[Federal Register Volume 90, Number 227 (Friday, November 28, 2025)]
[Notices]
[Page 54636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-21411]
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DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
[Docket No.: PTO-P-2025-0479]
Grant of Interim Extension of the Term of U.S. Patent No.
8,785,125; the Aptima[supreg] HPV Assay With the Panther[supreg] 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 a
certificate under 35 U.S.C. 156(d)(5) for a one-year interim extension
of the term of U.S. Patent No. 8,785,125 ('125 patent).
FOR FURTHER INFORMATION CONTACT: Ali Salimi, Senior Legal Advisor,
Office of Patent Legal Administration, at 571-272-0909 or
[email protected]; or Andrea S. Grossman, Legal Advisor at (571)
270-3314 or email [email protected].
SUPPLEMENTARY INFORMATION: 35 U.S.C. 156 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. 35 U.S.C.
156(d)(5) generally provides that the term of such a patent may be
extended for no more than five interim periods of up to one year each,
if the approval phase of the regulatory review period (RRP) is
reasonably expected to extend beyond the expiration date of the patent.
On November 20, 2025, Gen-Probe Incorporated, the patent owner of
record of the '125 patent, timely filed an application under 35 U.S.C.
156(d)(5) for an interim extension of the term of the '125 patent. The
'125 patent claims the medical device known by tradename Aptima[supreg]
HPV Assay with the Panther[supreg] System and a method of using this
medical device. The application indicates that the approval phase
``continues'' for the regulatory period, as described in 35 U.S.C.
156(g)(1)(B)(ii), for Premarket Approval (PMA) 100042/S038 for the
Aptima[supreg] HPV Assay with the Panther[supreg] System and is ongoing
before the Food and Drug Administration for permission to market and
use the product commercially.
Review of the patent term extension application indicates that,
except for permission to market or use the product commercially, the
'125 patent would be eligible for an extension of the patent term under
35 U.S.C. 156. Because it appears reasonable to expect the approval
phase of the RRP to continue beyond the expiration date of the patent,
i.e., December 8, 2025, interim extension of the '125 patent's 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. 8,785,125 is granted for a period of one year from the
original expiration date of the patent.
Charles Kim,
Deputy Commissioner for Patents, United States Patent and Trademark
Office.
[FR Doc. 2025-21411 Filed 11-26-25; 8:45 am]
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