and any resulting ex
parte reexamination proceeding. The material to patentability standard
(§ 1.56(b)) applicable to patent applications is also applicable to
an ex parte reexamination proceeding under 35 U.S.C. 257 resulting from
a supplemental examination proceeding because, like patent application
examination, an ex parte reexamination proceeding under 35 U.S.C. 257
is not limited to patents and printed publications. In contrast, the
material to patentability standard (§ 1.555(b)) applicable to ex
parte reexaminations under 35 U.S.C. 302 is limited to patents and
printed publications. Any reference to "applicant" in § 1.56(b)
will be read as "patent owner" in the context of a supplemental
examination proceeding and any resulting ex parte reexamination
proceeding under 35 U.S.C. 257, because these proceedings are only
available to a patent owner.
   Section 1.937: Section 1.937(d) is added to provide that a petition
in an inter partes reexamination proceeding must be accompanied by the
fee set forth in § 1.20(c)(6), except for petitions under §
1.956 to extend the period for response by a patent owner, petitions
under § 1.958 to accept a delayed response by a patent owner,
petitions under § 1.78 to accept an unintentionally delayed benefit
claim, and petitions under § 1.530(l) for correction of
inventorship in an inter partes reexamination proceeding.

Comments and Responses to Comments

   As discussed previously, the Office proposed changes to the rules
of practice to implement section 12 of the AIA (supplemental
examination) and to set or adjust fees in ex parte and inter partes
reexamination proceedings in a notice of proposed rulemaking published
in January of 2012. See Changes to Implement the Supplemental
Examination Provisions of the Leahy-Smith Invents Act and to Revise
Reexamination Fees, 77 FR at 3666-81. The Office received thirty-six
comments in response to this notice from intellectual property
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organizations, industry, law firms, individual patent
practitioners, and the general public. The comments and the Office's
responses to the comments follow:

Fees

   Comment 1: A number of comments suggested that the fees for ex
parte reexamination, and for supplemental examination and any ex parte
reexamination ordered under 35 U.S.C. 257 as a result of the
supplemental examination, are too high, and suggested a variety of
alternative fee structures.
   Response: The Office is adjusting the fee for filing a request for
ex parte reexamination, and is setting the fees for filing supplemental
examination and any resulting ex parte reexamination, to comply with 35
U.S.C. 41(d)(2). 35 U.S.C. 41(d)(2) permits the Office to set fees not
otherwise specified in 35 U.S.C. 41. 35 U.S.C. 41(d)(2) specifies that
such fees must be set at an amount that recovers the estimated average
cost to the Office for the service.
   Section 10 of the AIA also authorizes the Office to set or adjust
fees, but unlike 35 U.S.C. 41(d)(2), permits fees to be set above or
below cost recovery so long as the aggregate revenue equals the
aggregate costs, including administrative costs. Section 10 of the AIA
sets out a process that the Office must follow when setting or
adjusting patent under that provision. The process set out in section
10 of the AIA, however, would not feasibly permit supplemental
examination and the related ex parte and inter partes reexamination
fees to be in place by September 16, 2012, the effective date of the
supplemental examination provisions of the AIA. Therefore, the fee for
filing an ex parte reexamination request is being adjusted, and the
fees for filing supplemental examination and any resulting ex parte
reexamination are being set, by this final rule under 35 U.S.C.
41(d)(2).
   The Office has analyzed its ex parte and inter partes reexamination
costs in order to estimate the cost of supplemental examination and
resulting ex parte reexamination proceedings. The analysis of the
Office's ex parte and inter partes reexamination costs revealed that
the Office's current ex parte and inter partes reexamination fees are
not set at amounts that recover the Office's costs for these processes
or services. This final rule sets these fees at amounts that more
accurately reflect the estimated average cost to the Office for these
processes or services. The Office's analysis of the estimated fiscal
year 2013 costs for ex parte reexamination, supplemental examination
and any resulting reexamination, and petitions filed in ex parte and
inter partes reexamination proceedings is available via the Office's
Internet Web site (http://www.uspto.gov). Separately, the Office is in
the process of adjusting and setting all patent fees under section 10
of the AIA, and the fees set in this notice will be revisited and may
be proposed to be set or adjusted in that rulemaking.

   Comment 2: Several comments questioned why the cost calculations
published by the Office to support the fees for ex parte reexamination
and for supplemental examination are based on the cost of denying,
rather than granting, ex parte reexamination.
   Response: The cost calculations published by the Office, entitled
"Cost Calculations for Supplemental Examination and Reexamination,"
are posted on the Office's Internet Web site at www.uspto.gov. These
calculations are based on the costs incurred by the Office to process
and analyze a request for reexamination, to draft an order granting or
denying reexamination, and to conduct reexamination. The costs to
process and analyze a request for reexamination are the same regardless
of whether the examiner grants the request and orders reexamination, or
denies reexamination. This cost amount is specified as the fee for a
denied request for ex parte reexamination because it is the fee amount
retained by the Office if the Office decides not to institute
reexamination.
   The decision as to whether the information submitted in a request
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for supplemental examination raises a substantial new question of
patentability is identical to the decision as to whether the
information submitted in a request for ex parte reexamination raises a
substantial new question of patentability, except that the information
submitted in a request for supplemental examination is not limited to
patents and printed publications, and may be directed to issues of
patentability in addition to those permitted in ex parte reexamination,
such as issues under 35 U.S.C. 101 and 112. For this reason, the
estimated cost for processing and examining a request for supplemental
examination is based on the Office's cost for processing and examining
a request for ex parte reexamination up to the decision to grant or
deny the request for reexamination.

   Comment 3: Several comments requested clarification as to why there
exists a significant difference between the proposed fee for treating
certain petitions in reexamination proceedings and the fees for
treating other petitions outside of reexamination.
   Response: The Office is adjusting the fee for processing and
treating certain petitions in reexamination proceedings to comply with
35 U.S.C. 41(d), which does not authorize the Office to set the fee at
an amount that is below the estimated average cost for the Office to
process and treat the petition. As discussed previously, an analysis of
the Office's ex parte and inter partes reexamination costs revealed
that the Office's current fees for certain petitions in reexamination
are not set at amounts that recover the Office's costs for these
services. With the exception of certain types of reexamination
petitions which are expressly excluded by the rules, petitions in
reexamination proceedings involve issues of greater complexity, which
require additional time to analyze and decide than other patent-related
petitions. Reexamination petitions also tend to involve a greater
number of issues than other patent-related petitions. Therefore, the
fee for filing certain reexamination petitions is being adjusted, by
this final rule, to an amount that more accurately reflects the
estimated average costs to the Office to process and treat these
petitions. As discussed previously, the Office's analysis of the
estimated fiscal year 2013 costs for processing and treating petitions
filed in ex parte and inter partes reexamination proceedings, as well
as the Office's estimated fiscal year 2013 costs for supplemental
examination and ex parte reexamination, are available via the Office's
Internet Web site (http://www.uspto.gov).

   Comment 4: A number of comments suggested that the Office should
not charge fees for supplemental examination which are in excess of
costs, as suggested by the Office's published executive summary of the
patent fee proposal in accordance with section 10 of the AIA, submitted
to the Patent Public Advisory Committee (PPAC) on February 7, 2012. A
number of comments suggested the small and micro entity subsidies
permitted under section 10 of the AIA be applied to supplemental
examination and reexamination. Several comments also suggested that the
costs incurred by the Office for processing and analyzing a denied
request for ex parte reexamination, on which the fee for filing a
request for supplemental examination request is based, includes the
costs for analyzing any non-patent documents submitted as part of the
request which have a length greater than 20 pages. These comments
suggested that the Office is inappropriately applying a surcharge for
submitting these documents as part of a request for supplemental
examination (the document size fee), without first reducing the fee for
filing a supplemental examination request by an amount which reflects the
average cost, per request, for analyzing these documents submitted with
a denied request for ex parte reexamination.
   Response: As discussed previously, the Office is separately in the
process of adjusting and setting patent fees under section 10 of the
AIA in a separate rulemaking, but that process would not feasibly
permit supplemental examination and the related ex parte and inter
partes reexamination fees to be in place by September 16, 2012, the
effective date of the supplemental examination provisions of the AIA.
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Therefore, the fee for filing an ex parte reexamination request is
being adjusted, and the fees for filing supplemental examination and
any resulting ex parte reexamination are being set, by this final rule
under 35 U.S.C. 41(d)(2). 35 U.S.C. 41(d)(2) does not provide for small
or micro entity fee reductions. The fees set in this final rule will be
revisited and may be proposed to be set or adjusted in the rulemaking
under section 10 of the AIA.
   To address the concern that the document size fees may result in a
double recovery of fee revenue, the Office reviewed all requests for ex
parte reexamination by a patent owner that met the requirements of 37
CFR 1.510 to be entitled to a filing date in fiscal year 2010 (59
requests) to determine: (1) the number of non-patent documents in these
requests that were between 21 and 50 pages in length; and (2) the
number of non-patent documents in these requests that were over 50
pages in length and the page length of each of these documents. In
fiscal year 2010, patent owner-filed requests for ex parte
reexamination contained three non-patent documents between 21 and 50
pages in length (which would have cost an additional $510) and two non-
patent documents which were over 50 pages in length: one between 100
and 150 pages in length (which would have cost an additional $730), and
one between 150 and 200 pages in length (which would have cost an
additional $1,010). Thus, the patent owner-filed requests for ex parte
reexamination that received a filing date in fiscal year 2010 would, if
submitted as requests for supplemental examination, have resulted in an
additional $2,250 in document size fees, which amounts to an average of
$38.14 per patent owner-filed request for ex parte reexamination
($2,250/59), or $40, when rounded to the nearest ten dollars.
Accordingly, the fee for filing a request for supplemental examination,
$5,140, has been reduced from the originally proposed fee ($5,180) by
the Office's average cost, per request, for analyzing non-patent
documents greater than 20 pages in length submitted as part of a patent
owner-filed request for ex parte reexamination in fiscal year 2010
($40).

   Comment 5: A number of comments suggested that payment of the fee
for reexamination ordered under 35 U.S.C. 257 should not be required
until after reexamination is ordered.
   Response: 35 U.S.C. 257(b) provides that "reexamination shall be
conducted according to procedures established by chapter 30 * * * ."
35 U.S.C. 305 expressly provides that, after the order (and after the
time period set for filing a patent owner statement under 35 U.S.C.
304, which is excluded by 35 U.S.C. 257(b)), "reexamination will be
conducted * * * with special dispatch." Therefore, once reexamination
is ordered, the Office is required by statute to conduct the
reexamination proceeding with special dispatch. To permit a delay in
prosecution caused by any time period within which the patent owner
would be permitted to pay the reexamination fee would be contrary to
the Office's mandate to conduct the reexamination with special
dispatch. This final rule requires payment of the reexamination fee
upon the filing of the request to permit the Office to commence any
reexamination ordered under 35 U.S.C 257 in a timely manner. See
§ 1.610(a). If reexamination is not ordered, this final rule expressly
provides that the patent owner will obtain a refund of the
reexamination fee. See §§ 1.26(c)(3) and 1.625(c).

   Comment 6: A number of comments suggested that if the patent owner
cancels the claims within a set time period after reexamination is
ordered under 35 U.S.C. 257, a significant portion of the reexamination
fee should be refunded.
   Response: 35 U.S.C. 257(b) expressly requires, if reexamination is
ordered, that "fees established and applicable to ex parte
reexamination proceedings under chapter 30 shall be paid." 35 U.S.C.
257(b) does not provide for a refund due to claim cancellation during
the reexamination. Moreover, in ex parte reexamination, the only method
by which the patent owner may file an amendment to cancel claims after
the order and prior to a first Office action is by filing a patent
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owner's statement under 35 U.S.C. 304. 35 U.S.C. 257(b), however,
expressly excludes the right of the patent owner to file a statement
under 35 U.S.C. 304. Therefore, the filing of any amendment to cancel
claims after the order granting reexamination under 35 U.S.C. 257 and
before the initial Office action on the merits is statutorily
precluded. Finally, there is no reason to believe that the processing
and examination costs would be less for an ex parte reexamination in
which an amendment has been filed (or claims have been canceled) than
for an ex parte reexamination in which no amendment has been filed.

