Extension and Termination of the After Final Consideration Pilot Program 2.0, 79899-79900 [2024-22481]
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Federal Register / Vol. 89, No. 190 / Tuesday, October 1, 2024 / Notices
Notification to Interested Parties
We are issuing and publishing these
results in accordance with sections
751(a)(1) and 777(i)(1) of the Act and 19
CFR 351.221(b)(4).
Dated: September 6, 2024.
Abdelali Elouaradia,
Deputy Assistant Secretary for Enforcement
and Compliance.
Appendix
List of Topics Discussed in the Preliminary
Decision Memorandum
I. Summary
II. Background
III. Scope of the Order
IV. Discussion of the Methodology
V. Currency Conversion
VI. Recommendation
[FR Doc. 2024–22521 Filed 9–30–24; 8:45 am]
BILLING CODE 3510–DS–P
DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No. PTO–P–2024–0047]
Grant of Interim Extension of the Term
of U.S. Patent No. 7,199,162—
GRAFAPEXTM (Treosulfan)
United States Patent and
Trademark Office, Commerce.
ACTION: Notice of interim patent term
extension.
AGENCY:
khammond on DSKJM1Z7X2PROD with NOTICES
Charles Kim,
Deputy Commissioner for Patents, United
States Patent and Trademark Office.
[FR Doc. 2024–22480 Filed 9–30–24; 8:45 am]
The United States Patent and
Trademark Office has issued a
certificate for a one-year interim
extension of the term of U.S. Patent No.
7,199,162.
FOR FURTHER INFORMATION CONTACT:
Kathleen Kahler Fonda, Senior Legal
Advisor (telephone (571) 272–7754;
email kathleen.fonda@uspto.gov).
Alternatively, mail may be addressed to
Commissioner for Patents, Mail Stop
Hatch-Waxman PTE, P.O. Box 1450,
Alexandria, VA 22313–1450, and
marked to the attention of Ms. Fonda.
SUPPLEMENTARY INFORMATION: Section
156 of title 35, United States Code,
generally provides that the term of a
patent may be extended for a period of
up to five years if the patent claims a
product, or a method of making or using
a product, that has been subject to
certain defined regulatory review, and
that the patent may be extended for
interim periods of up to one year if the
regulatory review is anticipated to
extend beyond the expiration date of the
patent.
On August 20, 2024, Medac
Gesellschaft für Klinische
Spezialpräparate mbH, the patent owner
of record, timely filed an application
SUMMARY:
VerDate Sep<11>2014
17:42 Sep 30, 2024
Jkt 265001
under 35 U.S.C. 156(d)(5) for a fourth
interim extension of the term of U.S.
Patent No. 7,199,162. The patent claims
a method of using the human drug
product GRAFAPEXTM (treosulfan). The
application for patent term extension
indicates that New Drug Application
214759 was submitted to the Food and
Drug Administration on August 11,
2020, and its review in order for the
patent owner to obtain permission to
market and use the product
commercially is ongoing.
Review of the patent term extension
application indicates that, except for
permission to market or use the product
commercially, the subject patent would
be eligible for an extension of the patent
term under 35 U.S.C. 156, and that the
patent should be extended for one year
as required by 35 U.S.C. 156(d)(5)(B).
Because the regulatory review period
will continue beyond the thriceextended expiration date of the patent,
October 12, 2024, interim extension of
the patent term under 35 U.S.C.
156(d)(5) is appropriate.
A fourth interim extension under 35
U.S.C. 156(d)(5) of the term of U.S.
Patent No. 7,199,162 is granted for a
period of one year from the thriceextended expiration date of the patent.
BILLING CODE 3510–16–P
DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No.: PTO–P–2024–0051]
Extension and Termination of the After
Final Consideration Pilot Program 2.0
United States Patent and
Trademark Office, Department of
Commerce.
ACTION: Notice.
AGENCY:
On April 3, 2024, the United
States Patent and Trademark Office
(USPTO), when setting and adjusting
patent fees for fiscal year 2025,
proposed a new fee to recuperate costs
affiliated with the submission of a
request for consideration under the
After Final Consideration Pilot Program
2.0 (AFCP 2.0). Commenters on the
proposal expressed concerns about the
AFCP 2.0 and the proposed fee. In view
of these comments, the USPTO has
decided to allow AFCP 2.0 to expire.
While the program currently runs
through September 30, 2024, to
accommodate those who may be in the
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
79899
process of preparing to use the program,
the USPTO will provide a short
extension of the expiration of the
program. The USPTO is setting
December 14, 2024, as the last day to
submit a request for participation under
the program.
DATES: The USPTO will not accept
requests for consideration under the
AFCP 2.0 filed after December 14, 2024.
