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[Federal Register Volume 65, Number 236 (Thursday, December 7, 2000)]
[Notices]
[Page 76658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-31215]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Prospective Grant of Exclusive License: Methods and Compositions 
for the Detection and Treatment of Insulin Dependent Diabetes

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

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)(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: 
US Patent Application Serial Number 08/548,159 filed 10/95 by McClaren, 
Notkins, Lan, and Li, and foreign counterparts, and US Patent 
Application Serial Number 08/514,213 filed 8/95, and foreign 
counterparts, by McClaren, Notkins, and Lan--both entitled ``Methods 
and Compositions for the Detection and Treatment of Insulin Dependent 
Diabetes'' to BioSeek Inc., of New York, NY. The United States of 
America is an assignee of the patent rights to these inventions.

DATES: Only written comments and/or application for a license which are 
received by the NIH Office of Technology Transfer on or before February 
5, 2001 will be considered.

ADDRESSES: Requests for a copy of the patent applications, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: John Rambosek, Ph.D. Office of Technology 
Transfer, National Institutes of Health, 6011 Executive Boulevard, 
Su9ite 325, Rockville, MD 20852-3804; Email:[email protected]; Telephone: 
(301) 496-7056, ext. 270; Facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: Insulin-dependent diabetes mellitus (IDDM) 
affects close to one million people in the United States. It is 
autoimmune disease in which the immune system produces antibodies that 
attack the body's own insulin-manufacturing cells in the pancreas. 
Patients require daily injections of insulin to regulate blood sugar 
levels. The invention identifies two proteins, named IA-2 and IA-
2, that are important markers for type I (juvenile, insulin-
dependent) diabetes. IA-2/IA-2, when used in diagnostic tests, 
recognized autoantibodies in 70 percent of IDDM patients. Combining IA-
2 and IA-2 with other known markers increased the level of 
identification to 90 percent of individuals with IDDM. Moreover, the 
presence of autoantiboides to IA-2 and IA-2 in otherwise 
normal individuals was highly predictive in identifying those at risk 
of ultimately developing clinical disease. It is now possible to 
develop a rapid and effective test that can screen large populations 
for IDDM. In addition, IA-2 and IA-2 are candidates for immune 
tolerance and prevention of disease development. 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 
license may be limited to use of the invention for diagnostic and 
therapeutic uses in the detection and treatment of diabetes. The 
prospective exclusive license may be granted unless, within 60 days 
from the date of this published Notice, 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: November 30, 2000.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 00-31215 Filed 12-6-00; 8:45 am]
BILLING CODE 4140-01-M
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