[Federal Register Volume 72, Number 41 (Friday, March 2, 2007)]
[Notices]
[Pages 9539-9540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-3694]


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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.

Model for Study of Glomerular Disorders: Conditionally-Immortalized 
Mouse Podocyte Cell Line With Tet-on-Regulated Gene Expression

    Description of Technology: Podocytes, cells of the visceral 
epithelium in the kidneys, are a key component of the glomerular 
filtration barrier. As such, they play a vital role in glomerular 
disorders, which are a major cause of chronic kidney disease. Examples 
of these disorders include focal segmental glomerulosclerosis, 
membranous glomerulonephritis, minimal change disease, and diabetic 
nephropathy.
    The inventors have developed a conditionally-immortalized mouse 
podocyte cell line with tightly controlled conditional gene expression. 
The cell line has been conditionally immortalized through the 
introduction of the H-2Kb-tsA58 transgene, which is a temperature-
sensitive mutant of the SV40T antigen. Inducible gene expression is 
tightly controlled through two introduced transgenes, podocin-rtTA and 
CMV-tTS, that produce a ``Tet-on'' system wherein gene expression is 
induced by tetracycline or doxycycline. The combination of the two 
transgenes for Tet-on gene expression has resulted in much tighter 
regulation and lower background expression compared to cells carrying 
the podocin-rtTA transgene alone.
    Applications: Model system for study of glomerular disorders; Model 
system for podocyte cell biology.
    Market: Glomerular disorders are a major cause of chronic kidney 
disease. Approximately 20 to 35 percent of patients requiring renal 
replacement therapy have a glomerular disorder.
    Inventors: Jeffrey B. Kopp (NIDDK) et al.
    Relevant Publication: T Shigehara, C Zaragoza, C Kitiyakara, H 
Takahashi, H Lu, M Moeller, LB Holzman, and JB Kopp. Inducible 
podocyte-specific gene expression in transgenic mice. J Am Soc Nephrol. 
2003 Aug;14(8):1998-2003.
    Patent Status: HHS Reference No. E-049-2007/0--Research Tool.
    Licensing Status: This technology is available as a research tool 
under a Biological Materials License.
    Licensing Contact: Tara L. Kirby, PhD.; 301/435-4426; 
[email protected].
    Collaborative Research Opportunity: The NIDDK Kidney Disease 
Section is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate, or 
commercialize a model system for the study of glomerular disorders. 
Please contact Jeffrey B. Kopp, MD, by phone (301/594-3403), fax (301/
402-0014) or e-mail ([email protected]) for more information.

Latrophilin 3, a Gene Involved in Attention Deficit Hyperactivity 
Disorder

    Description of Technology: Attention Deficit Hyperactivity Disorder 
(ADHD) is the most common behavioral disorder in childhood, and is 
estimated to affect three to five percent of people in the United 
States, both children and adults. Treatment typically involves a 
combination of behavior modification, educational interventions, and 
medication. There are a variety of medications available for treatment 
of ADHD; the most frequently prescribed drugs are stimulants or 
antidepressants. However, currently there is no way to tell in advance 
which medication will be most helpful for a particular individual.
    The inventors have identified haplotypes of latrophilin 3 (LPHN3) 
that increase susceptibility for development of ADHD. LPHN3 is a G-
protein coupled receptor that is specifically expressed in the brain's 
mesolimbic system, which is associated with ADHD. The invention 
describes methods of identifying LPHN3 haplotypes in an individual for 
determining susceptibility for development of ADHD. Identification of 
LPHN3 haplotypes in an ADHD-affected individual may also make possible 
individualized drug treatment plans.
    Applications: Identify individuals with enhanced susceptibility for 
ADHD; Use LPHN3 haplotype information to design individualized 
treatments.
    Inventors: Maximillian Muenke (NHGRI), Mauricio Arcos-Burgos 
(NHGRI), and F. Xavier Castellanos (NIMH).
    Patent Status: U.S. Provisional Application No. 60/850,972 filed 11 
Oct 2006 (HHS Reference No. E-312-2006/0-US-01).
    Licensing Status: Available for exclusive or nonexclusive 
licensing.
    Licensing Contact: Tara Kirby, PhD.; 301/435-4426; 
[email protected].

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;

[[Page 9540]]

Tool for the development of MATER-based contraceptives.
    Market: Approximately 10% of women of reproductive age experience 
infertility, and approximately 5% per year experience menstrual 
irregularity.
    Development Status: Established research test, ready for additional 
clinical research and commercial development.
    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.
    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.
    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.
    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.
    Patent Status:
    1. PCT Application No. PCT/US01/10981 filed 04 Apr 2001, which 
published as WO02/032955 on 25 Apr 2002 (HHS Reference No. E-239-2000/
0-PCT-02).
    2. U.S. Application No. 10/399,443 filed 16 Apr 2003 (allowed) (HHS 
Reference No. E-239-2000/0-US-03).
    3. U.S. Application No. 11/586,160 filed 24 Oct 2006 (HHS Reference 
No. E-239-2000/0-US-08).
    4. U.S. Application No. 11/586,075 filed 24 Oct 2006 (HHS Reference 
No. E-239-2000/0-US-09).
    5. U.S. Application No. 10/677,943 filed 01 Oct 2003 (allowed) (HHS 
Reference No. E-239-2000/1-US-02).
    6. Foreign counterparts pending in Australia, Canada, Europe, and 
Japan.
    Licensing Availability: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Tara L. Kirby, Ph.D.; 301/435-4426; 
[email protected].

    Dated: February 26, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-3694 Filed 3-1-07; 8:45 am]
BILLING CODE 4140-01-P