[Federal Register Volume 76, Number 150 (Thursday, August 4, 2011)]
[Notices]
[Pages 47217-47218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-19817]


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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.

CDK4-Transformed Mouse Podocytes Useful for Studying Glomerular 
Diseases

    Description of Technology: Podocytes, cells of the visceral 
epithelium in the kidneys, are a key component of the glomerular 
filtration barrier. Podocyte damage and loss contribute to the 
initiation of glomerular diseases. Cyclin-dependent kinase 4 (CDK4), a 
catalytic subunit of the cyclin D-CDK4 serine/threonine kinase complex, 
is a critical regulator of the cell cycle. Recent studies showed that 
cells immortalized with CDK4 are useful to study pathophysiology. NIH 
investigators have generated mouse podocytes transformed with CDK4 as a 
nonviral immortalizing gene. These transformed podocytes show podocyte 
characteristics and express podocyte markers. Furthermore, confluent 
CDK4-podocyte cultures show higher levels of gene expression for 
multiple podocyte differentiation genes compared with subconfluent or 
lower density culture.
    Development Stage:
     Early-stage.
     Pre-clinical.
     In vitro data available.
    Potential Commercial Applications:
     Model system for study of glomerular disorders.
     Useful tools to study podocyte biology.
    Competitive Advantage: Better model system to study podocyte 
structure and function.
    Inventors: Drs. Toru Sakairi and Jeffrey B. Kopp (NIDDK).
    Publication: Sakairi T, et al. Cell-cell contact regulates gene 
expression in CDK4-transformed mouse podocytes. Am J Physiol Renal 
Physiol. 2010 Oct;299(4):F802-809. [PMID: 20668098].
    Intellectual Property: HHS Reference No. E-287-2010/0--Research 
Tool (Materials available for licensing: CDK4 podocytes). Patent 
protection is not being pursued for this technology.
    Related Technology: HHS Reference No. E-049-2007/0--Model for Study 
of Glomerular Disorders: Conditionally-Immortalized Mouse Podocyte Cell 
Line with Tet-on-Regulated Gene Expression (Dr. Jefferey B. Kopp, 
NIDDK).
    Licensing Contact: Suryanarayana (Sury) Vepa, PhD; 301-435-5020; 
[email protected].

Conditionally Immortalized Human Podocyte Cell Lines

    Description of Technology: Podocytes, cells of the visceral 
epithelium in the kidneys, are a key component of the glomerular 
filtration barrier. Podocyte damage and loss contribute to the 
initiation of glomerular diseases. NIH investigators recently 
established long-term urinary cell cultures from two patients with 
focal segmental glomerulosclerosis and two healthy volunteers, via 
transformation with the thermosensitive SV40 large T antigen (U19tsA58) 
together with human telomerase (hTERT). Characterization of randomly 
selected clonal cell lines from each human subject showed mRNA 
expression for the podocyte markers synaptopodin, nestin, and CD2AP in 
all clones. Podocin mRNA was absent from all clones. The expression of 
nephrin, Wilms tumor 1 (WT1), and podocalyxin mRNA varied among the 
clones, which may be due to transformation and/or cloning. These novel 
human urine-derived podocyte-like epithelial cell lines (HUPECs) 
generated from urine of patients and healthy volunteers will be useful 
to study podocyte cell biology.
    Development Stage:
     Early-stage.
     Pre-clinical.
     In vitro data available.
    Potential Commercial Applications:
     Model system for study of glomerular disorders.
     Useful tools to study podocyte biology.
    Competitive Advantage: These podocyte-like cells are unique and 
novel compared to the currently available podocyte cells because these 
are obtained from individuals with glomerular disease.
    Inventors: Drs. Toru Sakairi and Jeffrey B. Kopp (NIDDK).
    Publication: Sakairi T, et al. Conditionally immortalized human 
podocyte cell lines established from urine. Am J Physiol Renal Physiol. 
2010 Mar;298(3):F557-67. [PMID: 19955187]
    Intellectual Property: HHS Reference No. E-252-2010/0--Research 
Tool. Patent protection is not being pursued for this technology.
    Related Technologies:
     HHS Reference No. E-049-2007/0--Model for Study of 
Glomerular Disorders: Conditionally-Immortalized Mouse Podocyte Cell 
Line with Tet-on-Regulated Gene Expression (Dr. Jefferey B. Kopp, 
NIDDK).
     HHS Reference No. E-287-2010/0--CDK4-Transformed Mouse 
Podocytes Useful for Studying Glomerular Diseases (Drs. Toru Sakairi 
and Jeffrey B. Kopp, NIDDK)
    Licensing Contact: Suryanarayana (Sury) Vepa, PhD; 301-435-5020; 
[email protected].

