Government-Owned Inventions; Availability for Licensing, 52697-52698 [2016-18861]

Download as PDF Federal Register / Vol. 81, No. 153 / Tuesday, August 9, 2016 / Notices asabaliauskas on DSK3SPTVN1PROD with NOTICES individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel; NIDCD Institutional Research Training Grant Application Review. Date: September 7, 2016. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW., Washington, DC 20015. Contact Person: Shiguang Yang, DVM, Ph.D., Scientific Review Officer Division of Extramural Activities NIDCD, NIH, 6001 Executive Blvd., Room 8349, Bethesda, MD 20892, 301–496–8683, yangshi@ nidcd.nih.gov. Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel; NIDCD Clinical Research Center Grant (P50) Review. Date: September 14, 2016. Time: 11:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Katherine Shim, Ph.D., Scientific Review Officer, Division of Extramural Activities, NIH/NIDCD, 6001 Executive Blvd., Room 8351, Bethesda, MD 20892, 301–496–8683, katherine.shim@ nih.gov. Name of Committee: National Institute on Deafness and Other Communication Disorders, Special Emphasis Panel; P50 Review Meeting. Date: September 19, 2016. Time: 2:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Kausik Ray, Ph.D., Scientific Review Officer, National Institute on Deafness and Other Communication Disorders, National Institutes of Health, Rockville, MD 20850, 301–402–3587, rayk@ nidcd.nih.gov. Name of Committee: National Institute on Deafness and Other Communication Disorders, Special Emphasis Panel; Revised CRC Grant Review. Date: September 20, 2016. Time: 11:00 a.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Sheo Singh, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Activities, 6001 Executive Blvd., Room 8351, Bethesda, VerDate Sep<11>2014 20:00 Aug 08, 2016 Jkt 238001 52697 MD 20892, 301–496–8683, singhs@ nidcd.nih.gov. Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel; VSL Clinical Trial Review. Date: September 22, 2016. Time: 11:00 a.m. to 12:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Shiguang Yang, DVM, Ph.D., Scientific Review Officer, Division of Extramural Activities, NIDCD, NIH, 6001 Executive Blvd., Room 8349, Bethesda, MD 20892, 301–496–8683, yangshi@ nidcd.nih.gov. Name of Committee: National Institute on Deafness and Other Communication Disorders, Special Emphasis Panel; Synaptopathy R01 Review. Date: October 4, 2016. Time: 1:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Kausik Ray, Ph.D., Scientific Review Officer, National Institute on Deafness and Other Communication Disorders, National Institutes of Health, Rockville, MD 20850, 301–402–3587, rayk@ nidcd.nih.gov. Name of Committee: Communication Disorders Review Committee. Date: October 6–7, 2016. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Eliane Lazar-Wesley, Scientific Review Officer, Division of Extramural Activities, National Institute on Deafness and other Communication Disorders/NIH, 6001 Executive Blvd., MSC 9670, Bethesda, MD 20892–8401, 301–496– 8683, el6r@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.173, Biological Research Related to Deafness and Communicative Disorders, National Institutes of Health, HHS) DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: August 3, 2016. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2016–18864 Filed 8–8–16; 8:45 am] Government-Owned Inventions; Availability for Licensing BILLING CODE 4140–01–P PO 00000 National Institutes of Health Center for Scientific Review; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Risk, Prevention, and Health Behavior. Date: August 11, 2016. Time: 10:00 a.m. to 11:00 a.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Martha M. Faraday, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3110, MSC 7808, Bethesda, MD 20892, faradaym@ csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: August 4, 2016. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–18865 Filed 8–8–16; 8:45 am] BILLING CODE 4140–01–P National Institutes of Health AGENCY: National Institutes of Health, HHS. ACTION: Frm 00088 Fmt 4703 Sfmt 4703 E:\FR\FM\09AUN1.SGM Notice. 