Government-Owned Inventions; Availability for Licensing, 19856-19857 [2024-05881]

Download as PDF 19856 Federal Register / Vol. 89, No. 55 / Wednesday, March 20, 2024 / Notices Only written comments and/or applications for a license which are received by the National Institute of Allergy and Infectious Diseases’ Technology Transfer and Intellectual Property Office on or before April 4, 2024 will be considered. ADDRESSES: Requests for copies of the patent applications, inquiries, and comments relating to the contemplated Exclusive Patent License should be directed to: Wade Green, Ph.D., Lead Technology Transfer and Patent Specialist, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases Telephone: (301) 761–7505; Email: wade.green@nih.gov. SUPPLEMENTARY INFORMATION: DATES: khammond on DSKJM1Z7X2PROD with NOTICES Intellectual Property 1. United States Provisional Patent Application No. 62/842,590, filed May 03, 2019, titled ‘‘Neutralizing antibodies to Plasmodium falciparum circumsporozoite protein and their use’’ [HHS Reference No. E–087–2019–0–US– 01]; 2. International Patent Application No. PCT/US2020/031345, filed May 04, 2020, titled ‘‘Neutralizing antibodies to Plasmodium falciparum circumsporozoite protein and their use’’ [HHS Reference No. E–087–2019–0– PCT–01]; 3. European Patent Application No. 20727798.9, filed May 04, 2020, titled ‘‘Neutralizing antibodies to Plasmodium falciparum circumsporozoite protein and their use’’ [HHS Reference No. E– 087–2019–0–EP–02]; and 4. United States Patent Application No. 17/608,381, filed October 02, 2021, titled ‘‘Neutralizing antibodies to Plasmodium falciparum circumsporozoite protein and their use’’ [HHS Reference No. E–087–2019–0–US– 03]. 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 following: ‘‘Production of the L9LS monoclonal antibody in transgenic bovine and ovine species.’’ The E–087–20219 patent family is primarily directed to (1) compositions of matter of the L9LS monoclonal antibody, (2) methods of treating and preventing infection with Plasmodium falciparum using the L9LS monoclonal antibody, and (3) methods of manufacturing the L9LS monoclonal antibody. The exclusive field of use VerDate Sep<11>2014 16:52 Mar 19, 2024 Jkt 262001 which may be granted to Taurgen applies to only manufacturing of the L9LS monoclonal antibody in transgenic bovine and ovine species. Accordingly, the proposed scope of rights which may be conveyed under the license covers only a portion of total scope of the E– 087–2019 patent family and only a subset of the possible methods of manufacturing the L9LS monoclonal antibody. 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 Institute of Allergy and Infectious Diseases 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. Complete license applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information from 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: March 14, 2024. Surekha Vathyam, Acting Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2024–05878 Filed 3–19–24; 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 SUMMARY: PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 inventions to extend market coverage for companies and may also be available for licensing. FOR FURTHER INFORMATION CONTACT: Peter Tung at 240–669–5483 or peter.tung@nih.gov. Licensing information may be obtained by communicating with 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 information related to the invention. Licensing information and copies of the patent applications listed below may be obtained by communicating with the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852 by contacting Peter Tung at 240–669–5483 or peter.tung@nih.gov. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications related to the invention. SUPPLEMENTARY INFORMATION: Technology description follows: Next-Generation MSP1-Targeted Malaria Immunotherapy: Enhanced Vaccine Candidates and Monoclonal Antibodies Description of Technology This technology encompasses the development of highly advanced malaria vaccine candidates and human monoclonal antibodies, both centered on targeting the Merozoite Surface Protein 1 (MSP1) of the Plasmodium falciparum malaria parasite. The innovation lies in utilizing a novel computational design and in vitro screening process, which has created MSP1 vaccine candidates that are significantly more immunogenic, stable, and cost-effective than existing alternatives. These vaccines focus on the 19 kDa carboxy-terminus fragment of MSP1. They contain engineered amino acid changes and are displayed on self-assembling nanoparticles to elicit a more potent immune response, potentially offering more robust and durable protection against malaria. Additionally, the technology includes the production of enhanced human monoclonal antibodies with improved affinity for the same fragment of MSP1, designed to overcome the parasite’s immune evasion tactics. These advancements hold immense promise for significantly improving malaria prevention and treatment. They could lead to the development of more E:\FR\FM\20MRN1.SGM 20MRN1 Federal Register / Vol. 89, No. 55 / Wednesday, March 20, 2024 / Notices effective vaccines and therapeutic antibodies, providing a critical solution to a significant global health challenge. 