Prospective Grant of Exclusive Patent License: MicroRNA Therapeutics for Treating Squamous Cell Carcinomas, 36809-36810 [2017-16524]

Download as PDF Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices The prospective Exclusive Patent License will be royalty bearing and 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. Complete applications for a license in the prospective field of use that are timely filed in response to this notice will be treated as objections to the grant of the contemplated Exclusive Patent License. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: July 25, 2017. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. National Institutes of Health National Institute on Aging; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. mstockstill on DSK30JT082PROD with NOTICES BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent License: MicroRNA Therapeutics for Treating Squamous Cell Carcinomas AGENCY: National Institutes of Health, Notice. The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to MiRecule, Inc., located in Rockville, Maryland, to practice the inventions embodied in the patent applications listed in the SUPPLEMENTARY INFORMATION section of this notice. DATES: Only written comments and/or applications for a license which are received by the NHLBI Office of Technology Transfer and Development August 22, 2017 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: Michael Shmilovich, Esq., Senior Licensing and Patent Manager, 31 Center Drive, Room 4A29, MSC2479, Bethesda, MD 20892–2479, phone number 301–435–5019, or shmilovm@ mail.nih.gov. SUPPLEMENTARY INFORMATION: The following represents the intellectual property to be licensed under the prospective agreement: HHS Ref. No. E– 043–2016/0, including provisional patent application 62/304,844 filed March 7, 2016 and International Patent Application PCT/US2017/021178 filed March 7, 2017 both entitled ‘‘MicroRNAs And Methods Of Their Use,’’ and all continuing U.S. and foreign patents/patent applications for the technology family, to MiRecule. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. SUMMARY: DEPARTMENT OF HEALTH AND HUMAN SERVICES Name of Committee: National Institute on Aging Special Emphasis Panel; Drugs Targeting Pathways of Aging. Date: September 13, 2017. Time: 3:00 p.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 2W200, 7201 Wisconsin Avenue, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Anita H. Undale, Ph.D., MD, Scientific Review Branch, National Institute on Aging, Gateway Building, Suite 2W200, 7201 Wisconsin Avenue, Bethesda, Jkt 241001 [FR Doc. 2017–16521 Filed 8–4–17; 8:45 am] ACTION: BILLING CODE 4140–01–P 18:14 Aug 04, 2017 Dated: August 1, 2017. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. HHS. [FR Doc. 2017–16525 Filed 8–4–17; 8:45 am] VerDate Sep<11>2014 MD 20892, 240–747–7825, anita.undale@ nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 36809 With respect to persons who have an obligation to assign their right, title and interest to the Government of the United States of America, the patent rights in these inventions have been assigned to the Government of the United States of America. The prospective Exclusive Patent License territory may be worldwide for the following field of use: MicroRNA therapeutics for squamous cell carcinomas. The invention relates to the use of microRNAs (miRs), miR mimics, miR mimetics, and a combination thereof as anti-proliferative cancer therapeutics. In this case, miRs will be administered in a form complexed with nanoparticles in the form of liposomes decorated with anti-transferrin receptor (TfR) scFv fragments. Generally, miRs are a highly conserved class of small RNA molecules (about 18–24bp) that primarily bind the 3’-UTR region of mRNA molecules and either block translation or promote nuclease mediated degradation. The inventors found that mimics or mimetics derived from several members of the miR–30–5p family; and miR–30a– 5p and miR–30e–5p, have potential as anti-proliferative therapeutics in cancers including but not limited to squamous cell carcinomas and currently have a CRADA with NIDCD exploring their uses in treating head and neck squamous cell carcinoma (HNSSC). In an in vivo proof-of-concept using a murine xenograft tumor model for HNSSC, the inventors demonstrated that intraperitoneal administration of a nanoliposome formulated with an antitransferrin receptor antibody fragment and a synthetic miR–30a–5p mimic strongly delayed tumor growth. Other anti-cancer miR therapeutic mimics can be combines with miR–30 including miR–145–5p, miR–26a–5p, miR–26b– 5p, miR–375–5p, miR–30b–5p, miR– 30d–5p, or miR–338–3p. Modes of administration can be by intravenous injection, intraperitoneal injection, subcutaneous injection, or intratumoral injection. Therapeutic design employing miR mimicry focuses on nucleic acid modifications that exhibit better cytotoxicity than unmodified miRs or commercially available mimics. For example, it is accepted that modification of the 2’ position of individual nucleic acids in an oligonucleotide can improve affinity to complementary strands and confer resistance to nucleases and reduce adverse immunogenic reactions. By way of another example, bases 1, 6, and 20 of a passenger strand miR can be mutated to increase the stability of the resulting duplex; however, these mutation sites may differ from one E:\FR\FM\07AUN1.SGM 07AUN1 36810 Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices therapeutic miR to another. Tumor suppressing miR mimics can be synergistically combined with standard chemo- and radiation therapies in an anti-cancer regimen. