[Federal Register Volume 73, Number 232 (Tuesday, December 2, 2008)]
[Notices]
[Pages 73338-73340]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-28614]


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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.

Detection and Quantification of HIV Antigen

    Description of Technology: The invention relates to a novel, cost-
effective method of detecting HIV antigens, in particular HIV Gag (p24) 
antigen, in human biological samples. The method relies on using a 
novel combination of a bead coated with a primary high affinity 
monoclonal antibody specific for p24 antigen and a secondary antibody 
conjugated with a fluorescent label that is also specific for p24 
antigen. This detection method requires only approximately 50 [mu]l of 
sample, and is able to detect the presence of HIV p24 antigen over a 
range of concentrations from 20,000 picograms down to 0.3 picograms 
with very low intrasample variability. The upper and lower limits of 
the detection method can be adjusted by altering the components of the 
assay.
    Applications: Detection of HIV antigens in biological samples.
    Advantages:
     Cost-effective
     Minimal amounts of sample required
     High sensitivity and dynamic range
    Development Status: In vitro data can be provided upon request.
    Market: HIV Diagnostics.
    Inventors: Jean-Charles Grivel et al. (NICHD).
    Publications: Manuscript in press.
    Patent Status: U.S. Provisional Application No. 61/082,937 filed 23 
Jul 2008 (HHS Reference No. E-240-2008/0-US-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Kevin W. Chang, PhD; 301-435-5018; 
[email protected].

Compositions and Methods for Inhibition of Fat-Specific Protein 27

    Description of Technology: FSP27 expression is regulated by 
PPAR[gamma], a gene known to play a critical role in the development of 
fatty liver. Over-expression of FSP27 results in an increase in 
triglyceride accumulation and an increase in cystolic vacuoles 
containing lipid droplets which are associated with development of 
fatty liver disease or hepatic steatosis. This abnormal retention of 
lipids in liver cells occurs in diabetes and alcoholism and is 
correlated with decreased liver function which can often lead to 
cirrhosis and sometimes death. Presently, there are no adequate 
therapies for fatty liver disease.
    This technology is directed towards compositions and methods of 
inhibiting FSP27, which include antisense compounds, small molecule 
inhibitors and antibodies that target FSP27.
    Application: Potential new shRNA based therapy for steatotic liver 
disease (fatty liver).
    Market: Approximately 20 to 30% of the U.S. population has some 
degree of fatty liver disease, making it the most prevalent liver 
disease. Meanwhile, cirrhosis is one of the top ten causes of death in 
the U.S.

[[Page 73339]]

    Development Status: Preclinical studies are in progress.
    Inventors: Frank J. Gonzalez (NCI) et al.
    Publication: K Matsusue, T Kusakabe, T Noguchi, S Takiguchi, T 
Suzuki, S Yamano, FJ Gonzalez: Hepatic steatosis in the leptin-
deficient mouse is promoted by the PPARgamma target gene, fat-specific 
protein 27. Cell Metab. 2008 Apr; 7(4):302-311.
    Patent Status: U.S. Provisional Application No. 61/043,330 filed 08 
Apr 2008 (HHS Reference No. E-145-2008/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Fatima Sayyid, M.H.P.M.; 301-435-4521; 
[email protected].
    Collaborative Research Opportunity: The Laboratory of Metabolism, 
National Cancer Institute, is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize inhibitors of FSP27 for treatment 
of fatty liver disease. Please contact John D. Hewes, PhD at 301-435-
3121 or [email protected] for more information.

Detection of Hereditary Prostate Cancer

    Description of Technology: Inherited prostate cancer susceptibility 
genes with high penetrance are responsible for 5% to 10% of all cancer 
cases and up to 30% to 40% of early onset of the disease. Previous 
genetic linkage studies indicated that germline variations in a gene or 
genes on Xq27 were involved in prostate carcinogenesis. The linkage 
peak for prostate cancer overlies a region containing five SPANX genes 
whose expression has been detected in a variety of cancers. The 
investigators have identified an intra-chromosomal inversion involving 
more than a 400 kb sequence in prostate cancer patients but not in 
unaffected individuals. This technology can be used as an accurate, 
early prostate cancer susceptibility diagnostics method.
    Applications: High throughput screening assay to predict patient 
susceptibility to prostate cancer.
    Advantages: Easy, ready to use early stage prostate cancer 
diagnostic.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Market:
     Among men, prostate cancer is the most common cancer and 
the second leading cause of death.
     There will be approximately 186,320 newly diagnosed cases 
of prostate cancer and an estimated 28,660 deaths are expected to occur 
in the United States in 2008.
     An estimated 5 to 10 percent of all prostate cancers are 
considered hereditary and as many as 30% to 40% of early onset of the 
disease.
    Inventors: Natalay Kouprina (NCI) et al.
    Patent Status: U.S. Provisional Application No. 61/010,209 filed 01 
Jan 2008 (HHS Reference No. E-241-2007/0-US-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Jennifer Wong; 301-435-4633; 
[email protected].

