Grant of Interim Extension of the Term of U.S. Patent No. 6,406,699-ECI® (ELIAS Cancer Immunotherapy), 54893-54894 [2019-22329]

Download as PDF Federal Register / Vol. 84, No. 198 / Friday, October 11, 2019 / Notices Dated: October 8, 2019. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service. [FR Doc. 2019–22291 Filed 10–10–19; 8:45 am] BILLING CODE 3510–22–P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648–XR058 Taking and Importing Marine Mammals; Taking Marine Mammals Incidental to Alaska Fisheries Science Center Fisheries Research National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Notice of issuance of Letter of Authorization. AGENCY: jbell on DSK3GLQ082PROD with NOTICES SUMMARY: In accordance with the Marine Mammal Protection Act (MMPA), as amended, and implementing regulations, notification is hereby given that a Letter of Authorization (LOA) has been issued to the NMFS Alaska Fisheries Science Center (AFSC) for the take of marine mammals incidental to fisheries research conducted in multiple specified geographical regions. DATES: Effective from October 7, 2019, through October 7, 2024. ADDRESSES: The LOA and supporting documentation is available online: www.fisheries.noaa.gov/action/ incidental-take-authorization-noaafisheries-afsc-fisheries-and-ecosystemresearch. In case of problems accessing these documents, please call the contact listed below. FOR FURTHER INFORMATION CONTACT: Ben Laws, Office of Protected Resources, NMFS, (301) 427–8401. SUPPLEMENTARY INFORMATION: Background Paragraphs 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1371(a)(5)(A) and (D)) direct the Secretary of Commerce to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review. An authorization for incidental takings shall be granted if NMFS finds VerDate Sep<11>2014 17:56 Oct 10, 2019 Jkt 250001 that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth. NMFS has defined ‘‘negligible impact’’ in 50 CFR 216.103 as ‘‘an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.’’ Except with respect to certain activities not pertinent here, the MMPA defines ‘‘harassment’’ as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment). Summary of Request On September 6, 2017, we received an adequate and complete request from AFSC for authorization to take marine mammals incidental to fisheries research activities. On August 1, 2018 (83 FR 37638), we published a notice of proposed rulemaking in the Federal Register, requesting comments and information related to the proposed rule for thirty days. The final rule was published in the Federal Register on September 5, 2019 (84 FR 46788). For detailed information on this action, please refer to those documents. The regulations include mitigation, monitoring, and reporting requirements for the incidental take of marine mammals during fisheries research activities in the specified geographic regions. AFSC conducts fisheries research using trawl gear used at various levels in the water column, hook-and-line gear (including longlines with multiple hooks), gillnets, and other gear. If a marine mammal interacts with gear deployed by AFSC, the outcome could potentially be Level A harassment, serious injury (i.e., any injury that will likely result in mortality), or mortality. We pooled the estimated number of incidents of take resulting from gear interactions and assessed the potential impacts accordingly. AFSC also uses various active acoustic devices in the conduct of fisheries research, and use of PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 54893 these devices has the potential to result in Level B harassment of marine mammals. Level B harassment of pinnipeds hauled out on land may also occur as a result of visual disturbance from vessels conducting AFSC research. AFSC is authorized to take individuals of 19 species by Level A harassment, serious injury, or mortality and of 25 species by Level B harassment. Authorization We have issued an LOA to AFSC authorizing the take of marine mammals incidental to fishery research activities, as described above. Take of marine mammals will be minimized through implementation of the following mitigation measures: (1) Required monitoring of the sampling areas to detect the presence of marine mammals before deployment of certain research gear; and (2) implementation of a ‘‘move-on’’ rule in certain circumstances that is expected to reduce the potential for physical interaction with marine mammals. Additionally, the rule includes an adaptive management component that allows for timely modification of mitigation or monitoring measures based on new information, when appropriate. The AFSC will submit reports as required. Based on these findings and the information discussed in the preamble to the final rule, the activities described will have a negligible impact on marine mammal stocks and will not have an unmitigable adverse impact on the availability of the affected marine mammal stock for subsistence uses. Dated: October 7, 2019. Catherine G. Marzin, Deputy Director, Office of Protected Resources, National Marine Fisheries Service. [FR Doc. 2019–22251 Filed 10–10–19; 8:45 am] BILLING CODE 3510–22–P DEPARTMENT OF COMMERCE Patent and Trademark Office [Docket No. PTO–P–2019–0037] 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: SUMMARY: The United States Patent and Trademark Office has issued an order granting interim extension for a oneyear interim extension of the term of U.S. Patent No. 6,406,699. E:\FR\FM\11OCN1.SGM 11OCN1 54894 Federal Register / Vol. 84, No. 198 / Friday, October 11, 2019 / Notices FOR FURTHER INFORMATION CONTACT: Mary C. Till by telephone at (571) 272– 