[Federal Register Volume 72, Number 128 (Thursday, July 5, 2007)]
[Notices]
[Page 36716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-12898]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Method for the Diagnosis 
and Treatment of Vascular Disease

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 Endothelix, Inc., having a place of 
business in Houston TX, to practice the invention embodied in HHS Ref. 
Nos. E-037-2003 and E-125-2003, both entitled ``Method for the 
Diagnosis and Treatment of Vascular Disease'', corresponding to U.S. 
Patent Application No. 60/426,545 filed November 15, 2002, U.S. Patent 
Application No. 60/445,417 filed February 5, 2003, PCT Patent 
Application PCT/US03/36317 filed November 12, 2003, and U.S. Patent 
Application No.10/534,626 filed May 11, 2005. The contemplated 
exclusive license may be limited to the following field of use: an FDA-
approvable vascular endothelial function diagnostic test. The patent 
rights in this invention have been assigned to the United States of 
America.

DATES: Only written comments and/or application for a license which are 
received by the NIH Office of Technology Transfer on or before 
September 4, 2007 will be considered.

ADDRESSES: Requests for a copy of the patent, inquiries, comments, and 
other materials relating to the contemplated license should be directed 
to: Tara L. Kirby, PhD, 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: Cardiovascular disease is a major health 
risk throughout the industrialized world. Atherosclerosis, the most 
prevalent of cardiovascular diseases, is the primary cause of heart 
attack, stroke, and gangrene of the extremities. It is also the 
principal cause of death in the United States.
    The inventors have developed a technique for evaluating vascular 
function by counting endothelial progenitor cells (EPCs) in a blood 
sample. They found that decreased numbers of EPCs correlate 
significantly with decreased vascular function. A diagnostic test 
developed utilizing this discovery would have the advantages of being 
minimally invasive and low cost compared to other currently available 
diagnostics.
    The invention describes methods for diagnosing decreased vascular 
function, detecting increased cardiovascular risk, and diagnosing 
atherosclerosis. Also included are methods for assaying the number of 
endothelial progenitor cells and methods for treating a subject with 
decreased vascular function by administering a therapeutically 
effective amount of endothelial progenitor cells.
    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, 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: June 26, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-12898 Filed 7-3-07; 8:45 am]
BILLING CODE 4140-01-P