Government-Owned Inventions; Availability for Licensing, 50667-50668 [2018-21762]

Download as PDF Federal Register / Vol. 83, No. 195 / Tuesday, October 9, 2018 / Notices 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 A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications.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. amozie on DSK3GDR082PROD with NOTICES1 Hybridoma Cell Lines Producing Antibodies to RSV NS1 Description of Technology: This technology provides a new set of hybridoma cell lines each expressing a single monoclonal antibody against human respiratory syncytial virus (RSV) nonstructural protein 1 (NS1). These antibodies have variously been shown to detect NS1 protein in an enzymelinked immunosorbent assay (ELISA), Western blot assay, immunofluorescence microscopy of paraformaldehyde-fixed cells, and flow cytometry. The various antibodies can vary in their efficiency in each of these assays. This technology provides a unique set of qualified monoclonal antibodies against RSV NS1 protein which currently do not exist. These antibodies and cell lines may be of interest to any persons investigating RSV infection processes, particularly as it relates to the activity of NS1 in such an infection process. 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: • Viral diagnostics • Vaccine research Competitive Advantages: • Ease of manufacture • Unique research tool Development Stage: • In vitro data assessment Inventors: Thomas McCarty (NIAID), Joseph Marcotrigiano (NIAID), Peter Collins (NIAID). Publications: None. Intellectual Property: HHS Reference No. E–018–2018/0—U.S. Provisional Application No. 62/661,320, filed April 23, 2018 (pending). Licensing Contact: Peter Soukas, J.D., 301–594–8730; peter.soukas@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 VerDate Sep<11>2014 19:13 Oct 05, 2018 Jkt 247001 commercialize for development of a vaccine for respiratory or other infections. For collaboration opportunities, please contact Peter Soukas, J.D., 301–594–8730; peter.soukas@nih.gov. 50667 HIV–1 is an enveloped virus, which hides from humoral recognition behind a wide array of protective mechanisms. During infection, the major envelope protein of HIV–1 is cleaved by host cell proteases into two smaller versions (gp120 and gp41). Together gp120 and Dated: September 25, 2018. gp41 make up the HIV–1 Env spike, Suzanne M. Frisbie, which is a target for neutralizing Deputy Director, Technology Transfer and antibodies. It is believed that Intellectual Property Office, National Institute immunization with an effective of Allergy and Infectious Diseases. immunogen based on the HIV–1 Env [FR Doc. 2018–21764 Filed 10–5–18; 8:45 am] glycoprotein can elicit a neutralizing BILLING CODE 4140–01–P response, which may be protective against HIV–1 infection. Researchers at the Vaccine Research DEPARTMENT OF HEALTH AND Center (VRC) of the National Institute of HUMAN SERVICES Allergy and Infectious Diseases used knowledge from the crystal structure of National Institutes of Health an HIV–1 neutralizing antibody, VRC34.01, in complex with its epitope Government-Owned Inventions; on the HIV–1 Env trimer, to develop Availability for Licensing novel immunogens. HIV–1 uses a fusion AGENCY: National Institutes of Health, peptide, located at the N-terminus of the HHS. gp41 subunit, to fuse with a target cell ACTION: Notice. to infect the cell. The crystal structure revealed the epitope recognized by SUMMARY: The invention listed below is VRC34.01 to be composed primarily of owned by an agency of the U.S. the exposed 8 residues of the fusion Government and is available for peptide at the N-terminus of the gp41 licensing to achieve expeditious subunit. Researchers designed fusion commercialization of results of peptide immunogens that were federally-funded research and comprised of the exposed residues of development. Foreign patent the fusion peptide coupled to highly applications are filed on selected immunogenic carrier proteins to focus inventions to extend market coverage the immune response to this conserved for companies and may also be available site of vulnerability. The fusion peptide for licensing. can be displayed on scaffold proteins and—when coupled to HIV–1 Env FOR FURTHER INFORMATION CONTACT: trimer boosts—has the potential to elicit Barry Buchbinder, Ph.D., 240–627– antibodies capable of neutralizing 3678; barry.buchbinder@nih.gov. Licensing information and copies of the diverse HIV–1 strains in mice, guinea pigs and rhesus macaques, and might U.S. patent application listed below therefore serve as the basis for an may be obtained by communicating effective HIV vaccine. with the indicated licensing contact at This technology is available for the Technology Transfer and licensing for commercial development Intellectual Property Office, National in accordance with 35 U.S.C. 209 and 37 Institute of Allergy and Infectious CFR part 404. Diseases, 5601 Fishers Lane, Rockville, Potential Commercial Applications: MD, 20852; tel. 301–496–2644. A signed Confidential Disclosure Agreement will HIV–1 vaccine be required to receive copies of Competitive Advantages: unpublished patent applications. Potential to be a broadly neutralizing HIV–1 vaccine