[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]


-----------------------------------------------------------------------

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