Fast-Track Pilot Program for Appeals Related to COVID-19
| Published date | 15 April 2021 |
| Citation | 86 FR 19877 |
| Record Number | 2021-07704 |
| Section | Notices |
| Court | Commerce Department,Patent And Trademark Office |
19877
Federal Register / Vol. 86, No. 71 / Thursday, April 15, 2021 / Notices
public/do/PRAMain. Find this
particular information collection by
selecting ‘‘Currently under 30-day
Review—Open for Public Comments’’ or
by using the search function and
entering either the title of the collection
or the OMB Control Number 0648–0633.
Sheleen Dumas,
Department PRA Clearance Officer, Office of
the Chief Information Officer, Commerce
Department.
[FR Doc. 2021–07742 Filed 4–14–21; 8:45 am]
BILLING CODE 3510–22–P
DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No. PTO–P–2021–0019]
Fast-Track Pilot Program for Appeals
Related to COVID–19
AGENCY
: United States Patent and
Trademark Office, Department of
Commerce.
ACTION
: Notice.
SUMMARY
: The United States Patent and
Trademark Office (USPTO) is initiating
the Fast-Track Pilot Program for
Appeals Related to COVID–19 to
provide for the advancement of
applications out of turn in ex parte
appeals related to COVID–19 before the
Patent Trial and Appeal Board (PTAB).
An appellant who has filed an ex parte
appeal of an application with claim(s)
that cover a product or process related
to COVID–19 (such product or process
must be subject to an applicable U.S.
Food and Drug Administration (FDA)
approval for COVID–19 use) and
received a notice that the appeal has
been docketed may file a petition at no
cost to expedite the review of his or her
appeal without paying a petition fee.
The Fast-Track Pilot Program for
Appeals Related to COVID–19 sets a
target of reaching a decision on an ex
parte appeal within six months from the
date the appeal is entered into the pilot
program.
DATES
: Applicability Date: Petitions for
the pilot program can be filed starting
on April 15, 2021. Duration: The Fast-
Track Pilot Program for Appeals Related
to COVID–19 is offered on a temporary
basis, and petitions to request inclusion
of an ex parte appeal in the pilot
program will be accepted until 500
appeals have been accorded fast-track
status under the program. The USPTO
may extend the Fast-Track Pilot
Program for Appeals Related to COVID–
19 (with or without modification) or
may terminate it depending on the
workload and resources needed to
administer the program, feedback from
the public, and the effectiveness of the
program. If the pilot program is
extended or terminated, the USPTO will
notify the public.
FOR FURTHER INFORMATION CONTACT
:
Steven Bartlett, PTAB, by telephone at
571–272–9797, or by email at
COVIDfasttrackappeals@uspto.gov.
SUPPLEMENTARY INFORMATION
:
Background
Appeals to the PTAB are normally
taken up for decision in the order in
which they are docketed. See USPTO
Standard Operating Procedure 1 (Sept.
20, 2018), available at www.uspto.gov/
patents-application-process/patent-
trial-and-appeal-board/resources.
Currently, the average appeal pendency
is about 13 months. See PTAB Statistics,
available at www.uspto.gov/patents-
application-process/patent-trial-and-
appeal-board/statistics. However, a
small number of appeals are advanced
out of turn due to a special status. For
example, reexamination proceedings,
which are handled by the USPTO with
‘‘special dispatch,’’ and reissue
applications are treated as special
throughout their pendency, including
during appeal. See Manual of Patent
Examining Procedure (MPEP) 708.01.
Applications that have been ‘‘made
special’’ during examination through a
petition based on the age or health of an
applicant, or for other reasons listed in
37 CFR 1.102 (a)–(d), also maintain their
special status through any appeal. See
MPEP 1203(II). Furthermore, for the
same reasons, an appellant may petition
the PTAB to have an application on
appeal made special. See id. Currently,
about 1.1% of appeals are given a
special status through one of the above
methods.
