Revision of Patent Term Adjustment Provisions Relating to Information Disclosure Statements, 74700-74703 [2011-30933]

Agencies

• DEPARTMENT OF COMMERCE
• Patent and Trademark Office

[Federal Register Volume 76, Number 231 (Thursday, December 1, 2011)]
[Rules and Regulations]
[Pages 74700-74703]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-30933]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

37 CFR Part 1

[Docket No. PTO-P-2011-0014]
RIN 0651-AC56


Revision of Patent Term Adjustment Provisions Relating to 
Information Disclosure Statements

AGENCY: United States Patent and Trademark Office, Commerce.

ACTION: Final rule.

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SUMMARY: The United States Patent and Trademark Office (Office) is 
revising the patent term adjustment provisions of the rules of practice 
in patent cases. The patent term adjustment provisions of the American 
Inventors Protection Act of 1999 (AIPA) provide for a reduction of any 
patent term adjustment if the applicant failed to engage in reasonable 
efforts to conclude prosecution of the application. The Office is 
revising the rules of practice pertaining to the reduction of patent 
term adjustment for applicant delays to exclude information disclosure 
statements resulting from the citation of information in a counterpart 
application that are promptly filed with the Office. The rule change 
allows the diligent applicant to avoid patent term adjustment reduction 
for an IDS submission that results from a communication from the 
Office. Presently, the rule only provides relief if the IDS was cited 
as a result of a communication from a foreign patent office. Under this 
final rule, there will be no reduction of patent term adjustment in the 
following situations: when applicant promptly submits a reference in an 
information disclosure statement after the mailing of a notice of 
allowance if the reference was cited by the Office in another 
application, or when applicant promptly submits a copy of an Office 
communication (e.g., an Office action) in an information disclosure 
statement after the mailing of a notice of allowance if the Office 
communication was issued by the Office in another application or by a 
foreign patent office in a counterpart foreign application. The above 
changes are intended to ensure compliance with AIPA in light of the 
evolving case law.

DATES: Effective Date: December 1, 2011.

FOR FURTHER INFORMATION CONTACT: Kery A. Fries, Senior Legal Advisor, 
Office of Patent Legal Administration, by telephone at (571) 272-7757, 
by mail addressed to: Box Comments--Patents, Commissioner for Patents, 
P.O. Box 1450, Alexandria, VA 22313-1450, marked to the attention of 
Kery A. Fries.

SUPPLEMENTARY INFORMATION: The AIPA amended 35 U.S.C. 154(b) to provide 
patent term adjustment for certain delays during the patent examination 
process. See Public Law 106-113, 113 Stat. 1501, 1501A-552 through 
1501A-591 (1999)). Specifically, under the patent term adjustment 
provisions of 35 U.S.C. 154(b) as amended by the AIPA, an applicant is 
entitled to patent term adjustment for the following reasons: (1) If 
the Office fails to take certain actions during the examination and 
issue process within specified time frames (35 U.S.C. 154(b)(1)(A)); 
(2) if the Office fails to issue a patent within three years of the 
actual filing date of the application in the United States (35 U.S.C. 
154(b)(1)(B)); and (3) for delays due to interference, secrecy order, 
or successful appellate review (35 U.S.C. 154(b)(1)(C)). The AIPA, 
however, sets forth a number of conditions and limitations on any 
patent term adjustment accrued under 35 U.S.C. 154(b)(1). Specifically, 
35 U.S.C. 154(b)(2)(C) provides, in part, that ``[t]he period of 
adjustment of the term of a patent under [35 U.S.C. 154(b)(1)] shall be 
reduced by a period equal to the period of time during which the 
applicant failed to engage in reasonable efforts to conclude 
prosecution of the application'' and that ``[t]he Director shall 
prescribe regulations establishing the circumstances that constitute a 
failure of an applicant to engage in reasonable efforts to conclude 
processing or examination of an application.'' 35 U.S.C. 
154(b)(2)(C)(i) and (iii). The Office implemented the patent term 
adjustment provisions of 35 U.S.C. 154(b) as amended by the AIPA, 
including setting forth the circumstances that constitute a failure of 
an applicant to engage in reasonable efforts to conclude processing or 
examination of an application, in a final rule published in September 
of 2000. See Changes to Implement Patent Term Adjustment Under Twenty-
Year Patent

[[Page 74701]]

