03-29490. Prospective Grant of Exclusive License: Methods and Devices for Intramuscular Stimulation of Upper Airway and Swallowing Muscle Groups

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

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, is contemplating the grant of an exclusive worldwide license to practice the invention embodied in: E-181-2002; U.S. Provisional Patent Application 60/413,773 entitled “Methods and Devices for Intramuscular Stimulation of Upper Airway and Swallowing Muscle Groups,” to Medtronic, Inc., a corporation incorporated under the laws of the state of Minnesota and having a place of business at 710 Medtronic Parkway, Minneapolis, MN 55432 and its wholly owned affiliate Medtronic Xomed, Inc., a corporation incorporated under the laws of the state of Delaware and having a place of business at 6743 Southpoint Drive North, Jacksonville, FL 32216. The United States of America is an assignee to the patent rights of these inventions.

The contemplated exclusive license may be limited to the treatment of dysphagia using the Medtronic Implantable Pulse Generator (IPG) System but excluding the use of devices and systems described and claimed in U.S. Patent Nos. 6,185,452; 5,193,540; 5,193,539; 5,324,316; 5,358,514.

DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before January 26, 2004, 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, J.D., Technology Licensing Specialist, 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 Confidential Disclosure Agreement will be required to receive copies of the patent application.

SUPPLEMENTARY INFORMATION:

The patent application covers devices and methods for intramuscular stimulation (stimulation of the geniohyoid, mylohyoid, and thyrohyoid muscles) in patients with neuromuscular disorders. The invention provides autonomous control of both hyolaryngeal elevations, anterior hyoid motion and opening of the upper esophageal sphincter for swallowing, vocalization and speech. Primarily, the technology allows self-stimulation of swallowing and can return oral feeding to dysphagia patients. Electrodes are attached to the appropriate musculature of the neck and an electrode stimulator or subcutaneous signal generator modulates electrostatic pulses through the electrodes that cause the attached muscles to contract thus simulating natural swallowing or vocalization depending on placement.

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 60 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: November 19, 2003.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer.