[Federal Register Volume 70, Number 232 (Monday, December 5, 2005)]
[Notices]
[Pages 72452-72453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-6803]


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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.

Mitotic Spindle ASPM as a Diagnostic Marker for Neoplasia and Uses 
Thereof

Paul K. Goldsmith, Vladmir Larionov, Natalay Kouprina and John I. 
Risinger (NCI)
U.S. Provisional Application No. 60/696,212 filed 01 Jul 2005 (HHS 
Reference No. E-210-2005/0-US-01)
Licensing Contact: Mojdeh Bahar; 301/435-2950; [email protected].

    Cancer is responsible for approximately 23% of deaths in the United 
States of America. A high percentage of these deaths are caused by the 
lack of a precise diagnostic method that can detect malignancy in a 
particular tissue at an early stage. This invention provides for 
diagnostic methods, compositions, and kits that are useful for 
identifying neoplasia by measuring Abnormal Spindle-like Microcephaly 
associated (ASPM) expression in a patient sample. The ASPM gene is the 
human ortholog of the Drosophila melanogaster `abnormal spindle' gene 
(asp), which is essential for normal mitotic spindle function in 
embryonic neuroblasts. By measuring ASPM expression levels one can also 
determine if a particular subject has a higher propensity to develop 
neoplasia. This invention is particularly useful in detecting neoplasia 
in hard to diagnose cancers like ovarian and uterine cancer.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Monoclonal Antibodies That Bind or Neutralize Hepatitis B Virus

Robert H. Purcell (NIAID) et al.
U.S. Provisional Application No. 60/644,309 filed 14 Jan 2005 (HHS 
Reference No. E-144-2004/0-US-01)
Licensing Contact: Chekesha S. Clingman; 301/435-5018; 
[email protected]..

    Hepatitis B virus (HBV) chronically infects over 300 million people 
worldwide. Many of them will die of chronic hepatitis or hepatocellular

[[Page 72453]]

carcinoma. The present technology relates to the isolation and 
characterization of a novel neutralizing chimpanzee monoclonal antibody 
to HBV. The antibody was identified through a combinatorial antibody 
library constructed from bone marrow cells of a chimpanzee 
experimentally infected with HBV. The selected monoclonal antibody has 
been shown to react equally well with wild-type HBV and the most common 
neutralization escape mutant variants. Therefore, this monoclonal 
antibody with high affinity and broad reactivity may have distinct 
advantages over other approaches to immunoprophylaxis and immunotherapy 
of chronic HBV infection, as most of the monoclonal antibodies 
currently in use are not sufficiently and broadly reactive to prevent 
the emergence of neutralization escape mutants of HBV. This technology 
describes such antibodies, fragments of such antibodies retaining 
hepatitis B virus-binding ability, fully human or humanized antibodies 
retaining hepatitis B virus-binding ability, and pharmaceutical 
compositions including such antibodies. This invention further 
describes isolated nucleic acids encoding the antibodies and host cells 
transformed with nucleic acids. In addition, this invention provides 
methods of employing these antibodies and nucleic acids in the in vitro 
and in vivo diagnosis, prevention and therapy of HBV diseases.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Polypeptide Multimers Having Antiviral Activity

Carol Weiss et al. (FDA)
PCT Application No. PCT/US03/25295 filed 14 Aug 2003, which published 
as WO 2005/018666 on 03 Mar 2005 (HHS Reference No. E-155-2003/0-PCT-
01)
Licensing Contact: Susan Ano; 301/435-5515; [email protected].

    The technology describes polypeptide multimers that have antiviral 
and immunogenic activity against HIV. These multimers consist of at 
least one monomer of the highly conserved N and C heptad regions of 
gp41 in a ratio of at least 2:1 N to C heptad, with the N and C heptads 
being connected by linkers. The monomer forms homodimers and 
homotrimers in solution and mimic fusion intermediate structure. 
Further, the technology also describes a method of raising a broadly 
neutralizing antibody response to HIV by administering the polypeptide 
multimers mentioned above. Thus, these polypeptide multimers may be 
used as antiviral (anti-HIV) agents. Because the structure of these 
polypeptide multimers mimics the gp41 fusion intermediate, they can 
also be used to identify compounds that may inhibit the fusion process.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

    Dated: November 15, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E5-6803 Filed 12-2-05; 8:45 am]
BILLING CODE 4140-01-P