E6-2015. Government-Owned Inventions; Availability for Licensing

AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

SUMMARY:

The inventions listed below are owned by an agency 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.

Autoantibody Screening for Cancer Diagnosis

Yoon S. Cho-Chung (NCI).

U.S. Provisional Application filed (HHS Reference No. E-057-2006/0-US-01).

Licensing Contact: David A. Lambertson; 301/435-4632; [e-mail].

There are a number of specific antigens, such as alpha-fetal protein (AFP), nonmucinous ovarian cancer antigen (CA125), vascular endothelial growth factor (VEGF), prostate-specific antigen (PSA), which are secreted into the serum of patients who have particular cancers. Kits for detecting these antigens are generally used as a means of diagnosing patients as having a specific cancer. However, the current methods suffer from a lack of sensitivity.

The instant technology provides a method for the early diagnosis of different cancers that does not suffer the drawbacks of the current assays. The inventors observed that auto-antibodies against the cancer marker antigens can be detected in the serum of patients with particular cancers. This new technology is designed to screen for the autoantibodies for a spectrum of secreted tumor antigens in a single assay (BBA, in press). This provides a highly sensitive assay for diagnosing cancer at an early stage, or when the tumor is of a very small size. Claims of the instant invention are drawn to methods and kits for performing this analysis as a means of diagnosing cancer.

In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors.

Therapeutic HIV Vaccine Vectors for Individuals Receiving Antiretroviral Therapy

Barbara K. Felber et al. (NCI).

U.S. Provisional Application filed 09 Jul 2004 (HHS Reference No. E-249-2004/0-US-01); PCT Application No. PCT/US2005/024498 filed 11 Jul 2005 (HHS Reference No. E-249-2004/1-PCT-01);

PCT Application No. PCT/US01/45624 filed 01 Nov 2001, which published as WO 02/36806 on 10 May 2002 (HHS Reference No. E-308-2000/0-PCT-02);

National Stage filed in EP, CA, AU, JP, and U.S. (HHS Reference No. E-308-2000/0-US-07).

Licensing Contact: Susan Ano; 301/435-5515; [e-mail].

Antiretroviral therapy (ART) against HIV leads to control of viremia, but it does not eradicate the virus. Thus, interruption of ART leads to virus rebound. In addition, prolonged ART is associated with toxicity and development of virus resistance. The technology describes the use of DNA vaccine vectors that produce either secreted or intracellularly degraded antigens for administration to individuals receiving ART. These DNA vectors have recently been shown to work unusually well in controlling viremia when administered as DNA vaccines to SIV-infected monkeys that are undergoing treatment with antiretroviral agents. The current technologies would decrease the drug dependence and assist in clearing or reducing virus burden.

In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors.

Haplotypes of Human Bitter Taste Receptor Genes

Dennis Drayna and Un-Kyung Kim (NIDCD).

PCT International Application No. PCT/US2004/019489, filed 18 June 2004 (priority date 19 June 2003), International Publication No. WO 2005/007891, Publication Date 27 January 2005 and global IP (HHS Reference Nos. E-222-2003/0 and E-222-2003/1).

Licensing Contact: Susan Carson, D.Phil., 301 435-5020; [e-mail].

Bitter taste has evolved in mammals as a crucial, important warning signal against ingestion of poisonous or toxic compounds. However, many beneficial compounds are also bitter, and taste masking of bitter tasting pharmaceutical compounds is a billion dollar industry. The diversity of compounds that elicit bitter-taste sensations is very large and more than two dozen members of the T2R bitter taste receptor family have been identified. Individuals are now known to be genetically predisposed to respond or not to respond to the bitter taste of a number of substances. For example, large individual differences in the perception of bitterness have been well documented in compounds as different as nicotine, thiocyanates such as those found in cruciferous vegetables, and many bitter beta-glucopyranosides. This may have broad implications for nutritional status and tobacco use and common allelic variants of a member of the T2R bitter taste receptor gene family have been shown to underlie variation in the ability to taste phenylthiocarbamide (PTC) [Science (2003) 299, 1221-1225; HHS Ref No: E-169-2001/0].

Scientists at the NIDCD have extended these results to other bitter taste receptors and have sequenced 22 of the 24 known T2R genes in a series of populations worldwide, including Northern Europeans, Hungarians, Japanese, Cameroonians, Pygmies and South American Indians and the present invention includes these isolated sequences and their variants. This includes a total of 127 SNPs and 103 different protein coding haplotypes, including those defined for the PTC Receptor (T2R38) [E-169-2001/0]. The inventors showed that 77% of the SNPs identified caused an amino acid substitution in the encoded receptor protein, giving rise to a very high degree of receptor protein variation in the population (Kim et al. (2005) Human Mutation 26, 199-204). The frequencies of these different haplotypes have been shown to differ in different populations which will aid in population-specific studies, such as those targeting differences in taste perception between Europeans and Asians, for example.

The invention available for licensing includes these novel SNPs and haplotypes and methods of use, which can be used to better identify and characterize different groups of individuals within and between populations that vary in their bitter taste abilities. This is important to the food and flavoring industry, for example, where these variants can be used to aid in the development of a variety of taste improvements in foods and orally administered medications. [Also available for licensing in the Human Taste Receptor Haplotype patent portfolio is HHS Ref No. E-169-2001/0-PCT-02: Phenylthiocarbamide Taste Receptor, International Publication No. WO 2003/008627, PCT filed July 19, 2002 and global IP, and HHS Ref. No 099-2005/0: Human Sweet and Umami Taste Receptor Genes, U.S. Provisional Patent Application No. 60/671,173 filed April 2005].

In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors.

Dated: February 2, 2006.

Steven M. Ferguson,

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