Patent Term Adjustment Reductions in View of the Federal Circuit Decision in Supernus Pharm., Inc. v. Iancu.
| Published date | 16 June 2020 |
| Citation | 85 FR 36335 |
| Record Number | 2020-11786 |
| Section | Rules and Regulations |
| Court | Patent And Trademark Office |
Federal Register, Volume 85 Issue 116 (Tuesday, June 16, 2020)
[Federal Register Volume 85, Number 116 (Tuesday, June 16, 2020)]
[Rules and Regulations]
[Pages 36335-36342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11786]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
37 CFR Part 1
[Docket No. PTO-P-2019-0019]
RIN 0651-AD38
Patent Term Adjustment Reductions in View of the Federal Circuit
Decision in Supernus Pharm., Inc. v. Iancu.
AGENCY: United States Patent and Trademark Office, Department of
Commerce.
ACTION: Final rule.
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SUMMARY: The United States Patent and Trademark Office (USPTO or
Office) is revising the rules of practice pertaining to patent term
adjustment in view of the decision by the U.S. Court of Appeals for the
Federal Circuit (Federal Circuit) in Supernus Pharm., Inc. v. Iancu
(Supernus). The Federal Circuit in Supernus held that a reduction of
patent term adjustment must be equal to the period of time during which
the applicant failed to engage in reasonable efforts to conclude
prosecution of the application. The USPTO is revising the provisions
pertaining to reduction of patent term adjustment for alignment with
the Federal Circuit decision in Supernus.
DATES:
Effective date: This final rule is effective on July 16, 2020.
Applicability date: The changes in this final rule apply to
original utility and plant patents issuing from applications filed on
or after May 29, 2000, in which a notice of allowance was mailed on or
after July 16, 2020.
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 USPTO is revising 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 Supernus Pharm., Inc. v. Iancu,
913 F.3d 1351 (Fed. Cir. 2019). The Federal Circuit in Supernus held
that a reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C)
must be equal to the period of time during which the applicant failed
to engage in reasonable efforts to conclude prosecution of the
application. The regulations pertaining to a reduction of patent term
adjustment due to a failure of an applicant to engage in reasonable
efforts to conclude processing or examination of an application are set
forth in 37 CFR 1.704. Several provisions in 37 CFR 1.704 (i.e., 37 CFR
1.704(c)(2), (3), (6), (9), and (10)) specify a period of reduction
corresponding to the consequences to the USPTO of the applicant's
failure to engage in reasonable efforts to conclude prosecution, rather
than ``the period from the beginning to the end of the applicant's
failure to engage in reasonable efforts to conclude prosecution,'' as
provided for in Supernus. 913 F.3d at 1359. Therefore, the USPTO is
revising these provisions of 37 CFR 1.704 for consistency with the
Federal Circuit's decision in Supernus.
Summary of Major Provisions: This rulemaking pertains to the patent
term adjustment regulations establishing the circumstances that
constitute a failure of an applicant to engage in reasonable efforts to
conclude processing or examination of an application and resulting
reduction of any patent term adjustment (37 CFR 1.704). This rulemaking
specifically revises the period of reduction of patent term adjustment
in the provisions of 37 CFR 1.704 pertaining to deferral of issuance of
a patent (37 CFR 1.704(c)(2)), abandonment of an application (37 CFR
1.704(c)(3)), submission of a preliminary amendment (37 CFR
1.704(c)(6)), submission of papers after a decision by the Patent Trial
and Appeal Board or by a Federal court (37 CFR 1.704(c)(9)), and
submission of papers after a notice of allowance under 35 U.S.C. 151
(37 CFR 1.704(c)(10)) to specify a period of reduction corresponding to
``the period from the beginning to the end of the applicant's failure
to engage in reasonable efforts to conclude prosecution'' (rather than
corresponding to the consequences to the USPTO of the applicant's
failure to engage in reasonable efforts to conclude prosecution) for
consistency with the Federal Circuit's decision in Supernus. 913 F.3d
at 1359. This rulemaking also revises 37 CFR 1.704(c)(10) to exclude
after-allowance amendments or other after-allowance papers that are
``expressly requested by the Office'' from the after-allowance
amendments or other after-allowance papers that will result in a
reduction of patent term adjustment under 37 CFR 1.704(c)(10).
Costs and Benefits: This rulemaking is not economically significant
under Executive Order 12866 (Sept. 30, 1993).
Background
Section 532(a) of the Uruguay Round Agreements Act, or URAA (Pub.
L. 103-465, 108 Stat. 4809 (1994)), amended 35 U.S.C. 154 to provide
that the term of a patent ends on the date that is twenty years from
the filing date of the application, or the earliest filing date for
which a benefit is claimed under 35 U.S.C. 120, 121, or 365(c). The
URAA also contained provisions, codified at 35 U.S.C. 154(b), for
patent term extension due to certain examination delays. Under the
patent term extension provisions of 35 U.S.C. 154(b), as amended by the
URAA, an applicant is entitled to patent term extension for delays due
to interference (which has since been replaced by derivation), secrecy
order, or successful appellate review. See 35 U.S.C. 154(b) (1995).
