[Federal Register Volume 70, Number 19 (Monday, January 31, 2005)]
[Notices]
[Page 4880]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1683]



[[Page 4880]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Commercializing 
Instruments, Reagents and Related Products Used for Template-Dependent 
Sequencing-by-Synthesis of Nucleic Acids at the Single Molecule Level, 
Wherein a Polymerase Carries the Donor Label

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), 
Department of Health and Human Services, is contemplating the grant of 
an exclusive license to practice the invention embodied in Patent 
Applications U.S. 60/151,580, filed August 29, 1999; PCT/US00/23736, 
filed August 29, 2000 and U.S. 10/070,053, filed June 10, 2002; 
entitled ``High Speed Parallel Molecular Nucleic Acid Sequencing'', to 
VisiGen Biotechnologies, Inc., having a place of business in Houston, 
Texas. The patent rights in this invention have been assigned to the 
United States of America.

DATES: Only written comments and/or application for a license that are 
received by the NIH Office of Technology Transfer on or before April 1, 
2005, will be considered.

ADDRESSES: Requests for a copy of the patent application, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Cristina Thalhammer-Reyero, Ph.D., M.B.A., 
Office of Technology Transfer, National Institutes of Health, 6011 
Executive Boulevard, Suite 325, Rockville, MD 20852-3804; e-mail: 
[email protected]; telephone: 301-435-4507; facsimile: 301-402-
0220.

SUPPLEMENTARY INFORMATION: The invention relates to a method and 
apparatus for DNA and RNA sequencing, also known as Two Dye Sequencing 
(TDS). This invention is based on Fluorescence Resonance Energy 
Transfer (FRET), a technology increasingly in use for several molecular 
analysis purposes. In particular, the method consists of: (1) 
Attachment of engineered DNA polymerases labeled with a donor 
fluorophore to the surface (chamber) of a microscope field of view, (2) 
addition to the chamber of DNA with an annealed oligonucleotide primer, 
which is bound by the polymerase, (3) further addition of four 
nucleotide triphosphates, each labeled on the base with a different 
fluorescent acceptor dye, (4) excitation of the donor fluorophore with 
light of a wavelength specific for the donor but not for any of the 
acceptors, resulting in the transfer of the energy associated with the 
excited state of the donor to the acceptor fluorophore for a given 
nucleotide, which is then radiated via FRET, (5) identification of the 
nucleotides most recently incorporated into the complementary nucleic 
acid strand by recording the fluorescent spectrum of the individual dye 
molecules at specific locations in the microscope field, and (6) 
converting the sequential spectrum into a DNA sequence for each DNA 
molecule in the microscope field of view.
    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 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.
    The field of use may be limited to ``Commercializing Instruments, 
Reagents and Related Products Used for Template-Dependent Sequencing-
by-Synthesis of Nucleic Acids at the Single Molecule Level, wherein a 
Polymerase Carries the Donor Label.''
    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: January 21, 2005.
Mark L. Rohrbaugh,
Director, Office of Technology Transfer, National Institutes of Health.
[FR Doc. 05-1683 Filed 1-28-05; 8:45 am]
BILLING CODE 4140-01-P