03-15973. 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 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.

Zap70 Protein Expression as a Marker for Chronic Lymphocytic Leukemia (CLL)

Louis M. Staudt et al. (NCI)

Serial No. 60/375,966 filed 25 Apr 2002 and Serial No. 10/309,548 filed 03 Dec 2002

Licensing Contact: Catherine Joyce; 301/435-5031; [e-mail].

The presence or absence of somatic mutations in the expressed immunoglobulin heavy chain variable regions (IgVH) of chronic lymphocytic leukemia (CLL) cells provides prognostic information. Patients whose leukemic cells express unmutated IgVH regions (Ig-unmutated CLL) often have progressive disease whereas patients whose leukemic cells express mutated IgVH regions (Ig-mutated CLL) more often have an indolent disease. Given the difficulty in performing IgVH sequencing in a routine diagnostic laboratory, this prognostic distinction is currently unavailable to most patients.

The present invention relates to the discovery that ZAP-70 expression also distinguishes the two CLL subtypes. Ig-unmutated CLL expressed ZAP-70 5.54-fold more highly than Ig-mutated CLL. ZAP-70 expression correctly predicted IgVH mutation status in 93% of patients, and ZAP-70 expression and IgVH mutation status were comparable in their ability to predict time to treatment requirement following diagnosis. Clinically applicable RNA and protein-based assays for ZAP-70 expression have been developed. These assays would yield important prognostic information for CLL patients.

The above-mentioned invention is available for licensing on an exclusive or non-exclusive basis.

ABCA13 Nucleic Acids and Proteins, and Uses Thereof

Michael Dean et al. (NCI)

DHHS Reference No. E-304-2000/0 filed August 20, 2003

Licensing Contact: Catherine Joyce; 301/435-5031; e-mail: [e-mail].

This technology relates to the identification of a novel gene in the ABC (ATP-binding cassette transporter) gene superfamily, the ABCA13 gene. The ABC proteins are involved in extra- and intracellular membrane transport of various substrates such as ions, amino acids, peptides, sugars, vitamins, or steroid hormones and at least 14 members of the ABC gene superfamily have been described as associated with human disease. ABCA13 has high similarity with other ABCA subfamily genes that are associated with human inherited diseases. This includes ABCA1, the gene responsible for the cholesterol transport disorders Tangier disease and familial hypoalphalipoproteinemia, and ABCA4, the gene responsible for several retinal degeneration disorders. The ABCA13 gene is expressed in trachea, testes, and bone marrow. The ABCA13 gene maps to chromosome 7p12.3, a region that contains an inherited disorder affecting the pancreas and bone marrow (Shwachman-Diamond syndrome) as well as a locus involved in T-cell tumor invasion and metastasis (INM7), and therefore is a positional candidate for these disorders.

The above-mentioned invention is available for licensing on an exclusive or non-exclusive basis.

Dated: June 16, 2003.

Steven M. Ferguson,

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