[Federal Register Volume 77, Number 157 (Tuesday, August 14, 2012)]
[Rules and Regulations]
[Pages 48827-48853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-17917]



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Vol. 77

Tuesday,

No. 157

August 14, 2012

Part VII





Department of Commerce





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Patent and Trademark Office





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37 CFR Part 1





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

Federal Register / Vol. 77 , No. 157 / Tuesday, August 14, 2012 / 
Rules and Regulations

[[Page 48828]]


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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.

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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 
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

[[Page 48829]]

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 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 
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

[[Page 48830]]

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.
    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 
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

[[Page 48831]]

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 
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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 
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

[[Page 48832]]

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, Sec.  1.20(c)(1) is 
amended to set a fee of $17,750 for filing a request for ex parte 
reexamination under Sec.  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 Sec.  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 Sec. Sec.  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 Sec. Sec.  1.550(i) and 
1.937(d)), including petitions under Sec. Sec.  1.59, 1.181, 1.182, and 
1.183. The petitions enumerated in Sec. Sec.  1.550(i) and 1.937(d) are 
petitions under Sec. Sec.  1.550(c) and 1.956 to extend the period for 
response by a patent owner, petitions under Sec. Sec.  1.550(e) and 
1.958 to accept a delayed response by a patent owner, petitions under 
Sec.  1.78 to accept an unintentionally delayed benefit claim, and 
petitions under Sec.  1.530(l) for correction of inventorship in ex 
parte or inter partes reexamination proceedings. The petitions 
enumerated in Sec. Sec.  1.550(i) and 1.937(d), however, remain subject 
to any applicable fees other than the fee set forth in Sec.  
1.20(c)(6), including the fees required by the appropriate rule 
governing each petition.
    The Office is also adding new Sec.  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 Sec.  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 
request paid by the reexamination requester, less the fee set forth in 
Sec.  1.20(c)(7), will be refunded to the reexamination requester. If 
the Director decides not to institute an ex parte reexamination 
proceeding under Sec.  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 Sec.  
1.20(k)(2), will be made to the patent owner who requested the 
supplemental examination proceeding. The provision in Sec.  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 Sec.  1.20(c)(6), except for petitions under Sec.  
1.550(c) to extend the period for response by a patent owner, petitions 
under Sec.  1.550(e) to accept a delayed response by a patent owner, 
petitions under Sec.  1.78 to accept an unintentionally delayed benefit 
claim, and petitions under Sec.  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 Sec. Sec.  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 Sec. Sec.  
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 
Sec.  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 Sec.  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 Sec.  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

[[Page 48833]]

the period of enforceability of the patent. This time period is being 
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 Sec. Sec.  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 Sec.  1.510(a) and MPEP Sec.  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 
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 Sec.  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 
Sec.  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

[[Page 48834]]

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, Sec.  1.610(a) requires that the request be 
accompanied by the fee for filing a request for supplemental 
examination as set forth in Sec.  1.20(k)(1), the fee for ex parte 
reexamination ordered as a result of a supplemental examination 
proceeding as set forth in Sec.  1.20(k)(2), and any applicable 
document size fees as set forth in Sec.  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 
Sec.  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 
Sec.  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 Sec.  1.610(b)(2), accompanied by a 
written English translation of all of the necessary and pertinent parts 
of any non-English language document. Items of information that form 
part of the discussion within the body of the request as specified in 
Sec.  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 Sec.  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 Sec.  3.73(c) establishing the entirety of the 
ownership in the patent requested to be examined. As discussed 
previously, Sec.  1.601(a) requires that a request for supplemental 
examination of a patent must be filed by the owner(s) of the entire 
right.

[[Page 48835]]

    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 Sec. Sec.  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 Sec.  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 Sec. Sec.  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 Sec.  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, 
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 Sec.  
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 Sec.  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 
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 Sec.  1.620(c).

[[Page 48836]]

    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., Sec.  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 Sec.  
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 
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 Sec.  1.20(k)(2), 
will be refunded in accordance with Sec.  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 Sec. Sec.  
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 Sec.  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 Sec.  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 Sec.  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 Sec.  1.552(c); and (4) information 
material to patentability will be defined by Sec.  1.56(b) for the 
purposes of a supplemental examination proceeding and any resulting ex 
parte reexamination proceeding. The material to patentability standard 
(Sec.  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 (Sec.  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 Sec.  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 Sec.  1.20(c)(6), except for petitions under Sec.  
1.956 to extend the period for response by a patent owner, petitions 
under Sec.  1.958 to accept a delayed response by a patent owner, 
petitions under Sec.  1.78 to accept an unintentionally delayed benefit 
claim, and petitions under Sec.  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 
organizations, industry, law firms, individual patent

[[Page 48837]]

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 
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

[[Page 48838]]

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. 
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 Sec.  
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 Sec. Sec.  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 
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

[[Page 48839]]

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

    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 Sec.  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 
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,

[[Page 48840]]

