82_FR_13020 82 FR 12976 - Government-Owned Inventions; Availability for Licensing

82 FR 12976 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 44 (March 8, 2017)

Page Range12976-12977
FR Document2017-04501

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 82 Issue 44 (Wednesday, March 8, 2017)
[Federal Register Volume 82, Number 44 (Wednesday, March 8, 2017)]
[Notices]
[Pages 12976-12977]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-04501]


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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.

-----------------------------------------------------------------------

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: Licensing information and copies of 
the patent applications 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to receive copies of unpublished patent applications.

[[Page 12977]]


SUPPLEMENTARY INFORMATION: Technology description follows.

AMA1-RON2 Complex-Based Vaccine Against Malaria

Description of Technology

    This technology relates to a malaria vaccine composed of a protein 
complex of Apical Membrane Antigen (AMA1) and rhoptry neck protein 2 
(RON2) with an adjuvant. AMA1 is a crucial component of the Plasmodium 
invasion machinery and is a leading candidate for antimalarial vaccine 
development. AMA1-based vaccines have shown ability to block red cell 
invasion in in vitro assays, but protection has so far not translated 
to in vivo human infections. NIAID investigators have demonstrated that 
interaction between AMA1 and RON2 (or peptide thereof) is essential for 
malaria parasites to successfully enter human red blood cells (RBCs). 
Vaccination with un-complexed AMA1 and RON2 did not protect against 
lethal malaria. However, vaccination with a pre-formed AMA1-RON2 
complex, highlighted in this technology, produced antibodies that 
protected against lethal malaria in an in vivo mouse model (P. yoelli) 
and blocked the entry of human malaria parasites into RBCs in vitro. 
Additionally, the inhibitory antibody response induced by the AMA1-RON2 
complex was greater than AMA1 alone or when AMA1 and RON2 proteins were 
administered in a un-complexed form.
    Immunization using the AMA1-RON2 complex of this technology 
represents a candidate for an effective malaria vaccine against 
multiple Plasmodium species.
    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

 Malaria vaccine

Competitive Advantages

    Lower-cost malarial prevention for developing/developed countries.

Development Stage

     Early-stage.
     In vitro data available.
     In vivo data available (animal).
    Inventors: Prakash Srinivasan and Louis Miller (NIAID).
    1. Publications: Srinivasan P, et al. Binding of Plasmodium 
merozoite proteins RON2 and AMA1 triggers commitment to invasion. Proc 
Natl Acad Sci U S A. 2011 Aug 9;108(32):13275-80. [PMID 21788485].
    2. Srinivasan P, et al. Disrupting malaria parasite AMA1-RON2 
interaction with a small molecule prevents erythrocyte invasion. Nat 
Commun. 2013;4:2261. [PMID 23907321].
    Intellectual Property: HHS Reference No. E-066-2013/0--U.S. 
Provisional Application No. 61/841,479 filed 01 Jul 2013; PCT 
Application No. PCT/US2014/045065, filed July 1, 2014; European 
Application No. 14742116.8, filed July 1, 2014 (pending); U.S. 
Application No. 14/902,117, filed August December 30, 2015 (pending); 
and Chinese Application No. 201480037643.1, filed December 31, 2015 
(pending).
    Licensing Contact: Peter Tung, 240-669-5483; [email protected]. 
Collaborative Research Opportunity: The National Institute of Allergy 
and Infectious Diseases is seeking statements of capability and 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize AMA1-RON2 vaccine by providing well 
established human adjuvants and clinical trial funding. For 
collaboration opportunities, please contact Peter Tung, 240-669-5483; 
[email protected].

    Dated: February 24, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2017-04501 Filed 3-7-17; 8:45 am]
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                                                  12976                        Federal Register / Vol. 82, No. 44 / Wednesday, March 8, 2017 / Notices

