[Federal Register Volume 74, Number 86 (Wednesday, May 6, 2009)]
[Notices]
[Pages 20957-20958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-10450]


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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

[[Page 20958]]

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.

Genetic Mutations Associated With Stuttering

    Description of Technology: NIH investigators, for the first time, 
identified specific mutations associated with stuttering. These 
mutations are located within the genes encoding three enzymes, Glc-NAc 
phosphotransferase catalytic subunit [GNPTAB], Glc-NAc 
phosphotransferase recognition subunit [GNPTG], and N-
acetylglucosamine-1-phosphodiester alpha-N-acetylglucosaminidase 
[NAGPA]. Together these constitute the pathway that targets lysosomal 
enzymes to their proper location. This pathway is associated with 
lysosomal storage disorders, and thereby this discovery provides 
potential novel therapeutic targets for amelioration of stuttering. 
This discovery has the potential to facilitate DNA-based (micro-array) 
testing among individuals who stutter, as well as enzyme-replacement 
therapy and small-molecule chaperone therapy for treatment of 
stuttering. The mutations described in this invention may account for 
up to 5-10% of this disorder in individuals who stutter, estimated to 
represent 60,000-120,000 individuals in the United States.
    Applications: Genetic diagnosis of stuttering disorder; 
Therapeutics for stuttering disorder.
    Development Status: Early stage.
    Market: According to the Stuttering Foundation of America, 
stuttering affects over 3 million individuals in the United States.
    Inventors: Dennis T. Drayna (NIDCD), Changsoo P. Kang (NIDCD), et 
al.
    Patent Status: U.S. Provisional Application No. 61/150,954 filed 02 
Feb 2009 (HHS Reference No. E-084-2009/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Suryanarayana (Sury) Vepa, Ph.D., J.D.; 301-435-
5020; [email protected].

Mast Cells Defective in the Syk Protein Tyrosine Kinase

    Description of Technology: NIH investigators, through screening for 
variants of RBL-2H3 cells, have identified and developed TB1A2 mast 
cells that are defective in the expression of the Syk protein tyrosine 
kinase. These cells had no detectable Syk protein by immunoblotting or 
in vitro kinase reaction, and no detectable Syk mRNA by Northern 
hybridization. These TB1A2 cells failed to secrete or generate 
cytokines after high affinity receptor for immunoglobulin E (Fc epsilon 
RI) stimulation. In these Syk-deficient TB1A2 cells, aggregation of 
these receptors did not induce histamine release and there was no 
detectable increase in total cellular protein tyrosine phosphorylation. 
However, stimulation of these cells with the calcium ionophore did 
induce degranulation. These cells provide a useful experimental model 
to study the role of Syk tyrosine kinase in signal transduction 
pathways in immune cells.
    Inventors: Juan Zhang, Elsa H. Berenstein, and Reuben P. Siraganian 
(NIDCR).
    Publication: J Zhang, EH Berenstein, RL Evans, RP Siraganian. 
Transfection of Syk protein tyrosine kinase reconstitutes high affinity 
IgE receptor-mediated degranulation in a Syk-negative variant of rat 
basophilic leukemia RBL-2H3 cells. J Exp Med. 1996 July 1;184(1):71-79.
    Patent Status: HHS Reference No. E-342-2008/0--Research Tool. 
Patent protection is not being pursued for this technology.
    Licensing Status: Available for licensing under a Biological 
Materials License Agreement.
    Licensing Contact: Suryanarayana (Sury) Vepa, Ph.D., J.D.; 301-435-
5020; [email protected].
    Collaborative Research Opportunity: The National Institute of 
Dental and Craniofacial Research, Oral Infection and Immunity Branch, 
Receptors and Signal Transduction Section, is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize this 
technology. Please contact David W. Bradley, Ph.D. at 301-402-0540 or 
[email protected] for more information.

Novel Means of Regulation of Gene Expression: Modular and Artificial 
Splicing Factors

    Description of Technology: This discovery provides a new 
therapeutic approach for treatment of diseases caused by altered gene 
regulation resulting from defective alternative splicing of genes. This 
technology offers the following advantages over currently available 
methods for regulating splicing: (a) Delivery can be through standard 
gene therapy methods, such as viral vectors, (b) site of delivery of 
the artificial splicing factors can be controlled, which enables 
targeted expression and limited side effects, and (c) the artificial 
splicing factors described here can be readily adapted to a variety of 
splicing effector modules. This invention provides proteins that 
combine an RNA recognition module that can specifically target an 
endogenous pre-mRNA with splicing effector modules that alter splicing 
to favor a particular isoform of a mature mRNA.
    The artificial splicing factors disclosed here can be used to treat 
conditions requiring directed alternative splicing. For example, the 
artificial splicing factors described here can be used in combination 
with other anti-tumor drugs as a cancer treatment. Other examples where 
this technology may find use include diabetes (insulin receptor), 
psoriasis (fibronectin), polycystic kidney disease (PKD2), and prostate 
cancer (fibroblast growth factor receptor 2).
    Applications: Therapeutics for diabetes, psoriasis, polycystic 
kidney disease, and prostate cancer; Research Tools.
    Development Status: Early stage.
    Inventors: Traci M. T. Hall (NIEHS), et al.
    Patent Status: U.S. Provisional Application No. 61/140,326 filed 23 
Dec 2008 (HHS Reference No. E-334-2008/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Suryanarayana (Sury) Vepa, Ph.D., J.D.; 301-435-
5020; [email protected].
    Collaborative Research Opportunity: The NIEHS Division of 
Intramural Research is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate, or commercialize Modular and Artificial Splicing Factors. 
Please contact Elizabeth M. Denholm, Ph.D. at 919-541-0981 or 
[email protected] or Traci Hall, Ph.D. at [email protected] for 
more information.

    Dated: April 29, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-10450 Filed 5-5-09; 8:45 am]
BILLING CODE 4140-01-P