[Federal Register Volume 67, Number 111 (Monday, June 10, 2002)]
[Notices]
[Pages 39729-39730]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-14440]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: ``High Throughput 
Infrared Spectroscopy''

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

ACTION: Notice.

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SUMMARY: This is a public 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 worldwide to practice the

[[Page 39730]]

inventions embodied in: U.S. Patent Application Nos. 60/092,769 filed 
July 14, 1998; 60/095,800 filed August 7, 1998; 09/353,325 filed July 
14, 1999 and PCT Application No. PCT/US99/15900 filed July 14, 1999 
(``High Throughput Infrared Spectroscopy'' by Neil Lewis); U.S. Patent 
Application Nos. 60/120,859 filed February 19, 1999; 60/143,801 filed 
July 14, 1999; 09/507,293 filed February 18, 2000 and PCT Application 
No. PCT/US00/19271 filed July 14, 2000 (``High Volume On Line 
Spectroscopic Composition Testing of Manufactured Pharmaceutical Dosage 
Units'' by Neil Lewis, David Strachan and Linda Kidder), to Spectral 
Dimensions, Inc., having a place of business in Olney, Maryland.
    The United States of America is an assignee to the patent rights of 
these inventions. The field of use for the contemplated exclusive 
license may be limited to instrumentation for inspection of finished 
pharmaceuticals and drug candidate screening.

DATES: Only written comments and/or applications for a license that are 
received by the NIH Office of Technology Transfer on or before 
September 9, 2002, will be considered.

ADDRESSESS: Requests for a copy of the patent application, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Dale D. Berkley, Ph.D., J.D., Technology 
Licensing Specialist, Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
MD 20852-3804; Telephone: (301) 496-7735, ext. 223; Facsimile: (301) 
402-0220; e-mail: [email protected]. A signed Confidential Disclosure 
Agreement will be required to receive copies of the patent application.

SUPPLEMENTARY INFORMATION: The invention is an infrared spectrometer 
having an array of cells with a number of cavities. A number of the 
cells typically contain a different reference material, and a plurality 
of cells are reserved to hold various samples. The cells have covers 
and can be individually purged before a measurement is made. Because 
reference and unknown samples can be processed at the same time, 
variation between measurements can be minimized. Using two connected 
cells, an instrument can monitor a reaction in real time, continuously 
determining relative concentrations of reagents, products and 
intermediates. The cells may form parts of process feed lines, such 
that multiple processes can be monitored in real time. The invention 
further comprises a pharmaceutical dosage unit manufacturing process 
control system that uses continuous spectral imaging to test the actual 
composition of pharmaceutical dosages even in packaged drugs. The 
system can screen for errors in coloring of ingredients, for 
contamination or breakdown that occurs independent of coloring and for 
other types of errors that might not otherwise be detected. The system 
can perform composition measurements through the end-user package walls 
to detect contamination or damage that occurs during packaging. The 
invention performs composition analysis by comparing spectral 
information with libraries of known spectral signatures, allowing small 
concentrations of potentially dangerous contaminants to be detected. 
Relative quantities of ingredients can be directly measured, such that 
a change in the ratio of these ingredients can be detected.
    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 90 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.

    Dated: May 29, 2002.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 02-14440 Filed 6-7-02; 8:45 am]
BILLING CODE 4140-01-P