Royalty Report: Medical, Device, Therapeutic – Collection: 4588

License Grant

Pursuant to the licensing agreement, as amended, the University granted a worldwide exclusive license under certain patents and patent applications generally relating to transcutaneous and subcutaneous bilateral neurostimulation for the treatment of neuropsychiatric and neurological disorders. The Licensee is obligated to use commercially reasonable efforts to develop and commercialize one or more licensed products, and thereafter make licensed products reasonably available to the public.

License Property

The license primarily relates to treatments for major neurological and neuropsychiatric disorders such as epilepsy, depression, attention deficit disorder, and post-traumatic stress disorder and to stents.

The present disclosure relates to methods, devices, and systems used for the treatment of mood, anxiety, cognitive, and behavioral disorders (collectively, neuropsychiatric disorders) via stimulation of the superficial elements of the trigeminal nerve (“TNS”). More specifically, minimally invasive systems, devices and methods of stimulation of the superficial branches of the trigeminal nerve located extracranially in the face, namely the supraorbital, supratrochlear, infraorbital, auriculotemporal, zygomaticotemporal, zygomaticoorbital, zygomaticofacial, nasal and mentalis nerves (also referred to collectively as the superficial trigeminal nerve) are disclosed herein.

The present disclosure generally relates to implantable neurostimulator systems, devices and methods of using the same and more particularly relates to implantable neurostimulator systems, devices and methods including at least one implantable electrode for treating neuropsychiatric disorders by stimulating superficial, cutaneous elements of cranial nerve(s).

License Grant

The Licensor hereby grants to the Licensee and its Affiliates a worldwide, exclusive license to make, have made, use, lease and sell Devices, and components and parts utilizing the Patent Rights for the purpose of advancing the theory, application and commercialization of induced neuroplasticity devices.

License Property

Patent Rights shall mean U.S. Patent Application 12/348301 and Provisional Patent Application 61/019,061.

The intellectual property relates to the PoNSTM device. The Patent Rights include one XYZ claim and 22 method claims, which cover a device in the form of a mouth piece that non-invasively delivers neurostimulation to the brain stem via the trigeminal nerve.

The intellectual property relating to the PoNSTM device is the subject of U.S. Patent Application 12/348301 and Provisional Patent Application 61/019,061. (Information on the patent applications was not available from the U.S. Patent and Trademark office.)

The device is held lightly in place by the lips and teeth around the neck of the tab that goes into the mouth and rests on the anterior, superior part of the tongue. The paddle-shaped tab of the device has a hexagonally patterned array of 143 gold-plated circular electrodes (1.50 mm diameter, on 2.34 mm centers) that is created by a photolithographic process used to make printed circuit boards. It uses low-level electrical current to stimulate the lingual branch projections of at least two cranial nerves in the anterior tongue through the gold-plated electrodes.

The brain's ability to recognize its operation in response to new information sources, new functional needs, or new communication pathways is referred to as neuroplasticity. Neuroplasticity is a process underlying all cerebral learning, training, and rehabilitation. Neuromodulation is the use of external tactile stimulation to intentionally change and regulate the internal electrochemical environment of the brain.  Traditional rehabilitation interventions have typically involved medication and various forms of therapies, including physical therapy. The PoNSTM device is being investigated in combination with physical therapy for the treatment of neurological symptoms from disease and trauma including traumatic brain injury (TBI) and Multiple Sclerosis.  The patent is pending on the device.

Field of Use

The Licensee is a company formed for the purpose of advancing the theory, application and commercialization of induced neuroplasticity devices to persons with sensory and neurological needs.

License Grant

Licensor hereby grants to Licensee, and Licensee hereby accepts from Licensor, upon the terms and conditions herein after specified, the exclusive, worldwide right and license under the Licensed Patents and Technology to further test and develop the Technology, to make, to have made, to use, to sell, to lease, to implant, and to have implanted and otherwise dispose of Products and to sublicense the rights created hereby pursuant to the terms.

