Government-Owned Inventions; Availability for Licensing, 51823-51824 [2010-20862]

Download as PDF Federal Register / Vol. 75, No. 162 / Monday, August 23, 2010 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: 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. erowe on DSK5CLS3C1PROD with NOTICES SUMMARY: Transforming Growth Factor Beta-1 (TGF-b1) Transgenic Mouse Model Description of Technology: Transforming Growth Factor-b1 (TGFb1) 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-b1 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 b1glo, which permits conditional, genespecific overexpression of TGF-b1. The model features a TGF-b1 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-b1. Thus, these mice may be crossbred with a variety of Cre transgenic mouse lines in order to study the role of TGF-b1 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 VerDate Mar<15>2010 15:31 Aug 20, 2010 Jkt 220001 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 51823 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]. 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 autoimmunemediated 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 MATERspecific 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. Patent Status Applications [FR Doc. 2010–20863 Filed 8–20–10; 8:45 am] • 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). BILLING CODE 4140–01–P Publications 1. Zhi-Bin Tong et al. A mouse gene encoding an oocyte antigen associated with autoimmune premature ovarian PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 • 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. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: 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 SUMMARY: E:\FR\FM\23AUN1.SGM 23AUN1 51824 Federal Register / Vol. 75, No. 162 / Monday, August 23, 2010 / Notices Licensing Contact: Suryanarayana Vepa, PhD, J.D.; 301–435–5020; vepas@mail.nih.gov. Collaborative Research Opportunity: The National Institute of Environmental Health Sciences, Laboratory of Molecular Carcinogenesis, Cell Adhesion Group, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact Elizabeth M. Denholm, PhD at 919–541–0981 or denholme@mail.nih.gov for more information. Matrix Metalloproteinase-9 Blade-1 Region Peptides: Use as Cell Migration Modulators erowe on DSK5CLS3C1PROD with NOTICES 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. Melanocyte Pigmentation or Proliferation With Neuregulin: Compositions and Methods to Treat Skin Disorders, Including Skin Cancer Description of Invention: Human skin pigmentation is regulated by complex and intricate interactions among melanocytes and keratinocytes in the epidermis and fibroblasts in the dermis. A number of factors secreted from keratinocytes and/or from fibroblasts have been shown to be involved in regulating skin pigmentation after UV exposure. NIH investigators have previously demonstrated that the less pigmented and thicker skin on the palms and soles is regulated by underlying fibroblasts in those areas, specifically via a secreted factor (DKK1) that modulates Wnt signaling. Now, using microarray analysis to compare gene expression patterns in 15 different primary dermal fibroblast populations derived from the dorsal trunk skin of three different skin phototypes (I, III and VI), these investigators have identified a number of genes that differ dramatically in expression. One among them, neuregulin 1 (NRG–1), secreted by fibroblasts derived from dark skin, effectively increases the pigmentation of melanocytes in tissue culture and in an artificial skin model and regulates their growth, suggesting it is one of the major factors determining human skin color. NRG-l was observed to be highly expressed by fibroblasts derived from darker skin. NIH investigators believe that NRG–1 increases the proliferation of human melanocytes via the phosphorylation of Akt. These results suggest a potential role for NRG–1 in regulating constitutive human skin color and perhaps its dysfunction in pigmentary skin diseases. Based on these observations, NIH investigators are currently developing compositions and methods of modulating pigmentation and proliferation of a melanocyte to prevent or treat skin disorders, including skin cancer. Applications: Description of Technology: Matrix metalloproteinase-9 (MMP–9) is an enzyme integrally involved in many normal physiological processes that require degradation and remodeling of the extracellular matrix, such as cell migration and invasion, wound repair, bone remodeling, angiogenesis, and embryonic growth. MMP–9 is shown to be involved in the progression of several diseases including many cancers, cardiovascular diseases, CNS diseases, respiratory diseases, and arthritis. In cancer, MMP–9 is thought to promote growth, migration, and spread of cancer cells by catalyzing the degradation of extracellular matrix proteins, releasing bound growth factors, and allowing cancer cells to escape from the primary tumor. NIH Inventors have discovered that specific polypeptides corresponding to Blade-1 region of MMP–9 hemopexin domain can stimulate migration of cells, specifically the migration of cells expressing b1 integrin. The present technology can be used to develop novel therapeutic candidates for the prevention and treatment of human disease conditions mediated by MMP–9 promoted cell migration, e.g., cancer, inflammation, fibrotic diseases, cardiovascular diseases, CNS diseases, respiratory diseases, angiogenesis and arthritis. Applications: Development of therapeutics for treating or preventing human diseases (cancer) using MMP–9 Blade-1 domain polypeptides or peptide analogs. Development Status: Early-stage. Inventors: SK Akiyama et al. (NIEHS) Patent Status: U.S. Provisional Application No. 61/360,328 filed 30 Jun 2010 (HHS Reference No. E–146–2010/ 0–US–01) Licensing Status: Available for licensing. VerDate Mar<15>2010 15:31 Aug 20, 2010 Jkt 220001 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 • Therapeutics for skin disorders. • Therapeutics for skin cancer. Development Status: Early stage and studies on reconstructed skin model and in melanocytes. Inventors: Vincent J. Hearing and Wonseon Choi (NCI) Related Publications: 1. Choi W, Wolber R, Gerwat W, Mann T, Hearing VJ. Characterization of the influence of fibroblasts on melanocyte function and pigmentation. In: Proc. XXth Intl. Pigment Cell Conf., edited by K. Jimbow, Bologna, Italy: Medimond, 2008, p. 79–82. 2. Choi W, Wolber R, Gerwat W, Mann T, Batzer J, Smuda C, Liu H, Kolbe L, Hearing VJ. A novel fibroblastderived melanogenic paracrine factor neuregulin-1 (NRG–1) that modulates the constitutive color and melanocyte function in human skin. J. Cell Sci. in press, 2010. Patent Status: U.S. Provisional Application No. 61/357,846 filed 23 Jun 2010 (HHS Reference No. E–100–2010/ 0–US–01). Licensing Status: Available for licensing. Licensing Contact: Suryanarayana Vepa, PhD, J.D.; 301–435–5020; vepas@mail.nih.gov. Collaborative Research Opportunity: The Center for Cancer Research, Laboratory of Cell Biology, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize the use of NRG–1 (or modifiers of its function) to regulate skin pigmentation. Please contact John Hewes, PhD at 301–435–3121 or hewesj@mail.nih.gov for more information. Dated: August 17, 2010. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2010–20862 Filed 8–20–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0001] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: E:\FR\FM\23AUN1.SGM Notice of public workshop. 23AUN1

