[Federal Register Volume 79, Number 117 (Wednesday, June 18, 2014)]
[Proposed Rules]
[Pages 34681-34685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-14186]
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DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
37 CFR Part 1
[Docket No.: PTO-P-2014-0023]
RIN 0651-AC96
Changes to Patent Term Adjustment in View of the Federal Circuit
Decision in Novartis v. Lee
AGENCY: United States Patent and Trademark Office, Commerce.
ACTION: Notice of proposed rulemaking.
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[[Page 34682]]
SUMMARY: The United States Patent and Trademark Office (Office) is
proposing changes to the rules of practice pertaining to the patent
term adjustment provisions in view of the decision by the U.S. Court of
Appeals for the Federal Circuit (Federal Circuit) in Novartis AG v.
Lee. The Federal Circuit confirmed in Novartis that any time consumed
by continued examination is subtracted in determining the extent to
which the period of application pendency exceeds three years,
regardless when the continued examination was initiated. The Federal
Circuit, however, decided that the time consumed by continued
examination does not include the time after a notice of allowance,
unless the Office actually resumes examination of the application after
allowance. The Office is proposing changes to the rules of practice to
provide that the time consumed by continued examination does not
include the time after a notice of allowance, unless the Office
actually resumes examination of the application after allowance. The
Office also is proposing changes to the rules of practice to provide
that the submission of a request for continued examination after a
notice of allowance has been mailed will constitute a failure of an
applicant to engage in reasonable efforts to conclude processing or
examination of an application and thus result in a reduction of any
period of patent term adjustment.
DATES: Comment Deadline Date: Written comments must be received on or
before August 18, 2014.
ADDRESSES: Comments should be sent by electronic mail message over the
Internet addressed to: [email protected]. Comments also may 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 Kery Fries, Senior Legal Advisor, Office of
Patent Legal Administration, Office of the Deputy Commissioner for
Patent Examination Policy.
Comments further may 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 submitted in plain text are
preferred, but may be submitted in ADOBE[supreg] portable document
format or MICROSOFT WORD[supreg] format. Comments not submitted
electronically should be submitted on paper in a format that
facilitates convenient digital scanning into ADOBE[supreg] portable
document format.
Comments 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: Kery Fries, Senior Legal Advisor,
Office of Patent Legal Administration, Office of the Deputy
Commissioner for Patent Examination Policy, at telephone number 571-
272-7757.
SUPPLEMENTARY INFORMATION:
Executive Summary: Purpose: The Office is proposing changes to the
rules of practice pertaining to the patent term adjustment provisions
of 35 U.S.C. 154(b) in view of the decision by the Federal Circuit in
Novartis, 740 F.3d 593 (Fed. Cir. 2014). The Federal Circuit confirmed
in Novartis that any time consumed by continued examination under 35
U.S.C. 132(b) is subtracted in determining the extent to which the
period defined in 35 U.S.C. 154(b)(1)(B) exceeds three years,
regardless when the continued examination under 35 U.S.C. 132(b) was
initiated. The Federal Circuit, however, decided that the time consumed
by continued examination under 35 U.S.C. 132(b) does not include the
time after a notice of allowance unless the Office actually resumes
examination of the application after allowance.
Summary of Major Provisions: The Office is proposing changes to the
rules of practice to provide that the time consumed by continued
examination under 35 U.S.C. 132(b) does not include the time after a
notice of allowance, unless the Office actually resumes examination of
the application after allowance. The Office also is proposing changes
to the rules of practice to provide that the submission of a request
for continued examination under 35 U.S.C. 132(b) after a notice of
allowance under 35 U.S.C. 151 has been mailed will constitute a failure
of an applicant to engage in reasonable efforts to conclude processing
or examination of an application and thus result in a reduction of any
period of patent term adjustment under 35 U.S.C. 154(b)(1).
Costs and Benefits: This rulemaking is not economically significant
under Executive Order 12866 (Sept. 30, 1993).