The American Inventors Protection Act of 1999, or AIPA (Pub. L.
106-113, 113 Stat. 1501, 1501A-552 through 1501A-591 (1999)), further
amended 35
[[Page 36336]]
U.S.C. 154(b) to include additional bases for patent term extension
(termed ``patent term adjustment'' in the AIPA). Generally, 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 USPTO fails to take certain actions
during the examination and issue process within specified time frames
(35 U.S.C. 154(b)(1)(A)) (known as ``A'' delays); (2) if the USPTO
fails to issue a patent within three years of the actual filing date of
the application (35 U.S.C. 154(b)(1)(B)) (known as ``B'' delays); and
(3) for delays due to interference (and now derivation), secrecy order,
or successful appellate review (35 U.S.C. 154(b)(1)(C)) (known as ``C''
delays). See 35 U.S.C. 154(b)(1). 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). See 35 U.S.C. 154(b)(2). 35 U.S.C.
154(b)(2)(C) sets forth one such limitation, providing, 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 USPTO implemented the AIPA patent term
adjustment provisions of 35 U.S.C. 154(b), including setting forth
circumstances that constitute a failure of an applicant to engage in
reasonable efforts to conclude processing or examination of an
application and resulting in a reduction of any patent term adjustment,
in a final rule published in September of 2000. See Changes to
Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 FR
56365 (Sept. 18, 2000) (AIPA patent term adjustment final rule). The
regulations establishing the circumstances that constitute a failure of
an applicant to engage in reasonable efforts to conclude processing or
examination of an application and resulting reduction of any patent
term adjustment are set forth in 37 CFR 1.704.
In January 2019, the Federal Circuit issued a decision in Supernus
pertaining to the patent term adjustment provisions of 35 U.S.C.
154(b)(2)(C). The Federal Circuit confirmed that 37 CFR 1.704(c)(8) ``
`is a reasonable interpretation of the [patent term adjustment]
statute' insofar as it includes `not only applicant conduct or behavior
that result in actual delay, but also those having the potential to
result in delay irrespective of whether such delay actually occurred.'
'' Supernus, 913 F.3d at 1356 (quoting Gilead Scis., Inc. v. Lee, 778
F.3d 1341, 1349-50 (Fed. Cir. 2015)). The Federal Circuit, however,
held that the USPTO may not reduce patent term adjustment by a period
that exceeds the ``time during which the applicant failed to engage in
reasonable efforts'' to conclude prosecution, specifically stating that
``[o]n the basis of the plain language of [35 U.S.C. 154(b)(2)(C)(i),]
. . . the [USPTO] may not count as applicant delay a period of time
during which there was no action that the applicant could take to
conclude prosecution of the patent.'' Id. at 1358. The Federal Circuit
specifically stated that:
Thus, the statutory period of PTA reduction must be the same
number of days as the period from the beginning to the end of the
applicant's failure to engage in reasonable efforts to conclude
prosecution. PTA cannot be reduced by a period of time during which
there is no identifiable effort in which the applicant could have
engaged to conclude prosecution because such time would not be
``equal to'' and would instead exceed the time during which an
applicant failed to engage in reasonable efforts.
Id. at 1359.
37 CFR 1.704(c)(1) through (c)(14) set forth: (1) The exemplary
circumstances prescribed by the USPTO ``that constitute a failure of an
applicant to engage in reasonable efforts to conclude processing or
examination of an application'' pursuant to 35 U.S.C.
154(b)(2)(C)(iii); and (2) the resulting period of reduction of any
patent term adjustment. The Federal Circuit decision in Supernus
involved a reduction to patent term adjustment under the provisions of
37 CFR 1.704(c)(8). The period of reduction of patent term adjustment
in 37 CFR 1.704(c)(8) is as follows: ``the number of days, if any,
beginning on the day after the date the initial reply was filed and
ending on the date that the supplemental reply or other such paper was
filed.'' 37 CFR 1.704(c)(8). This period corresponds to ``the period
from the beginning to the end of the applicant's failure to engage in
reasonable efforts to conclude prosecution,'' except in the rare
situation in which such period includes ``a period of time during which
there is no identifiable effort in which the applicant could have
engaged to conclude prosecution.'' Supernus, 913 F.3d at 1359. The
USPTO published a notice in May of 2019 setting out its implementation
of Supernus with respect to the provisions of 37 CFR 1.704(c)(8) and
other provisions of 37 CFR 1.704(c) that may include ``a period of time
during which there is no identifiable effort in which the applicant
could have engaged to conclude prosecution.'' See Patent Term
Adjustment Procedures in View of the Federal Circuit Decision in
Supernus Pharm., Inc. v. Iancu, 84 FR 20343 (May 9, 2019).
