[Federal Register Volume 87, Number 77 (Thursday, April 21, 2022)]
[Notices]
[Page 23858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-08492]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2022-0016]


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.

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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 8, 2022, Neovasc Medical Ltd., the patent owner of record, 
timely filed an application under 35 U.S.C. 156(d)(5) for a third 
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 there is a 
reasonable expectation that the regulatory review period will continue 
beyond the twice-extended expiration date of the patent, June 6, 2022, 
a third interim extension of the patent term under 35 U.S.C. 156(d)(5) 
is appropriate.
    A third 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 
twice-extended expiration date of the patent.

Robert Bahr,
Deputy Commissioner for Patents, United States Patent and Trademark 
Office.
[FR Doc. 2022-08492 Filed 4-20-22; 8:45 am]
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