Background: In January 2014, the Federal Circuit issued a decision
in Novartis pertaining to the patent term adjustment provisions of 35
U.S.C. 154(b), and specifically the impact of continued examination
under 35 U.S.C. 132(b) on patent term adjustment under the three-year
pendency provision of 35 U.S.C. 154(b)(1)(B). The Federal Circuit
confirmed in Novartis that any time consumed by continued examination
under 35 U.S.C. 132(b) is subtracted in determining the extent to which
the period defined in 35 U.S.C. 154(b)(1)(B) exceeds three years,
regardless when the continued examination under 35 U.S.C. 132(b) was
initiated. See 740 F.3d at 601 (``[t]he better reading of the language
is that the patent term adjustment time should be calculated by
determining the length of the time between application and patent
issuance, then subtracting any continued examination time (and other
time identified in (i), (ii), and (iii) of [35 U.S.C. 154](b)(1)(B)),
and determining the extent to which the result exceeds three years'').
The Federal Circuit, however, decided that the time consumed by
continued examination under 35 U.S.C. 132(b) does not include the time
after a notice of allowance unless the Office actually resumes
examination of the application after allowance. See 740 F.3d at 602
(``[t]he common-sense understanding of `time consumed by continued
examination,' 35 U.S.C. 154(b)(1)(B)(i), is time up to allowance, but
not later, unless examination on the merits resumes''). Therefore, the
Office is proposing changes to the rules of practice to provide that
the time consumed by continued examination under 35 U.S.C. 132(b) does
not include the time after a notice of allowance, unless the Office
actually resumes examination of the application after allowance.
The Office makes the patent term adjustment determination indicated
in the patent by a computer program that uses the information recorded
in the Office's Patent Application Locating and Monitoring (PALM)
system (except when an applicant requests reconsideration pursuant to
Sec. 1.705). See Changes to Implement Patent Term Adjustment Under
Twenty-Year Patent Term, 65 FR 56365, 56370, 56380-81 (Sept. 18, 2000)
(final rule). The decision in Novartis that the time consumed by
continued examination under 35 U.S.C. 132(b) does not include the time
after a notice of allowance unless the Office actually resumes
examination of the application after
[[Page 34683]]
allowance requires modifications of the Office's patent term adjustment
program, and these modifications of the Office's patent term adjustment
program have not yet been completed. The Office, however, calculates
the patent term adjustment manually when an applicant requests
reconsideration of a patent term adjustment determination pursuant to
Sec. 1.705. The Office is now deciding requests for reconsideration of
a patent term adjustment filed pursuant to Sec. 1.705 consistent with
the Federal Circuit decision in Novartis.
The patent term adjustment statutory provision also includes the
provision 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.'' See 35 U.S.C. 154(b)(2)(C)(i) and (iii). Under the
authority provided in 35 U.S.C. 154(b)(2)(C), the Office is proposing a
rule of practice that establishes the submission of a request for
continued examination under 35 U.S.C. 132(b) after a notice of
allowance under 35 U.S.C. 151 has been mailed as constituting a failure
of an applicant to engage in reasonable efforts to conclude processing
or examination of an application. This rule of practice is proposed to
ensure that an applicant does not obtain multiple periods of patent
term adjustment under 35 U.S.C. 154(b)(1)(B) for the time after a
notice of allowance under 35 U.S.C. 151 as a consequence of delaying
issuance of the application by filing request for continued examination
under 35 U.S.C. 132(b) after a notice of allowance under 35 U.S.C. 151.
Discussion of Specific Rules
The following is a discussion of proposed amendments to title 37 of
the Code of Federal Regulations, Part 1:
Section 1.703: Section 1.703(b)(1) is proposed to be amended to
provide that the time consumed by continued examination of the
application under 35 U.S.C. 132(b) is the number of days, if any, in
the period beginning on the date on which a request for continued
examination of the application under 35 U.S.C. 132(b) was filed and
ending on the date of mailing of a notice of allowance under 35 U.S.C.
