[Federal Register Volume 72, Number 103 (Wednesday, May 30, 2007)]
[Notices]
[Pages 30023-30024]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-10354]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Proteomics in Cancer 
Diagnostics and Therapy

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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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: (301) 435-
5019; Facsimile: (301) 402-0220; E-mail: [email protected]. A 
signed confidentiality nondisclosure

[[Page 30024]]

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.
[FR Doc. E7-10354 Filed 5-29-07; 8:45 am]
BILLING CODE 4140-01-P