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 
Sec.  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 
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 Sec.  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 Sec.  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 
Sec. Sec.  3.71 and 3.73, and MPEP Sec.  324 for establishing an 
assignee's right to take action when submitting a power of attorney. 
See MPEP Sec.  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 Sec.  1.183 requesting waiver of the 
provisions of Sec. Sec.  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 
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 Sec.  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 Sec.  1.32, or in a representative 
capacity under Sec.  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 Sec.  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

[[Page 48841]]

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 Sec.  3.73(c) establishing the 
entirety of the ownership in the patent requested to be examined. See 
Sec.  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 
patent owner to describe, in the request, how the claims distinguish 
over the cited prior art patents and printed publications (see MPEP 
Sec.  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 Sec.  1.610 discusses how 
the claims may be distinguished over the items of information submitted 
as part of the request. Furthermore, Sec.  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 
Sec.  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 Sec.  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 Sec.  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.
    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

[[Page 48842]]

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 Sec.  
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 Sec.  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 Sec. Sec.  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 
examination is requested. See Sec.  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 
Sec.  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 Sec. Sec.  1.605, 1.610, and 
1.615. The Office, however, has the discretion under Sec.  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

[[Page 48843]]

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. 
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), 
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.''

[[Page 48844]]

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 Sec.  1.601(b). If a third 
party files any petition or other paper in a supplemental examination 
proceeding, it will not be entered into the official file or 
considered. If such papers are inadvertently entered, they will be 
expunged. See Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  1.321(a) prior to 
filing any request for supplemental examination. See MPEP Sec.  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 Sec.  
1.570) since 35 U.S.C. 257(b) requires that any resulting reexamination 
be conducted according to procedures established for ex parte 
reexamination.

[[Page 48845]]

    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 Sec.  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 Sec.  
1.601(b). Accordingly, third parties are on notice that they have no 
participatory rights in a supplemental examination proceeding. 
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, Sec.  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 
Sec.  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 Sec.  
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 Sec.  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 
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

[[Page 48846]]

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.
    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 
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

[[Page 48847]]

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 
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

[[Page 48848]]

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 
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, 
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

[[Page 48849]]

(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 
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 
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

[[Page 48850]]

(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).

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

    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.,

[[Page 48851]]

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 
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

0
1. The authority citation for 37 CFR part 1 continues to read as 
follows:

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


0
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:


Sec.  1.20  Post issuance fees.

* * * * *
    (c) * * *

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

* * * * *

(6) For filing a petition in a reexamination proceeding,       $1,930.00
 except for those specifically enumerated in Sec.  Sec.
 1.550(i) and 1.937(d).....................................
(7) For a denied request for ex parte reexamination under      $4,320.00
 Sec.   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.........................................
 


0
3. Section 1.26 is amended by revising paragraph (c) to read as 
follows:


Sec.  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 
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 Sec.  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 Sec.  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.

0
4. Section 1.550 is amended by adding a new paragraph (i) to read as 
follows:


Sec.  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 Sec.  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 
Sec.  1.78 to accept an unintentionally delayed benefit claim, and 
petitions under Sec.  1.530(l) for correction of inventorship in a 
reexamination proceeding.

0
5. Subpart E, consisting of Sec. Sec.  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.

[[Page 48852]]

Subpart E--Supplemental Examination of Patents


Sec.  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.


Sec.  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 
Sec.  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 Sec.  1.610(b)(8).


Sec.  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 Sec.  1.20(k)(1), the fee for reexamination ordered as a result of a 
supplemental examination proceeding as set forth in Sec.  1.20(k)(2), 
and any applicable document size fees as set forth in Sec.  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 Sec.  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 Sec.  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 
by the patent owner in compliance with Sec.  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 Sec. Sec.  
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 
Sec.  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 Sec. Sec.  1.605, 1.615, and this section, 
the filing date of the supplemental examination request will be the 
receipt date of the corrected request.


Sec.  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 Sec.  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.


Sec.  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 the

[[Page 48853]]

determination 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 Sec.  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 
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).


Sec.  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 Sec.  1.20(k)(2), will be refunded in accordance with Sec.  
1.26(c).
    (d) Any ex parte reexamination ordered under 35 U.S.C. 257 will be 
conducted in accordance with Sec. Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  1.552(c); and
    (4) Information material to patentability will be defined by Sec.  
1.56(b), notwithstanding Sec.  1.555(b).

0
6. Section 1.937 is amended by adding a new paragraph (d) to read as 
follows:


Sec.  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 Sec.  1.20(c)(6), except for 
petitions under Sec.  1.956 to extend the period for response by a 
patent owner, petitions under Sec.  1.958 to accept a delayed response 
by a patent owner, petitions under Sec.  1.78 to accept an 
unintentionally delayed benefit claim, and petitions under Sec.  
1.530(l) for correction of inventorship in a reexamination proceeding.

    Dated: July 17, 2012.
David J. Kappos,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2012-17917 Filed 8-13-12; 8:45 am]
BILLING CODE 3510-16-P