Grant of Interim Extension of the Term of U.S. Patent No. 6,953,476; Reducer®, 11947-11948 [2021-04168]

Download as PDF Federal Register / Vol. 86, No. 38 / Monday, March 1, 2021 / Notices Unmitigable Adverse Impact Analysis and Determination There are no relevant subsistence uses of the affected marine mammal stocks or species implicated by this action. Therefore, NMFS has determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes. Endangered Species Act Section 7(a)(2) of the Endangered Species Act of 1973 (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, in this case with the NMFS Greater Atlantic Regional Fisheries Office (GARFO), whenever NMFS proposes to authorize take for endangered or threatened species. The NMFS Office of Protected Resources is proposing to authorize the incidental take of four species of marine mammals listed under the ESA: the North Atlantic right, fin, sei, and sperm whale. The OPR has requested initiation of section 7 consultation with NMFS GARFO for the issuance of this IHA. NMFS will conclude the ESA section 7 consultation prior to reaching a determination regarding the proposed issuance of the authorization. Proposed Authorization As a result of these preliminary determinations, NMFS proposes to issue an IHA to Mayflower for conducting marine site characterization surveys offshore of Massachusetts in the area of the Commercial Lease of Submerged Lands for Renewable Energy Development on the Outer Continental Shelf (OCS–A 0521) and along a potential submarine cable route to landfall at Falmouth, Massachusetts for a period of one year from the date of issuance, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated. A draft of the proposed IHA can be found at https:// www.fisheries.noaa.gov/permit/ incidental-take-authorizations-undermarine-mammal-protection-act. Request for Public Comments NMFS requests comment on our analyses, the proposed authorization, and any other aspect of this notice of proposed IHA for the proposed marine VerDate Sep<11>2014 18:48 Feb 26, 2021 Jkt 253001 site characterization surveys. NMFS also requests at this time comment on the potential Renewal of this proposed IHA as described in the paragraph below. Please include with your comments any supporting data or literature citations to help inform decisions on the request for this IHA or a subsequent Renewal IHA. On a case-by-case basis, NMFS may issue a one-time, one-year Renewal IHA following notice to the public providing an additional 15 days for public comments when (1) up to another year of identical or nearly identical, or nearly identical, activities as described in the Description of Proposed Activities section of this notice is planned or (2) the activities as described in the Description of Proposed Activities section of this notice would not be completed by the time the IHA expires and a Renewal would allow for completion of the activities beyond that described in the Dates and Duration section of this notice, provided all of the following conditions are met: • A request for renewal is received no later than 60 days prior to the needed Renewal IHA effective date (recognizing that the Renewal IHA expiration date cannot extend beyond one year from expiration of the initial IHA); • The request for renewal must include the following: 1. An explanation that the activities to be conducted under the requested Renewal IHA are identical to the activities analyzed under the initial IHA, are a subset of the activities, or include changes so minor (e.g., reduction in pile size) that the changes do not affect the previous analyses, mitigation and monitoring requirements, or take estimates (with the exception of reducing the type or amount of take); and 2. A preliminary monitoring report showing the results of the required monitoring to date and an explanation showing that the monitoring results do not indicate impacts of a scale or nature not previously analyzed or authorized. Upon review of the request for Renewal, the status of the affected species or stocks, and any other pertinent information, NMFS determines that there are no more than minor changes in the activities, the mitigation and monitoring measures will remain the same and appropriate, and the findings in the initial IHA remain valid. Dated: February 24, 2021. Donna S. Wieting, Director, Office of Protected Resources, National Marine Fisheries Service. [FR Doc. 2021–04161 Filed 2–26–21; 8:45 am] BILLING CODE 3510–22–P PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 11947 DEPARTMENT OF COMMERCE Patent and Trademark Office [Docket No.: PTO–P–2021–0011] Grant of Interim Extension of the Term of U.S. Patent No. 6,953,476; Reducer® 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 granting a one-year interim extension of the term of U.S. Patent No. 6,953,476. 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 ali.salimi@uspto.gov. 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 February 19, 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. 6,953,476. The patent claims a catheter delivered 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 extended expiration date of the patent, March 27, 2021, interim extension of the patent 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. SUMMARY: E:\FR\FM\01MRN1.SGM 01MRN1 11948 Federal Register / Vol. 86, No. 38 / Monday, March 1, 2021 / Notices 6,953,476 is granted for a period of one year from the extended expiration date of the patent. DEPARTMENT OF DEFENSE Robert Bahr, Deputy Commissioner for Patents, United States Patent and Trademark Office. Arms Sales Notification [FR Doc. 2021–04168 Filed 2–26–21; 8:45 am] BILLING CODE 3510–16–P VerDate Sep<11>2014 18:48 Feb 26, 2021 [Transmittal No. 20–48] Defense Security Cooperation Agency, Department of Defense (DoD). ACTION: Arms sales notice. AGENCY: The Department of Defense is publishing the unclassified text of an arms sales notification. FOR FURTHER INFORMATION CONTACT: Karma Job at karma.d.job.civ@mail.mil or (703) 697–8976. SUMMARY: Jkt 253001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 This 36(b)(1) arms sales notification is published to fulfill the requirements of section 155 of Public Law 104–164 dated July 21, 1996. The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 20–48 with attached Policy Justification and Sensitivity of Technology. SUPPLEMENTARY INFORMATION: Dated: February 23, 2021. Aaron T. Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense. BILLING CODE 5001–06–P E:\FR\FM\01MRN1.SGM 01MRN1

Agencies

[Federal Register Volume 86, Number 38 (Monday, March 1, 2021)]
[Notices]
[Pages 11947-11948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04168]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No.: PTO-P-2021-0011]


Grant of Interim Extension of the Term of U.S. Patent No. 
6,953,476; 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 a one-year interim extension of the term of U.S. Patent 
No. 6,953,476.

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 February 19, 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. 6,953,476. The 
patent claims a catheter delivered 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 extended expiration date of the 
patent, March 27, 2021, interim extension of the patent 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.

[[Page 11948]]

6,953,476 is granted for a period of one year from the extended 
expiration date of the patent.

Robert Bahr,
Deputy Commissioner for Patents, United States Patent and Trademark 
Office.
[FR Doc. 2021-04168 Filed 2-26-21; 8:45 am]
BILLING CODE 3510-16-P

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