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###### Department of Health and Human Services

###### National Institutes of Health 

# 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 Epithelium-Derived 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 receptor-targeted 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).                          ( print page 9541)    

*Biological Materials Availability:*                     Biological materials related to this technology are not available at this time.                 

*Licensing Availability:*                     This application is available for license on a non-exclusive or exclusive basis.                 

*Licensing Contact:*                     Susan S. Rucker; 301/435-4478; e-mail:                     *ruckersu@mail.nih.gov*.                 

## Genes Expressed in Prostate Cancer and Methods of Use 

*Description of Technology:*                     This invention is a novel gene, called New Gene Expressed in Prostate (NGEP). This gene appears to be expressed only in human prostate and prostate cancer. This gene has two known splice variants of significantly different size. The shorter splice variant encodes a cytoplasmic protein, while the longer splice variant encodes a plasma membrane protein, which has been detected on the plasma membrane of human cancer cells.                 

This patent application contains claims to the polypeptide, NGEP, nucleotides encoding NGEP, antibodies that bind NGEP polypeptides, and methods of using these polypeptides, polynucleotides, and antibodies. 

The presence of the protein on the cell surface and the selective expression in prostate and prostate cancer make this a potential target for prostate cancer diagnostics and therapeutics. Potential therapeutics could be gene-based, vaccines, antibodies, or immunoconjugates. 

*Inventors:*                     Ira Pastan, Tapan Bera, and Byungkook Lee (NCI.)                 

*Publications:*

1. S Das et al. NGEP, a prostate-specific plasma membrane protein that promotes the association of LNCaP cells. Cancer Res. 2007 Feb 15; 67(4):1594-1601. 

2. TK Bera et al. NGEP, a gene encoding a membrane protein detected only in prostate cancer and normal prostate. Proc Natl Acad Sci USA. 2004 Mar 2; 101(9):3050-3064. 

*Patent Status:*

1. U.S. Provisional Application No. 60/461,399 filed 08 Apr 2003 (HHS Reference No. E-148-2003/0-US-01).

2. PCT Application No. PCT/US04/10588 filed 05 Apr 2004, which published as WO 2004/092213 on 28 Oct 2004 (HHS Reference No. E-148-2003/0-PCT-02).

3. U.S. Patent Application No. 10/552,515 filed 06 Oct 2005 (HHS Reference No. E-148-2003/0-US-03).

*Licensing Status:*                     Available for non-exclusive licensing.                 

*Licensing Contact:*                     Jesse S. Kindra, J.D.; 301/435-5559;                     *kindraj@mail.nih.gov*.                 

Dated: February 22, 2007. 

Steven M. Ferguson, 

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

[FR Doc. E7-3695 Filed 3-1-07; 8:45 am] 

BILLING CODE 4140-01-P