83 FR 16377 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 73 (April 16, 2018)

Page Range		16377-16378
FR Document		2018-07821

The invention listed below is owned by an agency of the U.S. Government and is available for licensing 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.

Federal Register, Volume 83 Issue 73 (Monday, April 16, 2018)

[Federal Register Volume 83, Number 73 (Monday, April 16, 2018)]
[Notices]
[Pages 16377-16378]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-07821]


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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 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.

FOR FURTHER INFORMATION CONTACT: Dr. Amy Petrik, 240-627-3721; 
amy.petrik@nih.gov. Licensing information and copies of the U.S. patent 
application listed below may be obtained by communicating with the 
indicated licensing contact at the Technology Transfer and Intellectual 
Property Office, National Institute of Allergy and Infectious Diseases, 
5601 Fishers Lane, Rockville, MD, 20852; tel. 301-496-2644. A signed 
Confidential Disclosure Agreement will be required to receive copies of 
unpublished patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.

Novel Multivalent Nanoparticle Vaccines

    Description of Technology: Current seasonal influenza vaccines are 
designed to elicit immunity to circulating strains of influenza each 
year. The targeted strains are selected based on predictions of which 
strains are likely to be predominant in the human population for a 
given year. This prediction must be made well ahead of the influenza 
season to allow time for vaccine production and can be inaccurate.
    Scientists at NIAID's Vaccine Research Center are developing an 
alternative approach for design and production of seasonal influenza 
vaccines. The design includes recombinant fusion proteins that self-

[[Page 16378]]

assemble into nanoparticles with influenza antigenic proteins displayed 
on the nanoparticle surface (Nature 499, 102-106 (2013)). Further 
engineering these recombinant fusion proteins, the scientists have 
developed nanoparticles that simultaneously display multiple strains of 
influenza viral protein antigens (the receptor-binding domain of 
hemagglutinin) on their surface. Due to the heterogeneity of the 
antigenic protein derived from multiple strains, these nanoparticles 
are referred to as mosaic nanoparticles.
    Upon immunization of mice with mosaic nanoparticles displaying 
antigens from eight different H1N1 strains, the elicited antibodies 
neutralized a panel of H1N1 strains from 1918 through 2009 including 
the strains that had not been displayed on the mosaic nanoparticle. 
However, mice immunized with a mixture of the eight types of 
nanoparticles, each displaying a single antigenic protein, did not 
elicit a similar breadth of neutralizing antibody response.
    NIAID is continuing development of these vaccine candidates through 
animal studies and moving toward clinical evaluation.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as 
well as for further development and evaluation under a research 
collaboration.
    Potential Commercial Applications:
     Vaccine platform for seasonal influenza with broader 
protection coverage
    Competitive Advantages:
     Nucleic acid or recombinant protein-based vaccine
     Increased ease of production compared to current seasonal 
influenza vaccines
    Development Stage:
     In vivo (animal studies)
    Inventors: Barney S. Graham, Hadi Yassine, Masaru Kanekiyo (all 
from NIAID).
    Publications: Kanekiyo, M, et al. Manuscript under revision.
    Intellectual Property: HHS Reference Number E-060-2015 includes 
U.S. Patent Application No. 15/540,898 filed June 29, 2017 (Pending); 
Canada Patent Application No. 2,974,346 filed December 31, 2015 
(Pending); China Patent Application No. 201580076324.6 filed December 
31, 2015 (Pending); Europe Patent Application No. 15825772.5 filed July 
7, 2017 (Pending); India Patent Application No 201717026077 filed July 
21, 2017 (Pending); Australia Patent Application No. 2015373928 filed 
July 21, 2017; Brazil Patent Application No. BR112017014219-8 filed 
June 29, 2017; Israel Patent Application No. 253187 filed December 31, 
2015; Japan Patent Application No. 2017-534796 filed June 28, 2017; 
South Korean Patent Application No. 10-2017-7021112 filed July 27, 
2017; Singapore Patent Application No. 11201705264W filed June 23, 
2017.
    Related Intellectual Property: HHS Reference Number E-293-2011
    Licensing Contact: Dr. Amy Petrik, 240-627-3721; 
amy.petrik@nih.gov. Collaborative Research Opportunity: The National 
Institute of Allergy and Infectious Diseases is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate or commercialize influenza 
monoclonal antibody technologies. For collaboration opportunities, 
please contact Dr. Amy Petrik, 240-627-3721; amy.petrik@nih.gov.

