[Federal Register Volume 77, Number 16 (Wednesday, January 25, 2012)]
[Proposed Rules]
[Pages 3666-3681]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1480]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF COMMERCE

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: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: The United States Patent and Trademark Office (Office) is 
proposing to amend the rules of practice in patent cases to implement 
the supplemental examination provisions of the Leahy-Smith America 
Invents Act. 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 proposing 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 
to more accurately reflect the cost of these processes.

DATES: Written comments must be received on or before March 26, 2012.

ADDRESSES: Comments should be sent by electronic mail message over the 
Internet addressed to: supplemental_examination@uspto.gov. Comments 
may also be submitted by postal mail addressed to: Mail Stop Comments--
Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-
1450, marked to the attention of Cynthia L. Nessler, Senior Legal 
Advisor, Office of Patent Legal Administration, Office of the Associate 
Commissioner for Patent Examination Policy.
    Comments may also be sent by electronic mail message over the 
Internet via the Federal eRulemaking Portal. See the Federal 
eRulemaking Portal Web site (http://www.regulations.gov) for additional 
instructions on providing comments via the Federal eRulemaking Portal.
    Although comments may be submitted by postal mail, the Office 
prefers to receive comments by electronic mail message over the 
Internet because sharing comments with the public is more easily 
accomplished. Electronic comments are preferred to be submitted in 
plain text, but also may be submitted in ADOBE[reg] portable document 
format or MICROSOFT WORD[reg] format. Comments not submitted 
electronically should be submitted on paper in a format that 
facilitates convenient digital scanning into ADOBE[reg] portable 
document format.
    The comments will be available for public inspection at the Office 
of the Commissioner for Patents, currently located in Madison East, 
Tenth Floor, 600 Dulany Street, Alexandria, Virginia. Comments also 
will be available for viewing via the Office's Internet Web site 
(http://www.uspto.gov). Because comments will be made available for 
public inspection, information that the submitter does not desire to 
make public, such as an address or phone number, should not be included 
in the comments.

FOR FURTHER INFORMATION CONTACT: Cynthia L. Nessler, Senior Legal 
Advisor ((571) 272-7724), Kenneth M. Schor, Senior Legal Advisor ((571) 
272-7710), or Pinchus M. Laufer, Senior Legal Advisor ((571) 272-7726), 
Office of Patent Legal Administration, Office of the Associate 
Commissioner for Patent Examination Policy.

SUPPLEMENTARY INFORMATION: The Leahy-Smith America Invents Act was 
enacted into law on September 16, 2011. See Public Law 112-29, 125 
Stat. 284 (2011). The Office is proposing to amend the rules of 
practice in title 37 of the Code of Federal Regulation (CFR) to 
implement the supplemental examination provisions of section 12 of the 
Leahy-Smith America Invents Act. 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 proposing to set certain 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.
    Section 12 of the Leahy-Smith America Invents Act 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 certificate will indicate 
that ex parte reexamination has been 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) 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

[[Page 3667]]

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 supplemental examination or of any ex parte 
reexamination ordered under 35 U.S.C. 257, of a material fraud on the 
Office involving the patent requested to be examined, 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 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 Leahy-Smith America Invents Act also indicates, 
as discussed previously, 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 Leahy-Smith America Invents Act 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 or 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).
    To implement the supplemental examination provisions of the Leahy-
Smith America Invents Act, the Office is proposing to amend the rules 
of practice in patent cases as set forth herein. A request for 
supplemental examination of a patent must be filed by the patent owner. 
Each request for supplemental examination is limited to the 
presentation of ten items of information. Supplemental examination 
addresses allegations of inequitable conduct during patent litigation, 
which allegations typically concern far fewer than ten items of 
information. In addition, if a limit of ten items of information is not 
sufficient for a particular situation, more than one request for 
supplemental examination of the same patent may be filed at any time. 
The request for supplemental examination must be accompanied by the 
fees for processing and treating an ex parte reexamination ordered 
under 35 U.S.C. 257, as well as any applicable document size fees. The 
request for supplemental examination must meet certain content 
requirements. Specifically, the request for supplemental examination 
must include an identification of the patent for which supplemental 
examination is requested; a list of each item of information and its 
publication date, if applicable; a list identifying any other prior or 
concurrent post patent Office proceedings involving the patent to be 
examined; an identification of each aspect of the patent to be 
examined; an identification of each issue raised by each item of 
information; a separate, detailed explanation for each identified 
issue; an explanation of how each item of information is relevant to 
each aspect of the patent to be examined and of how each item of 
information raises each identified issue; a copy of each item of 
information; and a summary of the relevant portions of any submitted 
document, other than the request, that is over 50 pages in length. A 
request for supplemental examination that does not comply with the 
content requirements may not be granted a filing date. 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.
    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 the items of information presented and identified 
in the request. The supplemental examination certificate will state the 
result of this determination. 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 as an attachment to the patent. The electronically issued 
supplemental examination certificate will also remain as part of the 
public record for the patent. If the supplemental examination 
certificate states that no substantial new question of patentability 
was found, and ex parte reexamination will not be ordered, then the 
electronically issued supplemental examination certificate will be 
published in due course as an attachment to the patent.
    The Office must make its determination whether the items of 
information presented in the request raise a substantial new question 
of patentability within three months of the filing date of the 
supplemental examination 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 patent. See 35

