Prospective Grant of an Exclusive Patent License: Virus-Like Particles Vaccines Against Human Polyomaviruses, BK Virus (BKV) and JC Virus (JCV), 2555-2556 [2019-01430]

Download as PDF Federal Register / Vol. 84, No. 26 / Thursday, February 7, 2019 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES 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, 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: Cardiovascular and Respiratory Sciences Integrated Review Group; Respiratory Integrative Biology and Translational Research Study Section. Date: February 20–21, 2019. Time: 7:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Baltimore Marriott Waterfront, 700 Aliceanna Street, Baltimore, MD 21202. Contact Person: Bradley Nuss, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4142, MSC 7814, Bethesda, MD 20892, 301–451– 8754, nussb@csr.nih.gov. (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: February 1, 2019. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–01400 Filed 2–6–19; 8:45 am] BILLING CODE 4140–01–P [FR Doc. 2019–01348 Filed 2–6–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent License: Virus-Like Particles Vaccines Against Human Polyomaviruses, BK Virus (BKV) and JC Virus (JCV) ACTION: National Institutes of Health, Notice. The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the U.S. and foreign Patents and Patent Applications listed in the Supplementary Information section of this notice to BioE Holdings Inc. (parent company, Biological E Ltd.) located in Los Altos, California. SUMMARY: National Cancer Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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., Jkt 247001 Dated: February 1, 2019. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. HHS. National Institutes of Health 17:23 Feb 06, 2019 Name of Committee: National Cancer Institute Special Emphasis Panel; Outstanding Investigator Award (OIA). Date: March 7–8, 2019. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Gaithersburg Marriott Washingtonian Center, 9751 Washingtonian Boulevard, Gaithersburg, MD 20878. Contact Person: Klaus B. Piontek, Ph.D., Scientific Review Officer, Research Programs Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W116, Bethesda, MD 20892–9750, 240–276–5413 klaus.piontek@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) AGENCY: DEPARTMENT OF HEALTH AND HUMAN SERVICES VerDate Sep<11>2014 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 grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 2555 Only written comments and/or applications for a license which are received by the National Cancer Institute’s Technology Transfer Center on or before February 22, 2019 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, and comments relating to the contemplated an Exclusive Patent License should be directed to: Kevin W. Chang, Ph.D., Senior Technology Transfer Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, Rm. 1E530 MSC 9702, Bethesda, MD 20892–9702 (for business mail), Rockville, MD 20850– 9702, Telephone: (240)–276–5530; Facsimile: (240)–276–5504, Email: changke@mail.nih.gov. SUPPLEMENTARY INFORMATION: DATES: Intellectual Property United States Provisional Patent Application No. 61/508,897 filed July 18, 2011 and entitled, ‘‘Methods and Compositions for Inhibiting Polyomavirus-Associated Pathology’’ [HHS Reference No. E–168–2011–0–US– 01]; PCT Patent Application No. PCT/ US2012/047069 filed July 17, 2012, and entitled, ‘‘Methods and Compositions for Inhibiting Polyomavirus-Associated Pathology’’ [HHS Reference No. E–168– 2011–0–PCT–02]; Australian Patent No. 2012284122 issued September 14, 2017, and entitled, ‘‘Methods and Compositions for Inhibiting Polyomavirus-Associated Pathology’’ [HHS Reference No. E–168–2011–0– AU–03]; Canadian Patent Application No. 2842180 filed July 17, 2012 and entitled, ‘‘Methods and Compositions for Inhibiting Polyomavirus-Associated Pathology’’ [HHS Ref. No. E–168–2011– 0–CA–04]; European Patent Application No. 12741191.6 filed July 17, 2012 and entitled, ‘‘Methods and Compositions for Inhibiting Polyomavirus-Associated Pathology’’ [HHS Ref. No. E–168–2011– 0–EP–05]; Japanese Patent No. 6030650 issued October 28, 2016 and entitled, ‘‘Methods and Compositions for Inhibiting Polyomavirus-Associated Pathology’’ [HHS Ref. No. E–168–2011– 0–JP–06]; United States Patent No. 9,764,022 issued September 19, 2017 and entitled, ‘‘Methods and Compositions for Inhibiting Polyomavirus-Associated Pathology’’ [HHS Ref. No. E–168–2011–0–US–07]; United States Patent Application No. 15/694,567 filed September 1, 2017 and entitled, ‘‘Methods and Compositions for Inhibiting Polyomavirus-Associated Pathology’’ [HHS Ref. No. E–168–2011– 0–US–08]; United States Provisional Patent Application No. 61/919,043 filed December 20, 2013 and entitled, E:\FR\FM\07FEN1.SGM 07FEN1 2556 Federal Register / Vol. 84, No. 26 / Thursday, February 7, 2019 / Notices ‘‘Immunogenic JC Polyomavirus Compositions and Methods of Use’’ [HHS Reference No. E–549–2013–0–US– 01]; PCT Patent Application No. PCT/ US2014/071621 filed December 19, 2014, and entitled, ‘‘Immunogenic JC