FOR FURTHER INFORMATION CONTACT: Kery
Fries, Senior Legal Advisor, at 571–272–
7757; or Raul Tamayo, Senior Legal
Advisor, at 571–272–7728, both with
the Office of Patent Legal
Administration, Office of the Deputy
Commissioner for Patents.
SUPPLEMENTARY INFORMATION: On May
19, 2013, the USPTO modified the After
Final Consideration Pilot Program
(AFCP) to create the AFCP 2.0. The
three main differences between the
AFCP and the AFCP 2.0 are: (1) an
applicant must request to participate in
AFCP 2.0; (2) a response to an after final
rejection under AFCP 2.0 must include
a non-broadening amendment to at least
one independent claim; and (3) the
examiner will schedule an interview
with the applicant if the after-final
response did not result in a
determination by the examiner that all
pending claims in the application were
in condition for allowance.
The goal of the AFCP 2.0 was to
improve pendency by reducing the
number of Requests for Continued
Examination (RCE) and encourage
increased collaboration between the
applicant and the examiner to
effectively advance prosecution of the
application. The AFCP 2.0 does not
require any additional fees for an
applicant to request consideration of an
amendment after final rejection, but any
necessary existing fee, e.g., the fee for an
extension of time, is required. Initially,
the pilot program was scheduled to run
for approximately one year and was set
to end on September 30, 2014. The
USPTO notified the public that the
AFCP 2.0 may be extended (with or
without modifications) depending on
feedback from participants and based on
a determination of the effectiveness of
the pilot program. The USPTO
repeatedly extended the pilot program,
with the most recent extension set to
end on September 30, 2024.
Since 2016, applicants have filed
more than 60,000 AFCP 2.0 requests
annually. Due to the high usage of the
AFCP 2.0, costs to administer the
program are significant. A large part of
the AFCP 2.0’s high usage is due to
economic inefficiencies where
participants receive program benefits
without paying for the cost of the
E:\FR\FM\01OCN1.SGM
01OCN1
khammond on DSKJM1Z7X2PROD with NOTICES
79900
Federal Register / Vol. 89, No. 190 / Tuesday, October 1, 2024 / Notices
service directly. For fiscal year 2022, the
USPTO estimates it expended more than
$15 million in incurred costs associated
with examiners considering the merits
of AFCP 2.0 submissions. This cost is in
addition to the time spent by examiners
to initially evaluate the AFCP 2.0
request for program compliance,
interview time, and any additional
consultation with supervisors and
primary examiners.
On April 3, 2024, the USPTO
proposed a new fee for participation in
the AFCP 2.0 when setting and
adjusting patent fees for fiscal year 2025
(See Setting and Adjusting Patent Fees
During Fiscal Year 2025, 89 FR 23226).
The agency proposed to charge fees for
filing a request for consideration under
the AFCP 2.0 as follows: $500 for
requests filed by undiscounted entities;
$200 for requests filed by entities
entitled to the small entity discount;
and $100 for requests filed by entities
entitled to the micro entity discount.
The proposed fee would have offset the
USPTO’s costs of administering the
AFCP 2.0. The USPTO stated that if
there is sufficient public support for the
proposed fees, the USPTO would favor
continuing the pilot program. However,
the USPTO explained that if it was
unable to recover the costs of the AFCP
2.0 from participants, the USPTO would
consider terminating the program.
In response to the proposed new fee
for participation in the AFCP 2.0,
commenters expressed concerns about
the program and the fee. Because the
public is not widely receptive to paying
a fee to participate in the AFCP 2.0, the
USPTO has decided to terminate the
program after a brief extension to
December 14, 2024. Accordingly, the
USPTO will not consider any request for
consideration under the AFCP 2.0 filed
after December 14, 2024.
The USPTO is providing the
extension of the AFCP 2.0 until
December 14, 2024, to provide program
users with reasonable time to adjust to
the program’s upcoming termination
should they be in the process of
preparing a request for consideration
under AFCP 2.0. Applicants still have
various options available for after final
consideration. For example, under
routine examination practice, after the
close of prosecution, proposed
amendments that will place the
application either (1) in condition for
allowance or (2) in better form for
appeal, may be entered. See 37 CFR
1.116(b). Additionally, an examiner may
have an interview with the applicant to
advance prosecution. See sections
713.09 and 714.12 of the Manual of
Patent Examining Procedure (9th ed.,
Rev. 07.2022, February 2023) (MPEP),
VerDate Sep<11>2014
17:42 Sep 30, 2024
Jkt 265001
which may be viewed on, or
downloaded from the USPTO website at
mpep.uspto.gov or www.uspto.gov/
MPEP. Moreover, applicants still have
the option to file a pre-appeal brief
request for review at the time of the
filing of a notice of appeal, which
provides applicants with the
opportunity to have a panel decide if an
issue for appeal is, in fact, present in the
record. See section 1204.02 of the
MPEP.
