[Federal Register Volume 74, Number 183 (Wednesday, September 23, 2009)]
[Notices]
[Pages 48569-48570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-22974]


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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.

A Plasmid System for Monitoring Double-Stranded DNA Breaks in the Live 
Cell

    Description of Technology: This technology is useful for studying 
the role of chromosomal breaks in cancer and for drug and assay 
development related to treating cancer. The technology is a two-plasmid 
system for inducing and monitoring individual double-stranded DNA 
breaks in the nuclei of live cells. The first plasmid, lac-I-SceI-tet, 
which is stably transfected into cells, has a rare 18 base pair 
restriction endonuclease site called ISceI. This site is flanked by an 
array of 256 copies of the lac-repressor binding site and 96 copies of 
the tetracycline response element. Plasmids expressing tet and lac 
repressor proteins labeled in a complementary fashion can be 
cotransfected to visualize these arrays of repressor binding sites. The 
second

[[Page 48570]]

plasmid, RFP-I-SceI-GR, is a chimera between the ISceI endonuclease and 
the ligand binding domain of the glucocorticoid receptor (GR) in frame 
with red fluorescent protein (RFP). This GR chimera will translocate 
from the cytoplasm to the nucleus upon addition of triamcinolone 
acetonide, leading to rapid induction of a double-stranded break 
between the lac and tet arrays.
    Applications:
     Tool for drug studies relating to DNA stability and 
repair.
     Tool to probe the role of nuclear and DNA binding proteins 
in stability and repair.
    Inventors: Thomas A. Misteli and Evi Soutoglou (NCI).
    Related Publication: E Soutoglou, JF Dorn, K Sengupta, M Jasin, A 
Nussenzweig, T Ried, G Danuser, T Misteli. Positional stability of 
single double-strand breaks in mammalian cells. Nat Cell Biol. 2007 
Jun;9(6):675-682.
    Patent Status: HHS Reference No. E-264-2009/0--Research Tool. 
Patent protection is not being pursued for this technology.
    Licensing Status: This technology is available as a research tool 
under a Biological Materials License.
    Licensing Contact: Steve Standley, PhD; 301-435-4074; 
[email protected].

Mouse Embryonic Stem Cell-Based Functional Assay To Evaluate Mutations 
in BRCA2

    Description of Technology: Mutations in breast cancer 
susceptibility genes BRCA1 and BRCA2 have up to an 80 percent life time 
risk in developing breast cancer. There are no ``mutation hot spots'' 
and to date, more than 1,500 different mutations have been identified 
in BRCA2. The absence of tumor cell lines expressing various mutant 
BRCA2 alleles has hindered evaluations to determine the functional 
differences between different mutations.
    A simple, versatile and reliable mouse embryonic stem cell and 
bacterial artificial chromosome based assay to generate cell lines 
expressing mutant human BRCA2 has been developed and it has been used 
to classify 17 sequence variants. Available for licensing are wild-type 
and eleven mutant BRCA2 cell lines developed from this assay that have 
either truncations or point mutations. These cell lines may be used to 
evaluate the effect of DNA damaging agents, genotoxins and 
chemotherapeutic efficacy.
    Applications:
     Research tool to generate and study BRCA2 mutations.
     Method to screen for chemotherapeutics.
     Method to evaluate DNA damaging agents.
    Advantages: Ready to use portfolio of BRCA2 mutant cell lines to 
study BRCA2 mutant functional analysis.
    Market: An estimated 194,280 new cases of breast cancer will be 
diagnosed and may cause 40,610 deaths in the U.S. in 2009.
    Inventors: Shyam K. Sharan and Sergey Kuznetsov (NCI).
    Publication: SG Kuznetsov et al. Mouse embryonic stem cell-based 
functional assay to evaluate mutations in BRCA2. Nat Med. 2008 
Aug;14(8):875-881.
    Patent Status: HHS Reference No. E-261-2007/0--Research Tool. 
Patent protection is not being pursued for this technology.
    Licensing Status: Available for licensing.
    Licensing Contact: Jennifer Wong; 301-435-4633; 
[email protected].
    Collaborative Research Opportunity: The Mouse Cancer Genetics 
Program, Center for Cancer Research, National Cancer Institute, is 
seeking statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
mouse embryonic stem cell lines suitable for functional analysis of 
BRCA2 variants. Please contact John D. Hewes, Ph.D. at 301-435-3121 or 
[email protected] for more information.

Establishment of Two Cell Lines That Stably Express Luciferase for In 
Vivo Tracking

    Description of Technology: Available for licensing are two renal 
carcinoma cell lines, 786-O(luc) and 786-O/VHL/(luc) which both stably 
express luciferase. 786-O(luc) lacks von Hippel-Landau (VHL) protein 
expression and it has constitutively high expression of hypoxia-
inducible transcription factor-2alpha (HIF-2alpha). The second stably 
expresses VHL, a tumor suppressor, and has minimal HIF-2alpha 
expression. These cell lines can be tracked in vivo and can be used to 
study VHL-dependent and HIF-2alpha dependent events such as 
tumorigenesis. VHL mutations lead to the clinical manifestations of von 
Hippel-Lindau disease, a rare autosomal dominant syndrome characterized 
by abnormal growth of blood vessels in multiple organs, including the 
brain and kidneys.
    Applications: Model to study VHL pathology.
    Advantages: Cell lines that stably express luciferase for in vivo 
tracking.
    Benefits: Easy, ready to use positive and negative VHL and HIF-
2alpha cells that stably express luciferase for in vivo tests.
    Market:
     Incidence of VHL syndrome is 1 in 38,951.
     HCC is the third leading cause of cancer death worldwide.
     HCC is the fifth most common cancer in the world.
     Post-operative five-year survival rate of HCC patients is 
30-40 percent.
    Inventors: Leonard M. Neckers and W. Marston Linehan (NCI).
    Patent Status: HHS Reference No. E-005-2007/0--Research Tool. 
Patent protection is not being pursued for this technology.
    Licensing Status: Available for licensing.
    Licensing Contact: Jennifer Wong; 301-435-4633; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute, 
Urologic Oncology Branch, is seeking statements of capability or 
interest from parties interested in collaborative research to develop 
further uses for these two cell lines that stably express luciferase 
for in vivo tracking. Please contact John D. Hewes, Ph.D. at 301-435-
3121 or [email protected] for more information.

    Dated: September 17, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-22974 Filed 9-22-09; 8:45 am]
BILLING CODE 4140-01-P