82 FR 36809 - Prospective Grant of Exclusive Patent License: MicroRNA Therapeutics for Treating Squamous Cell Carcinomas
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 82, Issue 150 (August 7, 2017)
National Institutes of Health
Federal Register Volume 82, Issue 150 (August 7, 2017)
| Page Range | 36809-36810 | |
| FR Document | 2017-16524 |
[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)] [Notices] [Pages 36809-36810] From the Federal Register Online [www.thefederalregister.org] [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 [email protected]. 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
![Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices 36809
The prospective Exclusive Patent MD 20892, 240–747–7825, anita.undale@ With respect to persons who have an
License will be royalty bearing and may nih.gov. obligation to assign their right, title and
be granted unless within fifteen (15) (Catalogue of Federal Domestic Assistance interest to the Government of the United
days from the date of this published Program Nos. 93.866, Aging Research, States of America, the patent rights in
notice, the National Cancer Institute National Institutes of Health, HHS) these inventions have been assigned to
receives written evidence and argument Dated: August 1, 2017. the Government of the United States of
that establishes that the grant of the David Clary, America.
license would not be consistent with the Program Analyst, Office of Federal Advisory The prospective Exclusive Patent
requirements of 35 U.S.C. 209 and 37 Committee Policy. License territory may be worldwide for
CFR part 404. [FR Doc. 2017–16521 Filed 8–4–17; 8:45 am] the following field of use: MicroRNA
Complete applications for a license in BILLING CODE 4140–01–P
therapeutics for squamous cell
the prospective field of use that are carcinomas.
The invention relates to the use of
timely filed in response to this notice
DEPARTMENT OF HEALTH AND microRNAs (miRs), miR mimics, miR
will be treated as objections to the grant
HUMAN SERVICES mimetics, and a combination thereof as
of the contemplated Exclusive Patent
anti-proliferative cancer therapeutics. In
License. Comments and objections
National Institutes of Health this case, miRs will be administered in
submitted to this notice will not be
a form complexed with nanoparticles in
made available for public inspection Prospective Grant of Exclusive Patent the form of liposomes decorated with
and, to the extent permitted by law, will License: MicroRNA Therapeutics for anti-transferrin receptor (TfR) scFv
not be released under the Freedom of Treating Squamous Cell Carcinomas fragments. Generally, miRs are a highly
Information Act, 5 U.S.C. 552. conserved class of small RNA molecules
AGENCY: National Institutes of Health,
Dated: July 25, 2017. (about 18–24bp) that primarily bind the
HHS.
Richard U. Rodriguez, 3’-UTR region of mRNA molecules and
ACTION: Notice.
Associate Director, Technology Transfer either block translation or promote
Center, National Cancer Institute. SUMMARY: The National Heart, Lung and nuclease mediated degradation. The
[FR Doc. 2017–16525 Filed 8–4–17; 8:45 am] Blood Institute (NHLBI), National inventors found that mimics or
BILLING CODE 4140–01–P Institutes of Health, Department of mimetics derived from several members
Health and Human Services, is of the miR–30–5p family; and miR–30a–
contemplating the grant of an Exclusive 5p and miR–30e–5p, have potential as
DEPARTMENT OF HEALTH AND Patent License to MiRecule, Inc., located anti-proliferative therapeutics in cancers
HUMAN SERVICES in Rockville, Maryland, to practice the including but not limited to squamous
inventions embodied in the patent cell carcinomas and currently have a
National Institutes of Health applications listed in the CRADA with NIDCD exploring their
SUPPLEMENTARY INFORMATION section of uses in treating head and neck
National Institute on Aging; Notice of this notice. squamous cell carcinoma (HNSSC). In
Closed Meeting an in vivo proof-of-concept using a
DATES: Only written comments and/or
applications for a license which are murine xenograft tumor model for
Pursuant to section 10(d) of the HNSSC, the inventors demonstrated that
Federal Advisory Committee Act, as received by the NHLBI Office of
Technology Transfer and Development intraperitoneal administration of a
amended, notice is hereby given of the nanoliposome formulated with an anti-
following meeting. August 22, 2017 will be considered.
