Prospective Grant of an Exclusive Patent License: “Multifunctional RNA Nanoparticles and Methods of Uses” and “RNA/DNA Hybrid Nanoparticles Modified With Single Stranded RNA Toeholds and Uses Thereof”, 65694-65695 [2018-27671]

Download as PDF amozie on DSK3GDR082PROD with NOTICES1 65694 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices federal employees during a competition if the facilities and employees are made equitably available to all individuals and entities participating in the competition; (12) Must provide a statement agreeing to indemnify the federal government against third party claims for damages arising from or related to competition activities; (13) Must provide a statement agreeing to assume all risks and waive claims against the Federal Government and its related entities, except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from participation in this prize contest, whether the injury, death, damage, or loss arises through negligence or otherwise. (14) HHS has hereby waived the requirement for participants to obtain liability insurance in a specified amount for this competition. Participants are advised to consult with appropriate advisors to determine what amounts of insurance may be necessary for their own liability protection. (15) Shall not be currently on the Excluded Parties List (https:// www.epls.gov). without limitation, for advertising and promotional purposes relating to the competition. • Record Retention and FOIA: All materials submitted to HHS as part of a submission become HHS records and cannot be returned. Any confidential commercial information contained in a submission should be designated at the time of submission. Participants will be notified of any Freedom of Information Act requests for their submissions in accordance with 45 CFR 5.65. SUPPLEMENTARY INFORMATION: Information on obesity prevention and control in women and girls can be found at: https://www.cdc.gov/obesity/ resources/strategies-guidelines.html https://www.womenshealth.gov/a-ztopics/overweight-obesity-and-weightloss https://www.girlshealth.gov/nutrition/ healthyweight/ Details on the Shape of Health competition may be found at challenge.gov. FOR FURTHER INFORMATION CONTACT: Ann Abercrombie at Ann.Abercrombie@ hhs.gov. Additional Requirements Entrants shall not use the OWH or HHS logos or official seals in their submissions, and must not claim endorsement. HHS reserves the right to cancel, suspend, and/or modify the Shape of Health competition, or any part of it, for any reason, at HHS’ sole discretion. Payment of the Prize: Prizes awarded under this competition will be paid by electronic funds transfer and may be subject to Federal income taxes. HHS will comply with the Internal Revenue Service withholding and reporting requirements, where applicable. [FR Doc. 2018–27653 Filed 12–20–18; 8:45 am] Intellectual Property (IP) • Each entrant retains full ownership and title in and to their submission. Entrants expressly reserve all intellectual property rights not expressly granted under this publication notice. • By participating in the competition, each entrant hereby irrevocably grants to HHS a limited, non-exclusive, royalty-free, worldwide license and right to reproduce, publically perform, publically display, and use the submission for internal HHS business and to the extent necessary to administer the competition, and to publically perform and publically display the submission, including, VerDate Sep<11>2014 00:00 Dec 21, 2018 Jkt 247001 Dated: November 28, 2018. Brett Giroir, ADM, Assistant Secretary for Health. BILLING CODE 4150–33–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent License: ‘‘Multifunctional RNA Nanoparticles and Methods of Uses’’ and ‘‘RNA/DNA Hybrid Nanoparticles Modified With Single Stranded RNA Toeholds and Uses Thereof’’ AGENCY: National Institutes of Health, HHS. ACTION: Notice. The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patent Applications listed in the Supplementary Information section of this notice to Sixfold Biosciences Inc., (‘‘Sixfold’’) of Walnut, California. DATES: Only written comments and/or applications for a license which are received by the National Cancer Institute’s Technology Transfer Center on or before January 7, 2019 will be considered. SUMMARY: PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 Requests for copies of the patent application, inquiries, and comments relating to the contemplated an Exclusive Patent License should be directed to: Jasmine Yang, Sr. Licensing and Patenting Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 20892–9702 (for business mail), Rockville, MD 20850–9702 Telephone: (240)–276–5530; Facsimile: (240)-276– 5504 Email: jasmine.yang@nih.gov. SUPPLEMENTARY INFORMATION: ADDRESSES: Intellectual Property A. Multifunctional RNA Nanoparticles and Methods of Uses 1. U.S. Provisional Patent Application (Application No. 61/878,758) filed September 17, 2013, HHS Reference No.: E–765–2013–0–US–01 2. PCT Application (Application No. PCT/US2014/056007) filed September 17, 2014, HHS Reference No.: E–765–2013–0–US–02 3. European Patent Application (Application No. 14780963.6) filed September 17, 2014, HHS Reference No.: E–765–2013–0–EP–03 4. Australian Patent Application (Application No. 2014321443) filed September 17, 2014, HHS Reference No.: E–765–2013–0–AU–04 5. Canadian Patent Application (Application No. 2,924,509) filed September 17, 2014, HHS Reference No.: E–765–2013–0–CA–05 6. Japanese. Patent Application (Application No. 2016–543964) filed September 17, 2014, HHS Reference No.: E–765–2013–0–JP– 05 7. US Patent Application (Application No. 15/022,530) filed March 16, 2016, HHS Reference No.: E–765– 2013–0–US–07 B. RNA/DNA Hybrid Nanoparticles Modified with Single Stranded RNA Toeholds and Uses Thereof 1. U.S. Provisional Patent Application (Application No. 62/294,848) filed February 12, 2016, HHS Reference No.: E–078–2016–0–US–01 2. PCT Application (Application No. PCT/US2017/017661) filed February 13, 2017, HHS Reference No.: E–078–2016–0–US–02 3. US Patent Application (Application No. 16/076,878) filed August 9, 2018, HHS