While the Federal Circuit decision in Supernus involved 37 CFR
1.704(c)(8), there are several provisions in 37 CFR 1.704(c)(1) through
(c)(14) whose period of reduction corresponds to or includes the
consequences to the USPTO of the applicant's failure to engage in
reasonable efforts to conclude prosecution, rather than ``the period
from the beginning to the end of the applicant's failure to engage in
reasonable efforts to conclude prosecution.'' Supernus, 913 F.3d at
1359. Therefore, the USPTO is revising the periods of reduction of
patent term adjustment in 37 CFR 1.704(c) for consistency with the
Federal Circuit's decision in Supernus. The USPTO is also revising 37
CFR 1.704(c)(10) to exclude after-allowance amendments or other after-
allowance papers that are ``expressly requested by the Office'' from
the after-allowance amendments or other after-allowance papers that
will result in a reduction of patent term adjustment under 37 CFR
1.704(c)(10).
Discussion of Specific Rules
The following is a discussion of amendments to title 37 of the Code
of Federal Regulations, part 1:
Section 1.704(c)(2) is amended to change ``the date the patent was
issued'' to ``the earlier of the date a request to terminate the
deferral was filed or the date the patent was issued.'' The period of
reduction of patent term adjustment in Sec. 1.704(c)(2) is now as
follows: ``the number of days, if any, beginning on the date a request
for deferral of issuance of a patent under Sec. 1.314 was filed and
ending on the earlier of the date a request to terminate the deferral
was filed or the date the patent was issued.''
Section 1.704(c)(3) is amended to change ``the earlier of: (i) The
date of mailing of the decision reviving the application or accepting
late payment of the issue fee; or (ii) The date that is four months
after the date the grantable petition to revive the application or
accept late payment of the issue fee was filed'' to ``the date the
grantable petition to revive the application or accept late payment of
the issue fee was filed.'' The period of reduction of patent term
[[Page 36337]]
adjustment in Sec. 1.704(c)(3) is now as follows: ``the number of
days, if any, beginning on the date of abandonment or the day after the
date the issue fee was due and ending on the date the grantable
petition to revive the application or accept late payment of the issue
fee was filed.''
Section 1.704(c)(6) is amended to change ``the lesser of: (i) The
number of days, if any, beginning on the day after the mailing date of
the original Office action or notice of allowance and ending on the
date of mailing of the supplemental Office action or notice of
allowance; or (ii) Four months'' to ``the number of days, if any,
beginning on the day after the date that is eight months from either
the date on which the application was filed under 35 U.S.C. 111(a) or
the date of commencement of the national stage under 35 U.S.C. 371(b)
or (f) in an international application and ending on the date the
preliminary amendment or other preliminary paper was filed.'' This
eight-month period corresponds to the eight-month period in Sec.
1.704(c)(13) for placing an application in condition for examination.
See Changes to Implement the Patent Law Treaty, 78 FR 62367, 62385
(Oct. 21, 2013) (an application is expected to be in condition for
examination no later than eight months from its filing date (or date of
commencement of the national stage in an international application)).
The period of reduction of patent term adjustment in Sec. 1.704(c)(6)
is now as follows: ``the number of days, if any, beginning on the day
after the date that is eight months from either the date on which the
application was filed under 35 U.S.C. 111(a) or the date of
commencement of the national stage under 35 U.S.C. 371(b) or (f) in an
international application and ending on the date the preliminary
amendment or other preliminary paper was filed.''
Section 1.704(c)(9) is amended to change ``the lesser of: (i) The
number of days, if any, beginning on the day after the mailing date of
the original Office action or notice of allowance and ending on the
mailing date of the supplemental Office action or notice of allowance;
or (ii) Four months'' to ``the number of days, if any, beginning on the
day after the date of the decision by the Patent Trial and Appeal Board
or by a Federal court and ending on date the amendment or other paper
was filed.'' The period of reduction of patent term adjustment in Sec.
1.704(c)(9) is now as follows: ``the number of days, if any, beginning
on the day after the date of the decision by the Patent Trial and
Appeal Board or by a Federal court and ending on date the amendment or
other paper was filed.''
Section 1.704(c)(10) is amended to change ``the lesser of: (i) The
number of days, if any, beginning on the date the amendment under Sec.
1.312 or other paper was filed and ending on the mailing date of the
Office action or notice in response to the amendment under Sec. 1.312
or such other paper; or (ii) Four months'' to ``the number of days, if
any, beginning on the day after the date of mailing of the notice of
allowance under 35 U.S.C. 151 and ending on the date the amendment
under Sec. 1.312 or other paper was filed.'' The period of reduction
of patent term adjustment in Sec. 1.704(c)(10) is now as follows:
``the number of days, if any, beginning on the day after the date of
mailing of the notice of allowance under 35 U.S.C. 151 and ending on
the date the amendment under Sec. 1.312 or other paper was filed.''
Section 1.704(c)(10) is also amended to exclude ``an amendment
under Sec. 1.312 or other paper expressly requested by the Office''
from the amendments under Sec. 1.312 or other papers filed after a
notice of allowance that will result in a reduction of patent term
adjustment under Sec. 1.704(c)(10). Thus, an amendment under Sec.
