[Federal Register Volume 77, Number 3 (Thursday, January 5, 2012)]
[Proposed Rules]
[Pages 442-448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-33813]


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DEPARTMENT OF COMMERCE

United States Patent and Trademark Office

37 CFR Part 1

[Docket No. PTO-P-2011-0072]
RIN 0651-AC66


Changes To Implement Miscellaneous Post Patent Provisions of the 
Leahy-Smith America Invents Act

AGENCY: United States Patent and Trademark Office, Commerce.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Leahy-Smith America Invents Act expands the scope of 
information that any party may cite in a patent file, to include 
written statements made by a patent owner before a Federal court or the 
United States Patent and Trademark Office (Office) regarding the scope 
of any claim of the patent, and it provides for how such information 
may be considered in ex parte reexamination, inter partes review, and 
post grant review. The Leahy-Smith America Invents Act also provides 
for an estoppel that may attach with respect to ex parte reexamination 
based on an inter partes review or post grant review proceeding. The 
Office is revising the rules of practice to implement these post-patent 
provisions, as well as other miscellaneous provisions of the Leahy-
Smith America Invents Act.

DATES: Comment Deadline Date: To be ensured of consideration, written 
comments must be received on or before March 5, 2012.

ADDRESSES: Comments should be sent by electronic mail addressed to: 
[email protected]. Comments may also be submitted by 
mail addressed to: Mail Stop Comments--Patents, Commissioner for 
Patents, P.O. Box 1450, Alexandria, VA, 22313-1450, marked to the 
attention of

[[Page 443]]

Kenneth M. Schor, 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: Kenneth M. Schor, Senior Legal Advisor 
((571) 272-7710), or Joseph F. Weiss, Jr., Legal Advisor ((571) 272-
7759), Office of Patent Legal Administration, Office of the Associate 
Commissioner for Patent Examination Policy.

SUPPLEMENTARY INFORMATION: Section 6 of the Leahy-Smith America Invents 
Act replaces the current inter partes reexamination proceedings with 
inter partes review proceedings, and creates new post grant review 
proceedings. See Public Law 112-29, 125 Stat. 284 (2011). Section 6 of 
the Leahy-Smith America Invents Act also provides for an estoppel that 
may attach with respect to ex parte reexamination based on an inter 
partes review or post grant review proceeding. The Office is proposing 
to revise the rules of practice in title 37 of the Code of Federal 
Regulations (CFR) to implement these post-patent provisions, along with 
changes in nomenclature pertaining to the renaming of the ``Board of 
Patent Appeals and Interferences'' as the ``Patent Trial and Appeal 
Board'' and the replacement of references to interference proceedings 
with references to derivation proceedings. The post grant review, inter 
partes review, and derivation provisions of sections 3 and 6 of the 
Leahy-Smith America Invents Act will be implemented by separate 
rulemakings.