Katherine K. Vidal,
Under Secretary of Commerce for Intellectual
Property and Director of the United States
Patent and Trademark Office.
[FR Doc. 2024–22481 Filed 9–30–24; 8:45 am]
BILLING CODE 3510–16–P
CONSUMER FINANCIAL PROTECTION
BUREAU
[Docket No. CFPB–2024–0049]
Agency Information Collection
Activities: Comment Request
Consumer Financial Protection
Bureau.
ACTION: Notice and request for comment.
AGENCY:
In accordance with the
Paperwork Reduction Act of 1995
(PRA), the Consumer Financial
Protection Bureau (CFPB) requests the
revision of the Office of Management
and Budget’s (OMB’s) approval for an
existing information collection titled
‘‘Making Ends Meet Survey’’ approved
under OMB Number 3170–0080.
DATES: Written comments are
encouraged and must be received on or
before October 31, 2024 to be assured of
consideration.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
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 general, all
comments received will become public
records, including any personal
information provided. Sensitive
personal information, such as account
numbers or Social Security numbers,
should not be included.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information
should be directed to Anthony May,
Paperwork Reduction Act Officer, at
(202) 435–7278, or email: CFPB_PRA@
cfpb.gov. If you require this document
in an alternative electronic format,
SUMMARY:
PO 00000
Frm 00016
Fmt 4703
Sfmt 4703
please contact CFPB_Accessibility@
cfpb.gov. Please do not submit
comments to these email boxes.
SUPPLEMENTARY INFORMATION:
Title of Collection: Making Ends Meet
Survey.
OMB Control Number: 3170–0080.
Type of Review: Revision of a
currently approved collection.
Affected Public: Individuals or
households.
Estimated Number of Respondents:
5,500.
Estimated Total Annual Burden
Hours: 2,060.
Abstract: The Dodd-Frank Wall Street
Reform and Consumer Protection Act
charges the CFPB with researching,
analyzing, and reporting on topics
relating to the Bureau’s mission
including consumer behavior, consumer
awareness, and developments in
markets for consumer financial products
and services. To improve its
understanding of how consumers
engage with financial markets, the CFPB
has successfully used surveys under its
‘‘Making Ends Meet’’ program. The
‘‘Making Ends Meet’’ program has also
used the CFPB’s Consumer Credit
Information Panel (CCIP) as a frame to
survey people about their experiences in
consumer credit markets. The CFPB
seeks approval for two yearly surveys
under the ‘‘Making Ends Meet’’
program. These surveys solicit
information on the consumer’s
experience related to household
financial shocks, particularly shocks
related to the economic effects of the
COVID–19 pandemic, how households
respond to those shocks, and the role of
savings to help provide a financial
buffer.
The first survey will be a follow-up to
respondents from the CFPB’s 2024
‘‘Making Ends Meet’’ survey to better
understand household financial
experiences dealing with medical debt
as well as consumers’ interactions with
various financial products. The second
survey will go to a new sample of
consumers from the CCIP and will
address several topics of interest to the
CFPB, possibly including the impact of
natural disasters and other
environmental events, credit shopping
behavior, additional follow-up regarding
debt collection, and the assessment of
various fees throughout the financial
services ecosystem.
Request for Comments: The CFPB
published a 60-day Federal Register
notice on March 26, 2024 (89 FR 20950)
under Docket Number: CFPB–2024–
0013. The CFPB is publishing this
notice and soliciting comments on: (a)
Whether the collection of information is
E:\FR\FM\01OCN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 190 (Tuesday, October 1, 2024)]
[Notices]
[Pages 79899-79900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22481]
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No.: PTO-P-2024-0051]
Extension and Termination of the After Final Consideration Pilot
Program 2.0
AGENCY: United States Patent and Trademark Office, Department of
Commerce.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: On April 3, 2024, the United States Patent and Trademark
Office (USPTO), when setting and adjusting patent fees for fiscal year
2025, proposed a new fee to recuperate costs affiliated with the
submission of a request for consideration under the After Final
Consideration Pilot Program 2.0 (AFCP 2.0). Commenters on the proposal
expressed concerns about the AFCP 2.0 and the proposed fee. In view of
these comments, the USPTO has decided to allow AFCP 2.0 to expire.
While the program currently runs through September 30, 2024, to
accommodate those who may be in the process of preparing to use the
program, the USPTO will provide a short extension of the expiration of
the program. The USPTO is setting December 14, 2024, as the last day to
submit a request for participation under the program.
DATES: The USPTO will not accept requests for consideration under the
AFCP 2.0 filed after December 14, 2024.
