81 FR 57925 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 164 (August 24, 2016)

Page Range		57925-57926
FR Document		2016-20160

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.

Federal Register, Volume 81 Issue 164 (Wednesday, August 24, 2016)

[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)]
[Notices]
[Pages 57925-57926]
From the Federal Register Online  [www.thefederalregister.org]
[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

Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Notices 57925

OS specifically requests comments on Infertility Loan Repayment Program, National 93.337, 93.393–93.396, 93.837–93.844,
(1) the necessity and utility of the Institutes of Health, HHS) 93.846–93.878, 93.892, 93.893, National
proposed information collection for the Institutes of Health, HHS)
Dated: August 18, 2016.
proper performance of the agency’s Dated: August 17, 2016.
Michelle Trout,
functions, (2) the accuracy of the David Clary,
estimated burden, (3) ways to enhance Program Analyst, Office of Federal Advisory
Committee Policy. Program Analyst, Office of Federal Advisory
the quality, utility, and clarity of the Committee Policy.
[FR Doc. 2016–20150 Filed 8–23–16; 8:45 am]
information to be collected, and (4) the [FR Doc. 2016–20151 Filed 8–23–16; 8:45 am]
use of automated collection techniques BILLING CODE 4140–01–P
BILLING CODE 4140–01–P
or other forms of information
technology to minimize the information
DEPARTMENT OF HEALTH AND
collection burden. DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Terry S. Clark, HUMAN SERVICES
Asst Information Collection Clearance National Institutes of Health
National Institutes of Health
Officer.
Center For Scientific Review; Notice of
[FR Doc. 2016–20158 Filed 8–23–16; 8:45 am] Government-Owned Inventions;
Closed Meetings
BILLING CODE 4150–37–P Availability for Licensing
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as AGENCY: National Institutes of Health,
DEPARTMENT OF HEALTH AND amended (5 U.S.C. App.), notice is HHS.
HUMAN SERVICES hereby given of the following meetings. ACTION: Notice.
The meetings will be closed to the
National Institutes of Health SUMMARY: The invention listed below is
public in accordance with the
owned by an agency of the U.S.
provisions set forth in sections
Eunice Kennedy Shriver National Government and is available for
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Institute of Child Health & Human licensing and/or co-development in the
as amended. The grant applications and
Development; Notice of Closed U.S. in accordance with 35 U.S.C. 209
the discussions could disclose
Meeting and 37 CFR part 404 to achieve
confidential trade secrets or commercial
expeditious commercialization of
Pursuant to section 10(d) of the property such as patentable material,
results of federally-funded research and
Federal Advisory Committee Act, as and personal information concerning
development. Foreign patent
amended (5 U.S.C. App.), notice is individuals associated with the grant
applications are filed on selected
hereby given of the following meeting. applications, the disclosure of which
inventions to extend market coverage
The meeting will be closed to the would constitute a clearly unwarranted
for companies and may also be available
public in accordance with the invasion of personal privacy.
for licensing and/or co-development.
provisions set forth in sections Name of Committee: Center for Scientific ADDRESSES: Invention Development and
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Review Special Emphasis Panel; Shared and
as amended. The grant applications and High-End Instrumentation: Crystallography
Marketing Unit, Technology Transfer
the discussions could disclose and NMR. Center, National Cancer Institute, 9609
confidential trade secrets or commercial Date: September 20, 2016. Medical Center Drive, Mail Stop 9702,
property such as patentable material, Time: 8:00 a.m. to 6:00 p.m. Rockville, MD 20850–9702.
Agenda: To review and evaluate grant FOR FURTHER INFORMATION CONTACT:
and personal information concerning
applications. Information on licensing and co-
individuals associated with the grant Place: National Institutes of Health, 6701
applications, the disclosure of which development research collaborations,
Rockledge Drive, Bethesda, MD 20892,
would constitute a clearly unwarranted (Telephone Conference Call).
and copies of the U.S. patent
invasion of personal privacy. Contact Person: Michael Eissenstat, Ph.D., applications listed below may be
Scientific Review Officer, BCMB IRG, Center obtained by contacting: Attn. Invention
Name of Committee: National Institute of
for Scientific Review, National Institutes of Development and Marketing Unit,
Child Health and Human Development
Special Emphasis Panel, Developmental Health, 6701 Rockledge Drive, Room 4166, Technology Transfer Center, National
Mechanisms of Human Structural Birth Bethesda, MD 20892, 301–435–1722, Cancer Institute, 9609 Medical Center
Defects. eissenstatma@csr.nih.gov. Drive, Mail Stop 9702, Rockville, MD
Date: September 20, 2016. Name of Committee: Center for Scientific 20850–9702, Tel. 240–276–5515 or
Time: 2:00 p.m. to 5:00 p.m. Review Special Emphasis Panel; Shared and email ncitechtransfer@mail.nih.gov. A
Agenda: To review and evaluate grant High-End Instrumentation: Crystallography signed Confidential Disclosure
applications. and NMR.
Date: September 20, 2016.
Agreement may be required to receive
Place: National Institutes of Health,
Time: 8:00 a.m. to 6:00 p.m. copies of the patent applications.
Rockledge 6710B, 6710B Rockledge Drive,
Bethesda, MD 20817, (Telephone Conference Agenda: To review and evaluate grant SUPPLEMENTARY INFORMATION:
Call). applications. Technology description follows.
Contact Person: Sherry L Dupere, Ph.D., Place: National Institutes of Health, 6701 Title of invention: Processes for
Chief, Scientific Review Branch, Scientific Rockledge Drive, Bethesda, MD 20892, Producing and Purifying Nucleic Acid-
Review Branch, Eunice Kennedy Shriver (Virtual Meeting). Containing Compositions.
National Institute of Child Health and Contact Person: Sudha Veeraraghavan, Description of Technology: This
mstockstill on DSK3G9T082PROD with NOTICES

