01-27750. Government-Owned Inventions; Availability for Licensing

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

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 contacting Dale D. Berkley, Ph.D., J.D., at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: [phone] ext. 223; fax: [phone]; e-mail: [e-mail]. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.

Side Exit Guiding Catheter for Percutaneous Endomyocardial Injection

Robert Lederman (NHLBI)

DHHS Reference No. E-108-01/0 filed 10 Aug 2001

The invention is a device for delivering a therapeutic or diagnostic agent to the heart using a flexible catheter having a non-concentric guide wire to facilitate percutaneous delivery of the catheter across the aortic valve into the left ventricular cavity. The catheter has a side port through which the therapeutic or diagnostic can be delivered and, in particular, by which septal ablation for the treatment of conditions such as hypertrophic cardiomyopathy can be accomplished. This catheter is able to “turn around” on itself to treat areas of the myocardium immediately underneath the aortic valve through which the catheter enters. The side port can be used to introduce a needle, laser or radiofrequency probe to perform an endomyocardial ablation procedure.

Methods and Devices for Isolation and Analysis of Cellular Protein Content

Lance A. Liotta, Emmanuel P. Petricoin, Nicole Simone, Michael Emmert-Buck (NCI)

U.S. Patent Application No. 60/120,288 filed February 16, 1999; PCT Application No. PCT/US00/04023 filed February 16, 2000; U.S. Patent Application No. 09/913,667 filed August 16, 2001

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.

Isolation of Cellular Material Under Microscopic Visualization

Liotta et al. (NCI)

U.S. Patent 5,843,644 issued December 1, 1998; U.S. Patent 5,843,657 issued December 1, 1998; U.S. Patent 6,010,888 issued January 4, 2000; U.S. Patent 6,204,030 issued March 20, 2001; Serial No. 09/765,937 filed January 18, 2001

This Laser Capture Microdissection (LCM) invention is a method for directly extracting cellular material from a tissue sample using a laser beam to focally activate a special transfer film that bonds specifically to cells identified and targeted by microscopy within the tissue section. The transfer film with the bonded cells is then lifted off the thin tissue section, leaving all unwanted cells (which would contaminate the molecular purity of subsequent analysis) behind. The transparent transfer film is applied to the surface of the tissue section. Under the microscope, the diagnostic pathologist or researcher views the thin tissue section through the glass slide on which it is mounted and chooses microscopic clusters of cells to study. When the cells of choice are in the center of the field of view, the operator pushes a button, which activates a near IR laser diode integral with the microscope optics. The pulsed laser beam activates a precise spot on the transfer film immediately above the cells of interest. At this precise location the film melts and fuses with the underlying cells of choice. When the film is removed, the chosen cell(s) are tightly held within the focally expanded polymer, while the rest of the tissue is left behind. This allows multiple homogeneous samples within the tissue section or cytological preparation to be targeted and pooled for extraction of molecules and analysis. This technology is available for licensing on a non-exclusive basis.

Dated: October 29, 2001.

Jack Spiegel,

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