[[Page 3668]]

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. The information permitted in a 
supplemental examination is anticipated to be more resource-intensive 
than patents and printed publications to process, review, and treat, 
because the patent owner may present, in supplemental examination, an 
item of information that raises multiple issues in addition to those 
permitted to be raised in ex parte reexamination. For example, the 
patent owner may present one item of information that raises multiple 
issues of patentability, including issues under 35 U.S.C. 101 and 
issues under 35 U.S.C. 112 with respect to the original disclosure. For 
these reasons, the requirements set forth in the proposed rules 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.

Discussion of Specific Rules

    The following is a discussion of proposed amendments to Title 37 of 
the Code of Federal Regulations, Part 1.
    Section 1.20: The Office is proposing to amend Sec.  1.20 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]'').
    Section 10(a) of the Leahy-Smith America Invents Act provides that 
the Office 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 Public Law 112-29, 125 Stat. 283, 
316 (2011).
    Sections 10(d) and (e) of the Leahy-Smith America Invents Act 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 Public 
Law 112-29, 125 Stat. at 317-18. This process does 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 Leahy-Smith 
America Invents Act). Therefore, the Office is setting these fees 
pursuant to its authority under 35 U.S.C. 41(d)(2) in this rulemaking, 
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 such 
processing, services, or materials. 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 proposed fee 
amounts will be convenient to patent users.
    The Office is also in the process of developing a proposal to 
adjust patent fees under section 10 of the Leahy-Smith America Invents 
Act. The supplemental examination and ex parte and inter partes 
reexamination fees proposed in this notice will be revisited in 
furtherance of the Director's fee-setting efforts in this area.
    The Office has estimated its fiscal year 2013 cost for processing 
and treating a request for supplemental examination to be $5,180, and 
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 proposing to add a new Sec.  1.20(k)(1) to 
provide a fee of $5,180 for processing and treating a request for 
supplemental examination, and a new Sec.  1.20(k)(2) to provide a fee 
of $16,120 for conducting ex parte reexamination ordered as a result of 
a supplemental examination proceeding (the 2013 cost amounts 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. 
See Sec.  1.26(c).
    The Office has also estimated its fiscal year 2013 cost for 
processing and treating documents over 20 sheets in length that are 
submitted in a supplemental examination proceeding to be $166 for each 
document between 21 and 50 sheets in length, and $282 for each 
additional 50-sheet increment or a fraction thereof. Therefore, the 
Office is also proposing to add a new Sec.  1.20(k)(3) to provide 
document size fees for any documents over 20 sheets in length that are 
submitted in a supplemental examination proceeding, including (1) a fee 
of $170 for each document between 21 and 50 sheets in length; and (2) a 
fee of $280 for each additional 50-sheet increment or a fraction 
thereof (the 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. 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 analysis of the Office's ex parte and inter partes 
reexamination costs also 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. Thus, the Office is 
proposing to set fees for supplemental examination and resulting ex 
parte reexamination proceedings, adjust the fee for ex parte 
reexamination proceedings, and set 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 
$17,753. Therefore, the Office is proposing to amend Sec.  1.20(c)(1) 
to change the fee for filing a request for ex parte reexamination 
(Sec.  1.510(a)) from $2,520 to $17,750 (the 2013 cost amounts rounded 
to the nearest ten dollars).
    The Office is also proposing to add a new Sec.  1.20(c)(6) to 
provide a fee of $1,930 for filing a petition in an ex parte

[[Page 3669]]

or inter partes reexamination proceeding, except for those specifically 
enumerated in Sec. Sec.  1.550(i) and 1.937(d) (the 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 is $1,932. The proposed 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 proposed fee for treating a petition in an ex parte or inter 
partes reexamination proceeding will not apply to petitions 
specifically enumerated in Sec. Sec.  1.550(i) and 1.937(d). 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 Office is also proposing to add a new Sec.  1.20(c)(7) to 
provide a fee of $4,320 for a refused 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 
refusing 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 proposing changes to the inter partes 
reexamination filing fee as the Office cannot 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 proposed to be amended to provide 
that if the Director decides not to institute an ex parte reexamination 
proceeding (a refused 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 ex parte 
reexamination fee ($16,120) for supplemental examination, as set forth 
in Sec.  1.20(k)(2), will be made to the patent owner who requested the 
supplemental examination proceeding. The provision 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 refusal to 
institute an inter partes reexamination. 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 proposed to be 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(a) is proposed 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. 
Section 1.601(b) is proposed to require that the patent owner must 
establish an ownership interest in the patent as set forth in Sec.  
1.601(a) by filing, as part of the request, a submission in accordance 
with Sec.  3.73(b).
    Section 1.601(c) is proposed to prohibit third parties from filing 
papers or otherwise participating in any manner in a supplemental 
examination proceeding. Section 12 of the Leahy-Smith America Invents 
Act 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 the patent owner filed the 
request, 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 1.605: Section 1.605(a) is proposed to require that each 
request for supplemental examination may request that the Office 
consider, reconsider, or correct no more than ten 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 is 
limited to ten (10). 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) is also proposed to permit the filing of 
more than one request for supplemental examination of the same patent 
at any time. The patent owner is not precluded from obtaining review of 
any item of information as a result of the ten-item limit, because the 
patent owner may file multiple requests for supplemental examination of 
the same patent at any time.
    Section 1.605(b) is proposed to require 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 raises an issue under 35 
U.S.C. 101, and the issue is wholly contained in a discussion 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