1.312 or other paper not expressly requested by the USPTO (i.e., a
``voluntary'' amendment under Sec. 1.312 or other paper) after the
notice of allowance will result in a reduction of patent term
adjustment under Sec. 1.704(c)(10). An amendment under Sec. 1.312 or
other paper going beyond what was requested by the USPTO (i.e.,
including material not expressly requested by the USPTO in addition to
what was requested by the USPTO) would not be considered ``an amendment
under Sec. 1.312 or other paper expressly requested by the Office''
under Sec. 1.704(c)(10). In addition, the phrase ``expressly requested
by the Office'' requires a specific request in an Office action or
notice, or in an Examiner's Interview Summary (PTOL-413), for the
amendment under Sec. 1.312 or other paper. For example, generic
language in an Office action or notice, such as a statement in a notice
of allowability containing an examiner's amendment indicating that if
the changes and/or additions are unacceptable to applicant, an
amendment may be filed as provided by Sec. 1.312 (section 1302.04 of
the Manual of Patent Examining Procedure (MPEP)), is not a basis for
considering an amendment under Sec. 1.312 to be ``expressly requested
by the Office'' within the meaning of Sec. 1.704(c)(10) as adopted in
this final rule. Similarly, the provisions of Sec. Sec. 1.56, 1.97,
and 1.98 are not a basis for considering an information disclosure
statement including information that has come to the attention of the
applicant after a notice of allowance has been given or mailed to be a
paper ``expressly requested by the Office'' within the meaning of Sec.
1.704(c)(10). An information disclosure statement in compliance with
Sec. Sec. 1.97 and 1.98, however, will not be considered a failure to
engage in reasonable efforts to conclude prosecution of the application
under Sec. 1.704(c)(10) (or Sec. 1.704(c)(6), (8), or (9) if the
information disclosure statement is accompanied by a statement under
Sec. 1.704(d)). Finally, an amendment under Sec. 1.312 or other paper
expressly requested by the USPTO not filed within three months from the
date of mailing or transmission of the USPTO communication notifying
the applicant of such request will result in a reduction of patent term
adjustment under Sec. 1.704(b).
Section 1.704(c) is also amended to change ``mailing date'' to
``date of mailing'' throughout for consistency with the other
regulations pertaining to AIPA patent term adjustment (Sec. Sec. 1.702
through 1.705) and URAA patent term extension (Sec. 1.701). The USPTO
has been issuing Office actions and notices through the Electronic
Office Action Program since June of 2009 for patent applicants choosing
this form of notification. See Electronic Office Action, 1343 Off. Gaz.
Pat. Office 45 (June 2, 2009). The term ``date of mailing'' as used in
the regulations pertaining to AIPA patent term adjustment and URAA
patent term extension means the mailroom/notification date indicated on
the form PTOL-90 accompanying the Office action or notice
communication. See Electronic Office Action, 1343 Off. Gaz. Pat. Office
at 46 (``The mailroom/notification date will also be considered the
date of mailing of the correspondence for all other purposes (e.g.,
[Sec. Sec. ] 1.71(g)(2), 1.97(b), 1.701 through 1.705)'').
Applicability of the Changes in This Final Rule
The AIPA patent term adjustment provisions apply to original
utility and plant patents issuing from applications filed on or after
May 29, 2000 (applications and patents eligible for patent term
adjustment). The changes in this final rule apply to all applications
and patents eligible for patent term adjustment in which a notice of
allowance was mailed on or after July 16, 2020. The USPTO makes the
patent term adjustment determination indicated in the patent by a
computer
[[Page 36338]]
program that uses the information recorded in the USPTO's Patent
Application Locating and Monitoring (PALM) system (except when an
applicant requests reconsideration pursuant to Sec. 1.705(b)). See 65
FR at 56381 (response to comment 25). The USPTO is in the process of
modifying its patent term adjustment program to implement the changes
in this final rule. The USPTO calculates the patent term adjustment
manually when an applicant requests reconsideration of a patent term
adjustment determination pursuant to Sec. 1.705(b) (the fee required
for a reconsideration of a patent term adjustment determination
pursuant to Sec. 1.705(b) partially covers the USPTO's cost of
performing a manual patent term adjustment determination). The USPTO
will decide any timely request for reconsideration in compliance with
Sec. 1.705(b) of a patent term adjustment determination in
applications and patents eligible for patent term adjustment in which a
notice of allowance was mailed on or after July 16, 2020, consistent
with the changes in this final rule.
While the USPTO has adopted ad hoc procedures for seeking
reconsideration of the patent term adjustment determination in the past
when there have been changes to the interpretation of the provisions of
35 U.S.C. 154(b) as a result of court decisions, these ad hoc
procedures were adopted because former 35 U.S.C. 154(b)(4) provided a
time period for seeking judicial review that was not related to the
filing of a request for reconsideration of the USPTO's patent term
adjustment determination or the date of the USPTO's decision on any
request for reconsideration of the USPTO's patent term adjustment
determination. See Revisions to Implement the Patent Term Adjustment
Provisions of the Leahy-Smith America Invents Act Technical Corrections
Act, 79 FR 27755, 27759 (May 15, 2014). As Sec. 1.705(b) now provides
that its two-month time period may be extended under the provisions of
Sec. 1.136(a) (permitting an applicant to request reconsideration of
the patent term adjustment indicated on the patent as late as seven
months after the date the patent was granted), the USPTO is not
adopting an ad hoc procedure for requesting a patent term adjustment
recalculation directed to the changes in this final rule. The USPTO
will decide any timely request for reconsideration in compliance with
Sec. 1.705(b) of a patent term adjustment determination in
applications and patents eligible for patent term adjustment in which a
notice of allowance was mailed before July 16, 2020, consistent with
the changes in this final rule, if requested by the patentee.
