DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claims 23 have been renumbered claim 23 and claim 24.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3-6, 9-13, and 24 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being unpatentable by Gill(WO 2022221644 A2).
Regarding claim 1, Gill discloses a stimulation system for changing cerebral spinal fluid flow rates through the brain comprising: a stimulator, the stimulator comprising a sensory stimulation device designed to stimulate one or more sensory receptors; a power controller designed to provide a stimulation; a modulator system designed to control modulation of the stimulation; a communications module designed to send data and receive instructions executable by one of the stimulator, the modulator system, or the power controller to change the stimulation; a remote device comprising; a processor; a memory coupled to the processor, the memory comprising computer readable instructions executable by the processor, the processor operable when executing the instructions to send instructions to the communications module to change the stimulation(Disclosed herein, in one aspect, is a device assembly for neural stimulation of a plurality of target nerves in a patient, the device comprising: a) a power source; b) a first neural stimulator configured to deliver a first stimulation to a first target nerve of the plurality of target nerves, the first neural stimulator in operative communication with the power source; c) a second neural stimulator configured to deliver a second stimulation to a second target nerve of the plurality of target nerve, the second neural stimulator in operative communication with the power source, wherein the first target nerve is different from the second target nerve; d) a controller in operative communication with the power source, the first neural stimulator, and the second neural stimulator, wherein the controller is configured to deliver one or both of the first stimulation and the second stimulation[0014]. n some embodiments, the microcontroller is configured to be in operative communication with a memory component (e.g., a non-volatile memory component) to store different stimulation profiles that can be selected via user input from the interface for the electric current to be delivered to a given set of electrodes[0088]).
Regarding claim 3, Gill discloses the stimulation system of claim 1, wherein the stimulator further comprises a sensor(Accordingly, in some embodiments, such sensors, are in communication with the controller[0090]).
Regarding claim 4, Gill discloses the stimulation system of claim 3, wherein the sensor uses infrared light(In some embodiments, the one or more physiological parameters comprises measurements of cortical electrical activity through EEG monitoring, measurements of tissue oxygenation through near-infrared spectroscopy, blood oxygenation through an oximeter, blood flow velocity and/or pulsatility index through transcranial doppler ultrasound, laser speckle imaging, or through diffusion correlation spectroscopy, cerebral metabolism through combination of measures from near-infrared spectroscopy and diffusion correlation spectroscopy, or a combination thereof[00106]).
Regarding claim 5, Gill discloses the stimulation system of claim 4, wherein the sensor uses the fNIRS method(In some embodiments, a physiological monitoring system comprising an electroencephalogram (EEG), near-infrared spectroscopy, or other technology is capable of detecting cerebral blood flow, and/or any other key vital to monitor and provide safe stimulation ranges[0064]).
Regarding claim 6, Gill discloses the stimulation system of claim 3, wherein the sensor is an EEG sensor(In some embodiments, the one or more physiological monitors comprise monitoring pulse rate, blood pressure, mean arterial pressure, neural monitoring (e.g., via EEG), blood oxygenation levels, blood flow velocity and/or pulsatility index, calculations of tissue perfusion, brain functional activity, or a combination thereof[0091]).
Regarding claim 9, Gill discloses the stimulation system of claim 1, wherein the stimulator is in an eye mask, a headband, a cap, a neck piece, a pillow, a blower, or a mouthpiece(In some embodiments, the strap 706 comprises an elastic strap, an elastic band, or other stretchable material that enables the strap to securely wrap around a patient’s head, and thereby enabling a secure and sufficient contact of the electrode housing (and thereby electrodes) and a patient’s face[0161]).
Regarding claim 10, Gill discloses the stimulation system of claim 1, further comprising a second stimulator, the second stimulator comprising an electrical stimulator(a second neural stimulator configured to deliver a second stimulation to a second target nerve of the plurality of target nerve, the second neural stimulator in operative communication with the power source[0088]).
Regarding claim 11, Gill discloses the stimulation system of claim 10, wherein the second stimulator further has at least one electrode(the second stimulation profile comprises corresponding stimulation parameters corresponding to a current to be delivered to a second set of electrodes[00166]).
Regarding claim 12, Gill discloses the stimulation system of claim 1, wherein the remote device includes a wireless communication module designed to wirelessly communicate with the communications module(In some embodiments, the stimulation/monitoring component 201 is in operative communication with the programming component 203 via a cable (e.g., wired connection), dock (e.g., docked connection), and/or wirelessly (e.g., via Bluetooth, wi-fi, cellular data, etc)[00123]).
Regarding claim 13, Gill discloses the stimulation system of claim 1, wherein the stimulator is designed to change pressure placed on tissue(In some embodiments, the patient specific information comprises measurement such as electrode resistance, cerebral blood flow measurements, EEG waves measured, heart rate, blood pressure, pulse oxygen level, cerebral oxygenation, cerebral metabolic rate, blood flow velocity, partial pressure of oxygen in the brain tissue[0094]).
