05-1683. 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 ...

AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

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: [e-mail]; telephone: [phone]; 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.