   Comment 7: A number of comments suggested that the rule requiring
document size fees be modified or eliminated for non-patent documents
that are over 50 pages in length if a summary of the relevant portions
is provided. Several comments alternatively suggested that the
requirement to summarize non-patent documents over 50 pages in length
be eliminated, and that the document size fees should be retained to
recover the costs of reviewing lengthy documents in order to ensure the
consideration of any relevant information contained in the documents.
   Response: Even though a summary of the relevant portions of a
document over 50 pages in length is provided, the examiner is still
required to review the document. The document size fees, as set forth
in this final rule, recover the Office's costs of reviewing lengthy
documents. Additionally, the requirement for the summary directs the
Office's attention to the relevant information presented in lengthy
documents. Patent owners are encouraged to redact lengthy documents to
include only the relevant portions, unless the redaction would remove
context such that the examiner would not be provided with a full
indication of the relevance of the information.

Item of Information Limit

   Comment 8: A number of comments suggested that the Office replace
the limit on the number of items of information on which each request
for supplemental examination may be based, with a sliding fee scale
which would be based on, for example, a separate fee for each item of
information submitted.
   Response: The supplemental examination procedure was designed to
enable patent owners to present items of information for consideration,
reconsideration, or correction. The Office is required to conduct and
conclude supplemental examination within three months after a request
is filed. In order to meet this time frame, the Office is setting a
limit of twelve items of information that a patent owner may submit to
the Office in each request. The purpose of this limit is to
strike a balance between the needs of the patent owner and the ability
of the Office to timely conclude the proceeding. There is, however, no
limit to the number of issues that these twelve items of information
can raise, or to the number of separate requests for supplemental
examination of the same patent that a patent owner can file at any
time.
   Even though the basis for most inequitable conduct allegations is
typically far fewer than ten items of information, the Office has
raised the limit to twelve items of information in response to the
public's comments. A review of ex parte reexamination requests filed in
fiscal year 2011 revealed that in at least ninety-three percent of the
requests, the requester relied on twelve or fewer documents. In
addition, the Office is very mindful of the time necessary for
examiners to analyze the items of information submitted, particularly
since the items are not limited to patents and printed publications,
and since each item may raise multiple issues. This final rule limits
the number of items of information to twelve to establish a procedure
that not only is practical, but also enables an examiner to fully,
comprehensively, and timely analyze all submitted items of information
and issues to accurately determine whether there is a substantial new
question of patentability.

Merger
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   Comment 9: A number of comments questioned whether the Office will
consider merging multiple requests for supplemental examination of the
same patent and/or consolidating the reexamination proceedings
resulting from these requests. These comments also questioned how any
merger procedure contemplated by the Office will be conducted.
   Response: A supplemental reexamination proceeding must conclude
within three months from the filing date of the request. As a general
rule, the Office will not merge a supplemental examination proceeding
with any other supplemental examination proceeding. The Office,
however, reserves its option to merge supplemental examination
proceedings as circumstances arise. The Office likewise does not
anticipate that a supplemental examination proceeding or ex parte
reexamination proceeding resulting from a supplemental examination
proceeding will be merged with any other type of Office proceeding. The
Office similarly reserves its option to merge reexamination proceedings
that are ordered as a result of supplemental examination proceedings as
circumstances arise.

Items of Information

   Comment 10: A number of comments requested that the method of
counting the items of information be clarified. These comments
questioned whether a reference which raises an issue of anticipation
and also raises an issue of obviousness would be counted as one or two
items. One comment suggested that a combination of references under 35
U.S.C. 103 be counted as a single item. One comment suggested that
where multiple items of information can be deemed to be cumulative to
each other, the cumulative items be counted as one item.
   Response: When counting the number of items of information in a
request for supplemental examination, the Office will tally the number
of items of information, such as documents, presented. The Office will
not count the number of issues raised by, or the number of grounds
which the patent owner requests the Office to consider, when
determining the number of items of information. A single reference that
raises multiple issues under multiple grounds, for example, under 35
U.S.C. 102, 35 U.S.C. 103, and 35 U.S.C. 112, will be counted as a
single item of information. However, if the patent owner cites a
combination of multiple references under 35 U.S.C. 103, then each
reference of the combination will be counted as one item of
information. For example, if the patent owner states that the claims
are patentable under 35 U.S.C. 103 over the combination of reference A
in view of reference B, then reference A and reference B must be
separately listed as items of information, and will be counted as two
items. Cumulative items of information will each be separately counted.
For example, if the patent owner indicates that reference A is
cumulative to reference B, reference A and reference B will be counted
as two items of information. If the patent owner believes that multiple
items of information are cumulative to each other, the patent owner is
encouraged to select one or two documents as the items of information
that will be submitted with the request.

   Comment 11: One comment questioned whether a book of meeting
abstracts constitutes one or more items of information. Several
comments further questioned how supporting documents, such as
declarations, dated sales receipts, marketing catalogs, and tables of
data would be counted.
   Response: An "item of information" is defined as a document,
submitted as part of the request, that contains information believed to
be relevant to the patent, and that the patent owner is requesting the
Office to consider, reconsider, or correct. See § 1.605(b). If, for
example, the patent owner relies upon different abstracts, bound
together in a book of meeting abstracts, it is likely that the Office
will treat each abstract as a separate item of information. In this
example, the Office suggests that the patent owner cite to and rely
upon only the particular abstracts that are relevant to the patent and
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not cite to an entire book of meeting abstracts.
   A declaration or affidavit would be considered an item of
information. If the declaration presents two distinct items of
information, such as information relating to a potential ground under
35 U.S.C. 101 as to patent claim 1 that was not considered during the
prior examination of the patent, and information relating to erroneous
facts or data presented during the prior examination of the patent with
respect to an issue under 35 U.S.C. 103 as to patent claim 10, then
each item of information contained within the declaration will be
counted separately, resulting in two items of information. As another
example, if the declaration presents one item of information, such as
information regarding erroneous data presented during the prior
examination of the patent with respect to an issue under 35 U.S.C. 103
as to patent claim 10, and relies upon a single exhibit, such as a new
table of data, to support facts presented in the declaration, the
Office is likely to count the declaration, including the supporting
exhibit, as a single item of information. However, as a further
example, if the declaration presents information relating to a
potential sale of the invention and relies upon two separate and
distinct sales receipts (e.g., a sales receipt dated March 2011 which
provides evidence of the sale of the invention, and a second, separate
sales receipt dated October 2011, which provides evidence of a second,
separate sale of the invention), then each additional sales receipt
will be counted separately, resulting in two items of information (one
item consisting of the declaration and one sales receipt, and the
second item consisting of the second sales receipt). As a final
example, if the declaration relies not only upon a sales receipt as
evidence of a sale of the invention under 35 U.S.C. 102(b), but also
upon a reference patent as evidence of a potential ground under 35
U.S.C. 103, then again, each additional exhibit will be counted separately.
In this example, the reference patent will be counted as a second item of
information.
   A discussion within the body of the request will only be counted if
the information to be considered, reconsidered, or corrected is not, at
least in part, contained within or based on a supporting document. See
§ 1.605(b). If, for example, the discussion within the body of the
request identifies a sales receipt supplied as an exhibit to the
request as a potential ground under 35 U.S.C. 102(b), the discussion in
the body of the request regarding a sales receipt will not be counted
because the "information," i.e., the sale, is at least in part, if
not wholly, contained within or based on the sales receipt. Patent
owners are encouraged to draft the request for supplemental examination
in a manner that clearly and consistently sets forth the items of
information which the patent owner wishes the Office to consider,
reconsider, or correct.

   Comment 12: A number of comments questioned whether a new reference
cited in an information disclosure statement by the patent owner during
a reexamination ordered under 35 U.S.C. 257 will be designated as
"considered during the supplemental examination of the patent" within
the meaning of 35 U.S.C. 257(c) for purposes of enforceability.
   Response: 35 U.S.C. 257(c) specifies the effect of a supplemental
examination proceeding on the enforceability of the patent.
Specifically, 35 U.S.C. 257(c)(1) provides that, with two exceptions,
"[a] patent shall not be held unenforceable on the basis of conduct
relating to information that had not been considered, was inadequately
considered, or was incorrect in a prior examination of the patent if
the information was considered, reconsidered, or corrected during a
supplemental examination of the patent." A supplemental examination
proceeding commences with the receipt of a request for supplemental
examination, and concludes with the issuance of a supplemental
examination certificate. See 35 U.S.C. 257(a). Reexamination is not
ordered until after the supplemental examination certificate has
issued. See 35 U.S.C. 257(b) ("[i]f the certificate issued under
subsection (a) indicates that a substantial new question of
patentability is raised * * * the Director shall order
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reexamination"). Thus, if the patent owner wishes to ensure that the
benefits of 35 U.S.C. 257(c)(1) attach to an item of information, the
patent owner should submit the item of information as part of the
request for supplemental examination and not wait to submit it in an
information disclosure statement during a reexamination.

Ownership Requirement

   Comment 13: A number of comments suggested that an owner of less
than the entire right, title, and interest in the patent be permitted
to file a request for supplemental examination. A number of comments
suggested that filing by fewer than all of the owners be permitted when
a joint owner is deceased, is legally incapacitated, refuses to join,
or cannot be found after diligent effort, or where one of the owners is
an organization that is dissolved.
   Response: 35 U.S.C. 257(a) only permits a patent owner to file a
request for supplemental examination. All parties having an interest in
a patent are deemed "a patent owner" as a composite entity and must
act together in proceedings before the Office. See MPEP § 301
("Ownership/Assignability of Patents and Applications"), which
expressly states: "All parties having any portion of the ownership of
the patent property must act together as a composite entity in patent
matters before the Office." See also MPEP § 324.
   The Office's practice for supplemental examination is consistent
with ex parte reexamination practice, which requires a patent owner
requester of an ex parte reexamination to comply with the provisions of
§§ 3.71 and 3.73, and MPEP § 324 for establishing an
assignee's right to take action when submitting a power of attorney.
See MPEP § 2222.
   The Office may, under rare circumstances, permit less than all of
the owners to file a request for supplemental examination if a
grantable petition under § 1.183 requesting waiver of the
provisions of §§ 3.71 and 3.73(c) is filed. For example, such a
petition may be filed in the case of a deceased or legally
incapacitated joint owner, or where the joint owner refuses to join or
cannot be found after diligent effort. In the case of a deceased joint
owner, the heirs, administrators, or executors of the joint owner may
be permitted to join in filing the request for supplemental
examination. If one of the owners is legally incapacitated, the legal
representative of the joint owner may be permitted to join in filing
the request for supplemental examination. If a joint owner refuses to
sign or cannot be found or reached after diligent effort, the remaining
owners in the petition must include proof of the pertinent facts, a
showing that such action is necessary to preserve the rights of the
parties or to prevent irreparable damage, and the last known address of
all of the joint owners. Finally, if an owner of all or a portion of
the entire right, title, and interest of the patent is an organization
that is dissolved, the Office may require that a determination of the
ownership of the patent be obtained from a court of competent
jurisdiction.

   Comment 14: A number of comments suggested that a licensee, and in
particular, an exclusive licensee, be permitted to file a request for
supplemental examination. A number of comments also suggested that if
an assignee or any person with sufficient proprietary interest, as
authorized by 35 U.S.C. 118 as amended by the AIA, can apply for a
patent, then the same assignee may file a request for supplemental
examination. One comment questioned whether a legal representative of
the patent owner may file a request and conduct prosecution.
   Response: 35 U.S.C. 257(a) only permits a patent owner to file a
request for supplemental examination. Accordingly, the Office is not
authorized to permit a party who is not a patent owner, or a party who
merely states that it is, for example, an exclusive licensee or a
person with sufficient proprietary interest under 35 U.S.C. 118, to
file a request for supplemental examination.
   A legal representative of the patent owner may file a request for
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supplemental examination on behalf of the patent owner. The request,
however, may not be filed anonymously. The request must identify the
owner(s) of the entire right, title, and interest in the patent to be
examined, on whose behalf the legal representative is acting, as
required by this final rule. See § 1.610(b)(9). Where an attorney
or agent files a request on behalf of a patent owner, he or she may act
under a power of attorney under § 1.32, or in a representative
capacity under § 1.34. A patent owner may not be represented during
a supplemental examination proceeding or the resulting ex parte
reexamination proceeding by an attorney or other person who is not
registered to practice before the Office. Any correspondence from the
Office will be directed to the patent owner at the address indicated in
the file of the patent for which supplemental examination is requested
pursuant to § 1.33(c), regardless of the address of the person
filing the request.

