02-14440. Prospective Grant of Exclusive License: “High Throughput Infrared Spectroscopy''

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

ACTION:

Notice.

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 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: [phone], ext. 223; Facsimile: [phone]; e-mail: [e-mail]. 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.