[Federal Register Volume 72, Number 144 (Friday, July 27, 2007)]
[Notices]
[Pages 41337-41338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-14501]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

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

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing in the U.S. in accordance 
with 35 U.S.C. 207 to achieve expeditious commercialization of results 
of federally-funded research and development. Foreign patent 
applications are filed on selected inventions to extend market coverage 
for companies and may also be available for licensing.

ADDRESSES: Licensing information and copies of the U.S. patent 
applications listed below may be obtained by writing to the indicated 
licensing contact at the Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A 
signed Confidential Disclosure Agreement will be required to receive 
copies of the patent applications.

Transgenic Mouse Model for Lupus and Other Autoimmune Diseases

    Description of Technology: The inventors have developed a series of 
transgenic mice that overexpress Toll-Like Receptor 7 (TLR7) at 
different levels. Overexpression of TLR7 in these mice results in a 
lupus-like syndrome, the intensity of which correlates with the level 
of overexpression. As the pathology in these mice results from the 
overexpression of a single gene, it represents a superior model for 
lupus and other autoimmune diseases compared to other existing mouse 
models that dysregulate multiple genes to achieve the same pathologic 
syndrome.
    Two strains are currently available. The TLR7.Tg1 strain 
overexpresses TLR7 at approximately 16 times the wild-type level. The 
TLR7.Tg6 strain overexpresses TLR7 at approximately 4 times the level 
of a wild-type mouse; additionally, the transgene for this strain is 
located on the Y chromosome, which would be advantageous for cross-
breeding to other mouse lines.
    Inventors: Jonathan Deane et al. (NIAID).
    Related Publication: P. Pisitkun et al. Autoreactive B cell 
responses to RNA-related antigens due to TLR7 gene duplication. Science 
2006 Jun 16;312(5780):1669-1672.
    Patent Status: HHS Reference No. E-128-2007/0--Research Tool.
    Licensing Status: This technology is available for nonexclusive 
licensing.
    Licensing Contact: Tara L. Kirby, Ph.D.; 301/435-4426; 
[email protected].

Dysphagia Rehabilitation (Swallowing Recovery): Vibro-Tactile 
Stimulation Device and Method for Motor Control Recovery

    Description of Technology: Available for licensing and/or 
commercial development under a scientific collaboration, are device and 
method patents for volitional swallowing with a substitute sensory 
system. The inventions are potentially applicable to a wide variety of 
indications, including recovery post-stroke and post ex-tubation for 
example, after coronary bypass surgery. The device is being tested in 
dysphagic patients in two, on-going clinical trials at the National 
Institutes of Health. A collaborator or licensee is needed to support 
further clinical trials, validation studies, and final package 
development.
    Device: For the device patent, 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 to coordinate muscular 
movement with a button press to permit volitional swallowing. 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

[[Page 41338]]

stimulator, coupled to the movement sensor, for applying pressure to a 
patient's larynx prior to swallowing. The device can also be used to 
automatically trigger and retrain swallowing to prevent aspiration 
pneumonia post stroke or post extubation.
    Method: For the method patent, the instant device has also been 
claimed in a patent application asserting rights for improving 
voluntary initiation of swallowing in neurologically impaired patients. 
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. Combinations of two or more stimulation types are 
particularly useful. For example, the combined use of button press 
training with simultaneous vibratory and pressure stimulation on the 
neck to augment feedback to the brain stem swallowing centers to 
facilitate voluntary control of swallowing (thought to be largely an 
involuntary brain stem function) is particularly useful for treating 
dysphagic patients. Alternatively automatic cycles of stimulation at 
intervals during the day can be used for intensive retraining of 
swallowing post stroke or post-extubation to prevent aspiration.
    Inventors: Christy Ludlow (NINDS), Christopher Poletto (NINDS), 
Ianessa Humbert (NINDS), Newlin Morgan (NIMH).
    Patent Status: PCT Application No. PCT/US2006/025535 (HHS Reference 
No. E-251-2005/1-PCT-02).
    Licensing Contact: Michael A. Shmilovich, Esq.; 301/435-5019; 
[email protected].
    Collaborative Research Opportunity: For research and development 
collaborations with inventors, contact Heather Gunas at 301-435-3944 or 
e-mail at [email protected].

    Dated: July 19, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health. 5
[FR Doc. E7-14501 Filed 7-26-07; 8:45 am]
BILLING CODE 4140-01-P