09AUN1 52698 Federal Register / Vol. 81, No. 153 / Tuesday, August 9, 2016 / Notices 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 codevelopment 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 ncitechtransfer@mail.nih.gov. A signed Confidential Disclosure Agreement may be required to receive copies of the patent applications. SUPPLEMENTARY INFORMATION: Technology description follows. Title of invention: Vaccines for HIV. Description of Technology: Although the development of an effective HIV vaccine has been an ongoing area of research, the high variability in HIV–1 virus strains has represented a major challenge in successful development. Ideally, an effective candidate vaccine would provide protection against the majority of clades of HIV. Two major challenges are immunodominance and sequence diversity. One strategy for overcoming these two issues is to identify the conserved regions of the virus and exploit them for use in a targeted therapy. Researchers at the National Cancer Institute’s Vaccine Branch used conserved elements (CEs) of the polypeptides Gag and Env as immunogenic compositions to induce an immune response to HIV–1 envelope polypeptides and Gag polypeptides. conserved elements (CEs) of the polypeptides Gag and Env as immunogenic compositions to induce an immune response to HIV–1 envelope polypeptides and Gag polypeptides. This invention is based, in part, on the discovery that administration of one or more polypeptides comprising CEs, separated by linkers and collinearly arranged, of HIV Env or Gag CE proteins asabaliauskas on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 20:00 Aug 08, 2016 Jkt 238001 can provide a robust immune response compared to administration of a fulllength Env or Gag protein. The Env-CE DNA vaccines were tested in a rhesus macaque model and were able to induce a cellular and humoral immune response in this model whereas vaccination with the full length DNA did not produce the same effect. A robust increase in immunity was observed when rhesus macaques were subjected to a prime-boost protocol. First, rhesus macaques were primed with Env-CE DNA and boosted with full length Env resulting in an observed increase in both the cellular and humoral responses. A further increase in immune response was observed from priming with CE and boosting with a combination of CE and full length DNA resulting in a significantly improved breadth of immune responses. These improved protocols may help solve the immunodominance problem observed in current protocols. This is considered a major obstacle for HIV vaccine development. The CE vaccines described by this invention have potential for use as prophylactic and therapeutic HIV vaccines. Potential Commercial Applications: • HIV vaccines Value Proposition: • Addresses two key hurdles faced by current HIV vaccines: sequence diversity of HIV and immunodominance. • Induces cross-clade specific immune response. • The prime-boost immunization regimen is not limited to HIV, but can be employed to improve the induction of immune responses to any subdominant epitopes (cellular or humoral) to increase breadth, magnitude and quality of the immune response. Development Stage: Pre-clinical (in vivo validation). Inventor(s): George Pavlakis, Barbara Felber, Antonio Valentin, James Mullins. Intellectual Property: HHS Reference #E–087–2015/0–US–01, corresponding to U.S. Provisional Patent App. #62/ 161,123, filed on May 13, 2015, entitled: HIV Env Conserved Element DNA Vaccine. HHS Reference #E–009–2016/0–US– 01, corresponding to U.S. Provisional Patent App. #62/241,599, filed on October 14, 2015, entitled: Prime-Boost combination vaccine to Expand Breadth of Immunological Response. HHS Reference #E–087–2015/0–PCT– 02; corresponding to International Patent App. #PCT/US2016/032317; filed on May 13, 2016, entitled: Methods and Compositions for inducing an immune PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 response using Conserved Element Constructs. Publications • Kulkarni, V. et al. PLoS One;9:e86254. 2014. https://journals.plos.org/plosone/ article?id=10.1371/journal.pone.0086254 • Kulkarni, V. et al. PLos One Oct 22;9(10):e111085. doi: 10.1371/ journal.pone.0111085. eCollection, 2014. https://journals.plos.org/plosone/ article?id=10.1371/journal.pone.0111085 Related Technologies: HHS Reference #E–132–2012/0 Method of Altering the Immunodominance Hierarchy of HIV Gag by DNA Vaccine Expressing Conserved Regions. 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: john.hewes@ nih.gov. Dated: August 2, 2016. John D. Hewes, Technology Transfer Specialist, Technology Transfer Center, National Cancer Institute. [FR Doc. 2016–18861 Filed 8–8–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel; Review of Late Arriving K Mechanism Grant Applications. Date: August 17, 2016. Time: 8:00 a.m. to 11:00 a.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). E:\FR\FM\09AUN1.SGM 09AUN1

