[Federal Register Volume 60, Number 140 (Friday, July 21, 1995)]
[Notices]
[Page 37662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17983]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health


Prospective Grant of Exclusive License: Delta-Like Gene Expressed 
in Neuroendocrine Tumors

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 
an exclusive world-wide license to practice the inventions embodied in 
U.S. Patent Application 07/989,537 and corresponding foreign patent 
applications entitled, ``Delta-Like Gene Expressed in Neuroendocrine 
Tumors'' to ImClone Systems Incorporated of New York, NY. The patent 
rights in these inventions have been assigned to the United States of 
America.
    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.
    The present patent application covers a novel gene, delta-like, dlk 
and its corresponding protein. The protein contains EGF-like repeats 
and a transmembrane domain and appears to be a novel member of the 
family of EGF-like neurogenic genes. Such genes were initially found in 
Drosophila and are involved in embryonic developmental decisions to 
differentiate into epidermal or neuronal cells. One of these genes in 
Drosophila is termed, ``Delta'', hence the name of the current gene. 
dlk can be employed in genetic assays for detection of a primary or 
secondary pheochromocytoma, neuroblastoma, and small cell lung cancer 
or identification of a stage of these tumors.
    Although dlk may have utility as a cancer marker, recent research 
indicates another important application of this technology, as a 
hematopoietic stem cell growth factor. The adult bone marrow is the 
site of hematopoiesis with an estimated 0.01% of the cells being 
stromal cells. It is thought that the stem cells are found in micro-
environments associated with stromal cells which produce factor(s) 
which allows the maintenance and self-renewal of the stem cells. One or 
more stromal cell produced factor(s) may be required to keep the stem 
cells in an uncommitted state. When stem cells leave this micro-
environment they would no longer be in contact with this factor(s) and, 
consequently, they would differentiate toward one of the hematopoietic 
cell lineages.
    Delta is a 43 kDa protein which belongs to the epidermal growth 
factor-like superfamily. Delta was cloned by another group from a mouse 
stromal cell line PA-6, a cell line which has been reported to support 
the growth of hematopoietic stem cells. Delta may function as a ligand 
by binding to the extracellular domain of a Drosophila protein called 
Notch. Notch encodes a transmembrane protein with a large extracellular 
domain, is widely expressed including by hematopoietic cells, and its 
activation may keep cells in an uncommitted state.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
comments and other materials relating to the contemplated licenses 
should be directed to: Raphe Kantor, Ph.D., Technology Licensing 
Specialist, Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-
3804. Telephone: (301) 496-7735 ext. 247; Facsimile: (301) 402-0220. A 
signed Confidentiality Agreement will be required to receive copies of 
the patent applications. Applications for a license in the field of use 
filed in response to this notice will be treated as objections to the 
grant of the contemplated licenses. Only written comments and/or 
applications for a license which are received by NIH on or before 
September 19, 1995 will be considered. Comments and objections 
submitted 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: July 11, 1995.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 95-17983 Filed 7-20-95; 8:45 am]
BILLING CODE 4140-01-P