Comments and Responses to Comments
The USPTO published a notice proposing changes to the rules of
practice pertaining to patent term adjustment in view of the decision
by the Federal Circuit in Supernus. See Patent Term Adjustment
Reductions in View of the Federal Circuit Decision in Supernus Pharm.,
Inc. v. Iancu, 84 FR 53090 (Oct. 4, 2019). In response to the notice of
proposed rulemaking, the USPTO received seven comments from three
submitters, more particularly, from an intellectual property
organization, a healthcare company, and an individual patent
practitioner. The comments were supportive of the proposed changes to
Sec. 1.704(c) but included specific suggestions and questions. The
comments and the USPTO's responses thereto follow:
Comment (1): One comment suggests that the USPTO confirm that the
patent term reduction under Sec. 1.704(c)(3) does not apply where a
notice of abandonment has been withdrawn by the USPTO, either sua
sponte or as the result of a petition.
Response: Section 1.704(c)(3) addresses the situation in which an
abandoned application has been revived (Sec. 1.137), whereas Sec.
1.704(c)(4) addresses the situation in which a holding of abandonment
is withdrawn, and Sec. 1.704(c)(4) has not been amended in this final
rule. Section 1.704(c)(4) continues to provide that the failure to file
a petition to withdraw the holding of abandonment or to revive an
application within two months from the date of mailing of a notice of
abandonment will result in the period of adjustment set forth in Sec.
1.703 being reduced by ``the number of days, if any, beginning on the
day after the date two months from the date of mailing of a notice of
abandonment and ending on the date a petition to withdraw the holding
of abandonment or to revive the application was filed.''
Comment (2): One comment seeks clarification whether the USPTO
would extend the eight-month period to respond to the next business day
if the eight-month period ends on a Saturday, Sunday, or Federal
holiday under proposed Sec. 1.704(c)(6).
Response: Under 35 U.S.C. 21(b), ``[w]hen the day, or the last day,
for taking any action or paying any fee in the United States Patent and
Trademark Office falls on Saturday, Sunday, or a Federal holiday within
the District of Columbia, the action may be taken, or fee paid, on the
next succeeding secular or business day.'' Accordingly, any reduction
under Sec. 1.704(c)(6), as adopted in this final rule, would begin on
the day after the next succeeding secular or business day in this
situation. For example, if an application was filed on May 18, 2019,
and the USPTO mailed an Office action on February 28, 2020, but the
applicant had filed a preliminary amendment on February 17, 2020, that
required a supplemental Office action addressing the preliminary
amendment, the eight-month period would end on Tuesday January 21,
2020, under Sec. 1.704(c)(6), as adopted in this final rule, because
January 18 and 19, 2020, were weekend days and January 20, 2020, was a
Federal holiday. Thus, the period of reduction under Sec. 1.704(c)(6),
as adopted in this final rule, would begin on Wednesday, January 22,
2020 (i.e., Wednesday, January 22, 2020, would be ``day one''), and end
on February 17, 2020.
Comment (3): One comment requests clarification whether an
applicant could avoid a reduction of patent term adjustment under Sec.
1.704(c)(6) for the submission of a preliminary amendment or other
paper by having the examiner expressly request that the applicant
submit the preliminary amendment or other paper.
Response: Section 1.706(c)(6) does not contain a provision for
preliminary amendments or other papers expressly requested by the
examiner (like Sec. 1.704(c)(8)). Section 1.704(c)(6), however, does
not result in a reduction of patent term adjustment unless the
preliminary amendment or other preliminary paper: (1) Is submitted less
than one month before the mailing of an Office action under 35 U.S.C.
132 or notice of allowance under 35 U.S.C. 151; and (2) requires the
mailing of a supplemental Office action or notice of allowance. A
preliminary amendment or other paper expressly requested by the
examiner should not require the mailing of a supplemental Office action
or notice of allowance.
Comment (4): One comment suggests that the USPTO do a further study
of the impact to Sec. 1.704(c)(6).
Response: The eight-month period in Sec. 1.704(c)(6), as adopted
in this final rule, is consistent with the eight-month period in Sec.
1.704(c)(13), which is the time period at which an application is
expected to be in condition for examination. See 78 FR at 62385. The
USPTO's first action pendency has been decreasing in recent years, and
the USPTO expects that trend to continue. The USPTO will monitor the
impact that delays in placing an application in condition for
examination have on first action pendency and will adjust the
[[Page 36339]]
time periods in Sec. 1.704(c)(6) and (c)(13) as appropriate.