ADDRESSES: Requests for copies of the
transferrin receptor antibody fragment
The meeting will be closed to the and a synthetic miR–30a–5p mimic
public in accordance with the patent applications, inquiries, and
strongly delayed tumor growth. Other
provisions set forth in sections comments relating to the contemplated
anti-cancer miR therapeutic mimics can
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Exclusive Patent License should be
be combines with miR–30 including
as amended. The grant applications and directed to: Michael Shmilovich, Esq.,
miR–145–5p, miR–26a–5p, miR–26b–
the discussions could disclose Senior Licensing and Patent Manager,
5p, miR–375–5p, miR–30b–5p, miR–
confidential trade secrets or commercial 31 Center Drive, Room 4A29, MSC2479,
30d–5p, or miR–338–3p. Modes of
property such as patentable material, Bethesda, MD 20892–2479, phone
administration can be by intravenous
and personal information concerning number 301–435–5019, or shmilovm@
injection, intraperitoneal injection,
individuals associated with the grant mail.nih.gov.
subcutaneous injection, or intratumoral
applications, the disclosure of which SUPPLEMENTARY INFORMATION: The injection. Therapeutic design employing
would constitute a clearly unwarranted following represents the intellectual miR mimicry focuses on nucleic acid
invasion of personal privacy. property to be licensed under the modifications that exhibit better
Name of Committee: National Institute on
prospective agreement: HHS Ref. No. E– cytotoxicity than unmodified miRs or
Aging Special Emphasis Panel; Drugs 043–2016/0, including provisional commercially available mimics. For
Targeting Pathways of Aging. patent application 62/304,844 filed example, it is accepted that
Date: September 13, 2017. March 7, 2016 and International Patent modification of the 2’ position of
Time: 3:00 p.m. to 6:00 p.m. Application PCT/US2017/021178 filed individual nucleic acids in an
Agenda: To review and evaluate grant March 7, 2017 both entitled oligonucleotide can improve affinity to
applications. ‘‘MicroRNAs And Methods Of Their complementary strands and confer
mstockstill on DSK30JT082PROD with NOTICES
Place: National Institute on Aging, Use,’’ and all continuing U.S. and resistance to nucleases and reduce
Gateway Building, 2W200, 7201 Wisconsin foreign patents/patent applications for adverse immunogenic reactions. By way
Avenue, Bethesda, MD 20892 (Telephone
Conference Call).
the technology family, to MiRecule. The of another example, bases 1, 6, and 20
Contact Person: Anita H. Undale, Ph.D., patent rights in these inventions have of a passenger strand miR can be
MD, Scientific Review Branch, National been assigned to and/or exclusively mutated to increase the stability of the
Institute on Aging, Gateway Building, Suite licensed to the Government of the resulting duplex; however, these
2W200, 7201 Wisconsin Avenue, Bethesda, United States of America. mutation sites may differ from one
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![36810 Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices
therapeutic miR to another. Tumor DATES: Comments must reach the Coast contain the OMB Control Number of the
suppressing miR mimics can be Guard on or before October 6, 2017. ICR and the docket number of this
synergistically combined with standard ADDRESSES: You may submit comments request, [USCG–2017–0114], and must
chemo- and radiation therapies in an identified by Coast Guard docket be received by October 6, 2017.
anti-cancer regimen. number [USCG–2017–0114] to the Coast
This notice is made in accordance Submitting Comments
Guard using the Federal eRulemaking
with 35 U.S.C. 209 and 37 CFR part 404. Portal at http://www.regulations.gov. We encourage you to submit
The prospective Exclusive Patent See the ‘‘Public participation and comments through the Federal
License will be royalty bearing and may request for comments’’ portion of the eRulemaking Portal at http://
be granted unless within fifteen (15) SUPPLEMENTARY INFORMATION section for www.regulations.gov. If your material
days from the date of this published further instructions on submitting cannot be submitted using http://
notice, the NHLBI receives written comments. www.regulations.gov, contact the person
evidence and argument that establishes A copy of the ICR is available through in the FOR FURTHER INFORMATION
that the grant of the license would not the docket on the Internet at http:// CONTACT section of this document for
be consistent with the requirements of www.regulations.gov. Additionally, alternate instructions. Documents
35 U.S.C. 209 and 37 CFR part 404. copies are available from: Commandant mentioned in this notice, and all public
Complete applications for a license in (CG–612), Attn: Paperwork Reduction comments, are in our online docket at
the prospective field of use that are Act Manager, U.S. Coast Guard, 2703 http://www.regulations.gov and can be
timely filed in response to this notice Martin Luther King Jr. Ave. SE., Stop viewed by following that Web site’s
will be treated as objections to the grant 7710, Washington, DC 20593–7710. instructions. Additionally, if you go to
of the contemplated Exclusive Patent the online docket and sign up for email
FOR FURTHER INFORMATION CONTACT: Mr.