I. Background

    Section 6(g) of the Leahy-Smith America Invents Act amends 35 
U.S.C. 301 to expand the information that can be submitted in the file 
of an issued patent by including written statements made by a patent 
owner before a Federal court or the Office regarding the scope of any 
claim of the patent. The provision limits the Office's use of such 
written statements to determining the meaning of a patent claim in ex 
parte reexamination proceedings that have already been ordered and in 
inter partes review and post grant review proceedings that have been 
instituted. This provision is effective on September 16, 2012.
    Section 6(a) and (d) of the Leahy-Smith American Invents Act also 
contains provisions in new 35 U.S.C. 315(e)(1) and 35 U.S.C. 325(e)(1) 
for estopping a third party requester from filing a request for ex 
parte reexamination, in certain instances where the third party 
requester filed a petition for inter partes review or post grant review 
and a final written decision under 35 U.S.C. 318(a) or 35 U.S.C. 328(a) 
has been issued. In addition, a third party requester may not maintain 
an ex parte reexamination if the estoppel provisions are met during the 
pendency of the ex parte reexamination proceeding. The estoppel 
provisions apply to the real party(ies) in interest of the inter partes 
review or post grant review petitioner and any privy of such a 
petitioner. This provision is effective on September 16, 2012.
    In view of the estoppel provisions, the Office needs to be aware of 
any final written decision in an inter partes review or post grant 
review regarding the patentability of claims. Current Sec.  1.565(a) 
requires the patent owner to ``inform the Office of any prior or 
concurrent proceedings in which the patent is or was involved such as 
interferences, reissues, ex parte reexaminations, inter partes 
reexaminations, or litigation and the results of such proceedings.'' 
Because current Sec.  1.565(a) uses open language to provide a non-
exhaustive listing of proceedings that patent owner must inform the 
Office about, the current rule will include inter partes review and 
post grant review proceedings, once they become effective. In addition, 
the third party requester (to whom the inter partes review or post 
grant review estoppel statutes are directed) may inform the Office of a 
final written decision in an inter partes review or post grant review 
of the patent subject to the ex parte reexamination by filing a 
``Notification of Existence of Prior or Concurrent Proceedings and 
Decisions Thereon'' pursuant to Manual of Patent Examining Procedure 
(MPEP) Sec.  2282 (8th ed. 2001) (Rev. 8, July 2010). MPEP Sec.  2282 
provides that ``in order to ensure a complete file, with updated status 
information regarding prior or concurrent proceedings regarding the 
patent under reexamination, the Office will, at any time, accept from 
any parties, for entry into the reexamination file, copies of notices 
of suits and other proceedings involving the patent and copies of 
decisions or papers filed in the court from litigations or other 
proceedings involving the patent.'' [Emphasis added]
    Section 6(h)(1) of the Leahy-Smith America Invents Act amends 35 
U.S.C. 303 to expressly identify the authority of the Director to 
initiate reexamination based on patents and publications cited in a 
prior reexamination request under 35 U.S.C. 302, as well as on those 
cited under 35 U.S.C. 301 (which was previously expressly authorized). 
This provision is effective on September 16, 2012.
    Section 3(i) of the Leahy-Smith America Invents Act replaces 
interference proceedings with derivation proceedings; section 3(j) 
replaces the title ``Board of Patent Appeals and Interferences'' with 
``Patent Trial and Appeal Board'' in 35 U.S.C. 134, 145, 146, 154, and 
305; Section 6(a) replaces inter partes reexamination with inter partes 
review of a patent; Section 6(d) provides for post-grant review of 
patents; and Section 7 amends 35 U.S.C. 6(b) to define the duties of 
the Patent Trial and Appeal Board.

II. Discussion of Specific Rules

    Title 37 of the Code of Federal Regulations, Part 1, is proposed to 
be amended as follows:
    The undesignated center heading before Sec.  1.501: It is proposed 
that the undesignated center heading be revised to read ``Citation of 
prior art and written statements.''
    Section 1.501: Proposed Sec.  1.501 is rewritten to reflect the 
amendment to 35 U.S.C. 301 by section 6(g)(1) of the Leahy-Smith 
America Invents Act. New 35 U.S.C. 301(a)(2) would permit a submission 
under 35 U.S.C. 301 and 1.501 to contain, in addition to prior art

[[Page 444]]

