[Federal Register Volume 71, Number 173 (Thursday, September 7, 2006)]
[Notices]
[Pages 52802-52804]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14753]



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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, HHS.

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.

Differential Expression of Molecules Associated With Intra-Cerebral 
Hemorrhage

    Description of Technology: Stroke affects 15 million people 
worldwide each year, and is the number three leading cause of morbidity 
in the United States. Although most forms of stroke are ischemic in 
nature, approximately 10-15% of strokes are hemorrhagic. At present, 
clinical applications for distinguishing between these two forms of 
stroke do not exist.
    The present invention describes a highly predictive, cost-effective 
diagnostic assay capable of detecting whether an individual has 
suffered from an intracerebral hemorrhagic stroke and the likelihood of 
neurological recovery. It comprises a rapid screening device for 
measuring differential expression patterns of nucleic acid molecules or 
proteins of at least four hemorrhagic stroke-related genes. Accurate 
prediction of hemorrhagic stroke will improve rapid diagnosis and aid 
in determining early treatment regimens.
    Applications:
    1. Gene expression profile assay for determining hemorrhagic stroke 
victims.
    2. Means of differentiating between hemorrhagic stroke and ischemic 
stroke thereby optimizing patient response to stroke therapies.
    Market:
    1. Annually, fifteen billion people suffer from strokes worldwide, 
and an estimated 700,000 individuals have first-time or recurrent 
strokes each year in the United States alone.
    2. Almost three-fourth of all strokes occur in individuals over 65 
years of age.
    3. In 2006, the projected indirect and direct costs of stroke are 
$57.9 billion.
    Development Status: This technology requires clinical validation 
studies.
    Inventors: Alison Baird (NINDS) et al.
    Patent Status: U.S. Provisional Application No. 60/807,027 filed 11 
Jul 2006 (HHS Reference No. E-197-2006/0-US-01).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Fatima Sayyid, M.H.P.M.; 301/435-4521; 
[email protected].
    Collaborative Research Opportunity: NINDS is also seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
this assay for determining hemorrhagic stroke victims. For additional 
information, please contact: Heather Gunas, J.D., M.P.H; NINDS c/o NCI 
TTB; 6120 Executive Blvd., Suite 450, Rockville, MD 20852; Phone: 301-
451-3944; Fax: 301-402-2117; E-mail: [email protected].

Diagnosis and Prognosis of Fabry Disease by Detecting Neuronal 
Apoptosis Inhibitor Protein (NAIP) Expression

    Description of Technology: Fabry disease is a severe metabolic 
disorder that affects the vascular system of multiple tissues and 
organs. An estimated 1 in 40,000 individuals inherit this rare disease, 
and suffer from various complications including stroke, renal failure, 
and cardiac arrest. At present, molecular markers that directly measure 
cellular dysfunction to not exist, thus, prognosis for Fabry disease 
therapy can not be assessed.
    Available for licensing and commercial development is a rapid 
diagnostic assay to identify individuals with Fabry disease and an 
effective mechanism of evaluating enzyme replacement therapy. It 
provides a quick, inexpensive device for determining expression 
patterns of the neuronal apoptosis inhibitor protein (NAIP). Peripheral 
blood white cells of Fabry disease patients are analyzed for elevated 
levels of the marker NAIP, which is over-expressed in patients 
suffering from acute strokes. These elevated levels have been found in 
children with Fabry disease and point to the need for preventive 
therapies. Additionally, this test can be routinely utilized for 
evaluation of specific and non-specific therapies that aid in 
minimizing the complications associated with Fabry disease.
    Applications:
    1. Rapid diagnostic test to identify person at risk for Fabry 
disease.
    2. Reliable diagnostic test to identify subject response to Fabry 
disease therapy.
    Market: Individuals genetically susceptible to Fabry disease.
    Development Status: This technology requires analytic validation.
    Inventors: Raphael Schiffmann (NINDS) et al.
    Related Publications:
    1. DF Moore, H Li, N Jeffries, V Wright, RA Cooper Jr, A Elkahloun, 
MP Gelderman, E Zudaire, G Blevins, H Yu, E Goldin, AE Baird. Using 
peripheral blood mononuclear cells to determine a gene expression 
profile of acute ischemic stroke: a pilot investigation. Circulation. 
2005 Jan 18; 111(2):212-221.
    2. Y Okada, H Sakai, E Kohiki, E Suga, Y Yanagisawa, K Tanaka, S 
Hadano, H Osuga, JE Ikeda. A dopamine D4 receptor antagonist attenuates 
ischemia-induced neuronal cell damage via upregulation of neuronal 
apoptosis inhibitory protein. J Cereb Blood Flow Metab. 2005 Jul; 
25(7):794-806.
    3. N Inohara, M Chamaillard, C McDonald, G Nu[ntilde]ez. NOD-LRR 
proteins: role in host-microbial interactions and inflammatory disease. 
Annu Rev Biochem. 2005 Jul; 74:355-383.
    Patent Status: U.S. Provisional Application No. 60/806,295 filed 30 
Jun 2006 (HHS Reference No. E-196-2006/0-US-01).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Fatima Sayyid, M.H.P.M.; 301/435-4521; 
[email protected].