License. Comments and objections alerts, you will be notified when
submitted to this notice will not be Anthony Smith, Office of Information
Management, telephone 202–475–3532, comments are posted.
made available for public inspection
and, to the extent permitted by law, will or fax 202–372–8405, for questions on We accept anonymous comments. All
not be released under the Freedom of these documents. comments received will be posted
Information Act, 5 U.S.C. 552. SUPPLEMENTARY INFORMATION: without change to http://
www.regulations.gov and will include
Dated: July 25, 2017. Public Participation and Request for any personal information you have
Michael Shmilovich, Comments provided. For more about privacy and
Senior Licensing and Patenting Manager, This Notice relies on the authority of the docket, you may review a Privacy
NHLBI Office of Technology Transfer and the Paperwork Reduction Act of 1995; Act notice regarding the Federal Docket
Development. Management System in the March 24,
44 U.S.C. Chapter 35, as amended. An
[FR Doc. 2017–16524 Filed 8–4–17; 8:45 am] 2005, issue of the Federal Register (70
ICR is an application to OIRA seeking
BILLING CODE 4140–01–P the approval, extension, or renewal of a FR 15086).
Coast Guard collection of information Information Collection Request
(Collection). The ICR contains
DEPARTMENT OF HOMELAND information describing the Collection’s Title: Approval of Alterations to
SECURITY purpose, the Collection’s likely burden Marine Portable Tanks; Approval of
on the affected public, an explanation of Non-Specification Portable Tanks.
Coast Guard the necessity of the Collection, and OMB Control Number: 1625–0062.
[Docket No. USCG–2017–0114] other important information describing Summary: The information will be
the Collection. There is one ICR for each used to evaluate the safety of proposed
Information Collection Request to Collection. alterations to marine portable tanks and
Office of Management and Budget; The Coast Guard invites comments on
OMB Control Number: 1625–0062 non-specification portable tank designs
whether this ICR should be granted used to transfer hazardous materials
AGENCY:Coast Guard, DHS. based on the Collection being necessary during offshore operations.
Sixty-day notice requesting
ACTION:
for the proper performance of
Need: Approval by the Coast Guard of
comments. Departmental functions. In particular,
alterations to marine portable tanks
the Coast Guard would appreciate
under 46 CFR part 64 ensures that the
SUMMARY: In compliance with the comments addressing: (1) The practical
altered tank retains the level of safety to
Paperwork Reduction Act of 1995, the utility of the Collection; (2) the accuracy
which it was originally designed.
U.S. Coast Guard intends to submit an of the estimated burden of the
Information Collection Request (ICR) to Collection; (3) ways to enhance the Forms: Not applicable.
the Office of Management and Budget quality, utility, and clarity of Respondents: Owners of marine
(OMB), Office of Information and information subject to the Collection; portable tanks and owners/designers of
Regulatory Affairs (OIRA), requesting a and (4) ways to minimize the burden of non-specification portable tanks.
Reinstatement, without change, of a the Collection on respondents, Frequency: On occasion.
previously approved collection for including the use of automated Hour Burden Estimate: The estimated
which approval has expired for the collection techniques or other forms of annual burden remains 18 hours a year.
following collection of information: information technology. In response to
Authority: The Paperwork Reduction Act
1625–0062, Approval of Alterations to your comments, we may revise this ICR
mstockstill on DSK30JT082PROD with NOTICES
of 1995; 44 U.S.C. Chapter 35, as amended.
Marine Portable Tanks; Approval of or decide not to seek an extension of
Non-Specification Portable Tanks approval for the Collection. We will Dated: August 1, 2017.
without change. Our ICR describes the consider all comments and material Marilyn L. Scott-Perez,
information we seek to collect from the received during the comment period. U.S. Coast Guard, Chief, Office of Information
public. Before submitting this ICR to We encourage you to respond to this Management.
OIRA, the Coast Guard is inviting request by submitting comments and [FR Doc. 2017–16503 Filed 8–4–17; 8:45 am]
comments as described below. related materials. Comments must BILLING CODE 9110–04–P
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Document Created: 2017-08-05 03:00:00
Document Modified: 2017-08-05 03:00:00
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | 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. | |
| FR Citation | 82 FR 36809 |
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