Polyomavirus Compositions and Methods of Use’’ [HHS Reference No. E– 549–2013–0–PCT–02]; United States Patent No. 9,931,393 issued April 3, 2018, and entitled, ‘‘Immunogenic JC Polyomavirus Compositions and Methods of Use’’ [HHS Reference No. E– 549–2013–0–US–03]; and U.S. and foreign patent applications claiming priority to the aforementioned applications. The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America. The prospective exclusive license territory may be world-wide, and the field of use may be limited to the use of Licensed Patent Rights for the following: ‘‘Virus-Like Particle (VLP) BKV and JCV polyomavirus vaccine(s) for the prevention and/or treatment of BKV and/or JCV associated diseases in organ/kidney transplantation, bone marrow transplantation, and progressive multifocal leukoencephalopathy (PML).’’ This technology discloses vaccine compositions and methods for eliciting immune responses to prevent or treat infections by two human polyomaviruses, BK virus (BKV) and JC virus (JCV), and their associated diseases using the vaccine compositions, which employ the capsid protein of certain serotypes of BKV and JCV as the immunogen. In particular, the vaccine is composed of virus-like particles that are formed from the capsid proteins of the viruses. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404. In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a license application, will not be treated confidentially, and may be made publicly available. License applications submitted in response to this Notice will be presumed to contain business confidential information and any release VerDate Sep<11>2014 17:23 Feb 06, 2019 Jkt 247001 of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552. Dated: January 31, 2019. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2019–01430 Filed 2–6–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Environmental Health Sciences; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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 Environmental Health Sciences Special Emphasis Panel; Maintain and Enrich Resource Infrastructure for Existing Environmental Epidemiology Cohorts. Date: March 6, 2019. Time: 8:15 a.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Capital View Hotel, 2850 South Potomac Avenue, Arlington, VA 22202. Contact Person: Linda K. Bass, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, Nat. Institute Environmental Health Sciences, Research Triangle Park, NC 27709, (919) 541–1307, bass@niehs.nih.gov. Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel; Maintain and Enrich Resource Infrastructure for Existing Environmental Epidemiology Cohorts R24. Date: March 6, 2019. Time: 3:30 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Capital View, 2850 South Potomac Avenue, Arlington, VA 22202. Contact Person: Varsha Shukla, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 Training, Nat. Institute Environmental Health Sciences, Research Triangle Park, NC 27709, (984) 287–3288, varsha.shukla@nih.gov. Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel; Human Health Exposure Analysis Resource: Coordinating Center. Date: March 6, 2019. Time: 4:30 p.m. to 6:30 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Capital View Hotel, 2850 South Potomac Avenue, Arlington, VA 22202. Contact Person: Linda K. Bass, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, Nat. Institute Environmental Health Sciences, Research Triangle Park, NC 27709, (919) 541–1307, bass@niehs.nih.gov. Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel; Human Health Exposure Analysis Resource: Data Repository Center. Date: March 7, 2019. Time: 8:00 a.m. to 11:00 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Capital View Hotel, 2850 South Potomac Avenue, Arlington, VA 22202. Contact Person: Alfonso R. Latoni, Ph.D., Scientific Review Branch, Division of Extramural Research and Training, National Institute of Environmental Health Sciences, Research Triangle Park, NC 27709, 919–541– 7571, alfonso.latoni@nih.gov. Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel; Human Health Exposure Analysis Resource: Targeted Exposure Analysis Laboratories. Date: March 7–8, 2019. Time: 12:00 p.m. to 11:00 a.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Capital View Hotel, 2850 South Potomac Avenue, Arlington, VA 22202. Contact Person: Leroy Worth, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, Nat. Institute of Environmental Health, Research Triangle Park, NC 27709, (919) 541–0670, worth@niehs.nih.gov. Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel; Human Health Exposure Analysis Resource: UnTargeted Exposure Analysis Laboratories. Date: March 8, 2019. Time: 12:00 p.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Capital View Hotel, 2850 South Potomac Avenue, Arlington, VA 22202. Contact Person: Leroy Worth, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, Nat. Institute of Environmental Health Sciences, Research Triangle Park, NC 27709, (919) 541–0670, worth@niehs.nih.gov. Name of Committee: National Institute of Environmental Health Sciences Special E:\FR\FM\07FEN1.SGM 07FEN1

