[Federal Register Volume 63, Number 86 (Tuesday, May 5, 1998)]
[Notices]
[Pages 24820-24821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11933]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Highly Informative 
Microsatellite Repeat Polymorphic DNA Markers

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

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This is a 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 in the United States to practice the inventions 
embodied in U.S. Patent Application Serial No. 07/799,828 (issued as 
Patent No. 5,378,602 on January 3, 1995), entitled ``Twenty-Seven 
Highly Informative Microsatellite Repeat Polymorphic DNA Markers''; 
U.S. Patent Application Serial No. 07/922,723 (issued as Patent No. 
5,369,004 on November 29, 1994), entitled ``Five Highly Informative 
Microsatellite Repeat Polymorphic DNA Markers''; U.S. Patent 
Application Serial No. 07/952,277, entitled ``Eleven Highly Informative 
Microsatellite Repeat Polymorphic DNA Markers''; U.S. Patent 
Application Serial No. 08/074,275 (issued as Patent No. 5,468,610 on 
November 21, 1995), entitled ``Three Highly Informative Microsatellite 
Repeat Polymorphic DNA Markers''; and U.S. Patent Application Serial 
No. and 08/480,366 (issued as Patent No. 5,721,100 on February 24, 
1998), entitled, ``Three Highly Informative Microsatellite Repeat 
Polymorphic DNA Markers'' to Lifecodes Corporation, having a place of 
business in Stamford, Connecticut. The patent rights in these 
inventions have been assigned to the United States of America.
    The field of use would be DNA profiling assays for detecting 
polymorphisms of forensic and medical samples including blood, semen, 
tissue hair, saliva, urine, and mixtures of body fluids.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before July 
6, 1998, will be considered.

ADDRESSES: Requests for a copy of the patents, patent application, 
inquiries, comments and other materials relating to the contemplated 
license should be directed to: Charles Maynard, M.P.H., Technology 
Licensing Specialist, Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Box 13, Rockville, MD 
20852-3804; Telephone: (301) 496-7735, ext. 243; Facsimile: (301) 402-
0220. Properly filed competing applications for a license filed in 
response to this notice will be treated as objections to the 
contemplated license. A signed Confidential Disclosure Agreement will 
be required to receive a copy of the patent application.

SUPPLEMENTARY INFORMATION: A novel group of microsatellite repeat 
polymorphic deoxyribonucleic acid (DNA) markers is valuable for rapidly 
identifying and differentiating between individual human DNA sequences 
for forensic, genetic, and human DNA mapping studies. These nucleotides 
can also be used for paternity and prenatal screening, and genetic 
mapping. These new microsatellite DNA markers can be used as primers 
for rapid polymerase chain reaction (PCR) amplification of unique human 
DNA polymorphisms, which are naturally occurring mutations in DNA 
sequences that are often unique on the basis of as little as a single 
nucleotide sequence. Assays using these nucleotides are based on PCR 
and therefore need only small amounts of test DNA. The assays are easy 
to perform and relatively inexpensive and results can be obtained in 
less than 24 hours, compared with 3 or 4 days for other similar tests. 
Accordingly, the invention also relates to an improved PCR procedure 
and a PCR assay kit which comprise nucleotides according to the 
invention. The invention describes a method of the steps involved in 
extracting DNA from a sample to be tested, amplifying the extracted DNA 
and identifying the amplified extension products for each different 
sequence. Each different sequence is differentially labeled. The method 
is applicable to a wide variety of forensic and medical samples as 
stated above.
    DNA identity testing has revolutionized the field of forensic 
analysis of biological materials. The forensic test compares the 
genetic material in biologic specimens from a crime scene to that taken 
from a suspect. DNA testing transforms the DNA found in blood, serum, 
or other tissue from a crime scene or an individual into a unique 
genetic profile. The profile may serve as a means of making a positive 
identification in a rape, murder, or other violent crime. A number of 
loci in this application may also be useful in identity testing by 
discerning a DNA pattern that is unique to an individual.
    The prospective exclusive license will be royalty-bearing and will 
comply with the terms and conditions of 35 U.S.C.

[[Page 24821]]

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.
    Applications for a license in the exclusive field of use filed in 
response to this notice will be treated as objections to the grant of 
the contemplated licenses. 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: April 9, 1998.
Jack S. Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 98-11933 Filed 5-4-98; 8:45 am]
BILLING CODE 4140-01-M