License Property

Technology relates to a patent for Neurocyberenetic Prosthesis Technology.  This license agreement covers the method and devices of the neurocybernetic prosthesis ('NCP') System for vagus nerve and other cranial nerve stimulation for the control of epilepsy and other movement disorders. NCP System is an implantable medical device for the treatment of epilepsy.  The NCP system is an implantable, multiprogrammable pulse generator that delivers constant current electrical signals to the vagus nerve for the purpose of reducing the frequency and severity of epileptic seizures. The signals are delivered on a predetermined schedule, or may be initiated by the patient with an external magnet. The device is implanted in a subcutaneous pocket in the chest just below the clavicle, similar to pacemaker placement. The stimulation signal is transmitted from the prosthesis to the vagus nerve through a lead connected to an electrode which is a multi-turn silicone helix, with a platinum band on the inner turn of one helix. The prosthesis can be programmed with any IBM- compatible personal computer using NCP software and a programming wand.

Licensor owns a patent relating to Neurocyberenetic Prosthesis Technology (U.S. Patent No. 4,702,254) and other pending patent applications and know-how, and technology relating thereto (collectively referred to as the “Technology”).

4,702,254

US

NeuroCybernetic Prosthesis

Oct. 27, 1987

4,867,164

US

NeuroCybernetic Prosthesis

Sept. 19, 1989

50,258,807

US

NeuroCybernetic Prosthesis

June 25, 1991

577,549

Australia

NeuroCybernetic Prosthesis

March 3, 1989
1,259,379

Canada

NeuroCybernetic Prosthesis

September 12, 1989
0,156,854

Eurpoean

NeuroCybernetic Prosthesis

September 5, 1990

Austria, Belgium, Switzerland, Germany, France, United

Kingdom, Liechtenstein, Luxembourg, Netherlands, Sweden

503,504/84

Japan

Application Number

September 11, 1984

License Grant

Licensor agrees to grant to Licensee the exclusive worldwide right and license to all of Licensor's rights in and to the Licensed Patents, including but not limited to the exclusive worldwide right and license to make, have made, use, sell, import, export and otherwise dispose of the Licensed Products, and to practice the Licensed Methods.  This will also include the right to grant sublicenses to third parties.

License Property

Licensed Patents are for Treatment of Obesity by Bilateral Vagus Nerve Stimulation.

Field of Use

Licensee is engaged in designing, developing, investigating, testing, and marketing specialized medical devices primarily used or to be used for treating disorders by nervous system stimulation.

License Grant

The University's hereby grants to Licensee an exclusive license under the University's Patent Rights, in jurisdictions where the University's Patent Rights exist, to make, have made, use, sell, offer for sale and import Licensed Products and to practice Licensed Methods in the Field of Use to the extent permitted by law. Licensee will not make, use, have made, sell, offer for sale, or import Licensed Products outside the Field of Use.

The University's hereby grants to Licensee a non-exclusive license (the 'Copyright License') under Regents' Copyright Rights, in jurisdictions where the University's Copyright Rights exist, to use, produce, copy, reproduce, display, create derivative works of, perform, and distribute the Licensed Copyright Products in the Field of Use to the extent permitted by law.

The University's grants to Licensee the right to sublicense the University's Patent Rights granted to Licensee.

License Property

Technology refers to licensed products and to practice licensed methods to treat pain from headaches, migraines, trigeminal neuralgia or neuropathic disorders of the head and mouth. The agreement also includes a non-exclusive license to the copyright over certain user interface software for controlling and monitoring nerve stimulation.

Head Pain Management. The other innovation consists of technology designed to take advantage of the fact that stimulating the sensory fibers of a nerve can mask pain perception. The technology uses mechanical vibration (as opposed to electrical stimulation) to stimulate such fibers and is non-invasive and patient controllable. The target market for the commercialization of this technology would include migraine sufferers; those with trigeminal neuropathy, a debilitating, long-lasting oral pain, often arising from failed or compromised dental procedures; and others.

Provisional Patent Application No. 61/905,616 entitled, 'Device, System and Method for Reducing Headache Pain,' filed November 18th, 2013

“Copyright: Graphical User Interface Software to Control and Monitor Nerve Stimulation Device'

Field of Use

'Field of Use' means treatment of pain from headaches, migraines, trigeminal neuralgia, or neuropathic disorders of the head and mouth.