Novel Treatment of Vascular Cognitive Impairment

    Description of Technology: Available for licensing are methods and 
formulations for treating or preventing Vascular Cognitive Impairment 
(VCI) through mucosal administration of E-selectin, an inducible 
adhesion molecule on endothelial cells. Vascular dementia is defined as 
the loss of cognitive function resulting from ischemic, ischemic-
hypoxic, or hemorrhagic brain lesions as a result of cerebrovascular 
diseases and pathologic

[[Page 52803]]

changes. Presently no adequate medical treatment exists for VCI.
    Cerebrovascular disease causes proinflammatory cytokines such as 
IL-1 and TNF to induce the expression of E-selectin on human 
endothelium. E-selectin mediates the adhesion of various leukocytes, 
including neutrophils, monocytes, eosinophils, natural killer cells, 
and a subset of T cells to the activated endothelium. Activation of 
vascular endothelial cells by proinflammatory cytokines is believed to 
be involved in conversion of the luminal surface of endothelium from 
anticoagulant and anti-inflammatory to procoagulant and pro-
inflammatory. These vascular changes are thought to underlie the 
development of VCI.
    Mucosally administered antigens can inhibit immune responses in an 
antigen specific fashion by inducing a subset of lymphocytes to produce 
anti-inflammatory cytokines in the presence of the antigen. This type 
of tolerance has been termed ``bystander suppression''. In an animal 
model of VCI, intranasal administered E-selectin suppressed activation 
of vessel segments beginning to express E-selectin and thus prevented 
the development of VCI. Immunosuppression via antigen-specific 
modulation of the immune response (mucosal tolerance) should have no 
systemic immunosuppressive effects.
    Inventors: John M. Hallenbeck et al. (NINDS).
    Patent Status: U.S. Provisional Application No. 60/712,359 filed 30 
Aug 2005 (HHS Reference No. E-271-2005/0-US-01).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Norbert Pontzer, Ph.D., J.D.; 301/435-5502; 
[email protected].
    Collaborative Research Opportunity: The NINDS Stroke Branch is 
seeking statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
the use of E-selectin for treatment of VCI. For more information, 
please contact: Laurie Arrants, NINDS Technology Transfer Office, 301-
435-3112; [email protected].

