[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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: [email protected]. 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