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 .
Election/Restrictions
Applicant’s election with traverse of Group I (Claims 1-11) and withdrawal of Group II (Claims 12-20) in the reply filed on December 05, 2025 is acknowledged.
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.
Claims 1, 5, 7-9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Hamner et al. (US 20220233860 A1, hereinafter “Hamner”) in view of Ben-David et al. (US 20190001117 A1, hereinafter “Ben”).
Regarding Claim 1, Hamner discloses: A system for concurrent electrical stimulation of a user (Paragraph 0200, a neurostimulation system, delivers stimulation in synchronization with a prespecified phase of a measured biological rhythm or biological cycle, such as the breathing cycle, tonic sympathetic rhythm, cardiac rhythm, and the like), (Paragraph 0206, a system can include a plurality of stimulators that communicate with each other wirelessly and provided a synchronized, patterned stimulation. In some embodiments, multiple stimulators may be in electrical connection with multiple electrode pairs to stimulate multiple nerves simultaneously), the system comprising:
a first electrode configured to provide a first electrical stimulation to a first nervous system of the user (Paragraph 0018, the embodiments described herein that include multiple peripheral nerve stimulation can promote sympathovagal balance with at least one peripheral nerve modulating the sympathetic nervous system and at least one peripheral nerve modulating the parasympathetic nervous system can advantageously have the ability to selectively modulate either sympathetic and/or parasympathetic arms of the autonomic nervous system in response to detected sympathetic and/or parasympathetic overactivity);
one or more second electrodes configured to provide a second electrical stimulation to a second nervous system of the user (Paragraph 0313, as illustrated schematically in FIG. 14, a system 1400 can utilize three electrodes: a first electrode 1404 positioned over a first nerve, e.g., the tibial nerve 1402, a second electrode 1406 positioned over a second nerve, e.g., the saphenous nerve 1408, and a third electrode 1410 positioned, for example, on the outer side of the leg, opposite to the first two electrodes 1404, 1406. This third electrode 1410 would serve as a common cathode for the other two electrodes 1404, 1406),
one or more vibration electrodes configured to provide vibrational stimulation to an area of the user (Paragraph 0050, the stimulation comprises electrical stimulation, vibrational stimulation, acoustic stimulation, and/or magnetic stimulation), (Paragraph 0228, instead or in addition, involve stimulation modalities other than or in addition to electrical stimulation. For example, at least one of the first stimulation actuator or the second stimulation actuator may comprise a vibrational or mechanical actuating actuator (such as means for vibrating, generating and transferring vibration to for example the skin, (e.g., vibrator, sonic systems, solenoids, offset motor) including for example an element, device, mechanism, component or portion affector, or the like));
one or more motion sensors configured to detect motion of the user (Paragraph 0020, In some of the embodiments described herein, one, several or all of the following features are not included: (i) sensors configured to assess patient motion and/or collect motion data, (ii) accelerometers, gyroscopes, magnetometers, inertial measurement units. and (iii) EMG or other muscle sensors);
and a controller electronically connected to the first electrode, the one or more second electrodes, the one or more vibration electrodes, and the one or more motion sensors (Paragraph 0200, FIG. 1 illustrates a neurostimulation system including a monitoring unit, stimulating unit, and skin interface. The monitoring unit can include one or more sensors, a power source, and a user interface. The monitoring unit can be connected via wires or wirelessly to a stimulation unit. The stimulation unit can include a signal converter, controller, electrical pulse generator, user interface, and power source, and be operably connected, such as via a wired connection, to a skin interface including one, two, or more end effectors, such as electrodes for example), the controller configured to:
monitor motion of the user based on motion and orientation signals received from the one or more motion sensors (Paragraph 0020, In some of the embodiments described herein, one, several or all of the following features are not included: (i) sensors configured to assess patient motion and/or collect motion data, (ii) accelerometers, gyroscopes, magnetometers, inertial measurement units. and (iii) EMG or other muscle sensors);