An In-Vitro Cell System Useful For Identification of ROR[gamma] 
Antagonists

    Description of Technology: The retinoid-related orphan receptors 
alpha, beta and gamma (ROR[alpha], [beta] and [gamma], also referred to 
as NR1F1, 2 and 3, respectively) comprise a distinct subfamily of 
nuclear receptors. Study of ROR-deficient mice has implicated RORs in 
the regulation of a number of biological processes and revealed 
potential roles for these proteins in several pathologies. NIH 
investigators have developed an in-vitro system using CHO cells stably 
expressing a TET-On expression vector regulating ROR[gamma] and a RORE-
Luciferase reporter. This system

[[Page 47218]]

allows inducible expression of ROR[gamma] upon addition of doxycycline. 
Upon its induction ROR[gamma] binds to the RORE in the luciferase 
reporter plasmid and induces luciferase. This system can be used to 
identify ROR[gamma] antagonists. This system has been tested 
successfully in 1536-well plate high throughput analysis.
    Potential Commercial Applications: Identification of therapeutic 
compounds to treat asthma, inflammation, and various autoimmune 
diseases such as osteoarthritis, multiple sclerosis.
    Competitive Advantages: Novel and unique system to screen and 
identify chemical and drugs for their ROR[gamma] antagonistic activity.
    Development Stage:
     Early-stage.
     Pre-clinical.
     In vitro data available.
    Inventors: Drs. Yukimasa Takeda and Anton M. Jetten (NIEHS).
    Publications:
    1. Jetten AM. Retinoid-related receptors (RORs): Critical roles in 
development, immunity, circadian rhythm, and cellular metabolism. Nucl 
Recept Signal. 2009;7:1-32. [PMID: 19381306].
    2. Yang XO, et al. T helper 17 lineage differentiation is 
programmed by orphan receptors ROR alpha and ROR gamma. Immunity 2008 
Jan;28(1):29-39. [PMID: 18164222].
    3. Kurebayashi S, et al. Retinoid-related orphan receptor gamma 
(RORgamma) is essential for lymphoid organogenesis and controls 
apoptosis during thymopoiesis. Proc Natl Acad Sci USA. 2000 Aug 
29;97(18):10132-10137. [PMID:10963675].
    Intellectual Property: HHS Reference No. 253-2010/0--Research Tool. 
Patent protection is not being pursued for this technology.
    Related Technology: HHS Reference No. E-222-2009/0--RORgamma (RORC) 
Deficient Mice Which Are Useful for the Study of Lymph Node 
Organogenesis and Immune Responses (Dr. Anton M. Jetten, NIEHS).
    Licensing Contact: Suryanarayana (Sury) Vepa, PhD; 301-435-5020; 
[email protected].
    Collaborative Research Opportunity: The NIEHS, Laboratory of 
Respiratory Biology, Cell Biology Group, is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize retinoid-
related orphan receptors (RORs) function in chronic diseases. For 
collaboration opportunities, please contact Elizabeth M. Denholm, PhD 
at [email protected].

    Dated: July 27, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-19817 Filed 8-3-11; 8:45 am]
BILLING CODE 4140-01-P