Government-Owned Inventions; Availability for Licensing, 51823-51824 [2010-20862]
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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
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15:31 Aug 20, 2010
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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
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• 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.
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• 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]
-----------------------------------------------------------------------
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