[Federal Register: May 16, 2003 (Volume 68, Number 95)]
[Notices]               
[Page 26631-26632]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16my03-100]                         

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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 agencies 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.

Methods and Apparatus for Performing Multiple Simultaneous 
Manipulations of Biomolecules in a Two-Dimensional Array

Michael Emmert-Buck, et al. (NCI).

DHHS Reference No. E-339-2002/0

Filed Nov. 25, 2002.

Licensing Contact: Susan Ano; 301/435-5515; anos@od.nih.gov.
    This technology concerns a method and apparatus for accomplishing 
and/or facilitating the analysis of multiple biomolecules separated in 
a two-dimensional array, such as gel, membrane, tissue biopsy, etc. The 
invention employs a separator, termed an External Movement Inhibitor 
Device, that allows biomolecules to be transferred from an array such 
as those listed above to another support system while maintaining the 
two-dimensional spatial relationship of the biomolecules as in the 
array. The biomolecules can subsequently be subjected to various 
manipulations such as amplification, reverse transcription, labeling, 
cloning, etc., after which multiple well-established methods for 
quantitative and qualitative analysis can be used. The technology 
allows detection/analysis of all molecules regardless of their 
abundance.

Methods for Assessing the Ability of HIV Patients to Restrict HIV 
Replication

Mark Connors, Stephen Migueles (NIAID).

DHHS Reference No. E-260-2002/0

Filed Sep. 20, 2002.

Licensing Contact: Susan Ano; 301/435-5515; anos@od.nih.gov.
    One of the current obstacles for the design and testing of 
effective vaccines and immunotherapies of HIV is the lack of in vitro 
correlates that will predict the ability to restrict virus replication. 
This invention relates to methods for evaluating the effectiveness of 
HIV therapies and vaccines and methods for assessing the ability of HIV 
patients to restrict virus replication. Upon restimulation of 
CD8+ T cells, the expression of perforin in these cells, and 
the cell cycle stage of these cells may be measured and used as in 
vitro markers for monitoring the patient's ability to restrict HIV 
replication and the effectiveness of the therapies and vaccines 
applied. Significant proliferation of CD8+ T cells, the 
presence of perforin in these cells, and the ability of these cells to 
progress beyond the G1 stage signify the patient's ability 
to restrict HIV replication and a favorable effect of the therapies or 
vaccines. These methods may be advantageously applied in conjunction 
with other measurements of HIV specific immune response such as HLA 
tetramers.

Safer Attenuated Virus Vaccines with Missing or Diminished Latency of 
Infection

Jeffrey Cohen (NIAID), Edward Cox (FDA), Lesley Pesnicak (NIAID).

DHHS Reference No. E-250-2002/0

Filed Nov. 5, 2002.

Licensing Contact: Susan Ano; 301/435-5515; anos@od.nih.gov.
    This technology describes 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. Specific examples of gene deletion 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.

HTLV-1 Cell Binding and Inhibition

Bishop Hague, Tong Mao Zhao, Thomas Kindt (NIAID).

DHHS Reference No. E-240-2002/0

Filed Oct 30, 2002.

Licensing Contact: Susan Ano; 301/435-5515; anos@od.nih.gov.
    This technology describes methods for inhibiting human T-cell 
lymphotropic virus type I (HTLV-I) infection in cells and for reducing 
viral load or titer in infected individuals. As many as 20 million 
people worldwide are infected with HTLV-I, and approximately 1 million 
will develop adult T-cell leukemia/lymphoma, myelopathy, or tropic 
spastic paraparesis (a condition similar to multiple sclerosis) as a 
result of infection. Previous treatments have proven ineffective. The 
current invention relates to the surprising results that adenosine 
receptor antagonists specific for type A2A and A2B adenosine receptors 
prevent binding of HTLV-I to cells. Such antiviral use of adenosine 
receptor antagonists has not been suggested elsewhere. This technology 
also has veterinary application, as such treatment methods could be 
used against feline leukemia virus infections.

Flp-in T-Rex Jurkat Cell Line

Steven Zeichner, Naoto Yoshizuka (NCI).

DHHS Reference No. E-161-2003.

Licensing Contact: Michael Shmilovich; 301/435-5019; 
mish@codon.nih.gov.
    This Flp-in T-Rex Jurkat cell line offers rapid and efficient 
generation of cell lines containing a gene of interest

[[Page 26632]]

by FRT-Flp recombinase mediated integration.
    A cell line can be stably transformed with both the pFRT/lacZeo 
(already in the parental Flp-in Jurkat cell line) and the pcDNA6/TR 
plasmids. A gene of interest is cloned into plasmid, pcDNA5/FRT/TO. 
When pcDNA5/FRT/TO, including the gene of interest, is co-transfected 
along with a plasmid supplying a source of Flp recombinase into the 
cell line, the recombinase mediates the insertion of the gene of 
interest into the Flp recombination target (FRT) site in the pFRT/
lacZeo plasmid that becomes integrated into the DNA of the cell line. 
The gene of interest can then be expressed in a tetracycline inducible 
fashion.

Method of Assessing Ischemia in a Patient

Steven Warach and Lawrence Latour (NINDS).

DHHS Reference No. E-082-2002 Filed Mar. 17, 2002.

Licensing Contact: Michael Shmilovich; 301/435-5019; 
mish@codon.nih.gov.
    Hyperintense acute reperfusion marker (HARM) is well correlated 
with reperfusion and is a precursor to or concomitant with reperfusion 
injury and hemorrhagic transformation. The inventors have developed a 
novel technique of assessing early blood brain barrier disruption 
associated with ischemic stroke in a patient by administering a 
contrast agent to the patient, acquiring a fluid-attenuated inversion-
recovery (FLAIR) image, and observing the presence or absence of HARM 
on the acquired image. The technique can also be used to determine the 
effectiveness of a therapeutic protocol for the treatment or prevention 
of reperfusion injury or hemorrhagic transformation in a patient that 
has suffered an ischemic event.

    Dated: May 9, 2003.
Steven M. Ferguson,
Acting Director, Division of Technology Development and Transfer, 
Office of Technology Transfer, National Institutes of Health.
[FR Doc. 03-12278 Filed 5-15-03; 8:45 am]

BILLING CODE 4140-01-P