                                                    Name of Committee: Center for Scientific                Contact Person: Raymond Jacobson, Ph.D.,            property such as patentable material,
                                                  Review Special Emphasis Panel; Member                   Scientific Review Officer, Center for                 and personal information concerning
                                                  Conflict: Integrative Nutrition and Molecular           Scientific Review, National Institutes of             individuals associated with the contract
                                                  Endocrinology.                                          Health, 6701 Rockledge Drive, Room 5858,
                                                                                                                                                                proposals, the disclosure of which
                                                    Date: March 29, 2017.                                 MSC 7849, Bethesda, MD 20892, 301–996–
                                                    Time: 2:00 p.m. to 4:00 p.m.                          7702, jacobsonrh@csr.nih.gov.                         would constitute a clearly unwarranted
                                                    Agenda: To review and evaluate grant                                                                        invasion of personal privacy.
                                                                                                            Name of Committee: Center for Scientific
                                                  applications.                                           Review Special Emphasis Panel; RFA HD–                  Name of Committee: National Institute of
                                                    Place: National Institutes of Health, 6701            17–008: Autism Centers of Excellence:                 Dental and Craniofacial Research Special
                                                  Rockledge Drive, Bethesda, MD 20892                     Networks (R01).                                       Emphasis Panel; NIDCR Loan Repayment
                                                  (Telephone Conference Call).                              Date: March 31, 2017.                               Program SEP.
                                                    Contact Person: Raul Rojas, Ph.D.,                      Time: 8:00 a.m. to 5:00 p.m.                          Date: March 29–31, 2017.
                                                  Scientific Review Officer, Center for                     Agenda: To review and evaluate grant                  Time: 8:00 a.m. to 5:00 p.m.
                                                  Scientific Review, National Institutes of               applications.                                           Agenda: To review and evaluate contract
                                                  Health, 6701 Rockledge Drive, Room 6185,                  Place: Embassy Suites at the Chevy Chase            proposals.
                                                  Bethesda, MD 20892, (301) 451–6319, rojasr@             Pavilion, 4300 Military Road NW.,                       Place: National Institutes of Health, 6701
                                                  mail.nih.gov.                                           Washington, DC 20015.                                 Rockledge Drive, Bethesda, MD 20892
                                                    Name of Committee: Center for Scientific                Contact Person: Jane A. Doussard-                   (Virtual Meeting).
                                                  Review Special Emphasis Panel; PAR Panel:               Roosevelt, Ph.D., Scientific Review Officer,            Contact Person: Latarsha J. Carithers,
                                                  Basic Research in Cancer Health Disparities/            Center for Scientific Review, National                Ph.D., Scientific Review Officer, Division of
                                                  Diversity.                                              Institutes of Health, 6701 Rockledge Drive,           Extramural Activities, NIDCR, 6701
                                                    Date: March 30–31, 2017.                              Room 3184, MSC 7848, Bethesda, MD 20892,              Democracy Boulevard, Suite 672, Bethesda,
                                                    Time: 8:00 a.m. to 5:00 p.m.                          (301) 435–4445, doussarj@csr.nih.gov.                 MD 20892, 301–594–4859,
                                                    Agenda: To review and evaluate grant                                                                        latarsha.carithers@nih.gov.
                                                                                                            Name of Committee: Center for Scientific
                                                  applications.                                           Review Special Emphasis Panel; Program                (Catalogue of Federal Domestic Assistance
                                                    Place: Hilton Washington/Rockville, 1750              Project: Review of Program Project.                   Program Nos. 93.121, Oral Diseases and
                                                  Rockville Pike, Rockville, MD 20852.                      Date: March 31, 2017.                               Disorders Research, National Institutes of
                                                    Contact Person: Ola Mae Zack Howard,                    Time: 12:00 p.m. to 4:00 p.m.                       Health, HHS)
                                                  Ph.D., Scientific Review Officer, Center for              Agenda: To review and evaluate grant                  Dated: March 2, 2017.
                                                  Scientific Review, National Institutes of               applications.                                         Natasha M. Copeland,
                                                  Health, 6701 Rockledge Drive, Room 4192,                  Place: National Institutes of Health, 6701
                                                                                                                                                                Program Analyst, Office of Federal Advisory
                                                  MSC 7806, Bethesda, MD 20892, 301–451–                  Rockledge Drive, Bethesda, MD 20892
                                                                                                                                                                Committee Policy.
