Notice: Government-Owned Inventions; Availability for Licensing

Federal Register: Volume 76, Number 197 (Wednesday, October 12, 2011)
                  Pages 63309-63310

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: 301-496-7057; fax: 301-402-0220. A 
signed Confidential Disclosure Agreement will be required to receive 
copies of the patent applications.

Human Phospho-Serine134 Glucocorticoid Receptor Polyclonal Antibody: 
Useful for the Characterization of Glucocorticoid Signaling Processes, 
e.g., in Cancer and Inflammation

    Description of Technology: The glucocorticoid receptor (GR) 
functions as a hormone-dependent transcription factor that is involved 
in the maintenance of basal and stress-related homeostasis. Serine 134 
is a newly discovered phosphorylation target on the human 
glucocorticoid receptor that becomes phosphorylated during stress-
activating conditions such as ultraviolet irradiation, nutrient 
starvation, and oxidative stress. The inventors have developed a rabbit 
polyclonal antibody that specifically recognizes the Ser 134 
phosphorylated form of the human glucocorticoid receptor. This antibody 
may be particularly useful for a variety of basic research 
applications, such as the characterization and study of glucocorticoid 
signaling in cancer, inflammation, and other diseases.
    The antibody is available as crude antisera and has been epitope 
purified; it has cross reactivity with human, rat, and mouse tissues.
    Potential Commercial Applications: Western analysis, 
immunoprecipitation, and immunofluorescence studies.
    Inventors: Amy Beckley and John Cidlowski (NIEHS).
    Related Publication: Molecular and Cellular Biology, In Press.
    Intellectual Property: HHS Reference No. E-182-2011/0--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: Tara Kirby Ph.D.; 301-435-4426; tarak@nih.gov.
    Collaborative Research Opportunity: The NIEHS, Molecular Endocrine 
Group, is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate, or 
commercialize Human Phospho-Serine134 Glucocorticoid Receptor 
Polyclonal Antibody. Please contact Elizabeth M. Denholm at 
denholme@niehs.nih.gov for more information.

Infectious Hepatitis E Virus Genotype 3 Recombinants--Prospective 
Vaccine Candidates and Vector System

    Description of Technology: Infection by Hepatitis E virus (HEV) is 
a relevant health issue in a number of developing countries and it is 
also an emerging food-borne disease of industrialized countries. 
Genotype 1 and 2 infections are found exclusively in humans while 
genotype 3 and 4 viruses have been found not only in humans, but also 
swine, deer, mongoose, cattle, and rabbits. In particular, genotype 3 
and 4 viruses are ubiquitously found in swine and undercooked pork is 
thought to be one of the sources of infection for cases of human 
infections in industrialized countries.
    This technology is a recombinant, infectious genotype 3 HEV that 
has been adapted to grow in cell culture and can potentially be used to 
develop vaccines against HEV or as a vector system to insert exogenous 
sequences into HEV. The virus (strain Kernow-C1, genotype 3) originated 
from a chronically infected

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human subject and was adapted to grow in human hepatoma cells. The 
adapted virus is unique in that it contains an insertion of a portion 
of a human ribosomal protein in Open Reading Frame 1 of the virus. 
Desired exogenous sequences could potentially be placed in lieu of the 
insert without inactivating the virus, making the subject technology a 
prospective HEV vector platform.
    Potential Commercial Applications:
     Vaccine--An infectious, recombinant HEV genotype 3 cDNA 
clone that could potentially be developed into a vaccine candidate.
     HEV Vector Platform-- Desired exogenous sequences can be 
inserted into the viral genome without inactivating the virus.
    Competitive Advantages:
     Most of the HEV vaccines under development are subunit 
based while the subject technology could potentially be developed into 
a live, attenuated virus based vaccine.
     Ability to insert exogenous sequences into the viral 
genome without inactivating the virus makes this subject technology a 
potential HEV based vector platform.
    Development Stage:
     Early-stage
     Pre-clinical
     In vitro data available
    Inventors: Suzanne U. Emerson, Priyanka Shukla, Hanh T. Nguyen, and 
Robert H. Purcell (NIAID).
    Publication: Shukla P, et al. Cross-species infections of cultured 
cells by hepatitis E virus and discovery of an infectious virus-host 
recombinant. Proc Natl Acad Sci U S A. 2011 Feb 8;108(6):2438-2443. 
[PMID 21262830].
    Intellectual Property: HHS Reference No. E-074-2011/0--U.S. 
Provisional Patent Application No. 61/431,377 filed 10 Jan 2011.
    Licensing Contact: Kevin W. Chang, PhD; 301-435-5018; 
changke@mail.nih.gov.
    Collaborative Research Opportunities: The National Institute of 
Allergy and Infectious Diseases is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize hepatitis E virus vaccines. For 
collaboration opportunities, please contact Wade Green, PhD at 301-827-
0258 or williamswa@niaid.nih.gov.

Diagnostic H5N1 Avian Influenza Virus Peptides

    Description of Technology: The recent spread of highly pathogenic 
H5N1 avian influenza viruses among poultry and transmission of these 
viruses to humans raises concerns of a potential influenza pandemic. 
There is a need to track the spread of these viruses both in the animal 
and human populations to avert or reduce the impact of any potential 
influenza pandemic as well as to know the actual number (accurate 
surveillance) of people infected with H5N1, including individuals with 
subclinical H5N1 infection.
    The subject technology is a specific combination of H5N1 peptides 
useful for assays to detect antibodies generated against a wide range 
of different H5N1 strains. The combination of peptides was able to 
specifically detect anti-H5N1 antibodies from serum samples of H5N1 
survivors at early and later times post infection while excluding 
antibodies generated in individuals infected with other strains of 
influenza virus. Also, the peptides did not react with sera from 
individuals vaccinated with H5N1 vaccine, in contrast to the strain-
specific detection of anti-H5N1 antibodies in sera from infected 
individuals. Immunoassays using the H5N1 peptide combination provide 
highly specific, sensitive and reproducible methods for diagnosing H5N1 
infection in humans and animals.
    Potential Commercial Applications: Diagnostics for influenza virus 
specific antibodies in humans and animals.
    Competitive Advantages: High specificity, sensitivity, and 
reproducibility.
    Development Stage: Data obtained from clinical samples can be 
provided upon request.
    Inventors: Hana Golding and Surender Khurana (FDA).
    Intellectual Property: HHS Reference No. E-093-2010/0--PCT 
Application No. PCT/US2011/032555 filed 14 Apr 2011.
    Related Technology: HHS Reference No. E-236-2007/3--U.S. Patent 
Application No. 12/664,052 filed 10 Dec 2008.
    Licensing Contact: Kevin W. Chang, PhD; 301-435-5018; 
changke@mail.nih.gov.

    Dated: October 4, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-26338 Filed 10-11-11; 8:45 am]
BILLING CODE 4140-01-P