Content of Request

   Comment 15: A number of comments suggested that the content
requirements for a supplemental examination request are overly
burdensome, and suggested a variety of alternative and simplified
requirements. A number of comments suggested that the detailed content
requirements may potentially expose the patent owner to subsequent
allegations of inequitable conduct based on an omission, or a specific
statement or characterization, made in a supplemental examination request.
   Response: In response to the public's comments, the Office has
revised the content requirements for a request for supplemental
examination to include the following: (1) An identification of the
number of the patent for which supplemental examination is requested;
(2) a list of the items of information that are requested to be
considered, reconsidered, or corrected; (3) a list identifying any
other prior or concurrent post-patent Office proceedings involving the
patent for which supplemental examination is being requested; (4) an
identification of each claim of the patent for which supplemental
examination is requested; (5) a separate, detailed explanation of the
relevance and manner of applying each item of information to each claim
of the patent for which supplemental examination is requested; (6) a
copy of the patent for which supplemental examination is requested and
a copy of any disclaimer or certificate issued for the patent; (7) a
copy of each listed item of information, accompanied by a written
English translation of all of the necessary and pertinent parts of any
non-English language item of information (except for items of
information that form part of the discussion within the body of the
request, or copies of U.S. patents and U.S. patent application
publications); (8) a summary of the relevant portions of any submitted
document, other than the request, that is over 50 pages in length; and
(9) an identification of the owner(s) of the entire right, title, and
interest in the patent requested to be examined, and a submission by
the patent owner in compliance with § 3.73(c) establishing the
entirety of the ownership in the patent requested to be examined. See
§ 1.610(b). These requirements balance the interests of the public
with the Office's need to make an accurate and comprehensive
determination, within the statutory three-month time period, whether
any of the items of information submitted as part of the request raise
a substantial new question of patentability.

   Comment 16: A number of comments questioned whether permitting an
explanation of how the claims distinguish over the items of information
would be contrary to the spirit of 35 U.S.C. 257(b), which provides
that "reexamination shall be conducted according to the procedures
established by chapter 30, except that the patent owner shall not have
the right to file a statement pursuant to section 304."
   Response: Section 1.610(c) permits the patent owner to include, in
the request, an explanation of how the claims patentably distinguish
over the submitted items of information. Section 1.610(c) is consistent
with established ex parte reexamination practice, which allows the
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patent owner to describe, in the request, how the claims distinguish
over the cited prior art patents and printed publications (see MPEP
§ 2217). This provision is not contrary to the spirit of 35 U.S.C.
257(b), which removes the right of the patent owner to file a statement
under 35 U.S.C. 304 during any subsequent reexamination. A patent
owner's statement under 35 U.S.C. 304 is filed after the order granting
reexamination and serves a different function. Specifically, patent
owner's statement under 35 U.S.C. 304 addresses the Office's
determination in the order granting reexamination that a substantial
new question of patentability has been raised by the request. In
contrast, a patent owner's explanation that may form part of the
request for supplemental examination under § 1.610 discusses how
the claims may be distinguished over the items of information submitted
as part of the request. Furthermore, § 1.610(c) is also consistent
with established ex parte reexamination practice, which allows the
patent owner to describe, in the request, how the claims distinguish
over the cited prior art patents and printed publications (see MPEP
§ 2217).

   Comment 17: A number of comments suggested that the requirements
for a copy of the patent for which supplemental examination is
requested, and for a copy of each item of information, are unnecessary
because such copies would be available to the Office. One comment
suggested that the Office may obtain copies of any items of information
that are available through the Common Citation Document (CCD), which
was launched by the Trilateral Offices.
   Response: The requirement for a copy of the patent for which
supplemental examination is requested assists in preventing an
inadvertent misidentification by the patent owner of the patent, for
example, by transposing some of the digits of the patent number in the
transmittal sheet and/or in the body of the request. The requirement
also assists the Office in quickly discovering such inadvertent errors
upon the receipt of the request. This requirement likwise assists in
preventing any similar misidentification by the Office, thus avoiding
an erroneous supplemental examination of a patent that is not owned by
the requester. A copy of each item of information is required for the
same reasons; i.e., to prevent any inadvertent misidentification of the
item of information in the list of items of information and/or in the
body of the request by the patent owner or the Office. However, copies
of items of information that form part of the discussion within the
body of the request as specified in § 1.605(b) are not required to
be submitted. Copies of items of information which are U.S. patents and
U.S. patent application publications are also not required, but may be
submitted. See § 1.610(b)(7).
   The Common Citation Document (CCD) is an effective work sharing
tool developed by the Trilateral Offices. Use of the CCD to obtain
copies of items of information would not be feasible. The Office is
required by statute to make a determination on the request within three
months from the filing date of the request. To receive a filing date, a
request for supplemental examination must be in a condition which
permits the Office to promptly initiate supplemental examination of the
patent. For the Office to be able to promptly initiate supplemental
examination, a copy of the subject patent and all items of information
must be available for review. If a copy of an item of information
identified in the request were not obtainable through the CCD tool due
to, for example, an inadvertent misidentification of the identifying
information by the patent owner, an inadvertent difficulty with the
hyperlink or other form of browser-executable code that appears on the
CCD Web site, or it being an inaccessible non-patent document, the
Office would not be able to initiate supplemental examination, and the
request would not be entitled to a filing date until the item could be
obtained. Accordingly, the final rule requires that a copy of the
patent for which supplemental examination is requested, and copies of
each item of information identified in the request, must be submitted
as part of the request.

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   Comment 18: A number of comments suggested that the requirement to
identify any other prior or concurrent post-patent Office proceedings
involving the patent for which supplemental examination is requested is
unnecessary because this information may be obtained by the Office.
   Response: The Office anticipates that a patent for which
supplemental examination is requested may be involved in other post-patent
Office proceedings, including another supplemental examination proceeding.
Daily monitoring by the Office for the potential filing, in each and
every supplemental examination proceeding, of any concurrent post-
patent Office proceedings would not be feasible. The patent owner is in
the best position to inform the Office of the existence of any other
post-patent Office proceedings, whether the Office proceedings are
prior or concurrent to the present supplemental examination proceeding.
For these reasons, the final rule requires a list identifying any other
prior or concurrent post-patent Office proceedings involving the patent
for which supplemental examination is being requested. See § 1.610(b)(3).

   Comment 19: A number of comments suggested that the requirement for
a summary of the relevant portions of any submitted document, other
than the request, that is over 50 pages in length be eliminated and/or
replaced with an alternative requirement, such as a requirement for a
summary of the entire document (rather than a summary of only the
relevant portions) with citations to the particular pages believed to
be relevant.
   Response: As discussed previously, the requirement for the summary
directs the Office's attention to the relevant information presented in
lengthy documents. Patent owners are encouraged to redact lengthy
documents to include only the relevant portions, unless the redaction
would remove context such that the examiner would not be provided with
a full indication of the relevance of the information.

   Comment 20: One comment questioned whether the required detailed
explanation of the relevance and manner of applying each item of
information will be available to the examiner during reexamination
ordered as a result of the supplemental examination, and whether the
required detailed explanation will be made part of the record.
   Response: The entire contents of a request for supplemental
examination, including the required detailed explanation of the
relevance and manner of applying each item of information will be
available to the examiner if a reexamination is ordered as a result of
the supplemental examination. Also, the contents of a request for
supplemental examination that has received a filing date will be made
part of the official record of the patent, and will be available to the
public.

   Comment 21: One comment questioned how the Office will address a
request to consider, reconsider, or correct an item of information
based on a given document in view of "all existing prior art for the
purposes of 35 U.S.C. 103."
   Response: If a patent owner requests the Office to consider an item
of information in view of "all existing prior art for the purposes of
35 U.S.C. 103" in a request for supplemental examination, the request
will not be given a filing date, due to the failure to comply with the
requirements of the request. See § 1.610(d). The request may only
be based on twelve items of information. If one item of information is
combined in the request with one or more additional items of
information, each item of information of the combination may be
separately counted. See §§ 1.605(a) and (d). If an item of
information is requested to be considered in view of all existing prior
art under 35 U.S.C. 103, each piece of prior art would need to be
provided and counted, and would presumably result in a number far
greater than twelve. In addition, the request must include inter alia:
(1) a list identifying each of the items of information that the patent
owner requests the Office to consider, reconsider, or correct; and (2)
a detailed explanation of the relevance and manner of applying each
item of information to each claim of the patent for which supplemental
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examination is requested. See § 1.610(b). A request to consider,
reconsider, or correct an item of information in view of "all existing
prior art for the purposes of 35 U.S.C. 103" will not be deemed to
meet these requirements.

Filing Date of Request

   Comment 22: A number of comments suggested that the procedure for
determining the filing date of a request for supplemental examination
is unduly strict, and suggested a variety of alternative procedures,
such as a procedure in which a filing date is granted to a
substantially complete request, or to any request that does not contain
a gross deficiency. These comments suggested that if an appropriately
corrected request is timely filed in response to a notice by the Office
of the defects, the request would retain the original filing date. A
number of comments also suggested that a broader range of non-
substantive or minimal defects, such as the mistakes in meeting format
requirements, or a deficiency in a fee payment, be included in the
exceptions to the requirement that the request be complete.
   Response: The Office appreciates the importance of the filing date
of a supplemental examination request. As discussed previously, the
Office has simplified the content requirements for the request for
supplemental examination to make it easier for a patent owner. See
§ 1.610(b). These requirements have been carefully formulated to
address the concerns of the public, while providing the Office with the
necessary information to make an accurate and comprehensive
determination on the request for supplemental examination within the
statutory three-month time period. As discussed previously, since the
statutory three-month period commences with the filing date of the
request, the final rule provides that a filing date will not be granted
if the request is not in compliance with §§ 1.605, 1.610, and
1.615. The Office, however, has the discretion under § 1.610(d) to
grant a filing date if the request contains only minor defects, such as
improper margins or other format issues.

   Comment 23: A number of comments suggested that the request not be
made public until after a filing date is granted to avoid a "race to
the court." These comments suggested that a request that is not
granted a filing date, due to the presence of one or more defects in
the request, could inform an accused infringer of the manner in which
an inequitable conduct charge could be raised in court. These comments
further suggested that such an inequitable conduct charge could be
maintained in court notwithstanding a later-filed corrected request for
supplemental examination that cures all of the defects of the
originally filed request, but which is given a filing date that is
later than the date on which the inequitable conduct charge is raised
in court by the accused infringer.
   Response: In response to the public's comments, the Office does not
intend to make a request for supplemental examination public until the
request is granted a filing date. The Office is establishing a
procedure in which the request, and any other papers or information
submitted as part of or accompanying the request, would not be viewable
in Public PAIR until a filing date is granted by the Office.

   Comment 24: A number of comments suggested that the statute permits
the filing date of the original request to be distinct from the date
that starts the three-month period to conduct the supplemental
examination when a corrected request is filed. These comments suggested
that the original filing date may be granted upon correction of any
defects, and that the date starting the three-month period may be
separately determined to be the date of the corrected request.
   Response: 35 U.S.C. 257(a) provides for a single date only-- "the
date a request for supplemental examination meeting the requirements of
this section is received." The statute does not authorize the Office
to grant a date that is separate and distinct from the date established
by the statute as a filing date. Thus, the date specified in 35 U.S.C.
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257(a) is both the filing date and the date that starts the three-month
period to conduct the supplemental examination.

