[Federal Register Volume 71, Number 89 (Tuesday, May 9, 2006)]
[Notices]
[Pages 26977-26978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-6987]


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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.

New Method for Quantification of Allele-Specific RNA Expression, That 
Can Be Used for Detection of Various Genetic Disorders

Drs. Marjan Huizing, Enriko Klootwijk, Paul Savelkoul, Carla Ciccone, 
William Gahl (NHGRI)
U.S. Provisional Application No. 60/718,321 filed 20 Sep 2005 (HHS 
Reference No. E-146-2005/0-US-01)
Licensing Contact: Cristina Thalhammer-Reyero; 301/435-4507; 
[email protected].

    Available for licensing and commercial development is a new method 
for quantification of allele-specific RNA expression. This invention 
describes methods for simultaneously detecting the levels of expression 
of a plurality of different RNA transcripts expressed from a gene of 
interest in a subject or a cell. This is a simple assay to validate and 
quantify allele-specific silencing, by applying a combination of a 
fluorescent primer/probe set that specifically recognizes the targeted 
allele where the probe is labeled with one fluorophore, and a primer/
probe set that specifically recognizes the normal allele, where the 
probe is labeled with another fluorophore in the same reaction tube. 
Furthermore, this method can be run on most real time PCR machines and 
requires very small amounts of RNA, less than 100 ng. This novel 
method, by comparing alleles within the same gene, expands on current 
real time PCR methods which compare one gene with another gene.
    The invention also describes methods for validating the 
effectiveness and specificity of allele-specific siRNAs, kits for 
performing such assays, as well as methods for diagnosis of autosomal-
dominant disorders, in which mutations in one allele result in a 
disease phenotype, such as Hutchinson-Gilford progeria, incontinentia 
pigmenti, neurofibromatosis, myotonic dystrophy, sialuria, Machado-
Joseph disease, spinocerebellar ataxia, frontotemporal dementia, 
amyotrophic lateral sclerosis, slow channel congenital myasthenic 
syndrome, spinobulbar muscular dystrophy, as well as compound 
heterozygous autosomal recessive disorders. Other diseases that can be 
diagnosed include diabetes, cystic fibrosis, homocystenuria, Hermansky-
Pudlak syndrome, cystinosis, Zellweger syndrome, beta-thalassemia, 
alkaptonuria, and cancer.
    A variety of diseases appear to be mediated or accompanied by 
aberrant expression of one allele, often a mutant of a gene. Such 
differences in allelic expression can serve as the basis for diagnostic 
test for such conditions, and the ability to specifically silence the 
expression of detrimental alleles could be a therapeutic method for 
treating the disease, hence this novel method has very wide 
applications.

Development of Gene Chip Technology for Vascular Risk Assessment

Alison E. Baird (NINDS) et al.
U.S. Provisional Application No. 60/687,515 filed 03 Jun 2005 (HHS 
Reference No. E-030-2005/0-US-01)
U.S. Provisional Application No. 60/691,730 filed 17 Jun 2005 (HHS 
Reference No. E-030-2005/1-US-01)
Licensing Contact: Fatima Sayyid; 301/435-4521; [email protected].

    Prevention of cardiovascular disorders such as myocardial 
infarction and stroke is an area of major public health importance. 
Currently, several risk factors for future cardiovascular disorders 
have been described and are in wide clinical use in the detection of 
individuals at high risk. However a large number of cardiovascular 
disorders occur in individuals with apparently low to moderate risk 
profiles, thereby limiting the ability to identify such patients. 
Moreover, many of the risk factors require accurate gathering of 
clinical information. An objective panel of biological markers which 
allow one to predict an individual's risk of vascular disease is 
therefore needed.
    The present provisional patent application is directed to utilizing 
blood mononuclear cells to evaluate vascular disease risk and determine 
a preventive regimen for reduction or minimization of such risk. The 
method includes screening for differential expression of vascular risk-
related molecules, such as DNA binding/transcription factor proteins, 
lysosomal or protein degradation enzymes, adhesion molecules, 
metabolism molecules, intracellular signaling molecules, immune 
response molecules and apoptosis. The technology is available to a 
collaborator for monitoring stroke treatment protocols, for definition 
of clinical trial protocol candidates, or for developing an 
``assessment chip'' that could be used to predict an individual's risk 
of developing a stroke in the future.

[[Page 26978]]

    The NINDS Stroke Neuroscience Unit is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize a vascular risk 
genetic chip technology. We seek a collaborative partner in the 
development of a chip that could be used to predict an individual's 
risk of developing a stroke in the future and to monitor the 
effectiveness of preventive measures once they have been instituted. 
Please contact Heather Gunas at [email protected] for more 
information.

Method of Inducing Memory B Cell Development and Terminal 
Differentiation

Peter E. Lipsky (NIAMS) et al.
U.S. Patent Application No. 11/197,221 filed 03 Aug 2005 (HHS Reference 
No. E-120-2003/2-US-01)
Licensing Contact: Thomas Clouse; 301/435-4076; [email protected].

    Cytokines exert their respective biochemical and physiological 
effects by binding to specific receptor molecules, which then stimulate 
signal transduction pathways. Interleukin-21 (1L-21) is a type I 
cytokine whose receptor is expressed on T, B, and NK cells.
    This invention specifically relates to the use of IL-21 to induce 
differentiation of immature B cells into memory B cells and plasma 
cells. This invention includes claims of methods for inducing 
differentiation of a B cell progenitor into memory B cells and/or 
plasma cells. It also includes claims for enhancing an immune response, 
treating subjects that lack memory B cells and plasma cells and methods 
for increasing or decreasing the number of B cells. This invention 
could conceivably be used in treating or preventing inflammatory 
disorders, autoimmune diseases, allergies, transplant rejection, 
cancer, and other immune system disorders.

Immunogenic Epitopes for Fibroblast Growth Factor-5 (FGF-5) Presented 
by HLA-A3 and HLA-A2

James C. Yang et al. (NCI)
U.S. Patent Application No. 11/134,703 filed 19 May 2005 (HHS Reference 
No. E-031-2003/1-US-01)
Licensing Contact: Michelle Booden; 301/451-7337; [email protected].

    Approximately 30,000 patients are diagnosed with renal cell 
carcinoma (RCC) each year in the United States, and an estimated 12,000 
patients die of this disease. Most patients are diagnosed with advanced 
local disease or metastatic disease. Current therapies include removal 
of the kidney (nephrectomy) or high dose immunotherapy with IL-2, which 
has been able to achieve success in only part (15-20%) of the patient 
population. Even with a successful nephrectomy, it is likely that 
patients with advanced local diseases will develop metastases. 
Therefore, new methods are needed to improve on IL-2 therapy and expand 
the curative potential of therapies for patients with RCC.
    The present invention discloses peptides for use in immunotherapy 
of tumors. The peptides, both an HLA-A2 and an HLA-A3 epitope, are 
derived from the amino acid sequence of an RCC-associated antigen, 
fibroblast growth factor-5 (FGF-5). Plans are underway to investigate 
both peptides in clinical trials of peptide vaccination in patients 
with advanced renal cancer. In addition, FGF-5 also appears to be over-
expressed in other common adenocarcinomas such as breast, prostate and 
bladder cancer and very few antigens suitable for vaccine therapies 
exist for those cancers.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

    Dated: May 2, 2005.
David R. Sadowski,
Acting Director, Division of Technology Development and Transfer, 
Office of Technology Transfer, National Institutes of Health.
[FR Doc. E6-6987 Filed 5-8-06; 8:45 am]
BILLING CODE 4167-01-P