Reference No.: E–078– 2016–0–US–03 4. European Patent Application (Application No. 17706653.7) filed September 12, 2018, HHS Reference No.: E–078–2016–0–EP–04 The patent rights in these inventions have been assigned and/or exclusively E:\FR\FM\21DEN1.SGM 21DEN1 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices amozie on DSK3GDR082PROD with NOTICES1 licensed to the government of the United States of America. The prospective exclusive license territory may be where patent applications are filed and the field of use may be limited to ‘‘Multifunctional RNA nanoparticle functionalized by RNA toeholds as a drug delivery agent carrying gene therapeutic or geneediting cargo and/or aptamers’’. Additional licensable fields of use are available (e.g. functionalized with proteins or imaging agent). The technologies disclose RNA and RNA/DNA (‘‘R/DNA’’) nanoparticles in the form of a hexameric ring that have arms attached off the sides of the ring in which the arms could be siRNAs, RNA aptamers, fluorescent dyes, imaging agents and/or proteins in various combinations and use of singlestranded RNA toeholds of lengths of 12 nucleotides or less contained in nucleic acid-based nanoparticles, such as the nanoring, which trigger the association of these nanoparticles and activates multiple functionalities such as gene silencing and/or cell-specific targeting. 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 Cancer Institute 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. License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information in 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; December 11, 2018. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2018–27671 Filed 12–20–18; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 00:00 Dec 21, 2018 Jkt 247001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke, Interagency Pain Research Coordinating Committee Call for Committee Membership Nominations AGENCY: National Institutes of Health, HHS. ACTION: Notice. The Department of Health and Human Services (HHS) (Department) has created the Interagency Pain Research Coordinating Committee (IPRCC) and is seeking nominations for this committee. DATES: Nominations are due by 5 p.m. on January 25, 2019. ADDRESSES: Nominations must be submitted through the webform on the IPRCC website: https://iprcc.nih.gov/ About/Membership-AgencyRepresentation/Nomination-Form. FOR FURTHER INFORMATION CONTACT: Linda Porter at 301–451–4460 or email at porterl@ninds.nih.gov. SUPPLEMENTARY INFORMATION: As specified in Public Law 111–148 (‘‘Patient Protection and Affordable Care Act’’) and amended in H.R. 6, (‘‘Support for Patients and Communities Act’’) the Committee will: (A) Develop a summary of advances in pain care research supported or conducted by the Federal agencies relevant to the diagnosis, prevention, treatment, and management of pain and diseases and disorders associated with pain, including information on best practices for the utilization of nonpharmacologic treatments, nonaddictive medical products, and other drugs or devices approved or cleared by the Food and Drug Administration; (B) identify critical gaps in basic and clinical research on (i) the symptoms and causes of pain, including the identification of relevant biomarkers and screening models and the epidemiology of acute and chronic pain; (ii) the diagnosis, prevention, treatment, and management of acute and chronic pain, including with respect to non-pharmacologic treatments, nonaddictive medical products, and other drugs or devices approved or cleared by the Food and Drug Administration; and (iii) risk factors for, and early warning signs of, substance use disorders in populations with acute and chronic pain; (C) make recommendations to the Director of NIH SUMMARY: PO 00000 Frm 00074 Fmt 4703 Sfmt 9990 65695 (i) to ensure that the activities of the National Institutes of Health and other Federal agencies are free of unnecessary duplication of effort; (ii) on how best to disseminate information on pain care and epidemiological data related to acute and chronic pain; and (iii) on how to expand partnerships between public entities and private entities to expand collaborative, crosscutting research. Membership on the committee will include six (6) non-Federal members from among scientists, physicians, and other health professionals and six (6) non-Federal members of the general public who are representatives of leading research, advocacy, and service organizations for individuals with painrelated conditions. Members will serve overlapping three year terms. It is anticipated that the committee will meet at least once a year. The Department strives to ensure that the membership of HHS Federal advisory committees is fairly balanced in terms of points of view represented and the committee’s function. Every effort is made to ensure that the views of diverse ethnic and racial groups and people with disabilities are represented on HHS Federal advisory committees, and the Department therefore, encourages nominations of qualified candidates from these groups. The Department also encourages geographic diversity in the composition of the Committee. Appointment to this Committee shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, disability, and cultural, religious, or socioeconomic status. The Department is soliciting nominations for 5 non-federal members from among scientists, physicians, and other health professionals and for 3 nonfederal members of the general public who represent a leading research, advocacy, or service organization for people with pain-related conditions. These candidates will be considered to fill positions opened through completion of current member terms. Nominations are due by 5 p.m. on January 25, 2019, using the IPRCC nomination webform: https:// iprcc.nih.gov/About/MembershipAgency-Representation/NominationForm. Dated: December 11, 2018. Walter J. Koroshetz, Director, National Institute of Neurological Disorders and Stroke, National Institutes of Health. [FR Doc. 2018–27737 Filed 12–20–18; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\21DEN1.SGM 21DEN1

