Government-Owned Inventions; Availability for Licensing, 50666-50667 [2018-21764]

Download as PDF 50666 Federal Register / Vol. 83, No. 195 / Tuesday, October 9, 2018 / Notices interpretation or other reasonable accommodations, should indicate the special accommodation when registering online or by notifying Jennifer Gillissen at jennifer.gillissen@ kauffmaninc.com by October 25. Authority: The National Clinical Care Commission is required under the National Clinical Care Commission Act (Pub. L. 115– 80). The Commission is governed by provisions of the Federal Advisory Committee Act (FACA), Public Law 92–463, as amended (5 U.S.C., App.) which sets forth standards for the formation and use of federal advisory committees. Dated: October 1, 2018. Don Wright, Deputy Assistant Secretary for Health (Disease Prevention and Health Promotion). [FR Doc. 2018–21854 Filed 10–5–18; 8:45 am] BILLING CODE 4150–32–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: 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 A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications.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. amozie on DSK3GDR082PROD with NOTICES1 SUMMARY: Attenuated Human Parainfluenza Virus Type 1 Expressing Ebola Virus Glycoprotein GP as an Intranasal Ebola Vaccine Description of Technology: Ebola virus (EBOV) hemorrhagic fever is one VerDate Sep<11>2014 19:13 Oct 05, 2018 Jkt 247001 of the most lethal viral infections and lacks a licensed vaccine. EBOV is transmitted by contact with body fluids from infected individuals including droplets or aerosols. Aerosolized EBOV could also be exploited for intentional virus spread. Therefore, vaccines that protect against mucosal and systemic exposure are needed. The NIH/NIAID has developed recombinant human parainfluenza virus type 1 (rHPIV1) bearing a stabilized attenuating mutation in the P/C gene to express the membrane-anchored form of EBOV glycoprotein GP as an intranasal (IN) EBOV vaccine. GP was codon optimized and expressed either as a fulllength protein or a chimeric form in which its transmembrane and cytoplasmic tail (TMCT) domains were substituted with those of the HPIV1 F protein in an effort to increase packaging into the vector particle and enhance immunogenicity. GP was inserted either preceding the N gene (pre-N) or between the N and P genes (N-P) of rHPIV1. All vectors replicated to high titers in vitro and had stable GP expression. Viruses were attenuated and replicated at low titers in the respiratory tract of African green monkeys. Two doses of candidates expressing GP from the pre-N position elicited higher GP neutralizing serum antibody titers than the N-P viruses, and unmodified GP induced higher levels than its TMCT counterpart. Unmodified EBOV GP was packaged into the HPIV1 particle, and the TMCT modification did not increase packaging or immunogenicity. Overall, the candidate expressing full-length GP from the Pre-N position was the most immunogenic. This invention relates to an attenuated and immunogenic IN vaccine candidate expected to be well tolerated in humans and is available for clinical evaluation. 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 • Bivalent or Multivalent live attenuated vaccines • B cell and T cell activation • Low-cost vaccines • Intranasal administration/needle-free delivery Development Stage: • In vivo data assessment (animal) PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 Inventors: Shirin Munir (NIAID), Matthias Lingemann (NIAID), Ursula Buchholz (NIAID), Peter Collins (NIAID). Publications: ‘‘Attenuated Human Parainfluenza Virus Type 1 Expressing Ebola Virus Glycoprotein GP Administered Intranasally Is Immunogenic in African Green Monkeys,’’ Lingemann M, Liu X, Surman S, Liang B, Herbert R, Hackenberg AD, Buchholz UJ, Collins PL, Munir S. J Virol. 2017 Apr 28;91(10). pii: e02469–16. doi: 10.1128/ JVI.02469–16. Print 2017 May 15. PMID: 28250127. Intellectual Property: HHS Reference No. E–142–2018/0. 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. 2018–21768 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. 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 SUMMARY: E:\FR\FM\09OCN1.SGM 09OCN1 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

Agencies

[Federal Register Volume 83, Number 195 (Tuesday, October 9, 2018)]
[Notices]
[Pages 50666-50667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21764]


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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.

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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: Peter Soukas, J.D., 301-594-8730; 
[email protected]. Licensing information and copies of the patent 
applications listed below may be

[[Page 50667]]

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.

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 enzyme-linked 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; 
[email protected].
    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; [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. 2018-21764 Filed 10-5-18; 8:45 am]
 BILLING CODE 4140-01-P