(currently provided for in Sec.  1.501), ``statements of the patent 
owner filed in a proceeding before a Federal court or the Office in 
which the patent owner took a position on the scope of any claim of a 
particular patent'' (claim scope statements of the patent owner). 
Proposed Sec.  1.501 provides that a submission can include prior art 
and claim scope statements of the patent owner. The term ``Federal 
court'' in 35 U.S.C. 301(a)(2) is understood to also include the United 
States Court of International Trade.
    Section 1.501(a): Proposed Sec.  1.501(a)(1), like current Sec.  
1.501(a), provides for submission to the Office of prior art directed 
to patents or printed publications allegedly bearing on the 
patentability of any claim of a particular patent. Section 1.501(a)(2) 
newly permits submission of statements of the patent owner filed in a 
proceeding before a Federal court or the Office in which the patent 
owner took a position on the scope of any claim of a patent (claim 
scope statements). Any statement submitted under this paragraph must be 
accompanied by any other documents, pleadings, or evidence from the 
proceeding in which the statement was filed that address the statement; 
and the statement and accompanying information under this paragraph 
must be submitted in redacted form to exclude information subject to an 
applicable protective order. For example, a third party may submit a 
deposition of the patent owner occurring during the course of the 
Federal court proceeding where the patent owner discusses the scope of 
a patent claim. A party submitting any submission that includes Sec.  
1.501(a)(2) information should also consider providing the following 
information to assist the Office in identifying the proceeding where 
the patent owner claim scope statement was made: (1) The forum in which 
the statement was made (the specific Federal court or the Office); (2) 
the Federal court or Office proceeding designation (case citation or 
numerical designation); (3) the status of the proceeding; (4) the 
relationship of the proceeding to the patent in which the submission is 
being made; (5) an identification of the specific papers of the 
proceeding containing the statement of the patent owner; and (6) an 
identification of the portion(s) of the papers relevant to the written 
statement being asserted to constitute a statement of the patent owner 
under 35 U.S.C. 301(a)(2). Any patent owner statement regarding the 
scope of any claim of a particular patent made outside of a Federal 
court or Office proceeding is not a written statement eligible for 
submission under 35 U.S.C. 301(a)(2), even though it may be later 
entered into a Federal court or Office proceeding by a party other than 
the patent owner. See H.R. Rep. No. 112-98, Part 1, at page 46 (2011) 
(``[t]his addition will counteract the ability of patent owners to 
offer differing interpretations of prior art in different 
proceedings'').
    Section 1.501(b): Proposed Sec.  1.501(b)(1) is directed to the 35 
U.S.C. 301(b) requirement that the submission include an explanation 
``in writing [of] the pertinency and manner of applying the prior art 
or written statements'' to at least one patent claim. Proposed Sec.  
1.501(b)(1) requires an explanation as to how the information in the 
submission is pertinent to the claim(s) of the patent and how it is 
applied to each of those claims. In some instances, a combination of 
prior art and written statements may be cited, while in other 
situations only prior art or written statements may be cited. In either 
situation, an explanation as to how the cited information applies to 
those specific claims must be included with the submission of patent 
owner statements under 35 U.S.C. 301(a)(2). Section 1.501(b)(1) 
requires an explanation of the additional information required by 35 
U.S.C. 301(c) (as a result of the Leahy-Smith America Invents Act), 
because the additional information addresses and provides context to 
the written statement of the patent owner; thus, it provides an 
additional explanation as to how the cited information is pertinent to 
the claim(s).
    Proposed Sec.  1.501(b)(2) is directed to the substance of the 
second sentence of current Sec.  1.501(a), which provides regulatory 
authorization for a patent owner submitter to include an explanation of 
how the claims differ from the prior art submitted. Proposed Sec.  
1.501(b)(2) simply adds statements of patent owner under 35 U.S.C. 
301(a)(2) to the current regulatory authorization.
    Section 1.501(c): Proposed Sec.  1.501(c) restates the last 
sentence of existing Sec.  1.501(a) directed to the timing for a 
submission under Sec. Sec.  1.502 and 1.902 when there is a 
reexamination proceeding pending for the patent in which the submission 
is made. Pursuant to current Sec. Sec.  1.502 and 1.902, entry (into 
the official patent file) of a proper submission that is made after the 
date of an order to reexamine will be delayed (with certain exceptions 
specified in Sec. Sec.  1.502 and 1.902) until the reexamination 
proceeding has been concluded by the issuance and publication of a 
reexamination certificate. This prevents harassment of the patent owner 
by frequent submissions of prior art made during a reexamination 
proceeding, as well as unwarranted interruption and delay of the 
reexamination proceeding, which would be contrary to the mandate under 
35 U.S.C. 305 and 35 U.S.C. 314(c) that all reexamination proceedings 
are to be ``conducted with special dispatch within the Office.''
    Section 1.501(d): Proposed Sec.  1.501(d) restates existing Sec.  
1.501(b), to permit the person making the submission to exclude his or 
her identity from the patent file by anonymously filing the submission.
    Section 1.501(e): Proposed Sec.  1.501(e) requires that a 
submission made under Sec.  1.501 must reflect that a copy of the 
submission has been served upon the patent owner at the correspondence 
address of record in the patent, and that service was carried out in 
accordance with Sec.  1.248. Service is required to provide notice to 
the patent owner of the submission. The presence of a certificate of 
service compliant with Sec.  1.248(b) is prima facie evidence of 
compliance with Sec.  1.501(e). If service upon patent owner is 
unsuccessful, the submission must include proof of a bona fide attempt 
to serve. Proof of a bona fide attempt to serve must include a 
statement of facts with an explanation of the inability to serve the 
submission upon patent owner, along with all supporting evidence of the 
attempt of service. The statement of facts must be signed by a person 
having firsthand knowledge of the facts recited, regarding unsuccessful 
service. The statement of facts should include the steps taken to 
locate and serve the patent owner. A statement of facts which provides 
a mere conclusion or assertion of unsuccessful service will not satisfy 
this requirement. Copies of documentary proof such as certified/
registered mail receipts, cover letters, telegrams or other forms of 
evidence that support a finding that the patent owner could not be 
served should be made part of the statement of facts. A submission will 
not be entered into the patent's Image File Wrapper (IFW) if it does 
not include either proof of service compliant with Sec.  1.248(b) or a 
sufficient explanation and proof of a bona fide attempt of service, and 
if such a submission is inadvertently entered, it will be expunged. 
Where a submission complies with the rule, all information included in 
the submission will be made of record in the IFW of the patent. A best 
practice for patent owners is to regularly monitor the IFW record of 
their patents in the event that a third party was unsuccessful in 
serving the patent owner at the correspondence