Agencies

[Federal Register Volume 75, Number 162 (Monday, August 23, 2010)]
[Notices]
[Pages 51823-51824]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-20862]


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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.

-----------------------------------------------------------------------

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

[[Page 51824]]

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.

Matrix Metalloproteinase-9 Blade-1 Region Peptides: Use as Cell 
Migration Modulators

    Description of Technology: Matrix metalloproteinase-9 (MMP-9) is an 
enzyme integrally involved in many normal physiological processes that 
require degradation and remodeling of the extracellular matrix, such as 
cell migration and invasion, wound repair, bone remodeling, 
angiogenesis, and embryonic growth. MMP-9 is shown to be involved in 
the progression of several diseases including many cancers, 
cardiovascular diseases, CNS diseases, respiratory diseases, and 
arthritis. In cancer, MMP-9 is thought to promote growth, migration, 
and spread of cancer cells by catalyzing the degradation of 
extracellular matrix proteins, releasing bound growth factors, and 
allowing cancer cells to escape from the primary tumor.
    NIH Inventors have discovered that specific polypeptides 
corresponding to Blade-1 region of MMP-9 hemopexin domain can stimulate 
migration of cells, specifically the migration of cells expressing 
[beta]1 integrin. The present technology can be used to develop novel 
therapeutic candidates for the prevention and treatment of human 
disease conditions mediated by MMP-9 promoted cell migration, e.g., 
cancer, inflammation, fibrotic diseases, cardiovascular diseases, CNS 
diseases, respiratory diseases, angiogenesis and arthritis.
    Applications: Development of therapeutics for treating or 
preventing human diseases (cancer) using MMP-9 Blade-1 domain 
polypeptides or peptide analogs.
    Development Status: Early-stage.
    Inventors: SK Akiyama et al. (NIEHS)
    Patent Status: U.S. Provisional Application No. 61/360,328 filed 30 
Jun 2010 (HHS Reference No. E-146-2010/0-US-01)
    Licensing Status: Available for licensing.
    Licensing Contact: Suryanarayana Vepa, PhD, J.D.; 301-435-5020; 
vepas@mail.nih.gov.
    Collaborative Research Opportunity: The National Institute of 
Environmental Health Sciences, Laboratory of Molecular Carcinogenesis, 
Cell Adhesion Group, is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate, or commercialize this technology. Please contact Elizabeth M. 
Denholm, PhD at 919-541-0981 or denholme@mail.nih.gov for more 
information.