151, unless prosecution in the application is reopened. If prosecution
in the application is reopened, the time consumed by continued
examination of the application under 35 U.S.C. 132(b) also includes the
number of days, if any, in the period or periods beginning on the date
on which a request for continued examination of the application under
35 U.S.C. 132(b) was filed or the date of mailing of an action under 35
U.S.C. 132, whichever occurs first, and ending on the date of mailing
of a subsequent notice of allowance under 35 U.S.C. 151. As discussed
previously, this proposed amendment is consistent with the decision in
Novartis that the time consumed by continued examination under 35
U.S.C. 132(b) does not include the time after a notice of allowance
unless the Office actually resumes examination of the application after
allowance.
Section 1.704: Section 1.704(c) is proposed to be amended to
include a new provision that establishes the submission of a request
for continued examination under 35 U.S.C. 132(b) after a notice of
allowance under 35 U.S.C. 151 has been mailed as constituting a failure
of an applicant to engage in reasonable efforts to conclude processing
or examination of an application, in which case the period of
adjustment set forth in Sec. 1.703 shall be reduced by the number of
days, if any, beginning on the date of mailing of the notice of
allowance under 35 U.S.C. 151 and ending on the date the request for
continued examination under 35 U.S.C. 132(b) was filed. As discussed
previously, this rule of practice is proposed to ensure that an
applicant does not obtain multiple periods of patent term adjustment
under 35 U.S.C. 154(b)(1)(B) for the time after a notice of allowance
under 35 U.S.C. 151 as a consequence of delaying issuance of the
application by filing request(s) for continued examination under 35
U.S.C. 132(b) after a notice of allowance under 35 U.S.C. 151. The
provisions of Sec. 1.704(d) would not be applicable to this new
provision as the information disclosure statement rules (Sec. Sec.
1.97 and 1.98) provide for the submission of an information disclosure
statement after a notice of allowance under 35 U.S.C. 151 has been
mailed up until the issue fee is paid without the need for the filing
of a request for continued examination under 35 U.S.C. 132(b) (Sec.
1.97(d)), and the Office has a program to allow for the submission of
an information disclosure statement even after the payment of the issue
fee (Quick Path Information Disclosure Statement (QPIDS) Pilot Program,
77 FR 27443 (May 10, 2012)).
Rulemaking Considerations
A. Administrative Procedure Act: This rulemaking proposes to amend
37 CFR 1.703 to provide that the time consumed by continued examination
under 35 U.S.C. 132(b) does not include the time after a notice of
allowance has been mailed, unless the Office actually resumes
examination of the application after allowance. This rulemaking also
proposes to amend 37 CFR 1.704 to include a provision that establishes
the submission of a request for continued examination under 35 U.S.C.
132(b) after a notice of allowance under 35 U.S.C. 151 has been mailed
as constituting a failure of an applicant to engage in reasonable
efforts to conclude processing or examination of an application. The
proposed amendment to 37 CFR 1.703 to provide that the time consumed by
continued examination under 35 U.S.C. 132(b) does not include the time
after a notice of allowance has been mailed, unless the Office actually
resumes examination of the application after allowance, simply
implements the Federal Circuit's ruling on the provisions of 35 U.S.C.
154(b)(1)(B)(i) in Novartis. Therefore, the proposed amendment to 37
CFR 1.703 is simply a procedural and/or interpretive rule. See Bachow
Commc'ns Inc. v. F.C.C., 237 F.3d 683, 690 (D.C. Cir. 2001) (rules
governing an application process are procedural under the
Administrative Procedure Act); Inova Alexandria Hosp. v. Shalala, 244
F.3d 342, 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, Inc. 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),
with respect to the proposed change to 37 CFR 1.703. 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 all of
these proposed changes (rather than only the proposed change to 37 CFR
1.704) for comment as it seeks the benefit of the public's views on the
Office's proposed implementation of the Federal Circuit's
interpretation of the provisions of 35 U.S.C. 154(b)(1)(B)(i) in
Novartis.
[[Page 34684]]
B. 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 changes proposed in this notice
will not have a significant economic impact on a substantial number of
small entities. See 5 U.S.C. 605(b).
