[Federal Register Volume 75, Number 234 (Tuesday, December 7, 2010)]
[Notices]
[Pages 76020-76021]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-30639]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Devices for Treating 
Dysphagia and Dysphonia

AGENCY: National Institutes of Health, Public Health Service, HHS

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), 
Department of Health and Human Services (HHS), is contemplating the 
grant of an exclusive worldwide license to practice the invention 
embodied in: HHS Ref. No. E-251-2005/0,/1,/2:

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      Patent/application number                Territory                Filing date                Status
----------------------------------------------------------------------------------------------------------------
60/695,424...........................  US......................  July 1, 2005............  Expired.
60/787,215...........................  US......................  March 30, 2006..........  Expired.
PCT/US2006/025535....................  Intl....................  June 30, 2006...........  Expired.
PCT/US2007/007993....................  Intl....................  March 20, 2007..........  Expired.
PCT/US2009/57158.....................  Intl....................  September 16, 2009......  Expired.
2006265985...........................  AU......................  December 18, 2007.......  Pending.
2,614,072............................  CA......................  June 30, 2006...........  Pending.
06785933.0...........................  EP......................  June 30, 2006...........  Pending.
2008-520302..........................  JP......................  June 30, 2006...........  Pending.
11/993,094...........................  US......................  December 19, 2007.......  Pending.
08112281.5...........................  HK......................  November 5, 2008........  Pending.
12/240,398...........................  US......................  September 29, 2008......  Pending.
12/211,633...........................  US......................  September 16, 2008......  Pending.
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to Passy-Muir, Inc., a company incorporated under the laws of the State 
of California having its headquarters in Irvine, California. The United 
States of America is the assignee of the rights of the above 
inventions. The contemplated exclusive license may be granted in a 
field of use limited to devices for treating dysphagia and dysphonia.

DATES: Only written comments and/or applications for a license received 
by the NIH Office of Technology Transfer on or before January 6, 2011 
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 A. Shmilovich, Esq., 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; E-mail: <a href="/cdn-cgi/l/email-protection#32415a5f5b5e5d445f725f535b5e1c5c5b5a1c555d44"><span class="__cf_email__" data-cfemail="97e4fffafefbf8e1fad7faf6fefbb9f9feffb9f0f8e1">[email protected]</span></a>. A 
signed confidentiality nondisclosure agreement will be required to 
receive copies of any patent applications that have not been published 
by the United States Patent and Trademark Office or the World 
Intellectual Property Organization.

SUPPLEMENTARY INFORMATION: The patents and patent applications intended 
for licensure disclose or cover a system, device and method for 
rehabilitating dysphagia due to stroke, ex-tubation or coronary bypass 
surgery. Swallowing recovery alleviates the risk of aspiration by 
augmenting volitional control using a simultaneous motor act (e.g., 
such as pressing a button to indicate when they are ready to swallow). 
It is believed that such motor training also initiates sensory 
stimulation, immediately preceding the motor act and that such sensory 
stimulation enhances excitation of a central pattern generator in the 
brain stem that augments the volitional control of swallowing. This 
principle is applicable to other neurological impairments; their 
associated enhancement of voluntary motor act control by the patient 
initiating immediately concurrent and related sensory stimulations. 
Neurological impairments that are contemplated include reflex actions 
involving interactions between afferent and efferent paths (at the 
spinal cord or in the brain stem) as well as higher order interactions. 
This invention includes methods for treating neurologically impaired 
humans using devices such as those that produce vibratory stimulation, 
pressure stimulation, auditory stimulation, temperature stimulation, 
visual stimulation, olfactory stimulation, taste stimulation, or a 
combination of these. Upon activation a vibrator moves and vibrates the 
larynx. Patients can initiate sensory stimulation immediately prior to 
the patient's own initiation of a swallow.

[[Page 76021]]

Specifically, the device allows the patient coordinate muscular 
movement with a button press to permit volitional swallowing.
    In one aspect of the invention, the device comprises a connector 
for attaching the device to the patient's neck, substantially over the 
patient's larynx. The device also comprises a contact section for 
contacting the patient's neck above the larynx. Additionally, the 
device also comprises a stimulator for applying at least one stimulus 
to the patient's larynx. Also, the device comprises an adjustment 
mechanism for shifting the position of the device over the patient's 
larynx.
    The device can also include a movement sensor for monitoring 
pressure on the patient's larynx and a swallowing detector. The 
swallowing detector includes a piezoelectric stretch receptor and a 
stimulator, coupled to the movement sensor, for applying pressure to a 
patient's larynx prior to swallowing. 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 404.7. 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 404.7.
    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: December 1, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-30639 Filed 12-6-10; 8:45 am]
BILLING CODE 4140-01-P


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