Mouse Monoclonal Antibody to the Nitrone Spin Trap 5,5-dimethyl-1-
pyrroline N-oxide (DMPO)

    Description of Technology: Oxidative stress resulting in the 
formation of biological radicals has been implicated in a number of 
human diseases, such as cancer as well as aging. There is, however, a 
paucity of reliable methods for in vivo or ex vivo detection of radical 
formation. Until now the only general technique that allowed for the 
detection of these highly reactive species was electron spin resonance 
(ESR) using spin traps. One of the most popular of these spin traps is 
5,5-dimethyl-1-pyrroline N-oxide (DMPO). In the ESR method, radicals 
are trapped by DMPO, and the DMPO spin adduct signal is measured 
quantitatively by an ESR spectrometer.
    The Research Tool available is a mouse monoclonal antibody that 
specifically reacts with DMPO-protein and DMPO-DNA adducts. The 
inventors have used DMPO-octanoic acid conjugated to ovalbumin as the 
antigen to develop this monoclonal antibody. This product was assayed 
by ELISA and found to be reactive against DMPO-protein adducts at a 
dilution of 1 [mu]g/ml of affinity purified mouse IgG when used in 
combination with alkaline phosphatase conjugated, affinity purified 
anti-mouse IgG (Goat).
    Applications:
     ELISA and Immunoblotting of protein-DMPO adducts.
     Immuno-spin trapping analyses of DNA radicals.
     Immunoprecipitation of protein-DMPO adducts.
    Market: DMPO is one of the most frequently used spin traps to 
detect free radicals and cited in over one thousand publications 
(Pubmed).
    Inventors: Ronald P. Mason and Marilyn Ehrenshaft (NIEHS).
    Patent Status: HHS Reference No. E-175-2006/0--Research Material. 
Patent protection is not being pursued for this technology.
    Licensing Status: Hybridoma producing the monoclonal antibody and 
the monoclonal antibody are available for Biological Material 
Licensing.
    Licensing Contact: Suryanarayana (Sury) Vepa, PhD, J.D.; 301-435-
5020; [email protected].

HIV gp41-Membrane Proximal External Region Arrayed on Hepatitis B 
Surface Antigen Particles for HIV Diagnostic and Vaccine Applications

    Description of Technology: This technology describes vectors 
encoding the membrane proximal external region (MPER) and select 
variants from HIV-1 gp41 linked to the hepatitis B surface antigen 
(HBsAg) and the resulting expressed particles for use in HIV diagnostic 
and vaccine applications. HIV-1 gp41 membrane proximal region contains 
two epitopes recognized by broadly neutralizing human monoclonal 
antibodies 2F5 and 4E10. However, immunization with gp41 MPER or the 
2F5 or 4E10 epitopes have failed to raise neutralizing antibodies. In 
the subject technology, the particles were shown to bind antibodies 
from broadly neutralizing human sera and to the two known broadly 
neutralizing antibodies 2F5 and 4E10 with high relative affinities, 
demonstrating that the relevant epitopes are accessible for antibody 
binding and the potential utility of the particles in diagnostic 
applications. Additionally, these particles could be used to screen 
phage-display libraries for novel broadly cross-reactive neutralizing 
antibodies, of which only five are currently known. These particles 
could also be used for selection of MPER specific B cells. Lastly, 
these particles have been shown to be immunogenic and raise antibodies 
that recognize HIV-1 Env gp160 expressed on the cell surface. These 
immunogens can elicit neutralizing antibodies specific for HIV gp41 
MPER, the MPER of gp41 is highly conserved across various HIV clades 
and therefore is likely to generate broadly neutralizing antibodies 
when administered in a proper presentation in a lipid context as is the 
case in HBsAg particles. Multiple copies of the MPER of HIV-1 gp41 
arrayed on the particles could significantly increase the immunogenic 
potential compared to monomeric molecules. An increase of this nature 
has been observed with HBsAg and HPV virus-like particles in hepatitis 
B and cervical cancer vaccines, respectively, suggesting that 
particulate array may improve the presentation of selected epitopes to 
the immune system.
    Applications: HIV vaccines; HIV diagnostics.

[[Page 73340]]

    Advantages: These immunogens can elicit neutralizing antibodies 
specific for HIV gp41 MPER, which is highly conserved across various 
HIV clades and therefore is likely to generate broadly neutralizing 
antibodies when administered in a proper presentation in a lipid 
context as is the case in HBsAg particles. Multiple copies of the MPER 
of HIV-1 gp41 arrayed on the particles could significantly increase the 
immunogenic potential compared to monomeric molecules.
    Inventors: Richard T. Wyatt (NIAID), Sanjay K. Phogat (NIAID), Ira 
Berkower (FDA).
    Patent Status:
     U.S. Provisional Application No. 60/653,930 filed 18 Feb 
2005 (HHS Reference No. E-123-2005/0-US-01).
     PCT Application No. PCT/US2006/005613 filed 17 Feb 2006, 
which published as WO 2006/112929 on 30 Nov 2006 (HHS Reference No. E-
123-2005/1-PCT-01).
     U.S. Patent Application No. 11/816,069 filed 10 Aug 2007 
(HHS Reference No. E-123-2005/1-US-02).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Cristina Thalhammer-Reyero, PhD, M.B.A.; 301/
435-4507; [email protected].

    Dated: November 24, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E8-28614 Filed 12-1-08; 8:45 am]
BILLING CODE 4140-01-P