The proposed changes to the patent term adjustment reduction
provisions do not impose any additional requirements or fees on
applicants. The proposed change to 37 CFR 1.703 simply implements the
Federal Circuit's ruling on the provisions of 35 U.S.C. 154(b)(1)(B)(i)
in Novartis and reflects how patent term adjustment is now calculated
in response to a request for reconsideration of patent term adjustment.
The proposed change to 37 CFR 1.704 specifies that the submission of a
request for continued examination under 35 U.S.C. 132(b) after a notice
of allowance under 35 U.S.C. 151 has been mailed constitutes a failure
of an applicant to engage in reasonable efforts to conclude processing
or examination of an application. This proposed change will not have a
significant economic impact on a substantial number of small entities
because applicants are not entitled to patent term adjustment for
examination delays that result from an applicant's delay in prosecuting
the application (35 U.S.C. 154(b)(2)(C)(i) and 37 CFR 1.704(a)) and
because applicants may avoid any consequences from this provision
simply by refraining from filing a request for continued examination
under 35 U.S.C. 132(b) after a notice of allowance under 35 U.S.C. 151
has been mailed.
For the foregoing reasons, the changes proposed in this notice will
not have a significant economic impact on a substantial number of small
entities.
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).
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. 801-808), the United States Patent and Trademark Office
will submit a report containing any final rule resulting from this
rulemaking and other required information to the U.S. Senate, the U.S.
House of Representatives, and the Comptroller General of the Government
Accountability Office.
L. Unfunded Mandates Reform Act of 1995: The changes set forth 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. 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. The changes proposed
in this rulemaking would: (1) Provide that the time consumed by
continued examination under 35 U.S.C. 132(b) does not include the time
after a notice of allowance, unless the Office actually resumes
examination of the application after allowance; and (2) provide that
the submission of a request for continued examination under 35 U.S.C.
132(b) after a notice of allowance under 35 U.S.C. 151 has been mailed
constitutes a failure of an applicant to engage in reasonable efforts
to conclude processing or examination of an application.
This rulemaking does not add any additional requirements (including
information collection requirements) or
[[Page 34685]]
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 or any other
information collections.
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
proposed to be 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), unless otherwise noted.
0
2. Section 1.703 is amended by revising paragraph (b)(1) to read as
follows:
Sec. 1.703 Period of adjustment of patent term due to examination
delay.
* * * * *
(b) * * *
(1) The number of days, if any, in the period beginning on the date
on which a request for continued examination of the application under
35 U.S.C. 132(b) was filed and ending on the date of mailing of a
notice of allowance under 35 U.S.C. 151, unless prosecution in the
application is reopened, in which case the period of adjustment under
Sec. 1.702(b) also does not include the number of days, if any, in the
period or periods beginning on the date on which a request for
continued examination of the application under 35 U.S.C. 132(b) was
filed or the date of mailing of an action under 35 U.S.C. 132,
whichever occurs first, and ending on the date of mailing of a
subsequent notice of allowance under 35 U.S.C. 151;
* * * * *
0
2. Section 1.704 is amended by redesignating paragraphs (c)(12) and
(13) as paragraphs (c)(13) and (14), respectively, and by adding a new
paragraph (c)(12) to read as follows:
Sec. 1.704 Reduction of period of adjustment of patent term.
* * * * *
(c) * * *
(12) Submission of a request for continued examination under 35
U.S.C. 132(b) after a notice of allowance under 35 U.S.C. 151 has been
mailed, in which case the period of adjustment set forth in Sec. 1.703
shall be reduced by the number of days, if any, beginning on the date
of mailing of the notice of allowance under 35 U.S.C. 151 and ending on
the date the request for continued examination under 35 U.S.C. 132(b)
was filed;
* * * * *
Dated: June 11, 2014.
Michelle K. Lee,
Deputy Under Secretary of Commerce for Intellectual Property and Deputy
Director of the United States Patent and Trademark Office.
[FR Doc. 2014-14186 Filed 6-17-14; 8:45 am]
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