License Grant

The Licensor hereby grants to the Licensee, and the Swiss Licensee hereby accepts, a non-exclusive, royalty-bearing right and license under the Licensed IP to use, make, have made, sell, offer to sell, distribute and import Licensed Products in the Territory during the Term for applications within the Field of Use; provided, however, that upon the occurrence of a License Conversion Event, the portion of the non-exclusive license consisting of the non-exclusive, royalty-bearing license to sell, offer to sell, distribute and import Licensed Products in the Territory during the Term for applications within the Field of Use (the Non-Exclusive Distribution License) shall immediately, and without the need for any action on the part of either party, convert into an exclusive, royalty-bearing license to sell, offer to sell, distribute and import Licensed Products in the Territory during the Term for applications within the Field of Use (Exclusive Distribution License); provided, however, that the exclusivity of such Exclusive Distribution License shall be subject to, and shall not impact, any license rights previously granted in favor of Greatbatch pursuant to the Greatbatch License Agreement; provided, further, however, that if the Licensee fails to obtain FDA Approval for the Licensed Products within six (6) years after the License Conversion Date, the Exclusive Distribution License shall become convertible by the Licensor, at its sole discretion, back into a Non-Exclusive Distribution License. For the avoidance of doubt, during the Term, the non-exclusive, royalty-bearing license to use, make and have made Licensed Products in the Territory during the Term for applications within the Field of Use shall continuously remain a non-exclusive license.  License Conversion Event means the first to occur of (i) receipt of a Conformité Européenne (CE) mark for the Licensed Products that permits sale of such Licensed Products within the European Economic Area for application within the Field of Use; (ii) receipt of FDA Approval or (iii) completion by the Licensee of a human clinical study demonstrating safety and efficacy required to obtain (A) a Conformité Européenne (CE) mark for the Licensed Products that permits sale of such Licensed Products within the European Economic Area for applications within the Field of Use, or (B) FDA Approval.

License Property

United States (U.S.) Licensed Patents:
8,954,148  Key Fob controller for an implantable neurostimulator  
8,483,836  Automated search to identify a location for electrical stimulation to treat a patient
8,515,545  Current steering neurostimulator device with unidirectional current sources
8,571,667  Active current control using the enclosure of an implanted pulse generator
8,738,153  Implantable lead with braided conductors
8,757,485  System and method for using clinician programmer and clinician programming data for inventory and manufacturing prediction and control
8,761,892  Active current control using the enclosure of an implanted pulse generator
8,761,897  Method and system of graphical representation of lead connector block and implantable pulse generators on a clinician programmer
8,781,592  Identifying an area for electrical stimulation to treat a patient
8,812,125  Systems and methods for the identification and association of medical devices
8,868,199  System and method of compressing medical maps for pulse generator or database storage
8,874,219  Arbitrary waveform generator and neural stimulation application
8,903,496  Clinician programming system and method
8,983,616  Method and system for associating patient records with pulse generators
8,996,115  Charge balancing for arbitrary waveform generator and neural stimulation application
8,996,117  Arbitrary waveform generator and neural stimulation application with scalable waveform feature
8,700,175  Devices and methods for visually indicating the alignment of a transcutaneous energy transfer device over an implanted medical device
9,002,466  Diversity antennas for neurostimulator programming devices
9,031,664  Current steering neurostimulator device with unidirectional current sources
9,031,666  Devices and methods for visually indicating the alignment of a transcutaneous energy transfer device over an implanted medical device
9,067,074  Automated search to identify a location for electrical stimulation to treat a patient
9,072,903  System and method of establishing a protocol for providing electrical stimulation with a stimulation system to treat a patient
9,098,610  Communication for implantable medical devices
9,101,767  Measuring load impedance with active stimulation pulses in an mplanted pulse generator
9,126,043  Patient handheld device for use with a spinal cord stimulation system
D663,035  Two-port implantable medical device
D665,086  Three-port implantable medical device
D665,087  Multi-port implantable medical device
D671,900  Pocket controller for implantable neurostimulator
D698,779  Clinician programmer for implantable neurostimulator

Field of Use

Field of Use means deep brain stimulation for movement disorders (i.e. Parkinson’s disease and/or essential tremor).