[Federal Register Volume 69, Number 125 (Wednesday, June 30, 2004)]
[Notices]
[Pages 39487-39488]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-14750]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing: SARS-
Related Technologies

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

[[Page 39488]]

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.

SARS Coronavirus MVA Vaccines and Therapy

Bernard Moss (NIAID).
U.S. Provisional Application No. 60/558,995 filed 05 Apr 2004 (DHHS 
Reference No. E-165-2004/0-US-01).
Licensing Contact: Michael Shmilovich; 301/435-5019; 
[email protected].

    Intranasal or intramuscular inoculations of BALB/c mice with 
modified vaccinia Ankara (MVA) vector encoding SARS-CoV Spike protein 
produced serum antibodies that recognized SARS S in ELISA and elicited 
protective immunity as shown by reduced titers of SARS-CoV in the upper 
and lower respiratory tracts of mice following challenge. Passive 
transfer of serum from mice immunized with MVA/S to naive mice also 
reduced the replication of SARS-CoV in the respiratory tract following 
challenge, demonstrating the role of antibody to S in protection.

Enhanced Sensitivity ELISA for SARS Diagnostic

Gary J. Nabel et al. (NIAID).
U.S. Provisional Application No. 60/503,508 filed 15 Sep 2003 (DHHS 
Reference No. E-334-2003/0-US-01).
U.S. Provisional Application No. 60/550,317 filed 08 Mar 2004 (DHHS 
Reference No. E-334-2003/1-US-01).
    Licensing Contact: Michael Shmilovich; 301/435-5019; 
[email protected].

    Reagents and protocols for extremely sensitive ELISA for use as a 
SARS diagnostic are described. The ELISA uses recombinant-expressed 
nucleoprotein (N) or spike (S) glycoprotein from the SARS coronavirus 
as capture antigens. As little as five (5) days after onset, detection 
of antibody response is possible. The ELISA described herein is more 
sensitive than existing technology because of the N and S proteins; 
existing ELISAs use formalin-inactivated whole virus or peptides.
    E-334-2003/1-US-01 also describes DNA Vaccines (CMV/R-SARS-S 
plasmid) including a nucleic acid encoding the peptide of SARS Spike 
glycoprotein, the RSV enhancer, the mouse ubiquitin enhancer (mUBB), 
and the CMV enhancer (Xu et al. 1998 Nature Med. 4: 37-42). Optionally 
the HTLV-1 R region (Takebe et al. 1988 Mol Cell Biol 8: 466-472) is 
also included.

Interferon-Alpha SARS Treatment

    Kathryn C. Zoon, Renqui Hu, Joseph B. Bekisz (NCI).
    U.S. Provisional Application filed 30 Apr 2004 (DHHS Reference No. 
E-278-2003/0-US-01).
    Licensing Contact: Michael Shmilovich; 301/435-5019; 
[email protected].

    The Public Health Service seeks a licensee to commercialize protein 
engineered human interferon alphas for treating and/or preventing a 
SARS-associated coronaviral infection in humans and other relevant 
mammalian species.

Soluble SARS Coronavirus Spike Protein (S Protein)

Dimiter S. Dimitrov, Xiadong Xiao (NCI).
U.S. Provisional Application No. 60/489,166 filed 21 Jul 2003 (DHHS 
Reference No. E-228-2003/0-US-01).
Licensing Contact: Michael Shmilovich; 301/435-5019; 
[email protected].

    The SARS coronavirus is etiologically linked to severe acute 
respiratory syndrome. Soluble forms of the SARS coronavirus spike 
protein have been cloned, expressed and characterized, and are 
available for licensing for use as research reagents, in the 
development of vaccines and inhibitors of the viral infection, for 
selection of monoclonal antibodies, and development of kits containing 
antibodies that bind to the spike protein. The filed patent application 
additionally claims the associated spike protein polypeptides, peptide 
fragments, and conserved variants thereof; nucleic acid segments and 
constructs that encode the spike protein, polypeptides and peptide 
fragments of the spike protein, and conserved variants thereof and 
coupled proteins that include the spike protein or a portion thereof 
and peptidomimetics.

    Dated: June 20, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 04-14750 Filed 6-29-04; 8:45 am]
BILLING CODE 4140-01-P