Grant of Interim Extension of the Term of U.S. Patent No. 6,406,699; ECI® (ELIAS Cancer Immunotherapy), 59063 [2022-21118]

Download as PDF Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 / Notices DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration [RTID 0648–XC409] Marine Mammals; File No. 26593 National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Notice; receipt of application. AGENCY: Notice is hereby given that Adam Pack, Ph.D., University of Hawaii at Hilo, 200 West Kawili Street, Hilo, HI 96720, has applied in due form for a permit to conduct research on humpback whales (Megaptera novaeangliae) and other cetaceans. DATES: Written, telefaxed, or email comments must be received on or before October 31, 2022. ADDRESSES: The application and related documents are available for review by selecting ‘‘Records Open for Public Comment’’ from the ‘‘Features’’ box on the Applications and Permits for Protected Species (APPS) home page, https://apps.nmfs.noaa.gov, and then selecting File No. 26593 from the list of available applications. These documents are also available upon written request via email to NMFS.Pr1Comments@ noaa.gov. Written comments on this application should be submitted via email to NMFS.Pr1Comments@noaa.gov. Please include File No. 26593 in the subject line of the email comment. Those individuals requesting a public hearing should submit a written request via email to NMFS.Pr1Comments@ noaa.gov. The request should set forth the specific reasons why a hearing on this application would be appropriate. FOR FURTHER INFORMATION CONTACT: Carrie Hubard or Courtney Smith, Ph.D., (301) 427–8401. SUPPLEMENTARY INFORMATION: The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361 et seq.), the regulations governing the taking and importing of marine mammals (50 CFR part 216), the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq.), and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222–226). The applicant proposes to study 29 cetacean species in Hawaiian and Alaskan waters, with a focus on humpback whales. The purpose of the research is to examine the behavioral khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:52 Sep 28, 2022 Jkt 256001 ecology, biology and communication systems of humpback whales as well as the abundance, distribution, behavior, and physiological stress levels of all cetacean species in the study area. Research would be conducted from boats, airplanes, unmanned aircraft systems, and underwater. Animals would be studied using photo-ID, videogrammetry, passive acoustic recordings, behavioral observations, collection of fecal and skin samples, and biopsy sampling. In addition, up to 150 video and acoustic recording suction cup tags would be deployed on humpback whales, annually. Threatened and endangered species that would be studied if encountered are: blue (Balaenoptera musculus), bowhead (Balaena mysticetus), false killer (Pseudorca crassidens) (Main Hawaiian Islands Insular distinct population segment (DPS)), fin (B. physalus), humpback (Central America and Mexico DPSs), North Pacific right (Eubalaena japonica), sei (B. borealis), and sperm whales (Physeter macrocephalus). The permit would be valid for 5 years. In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), an initial determination has been made that the activity proposed is categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement. Concurrent with the publication of this notice in the Federal Register, NMFS is forwarding copies of the application to the Marine Mammal Commission and its Committee of Scientific Advisors. Dated: September 26, 2022. Julia M. Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service. [FR Doc. 2022–21134 Filed 9–28–22; 8:45 am] BILLING CODE 3510–22–P DEPARTMENT OF COMMERCE Patent and Trademark Office [Docket No. PTO–P–2021–0053] Grant of Interim Extension of the Term of U.S. Patent No. 6,406,699; ECI® (ELIAS Cancer Immunotherapy) United States Patent and Trademark Office, Department of Commerce. ACTION: Notice of interim patent term extension. AGENCY: The United States Patent and Trademark Office has issued an order granting a one-year interim extension of SUMMARY: PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 59063 the term of U.S. Patent No. 6,406,699 (’699 patent). Raul Tamayo, Senior Legal Advisor, Office of Patent Legal Administration, at 571– 272–7728 or raul.tamayo@uspto.gov. FOR FURTHER INFORMATION CONTACT: 35 U.S.C. 156 generally provides that the term of a patent may be extended for a period of up to five years, if the patent claims a product, or a method of making or using a product, that has been subject to certain defined regulatory review. 35 U.S.C. 156(d)(5) generally provides that the term of such a patent may be extended for no more than five interim periods of up to one year each, if the approval phase of the regulatory review period (RRP) is reasonably expected to extend beyond the expiration date of the patent. On September 6, 2022, TVAX Biomedical I, LLC, the owner of record of the ’699 patent, timely filed an application under 35 U.S.C. 156(d)(5) for a fourth interim extension of the term of the ’699 patent. The ’699 patent claims a method of using a veterinary biological product in the cancer immunotherapy treatment known by the tradename ECI® (ELIAS Cancer Immunotherapy). The application for interim patent term extension indicates that a RRP as described in 35 U.S.C. 156(g)(5)(B)(ii) began for ECI® (ELIAS Cancer Immunotherapy) and is ongoing before the United States Department of Agriculture, Center for Veterinary Biologics, for permission to market and use the product commercially. Review of the interim patent term extension application indicates that, except for permission to market or use the product commercially, the ’699 patent would be eligible for an extension of the patent term under 35 U.S.C. 156. Because it is apparent that the RRP will continue beyond the thrice-extended expiration date of the ’699 patent, i.e., October 5, 2022, a fourth interim extension of the patent term under 35 U.S.C. 156(d)(5) is appropriate. A fourth interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. 6,406,699 is granted for a period of one year from the thriceextended expiration date of the ’699 patent. SUPPLEMENTARY INFORMATION: Robert Bahr, Deputy Commissioner for Patents, United States Patent and Trademark Office. [FR Doc. 2022–21118 Filed 9–28–22; 8:45 am] BILLING CODE 3510–16–P E:\FR\FM\29SEN1.SGM 29SEN1