Conduct of Supplemental Examination

   Comment 25: A number of comments suggested that the review by the
Office of the items of information presented in a request for
supplemental examination should not be generally limited to a review of
the issues identified in the request, but rather that the supplemental
examination should entail a general reassessment of all issues of
patentability. Several comments suggested that such a limitation is not
authorized by 35 U.S.C. 257. These comments also suggested that this
limitation would provide unwarranted unenforceability protection,
because a patent owner could include in its request a discussion of
some issues of patentability with respect to an item of information,
while withholding comment as to other relevant issues of patentability,
a court would be statutorily required to dismiss any allegations of
inequitable conduct based on any conduct relating to the items of
information.
   Response: 35 U.S.C. 257(a) expressly authorizes the Office to set
forth regulatory requirements governing supplemental examination: "A
patent owner may request supplemental examination * * * in accordance
with such requirements as the Director may establish." See also 35
U.S.C. 257(d)(2) ("[t]he Director shall issue regulations governing
the form, content, and other requirements of requests for supplemental
examination, and establishing procedures for reviewing information
submitted in such requests"). In response to the public comments, this
final rule has been clarified to state that the Office's determination
of whether a substantial new question of patentability affecting any
claim of the patent has been raised by any of the items of information
presented in the request will be generally limited to a review of the
item(s) of information identified in the request with respect to the
identified claim(s) of the patent. 35 U.S.C. 257(a) requires the Office
to determine, within three months of the filing date of each request,
whether any of the items of information on which the request is based
raises a substantial new question of patentability. In order to ensure
an accurate and comprehensive determination of whether the request
raises a substantial new question of patentability within the statutory
three-month period, it is reasonable to put the patent owner on notice
that unless the patent owner identifies the particular claim(s) which
the patent owner requests the Office to consider with respect to each
item of information, the record may not reflect that these claim(s)
were explicitly considered by the examiner. As to the level of
unenforceability protection, the issue of whether a court would be
statutorily required to dismiss all allegations of inequitable conduct
involving a particular item of information is within the purview of the
courts.

   Comment 26: A number of comments suggested that the term "material
fraud" be clarified. These comments suggested that the Office provide
guidance as to the standard and the burden of proof that will be used
for determining a threshold finding that is sufficient to justify a
referral to the Office of Enrollment and Discipline (OED) and/or the
Attorney General. A number of comments also suggested that any persons
implicated by a potential material fraud be provided notice and
opportunity to be heard prior to any referral to OED or to the Attorney
General, and that the patent owner be required to notify the person or
practitioner as to the particular items of information and the alleged
conduct pertaining to them.
   Response: 35 U.S.C. 257 does not provide for the Office to make any
definitive determination or finding of material fraud, nor does the
statute provide for the Office to set up procedures to make such a
determination. Moreover, the Office anticipates that such instances
will be rare. Accordingly, the Office does not intend to create a unit
to investigate instances of material fraud. If an employee of the
Office, such as an examiner in the Central Reexamination Unit (CRU),
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becomes aware, during the course of supplemental examination or of any
reexamination ordered under 35 U.S.C. 257, that a material fraud on the
Office may have been committed in connection with the patent subject to
a supplemental examination or resulting reexamination ordered under 35
U.S.C. 257, the employee would notify the supervisory official in
charge of the section of the Office to which the employee is assigned,
such as the Director of the CRU. The supplemental examination
proceeding, or any reexamination proceeding ordered under 35 U.S.C.
257, would continue. If the supervisory official concurs, he or she
would refer the matter to the Deputy Commissioner for Patent
Examination Policy. If the Deputy Commissioner for Patent Examination
Policy concurs, the matter would be referred to the Office's General
Counsel.

   Comment 27: One comment suggested that supplemental examination
should be available after litigation is filed. A number of comments
suggested that the Office specifically retain the discretion to permit
a supplemental examination proceeding to proceed concurrently with an
action brought under Section 337(a) of the Tariff Act of 1930 (19
U.S.C. 1337(a)) in which a defense of inequitable conduct has been
raised, if an ordered ex parte reexamination under 35 U.S.C. 257 has
proceeded to a stage at which it is likely to be concluded prior to the
trial proceeding. These comments suggested that if the ordered ex parte
reexamination under 35 U.S.C. 257 has not proceeded to such a stage,
then the Office should retain discretion to suspend the supplemental
examination or any ordered ex parte reexamination until the merits of
the defense are concluded in the trial proceeding.
   Response: If the patent owner files a request for supplemental
examination that is in compliance with 35 U.S.C. 257 and all applicable
rules, the Office is required under 35 U.S.C. 257(a) to conduct the
examination and conclude the proceeding within three months from the
filing date of the request. Any reexamination proceeding resulting from
the supplemental examination proceeding must, in accordance with 35
U.S.C. 257(b), be conducted "according to the procedures established
by chapter 30," which govern ex parte reexamination. If reexamination
is ordered, the Office is required to proceed with the reexamination.
35 U.S.C. 304 requires the Office to resolve any substantial new
question of patentability determined to be raised: "[i]f * * * the
Director finds that a substantial new question of patentability
affecting any claim of a patent is raised, the determination will
include an order for reexamination of the patent for resolution of the
question" (emphasis added). In addition, 35 U.S.C. 305 expressly
provides that, after the order (and after the time period set for
filing a patent owner statement under 35 U.S.C. 304, which is excluded
by 35 U.S.C. 257(b)), "reexamination will be conducted."
Therefore, once reexamination is ordered, the Office is required by
statute to conduct the reexamination. 35 U.S.C. 305 also requires that
an ex parte reexamination proceeding "be conducted with special
dispatch within the Office." See Ethicon v. Quigg, 849 F.2d 1422 (Fed.
Cir. 1988). For these reasons, any reexamination proceeding ordered
under 35 U.S.C. 257 will generally not be suspended. The patent owner
may wish to consider the provisions of 35 U.S.C. 257(c)(1) and (c)(2)
on the effectiveness of any supplemental examination on already pending
litigation when determining whether and when to file a request for
supplemental examination.

   Comment 28: One comment suggested that the rules make clear whether
the Office will hold in abeyance any petition or paper filed by a third
party in a supplemental examination proceeding until after the
proceeding is concluded.
   Response: In accordance with 35 U.S.C. 257(a), which only permits a
patent owner to file a request for supplemental examination, this final
rule expressly prohibits any party other than the patent owner from
filing papers or otherwise participating in any manner in the
supplemental examination proceeding. See § 1.601(b). If a third
party files any petition or other paper in a supplemental examination
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proceeding, it will not be entered into the official file or
considered. If such papers are inadvertently entered, they will be
expunged. See § 1.620(c).

Interviews

   Comment 29: A number of comments suggested that interviews be
permitted at the discretion of the examiner during the time period
prior to the issuance of a supplemental examination certificate.
Several comments suggested interviews be permitted as a matter of right
during this time period.
   Response: The Office must make a determination on the request
within the three-month statutory period, which limits the amount of
time that an examiner can devote to any one request. The prohibition of
interviews, as implemented in this final rule, will assist the Office
in meeting the statutory deadline. See § 1.620(e). A telephone call
to the Office to confirm the receipt of a request, or to discuss
general procedural questions, is not considered to be an interview for
the purposes of this provision. Additionally, the prohibition applies
only to supplemental examination proceedings. Interviews will be
permitted in any ex parte reexamination proceeding ordered as a result
of the supplemental examination proceeding, in accordance with the
regulations governing ex parte reexamination. Further, interviews are
generally permitted to discuss issues of patentability, which are
directly addressed during any reexamination proceeding ordered under 35
U.S.C. 257, and not during the supplemental examination proceeding.
Finally, the only determination made in a supplemental examination
proceeding is whether a substantial new question of patentability is
raised by any of the items of information submitted as part of the
request. The prohibition of interviews in a supplemental examination
proceeding, as implemented in this final rule, is consistent with
established ex parte reexamination practice, which prohibits interviews
involving a discussion of the patentability of the claims prior to a
first Office action on the merits. See § 1.560(a).

Amendments

   Comment 30: Several comments suggested that amendments be permitted
to be filed with the request for supplemental examination. These
comments suggested that permitting amendments to be filed with the
request would prevent the examiner from unnecessarily applying, in any
reexamination ordered under 35 U.S.C. 257, a rejection to a claim which
the patent owner intends to amend or cancel. One comment questioned
whether a discussion of proposed alternative claim language in the
request will be considered to be a prohibited proposed amendment.
   Response: 35 U.S.C. 257(a) permits a patent owner to present only
items of information in a request for supplemental examination. An
amendment is not an item of information and therefore the final rule
provides that no amendment may be filed in a supplemental examination
proceeding. See § 1.620(f). Any proposed amendment included with a
request for supplemental examination would not be considered by the
Office in making the determination of whether a substantial new
question of patentability is raised by any of the items of information.
Furthermore, if the Office makes the determination that no substantial
new question of patentability is raised, any amendment filed with the
request would remain in the file, and may create a cloud on the patent.
   An amendment may be submitted during a reexamination ordered under
35 U.S.C. 257. Patent owners, however, are reminded that 35 U.S.C.
257(b) expressly removes the right of the patent owner to file a
statement under 35 U.S.C. 304, which includes any amendment that the
patent owner may wish to file prior to an initial Office action on the
merits. As the patent owner is prohibited from filing a statement under
35 U.S.C. 304, no amendment may be filed, in any reexamination
proceeding ordered under 35 U.S.C. 257, until after the initial Office
action on the merits. As discussed previously, a patent owner may file
a statutory disclaimer under 35 U.S.C. 253 and § 1.321(a) prior to
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filing any request for supplemental examination. See MPEP § 1490.
Moreover, if the patent owner merely wishes to amend the patent claims,
the patent owner may file a reissue application instead of a request
for supplemental examination.

Supplemental Examination Certificate

   Comment 31: A number of comments suggested that the Office specify
that the electronically issued supplemental examination certificate
will display the filing date of the request. These comments also
suggested that the Office consider whether any ex parte reexamination
certificate published as a result of an ex parte reexamination ordered
under 35 U.S.C. 257 will be issued electronically, in the same manner
as the supplemental examination certificate. A number of comments
requested that the supplemental examination certificate list each item
of information presented by the request, and expressly state that the
item was considered during the supplemental examination of the patent
even if the item is determined not to raise a substantial new question
of patentability.
   Response: The electronically issued supplemental examination
certificate will display the filing date of the request. The Office is
mindful of the importance of the filing date in determining the effect
under 35 U.S.C. 257(c) of the supplemental examination proceeding. The
electronically issued supplemental examination certificate will also
list each of the items of information properly submitted as part of the
request, and state whether each of these items raises a substantial new
question of patentability affecting the identified claims of the
patent. Any ex parte reexamination certificate resulting from a
reexamination ordered under 35 U.S.C. 257 will be published in
accordance with established ex parte reexamination practice (see § 1.570)
since 35 U.S.C. 257(b) requires that any resulting reexamination be
conducted according to procedures established for ex parte reexamination.

   Comment 32: One comment suggested that supplemental examination
proceedings do not conclude with the issuance of the initial
(supplemental examination) certificate. This comment suggested that the
(ex parte reexamination) certificate, which is issued at the conclusion
of any reexamination ordered under 35 U.S.C. 257, should be designated
as the supplemental examination certificate.
   Response: 35 U.S.C. 257(a) requires that supplemental examination
"shall conclude with the issuance of a certificate indicating whether
the information presented in the request raises a substantial new
question of patentability." An ex parte reexamination certificate does
not indicate whether the information presented in the request raises a
substantial new question of patentability. Instead, it provides the
results of the Office's later determination, in any reexamination
ordered as a result of the supplemental examination proceeding, whether
the claims are patentable. In addition, if the Office determines in a
supplemental examination proceeding that none of the items of
information raise a substantial question of patentability, then
reexamination would not be ordered, and no reexamination certificate
would issue that could be designated as a supplemental examination
certificate. For these reasons, a supplemental examination proceeding
will conclude with the electronic issuance of a supplemental
examination certificate, which is separate and distinct from an ex
parte reexamination certificate. See § 1.625(a).

   Comment 33: One comment suggested that the order for reexamination
be published in the Official Gazette so as to put third parties on
notice that they are prohibited from making a submission or otherwise
participating in the reexamination.
   Response: The final rule specifically provides that no party other
than the patent owner may file any papers or otherwise participate in
any manner in a supplemental examination proceeding. See §
1.601(b). Accordingly, third parties are on notice that they have no
participatory rights in a supplemental examination proceeding.
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Furthermore, even in ex parte reexamination practice, third party
participation is limited. After the request has been filed by the third
party, there is no opportunity for the third party to participate,
other than to file a reply in response to any statement under 35 U.S.C.
304 filed by the patent owner prior to the first Office action. In any
reexamination resulting from a supplemental examination proceeding,
however, there is no request for reexamination filed by a third party.
For this reason, third parties have no participatory rights in any ex
parte reexamination proceeding ordered under 35 U.S.C. 257.

