80 FR 53552 - Prospective Grant of an Exclusive Patent Commercialization License: Caval-Aortic Devices for Aortic Valve Replacement
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 172 (September 4, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 172 (September 4, 2015)
| Page Range | 53552-53552 | |
| FR Document | 2015-21968 |
[Federal Register Volume 80, Number 172 (Friday, September 4, 2015)] [Notices] [Page 53552] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-21968] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent Commercialization License: Caval-Aortic Devices for Aortic Valve Replacement AGENCY: National Institutes of Health, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404, that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a worldwide exclusive license to practice the inventions embodied in: HHS Ref. No. E-553- 2013/0, U.S. Provisional Patent Application No. 61/863,071, filed August 7, 2013; International Patent Application PCT/US2013/072344 filed November 27, 2013 entitled ``Transvascular and Transcameral Device Access And Closure,'' to Transmural Systems, LLC, a limited liability company incorporated under the laws of the State of Massachusetts and having its principle place of business in Andover, Massachusetts. The contemplated exclusive license may be limited to caval-aortic devices for aortic valve replacement. DATES: Only written comments and/or applications for a license that are received by the NIH Office of Technology Transfer on or before October 5, 2015 will be considered. ADDRESSES: Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Michael Shmilovich, Esq. Senior Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852- 3804; Telephone: (301) 435-5019; Facsimile: (301) 402-0220; Email: [email protected]. SUPPLEMENTARY INFORMATION: The technology pertains to devices and methods for transcatheter correction of cardiovascular abnormalities and more specifically for the delivery of prosthetic valves to the heart. Featured is a device implant for closing a caval-aortic iatrogenic fistula created by the introduction of a transcatheter device from the inferior vena cava into the abdominal aorta. The occlusion device includes an expandable transvascular implant with an elastomeric surface capable of extending between a vein and artery which conforms to the boundaries of an arteriovenous fistula tract between the artery and vein. A guidewire channel is disposed within the occlusion device wherein the channel also has elastomeric wall surfaces that conform or can be expanded to the area so that it occludes the channel when the guidewire is not present. The implant is resiliently deformable into a radially compressed configuration for delivery through the catheter. When the device is not deformed into the radially compressed configuration, the distal end of the device is radially enlarged relative to the intermediate neck whereby the distal end forms an enlarged distal skirt, such as a disk or button shaped member. A polymer coating on the radially enlarged distal end conforms to the endoluminal aortic wall for deployment against an internal wall of the artery. The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404. The prospective exclusive license may be granted unless, within thirty (30) days from the date of this published notice, NIH 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 404. Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response 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: September 1, 2015. Richard U. Rodriguez, Acting Director, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2015-21968 Filed 9-3-15; 8:45 am] BILLING CODE 4140-01-P
![53552 Federal Register / Vol. 80, No. 172 / Friday, September 4, 2015 / Notices
Place: DoubleTree by Hilton Bethesda, 20852–3804; Telephone: (301) 435– DEPARTMENT OF HEALTH AND
8120 Wisconsin Avenue, Bethesda, MD 5019; Facsimile: (301) 402–0220; Email: HUMAN SERVICES
20814. shmilovm@mail.nih.gov.
Contact Person: Kimberly Firth, Ph.D., National Institutes of Health
SUPPLEMENTARY INFORMATION: The
National Institute on Aging, Gateway
Building, 7201 Wisconsin Avenue, Suite technology pertains to devices and
methods for transcatheter correction of National Institute on Aging; Notice of
2C212, Bethesda, MD 20892, 301–402–7702, Closed Meeting
kimberly.firth@nih.gov. cardiovascular abnormalities and more
(Catalogue of Federal Domestic Assistance specifically for the delivery of prosthetic Pursuant to section 10(d) of the
Program Nos. 93.866, Aging Research, valves to the heart. Featured is a device Federal Advisory Committee Act, as
National Institutes of Health, HHS) implant for closing a caval-aortic amended (5 U.S.C. App.), notice is
iatrogenic fistula created by the hereby given of the following meeting.
Dated: August 31, 2015. introduction of a transcatheter device The meeting will be closed to the
Melanie J. Gray, from the inferior vena cava into the public in accordance with the
Program Analyst, Office of Federal Advisory abdominal aorta. The occlusion device provisions set forth in sections
Committee Policy. includes an expandable transvascular 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
[FR Doc. 2015–21944 Filed 9–3–15; 8:45 am] implant with an elastomeric surface as amended. The grant applications and
BILLING CODE 4140–01–P capable of extending between a vein and the discussions could disclose
artery which conforms to the boundaries confidential trade secrets or commercial
of an arteriovenous fistula tract between property such as patentable material,
DEPARTMENT OF HEALTH AND the artery and vein. A guidewire and personal information concerning
HUMAN SERVICES channel is disposed within the individuals associated with the grant
occlusion device wherein the channel applications, the disclosure of which
National Institutes of Health also has elastomeric wall surfaces that would constitute a clearly unwarranted
conform or can be expanded to the area invasion of personal privacy.