                                                  4467, howardz@mail.nih.gov.                             (Telephone Conference Call).
                                                                                                            Contact Person: Jose H. Guerrier, Ph.D.,            [FR Doc. 2017–04482 Filed 3–7–17; 8:45 am]
                                                    Name of Committee: Center for Scientific
                                                  Review Special Emphasis Panel; PAR Panel:               Scientific Review Officer, Center for                 BILLING CODE 4140–01–P
                                                  Mycobacterial induced immunity in HIV-                  Scientific Review, National Institutes of
                                                  infected and uninfected individuals.                    Health, 6701 Rockledge Drive, Room 5218,
                                                    Date: March 30, 2017.                                 MSC 7852, Bethesda, MD 20892, 301–435–                DEPARTMENT OF HEALTH AND
                                                    Time: 8:30 a.m. to 4:00 p.m.                          1137, guerriej@csr.nih.gov.                           HUMAN SERVICES
                                                    Agenda: To review and evaluate grant                  (Catalogue of Federal Domestic Assistance
                                                  applications.                                           Program Nos. 93.306, Comparative Medicine;            National Institutes of Health
                                                    Place: Hilton Silver Spring, 8727 Colesville          93.333, Clinical Research, 93.306, 93.333,
                                                  Road, Silver Spring, MD 20910.                          93.337, 93.393–93.396, 93.837–93.844,                 Government-Owned Inventions;
                                                    Contact Person: Jingsheng Tuo, Ph.D.,                 93.846–93.878, 93.892, 93.893, National               Availability for Licensing
                                                  Scientific Review Officer, Center for                   Institutes of Health, HHS)
                                                  Scientific Review, National Institutes of                                                                     AGENCY:   National Institutes of Health,
                                                                                                            Dated: March 2, 2017.                               HHS.
                                                  Health, 6701 Rockledge Drive, Room 5207,
                                                                                                          David Clary,
                                                  Bethesda, MD 20892, 301–451–8754, tuoj@                                                                       ACTION:   Notice.
                                                  nei.nih.gov.                                            Program Analyst, Office of Federal Advisory
                                                    Name of Committee: Center for Scientific              Committee Policy.                                     SUMMARY:   The invention listed below is
                                                  Review Special Emphasis Panel; RFA–                     [FR Doc. 2017–04484 Filed 3–7–17; 8:45 am]            owned by an agency of the U.S.
                                                  RM16–007: Transformative Research Award                 BILLING CODE 4140–01–P                                Government and is available for
                                                  Review.                                                                                                       licensing to achieve expeditious
                                                    Date: March 31, 2017.                                                                                       commercialization of results of
                                                    Time: 8:00 a.m. to 5:00 p.m.                          DEPARTMENT OF HEALTH AND                              federally-funded research and
                                                    Agenda: To review and evaluate grant                  HUMAN SERVICES                                        development. Foreign patent
                                                  applications.                                                                                                 applications are filed on selected
                                                    Place: Residence Inn Bethesda, 7335                   National Institutes of Health                         inventions to extend market coverage
                                                  Wisconsin Ave., Bethesda, MD 20814.
                                                    Contact Person: Raymond Jacobson, Ph.D.,
                                                                                                                                                                for companies and may also be available
                                                                                                          National Institute of Dental and                      for licensing.
                                                  Scientific Review Officer, Center for                   Craniofacial Research; Notice of
                                                  Scientific Review, National Institutes of                                                                     FOR FURTHER INFORMATION CONTACT:
                                                  Health, 6701 Rockledge Drive, Room 5858,
                                                                                                          Closed Meeting                                        Licensing information and copies of the
                                                  MSC 7849, Bethesda, MD 20892, 301–996–                    Pursuant to section 10(d) of the                    patent applications listed below may be
                                                  7702, jacobsonrh@csr.nih.gov.                           Federal Advisory Committee Act, as                    obtained by communicating with the
                                                    Name of Committee: Center for Scientific              amended (5 U.S.C. App.), notice is                    indicated licensing contact at the
                                                  Review Special Emphasis Panel; RFA–                     hereby given of the following meeting.                Technology Transfer and Intellectual
mstockstill on DSK3G9T082PROD with NOTICES