Miscellaneous

   Comment 34: A number of comments suggested the rules be amended to
specify that a request for supplemental examination may be filed at any
time during the enforceability of the patent for which supplemental
examination is requested.
   Response: In response to the public's comments, § 1.601(c) now
provides that a request for supplemental examination of a patent may be
filed at any time during the period of enforceability of the patent.
This policy is consistent with ex parte reexamination practice. See
§ 1.510(a). If the patent is not enforceable, then the Office
believes that the benefits of 35 U.S.C. 257 will have no effect.

   Comment 35: One comment suggested that the rules should require the
patent owner to make a statement regarding why an item is not material.
   Response: The Office must determine whether any of the items of
information raises a substantial new question of patentability, not
whether any of the items of information is "material." Therefore, the
Office is not adopting a requirement that the patent owner state
whether or why an item of information is or is not material.

   Comment 36: One comment questioned whether the supplemental
examination request is subject to a page limit. This comment also
questioned whether the determination of a substantial new question of
patentability will be decided by the same or a different examiner from
the examiner in charge of the original prosecution of the patent. This
comment also questioned which post-patent proceeding would proceed
first if multiple post-patent proceedings are filed, such as a
supplemental examination proceeding, an ex parte reexamination
proceeding, and a post-grant review proceeding.
   Response: A request for supplemental examination is not subject to
a page limit requirement. However, if any document, other than the
request, is over 50 pages in length, then the patent owner must provide
a summary of the relevant portions of the document with citations to
the particular pages containing the relevant portions. See §
1.610(b)(8). In addition, any non-patent document that is submitted as
part of the request is subject to document size fees, if the document
is over 20 pages in length. See § 1.20(k)(3). The determination of
the substantial new question of patentability will not generally be
decided by the same examiner who examined the original patent
application, since the Office intends for supplemental examination
proceedings to be examined by the Central Reexamination Unit. If
multiple post-patent proceedings are simultaneously filed, any
determination of which proceedings to initiate, and the order in which
to initiate them, will be made on a case-by-case basis. Because a
supplemental reexamination proceeding must conclude within three months
from the filing date of the request, a supplemental examination
proceeding will not be suspended, as a general rule. The Office,
however, reserves its option to suspend a supplemental examination
proceeding as circumstances arise.

   Comment 37: One comment suggested the use of the term "ex parte
reexamination" to refer to reexamination under 35 U.S.C. 257 is
confusingly similar to the use of the same term when referring to ex
parte reexamination ordered under 35 U.S.C. 302. This comment suggests
the term "reexamination under 35 U.S.C. 257" be used to refer to
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reexamination ordered as a result of a supplemental examination
proceeding, and that "ex parte reexamination" only be used to refer
to ex parte reexamination ordered under 35 U.S.C. 302.
   Response: When it is necessary to distinguish ex parte
reexamination ordered under 35 U.S.C. 257 from ex parte reexamination
ordered under 35 U.S.C. 302, the Office will utilize language such as
"reexamination resulting from a supplemental examination proceeding"
or "ex parte reexamination ordered under 35 U.S.C. 257" to avoid
confusion.

Rulemaking Considerations

A. Administrative Procedure Act

   This final rule amends the rules of practice in patent cases to
implement the supplemental examination provisions of the AIA. The
Office is also adjusting the fee for filing a request for ex parte
reexamination and to set a fee for petitions filed in ex parte and
inter partes reexamination proceedings to more accurately reflect the
cost of these processes. The changes in this rulemaking do not change
the substantive criteria of patentability. These changes involve rules
of agency practice and procedure and/or interpretive rules. See Bachow
Commc'ns Inc. v. FCC, 237 F.3d 683, 690 (D.C. Cir. 2001) (rules
governing an application process are procedural under the Administrative
Procedure Act); Inova Alexandria Hosp. v. Shalala, 244 F.3d 342, 350 (4th
Cir. 2001) (rules for handling appeals were procedural where they did not
change the substantive standard for reviewing claims); Nat'l Org. of
Veterans' Advocates v. Sec'y of Veterans Affairs, 260 F.3d 1365, 1375
(Fed. Cir. 2001) (rule that clarifies interpretation of a statute is
interpretive).
   Accordingly, prior notice and opportunity for public comment are
not required pursuant to 5 U.S.C. 553(b) or (c) (or any other law). See
Cooper Techs. Co. v. Dudas, 536 F.3d 1330, 1336-37 (Fed. Cir. 2008)
(stating that 5 U.S.C. 553, and thus 35 U.S.C. 2(b)(2)(B), does not
require notice and comment rulemaking for "interpretative rules,
general statements of policy, or rules of agency organization,
procedure, or practice") (quoting 5 U.S.C. 553(b)(A)). The Office,
however, published proposed changes and an Initial Regulatory
Flexibility Act (IRFA) analysis for comment as it sought the benefit of
the public's views on the Office's proposed implementation of this
provision of the AIA. The Office provides the Final Regulatory
Flexibility Analysis as follows.