[[Page 3670]]

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.
    Section 1.605(c) is proposed to require 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 images.
    Section 1.605(d) is proposed to require that if an item of 
information is combined in the request with one or more additional 
items of information, including instances where it may be necessary to 
combine items of information in order to raise an issue to be 
considered, reconsidered, or corrected, each item of information of the 
combination may be separately counted. For example, if the patent owner 
requests consideration of a possible rejection of the claims under 35 
U.S.C. 103(a) over a combination of reference A in view of reference B, 
reference A and reference B will be separately counted as items of 
information. 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)(11).
    Section 1.610: Proposed Sec.  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).
    Proposed Sec.  1.610(b) sets forth content requirements for a 
request for supplemental examination. Section 1.610(b)(1) is proposed 
to require that the request 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 
the request.
    Section 1.610(b)(2) is proposed to require that the request include 
a table of contents for the request. Section 1.610(b)(3) is proposed to 
require that the request include an identification of the number, the 
date of issue, and the first named inventor of the patent for which 
supplemental examination is requested.
    Section 1.610(b)(4) is proposed to require that the request include 
a list of each item of information that is requested to be considered, 
reconsidered, or corrected, and the 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)(4) is also 
proposed to require a statement that: (1) Identifies each item of 
information that was not considered in the prior examination of the 
patent, and explains why consideration of the item of information is 
being requested; (2) identifies each item of information that was not 
adequately considered in the prior examination of the patent, and 
explains why reconsideration of the item of information is being 
requested; and (3) identifies each item of information that was 
incorrect in the prior examination of the patent, and explains how it 
is being corrected. For example, the patent owner may state that a 
declaration under Sec.  1.132, which was presented during the prior 
examination of the patent as evidence of unexpected results, provided 
analytical data that was later determined to be erroneous or incorrect. 
The patent owner may present a corrected declaration under Sec.  1.132 
and explain how the previously submitted, erroneous data is being 
corrected. As another example, the patent owner may submit a patent 
with the request as an item of information, and explain that the patent 
was not considered (or was inadequately considered) during the prior 
examination, and that consideration (or reconsideration) of the patent 
is requested because it raises an issue under 35 U.S.C. 103 with 
respect to the claims of the patent for which supplemental examination 
has been requested. An amendment, however, is not an item of 
information. If the patent owner merely wishes, without more, to amend 
the claims or to add new claims, in order to further define the 
invention, the patent owner may file a reissue application. Similarly, 
a benefit claim may be corrected merely by filing an appropriate 
petition and/or a reissue application, as applicable. However, the 
patent owner may also, if desired, file the appropriate petition with 
the request for supplemental examination in order to correct the 
benefit claim.
    Section 1.610(b)(5) is proposed to require 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 (e.g., ex parte or inter partes reexamination, reissue, 
supplemental examination, post-grant review, inter partes review), 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.
    Section 1.610(b)(6) is proposed to require that the request include 
an identification of each aspect of the patent to be examined. Examples 
of an ``aspect of the patent'' include the abstract, any drawing, 
specification, patent claims, or benefit claims. If any of the claims 
identified for examination include one or more means-plus-function or 
step-plus-function elements as set forth in 35 U.S.C. 112(f), as 
amended by the Leahy-Smith America Invents Act, the request must 
include an identification of the structure, material, or acts in the 
specification that correspond to each means-plus-function or step-plus-
function element of each claim to be examined.
    Section 1.610(b)(7) is proposed to require that the request include 
an identification of each issue of patentability raised by each item of 
information. An item of information may raise more than one issue of 
patentability. For example, a journal article or reference patent may 
raise an issue under 35 U.S.C. 102, 35 U.S.C. 103, 35 U.S.C. 112, or 
obviousness-type double patenting, as appropriate. A discussion in the 
body of the request may raise an issue under 35 U.S.C. 101. A sales 
invoice or advertisement may raise an issue under 35 U.S.C. 102.
    Section 1.610(b)(8) is proposed to require that the request include 
a separate, detailed explanation for each identified issue of 
patentability, in order to determine whether the submitted

