01-27751. Government-Owned Inventions; Availability for Licensing

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 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: [phone]; fax: [phone]. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.

Recombinant Proteins of the Swine Hepatitis E Virus and Their Uses as a Vaccine and Diagnostic Reagents for Medical and Veterinary Applications

Xiang-Jin Meng, Robert H. Purcell, Suzanne U. Emerson (NIAID)

DHHS Reference No. E-304-98/0 filed May 7, 2001

Licensing Contact: Carol Salata; 301/496-7735 ext. 232; e-mail: [e-mail]

This invention is based on the discovery of the swine hepatitis E virus (swine HEV), the first animal strain of HEV identified and characterized, and its ability to infect across species. The inventors have found that the swine HEV is widespread in the general pig population in the United States and other countries and that swine HEV can infect non-human primates. The inventors have amplified and sequenced the complete genome of swine HEV. The capsid gene (ORF2) of swine HEV has been cloned and expressed in a baculovirus expression system.

The possibility that swine HEV may infect humans raises a potential public health concern for zoonosis or xenozoonosis in the United States and perhaps other countries. Therefore, it is likely that a vaccine based on the recombinant capsid protein of swine HEV will protect humans against zoonotic, as well as other, HEV infections and pigs against infection with the swine HEV. Also, diagnostic reagents based on these recombinant proteins of swine HEV will be very useful in screening donor pigs used in xenotransplantation and in detecting swine HEV or similar virus infection in humans. The diagnostic reagents may also be useful for veterinary studies and monitoring pig herds in general.

Polymorphic Human GABA_A Receptorα-6 Subunit

David Goldman, Nakao Iwata, Mark Shuckit (NIAAA)

DHHS Reference No. E-061-98/0 filed February 19, 1999 and DHHS Reference No. E-061-98/1 filed February 18, 2000

Licensing Contact: Pradeep Ghosh; 301/496-7736 ext. 211; e-mail: [e-mail]

Gamma-aminobutyric acid (GABA) is a key inhibitory neurotransmitter in the mammalian central nervous system. Evidence indicates that GABA receptors are associated with various neuropsychiatric disorders. Currently, there are no reliable and sensitive markers on the market for the molecular diagnosis of alcoholism or anxiety disorders, although both groups of disorders are thought to involve GABA function. Alcohol modulates GABA function and shows cross-tolerance with benzodiazepines. Anxiety disorders are treated with benzodiazepines. Also, there are no molecular predictors of interindividual variation in response to the commonly used benzodiazepine drugs [such as valium) which act through GABA_A receptors. The α-6 subunit of GABA_A receptors is sensitive to alcohol and in a rat genetic model a genetic variant of the α-6 subunit had been directly related to sensitivity to alcohol and benzodiazepine drugs. This invention pertains to a particular polymorphism in the human α-6 subunit gene. This relatively common human sequence variant predicts sensitivity to both benzodiazepine drugs and ethanol. In children of alcoholics this substitution also correlates with susceptibility to alcoholism. Thus, this invention presents commercial opportunities both as a diagnostic screening tool in alcoholism, anxiety disorders and other neuropsychiatric diseases, and as a predictive tool for therapeutic and pathological responses to commonly administered benzodiazepine drugs.

Dated: October 29, 2001.

Jack Spiegel,

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