FOR FURTHER INFORMATION CONTACT: Kery Fries, Senior Legal Advisor, at
571-272-7757; or Raul Tamayo, Senior Legal Advisor, at 571-272-7728,
both with the Office of Patent Legal Administration, Office of the
Deputy Commissioner for Patents.
SUPPLEMENTARY INFORMATION: On May 19, 2013, the USPTO modified the
After Final Consideration Pilot Program (AFCP) to create the AFCP 2.0.
The three main differences between the AFCP and the AFCP 2.0 are: (1)
an applicant must request to participate in AFCP 2.0; (2) a response to
an after final rejection under AFCP 2.0 must include a non-broadening
amendment to at least one independent claim; and (3) the examiner will
schedule an interview with the applicant if the after-final response
did not result in a determination by the examiner that all pending
claims in the application were in condition for allowance.
The goal of the AFCP 2.0 was to improve pendency by reducing the
number of Requests for Continued Examination (RCE) and encourage
increased collaboration between the applicant and the examiner to
effectively advance prosecution of the application. The AFCP 2.0 does
not require any additional fees for an applicant to request
consideration of an amendment after final rejection, but any necessary
existing fee, e.g., the fee for an extension of time, is required.
Initially, the pilot program was scheduled to run for approximately one
year and was set to end on September 30, 2014. The USPTO notified the
public that the AFCP 2.0 may be extended (with or without
modifications) depending on feedback from participants and based on a
determination of the effectiveness of the pilot program. The USPTO
repeatedly extended the pilot program, with the most recent extension
set to end on September 30, 2024.
Since 2016, applicants have filed more than 60,000 AFCP 2.0
requests annually. Due to the high usage of the AFCP 2.0, costs to
administer the program are significant. A large part of the AFCP 2.0's
high usage is due to economic inefficiencies where participants receive
program benefits without paying for the cost of the
[[Page 79900]]
service directly. For fiscal year 2022, the USPTO estimates it expended
more than $15 million in incurred costs associated with examiners
considering the merits of AFCP 2.0 submissions. This cost is in
addition to the time spent by examiners to initially evaluate the AFCP
2.0 request for program compliance, interview time, and any additional
consultation with supervisors and primary examiners.
On April 3, 2024, the USPTO proposed a new fee for participation in
the AFCP 2.0 when setting and adjusting patent fees for fiscal year
2025 (See Setting and Adjusting Patent Fees During Fiscal Year 2025, 89
FR 23226). The agency proposed to charge fees for filing a request for
consideration under the AFCP 2.0 as follows: $500 for requests filed by
undiscounted entities; $200 for requests filed by entities entitled to
the small entity discount; and $100 for requests filed by entities
entitled to the micro entity discount. The proposed fee would have
offset the USPTO's costs of administering the AFCP 2.0. The USPTO
stated that if there is sufficient public support for the proposed
fees, the USPTO would favor continuing the pilot program. However, the
USPTO explained that if it was unable to recover the costs of the AFCP
2.0 from participants, the USPTO would consider terminating the
program.
In response to the proposed new fee for participation in the AFCP
2.0, commenters expressed concerns about the program and the fee.
Because the public is not widely receptive to paying a fee to
participate in the AFCP 2.0, the USPTO has decided to terminate the
program after a brief extension to December 14, 2024. Accordingly, the
USPTO will not consider any request for consideration under the AFCP
2.0 filed after December 14, 2024.
The USPTO is providing the extension of the AFCP 2.0 until December
14, 2024, to provide program users with reasonable time to adjust to
the program's upcoming termination should they be in the process of
preparing a request for consideration under AFCP 2.0. Applicants still
have various options available for after final consideration. For
example, under routine examination practice, after the close of
prosecution, proposed amendments that will place the application either
(1) in condition for allowance or (2) in better form for appeal, may be
entered. See 37 CFR 1.116(b). Additionally, an examiner may have an
interview with the applicant to advance prosecution. See sections
713.09 and 714.12 of the Manual of Patent Examining Procedure (9th ed.,
Rev. 07.2022, February 2023) (MPEP), which may be viewed on, or
downloaded from the USPTO website at mpep.uspto.gov or www.uspto.gov/MPEP. Moreover, applicants still have the option to file a pre-appeal
brief request for review at the time of the filing of a notice of
appeal, which provides applicants with the opportunity to have a panel
decide if an issue for appeal is, in fact, present in the record. See
section 1204.02 of the MPEP.
Katherine K. Vidal,
Under Secretary of Commerce for Intellectual Property and Director of
the United States Patent and Trademark Office.
[FR Doc. 2024-22481 Filed 9-30-24; 8:45 am]
BILLING CODE 3510-16-P