Comment (5): Several comments request clarification regarding Sec.
1.704(c)(10) and the submission of drawings and other papers in
response to a notice received from the USPTO. The comments suggest that
the USPTO should make a distinction as to whether the papers are being
voluntarily submitted or are being submitted in response to an Office
action or notice from the USPTO.
Response: Section 1.704(c)(10), as adopted in this final rule,
excludes ``an amendment under Sec. 1.312 or other paper expressly
requested by the Office'' from the amendments under Sec. 1.312 or
other papers filed after a notice of allowance that will result in a
reduction of patent term adjustment. Thus, only an amendment under
Sec. 1.312 or other paper not expressly requested by the USPTO (i.e.,
a ``voluntary'' amendment under Sec. 1.312 or other paper) after the
notice of allowance will result in a reduction of patent term
adjustment under Sec. 1.704(c)(10), as adopted in this final rule. An
amendment under Sec. 1.312 or other paper expressly requested by the
USPTO filed more than three months from the date of mailing or
transmission of the USPTO communication notifying the applicant of such
request, however, will result in a reduction of patent term adjustment
under Sec. 1.704(b). Thus, an amendment under Sec. 1.312 or other
paper expressly requested by the USPTO submitted within three months of
the date of mailing or transmission of the Office action or notice
requiring such an amendment under Sec. 1.312 or other paper will not
result in a reduction of patent term adjustment.
Comment (6): One comment asks whether the proposed change to Sec.
1.704(c)(10) affects the list of other papers not considered to be a
failure to engage in unreasonable efforts under this provision.
Response: The USPTO has previously indicated that the submission of
the following papers after a notice of allowance will not result in a
reduction of patent term adjustment under Sec. 1.704(c)(10): (1)
Fee(s) Transmittal (PTOL-85B); (2) power of attorney; (3) power to
inspect; (4) change of address; (5) change of entity status (micro/
small/not small entity status); (6) a response to the examiner's
reasons for allowance or a request to correct an error or omission in
the ``Notice of Allowance'' or ``Notice of Allowability''; (7) status
letters; (8) requests for a refund; (9) an inventor's oath or
declaration; (10) an information disclosure statement with a statement
in compliance with Sec. 1.704(d); (11) the resubmission by the
applicant of unlocatable paper(s) previously filed in the application
(Sec. 1.251); (12) a request for acknowledgment of an information
disclosure statement in compliance with Sec. Sec. 1.97 and 1.98,
provided that the applicant had requested that the examiner acknowledge
the information disclosure statement prior to the notice of allowance,
or the request for acknowledgement was the applicant's first
opportunity to request that the examiner acknowledge the information
disclosure statement; (13) comments on the substance of an interview
where the applicant-initiated interview resulted in a notice of
allowance; and (14) letters related to government interests (e.g.,
those between NASA and the USPTO). See Changes to Patent Term
Adjustment in View of the Federal Circuit Decision in Novartis v. Lee,
80 FR 1346, 1354 (Jan. 9, 2015); see also MPEP 2732. The USPTO is not
changing this indication of papers submitted after a notice of
allowance that will not result in a reduction of patent term adjustment
under Sec. 1.704(c)(10), except to also exclude ``an amendment under
Sec. 1.312 or other paper expressly requested by the Office'' from the
amendments under Sec. 1.312 or other papers filed after a notice of
allowance that will result in a reduction of patent term adjustment
under Sec. 1.704(c)(10).
Comment (7): One comment suggests that the rule change be applied
prospectively because it will alter patent prosecution. The comment
also asks the USPTO to clarify what impact the rule changes would have
on issued patents.
Response: The changes to Sec. 1.704 in this final rule apply to
applications and patents eligible for patent term adjustment in which a
notice of allowance was mailed on or after July 16, 2020. The USPTO,
however, will decide any timely request for reconsideration in
compliance with Sec. 1.705(b) of a patent term adjustment
determination in applications and patents eligible for patent term
adjustment in which a notice of allowance was mailed before July 16,
2020 consistent with the changes in this final rule if requested by the
patentee.
Rulemaking Considerations
A. Administrative Procedure Act
The changes in this rulemaking involve rules of agency practice and
procedure and/or interpretive rules. See Perez v. Mortg. Bankers Ass'n,
575 U.S. 92, 97 (2015) (Interpretive rules ``advise the public of the
agency's construction of the statutes and rules which it administers.''
(citation and internal quotation marks omitted)); 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.); Bachow Commc'ns Inc. v. FCC, 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.). Specifically, this rulemaking revises USPTO rules
that interpret certain statutory provisions pertaining to patent term
adjustment to specify a period of reduction corresponding to ``the
period from the beginning to the end of the applicant's failure to
engage in reasonable efforts to conclude prosecution'' (rather than to
the consequences to the USPTO of the applicant's failure to engage in
reasonable efforts to conclude prosecution) for consistency with the
Federal Circuit's decision in Supernus. 913 F.3d at 1359.
