[Federal Register Volume 62, Number 30 (Thursday, February 13, 1997)]
[Notices]
[Page 6791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-3530]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Prospective Grant of Exclusive License: Diagnostic Test for 
Alzheimer's Disease

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)(1)(i) that the National Institutes of Health (NIH), 
Department of Health and Human Services, is contemplating the grant of 
a worldwide, limited field of use, exclusive license to practice the 
inventions embodied in the patents and patent applications referred to 
below to NeuroLogic, Inc. of Washington, D.C. The patents and patent 
applications to be licensed are U.S. Patent No. 5,580,748 issued 
December 3, 1996 (U.S. Patent Application Serial No. 08/056,456 filed 
May 3, 1993), entitled ``Cell Test for Alzheimer's Disease,'' and all 
continuation applications, divisional applications, continuation-in-
part applications, and foreign counterpart applications related to U.S. 
Patent Application Serial No. 08/056,456.

SUPPLEMENTARY INFORMATION: 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 sixty (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.
    Alzheimer's disease (AD) represents the fourth leading cause of 
death in the United States, killing over 100,000 annually, and 
afflicting some 4 million Americans and is projected to affect over 14 
million by the year 2050. Various reports indicate that the incidence 
of Alzheimer's disease increases with age and estimate that the 
prevalence of AD in people over 80 years of age is between 20 and 50%. 
Under currently available technology AD can only be positively 
diagnosed by pathological examination of brain tissue during autopsy in 
conjunction with a clinical history of dementia.
    Present efforts to diagnosis the disease have been generally 
directed to the identification and detection of molecules present in 
blood samples or in cerebral spinal fluid (CSF). Current tests for the 
detection of Alzheimer's disease have met with varying degrees of 
commercial success. The proposed technology involves the identification 
of Alzheimer's disease utilizing fibroblast cells. The method consists 
of: Measuring the presence or absence of a specific potassium channel, 
measuring the effect of potassium channel blockers specific for the 113 
pS potassium channel on intracellular calcium levels, measuring the 
increase of intracellular calcium in response to an activator of 
intracellular calcium release in the cells of a patient, and measuring 
the amount of the G-protein, cp20.

ADDRESSES: Requests for a copy of these patent applications, inquiries, 
comments, and other materials relating to the contemplated license 
should be directed to: Stephen L. Finley, Ph.D., Technology Licensing 
Specialist, Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852; 
Telephone: (301) 496-7056, ext. 215; Facsimile: (301) 492-0220. A 
signed Confidential Disclosure Agreement will be required to receive a 
copy of any pending patent application. Applications for a license 
filed in response to this notice will be treated as objections to the 
grant of the contemplated license. Only written comments and/or 
applications for a license which are received by NIH on or before April 
14, 1997, will be considered. 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: February 4, 1997.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 97-3530 Filed 2-12-97; 8:45 am]
BILLING CODE 4140-01-M