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Notice

Prospective Grant of Exclusive License: Non-Invasive Diabetes Diagnostics

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Information about this document as published in the Federal Register.

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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), 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. Nos. E-091-1998 “Method For Non-Invasive Identification Of Individuals At Risk For Diabetes;” U.S. Patent No. 6,721,583; and HHS Ref. No. E-079-1998 “Optical Fiber Probe and Methods for Measuring Optical Properties;” U.S. Patent No. 6,678,541; to Eyelight Diagnostics, Inc., a corporation formed under the laws of the state of Connecticut and having a principle place of business therein. The United States of America is the assignee of the patent rights in the above inventions.

The contemplated exclusive license may be granted in a field of use limited to devices and integrated systems for non-invasive ocular clinical diagnostics for diabetes.

DATES:

Only written comments and/or applications for a license received by the NIH Office of Technology Transfer on or before January 12, 2009 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: shmilovm@mail.nih.gov. A signed confidentiality nondisclosure agreement may be required to receive copies of the patent applications. Start Printed Page 66917

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SUPPLEMENTARY INFORMATION:

The patent applications intended for licensure disclose and/or cover the following:

E-079-1998 “Method For Non-Invasive Identification of Individuals at Risk for Diabetes”

The invention describes a fiber optic probe assembly and methods of using the probe for both medical diagnostic and industrial applications. This device consists of a single light delivery source in combination with an array of light detector fibers. In use, the assembly has the ability to simultaneously acquire data from a variety of source/detector separations. The entire data set is saved in a format, for use with an appropriate mathematical model of light transport, to deduce optical properties of the test sample. The properties may be associated with the technique known as “optical biopsy” for diagnostic purposes. Industrial applications where a turbid mixture requires analysis can also employ the disclosed device and methods. Examples of some industrial uses would be manufacturing processes associated with pharmacology, food processing, and emulsion technology.

E-091-1998 “Optical Fiber Probe and Methods for Measuring Optical Properties”

The invention pertains to a non-invasive technique for the detection of ocular pathologies, including molecular changes associated with diabetes. Raman spectra emitted from the eye that is subject to a laser probe provides information regarding early markers of diabetes or diabetes-induced ocular pathologies. The invention compares spectra taken from the subject under study to spectra from a normal subject. Multivariate statistical methods are used to obtain predictive information based on the detected spectra, and to diagnose or predict the onset or stage of progression of diabetes-induced ocular pathology.

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.

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Dated: November 3, 2008.

Richard U. Rodriguez,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

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[FR Doc. E8-26788 Filed 11-10-08; 8:45 am]

BILLING CODE 4140-01-P