[[Page 3671]]

items of information are appropriate for supplemental examination, and 
to better analyze the information submitted with the request. The 
explanation must also discuss how each item of information is relevant 
to each aspect of the patent identified for examination. In addition, 
the explanation must discuss how each item of information raises each 
issue identified for examination. For example, the explanation must 
discuss how each claim limitation is met, or is not met, by an item of 
information, such as a patent which qualifies as prior art under 35 
U.S.C. 102.
    Section 1.610(b)(8)(i) is proposed to require that, where an 
identified issue involves the application of 35 U.S.C. 101 (other than 
double patenting) or 35 U.S.C. 112, the explanation must discuss the 
support in the specification for each limitation of each claim 
identified for examination with respect to this issue. Section 
1.610(b)(8)(ii) is proposed to require that, where an identified issue 
involves the application of 35 U.S.C. 102, 35 U.S.C. 103, or double 
patenting, the explanation must discuss how each limitation of each 
claim identified for examination with respect to this issue is met, or 
is not met, by each item of information. The detailed explanation may 
also include an explanation of how the claims distinguish over the 
items of information. For example, for an item of information that is 
identified as raising an issue under 35 U.S.C. 102 with respect to 
claims 1 through 10, such as a patent which qualifies as prior art 
under 35 U.S.C. 102, the explanation must discuss how each claim 
limitation in each of claims 1 through 10 is met, or is not met, by the 
item of information. Preferably, the explanation employs a claim chart 
that matches each claim limitation to cited portions of the item of 
information, as applicable. The requirements for this explanation are 
anticipated to be substantially similar to the requirements for a 
detailed explanation under Sec.  1.510(b)(2) in a request for ex parte 
reexamination, for items of information that raise issues that are 
relevant to the patent claims. In other words, this explanation must 
state, in sufficient detail, for each identified issue, how an item of 
information is applied to the patent.
    Section 1.610(b)(9) is proposed to require that the request include 
a copy of the patent for which supplemental examination is requested, 
and a copy of any disclaimer, certificate of correction, certificate of 
extension, supplemental examination certificate, post grant review 
certificate, inter partes review certificate, or ex parte or inter 
partes reexamination certificate issued for the patent.
    Section 1.610(b)(10) is proposed to require that the request 
include a copy of each item of information listed in Sec.  1.610(b)(4), 
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), and copies of U.S. patents and 
U.S. patent application publications, are not required to be submitted.
    Section 1.610(b)(11) is proposed to require 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)(12) is proposed to require that the request must 
include a submission by the patent owner in compliance with Sec.  
3.73(b) establishing the entirety of the ownership in the patent 
requested to be examined, as set forth in Sec.  1.601(b).
    Proposed Sec.  1.610(c) 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 such explanation, which will assist the Office in 
analyzing the request.
    Proposed Sec.  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, 1.615, and 1.610(a) and (b). A 
defective request may be granted a filing date if the defects are 
limited to the omission of one or more of the requirements set forth in 
Sec.  1.610(b)(1) or (b)(2), subject to the discretion of the Office.
    Proposed Sec.  1.610(e) provides that if the Office determines that 
the request, as originally submitted, is not entitled to a filing date 
pursuant to Sec.  1.610(d), then the patent owner will be so notified 
and will generally 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 ex parte 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) is proposed to require that all 
papers submitted in a supplemental examination proceeding must be 
formatted in accordance with Sec.  1.52, including the request and any 
other documents generated by the patent owner/requester, such as 
translations of non-English language documents, transcripts of audio or 
video recordings, affidavits or declarations, and summaries of 
documents over 50 pages in length pursuant to Sec.  1.610(b)(11). 
Exceptions include tables of contents, curriculum vitae, claim charts, 
court documents, third-party-generated affidavits or declarations, and 
any other document generated by a third party, including patents, 
patent application publications, and non-patent literature. However, 
such documents must be presented in a form having sufficient clarity 
and contrast between the paper and the text or image to permit the 
direct reproduction of readily legible copies by use of digital imaging 
and optical character recognition.
    Section 1.615(b) is proposed to require 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) is proposed to require 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

[[Page 3672]]

request. The standard for determining whether an item of information 
submitted with the request raises a substantial new question of 
patentability will be the standard set forth in the Manual of Patent 
Examining Procedure (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 
(8th ed. 2001) (Rev. 8, July 2010). This determination will generally 
be limited to a review of the issues identified in the request as 
applied to the identified aspect(s) of the patent. For example, a 
determination on a request that includes three items of information, 
wherein each item is identified as raising an issue under 35 U.S.C. 102 
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 having more issues addressed for an item of information, 
the patent owner must identify every issue and provide the required 
explanation(s) in the request for supplemental examination. Similarly, 
if the patent owner is interested in applying an item of information to 
more aspects of the patent (e.g., to more claims), the request for 
supplemental examination must include an identification of each aspect 
to which the item of information is to be applied and the required 
explanation(s). For example, if the patent owner fails to apply an item 
of information to certain claims, then the patent owner is not entitled 
to a determination for that item of information as applied to such 
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, will become a part of the official 
record of the patent.
    Proposed Sec.  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 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 raise 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.
    Proposed Sec.  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) is proposed to require 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 
bare notice 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 Office post patent proceedings, including 
another supplemental examination proceeding. Knowledge of other 
proceedings is important to ensure a quality determination. In 
addition, bare notice is required due to the statutory three-month 
period within which the Office must process the information. The notice 
is limited to an identification of the post patent 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.
    Section 1.620(e) is proposed to prohibit 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. As to any ex 
parte reexamination ordered as a result of the supplemental examination 
proceeding, interview practice is governed by the regulations governing 
ex parte reexamination proceedings. See, e.g., Sec.  1.560.
    Proposed Sec.  1.620(f) provides that no amendment to any aspect of 
the patent may be filed in a supplemental examination proceeding. 
Amendments to any aspect of the patent 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 proposed 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 
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.
    Proposed Sec.  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, of a material fraud on the 
Office involving 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).
    Section 1.625: Proposed Sec.  1.625(a) provides that a supplemental 
examination proceeding will conclude when the supplemental examination 
certificate is electronically issued. The supplemental examination 
certificate will be electronically issued in the Office image file 
wrapper (IFW) system and the Patent Application Information Retrieval 
(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 additional time to review the items of 
information provided by the request, which would otherwise not be 
available if the certificate were to go through the Office's 
publication process,

