[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)]
[Notices]
[Pages 57925-57926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20160]


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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: Processes for Producing and Purifying Nucleic 
Acid-Containing Compositions.
    Description of Technology: This technology consists of improved 
processes for producing and purifying nucleic acid-containing 
compositions, such as non-naturally occurring viruses, for example, 
recombinant polioviruses that can be used as oncolytic agents. Some of 
the improved processes relate

[[Page 57926]]

to producing viral DNA templates and for chromatographic purification 
of nucleic acid-containing compositions, in which the nucleic acid is 
quantified in chromatography fractions with the rapid detection of one 
or more nucleic acid sequences (e.g., using real time RT-qPCR 
detection). In addition, the invention includes improved processes for 
production and purification of oncolytic poliovirus, such as PVSRIPO. 
Compositions generated using these methods are also described.
    Potential Commercial Applications:
     Large-scale manufacturing for producing highly purified, 
live virus.
     Improved viral purification process that:
    [cir] Increases the yield and/or purity of the resulting product, 
while decreasing the purification time;
    [cir] is generally applicable to purification of any nucleic acid 
molecule-containing composition, such as virus-based composition, and 
can be used for the purification of live native or recombinant viruses 
necessary for clinical applications.
     Improved process for generating viral template plasmid 
(such as one that includes a DNA template for an RNA virus), which 
addresses the problem of genetic instability of the plasmids containing 
the viral genome (e.g., of a recombinant polio virus) in host (e.g., 
bacterial) cells, in which the plasmids are typically propagated.
    Value Proposition:
     Cost- and time-effective means of producing highly 
purified virus-based GMP products, such as oncolytic viruses, for 
regulatory approval.
    Development Stage: Clinical Phase I.
    Inventor(s): Trevor Broadt (NCI), Samir Shaban (NCI), Yueqing Xie 
(NCI), Jianwei Zhu (NCI), George Mitra (NCI).
    Intellectual Property: HHS Ref. No. E-267-2014/0-US-01, 
corresponding to US Provisional Patent App. No. 62/173,777, filed June 
10, 2015, entitled ``Processes for Production and Purification of 
Nucleic Acid Containing Compositions.''.
    HHS Ref. No. E-267-2014/0-PCT-02, corresponding to International 
Patent App. No. PCT/US2016/036888, filed June 10, 2016, entitled 
``Processes for Production and Purification of Nucleic Acid Containing 
Compositions''.
    Publications: Ouellette et al., BioProcessing J. 2005 4(2):31-38.
    Related Technologies: HHS Reference #E-240-2015/0 entitled 
``Methods of Analyzing Virus-Derived Therapeutics''.
    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. 2016-20160 Filed 8-23-16; 8:45 am]
BILLING CODE 4140-01-P