[Federal Register Volume 79, Number 11 (Thursday, January 16, 2014)]
[Notices]
[Pages 2821-2822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-00723]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2013-0063]


Grant of Interim Extension of the Term of U.S. Patent No. 
5,593,823; INTERCEPT[supreg] Blood System for Plasma

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 interim extension under 35 U.S.C. 156(d)(5) for a one-
year interim extension of the term of U.S. Patent No. 5,593,823.

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 [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 December 3, 2013, Cerus Corporation, the patent owner of record, 
timely filed an application under 35 U.S.C. 156(d)(5) for an interim 
extension of the term of U.S. Patent No. 5,593,823. The patent claims 
the medical device INTERCEPT[supreg] Blood System for Plasma. The 
application indicates that a Premarket Approval Application (PMA) was 
submitted to the Food and Drug Administration (FDA) in four modules. 
The PMA Shell number BM120078 was assigned on December 5, 2012. The 
first module was received by the FDA on March 1, 2013, the second 
module was received on June 3, 2013, by the FDA, the third module was 
received by the FDA on September 3, 2013, and the fourth module was 
received by the FDA

[[Page 2822]]

on November 29, 2013. The medical device is currently undergoing 
regulatory review before the FDA for permission to market or use the 
product commercially.
    Review of the 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, January 14, 2014, 
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. 5,593,823 is granted for a period of one year from the 
original expiration date of the patent.

    Dated: January 10, 2014.
Andrew Hirshfeld,
Deputy Commissioner for Patent Examination Policy, United States Patent 
and Trademark Office.
[FR Doc. 2014-00723 Filed 1-15-14; 8:45 am]
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