[Federal Register Volume 86, Number 39 (Tuesday, March 2, 2021)]
[Notices]
[Pages 12180-12181]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04170]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2021-0012]


Grant of Interim Extension of the Term of U.S. Patent No. 
8,858,612; Reducer[supreg]

AGENCY: United States Patent and Trademark Office, Department of 
Commerce.

ACTION: Notice of Interim Patent Term Extension.

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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. 8,858,612.

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 <a href="/cdn-cgi/l/email-protection#59383530772a3835303430192c2a292d36773e362f"><span class="__cf_email__" data-cfemail="c2a3aeabecb1a3aeabafab82b7b1b2b6adeca5adb4">[email protected]</span></a>.

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. 8,858,612. The 
patent claims methods of using 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

[[Page 12181]]

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. 8,858,612 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. 2021-04170 Filed 3-1-21; 8:45 am]
BILLING CODE 3510-16-P


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