Agencies

[Federal Register Volume 83, Number 245 (Friday, December 21, 2018)]
[Notices]
[Pages 65694-65695]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27671]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: 
``Multifunctional RNA Nanoparticles and Methods of Uses'' and ``RNA/DNA 
Hybrid Nanoparticles Modified With Single Stranded RNA Toeholds and 
Uses Thereof''

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The National Cancer Institute, an institute of the National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an Exclusive Patent License to practice the 
inventions embodied in the Patent Applications listed in the 
Supplementary Information section of this notice to Sixfold Biosciences 
Inc., (``Sixfold'') of Walnut, California.

DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute's Technology Transfer 
Center on or before January 7, 2019 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated an Exclusive Patent License 
should be directed to: Jasmine Yang, Sr. Licensing and Patenting 
Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 
1E530 MSC 9702, Bethesda, MD 20892-9702 (for business mail), Rockville, 
MD 20850-9702 Telephone: (240)-276-5530; Facsimile: (240)-276-5504 
Email: jasmine.yang@nih.gov.

SUPPLEMENTARY INFORMATION: 

Intellectual Property

A. Multifunctional RNA Nanoparticles and Methods of Uses

1. U.S. Provisional Patent Application (Application No. 61/878,758) 
filed September 17, 2013, HHS Reference No.: E-765-2013-0-US-01
2. PCT Application (Application No. PCT/US2014/056007) filed September 
17, 2014, HHS Reference No.: E-765-2013-0-US-02
3. European Patent Application (Application No. 14780963.6) filed 
September 17, 2014, HHS Reference No.: E-765-2013-0-EP-03
4. Australian Patent Application (Application No. 2014321443) filed 
September 17, 2014, HHS Reference No.: E-765-2013-0-AU-04
5. Canadian Patent Application (Application No. 2,924,509) filed 
September 17, 2014, HHS Reference No.: E-765-2013-0-CA-05
6. Japanese. Patent Application (Application No. 2016-543964) filed 
September 17, 2014, HHS Reference No.: E-765-2013-0-JP-05
7. US Patent Application (Application No. 15/022,530) filed March 16, 
2016, HHS Reference No.: E-765-2013-0-US-07

B. RNA/DNA Hybrid Nanoparticles Modified with Single Stranded RNA 
Toeholds and Uses Thereof

1. U.S. Provisional Patent Application (Application No. 62/294,848) 
filed February 12, 2016, HHS Reference No.: E-078-2016-0-US-01
2. PCT Application (Application No. PCT/US2017/017661) filed February 
13, 2017, HHS Reference No.: E-078-2016-0-US-02
3. US Patent Application (Application No. 16/076,878) filed August 9, 
2018, HHS Reference No.: E-078-2016-0-US-03
4. European Patent Application (Application No. 17706653.7) filed 
September 12, 2018, HHS Reference No.: E-078-2016-0-EP-04

    The patent rights in these inventions have been assigned and/or 
exclusively

[[Page 65695]]

licensed to the government of the United States of America.
    The prospective exclusive license territory may be where patent 
applications are filed and the field of use may be limited to 
``Multifunctional RNA nanoparticle functionalized by RNA toeholds as a 
drug delivery agent carrying gene therapeutic or gene-editing cargo 
and/or aptamers''. Additional licensable fields of use are available 
(e.g. functionalized with proteins or imaging agent).
    The technologies disclose RNA and RNA/DNA (``R/DNA'') nanoparticles 
in the form of a hexameric ring that have arms attached off the sides 
of the ring in which the arms could be siRNAs, RNA aptamers, 
fluorescent dyes, imaging agents and/or proteins in various 
combinations and use of single-stranded RNA toeholds of lengths of 12 
nucleotides or less contained in nucleic acid-based nanoparticles, such 
as the nanoring, which trigger the association of these nanoparticles 
and activates multiple functionalities such as gene silencing and/or 
cell-specific targeting. 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 Cancer Institute 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.
    License applications submitted in response to this Notice will be 
presumed to contain business confidential information and any release 
of information in 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; December 11, 2018.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2018-27671 Filed 12-20-18; 8:45 am]
 BILLING CODE 4140-01-P

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