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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.

## Polyclonal Antibodies Useful for the Detection of Vangl1 and Vangl2 Proteins Which Play a Role in Developmental Processes

*Description of Technology:*                     Vangl1 (Van Gogh like 1) and Vangl2 (Van Gogh like 2) are two core proteins mediating establishment of Planar Cell Polarity (PCP), which refers to the polarity of epithelial cells within a plane orthogonal to their apical-basal axis. Disruption of core PCP proteins leads to many developmental defects, including open neural tube, misorientation of sensory hair cells in the inner ear, polycystic kidney disease and skeletal deformations. In humans, mutations in Vangl1 and Vangl2 have been identified in patients with neural tube defects, such as spina bifida, the most common permanently disabling birth defect in the United States. NHGRI researchers have recently generated rabbit polyclonal antibodies against Vangl1 and phosphorylated Vangl2 proteins that are suitable for endogenous Vangl1 and Vangl2 detection.                

*Potential Commercial Applications:*                     Anti-Vangl1 and Vangl2 antibodies could be used in the development of diagnostic and therapeutic treatments for PCP-related developmental defects.                

*Development Stage:*
      - Pre-clinical.
      - In vitro data available.

*Inventors:*                     Yingzi Yang and Bo Gao (NHGRI); Yingzi Yang and Hai Song (NHGRI).                

*Publications:*

1. Gao B, et al. Wnt signaling gradients establish planar cell polarity by inducing Vangl2 phosphorylation through Ror2. Dev Cell. 2011 Feb 15;20(2):163-176. [PMID 21316585]

2. Song H, et al. Planar cell polarity breaks bilateral symmetry by controlling ciliary positioning. Nature. 2010 Jul 15;466(7304):378-382. [PMID 20562861]

*Intellectual Property:*                     HHS Reference Nos. E-135-2011/0 and E-136-2011/0—Research Tools. Patent protection is not being pursued for these technologies.                

*Licensing Contact:*                     Suryanarayana (Sury) Vepa, Ph.D., J.D.; 301-435-5020;                     *vepas@mail.nih.gov.*

## Novel Biomarkers for Alcohol-Induced Liver Disease (ALD)

*Description of Technology:*                     Alcohol-induced liver disease (ALD) is a leading cause of non accident-related deaths worldwide. ALD is reversible if identified in the early stages, but early diagnosis is difficult with existing tools. One problem associated with developing a new diagnostic tool is the genetic background associated heterogeneity in physiological responses to chronic alcohol consumption. The inventors of the present technology have solved this problem and have discovered background-independent novel biomarkers for ALD. In the current studies, the inventors generated two genetically distinct lines of PPARalpha-null mice and evaluated the levels of urine metabolites after alcohol exposure. The inventors have identified indole-3-lactic acid and phenyllactic acid as putative biomarkers for ALD. Indole-3-lactic acid and phenyllactic acid levels were significantly elevated in both lines of PPARalpha-null mice after two to three months of alcohol administration. The inventors had identified indole-3-lactic acid and phenyllactic acid to be background independent markers for ALD.                

*Potential Commercial Applications:*                     Useful for early non-invasive screening of ALD in large numbers of subjects irrespective of their genetic background.                

*Competitive Advantages:*
      - Easily adaptable for the development of highly sensitive spectroscopy-based assay kits.
      - Amenable for the development of high-throughput mass spectrometric analysis of urine samples to detect early onset of ALD.

*Development Stage:*
      - Early-stage.
      - Pre-clinical.
      - In vivo data available (animal).

*Inventors:*                     Soumen Kanti Manna and Frank J. Gonzalez (NCI).                

*Publications:*

1. Manna SK, et al. UPLC-MS-based urine metabolomics reveals indole-3-lactic acid and phenyllactic acid as conserved biomarkers for alcohol-induced liver disease in the Ppara-null mouse model. J Proteome Res. 2011 Sep 2;10(9):4120-4133. [PMID 21749142]

                    2. Manna SK, et al. Identification of noninvasive biomarkers for alcohol-induced liver disease using urinary metabolomics and the Ppara-null                           ( print page 11138)                        mouse. J Proteome Res. 2010 Aug 6;9(8):4176-4188. [PMID 20540569]                

*Intellectual Property:*                     HHS Reference No. E-172-2011/0—U.S. Provisional Application No. 61/507,573 filed 13 Jul 2011.                

*Licensing Contact:*                     Suryanarayana (Sury) Vepa, Ph.D., J.D.; 301-435-5020;                     *vepas@mail.nih.gov.*

## Biomarkers for Niemann-Pick Disease Type C and Related Disorders of Oxysterol Accumulation

*Description of Technology:*                     Niemann-Pick disease type C (NPC) is a lethal lysosomal storage disorder characterized by liver disease and progressive neurodegeneration. Lysosomal storage is impaired by oxidized cholesterol (oxysterol) accumulation. Presenting signs and symptoms are nonspecific, and the diagnosis is frequently difficult and delayed. The inventors established a rapid ELISA assay to evaluate biomarker levels in serum. The ELISA assay tests a novel combination of two biomarkers significantly elevated in NPC patients, Cathepsin D and Galectin-3. Other diseases can cause oxysterol accumulation, including other lysosomal storage diseases, cholesterol trafficking diseases, and neurodegenerative diseases. At least for the lysosomal storage diseases, the combination of elevated Cathepsin D and Galectin-3 appears specific for NPC. Cathepsin D is a lysosomal enzyme involved in protein degradation. The secreted Galectin-3 is mostly known as a chemoattractant for immune cells.                

*Potential Commercial Applications:*
      - NPC diagnosis.
      - NPC patient disease progression monitoring.
      - NPC therapeutic efficacy testing in Clinical Trials.
      - Application of above methods to related diseases.

*Competitive Advantages:*
      - Fast and non-invasive ELISA serum assay.
      - Potential for high sensitivity.
      - Cost effective.

*Development Stage:*
      - Pilot.
      - Early-stage.
      - In vivo data available (animal).
      - In vivo data available (human).

*Inventor:*                     Forbes D. Porter (NICHD).                

*Intellectual Property:*                     HHS Reference No. E-302-2011/0—U.S. Provisional Application No. 61/576,062 filed 15 Dec 2011.                

*Licensing Contact:*                     Betty B. Tong, Ph.D.; 301-594-6565;                     *tongb@mail.nih.gov.*

 Dated: February 21, 2012. 

Richard U. Rodriguez,

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

[FR Doc. 2012-4310 Filed 2-23-12; 8:45 am]

BILLING CODE 4140-01-P