[Federal Register: August 4, 2004 (Volume 69, Number 149)]
[Notices]
[Page 47160-47161]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04au04-85]

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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 Sequencing of
Single Nucleic Acid Molecules on a Substrate, Based on High Speed
Parallel Molecular Nucleic Acid Sequencing Method

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

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. Sec.  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 US 60/151,580, filed August 29, 1999; PCT/US00/
23736, filed August 29, 2000 and US 10/070,053, filed June 10, 2002;
entitled ``High Speed Parallel Molecular Nucleic Acid Sequencing'', to
Helicos BioSciences Corporation, having a place of business in
Cambridge, MA. 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 October
4, 2004 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; Email:
ThalhamC@mail.nih.gov; Telephone: 301-435-4507; Facsimile: 301-402-
0220.

SUPPLEMENTARY INFORMATION: The invention relates to a method and
apparatus for DNA sequencing, also known as Two Dye Sequencing (TDS).
This invention is based on Fluorescence Resonance Energy Transfer
(FRET), a technology increasingly in use for

[[Page 47161]]

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 added to the primer 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 sequencing of single nucleic
acid molecules on a substrate'.
    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. Sec.  552.

    Dated: July 28, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 04-17704 Filed 8-3-04; 8:45 am]
BILLING CODE 4140-01-P


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