Melanocyte Pigmentation or Proliferation With Neuregulin: Compositions 
and Methods to Treat Skin Disorders, Including Skin Cancer

    Description of Invention: Human skin pigmentation is regulated by 
complex and intricate interactions among melanocytes and keratinocytes 
in the epidermis and fibroblasts in the dermis. A number of factors 
secreted from keratinocytes and/or from fibroblasts have been shown to 
be involved in regulating skin pigmentation after UV exposure. NIH 
investigators have previously demonstrated that the less pigmented and 
thicker skin on the palms and soles is regulated by underlying 
fibroblasts in those areas, specifically via a secreted factor (DKK1) 
that modulates Wnt signaling. Now, using microarray analysis to compare 
gene expression patterns in 15 different primary dermal fibroblast 
populations derived from the dorsal trunk skin of three different skin 
phototypes (I, III and VI), these investigators have identified a 
number of genes that differ dramatically in expression. One among them, 
neuregulin 1 (NRG-1), secreted by fibroblasts derived from dark skin, 
effectively increases the pigmentation of melanocytes in tissue culture 
and in an artificial skin model and regulates their growth, suggesting 
it is one of the major factors determining human skin color. NRG-l was 
observed to be highly expressed by fibroblasts derived from darker 
skin. NIH investigators believe that NRG-1 increases the proliferation 
of human melanocytes via the phosphorylation of Akt. These results 
suggest a potential role for NRG-1 in regulating constitutive human 
skin color and perhaps its dysfunction in pigmentary skin diseases. 
Based on these observations, NIH investigators are currently developing 
compositions and methods of modulating pigmentation and proliferation 
of a melanocyte to prevent or treat skin disorders, including skin 
cancer.
    Applications:
     Therapeutics for skin disorders.
     Therapeutics for skin cancer.
    Development Status: Early stage and studies on reconstructed skin 
model and in melanocytes.
    Inventors: Vincent J. Hearing and Wonseon Choi (NCI)
    Related Publications:
    1. Choi W, Wolber R, Gerwat W, Mann T, Hearing VJ. Characterization 
of the influence of fibroblasts on melanocyte function and 
pigmentation. In: Proc. XXth Intl. Pigment Cell Conf., edited by K. 
Jimbow, Bologna, Italy: Medimond, 2008, p. 79-82.
    2. Choi W, Wolber R, Gerwat W, Mann T, Batzer J, Smuda C, Liu H, 
Kolbe L, Hearing VJ. A novel fibroblast-derived melanogenic paracrine 
factor neuregulin-1 (NRG-1) that modulates the constitutive color and 
melanocyte function in human skin. J. Cell Sci. in press, 2010.
    Patent Status: U.S. Provisional Application No. 61/357,846 filed 23 
Jun 2010 (HHS Reference No. E-100-2010/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Suryanarayana Vepa, PhD, J.D.; 301-435-5020; 
vepas@mail.nih.gov.
    Collaborative Research Opportunity: The Center for Cancer Research, 
Laboratory of Cell Biology, is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize the use of NRG-1 (or modifiers of 
its function) to regulate skin pigmentation. Please contact John Hewes, 
PhD at 301-435-3121 or hewesj@mail.nih.gov for more information.

    Dated: August 17, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-20862 Filed 8-20-10; 8:45 am]
BILLING CODE 4140-01-P
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