Use of LCAT To Reduce Cholesterol and Prevent Atherosclerosis

    Description of Technology: Available for licensing and commercial 
development is a method of decreasing accumulation of cholesterol in 
arteries of humans by administering lecithin-cholesterol 
acyltransferase (LCAT). This method is useful for the therapeutic 
treatment of subjects at risk for developing atherosclerosis.
    High plasma concentration of HDL cholesterol is associated with 
reduced risk of cardiovascular diseases (such as ischemic stroke and 
myocardial infarction). In contrast, low levels of HDL are associated 
with increased risk of atherosclerotic diseases. The plasma protein 
enzyme LCAT plays a critical role in the metabolism of HDL and it 
facilitates the removal of cholesterol from the body. Individuals with 
a mutation in the LCAT gene have low HDL plasma levels and exhibit an 
increased risk for atherosclerosis.
    Therefore, upregulation of LCAT function has been proposed as an 
HDL-C increasing therapy, and may have atheroprotective effects. This 
invention provides for several methods of administering LCAT 
polypeptide to decrease cholesterol accumulation in arteries.
    Development Status: Animal data available.
    Inventors: Silvia Santamarina-Fojo, Jeffrey M. Hoeg, H. Bryan 
Brewer (NHLBI).
    Relevant Publication: JM Hoeg et al. Overexpression of 
lecithin:cholesterol acyltransferase in transgenic rabbits prevents 
diet-induced atherosclerosis. Proc Natl Acad Sci USA. 1996 Oct 
15;93(21):11448-11453.
    Patent Status: U.S. Patent No. 6,635,641 issued on 21 Oct 2003 (HHS 
Reference No. E-007-1996/0-US-03); PCT Application No. PCT/US96/18159 
filed 09 Sep 1996, which was published as WO 1997/17434 on 15 May 1997 
(HHS Reference No. E-007-1996/0-PCT-02); Australian Patent No. 728257 
issued on 19 Apr 2001; and National Stage filings in Canada and Europe.
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: [email protected]; 301/496-7057.

Devices for Aseptic Lyophilization of Biological Samples

    Description of Technology: Biological materials are often 
lyophilized and stored in small aliquots for long-term preservation as 
a means of improving stability and expanding shelf life. At present, 
sterility of solutions cannot be preserved throughout the 
lyophilization process, and reconstituted samples must be filtered to 
remove contaminants such as fungi or bacteria, resulting in 
considerable loss of expensive sample via absorption by the filter. 
Thus, there exists a need for a device that eliminates microbial 
contamination throughout the lyophilization process and provides 
materials that are ready to use following lyophilization.
    This technology offers a functional method to prevent microbial 
contamination during lyophilization and a simple means to prevent 
contamination. It affords a convenient system for gas venting and 
exchange utilizing a microcentrifuge tube fitted with a cap 
incorporating a filter membrane. In a related technology, a unique, 
cost-effective multi-well plate assembly provides for simultaneous 
lyophilization of small sample volumes for high-throughput operations. 
Thus, these technologies are well-suited for researchers concerned 
about contamination during the lyophilization process. Given the 
spillage often occurring within centrifugal freeze-dryers, these 
technologies are also useful even when sterility is not needed, as they 
prevent contamination from the often-dirty interiors of laboratory 
centrifugal freeze-dryers, as well as cross-contamination between 
samples undergoing lyophilization. In addition, by extending shelf-
lives, these technologies enable researchers to purchase expensive 
biomolecules and pharmaceuticals in money-saving bulk quantities. 
Furthermore, these technologies permit cells to be grown and stored 
axenically, in small quantities, with or without lyophilization.
    Applications:
    1. Maximizes the shelf-lives of expensive biomolecules and 
pharmaceuticals.
    2. Makes practical the bulk purchase of expensive biomolecules and 
pharmaceuticals by extending shelf-lives.
    3. Makes possible the axenic storage of cells via aseptic freeze-
drying.
    4. Makes possible the production and use of small, sterile aliquots 
of precious materials by eliminating unnecessary filtration steps.
    5. Makes possible the sterile growth of cells in small volumes.
    Market:
    1. Researchers worldwide who utilize sterile, labile compounds.
    2. Researchers who utilize microbial, plant, or animal cell 
cultures.
    Development Status: Development is complete and invention has been 
successfully tested.
    Inventors: Geoffrey Kidd (NCI).
    Patent Status: U.S. Patent 5,958,778 issued 28 Sep 1999 (HHS 
Reference No. E-015-1995/2-US-01); U.S. Patent 6,503,455 issued 07 Jan 
2003 (HHS Reference No. E-015-1995/2-US-02); U.S. Patent Application 
10/238,147 filed 09 Sep 2002 (HHS Reference No. E-304-2003/0-US-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: [email protected]; 301/496-7057.


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    Dated: August 29, 2006.
Steven M. Ferguson,
Director,Division of Technology Development and Transfer,Office of 
Technology Transfer,National Institutes of Health.
 [FR Doc. E6-14753 Filed 9-6-06; 8:45 am]
BILLING CODE 4140-01-P