[Federal Register Volume 73, Number 35 (Thursday, February 21, 2008)]
[Notices]
[Pages 9578-9580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-3164]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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

[[Page 9579]]

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.

Development of Antigenic Chimeric St. Louis Encephalitis Virus/Dengue 
Virus Type Four Recombinant Viruses (SLEV/DEN4) as Vaccine Candidates 
for the Prevention of Disease Caused by SLEV

    Description of Invention: St. Louis Encephalitis Virus (SLEV) is a 
mosquito-borne flavivirus that is endemic in the Americas and causes 
sporadic outbreaks of disease in humans. SLEV is a member of the 
Japanese encephalitis virus serocomplex and is closely related to West 
Nile Virus (WNV). St. Louis encephalitis is found throughout North, 
Central, and South America, and the Caribbean, but is a major public 
health problem mainly in the United States. Prior to the outbreak of 
West Nile virus in 1999, St. Louis encephalitis was the most common 
human disease caused by mosquitoes in the United States. Since 1964, 
there have been about 4,440 confirmed cases of St. Louis encephalitis, 
with an average of 130 cases per year. Up to 3,000 cases have been 
reported during epidemics in some years. Many more infections occur 
without symptoms and go undiagnosed. At present, a vaccine or FDA-
approved antiviral therapy is not available.
    The inventors have previously developed a WNV/Dengue4Delta30 
antigenic chimeric virus as a live attenuated virus vaccine candidate 
that contains the WNV premembrane and envelope (prM and E) proteins on 
a dengue virus type 4 (DEN4) genetic background with a thirty 
nucleotide deletion (Delta30) in the DEN4 3'-UTR. Using a similar 
strategy, the inventors have generated an antigenic chimeric virus, 
SLE/DEN4Delta30. Preclinical testing results indicate that 
chimerization of SLE with DEN4Delta30 decreased neuroinvasiveness in 
mice, did not affect neurovirulence in mice, and appeared to 
overattenuate the virus for non-human primates. Modifications of the 
SLE/DEN4Delta30 vaccine candidate are underway to improve its 
immunogenicity.
    This application claims live attenuated chimeric SLE/DEN4Delta30 
vaccine compositions and bivalent WNV/SLE/DEN4Delta30 vaccine 
compositions. Also claimed are methods of treating or preventing SLEV 
infection in a mammalian host, methods of producing a subunit vaccine 
composition, isolated polynucleotides comprising a nucleotide sequence 
encoding a SLEV immunogen, methods for detecting SLEV infection in a 
biological sample and infectious chimeric SLEV.
    Application: Immunization against SLEV or SLEV and WNV.
    Development Status: Live attenuated vaccine candidates are 
currently being developed and preclinical studies in mice and monkeys 
are in progress. Suitable vaccine candidates will then be evaluated in 
clinical studies.
    Inventors: Stephen S. Whitehead, Joseph Blaney, Alexander Pletnev, 
Brian R. Murphy (NIAID).
    Patent Status: U.S. Provisional Application No. 60/934,730 filed 14 
Jun 2007 (HHS Reference No. E-240-2007/0-US-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Collaborative Research Opportunity: The NIAID Laboratory of 
Infectious Diseases is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate, or commercialize live attenuated virus vaccine candidates for 
St. Louis encephalitis virus. Please contact Dr. Whitehead at 301-496-
7692 for more information.

