Government-Owned Inventions; Availability for Licensing, 23014-23015 [2017-10156]

Download as PDF 23014 Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices Complete applications for a license in the prospective field of use that are timely filed in response to this notice will be treated as objections to the grant of the contemplated Exclusive Patent License. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: May 11, 2017. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2017–10154 Filed 5–18–17; 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: Manufacturing and Testing of PVSRIPO in the Treatment of Solid, Non-lymphoid Tumors Expressing Poliovirus Receptor CD155 AGENCY: National Institutes of Health, HHS. ACTION: 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 Commercialization Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Istari Oncology Incorporated located in North Carolina, U.S.A. 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 June 5, 2017 will be considered. SUMMARY: Requests for copies of the patent application, inquiries, and comments relating to the contemplated Exclusive Commercialization Patent License should be directed to: Lauren Nguyen-Antczak, Ph.D., J.D., Senior Licensing and Patenting 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: lauren.nguyen-antczak@nih.gov. SUPPLEMENTARY INFORMATION: asabaliauskas on DSK3SPTVN1PROD with NOTICES ADDRESSES: VerDate Sep<11>2014 19:15 May 18, 2017 Jkt 241001 Intellectual Property United States Provisional Patent Application No. 62/173,777, filed June 10, 2015 and entitled ‘‘Processes for Production and Purification of Nucleic Acid Containing Compositions’’ [HHS Reference No. E–267–2014/0–US–01]; PCT Patent Application PCT/US2016/ 036888, filed E–267–2014/0–PCT–02 and entitled ‘‘Processes for Production and Purification of Nucleic Acid Containing Compositions’’ [HHS Reference No. E–267–2014/0–PCT–02]; United States Provisional Patent Application No. 62/199,663, filed July 31, 2015 and entitled ‘‘Methods of Analyzing Virus-Derived Therapeutics’’ [HHS Reference No. E–240–2015/0–US– 01]; PCT Patent Application PCT/US2016/ 044788, filed July 29, 2016 and entitled ‘‘Methods of Analyzing Virus-Derived Therapeutics’’ [HHS Reference No. E– 240–2015/1–PCT–01]; 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 worldwide and the field of use may be limited to the use of Licensed Patent Rights for the following: ‘‘Manufacturing and Testing of PVSRIPO in the Treatment of Solid, Non-lymphoid Tumors expressing Poliovirus Receptor CD155, wherein PVSRIPO is genetically recombinant, non-pathogenic poliovirus:rhinovirus chimera that consists of the genome of the live attenuated poliovirus serotype 1 (SABIN) vaccine (PV1S) with its cognate IRES element replaced with that of HRV2.’’ The E–267–2014 technology discloses improved methods for large scale production of highly purified, therapeutic grade, oncolytic polioviruses. Invention processes provide industrial scale, and cGMP compliant manufacturing of PVSRIPO. The E–240–2015 technology discloses improved methods for detecting genetic micro-heterogeneity in manufactured batches of RNA virus-derived therapeutics, such as PVSRIPO. 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 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404. Complete applications for a license in the prospective field of use that are filed in response to this notice will be treated as objections to the grant of the contemplated Exclusive Commercialization Patent License Agreement. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: May 12, 2017. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2017–10155 Filed 5–18–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. 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. Dianca Finch, 240–669–5503; dianca.finch@nih.gov. 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. SUPPLEMENTARY INFORMATION: Technology description follows. SUMMARY: Products for Treatment and Prevention of Ebola Zaire Disease Description of Technology Scientists at the NIAID Vaccine Research Center have developed human E:\FR\FM\19MYN1.SGM 19MYN1 Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices monoclonal neutralizing antibodies for treatment and prevention of Ebola Zaire disease. The monoclonal antibodies (mAbs) bind to different regions of the Ebola glycoprotein that are unique for these two mAbs. Alone or in combination, the mAbs prevent or reverse Ebola Zaire virus disease in nonhuman primates. Nonclinical studies have demonstrated complete protection against disease with a single antibody and complete protection against viremia by addition of a second antibody. The current nonclinical pharmacology demonstrates a favorable pharmacokinetic profile and there is a first-in-time human clinical trial projected for 2017. The anticipated indications for this technology include pre-and post-symptomatic treatment, and pre-and post-exposure prophylaxis. 