[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)]
[Notices]
[Page 57927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20162]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is available for licensing and/or co-development in the 
U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve 
expeditious commercialization of results of federally-funded research 
and development. Foreign patent applications are filed on selected 
inventions to extend market coverage for companies and may also be 
available for licensing and/or co-development.

ADDRESSES: Invention Development and Marketing Unit, Technology 
Transfer Center, National Cancer Institute, 9609 Medical Center Drive, 
Mail Stop 9702, Rockville, MD 20850-9702.

FOR FURTHER INFORMATION CONTACT: Information on licensing and co-
development research collaborations, and copies of the U.S. patent 
applications listed below may be obtained by contacting: Attn. 
Invention Development and Marketing Unit, Technology Transfer Center, 
National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, 
Rockville, MD 20850-9702, Tel. 240-276-5515 or email 
[email protected]. A signed Confidential Disclosure 
Agreement may be required to receive copies of the patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.
    Title of invention: Methods of Analyzing Virus-Derived 
Therapeutics.
    Description of Technology: Researchers at the National Cancer 
Institute's Biopharmaceutical Development Program recently developed 
massively parallel sequencing methods for virus-derived therapeutics 
such as viral vaccines and oncolytic immunotherapies. The methods allow 
for the determination of micro-heterogeneity and quantitation of low 
frequency sequence variants, which have the possibility of supplanting 
monkey neurovirulence safety testing (MNVT), mutant analysis by PCR, 
and restriction enzyme cleavage (MAPREC) methods that are currently 
used to screen RNA virus-derived therapeutics.
    Potential Commercial Applications:
     Improved methods for detecting mutations in GMP-
manufactured virus-derived therapeutics, including viruses, viral 
template plasmids, or vaccines;
     The method allows for at least two different virus-derived 
therapeutics to be assayed simultaneously.
    Value Proposition:
     Provides a cost- and time-effective means of assaying a 
virus-derived therapeutic, such as oncolytic viruses, for viral 
sequence variants, for regulatory approval;
     RNA virus preparation steps increase the amount of viral 
RNA obtained;
     Demonstrated superiority of massively parallel sequencing 
(``MPS'') over mutant analysis by PCR and restriction enzyme cleavage 
(``MAPREC'') analysis.
    Development Stage: Clinical Phase I.
    Inventor(s): Trevor Broadt (NCI), Michael D. Harwich (American 
International Biotechnology, LLC), William T. Budd (American 
International Biotechnology, LLC), Gregory A. Myers (American 
International Biotechnology, LLC).
    Intellectual Property:

HHS Ref. No. E-240-2015/0-U.S.-01, corresponding to U.S. Provisional 
Patent App. No. 62/199,663, filed July 31, 201562/173,777, entitled 
``Methods of Analysis of RNA Virus-Derived Therapeutics''
HHS Ref. No. E-240-2015/0-PCT-02, corresponding to International Patent 
App. No. PCT/US2016/044788, filed July 29, 2016, entitled ``Methods of 
Analyzing Virus-Derived Therapeutics''

    Related Technologies: HHS Reference #E-267-2014/0 entitled 
``Processes for Production and Purification of Nucleic Acid Containing 
Compositions''.
    Contact Information: Requests for copies of the patent application 
or inquiries about licensing, research collaborations, and co-
development opportunities should be sent to John D. Hewes, Ph.D., 
email: [email protected].

    Dated: August 16, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology Transfer Center, National 
Cancer Institute.
[FR Doc. 2016-20162 Filed 8-23-16; 8:45 am]
 BILLING CODE 4140-01-P