05-1419. 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.

Null Mutation of the CCAAT/Enhancer Binding Protein Delta (Cebpd) Gene in Mice

G. Esta Sterneck et al. (NCI);

DHHS Reference No. E-032-2005/0—Research Tool;

Licensing Contact: John Stansberry; 301/435-5236; [e-mail].

The invention describes mice with a deletion of the C/EBPdelta gene and cell lines derived from such mice. C/EBPdelta (CCAAT/enhancer binding protein delta) is implicated in the acute phase inflammatory response, long-term memory, fat cell and osteoblast differentiation, ovarian hormone responses, mammary gland involution and cell death. C/EBPdelta may also be a tumor suppressor. Fibroblasts lacking C/EBPdelta exhibit transformed features such as impaired contact inhibition, reduced serum dependence and chromosomal instability. The mice and cell lines of the invention could be useful for the study of the function of C/EBPdelta such as its potential role in cancer, and to investigate how drug responses are modified in the absence of C/EBPdelta.

In addition to licensing, the technology is available for further development through collaborative research with the inventors via a Cooperative Research and Development Agreement (CRADA).

Active Chromatin Domains Are Defined by Acetylation Islands Revealed by Genome-Wide Mapping

Drs. Keji Zhao and Tae-Young Roh (NHLBI);

U.S. Provisional Application No. 60/619,430 filed 15 Oct 2004 (DHHS Reference No. E-008-2005/0-US-01);

Licensing Contact: John Stansberry; 301/435-5236; [e-mail].

Epigenetics play a critical role in cellular development and cellular transformation in many pathogenic processes. For example, many cancers are correlated with changes of their chromatin structure and are sensitive to drugs that module the levels of histone acetylation. Epigenetic regulation refers to the modification of histones, which does not involve changes of DNA sequences of target genes. The present technology maps the genome-wide distribution of histone H3 acetylation in human T cells and describes over 40,000 acetylation islands. These acetylation islands are epigenetic markers for transcriptional regulatory elements and chromatin-controlling elements. Changes in acetylation islands may be correlated with early development of T cell lymphoma or leukemia. Specifically, diseases characterized by aberrant transcriptional regulation could be diagnosed earlier with the application of this technology.

Method of Detecting Cancer Based on Immune Reaction to BORIS

Victor Lobanenkov et al. (NIAID);

U.S. Provisional Application No. 60/611,798 filed 21 Sep 2004 (DHHS Reference No. E-241-2004/0-US-01);

Licensing Contact: Mojdeh Bahar; 301/435-2950; [e-mail].

The invention provides a method of detecting autoantibodies to BORIS (brother of the regulator of imprinted sites) as a possible screen for cancer and a kit comprising BORIS peptides and epitopes. BORIS is a protein that is expressed in many cancers but not in normal tissues (except testis) and thus is a potential target for a cancer therapeutic or diagnostic.

Importantly, BORIS is a cancer-testis (CT) antigen, which despite that it is intracellular protein upon abnormal expression in cancer it appears to be immunogenic in humans. Thus, BORIS could be employed in cancer diagnosis using serum from patients. In fact, the inventors detected BORIS-specific antibodies in serum from patients with gliomas, lung, breast and prostate cancer, but not in serum from normal controls.

Few other serum markers are currently in use for cancer diagnosis and they have limited predictive power. Thus, the detection of tumor related anti-BORIS antibodies suggests that the invention has great potential for detection and treatment of a wide variety of cancers.

In addition, the background of the current invention is found in DHHS Reference No. E-227-2001.

Primer and Probe Sequences for Use in a Diagnostic Tool for Diagnosing Benign Versus Malignant Thyroid Lesions

Steven K. Libutti et al. (NCI);

U.S. Provisional Application No. 60/622,643 filed 26 Oct 2004 (DHHS Reference No. E-124-2004/1);

Licensing Contact: Mojdeh Bahar; 301/435-2950; [e-mail].

The present invention discloses primer and probe sequences that can be used for distinguishing between benign and malignant thyroid lesions. Analysis of thyroid lesions by traditional means, such as fine needle biopsy, can result in indeterminate results. Thus, there is a need for methods that increase the precision of diagnosis. The primers and probes represent a 6 gene or 10 gene model for diagnosing benign from malignant thyroid cancer. Analysis of these genes in thyroid lesions taken from patients could be used for molecular classification of the lesions.

In addition to licensing, the technology is available for further development through collaborative research with the inventors via a Cooperative Research and Development Agreement (CRADA).

New Gene Encoding a Membrane Protein Highly Expressed in Many Breast Cancers and Not in Normal Tissues

B. Lee, K. Egland, and I. Pastan (NCI);

U.S. Provisional Application No. 60/493,522 filed 08 Aug 2003 (DHHS Reference No. E-292-2003/0-US-01);

U.S. Patent Application No. 10/913,196 filed 05 Aug 2004 (DHHS Reference No. E-292-2003/0-US-02);

PCT Application No. PCT/US04/25448 filed 06 Aug 2004 (DHHS Reference No. E-292-2003/0-PCT-03);

Licensing Contact: Brenda Hefti; 301/435-4632; [e-mail].

The current invention relates to a new polypeptide (termed 68h05) that is specifically detected in breast cancer and prostate cancer cells, and not in normal tissue. In addition, 16 out of 21 breast tumors and three out of three prostate tumors expressed 68h05. This invention might have utility as a vaccine therapeutic, antibody-based therapeutic, immunoconjugate therapeutic, or as a diagnostic for the diagnosis or treatment of breast or prostate cancer.

Dated: January 19, 2005.

Steven M. Ferguson,

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