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 • This MSP1-focused technology has the potential to transform malaria treatment and prevention worldwide, offering more effective vaccines and therapeutic antibodies for use in clinical settings, public health programs, and potentially in regions with high malaria prevalence. Competitive Advantages • This technology offers highly immunogenic and stable MSP1-based vaccine candidates and monoclonal antibodies, with superior efficacy, costeffectiveness, and ease of production compared to current alternatives. Development Stage khammond on DSKJM1Z7X2PROD with NOTICES Pre-Clinical Inventors: Niraj Tolia, Ph.D., Thayne Dickey, Ph.D., Palak Patel, Ph.D., Kazuotoyo Miura, Ph.D., Carole Long, Ph.D., all of NIAID. Publications: Patel, Palak N et al. ‘‘Neutralizing and interfering human antibodies define the structural and mechanistic basis for antigenic diversion.’’ Nature communications vol. 13,1 5888. 6 Oct. 2022, doi:10.1038/ s41467–022–33336–3. Intellectual Property: HHS Reference No. E–154–2022–0–US–01, US Provisional Application No. 63/369,909, filed on July 29, 2022; HHS Reference No. E–154–2022–0–PC–01, PCT Application No. PCT/US2023/070926, filed on July 25, 2023. Licensing Contact: To license this technology, please contact Peter Tung at 240–669–5483 or peter.tung@nih.gov, and reference E–154–2022. 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 this technology. For collaboration opportunities, please contact Peter Tung at 240–669–5483 or peter.tung@nih.gov. VerDate Sep<11>2014 16:52 Mar 19, 2024 Jkt 262001 19857 Dated: March 14, 2024. Surekha Vathyam, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds, National Institutes of Health, HHS) [FR Doc. 2024–05881 Filed 3–19–24; 8:45 am] Dated: March 15, 2024. Lauren A. Fleck, Program Analyst, Office of Federal Advisory Committee Policy. BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2024–05869 Filed 3–19–24; 8:45 am] BILLING CODE 4140–01–P National Institutes of Health Office of the Director, National Institutes of Health; Notice of Meeting Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Council of Councils. The meeting will be held as a virtual meeting and will be open to the public as indicated below. Individuals who plan to view the virtual meeting and need special assistance or other reasonable accommodations to view the meeting, should notify the Contact Person listed below in advance of the meeting. The meeting can be accessed from the NIH Videocast at the following link: https://videocast.nih.gov/. Name of Committee: Council of Councils. Date: April 05, 2024. Time: 01:00 p.m. to 02:30 p.m. Agenda: Welcome and Opening Remarks; Announcements; Primary Care Research Network; Proposed Council of Councils Working Group on AIM–AHEAD. Place: National Institutes of Health, Building 1, 1 Center Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Franziska Grieder, D.V.M., Ph.D., Executive Secretary, Council of Councils, Director, Office of Research Infrastructure Programs, Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director, NIH, 6701 Democracy Boulevard, Room 948, Bethesda, MD 20892, GriederF@mail.nih.gov, 301–435– 0744. This notice is being published less than 15 days prior to the meeting due to scheduling difficulties. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Information is also available on the Council of Council’s home page at https:// dpcpsi.nih.gov/council/ where an agenda will be posted before the meeting date. (Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93.232, Loan Repayment Program for Research Generally; 93.39, Academic Research Enhancement Award; 93.936, NIH Acquired PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Board of Scientific Counselors, NIAMS. The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Board of Scientific Counselors, NIAMS. Date: April 24–25, 2024. Time: April 24–25, 2024, 9:00 a.m. to 12:30 p.m.. Agenda: To review and evaluate personnel qualifications and performance, and competence of individual investigators. Place: NIH Bethesda Main Campus, Building 10, 12S233 (NIAMS 12th floor conference room), Bethesda, MD (Hybrid meeting). Contact Person: John J. O’Shea, MD, Ph.D., Scientific Director, Intramural Research Program, National Institute of Arthritis & Musculoskeletal and Skin Diseases, Building 10, Room 9N228, Bethesda, MD 20892, (301) 496–2612, osheaj@arb.niams.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.846, Arthritis, Musculoskeletal and Skin Diseases Research, National Institutes of Health, HHS) Dated: March 14, 2024. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2024–05824 Filed 3–19–24; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\20MRN1.SGM 20MRN1