Agencies

[Federal Register Volume 84, Number 26 (Thursday, February 7, 2019)]
[Notices]
[Pages 2555-2556]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01430]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Virus-Like 
Particles Vaccines Against Human Polyomaviruses, BK Virus (BKV) and JC 
Virus (JCV)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The National Cancer Institute, an institute of the National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an Exclusive Patent License to practice the 
inventions embodied in the U.S. and foreign Patents and Patent 
Applications listed in the Supplementary Information section of this 
notice to BioE Holdings Inc. (parent company, Biological E Ltd.) 
located in Los Altos, California.

DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute's Technology Transfer 
Center on or before February 22, 2019 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated an Exclusive Patent License 
should be directed to: Kevin W. Chang, Ph.D., Senior Technology 
Transfer Manager, NCI Technology Transfer Center, 9609 Medical Center 
Drive, Rm. 1E530 MSC 9702, Bethesda, MD 20892-9702 (for business mail), 
Rockville, MD 20850-9702, Telephone: (240)-276-5530; Facsimile: (240)-
276-5504, Email: changke@mail.nih.gov.

SUPPLEMENTARY INFORMATION: 

Intellectual Property

    United States Provisional Patent Application No. 61/508,897 filed 
July 18, 2011 and entitled, ``Methods and Compositions for Inhibiting 
Polyomavirus-Associated Pathology'' [HHS Reference No. E-168-2011-0-US-
01]; PCT Patent Application No. PCT/US2012/047069 filed July 17, 2012, 
and entitled, ``Methods and Compositions for Inhibiting Polyomavirus-
Associated Pathology'' [HHS Reference No. E-168-2011-0-PCT-02]; 
Australian Patent No. 2012284122 issued September 14, 2017, and 
entitled, ``Methods and Compositions for Inhibiting Polyomavirus-
Associated Pathology'' [HHS Reference No. E-168-2011-0-AU-03]; Canadian 
Patent Application No. 2842180 filed July 17, 2012 and entitled, 
``Methods and Compositions for Inhibiting Polyomavirus-Associated 
Pathology'' [HHS Ref. No. E-168-2011-0-CA-04]; European Patent 
Application No. 12741191.6 filed July 17, 2012 and entitled, ``Methods 
and Compositions for Inhibiting Polyomavirus-Associated Pathology'' 
[HHS Ref. No. E-168-2011-0-EP-05]; Japanese Patent No. 6030650 issued 
October 28, 2016 and entitled, ``Methods and Compositions for 
Inhibiting Polyomavirus-Associated Pathology'' [HHS Ref. No. E-168-
2011-0-JP-06]; United States Patent No. 9,764,022 issued September 19, 
2017 and entitled, ``Methods and Compositions for Inhibiting 
Polyomavirus-Associated Pathology'' [HHS Ref. No. E-168-2011-0-US-07]; 
United States Patent Application No. 15/694,567 filed September 1, 2017 
and entitled, ``Methods and Compositions for Inhibiting Polyomavirus-
Associated Pathology'' [HHS Ref. No. E-168-2011-0-US-08]; United States 
Provisional Patent Application No. 61/919,043 filed December 20, 2013 
and entitled,

[[Page 2556]]

``Immunogenic JC Polyomavirus Compositions and Methods of Use'' [HHS 
Reference No. E-549-2013-0-US-01]; PCT Patent Application No. PCT/
US2014/071621 filed December 19, 2014, and entitled, ``Immunogenic JC 
Polyomavirus Compositions and Methods of Use'' [HHS Reference No. E-
549-2013-0-PCT-02]; United States Patent No. 9,931,393 issued April 3, 
2018, and entitled, ``Immunogenic JC Polyomavirus Compositions and 
Methods of Use'' [HHS Reference No. E-549-2013-0-US-03]; and U.S. and 
foreign patent applications claiming priority to the aforementioned 
applications.
    The patent rights in these inventions have been assigned and/or 
exclusively licensed to the government of the United States of America.
    The prospective exclusive license territory may be world-wide, and 
the field of use may be limited to the use of Licensed Patent Rights 
for the following: ``Virus-Like Particle (VLP) BKV and JCV polyomavirus 
vaccine(s) for the prevention and/or treatment of BKV and/or JCV 
associated diseases in organ/kidney transplantation, bone marrow 
transplantation, and progressive multifocal leukoencephalopathy 
(PML).''
    This technology discloses vaccine compositions and methods for 
eliciting immune responses to prevent or treat infections by two human 
polyomaviruses, BK virus (BKV) and JC virus (JCV), and their associated 
diseases using the vaccine compositions, which employ the capsid 
protein of certain serotypes of BKV and JCV as the immunogen. In 
particular, the vaccine is composed of virus-like particles that are 
formed from the capsid proteins of the viruses.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive license will be royalty bearing, 
and the prospective exclusive license may be granted unless within 
fifteen (15) days from the date of this published notice, the National 
Cancer Institute receives written evidence and argument that 
establishes that the grant of the license would not be consistent with 
the requirements of 35 U.S.C. 209 and 37 CFR part 404.
    In response to this Notice, the public may file comments or 
objections. Comments and objections, other than those in the form of a 
license application, will not be treated confidentially, and may be 
made publicly available.
    License applications submitted in response to this Notice will be 
presumed to contain business confidential information and any release 
of information in these license applications will be made only as 
required and upon a request under the Freedom of Information Act, 5 
U.S.C. 552.

    Dated: January 31, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2019-01430 Filed 2-6-19; 8:45 am]
 BILLING CODE 4140-01-P

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