Patent Term Adjustment Reductions in View of the Federal Circuit Decision in Supernus Pharm., Inc. v. Iancu., 36335-36342 [2020-11786]

Agencies

• DEPARTMENT OF COMMERCE
• Patent and Trademark Office

[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