determine, based on motion signals received from the motion sensors, a physical position of the user (Paragraph 0250, the signals or input can also include sleep sensor sets, including but not limited to accelerometers, gyroscopes, infrared based motion sensors, and/or pressure sensors under a mattress, to measure night time motion as a measure of night time bowel events), (Paragraph 0287, Other instructional feedback activities may include, for example, holding one's breath, hyperventilating, closing one's eyes, opening one's eyes, stretching, lying supine, sitting, standing up, exercising, and the like);
activate, based on the [determined physical position] of the user, at least one selected from a group consisting of the first electrode and the one or more second electrodes (Paragraph 0073, In some embodiments, the method also includes adjusting the first electrical stimulation signal and the second electrical stimulation signal based on the one or more features of the measured rhythmic biological signal), (Paragraph 0287, a neurostimulation system is synchronized, and/or is in communication with a user signaling device configured to provide instructional feedback to a user to guide voluntarily controlled biological rhythmic processes such as breathing or movement such that the phases of the rhythmic process are synchronized with the timing of stimulation delivered to one or more peripheral nerves);
[and activate, based on the determined physical position of the user, the one or more vibration electrodes]
Hamner discloses adjusting the “electrical stimulation signal based on the one or more features of the measured rhythmic biological signal” and describes “voluntarily controlled biological rhythmic processes such as breathing or movement”, but does not explicitly disclose activation of the electrodes based on the determined physical position of the user.
Ben does disclose: a controller (Paragraph 0230, A control unit (103) orchestrates the stimulation by defining timing, intensity and pattern of each stimulator (104) by direct communication (113) with each stimulator. Control unit (103) may be integrated with other parts of the system or stand alone. The communication (113 and 112) of the control unit may be wired to the system's stimulators and detectors or this could be affected in a wireless configuration.) configured to: activate, based on the determined physical position of the user (Paragraph 0208, Motion sensor or actimetry sensor to monitor the activity intensity of the patient, like laying, seating, standing, walking etc):
at least one selected from a group consisting of the first electrode and the one or more second electrodes (Paragraph 0231, The detectors (102) may include one or more detectors from the list of: brain activity detector like EEG, heart rate detector like ECG, breathing detector, motion detector, […] Each specific detector or sensor (102) will sequentially measure attributes of the specific measured parameters and report (112) them directly to the control unit (103) to decide on the appropriate stimulation (114) by the dedicated stimulator (104))
and the one or more vibration electrodes (Paragraph 0224, FIG. 4 illustrates a specific embodiment of mechanical stimulation to the foot of a patient. A wearable footwear device (9) is used to generate pressure or vibrations at specific locations of the foot, thereby stimulating nerves. The properties of the mechanical pressure or vibration stimuli, such as intensity, frequency and activation pattern are controlled wirelessly or via connection wires by the control unit (not shown in this drawing). This mechanical stimulation can be activated in time and intensity so that it is synchronized with other stimulation methods such as like electrical stimulation, or cognitive stimulation. The dual stimuli enhance the brain's response so that is greater than a reaction to a single stimulus)
Ben and Hamner both disclose similar systems and methods of controlled electrical and vibrational nerve stimulation. Furthermore, similar to Ben, Hamner teaches adjusting stimulation based on biological signals and rhythms. It would have been obvious to one skilled in the art before the effective filing date to modify the controller disclosed by Hamner to incorporate the parameter-based stimulation adjustment taught by Ben.