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective Exclusive Patent License will be royalty bearing and may be granted unless within fifteen (15) days from the date of this published notice, the NHLBI 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. Complete applications for a license in the prospective field of use that are timely filed in response to this notice will be treated as objections to the grant of the contemplated Exclusive Patent License. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Comments must reach the Coast Guard on or before October 6, 2017. ADDRESSES: You may submit comments identified by Coast Guard docket number [USCG–2017–0114] to the Coast Guard using the Federal eRulemaking Portal at https://www.regulations.gov. See the ‘‘Public participation and request for comments’’ portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments. A copy of the ICR is available through the docket on the Internet at https:// www.regulations.gov. Additionally, copies are available from: Commandant (CG–612), Attn: Paperwork Reduction Act Manager, U.S. Coast Guard, 2703 Martin Luther King Jr. Ave. SE., Stop 7710, Washington, DC 20593–7710. FOR FURTHER INFORMATION CONTACT: Mr. Anthony Smith, Office of Information Management, telephone 202–475–3532, or fax 202–372–8405, for questions on these documents. SUPPLEMENTARY INFORMATION: Dated: July 25, 2017. Michael Shmilovich, Senior Licensing and Patenting Manager, NHLBI Office of Technology Transfer and Development. Public Participation and Request for Comments [FR Doc. 2017–16524 Filed 8–4–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG–2017–0114] Information Collection Request to Office of Management and Budget; OMB Control Number: 1625–0062 Coast Guard, DHS. Sixty-day notice requesting comments. AGENCY: ACTION: In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting a Reinstatement, without change, of a previously approved collection for which approval has expired for the following collection of information: 1625–0062, Approval of Alterations to Marine Portable Tanks; Approval of Non-Specification Portable Tanks without change. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below. mstockstill on DSK30JT082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:14 Aug 04, 2017 Jkt 241001 DATES: This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection’s purpose, the Collection’s likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection. The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise this ICR or decide not to seek an extension of approval for the Collection. We will consider all comments and material received during the comment period. We encourage you to respond to this request by submitting comments and related materials. Comments must PO 00000 Frm 00083 Fmt 4703 Sfmt 9990 contain the OMB Control Number of the ICR and the docket number of this request, [USCG–2017–0114], and must be received by October 6, 2017. Submitting Comments We encourage you to submit comments through the Federal eRulemaking Portal at https:// www.regulations.gov. If your material cannot be submitted using https:// www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. Documents mentioned in this notice, and all public comments, are in our online docket at https://www.regulations.gov and can be viewed by following that Web site’s instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted. We accept anonymous comments. All comments received will be posted without change to https:// www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086). Information Collection Request Title: Approval of Alterations to Marine Portable Tanks; Approval of Non-Specification Portable Tanks. OMB Control Number: 1625–0062. Summary: The information will be used to evaluate the safety of proposed alterations to marine portable tanks and non-specification portable tank designs used to transfer hazardous materials during offshore operations. Need: Approval by the Coast Guard of alterations to marine portable tanks under 46 CFR part 64 ensures that the altered tank retains the level of safety to which it was originally designed. Forms: Not applicable. Respondents: Owners of marine portable tanks and owners/designers of non-specification portable tanks. Frequency: On occasion. Hour Burden Estimate: The estimated annual burden remains 18 hours a year. Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. Dated: August 1, 2017. Marilyn L. Scott-Perez, U.S. Coast Guard, Chief, Office of Information Management. [FR Doc. 2017–16503 Filed 8–4–17; 8:45 am] BILLING CODE 9110–04–P E:\FR\FM\07AUN1.SGM 07AUN1