    Dated: April 5, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-07821 Filed 4-13-18; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices 16377

technology employs protein engineering Dated: April 5, 2018. Dated: April 10, 2018.
to stabilize S in its prefusion Suzanne M. Frisbie, Michelle D. Trout,
conformation, preventing structural Deputy Director, Technology Transfer and Program Analyst, Office of Federal Advisory
rearrangement, and exposing Intellectual Property Office, National Institute Committee Policy.
antigenically preferable surfaces. The of Allergy and Infectious Diseases. [FR Doc. 2018–07820 Filed 4–13–18; 8:45 am]
technology has been applied to several [FR Doc. 2018–07822 Filed 4–13–18; 8:45 am] BILLING CODE 4140–01–P
CoV spikes, including those from BILLING CODE 4140–01–P
human-relevant viruses, such as HKU1-
CoV, SARS-CoV, and MERS-CoV. DEPARTMENT OF HEALTH AND
Particularly for MERS–COV, stabilized S DEPARTMENT OF HEALTH AND HUMAN SERVICES
proteins have been shown to elicit HUMAN SERVICES
superior neutralizing antibody National Institutes of Health
responses up to 10-fold higher in animal National Institutes of Health
models and protect mice against lethal Government-Owned Inventions;
MERS-CoV infection. This technology is National Heart, Lung, and Blood Availability for Licensing
applicable for delivery via other Institute; Notice of Meeting AGENCY: National Institutes of Health,
platforms, such as mRNA. HHS.
This technology is available for Pursuant to section 10(d) of the
Federal Advisory Committee Act, as ACTION: Notice.
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37 amended, notice is hereby given of a SUMMARY: The invention listed below is
CFR part 404, as well as for further meeting of the Sleep Disorders Research owned by an agency of the U.S.
development and evaluation under a Advisory Board. Government and is available for
research collaboration. This meeting is open to the public but licensing to achieve expeditious
Potential Commercial Applications: is being held by virtual/teleconference. commercialization of results of
The stabilized prefusion coronavirus No physical meeting location is federally-funded research and
spike protein can be used as a vaccine provided for any interested individuals development. Foreign patent
antigen to elicit robust neutralizing to listen to and/or participate in the applications are filed on selected
antibody responses. meeting. Any individual interested in inventions to extend market coverage
listening to the meeting discussions for companies and may also be available
Competitive Advantages: for licensing.
must: access the website https://
• Improved immunogenicity nih.webex.com/nih/onstage/ FOR FURTHER INFORMATION CONTACT: Dr.
compared to other coronavirus S g.php?MTID=e9a4cbcaac003afd915c2c Amy Petrik, 240–627–3721;
vaccine formulations. 94a8c787585 and enter Event Password: amy.petrik@nih.gov. Licensing
• Increased protein expression, sdrab or call-in toll number 1–650–479– information and copies of the U.S.
stability, and manufacturability 3208 and enter access code: 625 446 patent application listed below may be
compared to wild-type CoV S. 354, for access to the meeting. obtained by communicating with the
Development Stage: Individuals require special assistance, indicated licensing contact at the
• In vivo data available (animal). should notify the Contact Person listed Technology Transfer and Intellectual
below in advance of the meeting. Property Office, National Institute of
Inventors: Barney Graham (NIAID),
Masaru Kanekiyo (NIAID), M. Gordon Name of Committee: Sleep Disorders Allergy and Infectious Diseases, 5601
Joyce (NIAID), Kizzmekia Corbett Research Advisory Board. Fishers Lane, Rockville, MD, 20852; tel.
(NIAID), Hadi Yassine (NIAID), Andrew Date: April 27, 2018. 301–496–2644. A signed Confidential
Ward (Scripps), Robert Kirchdoefer Time: 2:00 p.m. to 4:00 p.m. Disclosure Agreement will be required
(Scripps), Christopher Cottrell (Scripps), Agenda: Discussion of NIH Sleep Disorders to receive copies of unpublished patent
Jesper Pallesen (Scripps), Hannah Research Plan Revision. applications.
Place: National Institutes of Health, Two SUPPLEMENTARY INFORMATION:
Turner (Scripps), Nianshuang Wang
Rockledge Center, Conference Room 10167, Technology description follows.
(Dartmouth), Jason McLellan
6701 Rockledge Drive, Bethesda, MD 20892
(Dartmouth), (Virtual Meeting). Novel Multivalent Nanoparticle
Intellectual Property: HHS Reference Contact Person: Michael J. Twery, Ph.D., Vaccines
No. E–234–2016/0, U.S. Provisional Director, National Center on Sleep Disorders Description of Technology: Current
Patent Application Number 62/412,703, Research Division of Lung Diseases, National seasonal influenza vaccines are
filed October 25, 2016, PCT Patent Heart, Lung, and Blood Institute, National
designed to elicit immunity to
Application PCT/US2017/058370 filed Institutes of Health, 6701 Rockledge Drive,
circulating strains of influenza each
October 25, 2017. Suite 10042, Bethesda, MD 20892–7952, 301–
435–0199, twerym@nhlbi.nih.gov.
year. The targeted strains are selected
Licensing Contact: Amy Petrik, Ph.D., based on predictions of which strains
240–627–3721; amy.petrik@nih.gov. This notice is being published less than 15
days prior to the meeting due to the timing are likely to be predominant in the
Collaborative Research Opportunity: limitations of receiving input from committee human population for a given year. This
The National Institute of Allergy and members prior to presenting the plan to other prediction must be made well ahead of
Infectious Diseases is seeking statements audiences for comment and meeting a the influenza season to allow time for
of capability or interest from parties legislative reporting deadline. vaccine production and can be
srobinson on DSK3G9T082PROD with NOTICES