Regarding Claim 5, Hamner in view of Ben discloses all of the limitations of Claim 1. Hamner further discloses: wherein the first nervous system is a vagal nervous system (Paragraph 0070, In some embodiments, the first peripheral nerve is the auricular vagus nerve, and the second peripheral nerve is a nerve other than the auricular vagus nerve, and/or the second electrical nerve stimulation signal is offset at a preselected time interval from the first electrical stimulation signal), and wherein the second nervous system is a vestibular nervous system (Paragraph 0223, Cranial nerves, and branches thereof suitable for neuromodulation regulated by a biological signal could include, for example, any number of (including one, two three, or more of): olfactory, optic, oculomotor, trochlear, trigeminal […], vestibulocochlear, glossopharyngeal, vagus, meningeal vagus, accessory and hypoglossal nerves)
Regarding Claim 7, Hamner in view of Ben discloses all of the limitations of Claim 1. Hamner further discloses: further comprising one or more autonomic sensors configured to detect one or more autonomic functions of the user (Paragraph 0030, a biomedical sensor configured to detect autonomic nervous system activity of the patient and convert the detected activity into a corresponding autonomic detection signal).
Regarding Claim 8, Hamner in view of Ben discloses all of the limitations of Claim 7. Hamner further discloses: wherein the controller (Paragraph 0030, The controller can be configured to analyze the autonomic detection signal and recognize at least one of sympathetic and parasympathetic activity of the patient) is further configured to:
adjust, based on the one or more autonomic functions of the user, one or more stimulation parameters of the first electrode (Paragraph 0038, the controller is configured to adjust at least one of the first electrical stimulation signal and the second electrical nerve stimulation signal based on feedback received regarding the autonomic balance of the patient), (Paragraph 0030, The controller can also be configured to generate a first electrical nerve stimulation signal transcutaneously to the first peripheral nerve effector to stimulate a first peripheral nerve sufficient to modify at least one brain or spinal cord autonomic feedback loop upon detection of a predetermined portion of a first phase of the respiratory cycle);
and adjust, based on the one or more autonomic functions of the user, one or more stimulation parameters of the one or more second electrodes (Paragraph 0030, The controller can also be configured to generate a second electrical nerve stimulation signal transcutaneously to the second peripheral nerve effector to stimulate a second peripheral nerve associated with a parasympathetic nervous pathway of the patient to modify at least one brain or spinal cord autonomic feedback loop upon detection of a predetermined portion of a second phase of the respiratory cycle).
Regarding Claim 9, Hamner in view of Ben discloses all of the limitations of Claim 1. Hamner further discloses: wherein the one or more motions sensors includes at least one selected from a group consisting of a gyroscope and an accelerometer (Paragraph 0020, (i) sensors configured to assess patient motion and/or collect motion data, (ii) accelerometers, gyroscopes, magnetometers, inertial measurement units. and (iii) EMG or other muscle sensors).
Regarding Claim 11, Hamner in view of Ben discloses all of the limitations of Claim 1. Hamner further discloses: wherein the controller is further configured to activate (Paragraph 0305, systems and methods to use a neurostimulation regulated by a measured biological signal systems and methods can be utilized to treat inflammatory diseases), based on a measured indicator of inflammation, the first electrode (Paragraph 0248, Adjusting the electrical stimulation can include, for example, identifying sympathetic or parasympathetic overactivity in the patient, and adjusting the frequency of stimulation of the first nerve; and/or discontinuing electrical stimulation of the first nerve associated with a physiologic parameter, sign, or symptom, including but not limited to an inflammatory response in a patient; and initiating electrical stimulation of a second nerve associated with a physiologic parameter, sign, or symptom, including but not limited to an inflammatory response in a patient. Any of the foregoing neuromodulation systems and methods can utilize synchronization with one, two, or more biological rhythms as described elsewhere herein), (Paragraph 0248, stimulating a first peripheral nerve sufficient to have a therapeutic effect on the inflammatory response of a patient if abnormal sympathetic activity is present)
Claims 2, 4, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Hamner (US 20220233860 A1) in view of Ben-David (US 20190001117 A1), further in view of Paul et al. (US 20090082831 A1, hereinafter “Paul”).