                                                  RM16–007: Transformative Research Award                   The meeting will be closed to the                   Property Office, National Institute of
                                                  Review.
                                                                                                          public in accordance with the                         Allergy and Infectious Diseases, 5601
                                                    Date: March 31, 2017.
                                                    Time: 8:00 a.m. to 6:00 p.m.                          provisions set forth in sections                      Fishers Lane, Rockville, MD 20852; tel.
                                                    Agenda: To review and evaluate grant                  552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,            301–496–2644. A signed Confidential
                                                  applications.                                           as amended. The contract proposals and                Disclosure Agreement will be required
                                                    Place: Residence Inn Bethesda, 7335                   the discussions could disclose                        to receive copies of unpublished patent
                                                  Wisconsin Avenue, Bethesda, MD 20814.                   confidential trade secrets or commercial              applications.


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                                                                               Federal Register / Vol. 82, No. 44 / Wednesday, March 8, 2017 / Notices                                              12977

                                                  SUPPLEMENTARY INFORMATION:                              Acad Sci U S A. 2011 Aug                                Name of Committee: Center for Scientific
                                                  Technology description follows.                         9;108(32):13275–80. [PMID 21788485].                  Review Special Emphasis Panel; PAR–16–
                                                                                                             2. Srinivasan P, et al. Disrupting                 115: Optimization of Monoclonal Antibodies
                                                  AMA1–RON2 Complex-Based Vaccine                                                                               for Eliminating the HIV Reservoir.
                                                  Against Malaria                                         malaria parasite AMA1–RON2
                                                                                                                                                                  Date: March 28, 2017.
                                                                                                          interaction with a small molecule
                                                  Description of Technology                                                                                       Time: 10:00 a.m. to 1:00 p.m.
                                                                                                          prevents erythrocyte invasion. Nat
                                                                                                                                                                  Agenda: To review and evaluate grant
                                                     This technology relates to a malaria                 Commun. 2013;4:2261. [PMID                            applications.
                                                  vaccine composed of a protein complex                   23907321].                                              Place: National Institutes of Health, 6701
                                                  of Apical Membrane Antigen (AMA1)                          Intellectual Property: HHS Reference               Rockledge Drive, Bethesda, MD 20892.
                                                  and rhoptry neck protein 2 (RON2) with                  No. E–066–2013/0—U.S. Provisional                       Contact Person: Barna Dey, Ph.D.,
                                                  an adjuvant. AMA1 is a crucial                          Application No. 61/841,479 filed 01 Jul               Scientific Review Officer, Center for
                                                  component of the Plasmodium invasion                    2013; PCT Application No. PCT/                        Scientific Review, National Institutes of
                                                  machinery and is a leading candidate                    US2014/045065, filed July 1, 2014;                    Health, 6701 Rockledge Drive, Room 3184,
                                                  for antimalarial vaccine development.                   European Application No. 14742116.8,                  Bethesda, MD 20892, 301–451–2796, bdey@
                                                  AMA1-based vaccines have shown                          filed July 1, 2014 (pending); U.S.                    mail.nih.gov.
                                                  ability to block red cell invasion in in                Application No. 14/902,117, filed                       Name of Committee: Center for Scientific
                                                  vitro assays, but protection has so far                 August December 30, 2015 (pending);                   Review Special Emphasis Panel; PAR Panel:
                                                  not translated to in vivo human                         and Chinese Application No.                           Basic Research on HIV Persistence.
                                                  infections. NIAID investigators have                    201480037643.1, filed December 31,                      Date: March 28, 2017.
                                                  demonstrated that interaction between                   2015 (pending).                                         Time: 1:00 p.m. to 6:00 p.m.
                                                  AMA1 and RON2 (or peptide thereof) is                      Licensing Contact: Peter Tung, 240–                  Agenda: To review and evaluate grant
                                                                                                                                                                applications.
                                                  essential for malaria parasites to                      669–5483; peter.tung@nih.gov.
                                                                                                                                                                  Contact Person: National Institutes of
                                                  successfully enter human red blood                      Collaborative Research Opportunity:
                                                                                                                                                                Health, 6701 Rockledge Drive, Bethesda, MD
                                                  cells (RBCs). Vaccination with un-                      The National Institute of Allergy and                 20892.
                                                  complexed AMA1 and RON2 did not                         Infectious Diseases is seeking statements               Contact Person: Barna Dey, Ph.D.,
                                                  protect against lethal malaria. However,                of capability and interest from parties               Scientific Review Officer, Center for
                                                  vaccination with a pre-formed AMA1–                     interested in collaborative research to               Scientific Review, National Institutes of
                                                  RON2 complex, highlighted in this                       further develop, evaluate or                          Health, 6701 Rockledge Drive, Room 3184,
                                                  technology, produced antibodies that                    commercialize AMA1–RON2 vaccine by                    Bethesda, MD 20892, 301–451–2796, bdey@
                                                  protected against lethal malaria in an in               providing well established human                      mail.nih.gov.
                                                  vivo mouse model (P. yoelli) and                        adjuvants and clinical trial funding. For               Name of Committee: Center for Scientific
                                                  blocked the entry of human malaria                      collaboration opportunities, please                   Review Special Emphasis Panel; Member