SUPPLEMENTARY INFORMATION: Technology description follows. Development Stage: In vivo testing (rodents and non-human primates). HIV–1 Env Fusion Peptide Immunogens Inventors: Peter Kwong (NIAID), John and Their Use Mascola (NIAID), Kai Xu (NIAID), Rui Description of Technology: Millions of Kong (NIAID), Tongqing Zhou (NIAID), Li Ou (NIAID), Cheng Cheng (NIAID), people are infected with HIV–1 Wing-Pui Kong (NIAID), Gwo-Yu worldwide, and 2.5 to 3 million new Chuang (NIAID), Kevin Liu (NIAID), infections have been estimated to occur yearly. Although effective antiretroviral Michael Gordon Joyce (NIAID), Yongping Yang (NIAID), Baoshan Zhang therapies are available, millions (NIAID) succumb to AIDS every year, especially Publications: in Sub-Saharan Africa, underscoring the need to develop measures to prevent the (a) Kong, Rui, et al. ‘‘Fusion peptide of HIV–1 as a site of vulnerability to spread of this disease. PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\09OCN1.SGM 09OCN1 50668 Federal Register / Vol. 83, No. 195 / Tuesday, October 9, 2018 / Notices neutralizing antibody.’’ Science 352.6287 (2016): 828–833. (b) Xu, Kai, et al. ‘‘Epitope-based vaccine design yields fusion peptide-directed antibodies that neutralize diverse strains of HIV– 1.’’ Nature Medicine 24, 857–867 (2018). Intellectual Property: HHS Reference Number E–279–2016 includes U.S. Provisional Patent Application Number 62/403,266 filed 10/03/2016 and PCT Application Number PCT/US2017/ 054959 filed 10/03/2017 (pending). Licensing Contact: Barry Buchbinder, Ph.D., 240–627–3678; barry.buchbinder@nih.gov Dated: September 25, 2018. Suzanne M. Frisbie, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2018–21762 Filed 10–5–18; 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. SUMMARY: amozie on DSK3GDR082PROD with NOTICES1 FOR FURTHER INFORMATION CONTACT: Peter Soukas, J.D., 301–594–8730; peter.soukas@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. VerDate Sep<11>2014 19:13 Oct 05, 2018 Jkt 247001 Recombinant RSV B1 Expressing eGFP as a Reporter Gene Description of Technology: The inventors have created a reverse genetics system for RSV strain B1 of antigenic subgroup B encoding a replication-competent recombinant RSV that contains a codon-optimized G ORF and expresses enhanced green fluorescence protein (GFP). There are two antigenic subgroups of RSV, subgroups A and B, and most of the available information and reagents are for subgroup A. Immunity against either subgroup has reduced effectiveness in restricting the heterologous subgroup, suggesting that an effective RSV vaccine might need to contain both subgroups. The sequence of the wild type G gene was refractory to cloning into full-length antigenomic cDNA in E. coli, and so the inventors made and successfully used a codon optimized version. In addition, the inventors inserted an eGFP gene into the first gene position (promoter proximal). The resulting virus is replication-competent and efficiently expresses GFP in infected cells. This virus can be used as a tool to detect RSV-neutralizing antibodies to RSV subgroup B in a plaque-reduction assay. It also can be used to evaluate RSV infection in vitro and in vivo using GFP fluorescence to track infection. The antigenomic cDNA clone also provides the starting material for making liveattenuated subgroup B-specific RSV vaccine candidates containing defined mutations. These defined mutations can include ones that we previously developed for RSV subgroup A, and include stabilized point mutations, stabilized codon-deletions, and genedeletions. The present invention provides a reverse genetics system encoding strain B1 of RSV subgroup B containing a codon-optimized G ORF and encoding eGFP. This provides a tool for RSV subgroup B serology assays, for tracking RSV infection, and a starting point for making attenuated subgroup B strains for vaccine purposes. 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: • Viral diagnostics • Vaccine research • Serology assays • Vaccine manufacture Competitive Advantages: • Ease of manufacture • Unique research tool Development Stage: PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 • In vitro data assessment Inventors: Ursula Buchholz (NIAID), Peter Collins (NIAID). Publications: None. Intellectual Property: HHS Reference No. E–159–2018–0. Licensing Contact: Peter Soukas, J.D., 301–594–8730; peter.soukas@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 for development of a vaccine for respiratory or other infections. For collaboration opportunities, please contact Peter Soukas, J.D., 301–594–8730; peter.soukas@nih.gov. Dated: September 25, 2018. Suzanne M. Frisbie, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2018–21767 Filed 10–5–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request; Generic Clearance To Conduct Voluntary Customer/ Partner Surveys (NLM) AGENCY: National Institutes of Health, HHS. ACTION: Notice. In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. DATES: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. SUMMARY: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202–395–6974, Attention: Desk Officer for NIH. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of ADDRESSES: E:\FR\FM\09OCN1.SGM 09OCN1