Methods of Glycosylation and Bioconjugation

    Description of Technology: Eukaryotic cells express several classes 
of oligosaccharides attached to proteins or lipids. Animal glycans can 
be N-linked via beta-GlcNAc to Asn (N-glycans), O-linked via -GalNAc to 
Ser/Thr (O-glycans), or can connect the carboxyl end of a protein to a 
phosphatidylinositol unit (GPI-anchors) via a common core glycan 
structure. Beta (1,4)-galactosyltransferase I catalyzes the transfer of 
galactose from the donor, UDP-galactose, to an acceptor, N-
acetylglucosamine, to form a galactose-beta (1,4)-N-acetylglucosamine 
bond, and allows galactose to be linked to an N-acetylglucosamine that 
may itself be linked to a variety of other molecules. Examples of these 
molecules include other sugars and proteins. The reaction can be used 
to make many types of molecules having great biological significance. 
For example, galactose-beta (1,4)-N-acetylglucosamine linkages are 
important for many recognition events that control how cells interact 
with each other in the body, and how cells interact with pathogens. In 
addition, numerous other linkages of this type are also very important 
for cellular recognition and binding events as well as cellular 
interactions with pathogens, such as viruses. Therefore, methods to 
synthesize these types of bonds have many applications in research and 
medicine to develop pharmaceutical agents and improved vaccines that 
can be used to treat disease.
    The invention provides in vitro folding method for a polypeptidyl-
alpha-N-acetylgalactosaminyltransferase (pp-GalNAc-T) that transfers 
GalNAc to Ser/Thr residue on a protein. The application claims that 
this in vitro-folded recombinant ppGalNAc-T enzyme transfers modified 
sugar with a chemical handle to a specific site in the designed C-
terminal polypeptide tag fused to a protein. The invention provides 
methods for engineering a glycoprotein from a biological substrate, and 
methods for glycosylating a biological substrate for use in 
glycoconjugation. Also included in the invention are diagnostic and 
therapeutic uses.
    Application: Enzymes and methods are provided that can be used to 
promote the chemical linkage of biologically important molecules that 
have previously been difficult to link.
    Developmental Status: Enzymes have been synthesized and 
characterization studies have been performed.
    Inventors: Pradman Qasba and Boopathy Ramakrishnan (NCI/SAIC).
    Patent Status: U.S. Provisional Application No. 60/930,294 filed 14 
May 2007 (HHS Reference No. E-204-2007/0-US-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Peter A. Soukas, J.D.; 301-435-4646; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute 
is seeking statements of capability or interest from parties interested 
in collaborative research to further develop, evaluate, or 
commercialize this technology. Please contact John D. Hewes, Ph.D. at 
301-435-3121 or [email protected] for more information.

Chlamydia Vaccine

    Description of Invention: Chlamydia trachomatis is an obligate 
intracellular bacterial pathogen that colonizes and infects 
oculogenital mucosal surfaces. The organism exists as multiple 
serovariants that infect millions of people worldwide. Ocular 
infections cause trachoma, a chronic follicular conjunctivitis that 
results in scarring and blindness. The World Health Organization 
estimates that 300-500 million people are afflicted by

[[Page 9580]]

trachoma, making it the most prevalent form of infectious preventable 
blindness. Urogenital infections are the leading cause of bacterial 
sexually transmitted disease in both industrialized and developing 
nations. Moreover, sexually transmitted diseases are risk factors for 
infertility, the transmission of HIV, and human papilloma virus-induced 
cervical neoplasia. Control of C. trachomatis infections is an 
important public health goal. Unexpectedly, however, aggressive 
infection control measures based on early detection and antibiotic 
treatment have resulted in an increase in infection rates, most likely 
by interfering with natural immunity, a concept suggested by studies 
performed in experimental infection models. Effective management of 
chlamydial disease will likely require the development of an 
efficacious vaccine.
    This technology claims vaccine compositions that comprise an 
immunologically effective amount of PmpD protein from C. trachomatis. 
Also claimed in the application are methods of immunizing individuals 
against C. trachomatis. PmpD is an antigenically stable pan-
neutralizing target that, in theory, would provide protection against 
all human strains, thus allowing the development of a univalent vaccine 
that is efficacious against both blinding trachoma and sexually 
transmitted disease.
    Application: Prophylactics against C. trachomatis.
    Developmental Status: Preclinical studies have been performed.
    Inventors: Harlan Caldwell and Deborah Crane (NIAID).
    Publication: DD Crane et al. Chlamydia trachomatis polymorphic 
membrane protein D is a species-common pan-neutralizing antigen. Proc 
Natl Acad Sci USA. 2006 Feb 7;103(6):1894-1899.
    Patent Status: PCT Patent Application No. PCT/US2007/001213 filed 
16 Jan 2007, which published as WO 2007/082105 on 19 Jul 2007 (HHS 
Reference No. E-031-2006/0-PCT-02).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
[email protected].
    Collaborative Research Opportunity: The NIAID Laboratory of 
Intracellular Parasites is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate, or commercialize PmpD vaccine development. Please contact 
Harlan D. Caldwell, at [email protected] or 406-363-9333 for more 
information.

    Dated: February 11, 2008.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E8-3164 Filed 2-20-08; 8:45 am]
BILLING CODE 4140-01-P