Human Development, NIH, 6710 B Rockledge Ph.D., Scientific Review Officer, Center for
technology consists of improved
Drive, Room 2115, Bethesda, MD 20892– Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD processes for producing and purifying
7510, 301–451–3415, duperes@mail.nih.gov.
(Catalogue of Federal Domestic Assistance 20892, 301–435–1504, nucleic acid-containing compositions,
Program Nos. 93.864, Population Research; sudha.veeraraghavan@nih.gov. such as non-naturally occurring viruses,
93.865, Research for Mothers and Children; (Catalogue of Federal Domestic Assistance for example, recombinant polioviruses
93.929, Center for Medical Rehabilitation Program Nos. 93.306, Comparative Medicine; that can be used as oncolytic agents.
Research; 93.209, Contraception and 93.333, Clinical Research, 93.306, 93.333, Some of the improved processes relate

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57926 Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Notices

to producing viral DNA templates and Hewes, Ph.D., email: john.hewes@ • A computational approach that
for chromatographic purification of nih.gov. integrates several types of data to
nucleic acid-containing compositions, Dated: August 16, 2016. predict human skin sensitization
in which the nucleic acid is quantified John D. Hewes, hazard without using animals
in chromatography fractions with the (ICCVAM)
Technology Transfer Specialist, Technology
rapid detection of one or more nucleic Transfer Center, National Cancer Institute.
• A plan to adopt high throughput
acid sequences (e.g., using real time RT- assays and computational models for
[FR Doc. 2016–20160 Filed 8–23–16; 8:45 am]
qPCR detection). In addition, the detecting and measuring estrogen
BILLING CODE 4140–01–P
invention includes improved processes receptor bioactivity as an alternative
for production and purification of for three Tier 1 tests currently used in
oncolytic poliovirus, such as PVSRIPO. the Endocrine Disruptor Screening
DEPARTMENT OF HEALTH AND
Compositions generated using these Program to assess estrogen receptor
HUMAN SERVICES
methods are also described. activity (U.S. Environmental
Potential Commercial Applications: National Institutes of Health Protection Agency [EPA])
• Large-scale manufacturing for • Establishment of a Communities of
producing highly purified, live virus. Interagency Coordinating Committee Practice webinar seminar series
• Improved viral purification process on the Validation of Alternative discussing relevant topics (ICCVAM)
that: Methods Biennial Progress Report: • Evaluation of acute oral and dermal
Æ Increases the yield and/or purity of 2014–2015; Availability of Report toxicity data to determine if oral
the resulting product, while decreasing toxicity tests are sufficient to assign
the purification time; SUMMARY: The National Toxicology U.S. EPA dermal hazard
Æ is generally applicable to Program (NTP) Interagency Center for classifications, eliminating the need
purification of any nucleic acid the Evaluation of Alternative for separate acute dermal toxicity tests
molecule-containing composition, such Toxicological Methods (NICEATM) (NICEATM)
as virus-based composition, and can be announces availability of the • A series of workshops that drafted
used for the purification of live native Interagency Coordinating Committee on recommendations on use of an in vitro
or recombinant viruses necessary for the Validation of Alternative Methods test with potential to replace animal
clinical applications. (ICCVAM) Biennial Progress Report: use for pertussis vaccine testing
• Improved process for generating 2014–2015. This report, prepared in (NICEATM, U.S. Food and Drug
viral template plasmid (such as one that accordance with requirements of the Administration, other ICCVAM
includes a DNA template for an RNA ICCVAM Authorization Act of 2000 (42 agencies).
virus), which addresses the problem of U.S.C. 285l–3), describes activities and Availability of Report: The report is
genetic instability of the plasmids accomplishments from January 2014 available at http://ntp.niehs.nih.gov/
containing the viral genome (e.g., of a through December 2015. iccvamreport/2015/index.html. Links to