B. Final Regulatory Flexibility Analysis

   1. Description of the reasons that action by the agency is being
considered: The Office is revising the rules of patent practice to
implement the supplemental examination provisions of the AIA, which
take effect September 16, 2012. The Office is also adjusting the fee
for filing a request for ex parte reexamination, and setting a fee for
petitions filed in ex parte and inter partes reexamination proceedings,
to more accurately reflect the cost of these processes.
   2. Statement of the objectives of, and legal basis for, the final
rules: The objective of the rules is to implement the supplemental
examination provisions of the AIA by establishing a process which
allows: (1) patent owners to exercise their statutory right to request
supplemental examination to consider, reconsider, or correct
information believed to be relevant to a patent; and (2) the Office to
make its determination whether the information presented in the request
raises a substantial new question of patentability within three months
of the filing date of the supplemental examination request. The
objective of the rules to adjust the fee for filing a request for ex
parte reexamination, and to set a fee for petitions filed in ex parte
and inter partes reexamination proceedings, is to recover the estimated
average cost to the Office of ex parte reexamination proceedings and
petitions filed in ex parte and inter partes reexamination proceedings.
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   Section 12 of the AIA provides a legal basis for the rules to
implement supplemental examination. 35 U.S.C. 41(d)(2) provides a legal
basis for the rules to set the fee for supplemental examination, to
adjust the fee for filing a request for ex parte reexamination, and to
set a fee for petitions filed in ex parte and inter partes
reexamination proceedings. Specifically, 35 U.S.C. 41(d)(2) provides
that fees for all processing, services, or materials relating to
patents not specified in 35 U.S.C. 41 are to be set at amounts to
recover the estimated average cost to the Office of such processing,
services, or materials.
   3. Statement of significant issues raised by the public comments in
response to the IRFA and the Office's response to such issues: The
Office published an IRFA analysis to consider the economic impact of
the proposed rules on small entities. See Changes to Implement the
Supplemental Examination Provisions of the Leahy-Smith Invents Act and
to Revise Reexamination Fees, 77 FR at 3675-76. The Office did not
receive any comments that specifically referenced the IRFA or cited to
the Regulatory Flexibility Act.
   The Office received a few comments indicating that the Office may
be overestimating the number requests for supplemental examination that
will be submitted annually. The Office, however, did not receive any
comments indicating that the Office was understating the number of
requests for supplemental examination that will be submitted annually
by small entities. No change has been made in response to these
comments because the Office's estimates as to the impact on small
entities are conservative.
   No comments asserted that the Office's estimates concerning the
projected reporting, recordkeeping and other compliance requirements
were inaccurate.
   In response to general public comments, this final rule reduces the
number of procedural requirements for requesting supplemental
examination, which may have the effect of reducing the impact on all
entities requesting supplemental examination. In particular, the Office
has determined to not implement in this final rule the following
proposed requirements for a request for supplemental examination to
contain: (1) An identification of each item of information requiring
consideration, reconsideration, or correction, explaining why
consideration or reconsideration of the item of information is being
requested or how the item of information it is being corrected; (2) an
identification of the structure, material, or acts in the specification
that correspond to each means-plus-function or step-plus-function
element, as set forth in 35 U.S.C. 112(f), in any claim to be examined;
(3) an identification of each issue raised by each item of information;
(4) an explanation of the support in the specification for each
limitation of each claim identified for examination if an identified
issue involves the application of 35 U.S.C. 101 (other than double
patenting) or 35 U.S.C. 112; and (5) an explanation of how each
limitation of each claim identified for examination is met, or is not
met, by each item of information if an identified issue involves the
application of 35 U.S.C. 102, 35 U.S.C. 103, or double patenting. In
addition, the Office reduced the fee for requesting supplemental
examination by $40, to $5140.
   4. Description and estimate of the number of affected small
entities:
   a. Size Standard and Description of Entities Affected. The Small
Business Administration (SBA) small business size standards applicable
to most analyses conducted to comply with the Regulatory Flexibility
Act are set forth in 13 CFR 121.201. These regulations generally define
small businesses as those with fewer than a specified maximum number of
employees or less than a specified level of annual receipts for the
entity's industrial sector or North American Industry Classification
System (NAICS) code. As provided by the Regulatory Flexibility Act, and
after consultation with the Small Business Administration, the Office
formally adopted an alternate size standard as the size standard for
the purpose of conducting an analysis or making a certification under
the Regulatory Flexibility Act for patent-related regulations. See
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Business Size Standard for Purposes of United States Patent and
Trademark Office Regulatory Flexibility Analysis for Patent-Related
Regulations, 71 FR 67109 (Nov. 20, 2006), 1313 Off. Gaz. Pat. Office 60
(Dec. 12, 2006). This alternate small business size standard is the
SBA's previously established size standard that identifies the criteria
entities must meet to be entitled to pay reduced patent fees. See 13
CFR 121.802. If patent applicants identify themselves on a patent
application as qualifying for reduced patent fees, the Office captures
this data in the Patent Application Location and Monitoring (PALM)
database system, which tracks information on each patent application
submitted to the Office.
   Unlike the SBA small business size standards set forth in 13 CFR
121.201, the size standard for USPTO is not industry-specific.
Specifically, the Office's definition of small business concern for
Regulatory Flexibility Act purposes is a business or other concern
that: (1) meets the SBA's definition of a "business concern or
concern" set forth in 13 CFR 121.105; and (2) meets the size standards
set forth in 13 CFR 121.802 for the purpose of paying reduced patent
fees, namely, an entity: (a) whose number of employees, including
affiliates, does not exceed 500 persons; and (b) which has not
assigned, granted, conveyed, or licensed (and is under no obligation to
do so) any rights in the invention to any person who made it and could
not be classified as an independent inventor, or to any concern which
would not qualify as a non-profit organization or a small business
concern under this definition. See Business Size Standard for Purposes
of United States Patent and Trademark Office Regulatory Flexibility
Analysis for Patent-Related Regulations, 71 FR at 67112 (Nov 20, 2006),
1313 Off. Gaz. Pat. Office at 63 (Dec. 12, 2006).
   b. Overview of Estimates of Number of Entities Affected. The rules
will apply to any small entity that files a request for supplemental
examination, a request for ex parte reexamination, or a petition in an
ex parte and inter partes reexamination proceeding. To estimate the
number of requests for supplemental examination, ex parte
reexamination, and petitions filed in ex parte and inter partes
reexamination expected to be submitted annually by small entities, the
Office considered the information concerning ex parte reexamination
filings published in the United States Patent and Trademark Office
Performance and Accountability Report, Fiscal Year 2011. The Office
received 758 requests for ex parte reexamination in fiscal year 2011,
of which 104 (14 percent) were by the patent owner and 654 (86 percent)
were by a third party. See United States Patent and Trademark Office
Performance and Accountability Report, Fiscal Year 2011, at 171 (table
14A) (2011). Based upon that information, the Office estimates that it
will receive about 800 (758 rounded to be nearest 100) requests for ex
parte reexamination annually and that about 14 percent of all requests
for ex parte reexamination are filed by patent owners.
   c. Number of Entities Filing Requests for Ex parte Reexamination.
As discussed previously, the Office estimates that it will receive
about 800 requests for ex parte reexamination annually and that about
14 percent of all requests for ex parte reexamination are filed by
patent owners and 86 percent of all requests for ex parte reexamination
are filed by a third party. Thus, the Office estimates that it receives
approximately 110 (14 percent of 800 rounded to the nearest 10)
requests for ex parte reexamination filed by patent owners annually and
approximately 690 (86 percent of 800 rounded to the nearest 10)
requests for ex parte reexamination filed by third parties annually.
Due to the availability of supplemental examination beginning in fiscal
year 2013, the Office estimates that all 110 requests for ex parte
reexamination that would have been filed annually by patent owners will
instead be filed as requests for supplemental examination.
   As discussed previously, the Office estimates that approximately
690 requests for ex parte reexamination are filed by third parties
annually. Reexamination requesters are not required to identify their
small entity status. Therefore, the Office does not have precise data
on the number of requests for ex parte reexamination submitted annually
by small entities. However, the Office tracks the number of requests
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for ex parte reexamination that are filed in which the patent that is
the subject of the reexamination was prosecuted under small entity
status. For fiscal year 2011, approximately 36 percent of the requests
for ex parte reexamination that were filed requested reexamination of a
patent that was prosecuted under small entity status.
   It is difficult to estimate what fraction of the anticipated 690
requests for ex parte reexamination submitted annually will be by small
entities, because the entity status of the third party requester is not
necessarily the same as the entity status of the patentee and
reexamination requesters currently have no reason to identify whether
they are a small entity. The data that the Office keeps regarding the
number of requests for ex parte reexamination that are filed in which
the patent that is the subject of the reexamination was prosecuted
under small entity status provides no insight into the number of
requests for ex parte reexamination submitted by small entity third
party requesters. Therefore, for purposes of this analysis, the Office
is considering all 690 requests for ex parte reexamination expected to
be submitted annually as being submitted by small entities.
   d. Number of Entities Filing Petitions in Ex parte Reexamination
Proceedings. The rule to set a fee for petitions filed in reexamination
proceedings (except for those petitions specifically enumerated in 37
CFR 1.550(i) and 1.937(d)) will apply to any small entity that files a
petition in a reexamination proceeding. The Office decided 832
petitions in reexamination proceedings (ex parte and inter partes) in
fiscal year 2010. In view of the statutory mandate to conduct
reexamination proceedings with special dispatch, the Office estimates
that the number of petitions decided in reexamination proceedings in
fiscal year 2010 (i.e., 832) reasonably approximates the number of
petitions filed in reexamination proceedings that year. The Office
estimates that no more than 850 (832 rounded to the nearest 50) will be
filed annually in reexamination proceedings. The data that the Office
keeps regarding petitions filed in reexamination proceedings does not
indicate the number of petitions submitted by unique small entities.
Therefore, for purposes of this analysis, the Office is considering all
850 petitions expected to be submitted annually in a reexamination
proceeding as being submitted by small entities. Hence, the Office
estimates that no more than 850 small entities will file a petition in
a reexamination proceeding annually.
   e. Number of Entities Filing Request for Supplemental Examination.
As discussed previously, the Office estimates that it receives
approximately 110 requests for ex parte reexamination filed by patent
owners annually. In view of the benefits to patent owners afforded by
supplemental examination under 35 U.S.C. 257(c), the Office is
estimating that all 110 requests for ex parte reexamination that would
have been filed annually by patent owners will instead be filed as
requests for supplemental examination. However, the Office is also
estimating that more than 110 requests for supplemental examination
will be filed annually due to a combination of: (1) The benefits to
patent owners afforded by supplemental examination; (2) the fact that
the "information" that may form the basis of a request for
supplemental examination is not limited to patents and printed
publications; and (3) the fact that the issues that may be raised
during supplemental examination may include issues in addition to those
permitted to be raised in ex parte reexamination (e.g., issues under 35
U.S.C. 112).
   Because a main benefit afforded to patent owners by supplemental
examination is to potentially shield patent owners from a finding of
unenforceability due to inequitable conduct for the information
considered by the Office and subject to a written
decision by the Office, the Office estimates that the number of cases
annually in which inequitable conduct is pled in the United States
district courts represents an approximation of the upper limit of the
number of annual requests for supplemental examination that the Office
will receive. Data from the United States district courts reveals that
between 2,900 and 3,301 patent cases were filed each year during the
period between 2006 and 2010. See U.S. Courts, Judicial Business of the
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United States Courts,
www.uscourts.gov/uscourts/Statistics/JudicialBusiness/2010/appendices/
C02ASep10.pdf (last visited Nov. 11, 2011) (hosting annual reports for
1997 through 2010). Thus, the Office projects that no more than 3,300
(the highest number of yearly filings between 2006 and 2010 rounded to
the nearest 100) patent cases are likely to be filed annually. Note that
inequitable conduct is pled in approximately 40 percent of the patent
cases filed annually in U.S. District Courts. See Christian E. Mammen,
Controlling the "Plague": Reforming the Doctrine of Inequitable Conduct,
24 Berkeley Tech. L.J. 1329, 1358-60 (2010) (displaying a chart estimating
the steady increase in assertions of the inequitable conduct defense).
However, the number of patent cases in which a finding of inequitable
conduct is upheld by the U.S. Court of Appeals for the Federal Circuit
(Federal Circuit) is only a fraction of a percent. See id. The Office also
anticipates that the percentage of patent cases in which inequitable
conduct is pled and in which a finding of inequitable conduct is upheld by
the Federal Circuit will begin to decline due to the en banc decision by
the Federal Circuit in Therasense, Inc. v. Becton, Dickinson, and Co., 649
F.3d 1276 (Fed. Cir. 2011).
   The Office also anticipates that supplemental examination will lead
to a reduction in the number of district court patent infringement
cases in which inequitable conduct is pled as a defense. See H.R. Rep.
No. 112-98, Part 1, at pages 50 and 78 (2011) (the information
submitted in a request for supplemental examination cannot later be
used to hold the patent unenforceable or invalid on the basis of
inequitable conduct during civil litigation). The Office understands
that the costs related to inequitable conduct (e.g., discovery related
to inequitable conduct) are a significant portion of litigation costs.
See e.g., Mammen, Controlling the "Plague": Reforming the Doctrine of
Inequitable Conduct, 24 Berkeley Tech. L.J. at 1347.
   Therefore, the Office estimated that it will receive about 1,430
(40 percent of 3,300 plus the 110 requests for ex parte reexamination
filed by patent owners annually as discussed previously) requests for
supplemental examination annually. Assuming that requests for
supplemental examination will be filed by small entities in roughly the
same percentage as requests for ex parte reexamination where a small
entity prosecuted the underlying patent (36 percent), the Office
estimates that about 500 (36 percent of 1,430 (515) rounded to the
nearest 100) requests for supplemental examination will be submitted
annually by small entities.
   5. Description of the projected reporting, recordkeeping, and other
compliance requirements of the rules, including an estimate of the
classes of small entities which will be subject to the requirement and
the type of professional skills necessary for preparation of the report
or record: The rules will apply to any small entity that files a
request for supplemental examination, a request for ex parte
reexamination, or a petition in an ex parte or inter partes
reexamination proceeding. The rules to implement the supplemental
examination provisions of the AIA will impose procedural requirements
on patent owners who request supplemental examination to consider,
reconsider, or correct information believed to be relevant to a patent.
The rules will charge a fee to any patent owner who requests
supplemental examination, and change the fee applicable to any entity
that files a request for ex parte reexamination or a petition in an ex
parte or inter partes reexamination proceeding.
   All papers in a supplemental examination proceeding must be filed
in accordance with the requirements set forth in 37 CFR 1.601 and must
be formatted in accordance with the requirements set forth in 37 CFR
1.615. All "items of information" submitted as part of the request
must meet the requirements of 37 CFR 1.605. The request itself must
include the items set forth in 37 CFR 1.610. The rules to implement the
supplemental examination provisions of the AIA also require: (1) A fee
of $5,140.00 for processing and treating a request for supplemental
examination; (2) a fee of $16,120.00 for an ex parte reexamination
ordered as a result of a supplemental examination proceeding; and (3)
for processing and treating, in a supplemental examination proceeding,
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a non-patent document over 20 pages in length, a fee of $170.00 for a
document of between 21 and 50 pages, and a fee of $280.00 for each
additional 50 pages or a fraction thereof.
   A patent practitioner would have the type of professional skills
necessary for preparation of a request for supplemental examination.
Office staff with experience and expertise in a wide range of patent
prosecution matters as a patent practitioner estimate that preparing
and filing a request for supplemental examination will require about 25
patent practitioner hours, costing $9,275 (25 hours at the $371 per
hour mean rate for attorneys reported in the American Intellectual
Property Law Association (AIPLA) Report of the Economic Survey 2011).
As discussed previously, a request for supplemental examination is
comparable to a request for ex parte reexamination, in that both
present information to the Office for evaluation as to whether the
information raises a substantial new question of patentability. The
AIPLA Report of the Economic Survey 2011 indicates that the average
cost of preparing and filing a request for ex parte reexamination (the
current Office proceeding most similar to a request for supplemental
examination) is $19,000. The Office staff estimate for preparing a
supplemental examination is lower than the comparable ex parte
reexamination cost because a patentee in supplemental examination would
simply be preparing a supplemental examination request in compliance
with the applicable statutes and regulations with information already
at hand, whereas a third party requester in an ex parte reexamination
(the majority of ex parte reexamination requests being by third
parties) is not merely preparing an ex parte reexamination request in
compliance with the applicable statutes and regulations, but is also
seeking to convince the Office that the claims in the patent for which
reexamination is sought are unpatentable with patents and printed
publications that the third party must uncover as part of the process.
The Office estimates $19,000 for the cost to prepare and file a request
for supplemental examination even though many of the requirements
initially proposed have been eliminated in this final rule because the
requirements in this final rule closely track the requirements for ex
parte examination.
   The rules to adjust or set fees in ex parte reexamination are as
follows: (1) $17,750.00 for filing a request for ex parte
reexamination; (2) $1,930.00 for filing a petition in an ex parte or
inter partes reexamination proceeding, except for those specifically
enumerated in 37 CFR 1.550(i) and 1.937(d)); and (3) $4,320.00 for a
denied request for ex parte reexamination under 37 CFR 1.510
(this amount is included in the request for ex parte reexamination fee,
and is the portion not refunded if the request for reexamination is
denied). The rules to adjust the fee for filing a request for ex parte
reexamination, and to set a fee for petitions filed in ex parte and
inter partes reexamination proceedings, do not impose any discernible
reporting, recordkeeping, or other compliance requirements. The rules
to adjust the fee for filing a request for ex parte reexamination, and
to set a fee for petitions filed in ex parte and inter partes
reexamination proceedings, only adjust or establish certain fees (as
discussed previously) to more accurately reflect the cost of the
process or service.
   6. Description of any significant alternatives to the rules which
accomplish the stated objectives of applicable statutes and which
minimize any significant economic impact of the rules on small
entities: This analysis considered significant alternatives such as:
(1) The establishment of differing compliance or reporting requirements
or timetables that take into account the resources available to small
entities; (2) the clarification, consolidation, or simplification of
compliance and reporting requirements under the rule for such small
entities; (3) the use of performance rather than design standards; and
(4) an exemption from coverage of the rule, or any part thereof, for
such small entities. See 5 U.S.C. 603; see also 35 U.S.C. 41(h) (fee
reduction for small business concerns not applicable to fees set under
35 U.S.C. 41(d)(2)).
   With respect to the rules to implement the supplemental examination
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provisions of the AIA, the Office considered requiring less than, or
exempting small entities from, what is currently set forth at 37 CFR
1.601, 1.605, 1.610, and 1.615. As discussed previously, this final
rule adopts content requirements for a request for supplemental
examination that are comparable to the requirements for a request for
ex parte reexamination (e.g., list of each item of information to be
considered, reconsidered, or corrected, an identification of each claim
of the patent for which supplemental examination is requested, and a
separate, detailed explanation of the relevance and manner of applying
each item of information to each claim of the patent for which
supplemental examination is requested). See 37 CFR 1.510.
   One alternative the Office considered was proposed in the NPRM.
Namely, the Office considered, and proposed, to require that a request
for supplemental examination contain: (1) An identification of each
item of information requiring consideration, reconsideration, or
correction, explaining why consideration or reconsideration of the item
of information is being requested or how the item of information is
being corrected; (2) an identification of the structure, material, or
acts in the specification that correspond to each means-plus-function
or step-plus-function element, as set forth in 35 U.S.C. 112(f), in any
claim to be examined; (3) an identification of each issue raised by
each item of information; (4) an explanation of the support in the
specification for each limitation of each claim identified for
examination if an identified issue involves the application of 35
U.S.C. 101 (other than double patenting) or 35 U.S.C. 112; and (5) an
explanation of how each limitation of each claim identified for
examination is met, or is not met, by each item of information if an
identified issue involves the application of 35 U.S.C. 102, 35 U.S.C.
103, or double patenting. These proposed requirements were not included
in this final rule in response to public comments and because the
Office decided to make the requirements for requesting supplemental
examination closely track the requirements for requesting
reexamination.
   The Office adopted the requirements in this final rule because it
is in the patent owner's interest to have the supplemental examination
proceeding, and any reexamination proceeding ordered pursuant to the
supplemental examination request, concluded as soon as possible. See 35
U.S.C. 257(c)(2)(B) (stating that the potential benefits to patent
owners afforded by 35 U.S.C. 257(c)(1) shall not apply "unless the
supplemental examination, and any reexamination ordered pursuant to the
request, are concluded before the date on which [a patent infringement
action] is brought"). The information that may be submitted in a
supplemental examination is more extensive than the information
permitted in an ex parte reexamination proceeding, and the issues that
may be raised during supplemental examination include issues that are
not permitted to be raised in ex parte reexamination (e.g., issues
under 35 U.S.C. 101 and 112). The Office needs to require this
information to promptly resolve a supplemental examination proceeding,
and any reexamination proceeding ordered pursuant to the supplemental
examination request. Finally, it is in the patent owner's interest to
have the supplemental examination request be as complete as possible.
With these factors in mind, the Office designed the requirements set
forth in the final rules to permit: (1) efficient processing and
treatment of each request for supplemental examination within the
statutory three-month time period; and (2) completion of any
reexamination ordered as a result of the supplemental examination
proceeding with special dispatch.
   With respect to the rules to adjust the fee for filing a request
for ex parte reexamination, and to set a fee for petitions filed in
reexamination proceedings, the Office considered the alternative of not
adjusting or setting the fees, which would have reduced the economic
impact on small entities, but this alternative would not accomplish the
stated objectives of applicable statutes. See 35 U.S.C. 41(d)(2)
(provides that fees set by the Office recover the estimated average
cost to the Office of the processing, services, or materials); see also
35 U.S.C. 41(h) (fee reduction for small business concerns not
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applicable to fees set under 35 U.S.C. 41(d)(2)). In addition, a
decision to forego this fee adjustment and fee setting would have a
negative impact on Office funding, which in turn would have a negative
impact on the ability of the Office to meet the statutory mandate to
conduct reexamination proceedings with special dispatch.
   A request for supplemental examination is a unique submission (the
rule does not involve periodic reporting requirements). Thus, the
establishment of timetables that take into account the resources
available to small entities and consolidation of compliance and
reporting requirements is inapplicable. In addition, the use of
performance rather than design standards is also inapplicable to a
request for supplemental examination.
   7. Identification, to the extent practicable, of all relevant
Federal rules which may duplicate, overlap or conflict with the rules:
The Office is the sole agency of the United States Government
responsible for administering the provisions of title 35, United States
Code, pertaining to examination and granting patents. Therefore, no
other Federal, state, or local entity shares jurisdiction over the
examination and granting of patents.
   Other countries, however, have their own patent laws, and an entity
desiring a patent in a particular country must make an application for
patent in that country, in accordance with the applicable law. Although
the potential for overlap exists internationally, this cannot be
avoided except by treaty (such as the Paris Convention for the Protection
of Industrial Property or the Patent Cooperation Treaty (PCT)).
Nevertheless, the Office believes that there are no other duplicative or
overlapping rules.

