Grant of Interim Extension of the Term of U.S. Patent No. 9,314,630; Symplicity Spyral® System, Symplicity Spyral® Catheter, and Symplicity G3 Generator, 19269 [2023-06665]
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Federal Register / Vol. 88, No. 62 / Friday, March 31, 2023 / Notices
evaluation; 15 minutes per partner/
stakeholder response.
Total Annual Burden Hours: 933.
Needs and Uses: This request is for
revision and extension of a currently
approved information collection. A few
questions will be rewritten to improve
the usefulness of information collected.
A new question is proposed for
inclusion that will collect information
from Coastal Zone Management Act
programs about efforts in racial equity
and engagement with underserved
communities.
The Coastal Zone Management Act of
1972, as amended (16 U.S.C. 1451 et
seq.) requires that state coastal
management programs and national
estuarine research reserves developed in
accordance with the CZMA and
approved by the Secretary of Commerce
be evaluated periodically. This request
is to collect information to accomplish
those evaluations. NOAA’s Office for
Coastal Management conducts periodic
evaluations of the 34 coastal
management programs and 30 research
reserves and produces written findings
for each evaluation. The Office for
Coastal Management has access to
documents submitted in cooperative
agreement applications, performance
reports, and certain documentation
required by the CZMA and
implementing regulations. However,
additional information from each
coastal management program and
research reserve, as well as information
from the program and reserve partners
and stakeholders with whom each
works, is necessary to evaluate against
statutory and regulatory requirements.
Different information collection subsets
are necessary for (1) coastal
management programs, (2) their partners
and stakeholders, (3) research reserves,
and (4) their partners and stakeholders.
As part of this submission, a few
questions will be modified to clarify the
information that should be provided as
part of the information requests and
questionnaires sent to the coastal
program and reserve managers. One new
question about efforts in diversity,
inclusion, equity, and accessibility will
be included for coastal program and
reserve managers. A few questions will
be revised to clarify and improve the
usefulness of responses for the partners
and stakeholders’ survey.
Given the addition of a designated
research reserve since the last renewal
of this information collection and the
anticipated designation of additional
reserves in the coming years, and an
increase in Office for Coastal
Management staff capacity to conduct
evaluations, the number of CZMA
programs to be evaluated, on average, in
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the next three years will increase from
11 to 12 programs per year. This
increase in the number of programs to
be evaluated will also increase the
number of partner and stakeholder
respondents to this information
collection.
Affected Public: Business or other forprofit organizations; not-for-profit
institutions; state, local, or tribal
government; Federal government.
Frequency: CZMA programs will
complete once every five to six years.
Program partners and stakeholders are
invited to complete one survey for
program(s) that they work with on the
same schedule as that program(s) (once
every five to six years).
Respondent’s Obligation: Mandatory
for CZMA programs; voluntary for
program partners and stakeholders.
Legal Authority: Section 312 of the
Coastal Zone Management Act, as
amended (16 U.S.C. 1458).
This information collection request
may be viewed at www.reginfo.gov.
Follow the instructions to view the
Department of Commerce collections
currently under review by OMB.
Written comments and
recommendations for the proposed
information collection should be
submitted within 30 days of the
publication of this notice on the
following website 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 and
entering either the title of the collection
or the OMB Control Number 0648–0661.
Sheleen Dumas,
Department PRA Clearance Officer, Office of
the Under Secretary for Economic Affairs,
Commerce Department.
[FR Doc. 2023–06709 Filed 3–30–23; 8:45 am]
BILLING CODE 3510–JE–P
DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No. PTO–P–2023–0014]
Grant of Interim Extension of the Term
of U.S. Patent No. 9,314,630;
Symplicity Spyral® System, Symplicity
Spyral® Catheter, and Symplicity G3
Generator
United States Patent and
Trademark Office, Department of
Commerce.
ACTION: Notice of interim patent term
extension.
AGENCY:
The United States Patent and
Trademark Office has issued an order
SUMMARY:
PO 00000
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19269
granting a one-year interim extension of
the term of U.S. Patent No. 9,314,630
(’630 patent).
Ali
Salimi, Senior Legal Advisor, Office of
Patent Legal Administration, by
telephone at 571–272–0909 or by email
to ali.salimi@uspto.gov.
