[Federal Register Volume 78, Number 70 (Thursday, April 11, 2013)]
[Notices]
[Pages 21614-21615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-08414]


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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, 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.

FOR FURTHER INFORMATION CONTACT: 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.

Lentiviral Vectors with Dual Fluorescence/Luminescence Reporters

    Description of Technology: Twelve lentiviral vectors that express 
both fluorescent and luminescent markers as a single fusion protein 
under various gene promoters were constructed. Vectors have been 
developed previously to monitor tumors or tumor cells via 
bioluminescence or fluorescence alone. However, bioluminescence is not 
sensitive enough to sort individual tumor cells and fluorescence cannot 
be used effectively to view internal tumors. By combining the two 
reporters into a single fusion protein, the tumor can be effectively 
visualized within the animal as well as sorted from non-tumor cells for 
post-necropsy experiments. The added advantage of bioluminescent 
visualization allows for in vivo

[[Page 21615]]

experiments that more closely simulate the biological development of 
tumors in organs rather than at the surface of the skin. Additionally, 
since twelve different vectors with different gene promoters were 
developed, they can be tested in individual tumor models to find the 
best vector for visualizing that particular tumor cell line. The 
vectors are able to sustain long-term expression of both visualization 
markers, depending on the cell type and promoter in each vector.
    Potential Commercial Applications:
     The vectors will be extremely useful for experiments in 
which both in vivo and in vitro analysis is desired.
     The vectors can also be used for screening cancer cell 
lines and in tumor models for reporter gene activity.
     The vectors can be useful in drug development.
    Competitive Advantages:
     The bioluminescent marker allows for effective 
visualization of deep (non-surface) tumors in mice.
     The fluorescence label permits efficient sorting of tumor 
cells from normal (non-labeled) cells after tumors are excised from the 
mice.
     The vectors allow in vivo experiments that more closely 
simulate the biological development of tumors in organs rather than at 
surface of skin.
     The vectors sustain long-term expression.
    Development Stage:
     Early-stage
     Pre-clinical
     In vitro data available
     In vivo data available (animal)
    Inventors: Dominic Esposito, Chi-Ping Day, Glenn Y. Merlino (NCI)
    Publication: Day CP, et al. Lentivirus-mediated bifunctional cell 
labeling for in vivo melanoma study. Pigment Cell Melanoma Res. 2009 
Jun;22(3):283-95. [PMID 19175523]
    Intellectual Property: HHS Reference No. E-132-2011/0--Research 
Tool. Patent protection is not being pursued for this technology.
    Licensing Contact: Sury Vepa, J.D., Ph.D.; 301-435-5020; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute 
is seeking statements of capability or interest from parties interested 
in collaborative research to further develop, evaluate or commercialize 
dual luminescent/fluorescent vectors. For collaboration opportunities, 
please contact John D. Hewes, Ph.D. at [email protected].

Epigenetic Factors Associated with the Development of Age-related 
Macular Degeneration

    Description of Technology: Recent studies have demonstrated genetic 
associations between Age-related Macular Degeneration (AMD) and 
specific genes. In the case of identical twins in which only one twin 
develops AMD, a direct genetic cause seems unlikely. NIH researchers 
explored the epigenetic mechanisms that control the pathogenesis of 
AMD. A DNA methylation study identified sites on selected gene 
promoters that can potentially serve as markers to distinguish patients 
likely to develop AMD from those less likely to develop the disease. 
The strongest association was found in the IL17RC gene and later 
studies confirmed this association, first in siblings that were 
discordant for AMD and then in AMD patients as compared with age-
matched controls.
    Potential Commercial Applications: Diagnosis of Age-related Macular 
Degeneration.
    Competitive Advantages: This technology is potentially a more 
sensitive means of diagnosing patients with AMD.
    Development Stage: In vitro data available.
    Inventors: Lai Wei, Robert Nussenblatt, Baoying Liu, Chi-Chao Chan 
(NEI).
    Publication: Wei L, et al. Hypomethylation of the IL17RC promoter 
associates with age-related macular degeneration. Cell Rep. 2012 Nov 
29;2(5):1151-8. [PMID 23177625]
    Intellectual Property: HHS Reference No. E-075-2011/0--
     US Application No. 61/435,989 filed 25 Jan 2011
     PCT Application No. PCT/US2012/022511 filed 25 Jan 2011
    Licensing Contact: Jaime M. Greene; 301-435-5559; 
[email protected].

    Dated: April 5, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-08414 Filed 4-10-13; 8:45 am]
BILLING CODE 4140-01-P