                                                  parasites into RBCs in vitro.                           contact Peter Tung, 240–669–5483;                     Conflict: Cancer Research.
                                                  Additionally, the inhibitory antibody                   peter.tung@nih.gov.                                     Date: March 29, 2017.
                                                  response induced by the AMA1–RON2                          Dated: February 24, 2017.                            Time: 11:00 a.m. to 6:00 p.m.
                                                  complex was greater than AMA1 alone                     Suzanne Frisbie,                                        Agenda: To review and evaluate grant
                                                  or when AMA1 and RON2 proteins                                                                                applications.
                                                                                                          Deputy Director, Technology Transfer and
                                                  were administered in a un-complexed                     Intellectual Property Office, National Institute
                                                                                                                                                                  Place: National Institutes of Health, 6701
                                                  form.                                                                                                         Rockledge Drive, Bethesda, MD 20892,
                                                                                                          of Allergy and Infectious Diseases.
                                                     Immunization using the AMA1–RON2                                                                           (Telephone Conference Call).
                                                                                                          [FR Doc. 2017–04501 Filed 3–7–17; 8:45 am]
                                                  complex of this technology represents a                                                                         Contact Person: C–L Albert Wang, Ph.D.,
                                                                                                          BILLING CODE 4140–01–P                                Scientific Review Officer, Center for
                                                  candidate for an effective malaria
                                                  vaccine against multiple Plasmodium                                                                           Scientific Review, National Institutes of
                                                  species.                                                                                                      Health, 6701 Rockledge Drive, Room 4146,
                                                                                                          DEPARTMENT OF HEALTH AND                              MSC 7806, Bethesda, MD 20892, 301–435–
                                                     This technology is available for                     HUMAN SERVICES                                        1016, wangca@csr.nih.gov.
                                                  licensing for commercial development
                                                  in accordance with 35 U.S.C. 209 and 37                                                                         Name of Committee: Center for Scientific
                                                                                                          National Institutes of Health
                                                  CFR part 404, as well as for further                                                                          Review Special Emphasis Panel; Member
                                                                                                          Center for Scientific Review; Notice of               Conflict: Vaccine, Host Defense and
                                                  development and evaluation under a
                                                                                                                                                                Inflammation.
                                                  research collaboration.                                 Closed Meetings
                                                                                                                                                                  Date: March 29, 2017.
                                                  Potential Commercial Applications                         Pursuant to section 10(d) of the                      Time: 3:00 p.m. to 7:00 p.m.
                                                                                                          Federal Advisory Committee Act, as                      Agenda: To review and evaluate grant
                                                  • Malaria vaccine                                                                                             applications.
                                                                                                          amended (5 U.S.C. App.), notice is
                                                  Competitive Advantages                                  hereby given of the following meetings.                 Place: National Institutes of Health, 6705
                                                                                                                                                                Rockledge Drive, Bethesda, MD 20817
                                                    Lower-cost malarial prevention for                      The meetings will be closed to the                  (Telephone Conference Call).
                                                  developing/developed countries.                         public in accordance with the                           Contact Person: Betty Hayden, Ph.D.,
                                                                                                          provisions set forth in sections                      Scientific Review Officer, Center for
                                                  Development Stage
                                                                                                          552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,            Scientific Review, National Institutes of
                                                    • Early-stage.                                        as amended. The grant applications and                Health, 6701 Rockledge Drive, Room 4206,
                                                    • In vitro data available.                            the discussions could disclose
mstockstill on DSK3G9T082PROD with NOTICES




                                                                                                                                                                MSC 7812, Bethesda, MD 20892, 301–435–
                                                    • In vivo data available (animal).                    confidential trade secrets or commercial              1223, haydenb@csr.nih.gov.
                                                    Inventors: Prakash Srinivasan and                     property such as patentable material,                 (Catalogue of Federal Domestic Assistance
                                                  Louis Miller (NIAID).                                   and personal information concerning                   Program Nos. 93.306, Comparative Medicine;
                                                    1. Publications: Srinivasan P, et al.                 individuals associated with the grant                 93.333, Clinical Research, 93.306, 93.333,
                                                  Binding of Plasmodium merozoite                         applications, the disclosure of which                 93.337, 93.393–93.396, 93.837–93.844,
                                                  proteins RON2 and AMA1 triggers                         would constitute a clearly unwarranted                93.846–93.878, 93.892, 93.893, National
                                                  commitment to invasion. Proc Natl                       invasion of personal privacy.                         Institutes of Health, HHS)



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Document Created: 2017-03-08 05:07:08
Document Modified: 2017-03-08 05:07:08
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactLicensing information and copies of the patent applications 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 Citation82 FR 12976 

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