[Federal Register Volume 70, Number 118 (Tuesday, June 21, 2005)]
[Notices]
[Pages 35686-35687]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-12130]


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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, DHHS.

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.

Epitopes of Ebola Virus Glycoproteins Useful for Vaccine Development

Carolyn A. Wilson et al. (FDA)

U.S. Provisional Application No. 60/532,677 filed 23 Dec 2003 (DHHS 
Reference No. E-271-2003/0-US-01); PCT Patent Application filed 23 Dec 
2004 (DHHS Reference No. E-271-2003/1-PCT-01).
Licensing Contact: Susan Ano; 301/435-5515; [email protected].

    The current technology relates to the identification of two highly 
conserved linear domains of Ebola or Marburg envelope glycoprotein (GP) 
and of amino acid residues within these regions critical for virus 
infection. The identified domains could provide targets for rational 
design and development of broadly cross-protective antivirals and 
vaccines. There are currently no licensed vaccines against Ebola and 
Marburg. The linear domains (or portions) could potentially be used as 
immunogens in a vaccine. Mutations containing these epitopes have been 
identified to result in the formation of non-infectious Ebola viral 
particles, which could be useful for developing vaccines against Ebola 
virus, a category A biodefense agent. Vaccines utilizing these non-
infectious particles may be safer than vaccines that use other common 
approaches, e.g. live-attenuated virus vaccines. This technology 
describes the polypeptides that form the non-infectious Ebola viral 
particles, the polynucleotide sequences encoding the polypeptides, 
vectors comprising the polynucleotides, host cells transformed with 
such vectors, vaccines and methods suitable for use in the prevention 
and/or treatment of hemorrhagic fever due to Ebola or Marburg, and a 
molecular decoy comprising the polynucleotides. These additional 
materials could also form the basis of an Ebola vaccine or antiviral 
therapy. Diagnostic applications involving the aforementioned materials 
are also described. Development of antiviral compounds and vaccines for 
treatment and prevention of Ebola and Marburg infections would be of 
tremendous benefit for biodefense and public health. However, the 
current Ebola vaccine technologies such as DNA-based vaccines and 
subunit vaccines either have safety risks or lack broad cross-
protectivity. Therefore, the present technology could provide a 
promising technology to make safe and broad cross-reactive antivirals 
or vaccines against Ebola and Marburg viruses.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Detection and Identification of Mycobacterium Using SecA

Steven H. Fischer and Adrian M. Zelazny (CC)

U.S. Provisional Application No. 60/548,371 filed 27 Feb 2004 (DHHS 
Ref. No. E-238-2003/0-US-01); PCT Application No. PCT/US05/06609 filed 
28 Feb 2005 (DHHS Ref. No. E-238-2003/0-PCT-02).
Licensing Contact: Robert M. Joynes, J.D.; 301/594-6565; 
[email protected].

    This invention relates to a method of detecting a wide variety of 
Mycobacterium and Nocardia species in a sample. The method involves 
hybridizing an amplified Mycobacterium/Nocardia genus-specific secA 
nucleic acid to a Mycobacterium/Nocardia species-specific secA probe 
oligonucleotide, wherein the amplification utilizes at least two 
Mycobacterium/Nocardia genus-specific primers, and detecting 
hybridization of the Mycobacterium/Nocardia-specific secA nucleic acid. 
The Mycobacterium/Nocardia genus-specific primers bind within a 
conserved region of the nucleic acid sequence encoding a Mycobacterium/
Nocardia bi-genus-specific secA protein, wherein the conserved region 
is in the 5' half of the Mycobacterium/Nocardia secA gene and includes 
a substrate specificity domain.
    The approach for detection of Mycobacterium/Nocardia species in 
clinical materials could potentially be used as a universal system for 
detection of any member of the genus Mycobacterium and the genus 
Nocardia and identification at the species or complex level. The system 
currently identifies all mycobacteria tested to date. With a few 
modifications, we believe it will also detect all Nocardia species of 
clinical significance. Contrary to commercial methods based on 16S rRNA 
and ITS, the SecA method will detect both Mycobacterium and Nocardia 
species. The region targeted has sufficient sequence variation for 
discrimination at the species or complex level.
    Based on the information available to date, the SecA approach could 
be potentially used to replace acid-fast smears (AFB) and modified 
acid-fast smears, could provide definitive detection and identification 
of a large variety of Mycobacterium and Nocardia species present in 
clinical materials, and could be used as a single confirmation and 
species identification system for suspected positive Mycobacterium or 
Nocardia cultures. The invention also contemplates devices, including 
arrays, and kits for

[[Page 35687]]

detecting Mycobacterium or Nocardia species in a sample.
    This technology is related to Dr. Fischer's other technology, E-
278-1999/0, ``Multiplex Hybridization System for the Identification of 
Pathogenic Mycobacterium and Method of Use'' (published in the Federal 
Register on September 7, 2002, 65 FR 54288). The distinguishing feature 
in the current invention that makes it a vast improvement over E-278-
1999/0 is the ability to detect all 29 Mycobacterium species tested to 
date and potentially all Nocardia species in a clinical sample.

Cloned Genomes of Infectious Hepatitis C Virus and Uses Thereof

Masayuki Yanagi, Jens Bukh, Suzanne U. Emerson, Robert H. Purcell 
(NIAID)

U.S. Patent No. 6,153,421 issued on 28 Nov 2000 (DHHS Reference No. E-
050-1998/0-US-01); U.S. Patent Application No. 09/662,454 filed 14 Sep 
2000 (DHHS Reference No. E-050-1998/0-US-03); Canadian Application 
2295552; Australian Application 84889/98; European Application 
98935702.5.
Licensing Contact: Chekesha S. Clingman; 301/435-5018; 
[email protected].

    The current invention provides nucleic acid sequences comprising 
the genomes of infectious hepatitis C viruses (HCV) of genotype 1a and 
1b. It covers the use of these sequences, and polypeptides encoded by 
all or part of the sequences, in the development of vaccines and 
diagnostic assays for HCV and the development of screening assays for 
the identification of antiviral agents for HCV.
    Additional information can be found in: Yanagi et al., 
``Transcripts from a single full-length cDNA clone of hepatitis C virus 
are infectious when directly transfected into the liver of a 
chimpanzee,'' Proc. Natl. Acad. Sci. USA (1997 August) 94(16):8738-
8743; and Yanagi et al., ``Transcripts of a chimeric cDNA clone of 
hepatitis C virus genotype 1b are infectious in vivo,'' Virology (25 
April 1998) 244(1):161-172.

    Dated: June 6, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-12130 Filed 6-20-05; 8:45 am]
BILLING CODE 4140-01-P