[[Page 445]]

address of record. Such regular monitoring allows a patent owner to be 
aware of all information added to its patent files.
    Section 1.501(f): Proposed Sec.  1.501(f) limits the use of 
statements of the patent owner and accompanying information submitted 
under Sec.  1.501(a)(2) to what is provided for in 35 U.S.C. 301(d). 
Thus, statements of the patent owner and accompanying information 
submitted under paragraph (a)(2) may only be used for determination of 
the proper meaning of a patent claim in: (1) An ex parte reexamination 
proceeding that has been ordered pursuant to 35 U.S.C. 304; (2) an 
inter partes review proceeding that has been instituted pursuant to 35 
U.S.C. 314; and (3) a post grant review proceeding that has been 
instituted pursuant to 35 U.S.C. 324. Proposed Sec.  1.501(f) follows 
from new 35 U.S.C. 301(d), which provides that ``a written statement 
submitted pursuant to subsection (a)(2)'' ``shall not be considered by 
the Office for any purpose other than to determine the proper meaning 
of a patent claim in a proceeding that is ordered or instituted 
pursuant to section 304, 314, or 324.'' The reference to 35 U.S.C. 314 
is understood to apply to inter partes review, and not to inter partes 
reexamination, because inter partes reexamination is being replaced by 
inter partes review on the date that 35 U.S.C. 301(d) becomes effective 
(i.e., September 16, 2012). While inter partes reexamination 
proceedings already ordered will continue after September 16, 2012, 35 
U.S.C. 314 is understood not to apply to such proceedings.
    Section 1.510: Proposed Sec.  1.510(b)(2) is revised, and new 
Sec. Sec.  1.510(b)(6) and (b)(7) are added to implement provisions of 
the Leahy-Smith America Invents Act. Section 1.510(b)(2) is revised to 
require that a request for reexamination identify every claim for which 
reexamination is requested, and for any statement of the patent owner 
submitted pursuant to Sec.  1.501(a)(2) which is relied upon in the 
detailed explanation, explain how that statement is being used to 
determine the proper meaning of a patent claim in connection with prior 
art applied to that claim. New 35 U.S.C. 301(d) provides that a 
statement of the patent owner, pursuant to Sec.  1.501(a)(2), may be 
relied upon in the ex parte reexamination proceeding only after 
reexamination has been ordered. In order to comply with the requirement 
of 35 U.S.C. 302 that the ``request must set forth the pertinency and 
manner of applying cited prior art to every claim for which 
reexamination is requested,'' the ``detailed explanation'' provided in 
the request (pursuant to Sec.  1.510(b)(2)) must explain how each Sec.  
1.501(a)(2) statement is being used to determine the proper meaning of 
a patent claim in connection with the applied prior art. This must be 
explained for each claim for which the Sec.  1.501(a)(2) statement is 
being used in the request, and the explanation will be considered by 
the Office during the examination stage, if reexamination is ordered. 
At the order stage, the Office will use the broadest reasonable 
interpretation of the claims, without consideration to any Sec.  
1.501(a)(2) statement relied upon in the detailed explanation of a 
request.
    New Sec.  1.510(b)(6) requires that the request contain a 
certification that the statutory estoppel provisions of inter partes 
review and post grant review do not bar the third party from requesting 
ex parte reexamination. To complement this revision, Sec.  1.510(b)(7) 
requires that the request contain, as part of the certification, a 
statement identifying the real party(ies) in interest to the extent 
necessary to determine whether an inter partes review or post grant 
review filed subsequent to an ex parte reexamination bars the third 
party from maintaining a pending ex parte reexamination. An ex parte 
reexamination requester has the option to remain anonymous. In order to 
do so, the requester must: (1) Submit the statement identifying the 
real party(ies) in interest as a separate paper; (2) title the paper as 
a statement identifying the real party(ies) in interest; (3) request in 
the paper that the Office to retain the paper in confidence by sealing 
it; and (4) include, in a clear and conspicuous manner, an appropriate 
instructional label designating the statement as a non-public 
submission, e.g., NOT OPEN TO THE PUBLIC FOR OFFICE USE ONLY. The 
Office will then maintain the real party(ies) in interest statement as 
a sealed, non-public submission.
    The estoppel provisions of inter partes review and post grant 
review are provided in new 35 U.S.C. 315(e)(1) and 325(e)(1), 
respectively. These estoppel provisions bar a request for ex parte 
reexamination (or maintenance of an ex parte reexamination) by a third 
party requester, the requester's real party(ies) in interest, or a 
privy, where the requester petitioned for an inter partes review or 
post grant review of a claim in the patent that resulted in a final 
written decision with respect to that claim on any ground that the 
petitioner raised or reasonably could have raised during that inter 
partes review or post grant review. The certification and 
identification in new Sec. Sec.  1.510(b)(6) and 1.510(b)(7) are 
consistent with the practice of real party(ies) in interest 
identification certification used for existing inter partes 
reexamination. As was the case for implementation of Sec. Sec.  
1.915(b)(7) and 1.915(b)(8) for inter partes reexamination, the 
certification and identification to be implemented via new Sec. Sec.  
1.510(b)(6) and 1.510(b)(7) address Congress's desire to prevent 
harassment of the patent owner by third parties. See H.R. Rep. No. 112-
98 (Part 1), at 48.
    Section 1.515: Section 1.515 is revised to add: ``A statement 
pursuant to Sec.  1.501(a)(2) will not be considered by the examiner in 
the examiner's determination on the request.'' New 35 U.S.C. 301(d) 
states: ``A written statement submitted pursuant to subsection (a)(2), 
and additional information submitted pursuant to subsection (c) [of 35 
U.S.C. 301], shall not be considered by the Office for any purpose 
other than to determine the proper meaning of a patent claim in a 
proceeding that is ordered * * * pursuant to section 304.'' The Office 
interprets 35 U.S.C. 301(d) as prohibiting it from considering a Sec.  
1.501(a)(2) written statement when making the determination of whether 
to order ex parte reexamination under 35 U.S.C. 303. See also H.R. Rep. 
No. 112-98, Part 1, at page 46 (2011). In making the Sec.  1.515(a) 
determination of whether to order ex parte reexamination, the Office 
will generally (except in the rare case of an expired patent), give the 
claims the broadest reasonable interpretation consistent with the 
specification (See In re Yamamoto, 740 F.2d 1569, 222 USPQ 934 (Fed. 
Cir. 1984)). Consideration of the evidentiary weight to be accorded to 
a 35 U.S.C. 301(a)(2) statement (as to the meaning of the claims with 
respect to the ultimate patentability decision) will not be given 
unless reexamination is ordered. If reexamination is ordered, the 
patent owner statements submitted pursuant to 35 U.S.C. 301(a)(2) will 
be considered to the fullest extent possible when determining the scope 
of any claims in the patent which are subject to reexamination.
    Section 1.552: Sec.  1.552 is rewritten to include new subsection 
Sec.  1.552(d) to reflect the amendment of 35 U.S.C. 301 by section 
6(g)(1) of the Leahy-Smith America Invents Act. Proposed Sec.  1.552(d) 
states: ``Any statement of the patent owner and any accompanying 
information submitted pursuant to Sec.  1.501(a)(2) which is of record 
in the patent being reexamined (which includes any reexamination files 
for the patent) may be used after a reexamination proceeding has been 
ordered to determine the proper meaning of a patent claim when applying 
patents or printed