[[Page 3673]]

which currently takes approximately eight weeks to complete. 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.
    Proposed Sec.  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.
    Proposed Sec.  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 reexamination fee for supplemental 
examination, as set forth in Sec.  1.20(k)(2), will be refunded in 
accordance with Sec.  1.26(c).
    Proposed Sec.  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 aspect 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; (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; 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. Because supplemental examination is not limited to patents 
and printed publications, any aspect of the patent, including the 
original specification, may be examined. The material to patentability 
standard applicable to patent applications (Sec.  1.56(b)) is proposed 
for ex parte reexamination resulting from a supplemental examination 
because the material to patentability standard applicable to ex parte 
reexaminations (Sec.  1.555(b)) is limited to patents and printed 
publications, and an ex parte reexamination resulting from supplemental 
examination is not limited to patents and printed publications. Any 
reference to ``applicant'' in Sec.  1.56(b) will be read as ``patent 
owner.''
    Section 1.937: Section 1.937(d) is proposed to be 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.
    The Office would also make appropriate reference to supplemental 
examination in title 37 CFR (e.g., Sec. Sec.  3.71, 3.73).

Rulemaking Considerations

A. Administrative Procedure Act

    This notice proposes to amend the rules of practice in patent cases 
to implement the supplemental examination provisions of the Leahy-Smith 
America Invents Act. The Office is also proposing 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 
to more accurately reflect the cost of these processes. The changes 
being proposed in this notice do not change the substantive criteria of 
patentability. These proposed changes involve rules of agency practice 
and procedure and/or interpretive rules. See Bachow Commc'ns Inc. v. 
FCC, 237 F.3d 683, 690 (DC Cir. 2001) (rules governing an application 
process are procedural under the Administrative Procedure Act); Inova 
Alexandria Hosp. v. Shalala, 244 F.3d 242, 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) and 
thirty-day advance publication is not required pursuant to 5 U.SC. 
553(d) (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, is publishing these proposed changes 
and the Initial Regulatory Flexibility Act analysis, below, for comment 
as it seeks the benefit of the public's views on the Office's proposed 
implementation of these provisions of the Leahy-Smith America Invents 
Act.

B. Initial Regulatory Flexibility Analysis

1. Description of the Reasons That Action by the Agency Is Being 
Considered
    The Office is proposing to amend the rules of patent practice to 
implement the supplemental examination provisions of the Leahy-Smith 
America Invents Act, which take effect September 16, 2012. The Office 
is also proposing 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, to more accurately reflect the 
cost of these processes.
2. Succinct Statement of the Objectives of, and Legal Basis for, the 
Proposed Rules
    The objective of the proposed rules to implement the supplemental 
examination provisions of the Leahy-Smith America Invents Act is to 
establish 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 proposed rules 
to adjust the fee for

[[Page 3674]]

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 Leahy-Smith America Invents Act provides a legal 
basis for the proposed rules to implement supplemental examination. 35 
U.S.C. 41(d)(2) provides a legal basis for the proposed 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. 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 SBA's 
previously established size standard that identifies the criteria 
entities must meet to be entitled to pay reduced patent fees. See 13 
CFR 121.802. If patent applicants identify themselves on a patent 
application as qualifying for reduced patent fees, the Office captures 
this data in the Patent Application Location and Monitoring (PALM) 
database system, which tracks information on each patent application 
submitted to the Office.
    Unlike the SBA small business size standards set forth in 13 CFR 
121.201, the size standard for USPTO is not industry-specific. 
Specifically, the Office's definition of small business concern for 
Regulatory Flexibility Act purposes is a business or other concern 
that: (1) Meets the SBA's definition of a ``business concern or 
concern'' set forth in 13 CFR 121.105; and (2) meets the size standards 
set forth in 13 CFR 121.802 for the purpose of paying reduced patent 
fees, namely, an entity: (a) Whose number of employees, including 
affiliates, does not exceed 500 persons; and (b) which has not 
assigned, granted, conveyed, or licensed (and is under no obligation to 
do so) any rights in the invention to any person who made it and could 
not be classified as an independent inventor, or to any concern which 
would not qualify as a non-profit organization or a small business 
concern under this definition. See Business Size Standard for Purposes 
of United States Patent and Trademark Office Regulatory Flexibility 
Analysis for Patent-Related Regulations, 71 FR at 67112 (Nov 20, 2006), 
1313 Off. Gaz. Pat. Office at 63 (Dec. 12, 2006).
    b. Overview of Estimates of Number of Entities Affected. The 
proposed 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 about 14 
percent of all requests for ex parte reexamination are filed by patent 
owners. 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. 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. Therefore, the Office estimates 
that a total of approximately 690 (86 percent of 800 rounded to the 
nearest 10) requests for ex parte reexamination (all by third parties) 
will be filed 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 sought 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 reexamination requesters are not required to identify 
their small entity status. 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 proposed 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

