[Federal Register Volume 80, Number 172 (Friday, September 4, 2015)]
[Notices]
[Page 53552]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21968]


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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.

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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