[Federal Register Volume 72, Number 118 (Wednesday, June 20, 2007)]
[Notices]
[Pages 34021-34022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-11826]


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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.

Construction of Recombinant Baculoviruses Carrying the Gene Encoding 
the Major Capsid Protein, VP1, From Calicivirus Strains (Including 
Norovirus Strains Toronto, Hawaii, Desert Shield, Snow Mountain, and 
MD145-12)

    Description of Technology: The noroviruses (known as ``Norwalk-like 
viruses'') are associated with an estimated 23,000,000 cases of acute 
gastroenteritis in the United States each year. Norovirus illness often 
occurs in outbreaks, affecting large numbers of individuals, 
illustrated recently by well-publicized reports of gastroenteritis 
outbreaks on several recreational cruise ships and in settings such as 
hospitals and schools. Norovirus disease is clearly important in terms 
of medical costs and missed workdays, and accumulating data support its 
emerging recognition as important agents of diarrhea-related morbidity.
    Because the noroviruses cannot be propagated by any means in the 
laboratory, an important strategy in their study is the development of 
molecular biology-based tools. This invention reports the development 
of recombinant baculoviruses carrying the capsid gene from several 
caliciviruses associated with human disease. Growth of these 
baculovirus recombinants in insect cells results in the expression of 
virus-like particles (VLPs) that are antigenically indistinguishable 
from the native calicivirus particle. These VLPs can be purified in 
large quantities for use as diagnostic reagents and potential vaccine 
candidates.
    Inventors: Kim Y. Green, Judy F. Lew, Adriene D. King, Stanislav V. 
Sosnovtsev, Gael M. Belliot (NIAID).
    Publication: An example of the application of these materials is 
further described in KY Green et al., ``A predominant role for Norwalk-
like viruses as agents of epidemic gastroenteritis in Maryland nursing 
homes for the elderly,'' J. Infect. Dis. 2002 Jan. 15;185(2):133-146.
    Patent Status: HHS Reference No. E-198-2003/0--Research Material.
    Licensing Status: The materials embodied in this invention are 
available nonexclusively through a biological materials license.
    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
[email protected]
    Collaborative Research Opportunity: The Laboratory of Infectious 
Diseases, NIAID, NIH, is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate, or commercialize norovirus VLP antigens. Please contact Kim 
Y. Green at [email protected] for more information.

Full-Length cDNA Clone Representing the Consensus Sequence of the RNA 
Genome of a Human Norovirus (strain MD145-12) That Encodes Biologically 
Active Proteins

    Description of Technology: The invention provides for a full-length 
cloned cDNA copy of the RNA genome of a predominant norovirus strain 
(Genogroup II.4) designated MD145-12 that was associated with human 
gastrointestinal illness. The noroviruses, which were formerly known as 
``Norwalk-like'' viruses are estimated to cause 23 million cases of 
acute gastroenteritis in the USA each year. The virus has been 
designated into category B of the CDC biodefense-related priority 
pathogens because it can be used as an agent of bioterrorism. The 
subject cDNA clone of the virus encodes proteins of the MD145-12 strain 
that, when expressed in vitro, exhibit properties that would be 
expected from those produced by the original infectious virus. This 
cDNA clone is presently the only source to obtain norovirus proteins to 
facilitate studies

[[Page 34022]]

aimed at developing control strategies such as vaccines and therapeutic 
drugs.
    Inventors: Gael M. Belliot, Kim Y. Green, Stanislav V. Sosnovtsev 
(NIAID)
    Patent Status: HHS Reference No. E-212-2003/0--Research Material
    Licensing Status: The cDNA clone for norovirus strain MD145-12 is 
available for licensing via a biological material license (BML).
    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
[email protected].
    Collaborative Research Opportunity: The Laboratory of Infectious 
Diseases, NIAID, NIH, is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate, or commercialize reagents derived from a cDNA clone of the 
genome of a predominant human norovirus strain, Genogroup II.4. Please 
contact Kim Y. Green at [email protected] for more information.