Accordingly, prior notice and opportunity for public comment for
the changes in this rulemaking are not required pursuant to 5 U.S.C.
553(b) or (c) or any other law. See Perez, 575 U.S. at 101 (Notice-and-
comment procedures are required neither when an agency ``issue[s] an
initial interpretive rule'' nor ``when it amends or repeals that
interpretive rule.''); 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), do 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))). However, the USPTO chose to seek public comment before
implementing the rule to benefit from the public's input.
B. Regulatory Flexibility Act
For the reasons set forth herein, the Senior Counsel for Regulatory
and Legislative Affairs in the Office General Law of the USPTO has
certified to the Chief Counsel for Advocacy of the Small Business
Administration that the changes adopted in this notice will not have a
significant economic impact on a substantial number of small entities.
See 5 U.S.C. 605(b).
This rulemaking does not impose any additional requirements or fees
on applicants. This rulemaking also does not change the circumstances
defined as constituting a failure of an applicant to engage in
reasonable efforts to conclude processing or examination of an
[[Page 36340]]
application (35 U.S.C. 154(b)(2)(C)(iii)). This rulemaking implements
the Federal Circuit's ruling on the provisions of 35 U.S.C.
154(b)(2)(C)(i) in Supernus to reflect the applicable period of
reduction in the event that there is a failure of an applicant to
engage in reasonable efforts to conclude processing or examination.
This rulemaking specifically revises the period of reduction of patent
term adjustment in the provisions of 37 CFR 1.704 pertaining to
deferral of issuance of a patent (37 CFR 1.704(c)(2)), abandonment of
an application (37 CFR 1.704(c)(3)), submission of a preliminary
amendment (37 CFR 1.704(c)(6)), submission of papers after a decision
by the Patent Trial and Appeal Board or by a Federal court (37 CFR
1.704(c)(9)), and submission of papers after a notice of allowance
under 35 U.S.C. 151 (37 CFR 1.704(c)(10)) to specify a period of
reduction corresponding to ``the period from the beginning to the end
of the applicant's failure to engage in reasonable efforts to conclude
prosecution'' (rather than to the consequences to the USPTO of the
applicant's failure to engage in reasonable efforts to conclude
prosecution) for consistency with the Federal Circuit's decision in
Supernus. 913 F.3d at 1359. The changes in this rulemaking will not
have a significant economic impact on a substantial number of small
entities because applicants are not entitled to patent term adjustment
that have not been reduced by a period equal to the period of the
applicant's failure to engage in reasonable efforts to conclude
processing or examination (35 U.S.C. 154(b)(2)(C)(i) and 37 CFR
1.704(a)), and because applicants may avoid adverse patent term
adjustment consequences by refraining from actions or inactions defined
as constituting a failure of an applicant to engage in reasonable
efforts to conclude processing or examination.
For the foregoing reasons, the changes 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 under
Executive Order 12866 (Sept. 30, 1993).
D. Executive Order 13563 (Improving Regulation and Regulatory Review)
The USPTO has complied with Executive Order 13563 (Jan. 18, 2011).
Specifically, the USPTO 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 online 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 13771 (Reducing Regulation and Controlling
Regulatory Costs)
This rulemaking is not an Executive Order 13771 (Jan. 30, 2017)
regulatory action because it is not significant under Executive Order
12866 (Sept. 30, 1993).
F. 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).
G. 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).
H. 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).
I. Executive Order 13783 (Promoting Energy Independence and Economic
Growth)
This rulemaking does not potentially burden the development or use
of domestically produced energy resources, with particular attention to
oil, natural gas, coal, and nuclear energy resources under Executive
Order 13783 (Mar. 28, 2017).
J. Executive Order 13772 (Core Principles for Regulating the United
States Financial System)
This rulemaking does not involve regulation of the United States
financial system under Executive Order 13772 (Feb. 3, 2017).
K. 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).
L. 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).
M. 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).
N. 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
USPTO will submit a report containing the 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.
O. Unfunded Mandates Reform Act of 1995
The changes set forth in this rulemaking do not involve a Federal
intergovernmental mandate that will result in the expenditure by State,
local, and tribal governments, in the aggregate, of $100 million (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 (as adjusted) or more in any one year, and will not
significantly or uniquely affect small governments. Therefore, no
actions are necessary under the provisions of the Unfunded Mandates
Reform Act of 1995. See 2 U.S.C. 1501 et seq.
[[Page 36341]]
P. 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.
Q. 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 that
involve the use of technical standards.
R. Paperwork Reduction Act
The Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.)
requires that the USPTO consider the impact of paperwork and other
information collection burdens imposed on the public. 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.
This rulemaking does not impose any additional requirements
(including information collection requirements) or fees for patent
applicants or patentees. Therefore, the USPTO 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, Biologics, Courts, Freedom
of information, Inventions and patents, Reporting and record keeping
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), unless otherwise noted.
0
2. Section 1.704 is amended by revising paragraph (c) to read as
follows:
Sec. 1.704 Reduction of Period of Adjustment of Patent Term.
