[Federal Register Volume 69, Number 173 (Wednesday, September 8, 2004)]
[Notices]
[Pages 54296-54297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-20294]


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

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 contacting Susan Ano, 
Ph.D., Technology Licensing Specialist, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, Maryland 20852-3804; telephone: 301/435-5515; fax: 301/402-
0220; e-mail: [email protected]. A signed Confidential Disclosure 
Agreement will be required to receive copies of the patent 
applications.

Safer Attenuated Virus Vaccines With Missing or Diminished Latency of 
Infection

Jeffrey Cohen et al. (NIAID)

U.S. Provisional Application Filed 28 Jun 2004 (DHHS Reference No. E-
217-2004/0-US-01)
    This technology describes recombinant viruses that have weakened 
ability to establish and/or maintain latency and their use as live 
vaccines. The viruses have one or more genetic mutations that allow for 
continued replication but that inhibit latency. The vaccine materials 
and methods for their construction are exemplified with the virus that 
causes chickenpox and whose latent infection results in shingles, a 
condition that affects up to an estimated 1 million people per year in 
the United States alone. Additionally, there are veterinary

[[Page 54297]]

applications of this technology. Specific examples of gene deletions, 
modifications, and/or insertions are described. Furthermore, 
replacement of these deleted genes with other desirable viral antigen 
encoding sequence(s) and/or cytokine genes in order to enhance a 
desired immunological response is also described. Aspects of this 
technology are relevant to other live virus vaccines, thus increasing 
the safety of such vaccines.

Anti-Vaccinia Monoclonal Antibody

Jonathan Yewdell et al. (NIAID)

DHHS Reference No. E-123-2004/0--Research Tool
    The current technology describes a monoclonal antibody that reacts 
with a vaccinia virus protein abundantly expressed under an early viral 
promoter after infection of cells. The antibody is useful for 
quantitating vaccinia virus infected cells and for studying the 
function of the protein to which it binds, which is known to be a 
double stranded RNA binding protein involved in resistance of the virus 
to interferons. This antibody is available for licensing through a 
biological materials license agreement.

New Surrogate Marker for Diagnosis of HIV/AIDS Infection and for 
Evaluation of Treatment Effectiveness

Gene M. Shearer et al. (NCI)

U.S. Provisional Application 60/564,588 Filed 23 Apr 2004 (DHHS 
Reference No. E-045-2004/0-US-01)
    This technology describes the identification of a new surrogate 
marker, TNF-related apoptosis-inducing ligand (TRAIL), that can be 
universally employed to monitor the progression of HIV infection and 
other conditions and diseases associated with immune system activation 
and immunoassays for assessing the amount of TRAIL in a biological 
sample. In the case of HIV infection, measuring levels of this 
surrogate marker can distinguish among infected individuals with high 
viral load, infected individuals with low viral load, and uninfected 
individuals. Only two surrogate markers are currently recognized by the 
Food and Drug Administration as clinically relevant to HIV progression, 
HIV viral load and the absolute number of peripheral CD4 +T cells. 
Tests for assessing HIV viral load employ PCR, the use of which has 
drawbacks, including cross-contamination. TRAIL has mechanistic 
implications for HIV-1 pathogenesis and directly correlates to viral 
load but not necessarily inversely with CD4+ T cell count. Other 
surrogate markers have been proposed but do not consistently reflect 
AIDS progression in all individuals or may result in overlooking 
possible treatments that may affect disease progression but do not 
affect the chosen marker. Therefore, use of this new surrogate marker 
to assess disease progression in infected individuals and to evaluate 
the effectiveness of various treatment regimens has several advantages 
over currently used methods.

Peptide Mimotopes of Lipooligosaccharide From Nontypeable Haemophilus 
influenzae and Moraxella catarrhalis as Peptide Vaccines

Xin-Xing Gu (NIDCD)

U.S. Provisional Application No. 60/441,928 Filed 22 Jan 2003 (DHHS 
Reference No. E-344-2002/0-US-01)
PCT Application No. PCT/US04/01457 Filed 21 Jan 2004 (DHHS Reference 
No. E-344-2002/0-PCT-02)
U.S. Provisional Application No. 60/531,239 Filed 19 Dec 2003 (DHHS 
Reference No. E-083-2004/0-US-01)
U.S. Provisional Application No. 60/571,889 filed 17 May 2004 (DHHS 
Reference No. E-083-2004/1-US-01)
    These inventions relate to peptide mimotopes of 
lipooligosaccharides (LOS) from nontypeable Haemophilus influenzae 
(NTHi) and Moraxella catarrhalis that are suitable for developing novel 
vaccines against the respective pathogens, for which there are 
currently no licensed vaccines. The mimotopes not only immunologically 
mimic LOS from NTHi and Moraxella catarrhalis but will also bind to 
antibodies specific for the respective LOS. NTHi and Moraxella 
catarrhalis are common pathogens that cause otitis media in children 
and lower respiratory tract infections in adults. The effectiveness of 
a vaccine could be increased by substitution of a LOS epitope with a 
peptide mimic. Preliminary experiments have shown that some of the 
mimic peptides conjugated to a carrier were as effective as their 
respective LOS-based vaccine in stimulating a humoral immune response 
in rabbits. A single consensus amino acid sequence was identified for 
Moraxella catarrhalis, while four such sequences were identified for 
NTHi. Thus, the identified peptides are promising candidates for 
developing novel vaccines for NTHi or Moraxella catarrhalis.

    Dated: August 27, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 04-20294 Filed 9-7-04; 8:45 am]
BILLING CODE 4140-01-P