[Federal Register Volume 68, Number 228 (Wednesday, November 26, 2003)]
[Notices]
[Pages 66472-66473]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-29490]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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.

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[[Page 66473]]

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: (301) 435-5019; Facsimile: (301) 402-0220; E-
mail: [email protected]. 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.
[FR Doc. 03-29490 Filed 11-25-03; 8:45 am]
BILLING CODE 4140-01-P