[[Page 446]]

publications.'' New 35 U.S.C. 301(a)(2) permits a submission under 35 
U.S.C. 301 to contain ``statements of the patent owner filed in a 
proceeding before a Federal court or the Office in which the patent 
owner took a position on the scope of any claim of a particular 
patent.'' Thus, written statements cited under new 35 U.S.C. 301(a)(2) 
may be considered after an ex parte reexamination proceeding has been 
ordered, but not in making the determination of whether to order ex 
parte reexamination under 35 U.S.C. 303. See 35 U.S.C. 301(d). See also 
H.R. Rep. No. 112-98, Part 1, at page 46 (2011).
    The Office also proposes to change the nomenclature in title 37 CFR 
to reflect renaming the ``Board of Patent Appeals and Interferences'' 
as the ``Patent Trial and Appeal Board,'' including changes for the new 
trial proceedings of inter partes review, post grant review, and 
derivation. Specifically, the Office proposes to change ``Board of 
Patent Appeals and Interferences'' to the ``Patent Trial and Appeal 
Board'' in 37 CFR parts 1, 11, and 41 (in Sec. Sec.  1.1(a)(1)(ii), 
1.4(a)(2), 1.6(d)(9), 1.8(a)(2)(i)(C), 1.9(g), 1.17(b), 1.36(b), 
1.48(j), 1.136(a)(1)(iv), 1.136(a)(2), 1.136(b), 1.181(a)(1), 
1.181(a)(3), 1.191, 1.197(a), 1.198, 1.248(c), 1.294(b), 1.301, 
1.303(a), 1.304(a)(1), 1.304(a)(1)(ii), 1.324(d), 1.550(a), 
1.701(a)(3), 1.701(c)(3), 1.702(a)(3), 1.702(b)(4), 1.702(e), 
1.703(a)(5), 1.703(b)(4), 1.703(e), 1.704(c)(9), 1.937(a), 1.959, 
1.979(a), 1.979(b), 1.981, 1.983(a), 1.983(c), 1.983(d), 1.983(f), 
11.5(b)(1), 11.6(d), 41.1(a), 41.2, 41.10(a)-(c), and 41.77(a), and in 
the title of part 41). The Office likewise proposes to add specific 
references to trial proceedings before the Patent Trial and Appeal 
Board to Sec. Sec.  1.5(c), 1.6(d), 1.6(d)(9), 1.11(e), 1.136(a)(2), 
1.136(b), 1.178(b), 1.248(c), 1.322(a)(3), 1.324(a), 1.324(d), 
1.565(a), 1.565(e), 1.985(a), 1.985(b), 1.993, 10.1(s), 
11.10(b)(3)(iii), and 11.57(b)(1)(i). Finally, the Office proposes to 
add specific references to derivation proceedings to Sec. Sec.  
1.48(j), 1.55(a)(3)(i), 1.55(a)(4)(i)(A), 1.103(g), 1.136(a)(1)(v), 
1.313(b)(4), 1.701(a)(1), 1.701(c)(1)(i-ii), 1.701(c)(2)(iii), 
1.702(b)(2), 1.702(c), 1.703(b)(2)(i-ii), 1.703(b)(3)(iii), 1.703(c)(1-
2), 1.703(d)(3), and 5.3(b).

III. Rulemaking Considerations

    A. Administrative Procedure Act (APA): This proposed rule revises 
existing rules governing prior art citations and patent owner 
statements in a patent file and ex parte reexamination to implement the 
following provisions of sections 3 and 6 of the Leahy-Smith America 
Invents Act: (1) Section 6(g) which amends 35 U.S.C. 301, to expand the 
scope of information that can be submitted in the file of an issued 
patent; (2) the provisions of sections 6(a) and 6(d) (which newly enact 
inter partes review and post grant review, respectively) that provide 
for estoppels effective as to proceedings before the Office, including 
but not limited to reexamination; and (3) sections 3(j) and 7 which 
change the title ``Board of Patent Appeals and Interferences'' to 
``Patent Trial and Appeal Board,'' and change references to 
interference proceedings to derivation proceedings.
    Therefore, the changes in this proposed rule are merely procedural 
and/or interpretive. See Bachow Communs., 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.S.C. 
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 changes 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. Regulatory Flexibility Act: As prior notice and an opportunity 
for public comment are not required pursuant to 5 U.S.C. 553 or any 
other law, neither a regulatory flexibility analysis nor a 
certification under the Regulatory Flexibility Act (5 U.S.C. 601 et 
seq.) is required. See 5 U.S.C. 603.
    C. Executive Order 12866 (Regulatory Planning and Review): This 
rulemaking has been determined to be not 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).
    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).

