[Federal Register Volume 71, Number 13 (Friday, January 20, 2006)]
[Notices]
[Pages 3314-3315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-590]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: FDA Approvable Human 
Diagnostic for Osteoarthritis

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), 
Department of Health and Human Services, is contemplating the grant of 
an exclusive license worldwide to practice the invention embodied in 
U.S. Patent Application Number 60/602,334 filed August 18, 2005, 
entitled ``Biomarkers for Osteoarthritis,'' to PeptiFarma, Inc., having 
a place of business in San Diego, CA 92191. The contemplated exclusive 
license may be limited to an FDA approvable human diagnostic for 
osteoarthritis. The United States of America is an assignee of the 
patent rights in this invention.

DATES: Only written comments and/or application for a license which is 
received by the NIH Office of Technology Transfer on or before March 
21, 2006 will be considered.

ADDRESSES: Request for a copy of the patent, inquires, comments, and 
other materials relating to the contemplated license should be directed 
to: Marlene Astor, Technology Licensing Specialist, Office of 
Technology Transfer, National Institutes of Health, 6011 Executive 
Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: 301-435-
4426; Facsimile: 301-402-0220; e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Osteoarthritis is a chronic, often 
progressive and substantially disabling condition that becomes more 
common with advanced age. Osteoarthritis commonly involves the knees, 
hands, hips, neck and back resulting in pain and limitations of 
movement.
    Unfortunately clinically available tests are neither capable of 
detecting osteoarthritis early in its development, nor sensitive enough 
to adequately assess disease progression. A better means of diagnosing 
early osteoarthritis and its progression that can be used to assess the 
response to therapeutic treatments is needed. The currently available 
laboratory techniques are highly sensitive but either lack specificity 
or require large volumes of sample. Rolling Circle Amplification (RCA) 
is a new technology that precisely localizes unique signals arising 
from single reporter molecules. RCA has been incorporated into 
antibody-based microarray system protein chips that enable testing with 
high sensitivity and specificity for hundreds of proteins 
simultaneously, using small sample volumes.
    This invention describes a method of using RCA technology for 
detecting the expression of serum proteins that are perturbed in 
osteoarthritis patients. The results of this testing can be used to 
identify proteins associated with osteoarthritis presence, prediction 
of osteoarthritis development and prognosis, predict response to 
osteoarthritis treatment and potentially also identify future anti-
osteoarthritic drugs.
    The prospective exclusive license will be royalty-bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. 
The prospective exclusive license may be granted unless,

[[Page 3315]]

within 60 days from the date of this published Notice, the NIH receives 
written evidence and argument that establishes that the grant of the 
license would not be consistent with the requirements of 35 U.S.C. 209 
and 37 CFR 404.7.
    Properly filed competing applications for a license filed in 
response to this notice will be treated as objections to the 
contemplated license. Comments and objections submitted in response to 
this notice will not be made available for public inspection, and, to 
the extent permitted by law, will not be released under the Freedom of 
Information Act, 5 U.S.C. 552.

    Dated: January 10, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer National Institutes of Health.
 [FR Doc. E6-590 Filed 1-19-06; 8:45 am]
BILLING CODE 4167-01-P