[[Page 3675]]

statutory mandate to conduct reexamination proceedings with special 
dispatch, the Office estimates that the 832 petitions decided in 
reexamination proceedings in fiscal year 2010 reasonably approximates 
the number of petitions filed in reexamination proceedings in fiscal 
year 2010. In view of the proposed fee for petitions filed in 
reexamination proceedings, 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. 
In view of the benefits to patent owners afforded by supplemental 
examination at 35 U.S.C. 257(c), the Office is estimating that all 110 
requests for ex parte reexamination that would have been filed annually 
by patent owners will instead be filed as requests for supplemental 
examination. However, the Office is also estimating that more than 110 
requests for supplemental examination will be filed annually due to a 
combination of: (1) The benefits to patent owners afforded by 
supplemental examination; (2) the fact that the ``information'' that 
may form the basis of a request for supplemental examination is not 
limited to patents and printed publications; and (3) the fact that the 
issues that may be raised during supplemental examination may include 
issues in addition to those permitted to be raised in ex parte 
reexamination, e.g., issues under 35 U.S.C. 112.
    Because a main benefit afforded to patent owners by supplemental 
examination is to potentially shield patent owners from a finding of 
unenforceability due to inequitable conduct for the information 
considered by the Office and subject to a written decision by the 
Office, the Office estimates that the number of cases annually in which 
inequitable conduct is pled in the United States district courts 
represents a reasonable approximation 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 May 2011 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. The Office is specifically 
interested in receiving comments on litigation cost savings and other 
benefits the public may expect to realize from implementation of rules 
on supplemental examination.
    Therefore, the Office estimates that it will receive about 1,430 
(40 percent of 3,300 plus 110) requests for supplemental examination 
annually. Assuming that requests for supplemental examination will be 
filed by small entities in roughly the same percentage that requests 
for ex parte reexamination are currently filed by small entities (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.
4. Description of the Projected Reporting, Recordkeeping and Other 
Compliance Requirements of the Proposed 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 proposed 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 proposed rules to implement the 
supplemental examination provisions of the Leahy-Smith America Invents 
Act will impose compliance requirements on patent owners who request 
supplemental examination to consider, reconsider, or correct 
information believed to be relevant to a patent. The proposed 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 proposed rules to 
implement the supplemental examination provisions of the Leahy-Smith 
America Invents Act also require: (1) A fee of $5,120.00 for processing 
and treating a request for supplemental examination; (2) a fee of 
$15,930.00 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 sheets in length, a fee of $170.00 for a document of 
between 21 and 50 sheets, and a fee of $280.00 for each additional 50 
sheets or a fraction thereof.
    A patent practitioner would have the type of professional skills 
necessary for preparation of request for supplemental

[[Page 3676]]

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 $8,500 (25 hours at 
the $340 per hour median 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 American Intellectual Property Law Association 
(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 proposed rules to adjust or set fees in ex parte reexamination 
are as follows: (1) $17,550.00 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) for a refused 
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 
proposed 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 
proposed 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.
5. Description of Any Significant Alternatives to the Proposed Rules 
Which Accomplish the Stated Objectives of Applicable Statutes and Which 
Minimize Any Significant Economic Impact of the Proposed 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 proposed rules to implement the supplemental 
examination provisions of the Leahy-Smith America Invents Act, the 
Office considered requiring less than, or exempting small entities 
from, what is currently set forth at proposed 37 CFR 1.601, 1.605, 
1.610, and 1.615. Specifically, the Office considered not requiring any 
or all of, or exempting small entities from, the following content 
requirement of proposed 37 CFR 1.610: (1) A list of each item of 
information that is requested to be considered, reconsidered, or 
corrected, identifying each item of information that was not 
considered, adequately considered, or correctly considered in the prior 
examination of the patent, and 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 
each aspect of the patent for which supplemental examination is sought, 
including 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; and (4) a separate, detailed explanation for each 
identified issue, discussing how each item of information is relevant 
to each aspect of the patent identified for examination, and how each 
item of information raises each issue identified for examination, 
including where an identified issue involves the application of 35 
U.S.C. 101 (other than double patenting) or 35 U.S.C. 112, an 
explanation discussing the support in the specification for each 
limitation of each claim identified for examination with respect to 
this issue, and where an identified issue involves the application of 
35 U.S.C. 102, 35 U.S.C. 103, or double patenting, an explanation of 
how each limitation of each claim identified for examination with 
respect to this issue is met, or is not met, by each item of 
information.
    However, 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 proposed 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 proposed rules to adjust the fee for filing a 
request for ex parte reexamination, and to set a fee for petitions 
filed in reexamination