C. Executive Order 12866 (Regulatory Planning and Review)

   This rulemaking has been determined to be significant for purposes
of Executive Order 12866 (Sept. 30, 1993).

D. Executive Order 13563 (Improving Regulation and Regulatory Review)

   The Office has complied with Executive Order 13563. Specifically,
the Office has, to the extent feasible and applicable: (1) Made a
reasoned determination that the benefits justify the costs of the rule;
(2) tailored the rule to impose the least burden on society consistent
with obtaining the regulatory objectives; (3) selected a regulatory
approach that maximizes net benefits; (4) specified performance
objectives; (5) identified and assessed available alternatives; (6)
involved the public in an open exchange of information and perspectives
among experts in relevant disciplines, affected stakeholders in the
private sector, and the public as a whole, and provided on-line access
to the rulemaking docket; (7) attempted to promote coordination,
simplification, and harmonization across government agencies and
identified goals designed to promote innovation; (8) considered
approaches that reduce burdens and maintain flexibility and freedom of
choice for the public; and (9) ensured the objectivity of scientific
and technological information and processes.

E. Executive Order 13132 (Federalism)

   This rulemaking does not contain policies with federalism
implications sufficient to warrant preparation of a Federalism
Assessment under Executive Order 13132 (Aug. 4, 1999).

F. Executive Order 13175 (Tribal Consultation)

   This rulemaking will not: (1) Have substantial direct effects on
one or more Indian tribes; (2) impose substantial direct compliance
costs on Indian tribal governments; or (3) preempt tribal law.
Therefore, a tribal summary impact statement is not required under
Executive Order 13175 (Nov. 6, 2000).

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G. Executive Order 13211 (Energy Effects)

   This rulemaking is not a significant energy action under Executive
Order 13211 because this rulemaking is not likely to have a significant
adverse effect on the supply, distribution, or use of energy.
Therefore, a Statement of Energy Effects is not required under
Executive Order 13211 (May 18, 2001).

H. Executive Order 12988 (Civil Justice Reform)

   This rulemaking meets applicable standards to minimize litigation,
eliminate ambiguity, and reduce burden as set forth in sections 3(a)
and 3(b)(2) of Executive Order 12988 (Feb. 5, 1996). The rulemaking
carries out a statute designed to lessen litigation. See, e.g., H.R.
Rep. No. 112-98, Part 1, at pages 50 and 78 (2011) (information
submitted in a request for supplemental examination cannot later be
used to hold the patent unenforceable or invalid on the basis of
inequitable conduct during civil litigation).

I. Executive Order 13045 (Protection of Children)

   This rulemaking does not concern an environmental risk to health or
safety that may disproportionately affect children under Executive
Order 13045 (Apr. 21, 1997).

J. Executive Order 12630 (Taking of Private Property)

   This rulemaking will not effect a taking of private property or
otherwise have taking implications under Executive Order 12630 (Mar.
15, 1988).

K. Congressional Review Act

   Under the Congressional Review Act provisions of the Small Business
Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), the
United States Patent and Trademark Office will submit a report
containing this final rule and other required information to the United
States Senate, the United States House of Representatives, and the
Comptroller General of the Government Accountability Office. The
changes in this final rule are not expected to result in an annual
effect on the economy of 100 million dollars or more, a major increase
in costs or prices, or significant adverse effects on competition,
employment, investment, productivity, innovation, or the ability of
United States-based enterprises to compete with foreign-based
enterprises in domestic and export markets. Therefore, this final rule
is not a "major rule" as defined in 5 U.S.C. 804(2).

L. Unfunded Mandates Reform Act of 1995

   The changes set forth in this final rule do not involve a Federal
intergovernmental mandate that will result in the expenditure by State,
local, and tribal governments, in the aggregate, of 100 million dollars
(as adjusted) or more in any one year, or a Federal private sector
mandate that will result in the expenditure by the private sector of
100 million dollars (as adjusted) or more in any one year, and will not
significantly or uniquely affect small governments. Therefore, no
actions are necessary under the provisions of the Unfunded Mandates
Reform Act of 1995. See 2 U.S.C. 1501 et seq.

M. National Environmental Policy Act

   This rulemaking will not have any effect on the quality of the
environment and is thus categorically excluded from review under the
National Environmental Policy Act of 1969. See 42 U.S.C. 4321 et seq.

N. National Technology Transfer and Advancement Act
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   The requirements of section 12(d) of the National Technology
Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) are not
applicable because this rulemaking does not contain provisions which
involve the use of technical standards.

O. Paperwork Reduction Act

   The Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.)
requires that the USPTO consider the impact of paperwork and other
information collection burdens imposed on the public. This final rule
makes changes to the rules of practice that would impose new
information collection requirements and impact existing information
collection requirements previously approved by the Office of Management
and Budget (OMB) under OMB Control Number 0651-0064. Accordingly, the
Office submitted a proposed revision to the information collection
requirements under 0651-0064 to OMB for its review and approval when
the notice of proposed rulemaking was published. The Office also
published the title, description, and respondent description of the
information collection, with an estimate of the annual reporting
burdens, in the notice of proposed rulemaking (See Changes to Implement
the Supplemental Examination Provisions of the Leahy-Smith America
Invents Act and to Revise Reexamination Fees, 77 FR at 3678). The
Office did not receive any comments on the proposed revision to the
information collection requirements under 0651-0064.
   As discussed previously, however, this final rule adopts content
requirements for a request for supplemental examination that are
comparable to the requirements for a request for ex parte reexamination
(e.g., list of each item of information to be considered, reconsidered,
or corrected, an identification of each claim of the patent for which
supplemental examination is requested, and a separate, detailed
explanation of the relevance and manner of applying each item of
information to each claim of the patent for which supplemental
examination is requested). See 37 CFR 1.510. Thus, this final rule does
not adopt the proposed requirements that a request for supplemental
examination contain: (1) An identification of each item of information
requiring consideration, reconsideration, or correction, explaining why
consideration or reconsideration of the item of information is being
requested or how the item of information is being corrected; (2) an
identification of the structure, material, or acts in the specification
that correspond to each means-plus-function or step-plus-function
element, as set forth in 35 U.S.C. 112(f), in any claim to be examined;
(3) an identification of each issue raised by each item of information;
(4) an explanation of the support in the specification for each
limitation of each claim identified for examination if an identified
issue involves the application of 35 U.S.C. 101 (other than double
patenting) or 35 U.S.C. 112; and (5) an explanation of how each
limitation of each claim identified for examination is met, or is not
met, by each item of information if an identified issue involves the
application of 35 U.S.C. 102, 35 U.S.C. 103, or double patenting. This
final rule also adopts a fee for a request for supplemental examination
that is $40 less than the proposed fee.
   The Office has resubmitted the proposed revision to the information
collection requirements under 0651-0064 to OMB. The proposed revision
to the information collection requirements under 0651-0064 is available
at the OMB's Information Collection Review Web site
(www.reginfo.gov/public/do/PRAMain).
   Notwithstanding any other provision of law, no person is required
to respond to, nor shall a person be subject to a penalty for failure
to comply with, a collection of information subject to the requirements
of the Paperwork Reduction Act, unless that collection of information
displays a currently valid OMB control number.

List of Subjects in 37 CFR Part 1

   Administrative practice and procedure, Courts, Freedom of
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information, Inventions and patents, Reporting and recordkeeping
requirements, Small businesses.

   For the reasons set forth in the preamble, 37 CFR part 1 is amended
as follows:

PART 1--RULES OF PRACTICE IN PATENT CASES

.  1. The authority citation for 37 CFR part 1 continues to read as
follows:

   Authority:  35 U.S.C. 2(b)(2).

.  2. Section 1.20 is amended by revising paragraph (c)(1) and by adding
paragraphs (c)(6), (c)(7), and (k) to read as follows:


§ 1.20  Post issuance fees.

* * * * *
   (c) * * *

(1) For filing a request for ex parte reexamination              $17,750.00
(§ 1.510(a))


* * * * *

(6) For filing a petition in a reexamination proceeding,          $1,930.00
 except for those specifically enumerated in
 §§ 1.550(i) and 1.937(d)

(7) For a denied request for ex parte reexamination under         $4,320.00
 § 1.510 (included in the request for ex parte
 reexamination fee)


* * * * *
   (k) In supplemental examination proceedings:

(1) For processing and treating a request for supplemental        $5,140.00
 examination

(2) For ex parte reexamination ordered as a result of a          $16,120.00
 supplemental examination proceeding

(3) For processing and treating, in a supplemental
 examination proceeding, a non-patent document over 20
 pages in length, per document:
  (i) Between 21 and 50 pages                                       $170.00
  (ii) For each additional 50 pages or a fraction thereof,          $280.00
   in addition to the fee specified in paragraph (k)(3)(i)
   of this section


.  3. Section 1.26 is amended by revising paragraph (c) to read as follows:


§ 1.26  Refunds.

