[Federal Register Volume 71, Number 21 (Wednesday, February 1, 2006)]
[Notices]
[Pages 5345-5346]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1277]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: FDA Approvable Human DNA 
Diagnostic Test for Endometriosis

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 60/654,331 filed February 18, 2005, 
entitled ``Identification of Molecular Markers for Endometriosis in 
Blood Lymphocytes Using DNA Microarrays,'' to Ortho-Clinical 
Diagnostics, having a place of business in Raritan, NJ 08869. The 
contemplated exclusive license may be limited to an FDA approvable 
human DNA diagnostic test for endometriosis. The United States of 
America is the assignee of the patent rights in this invention.

DATES: Only written comments and/or application for a license which are 
received by the National Institutes of Health on or before April 3, 
2006 will be considered.

ADDRESSES: Requests 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: Endometriosis is a common, non-malignant 
gynecological disease that

[[Page 5346]]

affects up to twenty percent (20%) of women during their reproductive 
years. Endometriosis is characterized by the growth of endometrial 
tissue outside the uterus. This growth of tissue causes recurring 
severe pain and can lead to infertility. As the current procedure used 
for diagnosis is invasive and not entirely accurate, there is a need 
for a fast, accurate, and minimally invasive test to test for 
endometriosis.
    Using DNA microarray analysis of blood lymphocytes, the inventors 
have identified two gene markers expressed in blood that are able to 
discriminate between those women who have endometriosis and those that 
don't. This new technology would be minimally invasive and quick using 
a blood sample from a patient.
    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: January 23, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E6-1277 Filed 1-31-06; 8:45 am]
BILLING CODE 4140-01-P