[Federal Register Volume 69, Number 243 (Monday, December 20, 2004)]
[Notices]
[Pages 75993-75994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-27783]


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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.

The Use of Rabbits With Defined Immunoglobulin Light Chain Genes 
(Ckappa b Allotypes) To Optimize Production of Chimeric and 
Humanized Monoclonal Antibodies for Therapeutic, Imaging and Diagnostic 
Applications

Rose G. Mage, Cornelius Alexander (NIAID).
DHHS Reference No. E-332-2004/0--Research Tool.
Licensing Contact: Pradeep Ghosh; (301) 435-5282; [email protected].

    Biological materials are important research tools that can be used 
for diagnostic as well as therapeutic purposes. Antibodies have become 
viable drugs in the market today and there is a general market need for 
systems that may facilitate production of efficient and effective 
antibodies. In recent years, monoclonal antibodies have gained 
significant importance in their use, both as diagnostics and 
therapeutics, to intervene and combat diseases such as cancer, 
cardiovascular diseases, and infections. The present invention relates 
to the discovery of rabbits, genetically defined as b9, as the 
biological vehicle for the isolation of chimeric phage displaying Fab 
with human constant regions and rabbit immunoglobulin heavy and light 
chain variable regions for the development of diagnostic antibodies and 
humanized monoclonal therapeutic antibodies of high affinity and 
specificity (Popkov et al., J. Molec. Biol. 325: 325-335, 2003; Popkov 
et al. J. Immunol. Methods 288: 149-164, 2004). Recently, many 
effective antibodies have been developed as a result of the integration 
of antibody libraries with phage display technology. The rabbit model 
described in this invention may be used for production of antibodies 
that may cross react with both human and mouse antigens. Rabbit 
monoclonal antibodies that react with both human and mouse antigens are 
of particular relevance for the preclinical evaluation of therapeutic 
antibodies in mouse models of human diseases. Therefore, this invention 
has a broad commercial potential in its use as a source for producing 
monoclonal antibodies for therapeutic interventions in infectious, 
autoimmune and neurological diseases, nerve damage and cancer.

Methods for Diagnosis of Atherosclerosis

Paul Hwang et al. (NHLBI).
U.S. Provisional Application No. 60/607,031 filed 03 Sep 2004 (DHHS 
Reference No. E-276-2004/0-US-01).
Licensing Contact: Fatima Sayyid; 301/435-4521; [email protected].

    In industrialized countries coronary heart disease and stroke due 
to atherosclerosis are the leading causes of morbidity and mortality. 
Coronary heart disease is the single largest cause of death in the 
U.S.A. and will cost approximately $133.2 billion according to the 2004 
American Heart Association statistics update.
    The identification of more sensitive and specific markers of 
atherosclerosis that are non-invasive and cost-effective may have 
profound impacts on public health. One such strategy involves the 
detection of marker genes or their products in blood or serum. Such 
markers may help identify high-risk patients with subclinical 
atherosclerosis who may benefit from intensive primary prevention or 
they may help determine the activity of established disease for 
monitoring response to treatment, resulting in more targeted secondary 
prevention.
    The present invention relates to methods for detecting 
atherosclerosis using highly reactive biomarkers (FOS and/or DUSP1) 
expressed in blood cells or released into serum. Because these markers 
are also involved in pathogenesis, they may serve as potential targets 
for drug discovery and for intervention to modify disease progression.

An Improved Method To Separate and Expand Antigen-Specific T Cells

Jonming Li and John Barrett (NHLBI).
U.S. Provisional Application No. 60/606,197 filed 31 Aug 2004 (DHHS 
Reference No. E-246-2004/0-US-01).
Licensing Contact: Fatima Sayyid; (301) 435-4521; [email protected].

    Stem cell transplants can be used to treat patients with leukemia 
or other disorders. Transplanted donor T cells (lymphocytes) exert 
strong alloimmune

[[Page 75994]]

graft versus leukemia and other anti-tumor effects however they can 
also cause potentially lethal graft versus host disease (GVHD), 
requiring post-transplant immunosuppression. Such immunosuppression may 
place patients at a greater risk of contracting potentially fatal 
cytomegalovirus infection further reducing their capacity to be cured 
of their malignant disease.
    The transfer of T lymphocytes specific for leukemia cells or micro-
organism antigens can be useful since therapeutic immune effects would 
be enhanced while GVHD reactions would not be induced. Currently 
available methods for isolating and expanding antigen-specific T cells 
including selection using HLA tetramers, magnetic beads binding to 
activation markers or laborious limiting dilution techniques are 
unreliable, poorly reproducible, expensive and impede clinical 
progress.
    The present invention relates to methods for selecting and 
expanding antigen specific T-cells that recognize a pre selected target 
antigen, to purified populations of antigen-specific T cells that 
recognize a pre selected target antigen and to therapeutic uses of 
antigen-specific T cells that recognize a pre selected target antigen. 
Potential applications include treatment of cytomegalovirus, Epstein-
Barr virus and adenovirus reactivation following stem cell 
transplantation or organ transplantation, prevention and treatment of 
leukemic relapse after transplantation or chemotherapy using autologous 
expanded T cells, and selective depletion of alloreactive T cells from 
transplants which may produce GVHD.

Novel Compounds for Selectively Inactivating Pain Pathways

Peter Blumberg, Jeewoo Lee (NCI).
U.S. Provisional Application No. 60/558,003 filed 26 Mar 2004 (DHHS 
Reference No. E-141-2004/0-US-01).
Licensing Contact: Norbert Pontzer; 301/435-5502; 
[email protected].

    Available for licensing are compositions and methods for the long-
term control of pain and other pathological conditions caused by the 
over-activity of pain pathways. Neurons in the dorsal root, trigeminal 
and nodose ganglia project unmyelinated C-fibers and A[delta]-fibers 
that transmit pain and temperature sensation between the periphery and 
spinal cord. Along with acute and chronic pain, over activation of 
those pathways leads to neurogenic and neuropathic inflammation leading 
to such conditions as post-herpetic neuralgia, diabetic neuropathy, 
cystitis, and reflex sympathetic dystrophy among many others.
    These neurons are activated both centrally and peripherally by a 
relatively non-selective cation channel initially identified as site of 
action of capsaicin, the pungent ingredient in chili peppers. That 
channel is now called VR1 or TRPV1 and is found in high concentration 
only on C and A[delta] neurons. These inventors previously discovered 
and patented resiniferatoxin (RTX), an ultrapotent agonist of the VR1 
receptor. RTX desensitizes C and A[delta]-fibers when applied 
peripherally and may selectively ablate those neurons when applied 
centrally without causing substantial pain from activation of the 
neurons. RTX type compounds thus provide a method of controlling pain 
other conditions caused by C and A[delta]-fiber activity. The present 
invention provides new RTX analogues that may have an improved 
therapeutic index and metabolic profile.

    Dated: December 9, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 04-27783 Filed 12-17-04; 8:45 am]
BILLING CODE 4140-01-P