[[Page 3677]]

proceedings, the alternative of not adjusting or setting the fees would 
have a lesser economic impact on small entities, but 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 
proposed 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.
6. Identification, to the Extent Practicable, of All Relevant Federal 
Rules Which May Duplicate, Overlap or Conflict With the Proposed Rules
    The Office is the sole agency of the United States Government 
responsible for administering the provisions of title 35, United States 
Code, pertaining to examination and granting patents. Therefore, no 
other federal, state, or local entity shares jurisdiction over the 
examination and granting of patents.
    Other countries, however, have their own patent laws, and an entity 
desiring a patent in a particular country must make an application for 
patent in that country, in accordance with the applicable law. Although 
the potential for overlap exists internationally, this cannot be 
avoided except by treaty (such as the Paris Convention for the 
Protection of Industrial Property, or the Patent Cooperation Treaty 
(PCT)). Nevertheless, the Office believes that there are no other 
duplicative or overlapping rules.

C. Executive Order 12866 (Regulatory Planning and Review)

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

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

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

E. Executive Order 13132 (Federalism)

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

F. Executive Order 13175 (Tribal Consultation)

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

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.), 
prior to issuing any final rule, the United States Patent and Trademark 
Office will submit a report containing the 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 notice 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 notice is not expected to result in 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 rulemaking 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.

[[Page 3678]]

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 notice 
proposes 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 
USPTO will submit to the OMB a proposed revision to the information 
collection requirements under 0651-0064. The proposed revision will be 
available at the OMB's Information Collection Review Web site 
(www.reginfo.gov/public/do/PRAMain).
    Needs and Uses: This information collection is necessary so that a 
patent owner may file a request for supplemental examination of the 
patent. The Office will use this information to determine whether the 
information submitted with the supplemental examination request raises 
a substantial new question of patentability.
    Title of Collection: Patent Reexaminations and Supplemental 
Examination (formerly Patent Reexaminations).
    OMB Control Number: 0651-0064.
    Method of Collection: By mail, facsimile, hand delivery, or 
electronically to the USPTO.
    Affected Public: Individuals or households; businesses or other 
for-profits; and not-for-profit institutions.
    Estimated Number of Respondents: 9,560 responses per year.
    Estimated Time per Response: The USPTO estimates that it will take 
the public from 18 minutes (0.3 hours) to 135 hours to gather the 
necessary information, prepare the appropriate form or other documents, 
and submit the information to the USPTO.
    Estimated Total Annual Respondent Burden Hours: 235,365 hours per 
year. In addition, the USPTO anticipates that supplemental examination 
will produce significant benefits by leading to a reduction in the 
number of district court patent infringement cases in which inequitable 
conduct is pled as a defense.
    Estimated Total Annual Respondent Cost Burden: $80,024,100 per 
year.
    Estimated Total Annual Non-hour Respondent Cost Burden: $35,283,875 
per year in the form of fees and postage costs.
    The agency is soliciting comments to: (1) Evaluate whether the 
proposed information requirement is necessary for the proper 
performance of the functions of the agency, including whether the 
information will have practical utility; (2) evaluate the accuracy of 
the agency's estimate of the burden; (3) enhance the quality, utility, 
and clarity of the information to be collected; and (4) minimize the 
burden of collecting the information on those who are to respond, 
including by using appropriate automated, electronic, mechanical or 
other technological collection techniques or other forms of information 
technology.
    Please send comments on or before March 26, 2012 to Mail Stop 
Comments--Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, 
VA, 22313-1450, marked to the attention of Raul Tamayo, Legal Advisor, 
Office of Patent Legal Administration, Office of the Associate 
Commissioner for Patent Examination Policy. Comments should also be 
submitted to the Office of Information and Regulatory Affairs, Office 
of Management and Budget, New Executive Office Building, Room 10202, 
725 17th Street NW., Washington, DC 20503, Attention: Desk Officer for 
the Patent and Trademark Office, or via email at OIRA_submission@omb.eop.gov.
    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 discussed in the preamble, the United States Patent 
and Trademark Office proposes to amend 37 CFR part 1 as follows:

PART 1--RULES OF PRACTICE IN PATENT CASES

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

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

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


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 refused 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     $5,180.00
 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
 sheets in length, per document:
  (i) Between 21 and 50 sheets.............................       170.00
  (ii) For each additional 50 sheets or a fraction thereof.       280.00
 


    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.

[[Page 3679]]

    (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.
    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.
    5. Subpart E, consisting of Sec. Sec.  1.601, 1.605, 1.610, 1.615, 
1.620, and 1.625, is added to read as follows:
Subpart E--Supplemental Examination of Patents
Sec.
1.601 Filing of papers in supplemental examination.
1.605 Items of information.
1.610 Content of request for supplemental examination.
1.615 Format of papers filed in a supplemental examination 
proceeding.
1.620 Conduct of supplemental examination proceeding.
1.625 Conclusion of supplemental examination; publication of 
supplemental examination certificate; procedure after conclusion.

