Grant of Interim Extension of the Term of U.S. Patent No. 9,364,354; Reducer®, 24852 [2021-09846]
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Federal Register / Vol. 86, No. 88 / Monday, May 10, 2021 / Notices
was authorized is found in the previous
documents referenced above. The data
inputs and methods of estimating take
are identical to those used in the initial
IHA. NMFS has reviewed recent Stock
Assessment Reports, information on
relevant Unusual Mortality Events, and
recent scientific literature, and
determined that no new information
affects our original analysis of impacts
or take estimate under the initial IHA.
We refer to the documents related to
the initial IHA, which include the
Federal Register notice of the issuance
of the initial Year 1 and Year 2 IHAs for
the USACE’s construction work (85 FR
1140; January 9, 2020), the USACE’s
application, the Federal Register notice
of the proposed IHAs (84 FR 56781;
October 23, 2019), and all associated
references and documents.
Determinations
The USACE will conduct activities as
analyzed in the initial IHA. As
described above, the number of
authorized takes of the same species and
stocks of marine mammals are identical
to the numbers that were found to meet
the negligible impact and small
numbers standards and authorized
under the initial IHA and no new
information has emerged that would
change those findings. The re-issued
Year 1 IHA includes identical required
mitigation, monitoring, and reporting
measures as the initial IHA, and there is
no new information suggesting that our
analysis or findings should change.
Based on the information contained
here and in the referenced documents,
NMFS has determined the following: (1)
The required mitigation measures will
effect the least practicable impact on
marine mammal species or stocks and
their habitat; (2) the authorized takes
will have a negligible impact on the
affected marine mammal species or
stocks; (3) the authorized takes
represent small numbers of marine
mammals relative to the affected stock
abundances; and (4) the USACE’s
activities will not have an unmitigable
adverse impact on taking for subsistence
purposes as no relevant subsistence uses
of marine mammals are implicated by
this action.
khammond on DSKJM1Z7X2PROD with NOTICES
National Environmental Policy Act
To comply with the National
Environmental Policy Act of 1969
(NEPA; 42 U.S.C. 4321 et seq.) and
NOAA Administrative Order (NAO)
216–6A, NMFS must review our
proposed action with respect to
environmental consequences on the
human environment.
VerDate Sep<11>2014
19:05 May 07, 2021
Jkt 253001
Accordingly, NMFS has determined
that the issuance of the IHA qualifies to
be categorically excluded from further
NEPA review. This action is consistent
with categories of activities identified in
CE B4 of the Companion Manual for
NOAA Administrative Order 216–6A,
which do not individually or
cumulatively have the potential for
significant impacts on the quality of the
human environment and for which we
have not identified any extraordinary
circumstances that would preclude this
categorical exclusion.
Endangered Species Act (ESA)
Section 7(a)(2) of the Endangered
Species Act of 1973 (ESA: 16 U.S.C.
1531 et seq.) requires that each Federal
agency insure that any action it
authorizes, funds, or carries out is not
likely to jeopardize the continued
existence of any endangered or
threatened species or result in the
destruction or adverse modification of
designated critical habitat. To ensure
ESA compliance for the issuance of
IHAs, NMFS consults internally
whenever we propose to authorize take
for endangered or threatened species.
However, no incidental take of ESAlisted species is authorized or expected
to result from this activity. Therefore,
NMFS has determined that formal
consultation under section 7 of the ESA
is not required for this action.
Authorization
NMFS has issued an IHA to the
USACE for in-water construction
activities associated with the specified
activity from September 1, 2021 through
August 31, 2022. All previously
described mitigation, monitoring, and
reporting requirements from the initial
Year 1 IHA are incorporated.
Dated: May 5, 2021.
Catherine Marzin,
Acting Director, Office of Protected Resources,
National Marine Fisheries Service.
[FR Doc. 2021–09867 Filed 5–7–21; 8:45 am]
BILLING CODE 3510–22–P
DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No. PTO–P–2021–0027]
Grant of Interim Extension of the Term
of U.S. Patent No. 9,364,354; Reducer®
United States Patent and
Trademark Office, Department of
Commerce.
ACTION: Notice of interim patent term
extension.
AGENCY:
PO 00000
Frm 00014
Fmt 4703
Sfmt 4703
The United States Patent and
Trademark Office has issued an order
granting interim extension for a oneyear interim extension of the term of
U.S. Patent No. 9,364,354.
SUMMARY:
Ali
Salimi by telephone at (571) 272–0909;
by mail marked to his attention and
addressed to the Commissioner for
Patents, Mail Stop Hatch-Waxman PTE,
P.O. Box 1450, Alexandria, VA 22313–
1450; by fax marked to his attention at
(571) 273–0909; or by email to
ali.salimi@uspto.gov.
FOR FURTHER INFORMATION CONTACT:
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.
SUPPLEMENTARY INFORMATION:
On April 20, 2021, Neovasc Medical
Ltd., the patent owner of record, timely
filed an application under 35 U.S.C.
156(d)(5) for a second interim extension
of the term of U.S. Patent No. 9,364,354.
The patent claims the catheter
implantable device, Reducer®. The
application for patent term extension
indicates that a Premarket Approval
Application (PMA) P190035 was
submitted to the Food and Drug
Administration (FDA) on December 31,
2019.
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 once-extended
expiration date of the patent, June 6,
2021, a second interim extension of the
patent term under 35 U.S.C. 156(d)(5) is
appropriate.
A second interim extension under 35
U.S.C. 156(d)(5) of the term of U.S.
Patent No. 9,364,354 is granted for a
period of one year from the onceextended expiration date of the patent.
Robert Bahr,
Deputy Commissioner for Patents, United
States Patent and Trademark Office.
[FR Doc. 2021–09846 Filed 5–7–21; 8:45 am]
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[Federal Register Volume 86, Number 88 (Monday, May 10, 2021)]
[Notices]
[Page 24852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09846]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No. PTO-P-2021-0027]
Grant of Interim Extension of the Term of U.S. Patent No.
9,364,354; Reducer[supreg]
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 interim extension for a one-year interim extension of
the term of U.S. Patent No. 9,364,354.
FOR FURTHER INFORMATION CONTACT: Ali Salimi by telephone at (571) 272-
0909; by mail marked to his attention and addressed to the Commissioner
for Patents, Mail Stop Hatch-Waxman PTE, P.O. Box 1450, Alexandria, VA
22313-1450; by fax marked to his attention at (571) 273-0909; or by
email to [email protected].
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 April 20, 2021, Neovasc Medical Ltd., the patent owner of
record, timely filed an application under 35 U.S.C. 156(d)(5) for a
second interim extension of the term of U.S. Patent No. 9,364,354. The
patent claims the catheter implantable device, Reducer[supreg]. The
application for patent term extension indicates that a Premarket
Approval Application (PMA) P190035 was submitted to the Food and Drug
Administration (FDA) on December 31, 2019.
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 once-extended expiration date of
the patent, June 6, 2021, a second interim extension of the patent term
under 35 U.S.C. 156(d)(5) is appropriate.
A second interim extension under 35 U.S.C. 156(d)(5) of the term of
U.S. Patent No. 9,364,354 is granted for a period of one year from the
once-extended expiration date of the patent.
Robert Bahr,
Deputy Commissioner for Patents, United States Patent and Trademark
Office.
[FR Doc. 2021-09846 Filed 5-7-21; 8:45 am]
BILLING CODE 3510-16-P