Recently, the PTAB instituted the
Fast-Track Appeals Pilot Program, in
which the PTAB accepts petitions for
advancing out of turn and according
fast-track status to ex parte appeals that
have already been docketed. 85 FR
39888 (July 2, 2020). This pilot program
began on July 2, 2020 and will continue
for one year or until 500 appeals have
been accorded fast-track status under
the program. An appellant can seek fast-
track status by submitting a petition to
the Chief Administrative Patent Judge
under 37 CFR 41.3 and paying the fee
required under 37 CFR 41.20(a),
currently $420. The Fast-Track Appeals
Pilot Program sets a target of reaching a
decision on the ex parte appeal within
six months from the date an appeal is
entered into the pilot program. More
information on the Fast-Track Appeals
Pilot Program can be found at
www.uspto.gov/patents/ptab/fast-track-
appeals-pilot-program.
In an extraordinary situation, 37 CFR
1.183 permits the USPTO to suspend or
waive sua sponte any requirement of its
regulations that is not a requirement of
the patent statutes. The USPTO
considers the effects of the COVID–19
pandemic that began in approximately
January 2020 to be an ‘‘extraordinary
situation’’ within the meaning of 37 CFR
1.183 for affected patent applicants and
innovators. Consistent with the
USPTO’s determination under 37 CFR
1.183, the provisions of 35 U.S.C.
2(b)(2)(G), and the COVID–19
Prioritized Examination Pilot Program,
the USPTO has decided to implement
the Fast-Track Pilot Program for
Appeals Related to COVID–19, under
which an appellant may have any ex
parte appeal to the PTAB accorded fast-
track status by filing a petition under 37
CFR 41.3, without payment of the
petition fee under 37 CFR 41.20(a), for
certain applications that claim products
or processes that are subject to an
applicable FDA approval for COVID–19
use. Such approvals may include, but
are not limited to, an Investigational
New Drug (IND) application, an
Investigational Device Exemption (IDE),
a New Drug Application (NDA), a
Biologics License Application (BLA), a
Premarket Approval (PMA), or an
Emergency Use Authorization (EUA).
Information on INDs, IDEs, NDAs,
BLAs, PMAs, and EUAs may be
obtained at www.fda.gov.
The Fast-Track Pilot Program for
Appeals Related to COVID–19 will
accept petitions for advancing out of
turn and according fast-track status to ex
parte appeals until 500 appeals have
been accorded fast-track status under
the program. There is no time limit for
receipt of these 500 COVID–19 related
appeals. Additionally, the 500-appeal
threshold for COVID–19 related appeals
is distinct from the 500-appeal
threshold used for the regular fast-track
appeals pilot. The threshold of 500
granted petitions corresponds to
approximately 8% of the total number
of new appeals received in the average
fiscal year and was chosen in
accordance with maintaining the
PTAB’s overall decision pendency
goals. Once the threshold of 500 granted
petitions is met, the USPTO may extend
the Fast-Track Pilot Program for
Appeals Related to COVID–19 (with or
without modification) or may
discontinue it depending on the
workload and resources needed to
administer the program, feedback from
the public, and the effectiveness of the
program.
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Federal Register / Vol. 86, No. 71 / Thursday, April 15, 2021 / Notices
Requirements for Entry Into the Pilot
Program
The PTAB will accord fast-track status
to a pending ex parte appeal under the
following conditions:
(1) The application must be an
original utility, design, or plant
nonprovisional application. The Fast-
Track Pilot Program for Appeals Related
to COVID–19 is not available for
applications or proceedings that are
already treated as special during appeal,
such as reissue applications,
reexamination proceedings, appeals
made special due to the age or health of
an applicant, or appeals subject to any
other pilot program that advances an
appeal out of turn, including the Fast-
Track Appeals Pilot Program. See MPEP
708.01 for a complete list of cases that
are treated as special.
(2) Petition Requirements.
A petition under 37 CFR 41.3 must be
filed in the application involved in the
ex parte appeal for which fast-track
status is sought and must identify that
application and appeal by application
number and appeal number,
respectively. See MPEP 502.05. The
petition may be submitted via: (1) The
USPTO patent electronic filing systems
(EFS-Web or Patent Center), (2) the U.S.