[[Page 447]]

    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 proposed in 
this notice do not involve a Federal intergovernmental mandate that 
will result in the expenditure by State, local, and tribal governments, 
in the aggregate, of 100 million dollars (as adjusted) or more in any 
one year, or a Federal private sector mandate that will result in the 
expenditure by the private sector of 100 million dollars (as adjusted) 
or more in any one year, and will not significantly or uniquely affect 
small governments. Therefore, no actions are necessary under the 
provisions of the Unfunded Mandates Reform Act of 1995. See 2 U.S.C. 
1501 et seq.
    M. National Environmental Policy Act: This rulemaking will not have 
any effect on the quality of the environment and is thus categorically 
excluded from review under the National Environmental Policy Act of 
1969. See 42 U.S.C. 4321 et seq.
    N. National Technology Transfer and Advancement Act: The 
requirements of section 12(d) of the National Technology Transfer and 
Advancement Act of 1995 (15 U.S.C. 272 note) are not applicable because 
this rulemaking does not contain provisions which involve the use of 
technical standards.
    O. Paperwork Reduction Act: The Paperwork Reduction Act of 1995 (44 
U.S.C. 3501 et seq.) requires that the Office consider the impact of 
paperwork and other information collection burdens imposed on the 
public. This proposed rulemaking involves information collection 
requirements which are subject to review by the Office of Management 
and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3549). The collection of information involved in this notice has 
been submitted to OMB under OMB control number 0651-00xx. The proposed 
collection will be available at OMB's Information Collection Review Web 
site (http://www.reginfo.gov/public/do/PRAMain).
    Needs and Uses: This information collection is necessary so that 
the public may file, in a patent, submissions of patents and printed 
publications, and statements of the patent owner filed in a proceeding 
before a Federal court or the Office in which the patent owner took a 
position on the scope of any claim of the patent. The public may use 
this information to aid in ascertaining the patentability and/or scope 
of the claims of the patent.
    Title of Collection: Post Patent Public Submissions.
    OMB Control Number: 0651-00xx.
    Method of Collection: By mail, facsimile, hand delivery, or 
electronically to the Office.
    Affected Public: Individuals or households; businesses or other 
for-profits; and not-for-profit institutions.
    Estimated Number of Respondents: 1,000 responses per year.
    Estimated Time Per Response: The Office estimates that the 
responses in this collection will take the public 10 hours.
    Estimated Total Annual Respondent Burden Hours: 10,000 hours per 
year.
    Estimated Total Annual Respondent Cost Burden: $3,400,000 per year.
    The Office is soliciting comments to: (1) Evaluate whether the 
proposed information requirement is necessary for the proper 
performance of the functions of the Office, including whether the 
information will have practical utility; (2) evaluate the accuracy of 
the Office'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 5, 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.
    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 record keeping 
requirements, Small businesses, and Biologics.

    For the reasons set forth in the preamble, 37 CFR Part 1 is 
proposed to be amended as follows:

PART 1--RULES OF PRACTICE IN PATENT CASES

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

    Authority:  35 U.S.C. 2(b)(2), unless otherwise noted.

    2. The undesignated center heading before Sec.  1.501 is revised to 
read as follows:

Citation of Prior Art and Written Statements

    3. Section 1.501 is revised to read as follows:


Sec.  1.501  Citation of prior art and written statements in patent 
files.

    (a) Information content of submission: At any time during the 
period of enforceability of a patent, any person may file a written 
submission with the Office under this section, which is directed to the 
following information:
    (1) Prior art consisting of patents or printed publications which 
the person making the submission states to have a bearing on the 
patentability of any claim of the patent; or
    (2) Statements of the patent owner filed in a proceeding before a 
Federal court or the Office in which the patent owner took a position 
on the scope of any claim of the patent. Any statement submitted under 
this paragraph must be accompanied by any other documents, pleadings, 
or evidence from the proceeding in which the statement was filed that 
address the written statement, and such statement and accompanying

