[Federal Register Volume 73, Number 206 (Thursday, October 23, 2008)]
[Notices]
[Pages 63165-63166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-25219]


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

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 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.

[[Page 63166]]

Monoclonal Antibodies Against Orthopoxviruses

    Description of Technology: Concerns that variola (smallpox) virus 
might be used as a biological weapon have led to the recommendation of 
widespread vaccination with vaccinia virus. While vaccination is 
generally safe and effective for prevention of smallpox, it is well 
documented that various adverse reactions in individuals have been 
caused by vaccination with existing licensed vaccines. Vaccinia immune 
globulin (VIG) prepared from vaccinated humans has historically been 
used to treat adverse reactions arising from vaccinia immunization. 
However, VIG lots may have different potencies and carry the potential 
to transmit other viral agents.
    Chimpanzee Fabs against the B5 and A33 outer extracellular membrane 
proteins of vaccinia virus were isolated and converted into complete 
mAbs with human gamma1 heavy chain constant regions. The two mAbs 
displayed high binding affinities to B5 and A33. The mAbs inhibited the 
spread of vaccinia virus as well as variola virus (the causative agent 
of smallpox) in vitro, protected mice from subsequent intranasal 
challenge with virulent vaccinia virus, protected mice when 
administered 2 days after challenge, and provided significantly greater 
protection than that afforded by VIG.
    Application: Prophylactics or therapeutics against orthopoxviruses.
    Development Status: Preclinical studies have been performed.
    Inventors: Zhaochun Chen, Robert Purcell, Suzanne Emerson, Patricia 
Earl, Bernard Moss (NIAID).
    Publications:
    1. Z Chen et al. Chimpanzee/human mAbs to vaccinia virus B5 protein 
neutralize vaccinia and smallpox viruses and protect mice against 
vaccinia virus. Proc Natl Acad Sci USA. 2006 Feb 7; 103(6): 1882-1887.
    2. Z Chen et al. Characterization of chimpanzee/human monoclonal 
antibodies to vaccinia virus A33 glycoprotein and its variola virus 
homolog in vitro and in a vaccinia virus mouse protection model. J 
Virol. 2007 Sep; 81(17): 8989-8995.
    Patent Status: U.S. Patent Application No. 12/142,594 filed 19 Jun 
2008, claiming priority to 22 Dec 2005 (HHS Reference No. E-145-2004/3-
US-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 National Institute of 
Allergy and Infectious Diseases, Laboratory of Infectious Diseases, is 
seeking statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
Chimpanzee/human neutralizing monoclonal antibodies against 
orthopoxviruses. Please contact Dr. Robert Purcell at 301-496-5090 for 
more information.

Methods for Conjugation of Oligosaccharides or Polysaccharides to 
Protein Carriers Through Oxime Linkages via 3-Deoxy-D-Manno-Octulsonic 
Acid

    Description of Technology: This technology comprises new methods 
for the conjugation of O-specific polysaccharides/oligosaccharides (O-
SP/OS) derived from bacterial lipooligosaccharides/ lipopolysaccharides 
(LOS/LPS), after their cleavage from Lipid A, to carrier proteins, to 
serve as potential vaccines. Conjugation is performed between the 
carbonyl group on the terminal reducing end of the saccharide and the 
aminooxy group of a bifunctional linker bound further to the protein.
    The inventors have carried out the reaction under mild conditions 
and in a short time resulting in binding 3-deoxy-D-manno-octulosonic 
acid (KDO) on the saccharide to the protein. These conjugates preserve 
the external non-reducing end of the saccharide, are recognized by 
antisera, and induce immune responses in mice to both conjugate 
components (i.e., the OS and the associated carrier protein).
    Application: Cost effective and efficient manufacturing of 
conjugate vaccines.
    Inventors: Joanna Kubler-Kielb (NICHD), Vince Pozsgay (NICHD), Gil 
Ben-Menachem (NICHD), Rachel Schneerson (NICHD), et al.
    Patent Status: PCT Application No. PCT/US2007/016373 filed 18 Jul 
2007, which published as WO 2008/013735 on 31 Jan 2008; claiming 
priority to 21 Jul 2006 (HHS Reference No. E-183-2005/0-PCT-02).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Peter A. Soukas, J.D.; 301-435-4646; 
[email protected].

    Dated: October 14, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E8-25219 Filed 10-22-08; 8:45 am]
BILLING CODE 4140-01-P