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###### Department of Health and Human Services

###### National Institutes of Health 

# AGENCY:

National Institutes of Health, Public Health Service, DHHS.

# ACTION:

Notice.

# 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 5,610,053 entitled “DNA Sequence Which Acts as a Chromatin Insulator Element to Protect Expressed Genes from Cis-acting Regulatory Sequences in Mammalian Cells,” issued on March 11, 1997. The invention describes the isolation, identification, and characterization of a DNA element residing in higher eukaryotic chromatin structural domains. All fields of use are available for licensing. The patent rights in this technology have been assigned to the United States of America. 

# ADDRESSES:

Requests for copies of the issued patent, inquiries, comments and other materials relating to the contemplated licenses should be directed to: Girish C. Barua, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7735 ext. 266; Facsimile: 301/402-0220; E-mail: baruag@od.nih.gov. 

# SUPPLEMENTARY INFORMATION:

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 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. 

The NIH seeks licensee(s), who in accordance with requirements and regulations governing the licensing of government-owned inventions (37 CFR part 404), have meritorious plan(s) for the development of the DNA Chromatin Insulator technology to a marketable status to meet the needs of the public. 

Dated: September 29, 2000. 

Jack Spiegel, 

Director, Division of Technology Development and Transfer, Office of Technology Transfer.

[FR Doc. 00-25893 Filed 10-6-00; 8:45 am] 

BILLING CODE 4140-01-P