Regarding claim 24, Gill discloses a stimulation system for changing cerebral spinal fluid flow rates through the brain comprising: a stimulator, the stimulator having at least one implantable component with a stimulation means designed to stimulate one or more sensory receptors; a power controller designed to provide a stimulation; a modulator system designed to control modulation of the stimulation; a communications module designed to receive instructions executable by one of the stimulator, the modulator system, or the power controller to change the stimulation; a remote device comprising; a processor; a memory coupled to the processor, the memory comprising computer readable instructions executable by the processor, the processor operable when executing the instructions to send instructions to the communications module to change the stimulation(Disclosed herein, in one aspect, is a device assembly for neural stimulation of a plurality of target nerves in a patient, the device comprising: a) a power source; b) a first neural stimulator configured to deliver a first stimulation to a first target nerve of the plurality of target nerves, the first neural stimulator in operative communication with the power source; c) a second neural stimulator configured to deliver a second stimulation to a second target nerve of the plurality of target nerve, the second neural stimulator in operative communication with the power source, wherein the first target nerve is different from the second target nerve; d) a controller in operative communication with the power source, the first neural stimulator, and the second neural stimulator, wherein the controller is configured to deliver one or both of the first stimulation and the second stimulation[[0014]. n some embodiments, the microcontroller is configured to be in operative communication with a memory component (e.g., a non-volatile memory component) to store different stimulation profiles that can be selected via user input from the interface for the electric current to be delivered to a given set of electrodes[0088]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2, 7, 8, and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Gill in view of Black(WO 2019173468 A1).
Regarding claim 2, Gill discloses the stimulation system of claim 1, but fails to disclose wherein the sensory stimulation device is designed to change the temperature of the surrounding tissue. However, Black teaches “a thermoelectric device thermally coupled to the earpiece and configured to heat and/or cool the earpiece to thereby heat and/or cool the ear canal of the subject[abstract]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the nerve stimulation system of Gill with the neurostimulation method of Black. Doing so would specify a thermoelectric device in the system to control tissue temperature to enhance stimulation.
Regarding claim 7, Gill in view of Black teaches the stimulation system of claim 2, wherein the sensory stimulation device includes a thermoelectric device(Gill - In some embodiments, thermal stimulation comprises delivering one or more laser pulses to one or more target nerves, and/or using a thermoelectric heat pump[0069]).
Regarding claim 8, Gill in view of Black teaches the stimulation system of claim 7, wherein the thermoelectric device is a conformable thermoelectric device configured to conform to an anatomy(In some embodiments, the electrode housing 704 is flexible, and configured to conform with a wide variety of patient face shapes and/or head shapes[0161]).
Regarding claim 15, Gill discloses the stimulation system of claim 1, but fails to disclose wherein one of the modulator system, the power con- troller, or the stimulator is designed to create a stimulation wave having a predetermined periodicity, the stimulation wave further having a period of stimulation and a period of relaxation.
However, Black teaches “For each administered CVS stimulus, a time to entrainment (T.sub.E) and/or a time to relaxation (T.sub.R) of at least one physiological oscillatory pattern may be determined, such as cross-functional coupling. If the time to entrainment and the time to relaxation of the at least one physiological oscillatory pattern are within target ranges (e.g., exceed a threshold) for one of the at least one CVS stimulus, then that at least one CVS stimulus may be an optimized CVS stimulus, which may be administered to the subject (e.g., once, or on multiple occasions during a first or an initial or subsequent treatment interval) as treatment. Periodic measurements of the at least one physiological oscillatory pattern may be performed to gauge when durable gains have been achieved[0199]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the nerve stimulation system of Gill with the neurostimulation method of Black. Doing so would specify breaks or changes in the stimulation to allow the patient to relax.
Regarding claim 16, Gill discloses the stimulation system of claim 1, but fails to disclose wherein the stimulation wave provides stimulation during the period of stimulation and provides reduced stimulation during the period of relaxation. However, Black teaches “the subject while determining a time to entrainment (T.sub.E) of at least one physiological oscillatory pattern to the stimulus in the subject, and then ceasing the stimulus and then determining a time to relaxation (T.sub.R) of the oscillatory pattern from the entrainment[0208]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the nerve stimulation system of Gill with the neurostimulation method of Black. Doing so would specify breaks or changes in the stimulation to allow the patient to relax.
Regarding claim 17, Gill discloses the stimulation system of claim 1, but fails to disclose wherein the stimulation wave provides stimulation during the period of stimulation and provides an opposite stimulation during the period of relaxation. However, Black teaches “the subject while determining a time to entrainment (T.sub.E) of at least one physiological oscillatory pattern to the stimulus in the subject, and then ceasing the stimulus and then determining a time to relaxation (T.sub.R) of the oscillatory pattern from the entrainment[0208]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the nerve stimulation system of Gill with the neurostimulation method of Black. Doing so would specify breaks or changes in the stimulation to allow the patient to relax.
Regarding 18, Gill in view of Black teaches the stimulation system of claim 17, but Gill fails to disclose wherein the sensory stimulation device is configured to cool during the period of stimulation and is further configured to heat during the period of relaxation. However, Black teaches “The device used by the patient in Wilkinson for vestibular stimulation included a headset fashioned like music headphones with aluminum earpieces that contained a solid-state heater/cooler element which warmed and cooled the external ear canals via controlled, time- varying thermal waveforms[0223]. Measurements, during the application of VNM, can be made to see the onset and relaxation times associated with changes in acute habituation to sensory stimuli[0218]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the nerve stimulation system of Gill with the neurostimulation method of Black. Doing so would specify breaks or changes in the stimulation to allow the patient to relax.