[[Page 448]]

information under this paragraph must be submitted in redacted form to 
exclude information subject to an applicable protective order. 
Submission of a statement of the patent owner made outside of a Federal 
court or Office proceeding and later filed for inclusion in a Federal 
court or Office proceeding is not permitted by this section, and such a 
submission will not be entered into the patent file.
    (b) Explanation included: A submission pursuant to paragraph (a) of 
this section:
    (1) Must explain in writing the pertinence and manner of applying 
any prior art submitted under paragraph (a)(1) of this section and any 
written statement and accompanying information submitted under 
paragraph (a)(2) of this section to at least one claim of the patent, 
in order for the submission to become a part of the official file of 
the patent; and
    (2) May, if the submission is made by the patent owner, include an 
explanation of how the claims differ from any prior art submitted under 
paragraph (a)(1) of this section or any written statements and 
accompanying information submitted under paragraph (a)(2) of this 
section.
    (c) Reexamination pending: If a reexamination proceeding has been 
requested and is pending for the patent in which the submission is 
filed, entry of the submission into the official file of the patent is 
subject to the provisions of Sec. Sec.  1.502 and 1.902.
    (d) Identity: If the person making the submission wishes his or her 
identity to be excluded from the patent file and kept confidential, the 
submission papers must be submitted anonymously without any 
identification of the person making the submission.
    (e) Service of the submission: A submission made under this section 
must reflect that a copy of the submission has been served upon the 
patent owner at the correspondence address of record in the patent, in 
accordance with Sec.  1.248, or that a bona fide attempt of service was 
made. A submission that fails to include either proof of service or a 
sufficient explanation and proof of a bona fide attempt of service will 
not be entered into the patent file, and will be expunged if 
inadvertently entered.
    (f) Consideration of statements of patent owner: Statements of the 
patent owner and accompanying information submitted under paragraph 
(a)(2) of this section shall not be considered by the Office for any 
purpose other than as provided for in 35 U.S.C. 301(d) . If 
reexamination is ordered, the patent owner statements submitted 
pursuant to section 301(a)(2) will be considered when determining the 
scope of any claims in the patent subject to reexamination.
    4. Section 1.510 is amended by revising paragraph (b)(2), and 
adding new paragraphs (b)(6) and (b)(7), to read as follows:


Sec.  1.510  Request for ex parte reexamination.

* * * * *
    (b) * * *
    (2) An identification of every claim for which reexamination is 
requested, and a detailed explanation of the pertinency and manner of 
applying the cited prior art to every claim for which reexamination is 
requested. For each statement and accompanying information of the 
patent owner submitted pursuant to Sec.  1.501(a)(2) which is relied 
upon in the detailed explanation, the request must explain how that 
statement is being used to determine the proper meaning of a patent 
claim in connection with the prior art applied to that claim and how 
each relevant claim is being interpreted. If appropriate, the party 
requesting reexamination may also point out how claims distinguish over 
cited prior art.
* * * * *
    (6) A certification that the statutory estoppel provisions of both 
inter partes review (35 U.S.C. 315(e)(1)) and post grant review (35 
U.S.C. 325(e)(1)) do not prohibit the ex parte reexamination.
    (7) A statement identifying the real party(ies) in interest to the 
extent necessary to determine whether any inter partes review or post 
grant review filed subsequent to an ex parte reexamination bars a 
pending ex parte reexamination filed by the real party(ies) in interest 
or its privy from being maintained.
    5. Section 1.515 is amended by revising paragraph (a) to read as 
follows:


Sec.  1.515  Determination of the request for ex parte reexamination.

    (a) Within three months following the filing date of a request for 
an ex parte reexamination, an examiner will consider the request and 
determine whether or not a substantial new question of patentability 
affecting any claim of the patent is raised by the request and the 
prior art cited therein, with or without consideration of other patents 
or printed publications. A statement and any accompanying information 
submitted pursuant to Sec.  1.501(a)(2) will not be considered by the 
examiner in the examiner's determination on the request. The examiner's 
determination will be based on the claims in effect at the time of the 
determination, will become a part of the official file of the patent, 
and will be mailed to the patent owner at the address provided for in 
Sec.  1.33(c) and to the person requesting reexamination.
* * * * *
    6. Section 1.552 is amended by adding new paragraph (d) to read as 
follows:


Sec.  1.552  Scope of reexamination in ex parte reexamination 
proceedings.

* * * * *
    (d) Any statement of the patent owner and any accompanying 
information submitted pursuant to Sec.  1.501(a)(2) which is of record 
in the patent being reexamined (which includes any reexamination files 
for the patent) may be used after a reexamination proceeding has been 
ordered to determine the proper meaning of a patent claim when applying 
patents or printed publications.

    Dated: December 30, 2011.
David J. Kappos,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2011-33813 Filed 1-4-12; 8:45 am]
BILLING CODE 3510-16-P