Postal Service by Priority Mail Express
under 37 CFR 1.10 or with a certificate
of mailing under 37 CFR 1.8, or (3)
hand-delivery to the USPTO Customer
Service Window (MPEP 501). Electronic
submission of a petition is preferred for
faster petition processing. In addition,
the appeal for which fast-track status is
sought must be an appeal for which a
notice of appeal has been filed under 37
CFR 41.31 and an appeal docketing
notice has been mailed by the PTAB.
The petition must certify that the
application involved in the appeal
claims products or processes that are
subject to an applicable FDA approval
for COVID–19 use. Such approvals may
include, but are not limited to, an IND
application, an IDE, an NDA, a BLA, a
PMA, or an EUA. Information on INDs,
IDEs, NDAs, BLAs, PMAs, and EUAs
may be obtained at www.fda.gov.
The USPTO has created a form-
fillable Portable Document Format
(PDF), ‘‘Petition—Fast-Track Pilot
Program for Appeals Related to COVID–
19’’ (Form PTO/SB/454), that is
recommended for filing a petition under
37 CFR 41.3 for the Fast-Track Pilot
Program for Appeals Related to COVID–
19. Form PTO/SB/454 is available on
the USPTO’s website (www.uspto.gov/
patent/patents-forms). Form PTO/SB/
454 contains all necessary certifications
for participation in the program. Form
PTO/SB/454 does not collect
‘‘information’’ within the meaning of
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.). See 5 CFR
1320.3(h). Therefore, this notice does
not involve information collection
requirements that are subject to review
by the Office of Management and
Budget. It is recommended, but not
required, that appellants use Form PTO/
SB/454 when petitioning for entry into
the Fast-Track Pilot Program for
Appeals Related to COVID–19. Any
petition filed by any means other than
Form PTO/SB/454 must still contain the
required information.
(3) Signature Requirements.
The petition under 37 CFR 41.3 must
be signed by an applicant who is
prosecuting the applicant’s own case
under 37 CFR 1.31 (except that a juristic
entity must be represented by a
registered practitioner even if the
juristic entity is the applicant), a
registered practitioner who has a power
of attorney under 37 CFR 1.32, or a
registered practitioner who has the
authority to act under 37 CFR 1.34, in
order for the application involved in the
appeal to be accorded fast-track status.
(4) Fee.
The petition fee ordinarily required
under 37 CFR 41.20(a) will be waived
pursuant to 37 CFR 1.183.
(5) Limit on Number of Ex Parte
Appeals Accorded Fast-Track Status.
The number of granted petitions in
the Fast-Track Pilot Program for
Appeals Related to COVID–19 is limited
to a total of 500 granted petitions.
The threshold of 500 granted petitions
has been chosen to allow for robust
participation in the Fast-Track Pilot
Program for Appeals Related to COVID–
19 without compromising the PTAB’s
ability to deliver on other appeal
pendency goals. The limit of 500
granted petitions corresponds to
approximately 8% of the total number
of new appeals received in the average
fiscal year. The USPTO may modify or
terminate the pilot program depending
on the workload and resources needed
to administer the program, feedback
from the public, and the effectiveness of
the program.
Handling of Petitions in the Fast-Track
Pilot Program for Appeals Related to
COVID–19
Petitions for entry into the Fast-Track
Pilot Program for Appeals Related to
COVID–19 will be decided in the order
they are received. Petitions meeting the
requirements listed above for entry into
the pilot program will be granted, and
the petitioner will be notified by a
decision granting the petition to accord
fast-track status. Petitions not meeting
the requirements listed above for entry
into the pilot program will be denied,
and the petitioner will be notified of a
decision denying the petition. A
petitioner may reapply if a first petition
is denied. Any second petition filed by
a petitioner for the same application and
same appeal covered by a first, failed
petition will not be accorded the filing
date of the first petition for purposes of
determining whether the second
petition fell within the threshold of 500
granted petitions.