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. • Therapeutics • Diagnostics • Favorable pharmacokinetic profile • Favorable manufacturing • Complete protection against disease with a single unique mAb • Complete protection with fewer administrations and/or lower doses than any other mAb • Complete protection against viremia with two antibodies Development Stage • In vivo data available (animal) • Entering first-in-time human clinical trial (2017) Inventors: Nancy J. Sullivan (NIAID); Barney S. Graham (NIAID); Julie Ledgerwood (NIAID); Daphne A. Stanley (NIAID); Antonio Lanzavecchia (IRB) Davide Corti (IRB); John Trefry (USAMRIID/WR) Publications asabaliauskas on DSK3SPTVN1PROD with NOTICES [FR Doc. 2017–10156 Filed 5–18–17; 8:45 am] DEPARTMENT OF HOMELAND SECURITY Competitive Advantages Corti D, et al., Protective monotherapy against lethal Ebola virus infection by a potently neutralizing antibody. Science. 2016 Mar 18;351:1339–42. [PMID: 26917593] Misasi J, et al., Structural and molecular basis for Ebola virus neutralization by protective human antibodies. Science. 2016 Mar 18;3511343–6. [PMID: 26917592]. Intellectual Property HHS Reference No. E–045–2015—U.S. Provisional Application No. 62/087,087, 19:15 May 18, 2017 Dated: May 9, 2017. Suzanne Frisbie, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. BILLING CODE 4140–01–P Potential Commercial Applications VerDate Sep<11>2014 filed December 3, 2014; PCT Application No. PCT/US2015/060733, filed November 13, 2015 HHS Reference No. E–278–2016- U.S. Provisional Application No.62,080,094, filed November 14, 2014; PCT Application No. PCT/IB2015/002342, filed November 13, 2015 Licensing Contact: Dr. Dianca Finch, 240–669–5503; dianca.finch@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 products for treatment and prevention of Ebola Zaire disease. For collaboration opportunities, please contact Dr. Dianca Finch, 240–669– 5503; dianca.finch@nih.gov. Jkt 241001 U.S. Customs and Border Protection Notice of Issuance of Final Determination Concerning a Certain Visitor Management System U.S. Customs and Border Protection, Department of Homeland Security. ACTION: Notice of final determination. AGENCY: This document provides notice that U.S. Customs and Border Protection (‘‘CBP’’) has issued a final determination concerning the country of origin of a certain visitor management system known as the Raptor Basic System. Based upon the facts presented for purposes of U.S. Government procurement, CBP has concluded that China is the country of origin of the identification scanner and printer components of the Raptor Basic System, that the United States is the country of origin of the label component of the Raptor Basic System, and that Taiwan is the country of origin of the barcode scanner that is compatible with the Raptor Basic System. DATES: The final determination was issued on May 08, 2017. A copy of the final determination is attached. Any party-at-interest, as defined in 19 CFR 177.22(d), may seek judicial review of this final determination within June 19, 2017. SUMMARY: PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 23015 FOR FURTHER INFORMATION CONTACT: Robert Dinerstein, Valuation and Special Programs Branch, Regulations and Rulings, Office of Trade, at (202) 325–0132. SUPPLEMENTARY INFORMATION: Notice is hereby given that on May 08, 2017, pursuant to subpart B of Part 177, U.S. Customs and Border Protection Regulations (19 CFR part 177, subpart B), CBP issued a final determination concerning the country of origin of a certain visitor management system known as the Raptor Basic System, which may be offered to the U.S. Government under an undesignated government procurement contract. This final determination, HQ H277116, was issued under procedures set forth at 19 CFR part 177, subpart B, which implements Title III of the Trade Agreements Act of 1979, as amended (19 U.S.C. 2511–18). In the final determination, CBP concluded that the identification scanner and printer components of the Raptor Basic System were not substantially transformed in the United States, and thus remain products of China. Additionally, CBP concluded that the label component of the Raptor Basic System was a product of the United States and that the barcode scanner that is compatible with the Raptor Basic System was a product of Taiwan. Therefore, for purposes of U.S. Government procurement, China is the country of origin of the identification scanner and printer components of the Raptor Basic System, the United States is the country of origin of the label component of the Raptor Basic System, and Taiwan is the country of origin of the barcode scanner that is compatible with the Raptor Basic System. Section 177.29, CBP Regulations (19 CFR 177.29), provides that a notice of final determination shall be published in the Federal Register within 60 days of the date the final determination is issued. Section 177.30, CBP Regulations (19 CFR 177.30), provides that any party-at-interest, as defined in 19 CFR 177.22(d), may seek judicial review of a final determination within 30 days of publication of such determination in the Federal Register. Dated: May 08, 2017. Alice A. Kipel, Executive Director, Regulations and Rulings, Office of Trade. HQ H277116 May 08, 2017 OT:RR:CTF:VS H277116 AJR Ms. Heather Mims Centre Law and Consulting LLC 8330 Boone Boulevard, Suite 300 E:\FR\FM\19MYN1.SGM 19MYN1

