Federal Register / Vol. 72, No. 41 / Friday, March 2, 2007 / Notices 9539 

Determination 

Based on the foregoing, I hereby 

determine that it is the Government’s 

best interests to approve the use of 

Alternate 1 to the Clause at FAR 52.232–

23 which authorizes incorporation of a 

no-setoff provision. 

Dated: February 22, 2007. 

Daniel J. Frasier, 

Head of the Contracting Activity, Director, 

OAMP, OA, OM, National Institutes of Health. 

[FR Doc. 07–960 Filed 3–1–07; 8:45 am] 

BILLING CODE 4140–01–M 

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 

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-onRegulated 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, podocinrtTA and CMV-tTS, that produce a ‘‘Teton’’ 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; 

tarak@mail.nih.gov. 

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 

(jbkopp@nih.gov) 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; tarak@mail.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 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. 

Applications: Diagnostic test for 

women suffering from infertility or 

irregular menstrual periods; Tool for the 

study of early embryonic development; 


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9540 Federal Register / Vol. 72, No. 41 / Friday, March 2, 2007 / Notices 

Tool for the development of MATERbased 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; 

tarak@mail.nih.gov. 

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 

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 

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. 

Identification and Isolation of the 

Receptor for Pigment EpitheliumDerived Factor (PEDF) 

Description of Technology: This 

application describes and claims 

compositions and methods related to 

PEDF-R, a receptor for pigment 

epithelium-derived factor (PEDF). PEDF 

(aka serpin f1 gene product) is a protein, 

belonging to the serpin superfamily 

with neurotrophic, gliastatic, 

neuronotrophic, antiangiogenic, and 

antitumorigenic properties. However, 

PEDF lacks the characteristic ability of 

serpins to inhibit serine protease 

activity. In particular, the compositions 

and methods described and claimed in 

this application are related to the 

isolation, cloning, expression and 

characterization of a receptor for PEDF, 

PEDF-R. The PEDF-R gene (also known 

as TTS-2.2, iPLA-zeta, ATGL, desnutrin, 

or PNPLA2) is located on chromosome 

11. The sequence of the PEDF-R 

polypeptide is composed of 504 amino 

acids, and shares homology with other 

genes such as for adiponutrin and GS2, 

contains a patatin-like phospholipase 

A2 domain and up to four 

transmembrane regions. PEDF-R 

exhibits a potent phospholipase A2 

activity, binds to PEDF ligands with 

high affinity, and it localizes to plasma 

membranes. An extracellular loop 

region is available for the interactions 

with extracellular PEDF ligand, which 

stimulate the phospholipase activity of 

PEDF-R. The identification of this novel 

PEDF-R gene in the retina for a 

phospholipase-linked membrane 

protein with high affinity for PEDF, 

suggests a molecular pathway by which 

ligand/receptor interaction on the cell 

surface could generate a cellular signal. 

Applications: 

1. Basic research to further elucidate 

the role of PEDF and its receptor in 

signal transduction pathways. 

2. Development of drug screening 

assays to identify agonists and 

antagonists of PEDF activity. 

3. Development of new biological 

molecules to regulate PEDF signaling 

such as monoclonal antibodies and 

chimeric IgG-receptor constructs. 

Development Stage: Information on 

research being conducted in Dr. 

Becerra’s laboratory can be found on the 

Internet at http://www.nei.nih.gov/ 

intramural/protein_struct_func.asp. The 

ability of the receptor or receptortargeted molecules and biologics to be 

used as therapeutics remains the subject 

of early research and development 

efforts. 

Inventors: S. Patricia Becerra (NEI), 

Luigi Notari (NEI), Jorge Laborda 

(CDER/FDA), et al. 

Publications: 

1. The patent application has been 

published as WO 2005/014645 A2 on 17 

Feb 2005. 

2. L Notari et al. Identification of a 

lipase-linked cell membrane receptor for 

pigment epithelium-derived factor. J 

Biol Chem. 2006 Dec 8; 281(49):38022–

38037. 

Patent Status: 

1. U.S. Patent Application No. 10/ 

566,540 filed 16 Oct 2006, entitled 

‘‘PEDF-R Receptor and Uses,’’ is 

pending (HHS Reference No. E–314–

2003/2–US–02). The U.S. Application 

has not been published. Only U.S. 

Patent protection has been sought for 

this technology. There are no foreign 

counterpart patent applications. 

2. PCT/US2004/025560 filed 05 Aug 

2004 and published as WO 2005/014645 

A2 on 17 Feb 2005, now expired (HHS 

Reference No. E–314–2003/2–PCT–01). 

3. U.S. Provisional Application No. 

60/579,177 filed 12 Jun 2004, now 

abandoned (HHS Reference No. E–314–

2003/1–US–01). 

4. U.S. Provisional Application No. 

60/493,713 filed 07 Aug 2003, now 

abandoned (HHS Reference No. E–314–

2003/0–US–01). 


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