FOR FURTHER INFORMATION CONTACT:
35 U.S.C.
156 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. 35
U.S.C. 156(d)(5) generally provides that
the term of such a patent may be
extended for no more than five interim
periods of up to one year each, if the
approval phase of the regulatory review
period is reasonably expected to extend
beyond the expiration date of the patent.
On March 23, 2023, Medtronic Ireland
Manufacturing Unlimited Company, the
owner of record of the ’630 patent,
timely filed an application under 35
U.S.C. 156(d)(5) for an interim extension
of the term of the ’630 patent. The ’630
patent claims a method of using the
product Symplicity Spyral® system,
which includes the Symplicity Spyral
catheter and the Symplicity G3
generator. The application for interim
patent term extension indicates that a
Premarket Approval Application (PMA)
PMA–220026 was submitted to the Food
and Drug Administration (FDA) on
March 15, 2015, and that the FDA’s
review thereof is ongoing.
Review of the interim patent term
extension application indicates that,
except for permission to market or use
the product commercially, the ’630
patent would be eligible for an
extension of the patent term under 35
U.S.C. 156. Because it appears the
approval phase of the regulatory review
period will continue beyond the
expiration date of the patent, i.e., April
8, 2023, interim extension of the ’630
patent’s term under 35 U.S.C. 156(d)(5)
is appropriate.
An interim extension under 35 U.S.C.
156(d)(5) of the term of U.S. Patent No.
9,314,630 is granted for a period of one
year from the expiration date of the ’630
patent.
SUPPLEMENTARY INFORMATION:
Robert Bahr,
Deputy Commissioner for Patents, United
States Patent and Trademark Office.
[FR Doc. 2023–06665 Filed 3–30–23; 8:45 am]
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[Federal Register Volume 88, Number 62 (Friday, March 31, 2023)]
[Notices]
[Page 19269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06665]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No. PTO-P-2023-0014]
Grant of Interim Extension of the Term of U.S. Patent No.
9,314,630; Symplicity Spyral[supreg] System, Symplicity Spyral[supreg]
Catheter, and Symplicity G3 Generator
AGENCY: United States Patent and Trademark Office, Department of
Commerce.
ACTION: Notice of interim patent term extension.
-----------------------------------------------------------------------
SUMMARY: The United States Patent and Trademark Office has issued an
order granting a one-year interim extension of the term of U.S. Patent
No. 9,314,630 ('630 patent).
FOR FURTHER INFORMATION CONTACT: Ali Salimi, Senior Legal Advisor,
Office of Patent Legal Administration, by telephone at 571-272-0909 or
by email to [email protected].
SUPPLEMENTARY INFORMATION: 35 U.S.C. 156 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. 35 U.S.C.
156(d)(5) generally provides that the term of such a patent may be
extended for no more than five interim periods of up to one year each,
if the approval phase of the regulatory review period is reasonably
expected to extend beyond the expiration date of the patent.
On March 23, 2023, Medtronic Ireland Manufacturing Unlimited
Company, the owner of record of the '630 patent, timely filed an
application under 35 U.S.C. 156(d)(5) for an interim extension of the
term of the '630 patent. The '630 patent claims a method of using the
product Symplicity Spyral[supreg] system, which includes the Symplicity
Spyral catheter and the Symplicity G3 generator. The application for
interim patent term extension indicates that a Premarket Approval
Application (PMA) PMA-220026 was submitted to the Food and Drug
Administration (FDA) on March 15, 2015, and that the FDA's review
thereof is ongoing.
Review of the interim patent term extension application indicates
that, except for permission to market or use the product commercially,
the '630 patent would be eligible for an extension of the patent term
under 35 U.S.C. 156. Because it appears the approval phase of the
regulatory review period will continue beyond the expiration date of
the patent, i.e., April 8, 2023, interim extension of the '630 patent's
term under 35 U.S.C. 156(d)(5) is appropriate.
An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S.
Patent No. 9,314,630 is granted for a period of one year from the
expiration date of the '630 patent.
Robert Bahr,
Deputy Commissioner for Patents, United States Patent and Trademark
Office.
[FR Doc. 2023-06665 Filed 3-30-23; 8:45 am]
BILLING CODE 3510-16-P