Agencies

[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)]
[Notices]
[Pages 23014-23015]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10156]


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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: Dr. Dianca Finch, 240-669-5503; 
dianca.finch@nih.gov. 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.

SUPPLEMENTARY INFORMATION: Technology description follows.

Products for Treatment and Prevention of Ebola Zaire Disease

Description of Technology

    Scientists at the NIAID Vaccine Research Center have developed 
human

[[Page 23015]]

monoclonal neutralizing antibodies for treatment and prevention of 
Ebola Zaire disease. The monoclonal antibodies (mAbs) bind to different 
regions of the Ebola glycoprotein that are unique for these two mAbs. 
Alone or in combination, the mAbs prevent or reverse Ebola Zaire virus 
disease in non-human primates. Nonclinical studies have demonstrated 
complete protection against disease with a single antibody and complete 
protection against viremia by addition of a second antibody. The 
current nonclinical pharmacology demonstrates a favorable 
pharmacokinetic profile and there is a first-in-time human clinical 
trial projected for 2017. The anticipated indications for this 
technology include pre-and post-symptomatic treatment, and pre-and 
post-exposure prophylaxis.
    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

     Therapeutics
     Diagnostics

Competitive Advantages

     Favorable pharmacokinetic profile
     Favorable manufacturing
     Complete protection against disease with a single unique 
mAb
     Complete protection with fewer administrations and/or 
lower doses than any other mAb
     Complete protection against viremia with two antibodies

Development Stage

     In vivo data available (animal)
     Entering first-in-time human clinical trial (2017)
    Inventors: Nancy J. Sullivan (NIAID); Barney S. Graham (NIAID); 
Julie Ledgerwood (NIAID); Daphne A. Stanley (NIAID); Antonio 
Lanzavecchia (IRB) Davide Corti (IRB); John Trefry (USAMRIID/WR)

Publications

Corti D, et al., Protective monotherapy against lethal Ebola virus 
infection by a potently neutralizing antibody. Science. 2016 Mar 
18;351:1339-42. [PMID: 26917593]
Misasi J, et al., Structural and molecular basis for Ebola virus 
neutralization by protective human antibodies. Science. 2016 Mar 
18;3511343-6. [PMID: 26917592].

Intellectual Property

    HHS Reference No. E-045-2015--U.S. Provisional Application No. 62/
087,087, filed December 3, 2014; PCT Application No. PCT/US2015/060733, 
filed November 13, 2015 HHS Reference No. E-278-2016- U.S. Provisional 
Application No.62,080,094, filed November 14, 2014; PCT Application No. 
PCT/IB2015/002342, filed November 13, 2015
    Licensing Contact: Dr. Dianca Finch, 240-669-5503; 
dianca.finch@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 products for treatment and 
prevention of Ebola Zaire disease. For collaboration opportunities, 
please contact Dr. Dianca Finch, 240-669-5503; dianca.finch@nih.gov.

    Dated: May 9, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2017-10156 Filed 5-18-17; 8:45 am]
 BILLING CODE 4140-01-P