[Federal Register Volume 82, Number 183 (Friday, September 22, 2017)]
[Notices]
[Page 44391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20272]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2017-0038]


Grant of Interim Extension of the Term of U.S. Patent No. 
6,100,082; OCS<SUP>TM</SUP> Lung System

AGENCY: United States Patent and Trademark Office, 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. 6,100,082.

FOR FURTHER INFORMATION CONTACT: Mary C. Till by telephone at (571) 
272-7755; by mail marked to her 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 her attention at (571) 273-
7755; or by email to <a href="/cdn-cgi/l/email-protection#eea38f9c97c0ba878282ae9b9d9e9a81c0898198"><span class="__cf_email__" data-cfemail="703d1102095e24191c1c30050300041f5e171f06">[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 September 6, 2017, TransMedics, Inc, an exclusive licensee of 
the patent owner of record, the Department of Veterans Affairs, timely 
filed an application under 35 U.S.C. 156(d)(5) for an interim extension 
of the term of U.S. Patent No. 6,100,082. The patent claims the medical 
device product, the OCS Lung System. The application for patent term 
extension indicates that a Premarket Approval Application (PMA) P160013 
was submitted to the Food and Drug Administration (FDA) on April 28, 
2016.
    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 original expiration date of the 
patent, September 23, 2017, 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. 6,100,082 is granted for a period of one year from the 
original expiration date of the patent.

    Dated: September 14, 2017.
Robert Bahr,
Deputy Commissioner for Patent Examination Policy, United States Patent 
and Trademark Office.
[FR Doc. 2017-20272 Filed 9-21-17; 8:45 am]
 BILLING CODE 3510-16-P


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