[Federal Register Volume 80, Number 3 (Tuesday, January 6, 2015)]
[Notices]
[Pages 491-492]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-30945]
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DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
[Docket No.: PTO-P-2014-0068]
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 a second 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 5, 2014, Cerus Corporation, 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. 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 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 it is apparent that the regulatory review
period will continue beyond the extended expiration date of the patent,
January 14, 2015, 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
extended expiration date of the patent.
[[Page 492]]
Dated: December 23, 2014.
Andrew Hirshfeld,
Deputy Commissioner for Patent Examination Policy United States Patent
and Trademark Office.
[FR Doc. 2014-30945 Filed 1-5-15; 8:45 am]
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