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                -                       the agency or agencies that issued and signed a document                    
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###### Department of Health and Human Services

###### National Institutes of Health

# AGENCY:

National Institutes of Health, Public Health Service, DHHS. 

      ( print page 26872)    

# ACTION:

Notice.

# SUMMARY:

The inventions listed below are owned by agencies 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.

## Discovery of Proteins That Are Aberrantly Expressed in Laser Capture Microdissected Human Solid Tumors

Emmanuel Petricoin (FDA), Lance Liotta (NCI), Michael Emmert-Buck (NCI), Yingming Zhao (EM) 

DHHS Reference No. E-083-01/0 filed 01 February 2001 

*Licensing Contact:*                     Matthew Kiser; 301/496-7735 ext. 224; e-mail: kiserm@od.nih.gov

                    The post-genomic era has created a need for a direct method to monitor the levels of expressed proteins in developing, diseased or genetically altered tissues. Direct monitoring of tissue has proven difficult because of the heterologous, three-dimensional structure. Prior methods for extracting and analyzing biomolecules from tissue subpopulations were complicated, labor intensive, and did not utilize protein stabilizers. There has been no way to directly compare, without the danger of cross-contamination, the spectrum of proteins contained in normal cells with the proteins in tumor cells in a single tissue. Many of the hypotheses regarding altered protein levels in tumor cells have been based on work on cell lines and their viability in culture media. The amount and type of protein expressed by cells in the native tissue environment can be quite different than that of cultured cells. Thus, the need exists for a direct means of measuring protein levels to obtain results reflecting                     *in vivo*                     conditions. This technology supplies the means to obtain                     *in vivo*                     expression levels.                

The present invention describes devices and methods for performing protein analysis on laser capture microdissected cells, which facilitate proteomic analysis on cells of different populations. The protein content can be determined by any of the standard analytical techniques: immunoassays, 1D and 2D electrophoresis, Western blotting, LCQ-MS, MALDI/TOF, and SELDI. Specific applications include, but are not limited to, analysis of normal versus malignant cells, differential expression determination of cellular proteins at various disease states (e.g. normal, pre-malignant, tumor), and comparison of expression levels of different types of cancers (e.g. esophageal, prostate, breast, ovarian, lung, and colon cancer).

A second embodiment of this technology provides specific examples of tumor or tumor-stage linked protein “fingerprints” and specific proteins identified from these “fingerprints” as being aberrantly expressed in specific diseased cell types. Furthermore, methods of using these “fingerprints”, sub-sets thereof, and individual proteins in the diagnosis, prognosis, treatment, treatment selection, and drug development for disease are provided.

## Production and Use of Anti-Dorsalizing Morphogenetic Protein 

M. Moos Jr., M. Krinks, S. Wang (FDA) 

Serial No. 08/335,583 filed 08 Nov 1994, now US Patent 5,693,779 issued 02 Dec 1997 

*Licensing Contact:*                     Susan S. Rucker; 301/496-7056 ext. 245; e-mail: ruckers@od.nih.gov

This patent relates to the identification, isolation and cloning of the cDNA which encodes a protein, Anti-Dorsalizing Morphogenetic Protein-1 (ADMP-1). ADMP-1 is related to the bone morphogenetic proteins and is a member of the TGF beta superfamily. ADMP-1 is involved in the down-regulation of multiple factors related to tissue proliferation and may be useful in inhibiting inappropriate tissue proliferation such as that associated with psoriasis or melanoma.

This work has been published, in part, at Moos, M, et al. “Anti-dorsalizing morphogenetic protein is a novel TGF-beta homolog expressed in the Spemann organizer” Development 121(12):4293-301 (Dec 1995).

Dated: May 7, 2001. 

Jack Spiegel, 

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

[FR Doc. 01-12126 Filed 5-14-01; 8:45 am] 

BILLING CODE 4140-01-P