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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. 

# ADDRESSES:

Licensing information and copies of the U.S. patent applications listed below may be obtained by contacting Peter A. Soukas, J.D., at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7056 ext. 268; fax: 301/402-0220; e-mail: soukasp@od.nih.gov. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. 

# SUPPLEMENTARY INFORMATION:

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 inventions claim full-length sequences of HCV, HCV chimeras and HCV derivatives, and methods for using these full-length sequences for a variety of therapeutic and diagnostic applications, including vaccines. 

## Cloned Genomes of Infectious Hepatitis C Virus and Uses Thereof 

Masayuki Yanagi, Jens Bukh, Suzanne U. Emerson, Robert H. Purcell (NIAID) 

Serial No. 09/014,416 filed 27 Jan 1998, issued as U.S. Patent 6,153,421 on 28 Nov 2000; Serial No. 09/662,454 filed 14 Sep 2000; Canadian Application 2295552; Australian Application 84889/98; European Application 98935702.5

The current invention provides nucleic acid sequences comprising the genomes of infectious hepatitis C viruses (HCV) of genotype 1a and 1b. It covers the use of these sequences, and polypeptides encoded by all or part of the sequences, in the development of vaccines and diagnostic assays for HCV and the development of screening assays for the identification of antiviral agents for HCV. Additional information can be found in Yanagi et al., (1997) Proc. Natl. Acad. Sci., USA 94, 8738-8743 and Yanagi et al. (1998) Virology 244, 151-172. 

## Cloned Genome of Infectious Hepatitis C Virus of Genotype 2a and Uses Thereof 

Jens Bukh, Masayuki Yanagi, Robert H. Purcell, Suzanne U. Emerson (NIAID) 

DHHS Reference No. E-100-99/0, U.S. S/N 60/137,693 filed 04 Jun 1999; DHHS Reference No. E-100-99/1, PCT/US00/15466 filed 02 Jun 2000

The current invention provides a nucleic acid sequence comprising the genome of infectious hepatitis C viruses (HCV) of genotype 2a. The encoded polyprotein differs from those of the infectious clones of genotypes 1a and 1b (U.S. Patent 6,153,421) by approximately thirty (30) percent. It covers the use of this sequence and polypeptides encoded by all or part of the sequence, in the development of vaccines and diagnostic assays for HCV and the development of screening assays for the identification of antiviral agents for HCV. Additional information can be found in Yanagi et al. (1999), Virology 262, 250-263. 

## HCV/BVDV Chimeric Genomes and Uses Thereof 

Jae-Hwan Nam, Jens Bukh, Robert H. Purcell, Suzanne U. Emerson (NIAID) 

DHHS Reference No. E-102-99/0, U.S. S/N 60/137,817 filed 04 June 1999; DHHS Reference No. E-102-99/1, PCT/US00/15527 filed 02 Jun 2000

The current invention provides nucleic acid sequences comprising chimeric viral genome of hepatitis C Virus (HCV) and bovine viral diarrhea viruses (BVDV). The chimeric viruses are produced by replacing the structural region or a structural gene of an infectious BVDV clone with the corresponding region or gene of an infectious HCV. It covers the use of these sequences and polypeptides encoded by all or part of the sequences in the development of vaccines and diagnostic assays for HCV and the development of screening assays for the identification of antiviral agents for HCV. 

## Infectious cDNA Clone of GB Virus B and Uses Thereof 

Jens Bukh, Masayuki Yanagi, Robert H. Purcell, Suzanne U. Emerson (NIAID) 

DHHS Reference No. E-173-99/0, U.S. S/N 60/137,694 filed 04 Jun 1999; DHHS Reference No. E-173-99/1, PCT/US00/15293 filed 02 Jun 2000

The current invention provides nucleic acid sequences comprising the genomes of infectious GB virus B, the most closely related member of the Flaviviridae to hepatitis C virus (HCV). It also covers chimeric GBVB-HCV sequences and polypeptides for use in the development of vaccines and diagnostic assays for HCV and the development of screening assays for the identification of antiviral agents for HCV. Additional information can be found in Bukh et al. (1999), Virology 262, 470-478. 

Dated: June 11, 2001. 

Jack Spiegel, 

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

[FR Doc. 01-15462 Filed 6-19-01; 8:45 am] 

BILLING CODE 4140-01-P