[Federal Register Volume 75, Number 131 (Friday, July 9, 2010)]
[Notices]
[Pages 39545-39546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-16801]


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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.

Diagnostic H5N1 Avian Influenza Virus Peptides

    Description of Invention: 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

[[Page 39546]]

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.
    Applications: Diagnostics for influenza virus specific antibodies 
in humans and animals.
    Advantages: High specificity, sensitivity, and reproducibility.
    Development Status: Data obtained from clinical samples can be 
provided upon request.
    Market: Influenza virus diagnostics.
    Inventors: Hana Golding and Surender Khurana (FDA).

Patent Status

     U.S. Patent Application No. 12/664,052 filed 10 Dec 2009 
(HHS Reference No. E-236-2007/3-US-03).
     U.S. Provisional Patent Application No. 61/325,073 filed 
16 Apr 2010 (HHS Reference No. E-093-2010/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Kevin W. Chang, PhD; 301-435-5018; 
[email protected].

Bacterially Expressed Influenza Virus Recombinant HA Proteins for 
Vaccine and Diagnostic Applications

    Description of Invention: Pandemic H1N1 influenza virus is a 
recently emergent strain of influenza virus that the World Health 
Organization (WHO) estimates has killed at least 14,711 people 
worldwide. Avian influenza viruses are emerging health threats with 
pandemic potential. Due to their global health implications, there has 
been a massive international effort to produce protective vaccines 
against these influenza virus strains. Currently, influenza virus 
vaccines are produced in chicken eggs, a production method that is 
disadvantaged by lengthy vaccine production times and by inability to 
meet large-scale, global demands.
    The subject technologies are specific recombinant HA proteins from 
H1N1, H5N1, and other strains of influenza virus produced in bacteria. 
The HA proteins properly fold, form oligomers, bind fetuin, agglutinate 
red blood cells and induce strong neutralizing antibody titers in 
several in vivo animal models. The key advantages of this technology 
are that expression of these proteins in bacteria reduces the vaccine 
production time and offers the ease of scalability for global usage, an 
issue with current production methods. The recombinant HA proteins can 
also be used for diagnostic applications.

Applications

     Vaccines for the prevention of influenza infection.
     Diagnostics for influenza virus specific antibodies.

Advantages

     Novel vaccine candidates.
     Rapid production time.
    Development Status: In vitro and in vivo data can be provided upon 
request.

Market

     Vaccines.
     Diagnostics.
    Inventors: Hana Golding and Surender Khurana (FDA).
    Publications: Manuscripts are available for review under a 
Confidential Disclosure Agreement.

Patent Status

     U.S. Provisional Patent Application No. 61/257,785 filed 
03 Nov 2009 (HHS Reference No. E-032-2010/0-US-01).
     U.S. Provisional Patent Application No. 61/325,216 filed 
16 Apr 2010 (HHS Reference No. E-032-2010/1-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Kevin W. Chang, PhD; 301-435-5018; 
[email protected].

Substituted IL-15

    Description of Invention: Interleukin-15 (IL-15) is an immune 
system modulating protein (cytokine) that stimulates the proliferation 
and differentiation of T-lymphocytes. In the clinical context, IL-15 is 
being investigated for use in the treatment of diseases such as cancer. 
In vitro manufacture of IL-15 can be problematic.
    The invention relates to substituted IL-15 amino acid sequences of 
one or more amino acids that are predicted to reduce or eliminate 
deamidation of a specific aspargine amino acid residue found within the 
IL-15 protein. Deamidation can lead to protein degradation and 
interfere with the pharmaceutical purification and processing of IL-15. 
The invention also provides potential substituted gene sequences that 
encode the substituted IL-15 amino acid sequences. The substituted IL-
15 amino acid sequences may advantageously facilitate the refolding, 
purification, storage, characterization, and clinical testing of IL-15.
    Applications: IL-15 immunotherapies.
    Advantages: Potential decreased immunogenicity of pharmacologically 
active IL-15 expressed in E. coli.
    Development Status: Concept Development Phase.
    Market: Cancer immunotherapy; IL-15 based immunotherapies.
    Inventors: David F. Nellis et al. (NCI/SAIC).
    Patent Status: PCT Application No. PCT/US09/42355 filed 30 Apr 
2009, which published as WO 2009/135031 on 05 Nov 2009 (HHS Reference 
No. E-123-2008/0-PCT-02).
    Licensing Status: Available for licensing.
    Licensing Contact: Kevin W. Chang, PhD; 301-435-5018; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute 
Biological Research Branch is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize the topic of this technology. 
Please contact John D. Hewes, PhD at 301-435-3121 or 
[email protected] for more information.

    Dated: July 2, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-16801 Filed 7-8-10; 8:45 am]
BILLING CODE 4140-01-P