Subpart E--Supplemental Examination of Patents


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) The patent owner must establish the entirety of the ownership 
interest in the patent of paragraph (a) by filing, as part of the 
request, a submission in compliance with the provisions of Sec.  
3.73(b) of this chapter.
    (c) 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.


Sec.  1.605  Items of information.

    (a) Each request for supplemental examination may request that the 
Office consider, reconsider, or correct no more than ten 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.
    (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, including instances where it 
may be necessary to combine items of information in order to raise an 
issue to be considered, reconsidered, or corrected, 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)(11).


Sec.  1.610  Content of request for supplemental examination.

    (a) The request 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 each of the 
elements set forth in paragraphs (b)(1) through (b)(12) of this 
section.
    (1) A cover sheet itemizing each component submitted as part of the 
request.
    (2) A table of contents for the request.
    (3) An identification of the number, the date of issue, and the 
first named inventor of the patent for which supplemental examination 
is requested.
    (4) A list of each item of information that is requested to be 
considered, reconsidered, or corrected, and the publication date for 
each item of information, if applicable; and a statement that:
    (i) Identifies each item of information that was not considered in 
the prior examination of the patent, and explains why consideration of 
the item of information is being requested;
    (ii) Identifies each item of information that was not adequately 
considered in the prior examination of the patent, and explains why 
reconsideration of the item of information is being requested; and
    (iii) Identifies each item of information that was incorrect in the 
prior examination of the patent, and explains how it is being 
corrected.
    (5) 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 (e.g., ex parte or inter partes reexamination, reissue, 
supplemental examination, post-grant review, or inter partes review), 
the identifying number of any such proceeding (e.g., a control number 
or reissue application number), and the filing date of any such 
proceeding.
    (6) An identification of each aspect of the patent for which 
supplemental examination is sought, including 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.
    (7) An identification of each issue raised by each item of 
information.
    (8) A separate, detailed explanation for each identified issue, 
discussing how each item of information is relevant to each aspect of 
the patent identified for examination, and how each item of information 
raises each issue identified for examination, including:
    (i) Where an identified issue involves the application of 35 U.S.C. 
101 (other

[[Page 3680]]

than double patenting) or 35 U.S.C. 112, an explanation discussing the 
support in the specification for each limitation of each claim 
identified for examination with respect to this issue; and
    (ii) Where an identified issue involves the application of 35 
U.S.C. 102, 35 U.S.C. 103, or double patenting, an explanation of how 
each limitation of each claim identified for examination with respect 
to this issue is met, or is not met, by each item of information. The 
detailed explanation may also include an explanation of how the claims 
distinguish over the items of information.
    (9) A copy of the patent for which supplemental examination is 
requested and a copy of any disclaimer, certificate of correction, 
certificate of extension, supplemental examination certificate, post 
grant review certificate, inter partes review certificate, or 
reexamination certificate issued for the patent.
    (10) A copy of each item of information listed in paragraph (b)(3) 
of this section, 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), and copies of U.S. 
patents and U.S. patent application publications, are not required to 
be submitted.
    (11) 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.
    (12) A submission by the patent owner in compliance with Sec.  
3.73(b) of this chapter establishing the entirety of the ownership in 
the patent requested to be examined as set forth in Sec.  1.601(b).
    (c) The request may also include 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.  1.605, 
Sec.  1.615, and this section. A defective request may receive a filing 
date if the defects are limited to the omission of one or more of the 
requirements set forth in paragraph (b)(1) or (b)(2) of this section, 
subject to the discretion of the Office.
    (e) If the Office determines that the request, as originally 
submitted, does not meet the requirements of paragraph (d) of this 
section to be 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 of 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, including the request 
for supplemental examination and any other documents generated by the 
patent owner/requester, such as translations of non-English language 
documents, transcripts of audio or video recordings, affidavits or 
declarations, and summaries of documents over 50 pages in length 
pursuant to Sec.  1.610(b)(11). Exceptions include tables of contents, 
curriculum vitae, claim charts, court documents, third-party-generated 
affidavits or declarations, and any other document generated by a third 
party, including patents, patent application publications, and non-
patent literature. All documents must be presented in a form having 
sufficient clarity and contrast between the paper and the text or image 
to permit the direct reproduction of readily legible copies by use of 
digital imaging and optical character recognition.
    (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 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 presented in the 
request. The determination will generally be limited to a review of the 
issues identified in the request as applied to the identified aspects 
of the patent. The determination will be based on the claims in effect 
at the time of the 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 notice 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 proceeding, including the type (e.g., ex parte or inter partes 
reexamination, reissue, supplemental examination, post-grant review, or 
inter partes review), 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 to any aspect of the patent 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, of a 
material fraud on the Office involving 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 when the 
supplemental examination certificate is electronically issued. The 
supplemental

[[Page 3681]]

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 
reexamination fee for 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 aspect 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).
    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: January 19, 2012.
David J. Kappos,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2012-1480 Filed 1-24-12; 8:45 am]
BILLING CODE 3510-16-P