Federal Register, Volume 77 Issue 16 (Wednesday, January 25, 2012)

[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]

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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.

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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