Agencies

[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)]
[Notices]
[Pages 36809-36810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16524]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: MicroRNA 
Therapeutics for Treating Squamous Cell Carcinomas

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The National Heart, Lung and Blood Institute (NHLBI), National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an Exclusive Patent License to MiRecule, 
Inc., located in Rockville, Maryland, to practice the inventions 
embodied in the patent applications listed in the SUPPLEMENTARY 
INFORMATION section of this notice.

DATES: Only written comments and/or applications for a license which 
are received by the NHLBI Office of Technology Transfer and Development 
August 22, 2017 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: Michael Shmilovich, Esq., Senior Licensing and 
Patent Manager, 31 Center Drive, Room 4A29, MSC2479, Bethesda, MD 
20892-2479, phone number 301-435-5019, or shmilovm@mail.nih.gov.

SUPPLEMENTARY INFORMATION:  The following represents the intellectual 
property to be licensed under the prospective agreement: HHS Ref. No. 
E-043-2016/0, including provisional patent application 62/304,844 filed 
March 7, 2016 and International Patent Application PCT/US2017/021178 
filed March 7, 2017 both entitled ``MicroRNAs And Methods Of Their 
Use,'' and all continuing U.S. and foreign patents/patent applications 
for the technology family, to MiRecule. The patent rights in these 
inventions have been assigned to and/or exclusively licensed to the 
Government of the United States of America.
    With respect to persons who have an obligation to assign their 
right, title and interest to the Government of the United States of 
America, the patent rights in these inventions have been assigned to 
the Government of the United States of America.
    The prospective Exclusive Patent License territory may be worldwide 
for the following field of use: MicroRNA therapeutics for squamous cell 
carcinomas.
    The invention relates to the use of microRNAs (miRs), miR mimics, 
miR mimetics, and a combination thereof as anti-proliferative cancer 
therapeutics. In this case, miRs will be administered in a form 
complexed with nanoparticles in the form of liposomes decorated with 
anti-transferrin receptor (TfR) scFv fragments. Generally, miRs are a 
highly conserved class of small RNA molecules (about 18-24bp) that 
primarily bind the 3'-UTR region of mRNA molecules and either block 
translation or promote nuclease mediated degradation. The inventors 
found that mimics or mimetics derived from several members of the miR-
30-5p family; and miR-30a-5p and miR-30e-5p, have potential as anti-
proliferative therapeutics in cancers including but not limited to 
squamous cell carcinomas and currently have a CRADA with NIDCD 
exploring their uses in treating head and neck squamous cell carcinoma 
(HNSSC). In an in vivo proof-of-concept using a murine xenograft tumor 
model for HNSSC, the inventors demonstrated that intraperitoneal 
administration of a nanoliposome formulated with an anti-transferrin 
receptor antibody fragment and a synthetic miR-30a-5p mimic strongly 
delayed tumor growth. Other anti-cancer miR therapeutic mimics can be 
combines with miR-30 including miR-145-5p, miR-26a-5p, miR-26b-5p, miR-
375-5p, miR-30b-5p, miR-30d-5p, or miR-338-3p. Modes of administration 
can be by intravenous injection, intraperitoneal injection, 
subcutaneous injection, or intratumoral injection. Therapeutic design 
employing miR mimicry focuses on nucleic acid modifications that 
exhibit better cytotoxicity than unmodified miRs or commercially 
available mimics. For example, it is accepted that modification of the 
2' position of individual nucleic acids in an oligonucleotide can 
improve affinity to complementary strands and confer resistance to 
nucleases and reduce adverse immunogenic reactions. By way of another 
example, bases 1, 6, and 20 of a passenger strand miR can be mutated to 
increase the stability of the resulting duplex; however, these mutation 
sites may differ from one

[[Page 36810]]

therapeutic miR to another. Tumor suppressing miR mimics can be 
synergistically combined with standard chemo- and radiation therapies 
in an anti-cancer regimen.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective Exclusive Patent License will be royalty 
bearing and may be granted unless within fifteen (15) days from the 
date of this published notice, the NHLBI 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.
    Complete applications for a license in the prospective field of use 
that are timely filed in response to this notice will be treated as 
objections to the grant of the contemplated Exclusive Patent License. 
Comments and objections submitted to this notice will not be made 
available for public inspection and, to the extent permitted by law, 
will not be released under the Freedom of Information Act, 5 U.S.C. 
552.

    Dated: July 25, 2017.
Michael Shmilovich,
Senior Licensing and Patenting Manager, NHLBI Office of Technology 
Transfer and Development.
[FR Doc. 2017-16524 Filed 8-4-17; 8:45 am]
 BILLING CODE 4140-01-P

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