* * * * *
   (c) If the Director decides not to institute a reexamination
proceeding in response to a request for reexamination or supplemental
examination, fees paid with the request for reexamination or
supplemental examination will be refunded or returned in accordance
with paragraphs (c)(1) through (c)(3) of this section. The
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reexamination requester or the patent owner who requested a
supplemental examination proceeding, as appropriate, should indicate
the form in which any refund should be made (e.g., by check, electronic
funds transfer, credit to a deposit account). Generally, refunds will
be issued in the form that the original payment was provided.
   (1) For an ex parte reexamination request, the ex parte
reexamination filing fee paid by the reexamination requester, less the
fee set forth in § 1.20(c)(7), will be refunded to the requester if
the Director decides not to institute an ex parte reexamination
proceeding.
   (2) For an inter partes reexamination request, a refund of $7,970
will be made to the reexamination requester if the Director decides not
to institute an inter partes reexamination proceeding.
   (3) For a supplemental examination request, the fee for
reexamination ordered as a result of supplemental examination, as set
forth in § 1.20(k)(2), will be returned to the patent owner who
requested the supplemental examination proceeding if the Director
decides not to institute a reexamination proceeding.


.  4. Section 1.550 is amended by adding a new paragraph (i) to read as
follows:


§ 1.550  Conduct of ex parte reexamination proceedings.

* * * * *
   (i) A petition in an ex parte reexamination proceeding must be
accompanied by the fee set forth in § 1.20(c)(6), except for
petitions under paragraph (c) of this section to extend the period for
response by a patent owner, petitions under paragraph (e) of this
section to accept a delayed response by a patent owner, petitions under
§ 1.78 to accept an unintentionally delayed benefit claim, and
petitions under § 1.530(l) for correction of inventorship in a
reexamination proceeding.

.  5. Subpart E, consisting of §§ 1.601, 1.605, 1.610, 1.615, 1.620, and
1.625, is added to Part 1 to read as follows:

Subpart E - Supplemental Examination of Patents

Sec.
1.601 Filing of papers in supplemental examination.
1.605 Items of information.
1.610 Content of request for supplemental examination.
1.615 Format of papers filed in a supplemental examination
proceeding.
1.620 Conduct of supplemental examination proceeding.
1.625 Conclusion of supplemental examination; publication of
supplemental examination certificate; procedure after conclusion.

Subpart E - Supplemental Examination of Patents


§ 1.601  Filing of papers in supplemental examination.

   (a) A request for supplemental examination of a patent must be
filed by the owner(s) of the entire right, title, and interest in the
patent.
   (b) Any party other than the patent owner (i.e., any third party)
is prohibited from filing papers or otherwise participating in any
manner in a supplemental examination proceeding.
   (c) A request for supplemental examination of a patent may be filed
at any time during the period of enforceability of the patent.


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§ 1.605  Items of information.

   (a) Each request for supplemental examination may include no more
than twelve items of information believed to be relevant to the patent.
More than one request for supplemental examination of the same patent
may be filed at any time during the period of enforceability of the
patent.
   (b) An item of information includes a document submitted as part of
the request that contains information, believed to be relevant to the
patent, that the patent owner requests the Office to consider,
reconsider, or correct. If the information to be considered,
reconsidered, or corrected is not, at least in part, contained within
or based on any document submitted as part of the request, the
discussion within the body of the request relative to the information
will be considered as an item of information.
   (c) An item of information must be in writing in accordance with
§ 1.2. To be considered, any audio or video recording must be
submitted in the form of a written transcript.
   (d) If one item of information is combined in the request with one
or more additional items of information, each item of information of
the combination may be separately counted. Exceptions include the
combination of a non-English language document and its translation, and
the combination of a document that is over 50 pages in length and its
summary pursuant to § 1.610(b)(8).


§ 1.610  Content of request for supplemental examination.

   (a) A request for supplemental examination must be accompanied by
the fee for filing a request for supplemental examination as set forth
in § 1.20(k)(1), the fee for reexamination ordered as a result of a
supplemental examination proceeding as set forth in § 1.20(k)(2),
and any applicable document size fees as set forth in § 1.20(k)(3).
   (b) A request for supplemental examination must include:
   (1) An identification of the number of the patent for which
supplemental examination is requested.
   (2) A list of the items of information that are requested to be
considered, reconsidered, or corrected. Where appropriate, the list
must meet the requirements of § 1.98(b).
   (3) A list identifying any other prior or concurrent post-patent
Office proceedings involving the patent for which supplemental
examination is being requested, including an identification of the type
of proceeding, the identifying number of any such proceeding (e.g., a
control number or reissue application number), and the filing date of
any such proceeding.
   (4) An identification of each claim of the patent for which
supplemental examination is requested.
   (5) A separate, detailed explanation of the relevance and manner of
applying each item of information to each claim of the patent for which
supplemental examination is requested.
   (6) A copy of the patent for which supplemental examination is
requested and a copy of any disclaimer or certificate issued for the
patent.
   (7) A copy of each item of information listed in paragraph (b)(2)
of this section, accompanied by a written English translation of all of
the necessary and pertinent parts of any non-English language item of
information. The patent owner is not required to submit copies of items
of information that form part of the discussion within the body of the
request as specified in § 1.605(b), or copies of U.S. patents and
U.S. patent application publications.
   (8) A summary of the relevant portions of any submitted document,
other than the request, that is over 50 pages in length. The summary
must include citations to the particular pages containing the relevant
portions.
   (9) An identification of the owner(s) of the entire right, title,
and interest in the patent requested to be examined, and a submission
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by the patent owner in compliance with § 3.73(c) of this chapter
establishing the entirety of the ownership in the patent requested to
be examined.
   (c) The request may also include:
   (1) A cover sheet itemizing each component submitted as part of the
request;
   (2) A table of contents for the request;
   (3) An explanation of how the claims patentably distinguish over
the items of information; and
   (4) An explanation of why each item of information submitted with
the request does or does not raise a substantial new question of
patentability.
   (d) The filing date of a request for supplemental examination will
not be granted if the request is not in compliance with §§ 1.605, 1.615,
and this section, subject to the discretion of the
Office. If the Office determines that the request, as originally
submitted, is not entitled to a filing date, the patent owner will be
so notified and will be given an opportunity to complete the request
within a specified time. If the patent owner does not timely comply
with the notice, the request for supplemental examination will not be
granted a filing date and the fee for reexamination as set forth in
§ 1.20(k)(2) will be refunded. If the patent owner timely files a
corrected request in response to the notice that properly addresses all
of the defects set forth in the notice and that otherwise complies with
all of the requirements of §§ 1.605, 1.615, and this section,
the filing date of the supplemental examination request will be the
receipt date of the corrected request.


§ 1.615  Format of papers filed in a supplemental examination
proceeding.

   (a) All papers submitted in a supplemental examination proceeding
must be formatted in accordance with § 1.52.
   (b) Court documents and non-patent literature may be redacted, but
must otherwise be identical both in content and in format to the
original documents, and, if a court document, to the document submitted
in court, and must not otherwise be reduced in size or modified,
particularly in terms of font type, font size, line spacing, and
margins. Patents, patent application publications, and third-party-
generated affidavits or declarations must not be reduced in size or
otherwise modified in the manner described in this paragraph.


§ 1.620  Conduct of supplemental examination proceeding.

   (a) Within three months after the filing date of a request for
supplemental examination, the Office will determine whether a
substantial new question of patentability affecting any claim of the
patent is raised by any of the items of information presented in the
request. The determination will generally be limited to a review of the
item(s) of information identified in the request as applied to the
identified claim(s) of the patent. The determination will be based on
the claims in effect at the time of thedetermination and will become a
part of the official record of the patent.
   (b) The Office may hold in abeyance action on any petition or other
paper filed in a supplemental examination proceeding until after the
proceeding is concluded by the electronic issuance of the supplemental
examination certificate as set forth in § 1.625.
   (c) If an unauthorized or otherwise improper paper is filed in a
supplemental examination proceeding, it will not be entered into the
official file or considered, or if inadvertently entered, it will be
expunged.
   (d) The patent owner must, as soon as possible upon the discovery
of any other prior or concurrent post-patent Office proceeding
involving the patent for which the current supplemental examination is
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requested, file a paper limited to notifying the Office of the post-
patent Office proceeding, if such notice has not been previously
provided with the request. The notice shall be limited to an
identification of the post-patent Office proceeding, including the type
of proceeding, the identifying number of any such proceeding (e.g., a
control number or reissue application number), and the filing date of
any such proceeding, without any discussion of the issues of the
current supplemental examination proceeding or of the identified post-
patent Office proceeding(s).
   (e) Interviews are prohibited in a supplemental examination
proceeding.
   (f) No amendment may be filed in a supplemental examination
proceeding.
   (g) If the Office becomes aware, during the course of supplemental
examination or of any reexamination ordered under 35 U.S.C. 257 as a
result of the supplemental examination proceeding, that a material
fraud on the Office may have been committed in connection with the
patent requested to be examined, the supplemental examination
proceeding or any reexamination proceeding ordered under 35 U.S.C. 257
will continue, and the matter will be referred to the U.S. Attorney
General in accordance with 35 U.S.C. 257(e).


§ 1.625  Conclusion of supplemental examination; publication of
supplemental examination certificate; procedure after conclusion.

   (a) A supplemental examination proceeding will conclude with the
electronic issuance of a supplemental examination certificate. The
supplemental examination certificate will indicate the result of the
determination whether any of the items of information presented in the
request raised a substantial new question of patentability.
   (b) If the supplemental examination certificate states that a
substantial new question of patentability is raised by one or more
items of information in the request, ex parte reexamination of the
patent will be ordered under 35 U.S.C. 257. Upon the conclusion of the
ex parte reexamination proceeding, an ex parte reexamination
certificate, which will include a statement specifying that ex parte
reexamination was ordered under 35 U.S.C. 257, will be published. The
electronically issued supplemental examination certificate will remain
as part of the public record of the patent.
   (c) If the supplemental examination certificate indicates that no
substantial new question of patentability is raised by any of the items
of information in the request, and ex parte reexamination is not
ordered under 35 U.S.C. 257, the electronically issued supplemental
examination certificate will be published in due course. The fee for
reexamination ordered as a result of supplemental examination, as set
forth in § 1.20(k)(2), will be refunded in accordance with § 1.26(c).
   (d) Any ex parte reexamination ordered under 35 U.S.C. 257 will be
conducted in accordance with §§ 1.530 through 1.570, which
govern ex parte reexamination, except that:
   (1) The patent owner will not have the right to file a statement
pursuant to § 1.530, and the order will not set a time period
within which to file such a statement;
   (2) Reexamination of any claim of the patent may be conducted on
the basis of any item of information as set forth in § 1.605, and
is not limited to patents and printed publications or to subject matter
that has been added or deleted during the reexamination proceeding,
notwithstanding § 1.552(a);
   (3) Issues in addition to those raised by patents and printed
publications, and by subject matter added or deleted during a
reexamination proceeding, may be considered and resolved,
notwithstanding § 1.552(c); and
   (4) Information material to patentability will be defined by § 1.56(b),
notwithstanding § 1.555(b).

.  6. Section 1.937 is amended by adding a new paragraph (d) to read as
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follows:


§ 1.937  Conduct of inter partes reexamination.

* * * * *
   (d) A petition in an inter partes reexamination proceeding must be
accompanied by the fee set forth in § 1.20(c)(6), except for
petitions under § 1.956 to extend the period for response by a
patent owner, petitions under § 1.958 to accept a delayed response
by a patent owner, petitions under § 1.78 to accept an
unintentionally delayed benefit claim, and petitions under § 1.530(l)
for correction of inventorship in a reexamination proceeding.

July 17, 2012                                               DAVID J. KAPPOS
                  Under Secretary of Commerce for Intellectual Property and
                  Director of the United States Patent and Trademark Office

                                [1382 OG 206]