Agencies

[Federal Register Volume 83, Number 195 (Tuesday, October 9, 2018)]
[Notices]
[Pages 50667-50668]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21762]


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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: Barry Buchbinder, Ph.D., 240-627-3678; 
[email protected]. Licensing information and copies of the U.S. 
patent application listed below may be obtained by communicating with 
the indicated licensing contact at the Technology Transfer and 
Intellectual Property Office, National Institute of Allergy and 
Infectious Diseases, 5601 Fishers Lane, Rockville, MD, 20852; tel. 301-
496-2644. A signed Confidential Disclosure Agreement will be required 
to receive copies of unpublished patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.

HIV-1 Env Fusion Peptide Immunogens and Their Use

    Description of Technology: Millions of people are infected with 
HIV-1 worldwide, and 2.5 to 3 million new infections have been 
estimated to occur yearly. Although effective antiretroviral therapies 
are available, millions succumb to AIDS every year, especially in Sub-
Saharan Africa, underscoring the need to develop measures to prevent 
the spread of this disease.
    HIV-1 is an enveloped virus, which hides from humoral recognition 
behind a wide array of protective mechanisms. During infection, the 
major envelope protein of HIV-1 is cleaved by host cell proteases into 
two smaller versions (gp120 and gp41). Together gp120 and gp41 make up 
the HIV-1 Env spike, which is a target for neutralizing antibodies. It 
is believed that immunization with an effective immunogen based on the 
HIV-1 Env glycoprotein can elicit a neutralizing response, which may be 
protective against HIV-1 infection.
    Researchers at the Vaccine Research Center (VRC) of the National 
Institute of Allergy and Infectious Diseases used knowledge from the 
crystal structure of an HIV-1 neutralizing antibody, VRC34.01, in 
complex with its epitope on the HIV-1 Env trimer, to develop novel 
immunogens. HIV-1 uses a fusion peptide, located at the N-terminus of 
the gp41 subunit, to fuse with a target cell to infect the cell. The 
crystal structure revealed the epitope recognized by VRC34.01 to be 
composed primarily of the exposed 8 residues of the fusion peptide at 
the N-terminus of the gp41 subunit. Researchers designed fusion peptide 
immunogens that were comprised of the exposed residues of the fusion 
peptide coupled to highly immunogenic carrier proteins to focus the 
immune response to this conserved site of vulnerability. The fusion 
peptide can be displayed on scaffold proteins and--when coupled to HIV-
1 Env trimer boosts--has the potential to elicit antibodies capable of 
neutralizing diverse HIV-1 strains in mice, guinea pigs and rhesus 
macaques, and might therefore serve as the basis for an effective HIV 
vaccine.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404.
    Potential Commercial Applications:

HIV-1 vaccine

    Competitive Advantages:

Potential to be a broadly neutralizing HIV-1 vaccine

    Development Stage: In vivo testing (rodents and non-human 
primates).
    Inventors: Peter Kwong (NIAID), John Mascola (NIAID), Kai Xu 
(NIAID), Rui Kong (NIAID), Tongqing Zhou (NIAID), Li Ou (NIAID), Cheng 
Cheng (NIAID), Wing-Pui Kong (NIAID), Gwo-Yu Chuang (NIAID), Kevin Liu 
(NIAID), Michael Gordon Joyce (NIAID), Yongping Yang (NIAID), Baoshan 
Zhang (NIAID)
    Publications:

(a) Kong, Rui, et al. ``Fusion peptide of HIV-1 as a site of 
vulnerability to

[[Page 50668]]

neutralizing antibody.'' Science 352.6287 (2016): 828-833.
(b) Xu, Kai, et al. ``Epitope-based vaccine design yields fusion 
peptide-directed antibodies that neutralize diverse strains of HIV-1.'' 
Nature Medicine 24, 857-867 (2018).

    Intellectual Property: HHS Reference Number E-279-2016 includes 
U.S. Provisional Patent Application Number 62/403,266 filed 10/03/2016 
and PCT Application Number PCT/US2017/054959 filed 10/03/2017 
(pending).
    Licensing Contact: Barry Buchbinder, Ph.D., 240-627-3678; 
[email protected]

    Dated: September 25, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-21762 Filed 10-5-18; 8:45 am]
 BILLING CODE 4140-01-P