Construction of an Infectious Full-Length cDNA Clone of the Porcine 
Enteric Calicivirus RNA Genome

    Description of Technology: Porcine enteric calicivirus (PEC) is a 
member of the genus Sapovirus in the family Caliciviridae. This virus 
causes diarrheal illness in pigs. In addition, PEC serves as an 
important model for the study of enteric caliciviruses that cause 
diarrhea and that cannot be grown in cell culture (including the 
noroviruses represented by Norwalk virus and the sapoviruses 
represented by Sapporo virus). The development of an infectious cDNA 
clone is important because it enables the use of ``reverse genetics'' 
to engineer mutations of interest into the genome of PEC and to study 
their effects. In addition, it allows the introduction of foreign 
coding sequences into the genome of PEC that could be useful for 
vaccine development in swine and possibly humans. This discovery has 
both basic research applications such as mapping mutations involved in 
tissue culture adaptation, tissue tropism, and virulence as well as 
practical applications such as providing a genetic backbone for the 
development of chimeric vaccine viruses.
    Inventors: Kyeong-Ok Chang (NIAID), Stanislav V. Sosnovtsev 
(NIAID), Gael M. Belliot (NIAID), Kim Y. Green (NIAID), et al.
    Publication: The materials are further described in KO Chang et 
al., ``Cell-culture propagation of porcine enteric calicivirus mediated 
by intestinal contents is dependent on the cyclic AMP signaling 
pathway,'' Virology. 2002 Dec 20;304(2):302-310.
    Patent Status: HHS Reference No. E-214-2003/0--Research Material.
    Licensing Status: The materials embodied in this invention are 
available nonexclusively through a biological materials license.
    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
[email protected]
    Collaborative Research Opportunity: The Laboratory of Infectious 
Diseases, NIAID, NIH, is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate, or commercialize reagents derived from an infectious cDNA 
copy of the genome of porcine enteric calicivirus. Please contact Kim 
Y. Green at [email protected] for more information.

Enzymatically-Active RNA-Dependent RNA Polymerase From a Human 
Norovirus (Calicivirus)

    Description of Technology: The noroviruses (formerly known as 
``Norwalk-like viruses'') are associated with gastroenteritis 
outbreaks, affecting large numbers of individuals each year. Emerging 
data are supporting their increasing recognition as important agents of 
diarrhea-related morbidity and mortality. The frequency with which 
noroviruses are associated with gastroenteritis as ``food and water-
borne pathogens'' has led to the inclusion of caliciviruses as Category 
B Bioterrorism Agents/Diseases. Because the noroviruses cannot be 
propagated by any means in the laboratory, an important strategy in 
their study is the development of molecular biology-based tools and 
replication systems. This invention reports the isolation of the first 
recombinant, enzymatically-active proteinase and RNA dependent RNA 
polymerase (RdRp) complex for a human norovirus. This enzyme should 
facilitate studies aimed at developing therapeutic drugs for norovirus 
disease.
    Inventors: Gael M. Belliot, Stanislav V. Sosnovtsev, Kyeong-Ok 
Chang, Kim Y. Green (NIAID).
    Publication: The materials are further described in L Wei et al., 
``Proteinase-polymerase precursor as the active form of feline 
calicivirus RNA-dependent RNA polymerase,'' J. Virol. 2001 
Feb;75(3):1211-1219.
    Patent Status: HHS Reference No. E-283-2003/0--Research Material.
    Licensing Status: The materials embodied in this invention are 
available nonexclusively through a biological materials license.
    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
[email protected].
    Collaborative Research Opportunity: The Laboratory of Infectious 
Diseases, NIAID, NIH, is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate, or commercialize an active human norovirus proteinase-
polymerase enzyme. Please contact Kim Y. Green at [email protected] 
for more information.

    Dated: June 8, 2007.
Steven M. Ferguson,
Director,Division of Technology Development and Transfer,Office of 
Technology Transfer,National Institutes of Health.
 [FR Doc. E7-11826 Filed 6-19-07; 8:45 am]
BILLING CODE 4140-01-P