Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
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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 inventions listed below are owned by agencies of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. 

# ADDRESS:

Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. 

## Ribonuclease H1—A Protein Expressed in Escherichia coli From a Cloned Human RNase H1 cDNA 

Robert J. Crouch, Susana Cerritelli, Sergey Gaidamakov, and Hirofumi Yamada (NICHD) 

DHHS Reference No. E-047-01/0 

*Licensing Contact:*                     Sally Hu; 301/496-7056 ext. 265; e-mail: hus@od.nih.gov.                 

Available for licensing through a Materials License Agreement (no patent or patent application) are samples of purified human RNase H1 protein, expressed in E. coli from human RNase H1 cDNA. This protein is important for cellular functions such as DNA synthesis and repair. This protein also is related by sequence, structure and enzymatic mechanism to the RNase H of retroviruses such as HIV. Since the cellular and viral proteins have similar properties, it would be useful to screen for potential drugs that have little or only modest effects on the cellular protein while inhibiting the HIV enzyme. Thus, the availability of both the retroviral and human RNases H1 makes drug screening and anti-sense therapy possible to perform. 

## Methods for the Identification of Textual and Physical Structured Query Fragments for the Analysis of Textual and Biopolymer Information 

Robert J. Boissy (NIEHS) 

DHHS Reference No. E-270-99/0 filed 15 Nov 2000 

*Licensing Contact:*                     Dale Berkley; 301/496-7735 ext. 223; e-mail: berkleyd@od.nih.gov.                 

                    The invention comprises algorithms implemented in software for “structured combinatorial queries” that may be used for analyses of relatedness and information content in any textual information, and especially in biological sequences. The invention also includes experimental methods for isolating and comparing DNA fragments (“Structured Query Fragments” or SQFs) obtained using site-specific cleavage effectors acting on substrate DNA that is asymmetrically end-immobilized on a solid support. A small, structured array of such cleavage effectors may be used in a combinatorial fashion to generate progressively expanding sets of asymmetrically end-immobilized, double-stranded DNA. This ultimately yields extremely large numbers of SQFs, which typically have lengths in the range of 100-700 nucleotides (and are termed ranged SQFs). Thus, each SQF is defined by a method (a specific combinatorial pathway required to isolate it) and one or more properties (typically its length). These attributes yield sufficient information to identify and assign ranged SQFs to specific locations in known sequences automatically using the software disclosed in the invention. The invention shows how millions of individual ranged SQFs distributed throughout the human genome may be unambiguously identified at nucleotide resolution using a fragment analysis instrument. Accordingly, the invention provides a computational method that is flexible and efficient at comparing large amounts of textual information (typically biological sequence data), and a unique laboratory strategy that emulates the computational method and provides a highly scalable approach for physical analyses of polynucleotides. This laboratory strategy allows for the analysis and isolation of large numbers                           ( print page 6638)                        of specific SQFs of interest, without the use of cloning techniques or polynucleotide amplification protocols that require locus-specific primers.                 

## Probe Using Diffuse-Reflectance Spectroscopy 

Amir H. Gandjbakhche (NICHD), David W. Hattery (NICHD), James L. Mulshine (NCI), Paul D. Smith (ORS), Ernie Hawk (NCI), Victor Chernomordik (NICHD) 

DHHS Reference No. E-309-00/0 filed 06 Oct 2000 

*Licensing Contact:*                     Dale Berkley; 301/496-7735 ext. 223; e-mail: berkleyd@od.nih.gov.                 

The invention uses an oblique angle reflectance spectroscopy method to non-invasively quantify the thickness of the oral epithelium as a means for quantifying inflammation at sites in the oral cavity. In this technique, a toothbrush-sized probe is used to direct photon sources at two or more oblique angles and measure the scattered spectra to determine the thickness of the epithelial layer. Analysis of the spectra provides the location of the stroma/epithelium interface. The invention has applications in the assessment of drugs used in the treatment of Leukoplakia, which is characterized by a thickening of the oral epithelium as the underlying stroma remains unchanged. The invention provides a non-invasive technique for determining the efficacy of drugs used to treat the lesion, and promises to replace the need for uncomfortable punch biopsies. 

## Modified HCV Peptide Vaccine 

Jay A. Berzofsky (NCI), Pablo Sarobe (NCI), CD Pendleton (NCI), Stephen M. Feinstone (FDA) 

DHHS Reference Nos. E-192-98/0 filed 21 Aug 1998 and E-192-98/1 filed 17 Aug 1999 

*Licensing Contact:*                     Carol Salata; 301/496-7735 ext. 232; e-mail: salatac@od.nih.gov.                 

Hepatitis C virus (HCV) is a single stranded RNA virus responsible for the majority of non-A non-B hepatitis. Hepatitis C virus (HCV) has a worldwide distribution and is a major cause of liver cirrhosis and hepatocellular carcinoma in the U.S., Europe, and Japan. For this reason, development of a vaccine against hepatitis C is of great importance. 

The present invention provides immunogenic peptides of HCV core protein which elicit an enhanced immune response, methods for making these peptides, and methods for using these peptides for a variety of therapeutic, diagnostic, and prognostic applications, including a vaccine. More specifically, the present invention provides an isolated peptide, an isolated HCV core polypeptide, a fragment of an HCV core polypeptide and nucleic acids which encode the peptides and polypeptides of this invention. The invention provides a modified HCV core peptide that is more immunogenic than the corresponding natural core peptide for eliciting human cytotoxic T lymphocytes. 

Dated: January 8, 2001. 

Jack Spiegel, 

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. 

[FR Doc. 01-1643 Filed 1-19-01; 8:45 am] 

BILLING CODE 4140-01-P