[Federal Register Volume 79, Number 44 (Thursday, March 6, 2014)]
[Notices]
[Pages 12696-12697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-04928]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Start-Up Exclusive Evaluation 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 (HHS), is contemplating the grant of a worldwide 
exclusive evaluation option 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 Mehr Medical LLC, having 
its principle place of business in Andover Massachusetts.
    The contemplated exclusive license may be limited to caval-aortic 
devices for aortic valve replacement. Upon the expiration or 
termination of the start-up exclusive evaluation license, Mehr will 
have the right to execute a start-up exclusive patent commercialization 
license with no greater field of use and territory than granted in the 
evaluation license.

DATES: Only written comments and/or applications for a license that are 
received by the NIH Office of Technology Transfer on or before March 
21, 2014 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 
Patent 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 invention pertains to devices and 
methods for transcatheter correction of cardiovascular abnormalities 
and most 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

[[Page 12697]]

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 but 
when not deformed into the radially compressed configuration at least 
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 evaluation option license is being 
considered under the small business initiative launched on October 1, 
2011 and will comply with the terms and conditions of 35 U.S.C. 209 and 
37 CFR 404. The prospective exclusive evaluation option license, and a 
subsequent exclusive patent commercialization license, may be granted 
unless within fifteen (15) days from the date of this published notice, 
the 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: March 3, 2014.
Richard Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-04928 Filed 3-5-14; 8:45 am]
BILLING CODE 4140-01-P