The PTAB will communicate the
number of granted petitions for fast-
track appeal via the PTAB web page,
www.uspto.gov/PTABCOVIDFastTrack,
and appellants should take this
information into account when deciding
whether to file a petition. The PTAB
may also exercise discretion to grant a
small number of petitions in excess of
the threshold of 500 granted petitions.
Conduct of Fast-Track Pilot Program
for Appeals Related to COVID–19
(1) Time to Decision
The goal for rendering a decision on
the petition to accord fast-track status to
an ex parte appeal is no later than one
month from the filing date of the
petition. The goal for rendering a
decision on the ex parte appeal is no
later than six months from the date an
appeal is entered into the program,
which occurs when a petition to accord
fast-track status to the appeal is granted.
(2) When a Petition May Be Filed
A petition may be filed anytime
between (1) the date when the PTAB
issues a notice that the appeal has been
docketed to the PTAB, and (2) the date
at which the appellant withdraws the
appeal, a final decision is rendered by
the PTAB under 37 CFR 41.50, or PTAB
jurisdiction ends under 37 CFR 41.35.
Petitions for fast-track status may be
filed for ex parte appeals regardless of
whether the appeal is newly docketed or
was docketed previously. If the petition
complies with the formal requirements
(i.e., signature, identification of
application, certification that the
application claims a product or process
subject to an applicable FDA approval
for COVID–19 use), the appeal will be
given fast-track status in accordance
with current procedures, including the
overall program threshold described
above.
(3) Hearings
Inclusion in the Fast-Track Pilot
Program for Appeals Related to COVID–
19 may be requested for ex parte appeals
in which the appellant seeks an oral
hearing before the PTAB (heard
appeals), as well as those appeals for
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which no oral hearing is requested (on-
brief appeals). Hearings in ex parte
appeals accorded fast-track status under
the pilot program will be conducted
according to the ordinary PTAB hearing
procedures. Appellants seeking an oral
hearing should submit with the request
for oral hearing any preferences as to the
time, date, or location of the hearing.
The PTAB will make its best efforts to
schedule a hearing in accordance with
such preferences, consistent with the
goals of the pilot program. If the PTAB
is unable to accommodate an appellant’s
preferences, the PTAB will schedule the
hearing in an available hearing room at
any office, including a regional office,
and at a time and date best suited to
meeting the goals of the pilot program.
If no such hearing room is available, the
PTAB will schedule a hearing to be
conducted by videoconference or
telephone.
Because an appellant seeks a faster
decision and hearing room availability
is limited, an appellant in an ex parte
appeal accorded fast-track status may
not seek to relocate (to a different office)
the hearing after receiving a Notice of
Hearing. An appellant who does not
wish to attend the hearing at the
designated location may, however,
request to attend the hearing by
videoconference or telephone, in
accordance with current PTAB hearing
procedures. An appellant may also
waive the hearing and continue under
the Fast-Track Pilot Program for
Appeals Related to COVID–19 for
consideration and decision on the
briefs.
An appellant may not reschedule the
date or time of a hearing and remain in
the Fast-Track Pilot Program for
Appeals Related to COVID–19. If an
appellant in an ex parte appeal accorded
fast-track status must reschedule the
date or time of a hearing and is not
willing to waive the oral hearing, then
the appellant may opt out of the Fast-
Track Pilot Program for Appeals Related
to COVID–19, thereby regaining the
ability to reschedule or relocate the
hearing as per ordinary PTAB hearing
procedures.
(4) Termination of Fast-Track Status
Under the Fast-Track Pilot Program for
Appeals Related to COVID–19
Fast-track status will be maintained in
an ex parte appeal from the date at
which the petition for inclusion in the
Fast-Track Pilot Program for Appeals
Related to COVID–19 is granted until
the PTAB’s jurisdiction ends under 37
CFR 41.35(b). Activities subsequent to
an appellant’s withdrawal from the pilot
program or the PTAB’s decision,
including any reopened prosecution,
will not be treated as subject to fast-
track status, nor will filing a petition for
inclusion in the Fast-Track Pilot
Program for Appeals Related to COVID–
19 cause an application to be accorded
fast-track status outside the jurisdiction
of the PTAB. Additionally, any request
by an appellant that causes a delay in
the conduct of the appeal, such as for an
extension of time under 37 CFR
1.136(b), or for additional briefing, will
be cause for the removal of fast-track
status.