7755; by mail marked to her attention and addressed to the Commissioner for Patents, Mail Stop Hatch-Waxman PTE, P.O. Box 1450, Alexandria, VA 22313– 1450; by fax marked to her attention at (571) 273–7755; or by email to Mary.Till@uspto.gov. Section 156 of Title 35, United States Code, 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, and that the patent may be extended for interim periods of up to one year if the regulatory review is anticipated to extend beyond the expiration date of the patent. On September 23, 2019, TVAX Biomedical I, LLC, the patent owner of record, timely filed an application under 35 U.S.C. 156(d)(5) for an interim extension of the term of U.S. Patent No. 6,406,699. The patent claims a method of using a veterinary biological product in the cancer immunotherapy treatment ECI® (ELIAS Cancer Immunotherapy), which is the subject of a request for licensure from the United States Department of Agriculture, Center for Veterinary Biologics. The application for patent term extension indicates that PCN 96A7.50 is a product license that was assigned to the request for license from TVAX Biomedical I, LLC on November 7, 2017. Review of the patent term extension application indicates that, except for permission to market or use the product commercially, the subject patent would be eligible for an extension of the patent term under 35 U.S.C. 156, and that the patent should be extended for one year as required by 35 U.S.C. 156(d)(5)(B). Because the regulatory review period will continue beyond the original expiration date of the patent, October 5, 2019, interim extension of the patent term under 35 U.S.C. 156(d)(5) is appropriate. An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. 6,604,699 is granted for a period of one year from the original expiration date of the patent. jbell on DSK3GLQ082PROD with NOTICES SUPPLEMENTARY INFORMATION: Robert Bahr, Deputy Commissioner for Patent Examination Policy, United States Patent and Trademark Office. [FR Doc. 2019–22329 Filed 10–10–19; 8:45 am] BILLING CODE 3510–16–P VerDate Sep<11>2014 17:56 Oct 10, 2019 Jkt 250001 COMMITTEE FOR PURCHASE FROM PEOPLE WHO ARE BLIND OR SEVERELY DISABLED Procurement List; Additions and Deletions Committee for Purchase From People Who Are Blind or Severely Disabled. ACTION: Additions to and deletions from the Procurement List. AGENCY: This action adds products and a service to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes products from the Procurement List previously furnished by such agencies. SUMMARY: Date added to and deleted from the Procurement List: November 10, 2019. DATES: Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S Clark Street, Suite 715, Arlington, Virginia, 22202–4149. FOR FURTHER INFORMATION CONTACT: Michael R. Jurkowski, Telephone: (703) 603–2117, Fax: (703) 603–0655, or email CMTEFedReg@AbilityOne.gov. SUPPLEMENTARY INFORMATION: ADDRESSES: Additions On 6/7/2019, 8/16/2019, 8/30/2019 and 9/6/2019, the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed additions to the Procurement List. After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the products and a service and impact of the additions on the current or most recent contractors, the Committee has determined that the products and service listed below are suitable for procurement by the Federal Government under 41 U.S.C. 8501–8506 and 41 CFR 51–2.4. Regulatory Flexibility Act Certification I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were: 1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the products and service to the Government. 2. The action will result in authorizing small entities to furnish the products and service to the Government. PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-WagnerO’Day Act (41 U.S.C. 8501–8506) in connection with the products and service proposed for addition to the Procurement List. End of Certification Accordingly, the following products and a service are added to the Procurement List: Products NSN(s)—Product Name(s): MR 13067—Container, Clip Top, Ice Pack, Assorted Colors MR 13068—Container, Multi-Pack, Assorted Colors MR 13069—Container, Noodles, Assorted Colors MR 13070—Mug, Soup, 24 oz, Assorted Colors MR 13071—Mug, Thermal, Assorted Colors MR 13072—Container, Snap Top, Assorted Colors Mandatory Source of Supply: West Texas Lighthouse for the Blind, San Angelo, TX Contracting Activity: Military Resale-Defense Commissary Agency NSN(s)—Product Name(s): 8540–00–291–0389—Towel, Multifold, 3 Panel, Natural Mandatory Source of Supply: Outlook Nebraska, Inc, Omaha, NE Mandatory For: Total Government Requirement Contracting Activity: FEDERAL ACQUISITION SERVICE, GSA/FAS ADMIN SVCS ACQUISITION BR(2 NSN(s)—Product Name(s): MR 10781—Holder, Sponge, Duo, Includes Shipper 20781 Mandatory Source of Supply: Winston-Salem Industries for the Blind, Inc., WinstonSalem, NC Contracting Activity: Military Resale-Defense Commissary Agency NSN(s)—Product Name(s): 8540–01–169–9010—Towel, Paper, Absorbent, White, Roll, 11″ x 9″ Mandatory Source of Supply: Outlook Nebraska, Inc, Omaha, NE Mandatory For: Total Government Requirement Contracting Activity: DEFENSE LOGISTICS AGENCY, DLA TROOP SUPPORT Service Service Type: Janitorial and related services Mandatory for: GSA PBS Region 8, Old Chamber Building, 2nd Floor Judges Space, Billings, MT Mandatory Source of Supply: Community Option Resource Enterprises, Inc. (COR Enterprises), Billings, MT Contracting Activity: PUBLIC BUILDINGS SERVICE, PBS R8 Deletions On 8/30/2019 and 9/6/2019, the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed deletions from the Procurement List. E:\FR\FM\11OCN1.SGM 11OCN1