Claim(s) 14, and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Gill in view of Black(WO 2019173468 A1).
Regarding claim 14, Gill discloses the stimulation system of claim 1, but fails to disclose wherein one of the modulator system, the power controller, or the stimulator is designed to create a stimulation wave, the stimulation wave being configured to change blood vessel diameter. However, Bradley teaches “Accordingly, as used herein, the terms “stimulate” and “stimulation” refer generally to signals, methods and/or systems that affect the functioning of the target neural population (e.g., in an excitatory or inhibitory way) via an electrical field. Representative functions include blood vessel diameter, blood pressure, cardiac function, kidney function, adrenal function, gastrointestinal function, autoimmune function (e.g., via splenic modulation) hepatic function, brain function, and/or pancreatic function(Detailed Description, paragraph 3)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the nerve stimulation system of Gill with the neuromodulation method of Bradley. Doing so would specify stimulation has the ability to affect blood vessel diameter and alter flow in the patient.
Regarding claim 20, Gill disclose the a method of changing cerebral spinal fluid flow rates through the brain comprising: providing a stimulator, the stimulator comprising a sensory stimulation device designed to stimulate a sensory receptor; a power controller designed to provide a stimulation; a modulator system designed to control modulation of the stimulation; and providing a stimulation wave to the sensory receptor; stopping the stimulation wave(Disclosed herein, in one aspect, is a device assembly for neural stimulation of a plurality of target nerves in a patient, the device comprising: a) a power source; b) a first neural stimulator configured to deliver a first stimulation to a first target nerve of the plurality of target nerves, the first neural stimulator in operative communication with the power source; c) a second neural stimulator configured to deliver a second stimulation to a second target nerve of the plurality of target nerve, the second neural stimulator in operative communication with the power source, wherein the first target nerve is different from the second target nerve; d) a controller in operative communication with the power source, the first neural stimulator, and the second neural stimulator, wherein the controller is configured to deliver one or both of the first stimulation and the second stimulation[[0014]. n some embodiments, the microcontroller is configured to be in operative communication with a memory component (e.g., a non-volatile memory component) to store different stimulation profiles that can be selected via user input from the interface for the electric current to be delivered to a given set of electrodes[0088]); but Gill fails to disclose changing blood vessel diameter.
However, Bradley teaches “Accordingly, as used herein, the terms “stimulate” and “stimulation” refer generally to signals, methods and/or systems that affect the functioning of the target neural population (e.g., in an excitatory or inhibitory way) via an electrical field. Representative functions include blood vessel diameter, blood pressure, cardiac function, kidney function, adrenal function, gastrointestinal function, autoimmune function (e.g., via splenic modulation) hepatic function, brain function, and/or pancreatic function(Detailed Description, paragraph 3)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the nerve stimulation system of Gill with the neuromodulation method of Bradley. Doing so would specify stimulation has the ability to affect blood vessel diameter and alter flow in the patient.
Regarding claim 21, Gill in view of Bradley teaches the method of claim 20, further comprising the step of reducing central sympathetic tone(In some embodiments, stimulation using a device described herein is configured to be applied in this setting to increase cerebral or central blood flow during a procedure. In some embodiments, this is in the form of increased flow velocity or through more localized vasodilation. In some embodiments, this change in vascular tone or flow is visualized through existing fluoroscopy technology and a physician may alter the stimulation based on the desired response[00186]. In some embodiments, the devices, systems, and methods described herein are configured to help ease intraprocedural complications and/or help regulate homeostasis in the central nervous system (CNS)[0065]).
Regarding claim 22, Gill in view of Bradley teaches the method of claim 20, further comprising the step of modulating neurotransmitter levels in the brain(In some embodiments, stimulation delivered using a system or device described herein to a patient helps reactivate ascending pathways, activate the thalamus, and modulate neurotransmitters, among other mechanisms[00216]).
Regarding claim 23, Gill in view of Bradley teaches the method of claim 20, further comprising the step of reducing seizures by increasing CSF flow into the parenchyma to reduce non-synaptic coupling(In some embodiments, clinical indications such as those requiring inflammation modulation, increasing central or cerebral blood flow, managing pain, for monitoring and prevention of complications, and/or clearance of unwanted metabolites/proteins, among others, are appropriate use cases for systems and devices described herein to intervene[00211]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Gill in view of Mayer(US 20190247680 A1).
Regarding claim 19, Gill discloses the stimulation system of claim 1, but fails to disclose wherein the modulator system is a ventilation system. However, Mayer teaches “The first therapeutic device also comprises a memory device with control instructions for controlling the ventilator[0564]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the nerve stimulation system of Gill with the therapeutic energy system of Meyer. Doing so would specify a ventilator in the system to aid with circulation and airflow for the patient.
Conclusion
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/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796