Regarding Claim 2, Hamner in view of Ben discloses all of the limitations of Claim 1. Hamner further discloses: wherein the controller is further configured to:
determine, based on the motion signals, the physical position [as a sitting position] (Hamner, Paragraph 0250, the signals or input can also include sleep sensor sets, including but not limited to accelerometers, gyroscopes, infrared based motion sensors, and/or pressure sensors under a mattress, to measure night time motion as a measure of night time bowel events), (Hamner, Paragraph 0287, Other instructional feedback activities may include, for example, holding one's breath, hyperventilating, closing one's eyes, opening one's eyes, stretching, lying supine, sitting, standing up, exercising, and the like), (Ben, Paragraph 0208, Motion sensor or actimetry sensor to monitor the activity intensity of the patient, like laying, seating, standing, walking etc)
activate, in response to determining the physical position [as the sitting position], the first electrode for a predetermined period of time (Hamner, Paragraph 0073, In some embodiments, the method also includes adjusting the first electrical stimulation signal and the second electrical stimulation signal based on the one or more features of the measured rhythmic biological signal), (Ben, Paragraph 0231, The detectors (102) may include one or more detectors from the list of: brain activity detector like EEG, heart rate detector like ECG, breathing detector, motion detector, […] Each specific detector or sensor (102) will sequentially measure attributes of the specific measured parameters and report (112) them directly to the control unit (103) to decide on the appropriate stimulation (114) by the dedicated stimulator (104))
and activate, in response to determining the physical position [as the sitting position], the one or more second electrodes (Hamner, Paragraph 0073, the method also includes adjusting the first electrical stimulation signal and the second electrical stimulation signal based on the one or more features of the measured rhythmic biological signal), (Paragraph 0287, a neurostimulation system is synchronized, and/or is in communication with a user signaling device configured to provide instructional feedback to a user to guide voluntarily controlled biological rhythmic processes such as breathing or movement such that the phases of the rhythmic process are synchronized with the timing of stimulation delivered to one or more peripheral nerves.
Hamner in view of Ben discloses a motion sensor capable of detecting the physical position as a sitting position (Ben, Paragraph 0208, Motion sensor or actimetry sensor to monitor the activity intensity of the patient, like laying, seating, standing, walking etc), but does not provide further elaboration of assessment of user positioning. Paul more explicitly discloses a controller capable of
determining, based on the motion signals, the physical position as a sitting position (Paragraph 0143, the wake/activity monitor measures both the vibration and relative change in tilt to determine if a therapy user is in motion), (Paragraph 0150, A walking or running user will have a very small change in tilt angle but a large vibration. A user rolling over in bed will have a large change in tilt but a potentially small vibration measurement. Therefore both the vibration and change in tilt measurements are required to effectively discriminate between a user changing and leaving their sleep position. The tilt and vibration thresholds are consistent with those used in the research of human gait analysis, location determination, and activity context awareness);
activating, in response to determining the physical position as the sitting position (Paragraph 0143, The change in tilt component responds to slow changes in either the X or Y accelerometer channels. The tilt parameter is sensitive to a user changing their sleep position, sitting upright, or standing. The vibration component responds to the higher frequency content in the accelerations that characterize a user in motion at a fixed tilt, hence the vibration measurement is sensitive to walking or running), the first electrode for a predetermined period of time (Paragraph 0111, vestibular stimulation system 30, upon activation, delivers initial and subsequent stimulation therapy for a predetermined period of time, such as 30 minutes to 8 hours. This period of time can be set in advance, programmed by the user, or set in any conventional way. The therapy is initiated by the user actuating therapy on button 54. The initial therapy is delivered while the user is in a sleeping position (prone or sitting) with the therapy electrodes properly connected), (Paragraph 0151,As noted above, the state machine in the vestibular stimulation system uses the information provided by the accelerometer wake/activity monitor to disable and enable the stimulation therapy. The wake/activity function stop therapy when a user leaves their sleeping position),
and activating, in response to determining the physical position as the sitting position, the one or more second electrodes (Paragraph 0009, In accordance with the present invention, there is provided an apparatus for the stimulation of the vestibular system. The apparatus includes a housing, a power supply disposed in the housing, an electrode assembly adapted to be coupled to the housing, and a controller disposed in the housing and operatively coupled to the power supply. The controller controls delivery of energy from the power supply to the electrode assembly) ;
Similar to Hamner in view of Ben, Paul teaches a system for stimulation of the vestibular nervous system using various electrode placements. Furthermore, all of the aforementioned references teach motion sensors to detect patient positioning. It would have been obvious to one skilled in the art before the effective filing date to modify the controller disclosed by Hamner to incorporate the specific movement detection means taught by Paul to better adjust and accommodate stimulation intensity and duration for different users.
