[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