interested in collaborative research to (Catalogue of Federal Domestic Assistance inaccurate.
further develop, evaluate or Program Nos. 93.233, National Center for Scientists at NIAID’s Vaccine
commercialize norovirus diagnostics or Sleep Disorders Research; 93.837, Heart and Research Center are developing an
vaccines. For collaboration Vascular Diseases Research; 93.838, Lung alternative approach for design and
opportunities, please contact Amy Diseases Research; 93.839, Blood Diseases production of seasonal influenza
Petrik, Ph.D., 240–627–3721; and Resources Research, National Institutes vaccines. The design includes
amy.petrik@nih.gov. of Health, HHS) recombinant fusion proteins that self-

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16378 Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices

assemble into nanoparticles with BR112017014219–8 filed June 29, 2017; fax to 202–395–6974, Attention: Desk
influenza antigenic proteins displayed Israel Patent Application No. 253187 Officer for NIH.
on the nanoparticle surface (Nature 499, filed December 31, 2015; Japan Patent FOR FURTHER INFORMATION CONTACT: To
102–106 (2013)). Further engineering Application No. 2017–534796 filed June request more information on the
these recombinant fusion proteins, the 28, 2017; South Korean Patent proposed project or to obtain a copy of
scientists have developed nanoparticles Application No. 10–2017–7021112 filed the data collection plans and
that simultaneously display multiple July 27, 2017; Singapore Patent instruments, contact: Melba Rojas,
strains of influenza viral protein Application No. 11201705264W filed NIMH Project Clearance Liaison,
antigens (the receptor-binding domain June 23, 2017. Science Policy and Evaluation Branch,
of hemagglutinin) on their surface. Due Related Intellectual Property: HHS Office of Science Policy, Planning and
to the heterogeneity of the antigenic Reference Number E–293–2011 Communications, NIMH, Neuroscience
protein derived from multiple strains, Licensing Contact: Dr. Amy Petrik, Center, 6001 Executive Boulevard, MSC
these nanoparticles are referred to as 240–627–3721; amy.petrik@nih.gov. 9667, Bethesda, Maryland 20892, call
mosaic nanoparticles. Collaborative Research Opportunity: 301–443–4335, or email your request,
Upon immunization of mice with The National Institute of Allergy and including your mailing address, to
mosaic nanoparticles displaying Infectious Diseases is seeking statements nimhprapubliccomments@mail.nih.gov.
antigens from eight different H1N1 of capability or interest from parties SUPPLEMENTARY INFORMATION: This
strains, the elicited antibodies interested in collaborative research to proposed information collection was
neutralized a panel of H1N1 strains further develop, evaluate or previously published in the Federal
from 1918 through 2009 including the commercialize influenza monoclonal Register on January 29, 2018, pages
strains that had not been displayed on antibody technologies. For collaboration 4062–4063 (83 FR 4062) and allowed 60
the mosaic nanoparticle. However, mice opportunities, please contact Dr. Amy days for public comment. No public
immunized with a mixture of the eight Petrik, 240–627–3721; amy.petrik@ comments were received. The purpose
types of nanoparticles, each displaying nih.gov. of this notice is to allow an additional
a single antigenic protein, did not elicit Dated: April 5, 2018. 30 days for public comment. The
a similar breadth of neutralizing National Institute of Mental Health
Suzanne M. Frisbie,
antibody response. (NIMH), National Institutes of Health,
NIAID is continuing development of Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute may not conduct or sponsor, and the
these vaccine candidates through
of Allergy and Infectious Diseases. respondent is not required to respond
animal studies and moving toward
[FR Doc. 2018–07821 Filed 4–13–18; 8:45 am] to, an information collection that has
clinical evaluation.
BILLING CODE 4140–01–P been extended, revised, or implemented
This technology is available for
on or after October 1, 1995, unless it