* * * * *
(c) Circumstances that constitute a failure of the applicant to
engage in reasonable efforts to conclude processing or examination of
an application also include the following circumstances, which will
result in the following reduction of the period of adjustment set forth
in Sec. 1.703 to the extent that the periods are not overlapping:
(1) Suspension of action under Sec. 1.103 at the applicant's
request, 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 a request for suspension of action under Sec. 1.103 was filed and
ending on the date of the termination of the suspension;
(2) Deferral of issuance of a patent under Sec. 1.314, 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 a request for
deferral of issuance of a patent under Sec. 1.314 was filed and ending
on the earlier of the date a request to terminate the deferral was
filed or the date the patent was issued;
(3) Abandonment of the application or late payment of the issue
fee, 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 abandonment or the day after the date the issue fee was due and
ending on the date the grantable petition to revive the application or
accept late payment of the issue fee was filed;
(4) Failure to file a petition to withdraw the holding of
abandonment or to revive an application within two months from the date
of mailing of a notice of abandonment, 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 day after the date two months from the
date of mailing of a notice of abandonment and ending on the date a
petition to withdraw the holding of abandonment or to revive the
application was filed;
(5) Conversion of a provisional application under 35 U.S.C. 111(b)
to a nonprovisional application under 35 U.S.C. 111(a) pursuant to 35
U.S.C. 111(b)(5), 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 the application was filed under 35 U.S.C. 111(b) and ending
on the date a request in compliance with Sec. 1.53(c)(3) to convert
the provisional application into a nonprovisional application was
filed;
(6) Submission of a preliminary amendment or other preliminary
paper less than one month before the mailing of an Office action under
35 U.S.C. 132 or notice of allowance under 35 U.S.C. 151 that requires
the mailing of a supplemental Office action or notice of allowance, 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 day after the
date that is eight months from either the date on which the application
was filed under 35 U.S.C. 111(a) or the date of commencement of the
national stage under 35 U.S.C. 371(b) or (f) in an international
application and ending on the date the preliminary amendment or other
preliminary paper was filed;
(7) Submission of a reply having an omission (Sec. 1.135(c)), 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 day after the
date the reply having an omission was filed and ending on the date that
the reply or other paper correcting the omission was filed;
(8) Submission of a supplemental reply or other paper, other than a
supplemental reply or other paper expressly requested by the examiner,
after a reply has been filed, 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 day after the date the initial reply was filed
and ending on the date that the supplemental reply or other such paper
was filed;
(9) Submission of an amendment or other paper after a decision by
the Patent Trial and Appeal Board, other than a decision designated as
containing a new ground of rejection under Sec. 41.50(b) of this title
or statement under Sec. 41.50(c) of this title, or a decision by a
Federal court, less than one month before the mailing of an Office
action under 35 U.S.C. 132 or a notice of allowance under 35 U.S.C. 151
that requires the mailing of a supplemental Office action or
supplemental notice of allowance, 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 day after the date of the decision by
the Patent Trial and Appeal Board or by a Federal court and ending on
date the amendment or other paper was filed;
(10) Submission of an amendment under Sec. 1.312 or other paper,
other than an amendment under Sec. 1.312 or other paper expressly
requested by the Office or a request for continued examination
[[Page 36342]]
in compliance with Sec. 1.114, after a notice of allowance has been
given or 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 day after the date of mailing of the notice of allowance under
35 U.S.C. 151 and ending on the date the amendment under Sec. 1.312 or
other paper was filed;
(11) Failure to file an appeal brief in compliance with Sec. 41.37
of this chapter within three months from the date on which a notice of
appeal to the Patent Trial and Appeal Board was filed under 35 U.S.C.
134 and Sec. 41.31 of this chapter, 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 day after the date three months from the
date on which a notice of appeal to the Patent Trial and Appeal Board
was filed under 35 U.S.C. 134 and Sec. 41.31 of this chapter, and
ending on the date an appeal brief in compliance with Sec. 41.37 of
this chapter or a request for continued examination in compliance with
Sec. 1.114 was filed;
(12) Submission of a request for continued examination under 35
U.S.C. 132(b) after any 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
day after 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;
(13) Failure to provide an application in condition for examination
as defined in paragraph (f) of this section within eight months from
either the date on which the application was filed under 35 U.S.C.
111(a) or the date of commencement of the national stage under 35
U.S.C. 371(b) or (f) in an international 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 day after the date that is
eight months from either the date on which the application was filed
under 35 U.S.C. 111(a) or the date of commencement of the national
stage under 35 U.S.C. 371(b) or (f) in an international application and
ending on the date the application is in condition for examination as
defined in paragraph (f) of this section; and
(14) Further prosecution via a continuing application, in which
case the period of adjustment set forth in Sec. 1.703 shall not
include any period that is prior to the actual filing date of the
application that resulted in the patent.
* * * * *
Andrei Iancu,
Under Secretary of Commerce for Intellectual Property and Director of
the United States Patent and Trademark Office.
[FR Doc. 2020-11786 Filed 6-15-20; 8:45 am]
BILLING CODE 3510-16-P
