[Federal Register Volume 66, Number 215 (Tuesday, November 6, 2001)]
[Notices]
[Pages 56110-56111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-27750]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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: 301/496-7735 ext. 223; fax: 301/402-
0220; e-mail: [email protected]. 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

[[Page 56111]]

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.
[FR Doc. 01-27750 Filed 11-5-01; 8:45 am]
BILLING CODE 4140-01-P