licensing for commercial development
displays a currently valid OMB control
in accordance with 35 U.S.C. 209 and 37
DEPARTMENT OF HEALTH AND number.
CFR part 404, as well as for further
HUMAN SERVICES In compliance with Section
development and evaluation under a
3507(a)(1)(D) of the Paperwork
research collaboration. National Institutes of Health Reduction Act of 1995, the National
Potential Commercial Applications:
• Vaccine platform for seasonal Institutes of Health (NIH) has submitted
Submission for OMB Review; 30-Day to the Office of Management and Budget
influenza with broader protection Comment Request; Generic Clearance
coverage (OMB) a request for review and
for the Research Domain Criteria approval of the information collection
Competitive Advantages: (RDoC) Initiative (National Institute of
• Nucleic acid or recombinant listed below.
Mental Health) Proposed Collection: Generic
protein-based vaccine
• Increased ease of production AGENCY: National Institutes of Health, Clearance for the Research Domain
compared to current seasonal influenza HHS. Criteria (RDoC) Initiative, 0925–NEW,
vaccines National Institute of Mental Health
ACTION: Notice. (NIMH), National Institutes of Health
Development Stage:
• In vivo (animal studies) SUMMARY: In compliance with the (NIH).
Inventors: Barney S. Graham, Hadi Paperwork Reduction Act of 1995, the Need and Use of Information
Yassine, Masaru Kanekiyo (all from National Institutes of Health (NIH) has Collection: This request serves as notice
NIAID). submitted to the Office of Management that the National Institute of Mental
Publications: Kanekiyo, M, et al. and Budget (OMB) a request for review Health (NIMH) is seeking OMB approval
Manuscript under revision. and approval of the information of a generic plan to conduct information
Intellectual Property: HHS Reference collection listed below. collections to interface with the
Number E–060–2015 includes U.S. scientific community and promote the
DATES: Comments regarding this
Patent Application No. 15/540,898 filed RDoC Initiative. As the lead Federal
June 29, 2017 (Pending); Canada Patent information collection are best assured agency for research on mental illnesses,
Application No. 2,974,346 filed of having their full effect if received NIMH’s mission is to transform the
December 31, 2015 (Pending); China within 30 days of the date of this understanding and treatment of mental
Patent Application No. 201580076324.6 publication. illnesses through basic and clinical
filed December 31, 2015 (Pending); ADDRESSES: Written comments and/or research, paving the way for prevention,
srobinson on DSK3G9T082PROD with NOTICES

Europe Patent Application No. suggestions regarding the item(s) recovery, and cure. To this end, NIMH
15825772.5 filed July 7, 2017 (Pending); contained in this notice, especially launched the RDoC Initiative in 2009 to
India Patent Application No regarding the estimated public burden implement Strategy 1.4 of the 2008
201717026077 filed July 21, 2017 and associated response time, should be NIMH Strategic Plan: ‘‘Develop new
(Pending); Australia Patent Application directed to the: Office of Management ways of classifying disorders based on
No. 2015373928 filed July 21, 2017; and Budget, Office of Regulatory Affairs, dimensions of observable behaviors and
Brazil Patent Application No. OIRA_submission@omb.eop.gov or by brain functions.’’ The aim of RDoC is to

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Document Created: 2018-04-14 02:18:59
Document Modified: 2018-04-14 02:18:59

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		Dr. Amy Petrik, 240-627-3721; [email protected] Licensing information and copies of the U.S. patent application listed below may be obtained by communicating with the indicated licensing contact at the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD, 20852; tel. 301-496-2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications.
FR Citation		83 FR 16377

83 FR 16377 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 73 (April 16, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health