Government-Owned Inventions; Availability for Licensing, 85894 [2023-27113]

Download as PDF 85894 Federal Register / Vol. 88, No. 236 / Monday, December 11, 2023 / Notices verified the applicant’s claim that NDA 215383 was approved on August 13, 2021. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 342 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: December 5, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–27044 Filed 12–8–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health lotter on DSK11XQN23PROD with NOTICES1 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 SUMMARY: VerDate Sep<11>2014 17:35 Dec 08, 2023 Jkt 262001 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: Theodoric Mattes at 240–627–3827, or theodoric.mattes@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. SUPPLEMENTARY INFORMATION: Technology description follows: Vaccine for Cats To Block Toxoplasma Gondii Oocyst Shedding and Transmission Description of Technology: Toxoplasma gondii is the zoonotic causative agent of toxoplasmosis, a disease of significant concern for pregnant persons and livestock. A member of the phylum Apicomplexa, Toxoplasma gondii can infect almost any cell type found in mammals and birds. There are multiple transmission pathways, including consumption of undercooked meat from infected animals, consumption of unwashed plants, contaminated water supplies, blood transfers, and congenital transfer. Felines are considered the definitive host of Toxoplasma gondii. Direct or indirect transmission can occur via contact with the stool of infected felines. Researchers at the National Institute of Allergy and Infectious Diseases (NIAID), the U.S. Department of Agriculture (USDA), and the University of South Bohemia (Cˇeske´ Budeˇjovice, Czechia) have demonstrated that T. gondii strains lacking expression of either the intracellular transport protein IFT88 or the CYS–6-type surface antigen SRS15B prevent the formation of oocysts and have potential for broad immunity to T. gondii. The inventors propose that mass inoculation of felines, specifically wild or feral felines, with a live vaccine developed from these strains could result in a significant reduction in oocyst production and environment contamination, reducing further infection in a geographical area. It is also proposed that loss of IFT88 or SRS15B homologs in other Apicomplexa parasites, like Neospora, PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 Sarcocystis, or Cryptosporidium could have a similar impact. 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: • Live vaccine for felines against Toxoplasma gondii infection • Reduction in environmental Toxoplasma gondii oocysts Competitive Advantages: • 100% blocked Toxoplasma gondii oocyst shedding in felines • Detectable seroconversion protective against future Toxoplasma gondii infection • Scalable production strain with predictable inactivation of IFT88 or SRS15B gene • Materials available for development or licensing Development Stage: • Pre-Clinical Inventors: Michael Grigg (NIAID), Aline Sardinha da Silva (NIAID), Viviana Pszenny (NIAID), Jitender Dubey (USDA), and Julius Lukesˇ (University of South Bohemia, Czechia). Intellectual Property: HHS Reference No. E–118–2023–2. U.S. Provisional Patent Application No. 63/470,773 filed June 4, 2023. Licensing Contact: To license this technology, please contact Theodoric Mattes at 240–627–3827, or theodoric.mattes@nih.gov., and reference E–118–2023–2. 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 Theodoric Mattes at 240–627– 3827, or theodoric.mattes@nih.gov. Dated: December 5, 2023. Surekha Vathyam, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2023–27113 Filed 12–8–23; 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. E:\FR\FM\11DEN1.SGM 11DEN1

Agencies

[Federal Register Volume 88, Number 236 (Monday, December 11, 2023)]
[Notices]
[Page 85894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27113]


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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: Theodoric Mattes at 240-627-3827, 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.

SUPPLEMENTARY INFORMATION: Technology description follows:

Vaccine for Cats To Block Toxoplasma Gondii Oocyst Shedding and 
Transmission

    Description of Technology:
    Toxoplasma gondii is the zoonotic causative agent of toxoplasmosis, 
a disease of significant concern for pregnant persons and livestock. A 
member of the phylum Apicomplexa, Toxoplasma gondii can infect almost 
any cell type found in mammals and birds. There are multiple 
transmission pathways, including consumption of undercooked meat from 
infected animals, consumption of unwashed plants, contaminated water 
supplies, blood transfers, and congenital transfer. Felines are 
considered the definitive host of Toxoplasma gondii. Direct or indirect 
transmission can occur via contact with the stool of infected felines.
    Researchers at the National Institute of Allergy and Infectious 
Diseases (NIAID), the U.S. Department of Agriculture (USDA), and the 
University of South Bohemia ([Ccaron]esk[eacute] Bud[ecaron]jovice, 
Czechia) have demonstrated that T. gondii strains lacking expression of 
either the intracellular transport protein IFT88 or the CYS-6-type 
surface antigen SRS15B prevent the formation of oocysts and have 
potential for broad immunity to T. gondii. The inventors propose that 
mass inoculation of felines, specifically wild or feral felines, with a 
live vaccine developed from these strains could result in a significant 
reduction in oocyst production and environment contamination, reducing 
further infection in a geographical area. It is also proposed that loss 
of IFT88 or SRS15B homologs in other Apicomplexa parasites, like 
Neospora, Sarcocystis, or Cryptosporidium could have a similar impact.
    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:

 Live vaccine for felines against Toxoplasma gondii infection
 Reduction in environmental Toxoplasma gondii oocysts

    Competitive Advantages:

 100% blocked Toxoplasma gondii oocyst shedding in felines
 Detectable seroconversion protective against future Toxoplasma 
gondii infection
 Scalable production strain with predictable inactivation of 
IFT88 or SRS15B gene
 Materials available for development or licensing

    Development Stage:

 Pre-Clinical

    Inventors: Michael Grigg (NIAID), Aline Sardinha da Silva (NIAID), 
Viviana Pszenny (NIAID), Jitender Dubey (USDA), and Julius Luke[scaron] 
(University of South Bohemia, Czechia).
    Intellectual Property: HHS Reference No. E-118-2023-2. U.S. 
Provisional Patent Application No. 63/470,773 filed June 4, 2023.
    Licensing Contact: To license this technology, please contact 
Theodoric Mattes at 240-627-3827, or [email protected]., and 
reference E-118-2023-2.
    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 Theodoric Mattes at 240-627-3827, or 
[email protected].

     Dated: December 5, 2023.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2023-27113 Filed 12-8-23; 8:45 am]
BILLING CODE 4140-01-P
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