Term, 65 FR 56366 (Sept. 18, 2000) (patent term adjustment final rule).
    Section 1.704(c) provides that the submission of an information 
disclosure statement either that is after a notice of allowance, an 
initial reply, or that requires a supplemental Office action, results 
in a reduction of any patent term adjustment under 37 CFR 1.703. See 37 
CFR 1.704(c)(6), 1.704(c)(8), 1.704(c)(9), and (c)(10). Section 
1.704(d) provides that an information disclosure statement will not 
result in a patent term adjustment reduction under 37 CFR 1.704(c)(6), 
1.704(c)(8), 1.704(c)(9), or (c)(10) if it is accompanied by a 
statement that each item of information contained in the information 
disclosure statement was first cited in a communication from a foreign 
patent office in a counterpart application and that this communication 
was not received by any individual designated in 37 CFR 1.56(c) more 
than thirty days prior to the filing of the information disclosure 
statement. 37 CFR 1.704(d) permits applicants to submit information 
first cited in a communication from a foreign patent office in a 
counterpart application to the Office without a reduction in patent 
term adjustment if an information disclosure statement is promptly 
(within thirty-days of receipt of the communication) submitted to the 
Office.
    Recent decisions by the U.S. Court of Appeals for the Federal 
Circuit (Federal Circuit) underscore the importance of making 
information cited and Office actions issued in related copending 
foreign and domestic applications of record. See Dayco Products, Inc. 
v. Total Containment, Inc., 329 F.3d 1358 (Fed. Cir. 2003) and McKesson 
Info. Solutions, Inc. v. Bridge Medical, Inc., 487 F.3d 897 (Fed. Cir. 
2007); see also Larson Mfg. Co. v. Aluminart Products Ltd., 559 F.3d 
1317 (Fed. Cir. 2009) (relating to disclosure in a U.S. reexamination 
proceeding of U.S. Office actions that were issued in a continuation 
application of the patent under reexamination). The Office is revising 
37 CFR 1.704(d) to also embrace information first cited in a 
communication from the Office, as well as the communication (e.g., 
Office action) in a counterpart foreign or international application. 
These revisions are intended to ensure compliance with AIPA in light of 
the evolving case law. Obviously, meeting the conditions set forth in 
37 CFR 1.704(d) does not substitute for compliance with any relevant 
requirement of 37 CFR 1.97 or 1.98.

Discussion of Specific Rules

    Title 37 of the Code of Federal Regulations, Part 1, is amended as 
follows:
    Section 1.704: Section 1.704(d) is amended to change ``any 
communication from a foreign patent office in a counterpart 
application'' to ``any communication from a patent office in a 
counterpart foreign or international application or from the Office,'' 
and to add to this definition ``a communication that was issued by a 
patent office in a counterpart foreign or international application or 
by the Office.'' This change revises Sec.  1.704(d) to also embrace 
information first cited in a communication from the Office, as well as 
the communication (e.g., Office action) in a counterpart foreign or 
international application or from the Office itself.
    Response to Comments: The Office published a notice in April of 
2011 proposing to change the rules of practice pertaining to patent 
term extension and adjustment to: (1) Indicate that in most 
circumstances an examiner reopening prosecution of the application 
after a notice of appeal has been filed will be considered a decision 
in the review reversing an adverse determination of patentability for 
purposes of patent term adjustment or extension purposes; and (2) 
exclude information disclosure statements resulting from the citation 
of information by a foreign patent office in a counterpart application 
that are promptly filed with the Office from the provisions for the 
reduction of patent term adjustment for applicant delays. See Revision 
of Patent Term Extension and Adjustment Provisions Relating to 
Appellate Review and Information Disclosure Statements, 76 FR 18990 
(Apr. 6, 2011). The Office received eight written comments in response 
to this notice. The Office is revising its proposal concerning the 
reopening of prosecution of an application by the Office after a notice 
of appeal has been filed and will publish that proposal for public 
comment in a separate rulemaking. The comments and the Office's 
responses to the comments pertaining to information disclosure 
statements resulting from the citation of information by a foreign 
patent office in a counterpart application that are promptly filed with 
the Office follow.
    The comments on the Office's proposed change to 37 CFR 1.704(d) 
pertaining to information disclosure statements supported the proposed 
change. The Office also received comments on provisions of 37 CFR 1.704 
that the Office did not propose to change: (1) One comment suggested 
changing the thirty day to a three month period; and (2) one comment 
indicated that an information disclosure statement filed after a notice 
of appeal should not result in reduction under 37 CFR 1.704(c)(8).
    The Office did not propose to change the thirty-day period in 37 
CFR 1.704(d). The Office adopted the provisions of 37 CFR 1.704(d) in 
2000 to permit applicants to avoid a patent term adjustment impact if 
an information disclosure statement containing information that was 
cited in a communication from a foreign patent office in a counterpart 
application is promptly submitted to the Office. The Office does not 
consider an information disclosure statement filed more than thirty 
days after the information has been brought to applicant's attention to 
be promptly submitted.
    Regarding the second comment, 37 CFR 1.704(c)(8) does not provide 
for a reduction of any patent term adjustment simply because an 
applicant files an information disclosure statement after a notice of 
appeal has been filed.