Agencies

[Federal Register Volume 87, Number 188 (Thursday, September 29, 2022)]
[Notices]
[Page 59063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21118]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2021-0053]


Grant of Interim Extension of the Term of U.S. Patent No. 
6,406,699; ECI[supreg] (ELIAS Cancer Immunotherapy)

AGENCY: United States Patent and Trademark Office, Department of 
Commerce.

ACTION: Notice of interim patent term extension.

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SUMMARY: The United States Patent and Trademark Office has issued an 
order granting a one-year interim extension of the term of U.S. Patent 
No. 6,406,699 ('699 patent).

FOR FURTHER INFORMATION CONTACT: Raul Tamayo, Senior Legal Advisor, 
Office of Patent Legal Administration, at 571-272-7728 or 
[email protected].

SUPPLEMENTARY INFORMATION: 35 U.S.C. 156 generally provides that the 
term of a patent may be extended for a period of up to five years, if 
the patent claims a product, or a method of making or using a product, 
that has been subject to certain defined regulatory review. 35 U.S.C. 
156(d)(5) generally provides that the term of such a patent may be 
extended for no more than five interim periods of up to one year each, 
if the approval phase of the regulatory review period (RRP) is 
reasonably expected to extend beyond the expiration date of the patent.
    On September 6, 2022, TVAX Biomedical I, LLC, the owner of record 
of the '699 patent, timely filed an application under 35 U.S.C. 
156(d)(5) for a fourth interim extension of the term of the '699 
patent. The '699 patent claims a method of using a veterinary 
biological product in the cancer immunotherapy treatment known by the 
tradename ECI[supreg] (ELIAS Cancer Immunotherapy). The application for 
interim patent term extension indicates that a RRP as described in 35 
U.S.C. 156(g)(5)(B)(ii) began for ECI[supreg] (ELIAS Cancer 
Immunotherapy) and is ongoing before the United States Department of 
Agriculture, Center for Veterinary Biologics, for permission to market 
and use the product commercially.
    Review of the interim patent term extension application indicates 
that, except for permission to market or use the product commercially, 
the '699 patent would be eligible for an extension of the patent term 
under 35 U.S.C. 156. Because it is apparent that the RRP will continue 
beyond the thrice-extended expiration date of the '699 patent, i.e., 
October 5, 2022, a fourth interim extension of the patent term under 35 
U.S.C. 156(d)(5) is appropriate.
    A fourth interim extension under 35 U.S.C. 156(d)(5) of the term of 
U.S. Patent No. 6,406,699 is granted for a period of one year from the 
thrice-extended expiration date of the '699 patent.

Robert Bahr,
Deputy Commissioner for Patents, United States Patent and Trademark 
Office.
[FR Doc. 2022-21118 Filed 9-28-22; 8:45 am]
BILLING CODE 3510-16-P