Regarding Claim 4, Hamner in view of Ben and Paul discloses all of the limitations of Claim 2. Ben further discloses wherein the controller is further configured to: activate, in response to determining the physical position as the sitting position (Paragraph 0208, Motion sensor or actimetry sensor to monitor the activity intensity of the patient, like laying, seating, standing, walking etc), the one or more vibration electrodes (Paragraph 0224, FIG. 4 illustrates a specific embodiment of mechanical stimulation to the foot of a patient. A wearable footwear device (9) is used to generate pressure or vibrations at specific locations of the foot, thereby stimulating nerves. The properties of the mechanical pressure or vibration stimuli, such as intensity, frequency and activation pattern are controlled wirelessly or via connection wires by the control unit (not shown in this drawing). This mechanical stimulation can be activated in time and intensity so that it is synchronized with other stimulation methods such as like electrical stimulation, or cognitive stimulation. The dual stimuli enhance the brain's response so that is greater than a reaction to a single stimulus) at a first control mode (Paragraph 0226, Properties of the mechanical vibration, such as intensity, frequency and pattern, are controlled wirelessly or via connection wires by the control unit (not shown in this Figure). The mechanical stimulation can be activated in time and intensity synchronization with other stimulators, such as electrical and thermal stimulators).
Regarding Claim 6, Hamner in view of Ben discloses all of the limitations of Claim 1. Hamner further: wherein the controller is further configured to:
determine, based on the motion signals, the physical position is a standing position (Hamner, Paragraph 0250, the signals or input can also include sleep sensor sets, including but not limited to accelerometers, gyroscopes, infrared based motion sensors, and/or pressure sensors under a mattress, to measure night time motion as a measure of night time bowel events), (Hamner, Paragraph 0287, Other instructional feedback activities may include, for example, holding one's breath, hyperventilating, closing one's eyes, opening one's eyes, stretching, lying supine, sitting, standing up, exercising, and the like), (Ben, Paragraph 0208, Motion sensor or actimetry sensor to monitor the activity intensity of the patient, like laying, seating, standing, walking etc);
activate, [in response to the speed of the user being less than the speed threshold] the one or more vibration electrodes at a first control mode (Paragraph 0224, FIG. 4 illustrates a specific embodiment of mechanical stimulation to the foot of a patient. A wearable footwear device (9) is used to generate pressure or vibrations at specific locations of the foot, thereby stimulating nerves. The properties of the mechanical pressure or vibration stimuli, such as intensity, frequency and activation pattern are controlled wirelessly or via connection wires by the control unit (not shown in this drawing). This mechanical stimulation can be activated in time and intensity so that it is synchronized with other stimulation methods such as like electrical stimulation, or cognitive stimulation. The dual stimuli enhance the brain's response so that is greater than a reaction to a single stimulus);
and activate, [in response to the speed of the user being greater than or equal to the speed threshold], the one or more vibration electrodes at a second control mode (Paragraph 0226, Properties of the mechanical vibration, such as intensity, frequency and pattern, are controlled wirelessly or via connection wires by the control unit (not shown in this Figure). The mechanical stimulation can be activated in time and intensity synchronization with other stimulators, such as electrical and thermal stimulators).
