2010-30639. 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: [phone]; Facsimile: [phone]; E-mail: [e-mail]. 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. 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.