[Federal Register Volume 70, Number 16 (Wednesday, January 26, 2005)]
[Notices]
[Pages 3718-3719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1419]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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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: 301/496-7057; fax: 301/402-0220. 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; 
[email protected].

    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; 
[email protected].

    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; [email protected].

    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

[[Page 3719]]

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; [email protected].

    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; [email protected].

    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.
[FR Doc. 05-1419 Filed 1-25-05; 8:45 am]
BILLING CODE 4140-01-P