[Federal Register Volume 61, Number 47 (Friday, March 8, 1996)]
[Notices]
[Pages 9462-9463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5448]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health


Availability For Licensing: Chromatin Insulator Protecting 
Expressed Genes of Interest for Human Gene Therapy or Other Mammalian 
Transgenic Systems

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

ACTION: Notice.

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SUMMARY: The National Institutes of Health (NIH), Department of Health 
and Human Services (DHHS), seeks licensee(s) who can effectively pursue 
the preclinical, clinical and commercial development of the technology 
embodied in U.S. Patent Application SN 08/283,125 and corresponding 
foreign patent applications entitled, ``New DNA Fragment Acting as 
Chromatin Insulator to Protect Expressed Genes From CIS-Acting 
Regulatory Sequences in Mammalian Cells.'' The invention describes the 
isolation, identification, and characterization of a DNA element 
residing in higher eukaryotic chromatin structural domains. The 
technology provides the isolation of a functional DNA sequence 
comprising a chromatin insulating element from a vertebrate system and 
provides the first employment of the pure insulator element as a 
functional insulator in mammalian cells. The technology further relates 
to a method for insulating the expression of a gene from the activity 
of cis-acting regulatory sequences in eukaryotic chromatin.
    This technology could be of major importance in providing a 
mechanism and a tool to restrict the action of cis-acting regulatory 
elements on genes whose activities or encoded products are needed or 
desired to be expressed in mammalian transgenic systems. This 
technology provides the first pure insulator element to function solely 
as an insulator element in human cells. Accordingly, this technology 
could have tremendous practical implications for transgenic technology 
and human gene therapies, either in vitro or in vivo.
    The technology further provides a method and constructs for 
insulating the 

[[Page 9463]]
expression of a gene or genes in transgenic animals such that the 
transfected genes will be protected and stably expressed in the tissues 
of the transgenic animal or its offspring. For example, even if the DNA 
of the construct integrates into areas of silent chromatin in the 
genomic DNA of the host animal, the gene will continue to be expressed. 
The invention could provide a means of improving the stable integration 
and expression of any transgenic construct of interest, with 
efficiencies higher than are achieved presently. Use of this invention 
may represent a large potential savings for licensee's constructing 
transgenic cell lines or animals. All fields of use are available for 
licensing. The patent rights in this technology have been assigned to 
the United States of America.

SUPPLEMENTARY INFORMATION: The NIH seeks licensee(s), who in accordance 
with requirements and regulations governing the licensing of 
government-owned inventions (37 CFR part 404), have the most 
meritorious plan for the development of the DNA Chromatin Insulator 
technology to a marketable status to meet the needs of the public and 
with the best terms for the NIH. The criteria that NIH will use to 
evaluate license applications will include, but not be limited to those 
set forth by 37 CFR 404.7(a)(1) (ii)-(iv).

ADDRESS: Requests for copies of the patent applications, inquiries, 
comments and other materials relating to the contemplated licenses 
should be directed to: Joseph G. Contrera, M.S., J.D., Technology 
Licensing Specialist, Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3804; Telephone: (301) 496-7056 ext. 244; Facsimile: 
(301) 402-0220. A signed confidentiality agreement will be required to 
receive copies of the patent applications.

    Dated: February 23, 1996.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 96-5448 Filed 3-7-96; 8:45 am]
BILLING CODE 4140-01-M