Agencies

[Federal Register Volume 84, Number 198 (Friday, October 11, 2019)]
[Notices]
[Pages 54893-54894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-22329]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2019-0037]


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 interim extension for a one-year interim extension of 
the term of U.S. Patent No. 6,406,699.

[[Page 54894]]


FOR FURTHER INFORMATION CONTACT: Mary C. Till by telephone at (571) 
272-7755; by mail marked to her attention and addressed to the 
Commissioner for Patents, Mail Stop Hatch-Waxman PTE, P.O. Box 1450, 
Alexandria, VA 22313-1450; by fax marked to her attention at (571) 273-
7755; or by email to [email protected].

SUPPLEMENTARY INFORMATION: Section 156 of Title 35, United States Code, 
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, and that the patent may be extended for interim 
periods of up to one year if the regulatory review is anticipated to 
extend beyond the expiration date of the patent.
    On September 23, 2019, TVAX Biomedical I, LLC, the patent owner of 
record, timely filed an application under 35 U.S.C. 156(d)(5) for an 
interim extension of the term of U.S. Patent No. 6,406,699. The patent 
claims a method of using a veterinary biological product in the cancer 
immunotherapy treatment ECI[supreg] (ELIAS Cancer Immunotherapy), which 
is the subject of a request for licensure from the United States 
Department of Agriculture, Center for Veterinary Biologics. The 
application for patent term extension indicates that PCN 96A7.50 is a 
product license that was assigned to the request for license from TVAX 
Biomedical I, LLC on November 7, 2017.
    Review of the patent term extension application indicates that, 
except for permission to market or use the product commercially, the 
subject patent would be eligible for an extension of the patent term 
under 35 U.S.C. 156, and that the patent should be extended for one 
year as required by 35 U.S.C. 156(d)(5)(B). Because the regulatory 
review period will continue beyond the original expiration date of the 
patent, October 5, 2019, interim extension of the patent term under 35 
U.S.C. 156(d)(5) is appropriate.
    An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. 
Patent No. 6,604,699 is granted for a period of one year from the 
original expiration date of the patent.

Robert Bahr,
Deputy Commissioner for Patent Examination Policy, United States Patent 
and Trademark Office.
[FR Doc. 2019-22329 Filed 10-10-19; 8:45 am]
 BILLING CODE 3510-16-P