[Federal Register Volume 69, Number 34 (Friday, February 20, 2004)]
[Notices]
[Pages 7975-7976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-3710]


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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.

Strand-Specific Amplification

Vinay K. Pathak, David C. Thomas (NCI)
DHHS Reference No. E-018-2004/0-US-01 filed 04 Dec 2003
Licensing Contact: Michael Ambrose; 301/594-6565; 
[email protected].

    Replication of genetic material for all organisms involves 
synthesis of different strands of nucleic acid. In addition, 
replication of these strands requires the coordinated effort of several 
proteins and as such, are potential targets for drug therapy. In HIV 
infection, the potential for drug therapy targeted to specific steps in 
viral replication is advantageous as it might enable the therapeutic 
intervention to be more efficient and specific to the viral 
replication.
    This technology enables the researcher to evaluate the effects 
novel therapies and therapeutic protocols have on viral replication by 
assessing the impact of therapy on specific steps in viral replication. 
The technology involves using padlock probes that attached at the 5' 
and 3' ends and ligate together forming a circle. The circle is then 
amplified using the rolling amplification technique. The amplified 
circles can be detected and quantitated using real-time PCR for 
assessment.
    The technology can be used in the development of test kits for 
prognostics and therapeutic evaluation as well as assessing the effects 
and efficacy of new and novel therapeutics for HIV infection.

[[Page 7976]]

A Novel Approach to Genome-Wide Identification of Gene Regulatory 
Sequences

Gregory E. Crawford (NHGRI).
U.S. Provisional Application 60/511,905 filed 15 Oct 2003 (DHHS 
Reference No. E-286-2003/0-US-01)
Licensing Contact: Fatima Sayyid; (301) 435-4521; [email protected]

    Sequence analysis of the human genome has identified approximately 
30,000 protein-coding genes, but little is known about how most of 
these genes are regulated. A major goal of current genome research is 
to identify the location of all cis-acting gene regulatory elements for 
all genes. This will be necessary if we are to understand global gene 
regulation in different tissues as well as identify regulatory variants 
that make individuals more susceptible to common diseases.
    The present invention relates to methods of studying gene 
regulatory elements on a genome-wide scale. Particularly, it relates to 
methods of generating libraries of DNAse hypersensitive genomic 
sequences, which are believed to correlate well with the locations of 
gene regulatory elements. These methods involve obtaining nuclei from 
the cell sample, subjecting the nuclei to DNAse I digestion, and 
embedding the DNAsed sample in low melt agarose to substantially 
prevent non-specific shearing of the genomic DNA. The DNAsed fragments 
are then blunted and further processed, to permit isolation and 
analysis of the putative regulatory elements.

Retrovirus-Like Particles and Retroviral Vaccines

David E. Ott (NCI)
PCT Application filed 27 Oct 2003 (DHHS Reference No. E-236-2003/0-PCT-
01)
Licensing Contact: Susan Ano; (301) 435-5515; [email protected]
    This technology describes retrovirus-like particles and their 
production from retroviral constructs in which the gene encoding all 
but seven amino acids of the nucleocapsid (NC) protein was deleted. 
This deletion functionally eliminates packaging of the genomic RNA, 
thus resulting in non-infectious retrovirus-like particles. These 
particles can be used in vaccines or immunogenic compositions. Specific 
examples using HIV-1 constructs are given. Furthermore, efficient 
formation of these particles requires inhibition of the protease 
enzymatic activity, either by mutation to the protease gene in the 
construct or by protease inhibitor thereby ensuring the production of 
non-infectious retrovirus-like particles. This technology is further 
described in Ott et al., Journal of Virology, 2003, 77(5), 5547.

Aerosolized Capreomycin for Inhibition of Pulmonary Tuberculosis

Carl N. Kraus, Clifton E. Barry III, Bernard Doan (NIAID)
U.S. Provisional Application No. 60/500,001 filed 11 Sep 2002 (DHHS 
Reference No. E-286-2002/0-US-01).
Licensing Contact: Michael Ambrose; (301) 594-6565; 
[email protected].
    This technology involves the methods of reformulation of 
Capreomycin for the aerosol treatment of pulmonary tuberculosis.
    Tuberculosis is a devastating lung disease that is highly 
infectious and easily transmitted, especially in areas of overcrowding 
such as prisons. Furthermore, underdeveloped countries with large 
populations living in close quarters maintain an endemic disease 
reservoir limiting the health and economic viability of the population. 
The WHO estimates that as many as \1/3\ of the population may be 
infected. Current treatment requires the patient to take medication 
over an extended period of time, up to 12 months or more in some cases. 
This leads to clinical failure and the potential development of multi-
drug resistant strains. Resistant strains of tuberculosis further tax 
the health care delivery as second line anti-tubercular therapies are 
more likely to have side effects yet still require long-term adherence 
to therapy regimens.
    The disclosed technology provides for the delivery of Capreomycin 
in an aerosol formulation. This provides for ease of delivery in both 
first and second line tuberculosis regimens. Furthermore, the aerosol 
formulation does not require extensive training of health-care workers 
to administer the therapy, minimizing the need for added personnel in 
underdeveloped countries. This, along with the increased product 
stability will enhance patient adherence to therapy and the potential 
reduction of disease burden, both for the patient and the population.

    Dated: February 13, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 04-3710 Filed 2-19-04; 8:45 am]
BILLING CODE 4140-01-P