[Federal Register Volume 73, Number 232 (Tuesday, December 2, 2008)]
[Notices]
[Pages 73337-73338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-28611]


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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.

Method for Detection of Cancer Based on Spatial Genome Organization in 
the Cell Nucleus

    Description of Technology: The successful treatment of cancer is 
correlated with the early detection of the cancerous cells. 
Conventional cancer diagnosis is largely based on qualitative 
morphological criteria, but more accurate quantitative tests could 
greatly increase early detection of malignant cells. It has been 
observed that the spatial arrangement of DNA in the nucleus is altered 
in cancer cells in comparison to normal cells. Therefore, it is 
possible to distinguish malignant cells by mapping the position of 
labeled marker genes in the nucleus.
    This NIH invention provides methods of detecting abnormal cells in 
a sample using the spatial position of one or more genes within the 
nucleus of a cell, as well as a kit for detecting abnormal cells using 
such methods. The invention also provides methods of identifying gene 
markers for abnormal cells using the spatial position of one or more 
genes within the nucleus of a cell.
    Applications: Diagnostic for cancer from tumor biopsies after non-
invasive techniques such as a mammogram or PSA assay have suggested 
cancer.
    Advantages:
     Sensitive detection of cancer.
     Very small sample (100-200 cells) reduces the need for 
invasive procedures.
     Does not require mitotic chromosomes.
     Applicable to solid tumors and blood cancers.
     Single cell assay allows analysis of subpopulations from 
biopsy.
     Probes to all genomic regions are available.
     Alternative or complementary to conventional diagnostics.
     Measures metastatic potential of cancer cells.
     Determination of tumor type.
    Market:
     This novel in vitro diagnostic test for cancer has use in 
oncology laboratories of hospitals and commercial clinical 
laboratories.
     In the United States, almost 1.5 million new cancer cases 
are expected to be diagnosed in 2008.
    Development Status: Presently in the process of validating the 
assay using a larger set of tumor samples.
    Inventors: Tom Misteli and Karen Meaburn (NCI).
    Publication: KJ Meaburn and T Misteli. Locus-specific and activity-
independent gene repositioning during early tumorigenesis. J Cell Biol. 
2008 Jan 14;180(1):39-50.
    Patent Status: U.S. Provisional Application No. 61/094,318 filed 04 
Sep 2008 (HHS Reference No. E-283-2008/0-US-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Whitney Hastings; 301-451-7337; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute, 
Cell Biology of Genomes Group, is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize diagnostic methods for detection of 
cancer using spatial genome organization. Please contact John D. Hewes, 
Ph.D. at 301-435-3121 or [email protected] for more information.

A Novel, Non-Invasive and Therapeutically Useful High Throughput 
Technique To Isolate Highly Enriched Tumor Reactive Lymphocytes From 
Peripheral Blood-Potential Use in Adoptive Immunotherapy

    Description of Technology: The adoptive transfer of autologous 
antigen reactive lymphocytes has been shown to mediate significant 
tumor regression in some patients with metastatic cancer. However, the 
isolation of these T lymphocytes requires invasive surgery, which can 
lead to post-operative complications and delays in initiating adoptive 
immunotherapy with T cells.
    This technology is directed to the use of a novel high throughput 
technique to isolate highly enriched tumor reactive lymphocytes in a 
non-invasive manner from the peripheral blood of cancer patients for 
the purpose of cancer immunotherapy. The technique utilizes a highly 
sensitive PCR based screening assay.
    Applications: The isolated T lymphocytes can be used in adoptive 
immunotherapy for the treatment of metastatic cancer.
    Advantages:
     A rapid and non-invasive high throughput method of 
isolating tumor reactive T cells, which is otherwise difficult with 
conventional peripheral blood isolating techniques.
     The method is easy to use and based on a highly sensitive 
PCR based screening assay.
     The method can detect the presence of extremely rare T 
cells in a bulk population of peripheral blood cells.
    Development Status: The method of isolating tumor reactive T 
lymphocytes has been established. The method was successfully used to 
isolate tumor reactive T cells from peripheral blood of cancer 
patients.
    Inventor: Udai S. Kammula (NCI).
    Patent Status: U.S. Patent Application No. 61/027,623 filed 11 Feb 
2008 (HHS Reference No. E-003-2008/0-US-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Sabarni K. Chatterjee, PhD; 301-435-5587; 
[email protected]
    Collaborative Research Opportunity: The National Cancer Institute, 
Surgery Branch, is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate, or commercialize this high throughput T

[[Page 73338]]

cell isolation technology. Please contact John D. Hewes, PhD at 301-
435-3121 or [email protected] for more information.

Ectopic Thymidylate Synthase Accelerates the Development of 
Hyperplastic Foci and Adenomas in Pancreatic Islets

    Description of Technology: Thymidylate synthase (TS) is an E2F1-
regulated enzyme essential for DNA synthesis and repair. Elevated 
levels of TS protein and mRNA levels are associated with many human 
cancers. Previous research by the NIH inventors has demonstrated that 
ectopic expression of catalytically active TS is sufficient to induce a 
transformed phenotype in mammalian cells as manifested by foci 
formation, anchorage independent growth, and tumor formation in nude 
mice. Overexpression of hTS in murine islets provides a model to study 
genetic alterations associated with the progression from normal cells 
to hyperplasia and adenoma and suggests that this mouse model may be 
useful for cancer prevention and the development of therapeutic 
strategies.
    Applications:
     Transgenic mouse model to develop cancer therapeutics.
     Drug screening for tumor reduction and prevention.
    Market: Cancer therapeutic development.
    Development Status: Thymidylate synthase transgenic mice available.
    Inventor: Maria Zajac-Kaye (NCI).
    Patent Status: HHS Reference No. E-088-2006/0--Research Tool. 
Patent prosecution is not being pursued for this technology.
    Publications:
    1. L Rahman, D Voeller, M Rahman, S Lipkowitz, C Allegra, JC 
Barrett, FJ Kaye, M Zajac-Kaye. Thymidylate synthase as an oncogene: a 
novel role for an essential DNA synthesis enzyme. Cancer Cell. 2004 
Apr; 5(4):341-351.
    2. D Voeller, L Rahman, M Zajac-Kaye. Elevated levels of 
thymidylate synthase linked to neoplastic transformation of mammalian 
cells. Cell Cycle. 2004 Aug; 3(8):1005-1007.
    3. M Chen, L Rahman, D Voeller, E Kastanos, SX Yang, L Geigenbaum, 
C Allegra, FJ Kaye, P Steeg, M Zajac-Kaye. Transgenic expression of 
human thymidylate synthase accelerates the development of hyperplasia 
and tumors in the endocrine pancreas. Oncogene. 2007 Jul 19; 
26(33):4817-4824.
    Licensing Status: Available for licensing.
    Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute, 
Medical Oncology Branch, is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize the Thymidylate Synthase Transgenic 
Animal Model. Please contact John D. Hewes, PhD at 301-435-3121 or 
[email protected] for more information.

    Dated: November 24, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E8-28611 Filed 12-1-08; 8:45 am]
BILLING CODE 4140-01-P