E7-10354. Prospective Grant of Exclusive License: Proteomics in Cancer Diagnostics and Therapy

AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

SUMMARY:

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), a federal agency under the Department of Health and Human Services, is contemplating the grant of an exclusive worldwide license to practice the invention embodied in HHS Ref. No. E-261-1998 “Methods and Devices for Isolation and Analysis of Cellular Protein Content;” U.S. Patent 6,969,614; and E-039-2003/0 “Combinatorial Therapy for Protein Signaling Diseases,” U.S. Patent Application No. 10/798,799 filed March 10, 2004; to Theranostics Health, LLC, a Limited Liability Company formed under the laws of the state of Delaware and having a principle place of business in Rockville, Maryland. The United States of America is the assignee of the patent rights in the above inventions.

The contemplated exclusive license may be granted a field limited to proteomic diagnostics for cancer requiring regulatory approval.

DATES:

Only written comments and/or applications for a license received by the NIH Office of Technology Transfer on or before July 30, 2007 will be considered.

ADDRESSES:

Requests for a copy of the patent applications, inquiries, comments and other materials relating to the contemplated license should be directed to: Michael A. Shmilovich, Esq., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: [phone]; Facsimile: [phone]; E-mail: [e-mail]. A signed confidentiality nondisclosure agreement may be required to receive copies of the patent applications.

SUPPLEMENTARY INFORMATION:

The patent applications intended for licensure disclose and/or cover the following:

E-039-2003 “Combinatorial Therapy for Protein Signaling Diseases”

The invention is drawn to methods for individualizing therapy based on information obtained concerning deranged signaling pathways that cause disease. The invention includes the use of protein microarrays to detect the deranged signaling pathways that are specific for the subject's disease. The invention covers the use of combination therapy targeting multiple points in the protein network. The invention is based, in part, on the unexpected discovery that treatment of interconnected nodes in a protein signaling pathway can provide a synergistic improvement in therapeutic efficacy at reduced toxicity. For example, a protein signaling network of a diseased cell (e.g., colon cancer) is analyzed and the information obtained from the analysis is used to select at least two drugs whose targets are interconnected within the protein signaling network.

E-261-1998 “Methods and Devices for the Isolation and Analysis of Cellular Protein Content”

The invention is a comprehensive Laser Capture Microdissection (LCM) method for determining protein characteristics of a sample tissue cell to quantitatively discern and compare the protein content of healthy cells versus diseased cells. The tissue source of a tumor metastasis is available from the acquisition of this information. The focus in molecular biology is moving from genomics to proteomics, the study of variations in the protein levels of cells, caused by the state of the cell itself, whether healthy or unhealthy. The invention provides a method for using new and innovative methods for cell analysis. Previous methods, such as UV-laser ablation of unwanted tissue regions and oil well isolation of tissue cells, were complex, labor intensive, and did not utilize protein stabilizers. Direct comparisons between healthy cells and tumor cells were not made due to limitations of the methods. The new method consists of first using the new LCM method to obtain pure cell populations. Next, the sample is placed in a device so that the proteins are solubilized. Then the immunological and biochemical methods and subsequent analyses are performed. These techniques include (but are not limited to) immunoassays, 1D and 2D gel electrophoresis characterization, Western blotting, Matrix Assisted Laser Desorption Ionization/Time of Flight (MALDI/TOF) and Surface Enhanced Laser Desorption Ionization Spectroscopy (SELDI), Protein Arrays and Phosphoprotein Fingerprinting. The methods listed above allow for the direct comparison of both qualitative and quantitative tissue content of healthy and diseased cells, from the same sample. The sequential method of using LCM, protein isolation, analysis and comparison is superior to existing methods because the location of the tumor can be found simply using immunohistochemistry, and protein characteristics, such as amino acid sequence and binding ability can also be discerned. In addition, by using protein fingerprinting, the source of the tumor metastasis is found effectively. The invention has been tested extensively with the different methods listed above. This technology can be used in hospitals and research pathology labs for quantitative measure of protein characteristics of cells.

The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within sixty (60) days from the date of this published notice, NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.

Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

Dated: May 21, 2007.

Steven M. Ferguson,

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