| Allowance, Patent Term Adjustment or Extension |
Referenced Items (286, 287, 288, 289, 290, 291, 292, 293, 294, 295, 296, 297, 298, 299, 300, 301, 302) |
(293) 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.
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
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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 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
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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 Order 13563. Specifically,
the Office has, to the extent feasible and applicable: (1) Made a reasoned
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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
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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
1. The authority citation for 37 CFR Part 1 continues to read as
follows:
Authority: 35 U.S.C. 2(b)(2).
2. Section 1.704 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 §§ 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 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
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(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.
* * * * *
November 21, 2011 DAVID J. KAPPOS
Under Secretary of Commerce for Intellectual Property and
Director of the United States Patent and Trademark Office
[1374 OG 122]