Government-Owned Inventions; Availability for Licensing, 51823 [2010-20863]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[Federal Register Volume 75, Number 162 (Monday, August 23, 2010)]
[Notices]
[Page 51823]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-20863]



[[Page 51823]]

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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.

Transforming Growth Factor Beta-1 (TGF-[beta]1) Transgenic Mouse Model

    Description of Technology: Transforming Growth Factor-[beta]1 (TGF-
[beta]1) is a multifunctional cytokine that is involved in many 
physiological processes such as immune regulation, cell proliferation, 
angiogenesis, apoptosis, and extracellular matrix deposition. 
Overexpression of activated TGF-[beta]1 signaling pathway is known to 
play a role in many disease processes, such as inflammation, fibrosis 
and tumor metastasis.
    NIH inventors have developed a transgenic mouse model, designated 
[beta]1\glo\, which permits conditional, gene-specific overexpression 
of TGF-[beta]1. The model features a TGF-[beta]1 transgene for which 
expression is blocked by a floxed enhanced green fluorescent protein 
(EGFP) gene downstream of the promoter. Excision of the EGFP gene by 
Cre recombinase allows expression of TGF-[beta]1. Thus, these mice may 
be cross-bred with a variety of Cre transgenic mouse lines in order to 
study the role of TGF-[beta]1 in targeted organ systems and tissues.
    Inventors: Ashok B. Kulkarni and Bradford E. Hall (NIDCR).
    Publication: BE Hall, C Zheng, WD Swaim, A Cho, CN Nagineni, MA 
Eckhaus, KC Flanders, IS Ambudkar, BJ Baum, AB Kulkarni. Conditional 
overexpression of TGF-beta1 disrupts mouse salivary gland development 
and function. Lab Invest. 2010 Apr;90(4):543-555. [PubMed: 20142803].
    Patent Status: HHS Reference No. E-016-2010/0--Research Tool. 
Patent protection is not being pursued for this technology.
    Licensing Status: Available for licensing under a Biological 
Materials License.
    Licensing Contact: Tara Kirby, PhD; 301-435-4426; tk200h@nih.gov.

A Fertility Test To Detect Ovarian Autoimmune Disease Using Human 
Recombinant MATER Protein

    Description of Technology: The inventors have identified MATER, a 
gene that plays an important role in fertility, and have shown that 
antibodies against MATER protein are detected at higher frequencies in 
women experiencing infertility and irregular menstrual periods than in 
healthy women. The discovery of MATER as an important factor in 
autoimmune-mediated ovarian dysfunction will facilitate diagnosis and 
treatment of these disorders. In addition to its critical role in 
ovarian autoimmunity, the inventors have also discovered that the MATER 
gene plays an essential role in embryonic development.
    The invention discloses the MATER gene, MATER protein and MATER-
specific antibodies. Also disclosed are methods and kits for evaluating 
female infertility through detection of an abnormal autoimmune 
response, an abnormal MATER gene, or abnormal MATER protein expression.

Applications

     Diagnostic test for women suffering from infertility or 
irregular menstrual periods.
     Tool for the study of early embryonic development.
     Tool for the development of MATER-based contraceptives.
    Development Status: Established research test, ready for additional 
clinical research and commercial development.
    Market: Approximately 10% of women of reproductive age experience 
infertility, and approximately 5% per year experience menstrual 
irregularity.
    Inventors: Lawrence M. Nelson and Zhi-bin Tong (NICHD).

Publications

    1. Zhi-Bin Tong et al. A mouse gene encoding an oocyte antigen 
associated with autoimmune premature ovarian failure. Endocrinology. 
1999 Aug;140(8):3720-3726. [PubMed: 10433232].
    2. Zhi-Bin Tong et al. Developmental expression and subcellular 
localization of mouse MATER, an oocyte-specific protein essential for 
early development. Endocrinology. 2004 Mar;145(3):1427-1434. [PubMed: 
14670992].
    3. Zhi-Bin Tong et al. A human homologue of mouse Mater, a maternal 
effect gene essential for early embryonic development. Hum Reprod. 2002 
Apr; 17(4):903-911. [PubMed: 11925379].
    4. Zhi-Bin Tong et al. Mater, a maternal effect gene required for 
early embryonic development in mice. Nat Genet. 2000 Nov;26(3):267-268. 
[PubMed: 11062459].

Patent Status

     U.S. Patent 7,217,811 issued 15 May 2007 (HHS Reference 
No. E-239-2000/0-US-03).
     U.S. Patent 7,531,635 issued 12 May 2009 (HHS Reference 
No. E-239-2000/0-US-08).
     U.S. Patent 7,432,067 issued 07 Oct 2008 (HHS Reference 
No. E-239-2000/0-US-09).
     U.S. Patent 7,189,812 issued 13 Mar 2007 (HHS Reference 
No. E-239-2000/1-US-02).
     Foreign counterparts issued/pending in Australia, Canada, 
Europe, and Japan.
    Licensing Status: Available for licensing.
    Licensing Contact: Tara Kirby, PhD; 301-435-4427; tk200h@nih.gov.

    Dated: August 17, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-20863 Filed 8-20-10; 8:45 am]
BILLING CODE 4140-01-P