[Federal Register: January 31, 2005 (Volume 70, Number 19)]
[Page 4880]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[[Page 4880]]



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

ACTION: Notice.


SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37
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.,
Executive Boulevard, Suite 325, Rockville, MD 20852-3804; e-mail:
ThalhamC@mail.nih.gov; telephone: 301-435-4507; facsimile: 301-402-

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,
[FR Doc. 05-1683 Filed 1-28-05; 8:45 am]