Rulemaking Considerations

    A. Regulatory Flexibility Act: For the reasons set forth herein, 
the Deputy General Counsel for General Law of the United States Patent 
and Trademark Office has certified to the Chief Counsel for Advocacy of 
the Small Business Administration that the changes in this rulemaking 
will not have a significant economic impact on a substantial number of 
small entities. See 5 U.S.C. 605(b).
    This rulemaking expands the exception to the patent term adjustment 
reduction for filing an information disclosure statement after a notice 
of allowance or reply, or for filing an information disclosure 
statement that requires a supplemental Office action, for information 
cited by a foreign patent office in a counterpart application that is 
promptly filed with the Office, to embrace information first cited by 
the Office in another application. This rulemaking does not add any 
additional requirements (including information collection requirements) 
or fees for patent applicants or patentees. Therefore, the changes in 
this rulemaking will not have a significant economic impact on a 
substantial number of small entities.
    B. 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).
    C. Executive Order 13563 (Improving Regulation and Regulatory 
Review): The Office has complied with Executive

[[Page 74702]]

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.
    D. 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).
    E. 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).
    F. 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).
    G. 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).
    H. 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).
    I. 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).
    J. 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 U.S. 
Senate, the U.S. 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).
    K. Unfunded Mandates Reform Act of 1995: The changes 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.
    L. National Environmental Policy Act: This rulemaking will not have 
any effect on the quality of environment and is thus categorically 
excluded from review under the National Environmental Policy Act of 
1969. See 42 U.S.C. 4321 et seq.
    M. 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.
    N. Paperwork Reduction Act: The rules of practice pertaining to 
patent term adjustment and extension have been reviewed and approved by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501 et seq.) under OMB control number 0651-
0020. As discussed previously, this rulemaking expands the exception to 
the patent term adjustment reduction for filing an information 
disclosure statement after a notice of allowance or a reply, or for 
filing an information disclosure statement that requires a supplemental 
Office action, for information cited by a foreign patent office in a 
counterpart application that are promptly filed with the Office, to 
embrace information first cited by the Office in another application. 
This notice does not propose to add any additional requirements 
(including information collection requirements) or fees for patent 
applicants or patentees. Therefore, the Office is not resubmitting 
information collection packages to OMB for its review and approval 
because the changes in this rulemaking do not affect the information 
collection requirements associated with the information collections 
approved under OMB control number 0651-0020.
    Notwithstanding any other provision of law, no person is required 
to respond to nor shall any person be subject to a penalty for failure 
to comply with a collection of information subject to the requirements 
of the Paperwork Reduction Act unless that collection of information 
displays a currently valid OMB control number.

List of Subjects in 37 CFR Part 1

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

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

PART 1--RULES OF PRACTICE IN PATENT CASES

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

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


0
2. Section 1.704 is amended by revising paragraph (d) to read as 
follows:


Sec.  1.704  Reduction of period of adjustment of patent term.

* * * * *
    (d)(1) A paper containing only an information disclosure statement 
in compliance with Sec. Sec.  1.97 and 1.98 will not be considered a 
failure to engage in reasonable efforts to conclude prosecution 
(processing or examination) of the application under paragraphs (c)(6), 
(c)(8), (c)(9), or (c)(10) of this

[[Page 74703]]

section if it is accompanied by a statement that each item of 
information contained in the information disclosure statement:
    (i) Was first cited in any communication from a patent office in a 
counterpart foreign or international application or from the Office, 
and this communication was not received by any individual designated in 
Sec.  1.56(c) more than thirty days prior to the filing of the 
information disclosure statement; or
    (ii) Is a communication that was issued by a patent office in a 
counterpart foreign or international application or by the Office, and 
this communication was not received by any individual designated in 
Sec.  1.56(c) more than thirty days prior to the filing of the 
information disclosure statement.
    (2) The thirty-day period set forth in paragraph (d)(1) of this 
section is not extendable.
* * * * *

    Dated: November 21, 2011.
David J. Kappos,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2011-30933 Filed 11-30-11; 8:45 am]
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