recombinant polio virus) in host (e.g., ADDRESSES: The report is available at this report and all past ICCVAM annual
bacterial) cells, in which the plasmids http://ntp.niehs.nih.gov/iccvamreport/ and biennial reports are available at
are typically propagated. 2015/index.html. http://ntp.niehs.nih.gov/go/iccvam-bien.
Value Proposition: FOR FURTHER INFORMATION CONTACT: Dr. Background Information on ICCVAM
• Cost- and time-effective means of Warren Casey, Director, NICEATM; and NICEATM: ICCVAM is an
producing highly purified virus-based email: warren.casey@nih.gov; telephone: interagency committee composed of
GMP products, such as oncolytic (919) 316–4729. representatives from 15 federal
viruses, for regulatory approval. SUPPLEMENTARY INFORMATION: regulatory and research agencies that
Development Stage: Clinical Phase I. Background: The ICCVAM require, use, generate, or disseminate
Inventor(s): Trevor Broadt (NCI), Authorization Act of 2000 established toxicological and safety testing
Samir Shaban (NCI), Yueqing Xie (NCI), ICCVAM as a permanent interagency information. ICCVAM conducts
Jianwei Zhu (NCI), George Mitra (NCI). committee of the National Institute of technical evaluations of new, revised,
Intellectual Property: HHS Ref. No. E– Environmental Health Sciences (NIEHS) and alternative safety testing methods
267–2014/0–US–01, corresponding to under NICEATM. ICCVAM’s mission is and integrated testing strategies with
US Provisional Patent App. No. 62/ to facilitate development, validation, regulatory applicability and promotes
173,777, filed June 10, 2015, entitled and regulatory acceptance of new and the scientific validation and regulatory
‘‘Processes for Production and revised regulatory test methods that acceptance of testing methods that more
Purification of Nucleic Acid Containing reduce, refine, or replace the use of accurately assess the safety and hazards
Compositions.’’. animals in testing while maintaining of chemicals and products and replace,
HHS Ref. No. E–267–2014/0–PCT–02, and promoting scientific quality and the reduce, or refine (enhance animal well-
corresponding to International Patent protection of human health, animal being and lessen or avoid pain and
App. No. PCT/US2016/036888, filed health, and the environment. distress) animal use.
June 10, 2016, entitled ‘‘Processes for A provision of the ICCVAM The ICCVAM Authorization Act of
Production and Purification of Nucleic Authorization Act states that ICCVAM 2000 (42 U.S.C. 285l–3) establishes
Acid Containing Compositions’’. shall prepare ‘‘reports to be made ICCVAM as a permanent interagency
Publications: Ouellette et al., available to the public on its progress committee of NIEHS and provides the
BioProcessing J. 2005 4(2):31–38. under this Act.’’ The eighth ICCVAM authority for ICCVAM involvement in
Related Technologies: HHS Reference progress report is now available, which activities relevant to the development of
mstockstill on DSK3G9T082PROD with NOTICES

#E–240–2015/0 entitled ‘‘Methods of describes ICCVAM activities and alternative test methods. ICCVAM acts
Analyzing Virus-Derived Therapeutics’’. accomplishments from January 2014 to ensure that new and revised test
Contact Information: Requests for through December 2015. methods are validated to meet the needs
copies of the patent application or Summary of Report Contents: Key of federal agencies, increase the
inquiries about licensing, research ICCVAM, ICCVAM agency, and efficiency and effectiveness and federal
collaborations, and co-development NICEATM accomplishments agency test method review, and
opportunities should be sent to John D. summarized in the report include: optimize utilization of scientific

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Document Created: 2016-08-24 03:02:31
Document Modified: 2016-08-24 03:02:31

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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.
FR Citation		81 FR 57925

81 FR 57925 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 81, Issue 164 (August 24, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health