Prospective Grant of an Exclusive so that it occludes the channel when the
Patent Commercialization License: Name of Committee: National Institute on
guidewire is not present. The implant is
Caval-Aortic Devices for Aortic Valve Aging Special Emphasis Panel Menopause
resiliently deformable into a radially and Alzheimer’s Disease.
Replacement compressed configuration for delivery Date: October 27, 2015.
AGENCY: National Institutes of Health, through the catheter. When the device is Time: 12:00 p.m. to 5:00 p.m.
HHS. not deformed into the radially Agenda: To review and evaluate grant
ACTION: Notice. compressed configuration, the distal applications.
end of the device is radially enlarged Place: National Institute on Aging,
SUMMARY: This is notice, in accordance relative to the intermediate neck Gateway Building, 2C212, 7201 Wisconsin
with 35 U.S.C. 209 and 37 CFR 404, that whereby the distal end forms an Avenue, Bethesda, MD 20892, (Telephone
enlarged distal skirt, such as a disk or Conference Call).
the National Institutes of Health (NIH), Contact Person: Maurizio Grimaldi, Ph.D.,
Department of Health and Human button shaped member. A polymer MD, Scientific Review Officer, National
Services, is contemplating the grant of a coating on the radially enlarged distal Institute on Aging, National Institutes of
worldwide exclusive license to practice end conforms to the endoluminal aortic Health, 7201 Wisconsin Avenue, Room
the inventions embodied in: HHS Ref. wall for deployment against an internal 2C218, Bethesda, MD 20892, 301–496–9374,
No. E–553–2013/0, U.S. Provisional wall of the artery. grimaldim2@mail.nih.gov.
Patent Application No. 61/863,071, filed The prospective exclusive license will (Catalogue of Federal Domestic Assistance
August 7, 2013; International Patent be royalty bearing and will comply with Program Nos. 93.866, Aging Research,
Application PCT/US2013/072344 filed the terms and conditions of 35 U.S.C. National Institutes of Health, HHS)
November 27, 2013 entitled 209 and 37 CFR 404. The prospective
exclusive license may be granted unless, Dated: August 31, 2015.
‘‘Transvascular and Transcameral
Device Access And Closure,’’ to within thirty (30) days from the date of Melanie J. Gray,
Transmural Systems, LLC, a limited this published notice, NIH receives Program Analyst, Office of Federal Advisory
liability company incorporated under written evidence and argument that Committee Policy.
the laws of the State of Massachusetts establishes that the grant of the license [FR Doc. 2015–21945 Filed 9–3–15; 8:45 am]
and having its principle place of would not be consistent with the BILLING CODE 4140–01–P
business in Andover, Massachusetts. requirements of 35 U.S.C. 209 and 37
The contemplated exclusive license CFR 404.
may be limited to caval-aortic devices Properly filed competing applications DEPARTMENT OF HOMELAND
for aortic valve replacement. for a license filed in response to this SECURITY
DATES: Only written comments and/or notice will be treated as objections to
applications for a license that are the contemplated license. Comments Coast Guard
received by the NIH Office of and objections submitted in response to [Docket No. USCG–USCG–2015–0676]
Technology Transfer on or before this notice will not be made available
October 5, 2015 will be considered. for public inspection, and, to the extent Merchant Marine Personnel Advisory
permitted by law, will not be released Committee; Vacancies
ADDRESSES: Requests for a copy of the
under the Freedom of Information Act,
mstockstill on DSK4VPTVN1PROD with NOTICES
patent application, inquiries, comments AGENCY: Coast Guard, DHS.
5 U.S.C. 552.
and other materials relating to the ACTION: Request for applications.
contemplated license should be directed Dated: September 1, 2015.
to: Michael Shmilovich, Esq. Senior Richard U. Rodriguez, SUMMARY: The Coast Guard seeks
Licensing and Patenting Manager, Office Acting Director, Office of Technology applications for membership on the
of Technology Transfer, National Transfer, National Institutes of Health. Merchant Marine Personnel Advisory
Institutes of Health, 6011 Executive [FR Doc. 2015–21968 Filed 9–3–15; 8:45 am] Committee. This Committee advises the
Boulevard, Suite 325, Rockville, MD BILLING CODE 4140–01–P Secretary of the Department of
VerDate Sep<11>2014 16:57 Sep 03, 2015 Jkt 235001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\04SEN1.SGM 04SEN1](https://thefederalregister.org/doc/80_FR_53724/page/1.svg)
Document Created: 2015-12-15 09:58:30
Document Modified: 2015-12-15 09:58:30
| 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 that are received by the NIH Office of Technology Transfer on or before October 5, 2015 will be considered. | |
| FR Citation | 80 FR 53552 |
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