Hamner in view of Ben does not explicitly disclose a speed threshold. Paul more explicitly discloses: comparing the speed of the user to a speed threshold (Paragraph 0118, As noted above, controller 34, for example, uses accelerometer 220 to measure a therapy user's activity level and determine if therapy should be interrupted. The accelerometer's X and Y axis channels (XACC 222 and YACC 224) are used to calculate vibration and change in tilt levels and trip an alarm if either reaches a preset threshold level. The present invention also contemplates using the measured activity level to change the therapy state to either "interrupted", "active", or "out of sleeping position". The accelerometer and associated software are also used to control a secondary safety function so the integrity of the device is a consideration and any critical error must shut down therapy), (Figures 25A-25B), (Paragraph 0151, the state machine in the vestibular stimulation system uses the information provided by the accelerometer wake/activity monitor to disable and enable the stimulation therapy. The wake/activity function stop therapy when a user leaves their sleeping position).
Similar to Hamner in view of Ben, Paul teaches a system for stimulation of the vestibular nervous system using various electrode placements. Furthermore, all of the aforementioned references teach motion sensors to detect patient positioning and speed. It would have been obvious to one skilled in the art before the effective filing date to modify the controller disclosed by Hamner to incorporate the specific movement detection means taught by Paul to better adjust and accommodate stimulation intensity and duration for different users.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Hamner (US 20220233860 A1) in view of Ben-David (US 20190001117 A1), further in view of Ludlow et al. (US 20140276270 A1, hereinafter “Ludlow”).
Regarding Claim 10, Hamner in view of Ben discloses all of the limitations of Claim 1. Ben further: wherein the controller is further configured to:
activate, based on the determined physical position of the user (Ben, Paragraph 0208, Motion sensor or actimetry sensor to monitor the activity intensity of the patient, like laying, seating, standing, walking etc), the one or more vibration electrodes at a first vibration level (Paragraph 0226, Properties of the mechanical vibration, such as intensity, frequency and pattern, are controlled wirelessly or via connection wires by the control unit (not shown in this Figure). The mechanical stimulation can be activated in time and intensity synchronization with other stimulators, such as electrical and thermal stimulators);
and decrease, [over a first period of time], the first vibration level to a second vibration level (Paragraph 0224, This mechanical stimulation can be activated in time and intensity so that it is synchronized with other stimulation methods such as like electrical stimulation, or cognitive stimulation. The dual stimuli enhance the brain's response so that is greater than a reaction to a single stimulus).
Ludlow more explicitly discloses a first vibration level and a second vibration level (Paragraph 0006, The first vibrotactile stimulation is at a first vibrating rate. The second vibrotactile stimulation is at a second vibrating rate different than the first vibrating rate. Applying the first vibrotactile stimulation and applying the second vibrotactile stimulation may include the subject voluntary activating vibrotactile stimulators. Applying the first vibrotactile stimulation and applying the second vibrotactile stimulation may include automatically activating the vibrotactile stimulators) changing over a first period of time (Figures 6-7B), (Paragraph 0015, In some embodiments, the automatic stimulation module comprises an automatic timer. The automatic timer can include an automatic clock configured to initiate onset of the automatic stimulation module.)
Hamner in view of Ben disclose varying vibrational intensities, as well as varying durations of stimulation in their respective systems. It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Ludlow’s adjustable vibration stimulation rates, so as to better accommodate the individual comforts and needs of a user.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure
Driscoll et al. (US 20160279021 A1) discloses a vibratory ear stimulation system
Rosenbluth et al. (US 9452287 B2) discloses a peripheral nerve stimulator to treat tremors, utilizing noninvasive and/or implanted stimulators
Goodall et al. (US 20180021564 A1) discloses a nerve stimulation system with a headset and ear canal inserts
Manogue et al. (US 20200094055 A1) disclose methods for trigeminal and vagal nerve stimulation
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MISHAL ZAHRA HUSSAIN whose telephone number is (703)756-1206. The examiner can normally be reached M-F, 8:30am - 5:00pm.
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/MISHAL ZAHRA HUSSAIN/
Examiner
Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785