Agencies

[Federal Register Volume 81, Number 153 (Tuesday, August 9, 2016)]
[Notices]
[Pages 52697-52698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18861]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

[[Page 52698]]

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 
ncitechtransfer@mail.nih.gov. A signed Confidential Disclosure 
Agreement may be required to receive copies of the patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.
    Title of invention: Vaccines for HIV.
    Description of Technology: Although the development of an effective 
HIV vaccine has been an ongoing area of research, the high variability 
in HIV-1 virus strains has represented a major challenge in successful 
development. Ideally, an effective candidate vaccine would provide 
protection against the majority of clades of HIV. Two major challenges 
are immunodominance and sequence diversity. One strategy for overcoming 
these two issues is to identify the conserved regions of the virus and 
exploit them for use in a targeted therapy.
    Researchers at the National Cancer Institute's Vaccine Branch used 
conserved elements (CEs) of the polypeptides Gag and Env as immunogenic 
compositions to induce an immune response to HIV-1 envelope 
polypeptides and Gag polypeptides. conserved elements (CEs) of the 
polypeptides Gag and Env as immunogenic compositions to induce an 
immune response to HIV-1 envelope polypeptides and Gag polypeptides. 
This invention is based, in part, on the discovery that administration 
of one or more polypeptides comprising CEs, separated by linkers and 
collinearly arranged, of HIV Env or Gag CE proteins can provide a 
robust immune response compared to administration of a full-length Env 
or Gag protein. The Env-CE DNA vaccines were tested in a rhesus macaque 
model and were able to induce a cellular and humoral immune response in 
this model whereas vaccination with the full length DNA did not produce 
the same effect.
    A robust increase in immunity was observed when rhesus macaques 
were subjected to a prime-boost protocol. First, rhesus macaques were 
primed with Env-CE DNA and boosted with full length Env resulting in an 
observed increase in both the cellular and humoral responses. A further 
increase in immune response was observed from priming with CE and 
boosting with a combination of CE and full length DNA resulting in a 
significantly improved breadth of immune responses. These improved 
protocols may help solve the immunodominance problem observed in 
current protocols. This is considered a major obstacle for HIV vaccine 
development. The CE vaccines described by this invention have potential 
for use as prophylactic and therapeutic HIV vaccines.
    Potential Commercial Applications:
     HIV vaccines
    Value Proposition:
     Addresses two key hurdles faced by current HIV vaccines: 
sequence diversity of HIV and immunodominance.
     Induces cross-clade specific immune response.
     The prime-boost immunization regimen is not limited to 
HIV, but can be employed to improve the induction of immune responses 
to any subdominant epitopes (cellular or humoral) to increase breadth, 
magnitude and quality of the immune response.
    Development Stage: Pre-clinical (in vivo validation).
    Inventor(s): George Pavlakis, Barbara Felber, Antonio Valentin, 
James Mullins.
    Intellectual Property: HHS Reference #E-087-2015/0-US-01, 
corresponding to U.S. Provisional Patent App. #62/161,123, filed on May 
13, 2015, entitled: HIV Env Conserved Element DNA Vaccine.
    HHS Reference #E-009-2016/0-US-01, corresponding to U.S. 
Provisional Patent App. #62/241,599, filed on October 14, 2015, 
entitled: Prime-Boost combination vaccine to Expand Breadth of 
Immunological Response.
    HHS Reference #E-087-2015/0-PCT-02; corresponding to International 
Patent App. #PCT/US2016/032317; filed on May 13, 2016, entitled: 
Methods and Compositions for inducing an immune response using 
Conserved Element Constructs.

Publications

 Kulkarni, V. et al. PLoS One;9:e86254. 2014. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0086254
 Kulkarni, V. et al. PLos One Oct 22;9(10):e111085. doi: 
10.1371/journal.pone.0111085. eCollection, 2014. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0111085

    Related Technologies: HHS Reference #E-132-2012/0 Method of 
Altering the Immunodominance Hierarchy of HIV Gag by DNA Vaccine 
Expressing Conserved Regions.
    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: john.hewes@nih.gov.

    Dated: August 2, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology Transfer Center, National 
Cancer Institute.
[FR Doc. 2016-18861 Filed 8-8-16; 8:45 am]
 BILLING CODE 4140-01-P
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