Status of the Pilot Program
The Fast-Track Pilot Program for
Appeals Related to COVID–19 is being
adopted on a temporary basis until 500
appeals have been accorded fast-track
status under the program. The USPTO
may extend the Fast-Track Pilot
Program for Appeals Related to COVID–
19 (with or without modification) or
may discontinue the pilot program
depending on the workload and
resources needed to administer the
program, feedback from the public, and
the effectiveness of the program.
The USPTO will notify the public
when the threshold of 500 granted
petitions for the Fast-Track Pilot
Program for Appeals Related to COVID–
19 is about to be reached, and with any
further relevant information, on the
PTAB web page at www.uspto.gov/
PTABCOVIDFastTrack.
Andrew Hirshfeld,
Commissioner for Patents, Performing the
Functions and Duties of the Under Secretary
of Commerce for Intellectual Property and
Director of the United States Patent and
Trademark Office.
[FR Doc. 2021–07704 Filed 4–14–21; 8:45 am]
BILLING CODE 3510–16–P
CONSUMER PRODUCT SAFETY
COMMISSION
[Docket No. CPSC–2020–0027]
Agency Information Collection
Activities; Submission for OMB
Review; Comment Request; Warning
Label Comprehension and
Interpretation by Consumers for
Children’s Sleep Environments
AGENCY
: Consumer Product Safety
Commission.
ACTION
: Notice.
SUMMARY
: As required under the
Paperwork Reduction Act of 1995
(PRA), the Consumer Product Safety
Commission (CPSC or Commission)
announces that CPSC has submitted to
the Office of Management and Budget
(OMB) a new proposed collection of
information for a survey that will
evaluate consumer awareness of infant
sleep product warning labels. On
December 21, 2020, the CPSC published
a notice in the Federal Register
announcing the agency’s intent to seek
approval of this collection of
information. After reviewing and
considering the comments, the
Commission announces that it has
submitted to the OMB a request for
approval of this collection of
information. A copy of the proposed
survey, ‘‘Revised Supporting Statement’’
titled Consumer Product Safety
Commission: Warning Label
Comprehension and Interpretation by
Consumers for Children’s Sleep
Environments, is available at:
www.regulations.gov under Docket No.
CPSC–2020–0027, Supporting and
Related Material.
DATES
: Submit written or electronic
comments on the collection of
information by May 17, 2021.
ADDRESSES
: Send written comments and
recommendations for the proposed
information collection within 30 days of
publication of this notice to:
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting, ‘‘Currently
under 30-day Review—Open for Public
Comments,’’ or by using the search
function. In addition, written comments
that are sent to OMB also should be
submitted electronically at: http://
www.regulations.gov, under Docket No.
CPSC–2020–0027.
FOR FURTHER INFORMATION CONTACT
:
Cynthia Gillham, Consumer Product
Safety Commission, 4330 East-West
Highway, Bethesda, MD 20814; (301)
504–7991, or by email to: cgillham@
cpsc.gov.
SUPPLEMENTARY INFORMATION
:
A. Background
Under the Paperwork Reduction Act
of 1995 (PRA; 44 U.S.C. 3501–3520),
federal agencies must obtain approval
from OMB for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency data-
collection studies. The PRA establishes
procedures agencies must follow to
obtain OMB approval of a collection of
information, including notice and a
review of comments, among other
procedures. Agencies must provide
notice of the proposed collection of
information in the Federal Register, and
provide a 60-day comment period,
before submitting the collection to OMB
for approval. 44 U.S.C. 3506(c)(2)(A).
Agencies then must evaluate any public
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