Agencies

[Federal Register Volume 89, Number 55 (Wednesday, March 20, 2024)]
[Notices]
[Pages 19856-19857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05881]


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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: Peter Tung at 240-669-5483 or 
[email protected]. Licensing information may be obtained by 
communicating with 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 information related to the invention.
    Licensing information and copies of the patent applications listed 
below may be obtained by communicating with the Technology Transfer and 
Intellectual Property Office, National Institute of Allergy and 
Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852 by 
contacting Peter Tung at 240-669-5483 or [email protected]. A signed 
Confidential Disclosure Agreement will be required to receive copies of 
unpublished patent applications related to the invention.

SUPPLEMENTARY INFORMATION: Technology description follows:

Next-Generation MSP1-Targeted Malaria Immunotherapy: Enhanced Vaccine 
Candidates and Monoclonal Antibodies

Description of Technology

    This technology encompasses the development of highly advanced 
malaria vaccine candidates and human monoclonal antibodies, both 
centered on targeting the Merozoite Surface Protein 1 (MSP1) of the 
Plasmodium falciparum malaria parasite. The innovation lies in 
utilizing a novel computational design and in vitro screening process, 
which has created MSP1 vaccine candidates that are significantly more 
immunogenic, stable, and cost-effective than existing alternatives. 
These vaccines focus on the 19 kDa carboxy-terminus fragment of MSP1. 
They contain engineered amino acid changes and are displayed on self-
assembling nanoparticles to elicit a more potent immune response, 
potentially offering more robust and durable protection against 
malaria. Additionally, the technology includes the production of 
enhanced human monoclonal antibodies with improved affinity for the 
same fragment of MSP1, designed to overcome the parasite's immune 
evasion tactics. These advancements hold immense promise for 
significantly improving malaria prevention and treatment. They could 
lead to the development of more

[[Page 19857]]

effective vaccines and therapeutic antibodies, providing a critical 
solution to a significant global health challenge.
    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

     This MSP1-focused technology has the potential to 
transform malaria treatment and prevention worldwide, offering more 
effective vaccines and therapeutic antibodies for use in clinical 
settings, public health programs, and potentially in regions with high 
malaria prevalence.

Competitive Advantages

     This technology offers highly immunogenic and stable MSP1-
based vaccine candidates and monoclonal antibodies, with superior 
efficacy, cost-effectiveness, and ease of production compared to 
current alternatives.

Development Stage

Pre-Clinical
    Inventors: Niraj Tolia, Ph.D., Thayne Dickey, Ph.D., Palak Patel, 
Ph.D., Kazuotoyo Miura, Ph.D., Carole Long, Ph.D., all of NIAID.
    Publications: Patel, Palak N et al. ``Neutralizing and interfering 
human antibodies define the structural and mechanistic basis for 
antigenic diversion.'' Nature communications vol. 13,1 5888. 6 Oct. 
2022, doi:10.1038/s41467-022-33336-3.
    Intellectual Property: HHS Reference No. E-154-2022-0-US-01, US 
Provisional Application No. 63/369,909, filed on July 29, 2022; HHS 
Reference No. E-154-2022-0-PC-01, PCT Application No. PCT/US2023/
070926, filed on July 25, 2023.
    Licensing Contact: To license this technology, please contact Peter 
Tung at 240-669-5483 or [email protected], and reference E-154-2022.
    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 this technology. For collaboration 
opportunities, please contact Peter Tung at 240-669-5483 or 
[email protected].

    Dated: March 14, 2024.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2024-05881 Filed 3-19-24; 8:45 am]
BILLING CODE 4140-01-P
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