[Federal Register Volume 60, Number 244 (Wednesday, December 20, 1995)]
[Notices]
[Page 65660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-30935]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health


Opportunity For Licensing: Sequence Modification of 
Oligonucleotide Primers to Manipulate Non-Templated Nucleotide Addition

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

ACTION: Notice.

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SUMMARY: The National Institutes of Health (NIH) seeks licensees to 
commercialize a method to manipulate non-templated nucleotide addition 
to ensure that all amplified DNA products of polymerase chain reaction 
(PCR) are either specifically modified or unmodified.
    This technology was developed by Dr. Jeffrey R. Smith and Dr. John 
Carpten of the National Center for Human Genome Research and Dr. 
Michael Brownstein of the National Institute of Mental Health.
    The invention embodied in U.S. Provisional Patent Application 60/
005, 761 filed October 20, 1995, entitled ``Sequence Modification of 
Oligonucleotide Primers to Manipulate Non-Templated Nucleotide 
Addition,'' is owned by an agency of the U.S.Government and is 
available for licensing in the U.S. in accordance with 35 U.S.C. 207 or 
pursuant to 42 U.S.C. 241 to achieve expeditious commercialization of 
results of federally-funded research and development.

ADDRESSES: Requests for a summary of the technology or other questions 
and comments concerning the biomedical aspects of this technology 
should be directed to: Dr. Ronald King, National Center for Human 
Genome Research, 9000 Rockville Pike, Building 31, Room 3B13, Bethesda, 
MD 20892; Telephone: 301/402-2537; Fax 301/402-9722.
    Requests for a copy of the patent application, license application 
form, or other questions and comments concerning the licensing of this 
technology should be directed to: Carol Lavrich, Office of Technology 
Transfer, National Institutes of Health, 6011 Executive Boulevard, 
Suite 325, Rockville, MD 20852-3804; Telephone 301/496-7735 ext 287; 
Fax 301/402-0220. A signed Confidential Disclosure Agreement will be 
required to receive a copy of the patent application.

SUPPLEMENTARY INFORMATION: Thermostable DNA polymerases are employed in 
PCR to amplify DNA for sizing in medical diagnostics, forensics, and 
genotyping, as well as for molecular cloning. Several of these enzymes, 
including the widely used Taq DNA polymerase, can catalyze non-
templated addition of a nucleotide (predominantly adenosine) to the 3' 
end of amplification products. As a result, an amplified DNA fragment 
may be incorrectly sized by one base pair in length and introduce error 
into a genotyping study. Artifactual variations in marker size may 
adversely impact interpretations of family relationships, medical 
diagnosis, and forensics. Moreover, full automation of genotyping has 
been hampered by the necessity of manually editing collected data to 
correct for allele misidentification due to the unpredictability of 
non-templated nucleotide addition. In addition, TA cloning methods that 
rely upon the modification will often fail when the amplified DNA is 
not modified.
    In response to this problem, Drs. Smith, Carpten, and Brownstein 
have characterized short DNA sequences (``tails'') that may be added to 
the unlabeled primer of a PCR primer pair to confer modification by a 
thermostable DNA polymerase, or to protect from the modification. This 
allows uniformity in allele sizing that is essential for automated 
genotyping. Furthermore, this prevents introduction of error and 
enables high TA cloning efficiency.
    The NIH seeks licensee(s), who in accordance with requirements and 
regulations governing the licensing of government-owned inventions (37 
CFR part 404), have the most meritorious plan for the development of 
this method to meet the needs of the public and with the best terms for 
the NIH. The criteria that NIH will use to evaluate exclusive or non-
exclusive license applications will include those set forth by 37 CFR 
404.7(a)(1)(ii)-(iv).

    Dated: December 8, 1995.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 95-30935 Filed 12-19-95; 8:45 am]
BILLING CODE 4140-01-M