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 .
Response to Arguments
Applicant's arguments filed 02/03/2026 have been fully considered but they are not persuasive. The applicant argues that Yoo does not teach tracking the number of times a signal is detected in a preset window of time and adjusting a parameter by a multiple based on the number of times that the signal is detected. However, in paragraph [0230], Yoo teaches that “a button sensing module 622 which is configured to assess the number and duration of button presses over a given time period. This permits user input to include durations and patterns of button presses which serve as command signals that cause different adjustments of operation (e.g., pressing for two short durations can cause intensity to decrease”. Therefore, the number of times the signal (button presses) is detected is directly correlated to how the parameter is adjusted.
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.
Claim(s) 1-7 and 13-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kolafa et al (US20070255374A1); hereinafter Kolafa in view of Yoo et al (US20190001135A1); hereinafter Yoo (both cited previously).
Regarding claim 1, Kolafa teaches a system for vagus nerve stimulation (VNS) ([0023] IMD 110 for vagus nerve stimulation), comprising:
a VNS stimulator implantable in a human subject and configured to transmit electrical stimulation pulses to a vagus nerve of the human subject ([0023] IMD 110 comprises a neurostimulator for applying an electrical signal to a neural structure in a patient, particularly a cranial nerve such as a vagus nerve 113); and
at least one sensor configured to detect a signal corresponding to a predefined pattern of tactile input, a bodily gesture, and/or a voice command from the human subject ([0030] user input sensor 260 comprises an implanted tap sensor such as an accelerometer. The tap sensor provides an electronic signal to the IMD 110 in response to a patients' physical tap or touching of the skin over the location of the implanted tap sensor),
wherein the VNS stimulator comprises a controller configured to temporarily modulate at least one stimulation parameter of the electrical stimulation pulses upward, in response to detecting the signal ([0037]-[0038]IMD controller 234 determines an action to be performed according to the number of user activations of the user input sensor 260; three activations of sensor 260 in quick succession).
Kolafa fails to teach that if multiple manual stimulation boost requests are made during a time window that the stimulation boost duration or other stimulation parameter may be increased. Yoo teaches a system that can track a number of times that the signal is detected within a preset window of time, and
increase (i) a magnitude of the temporary modulation of the at least one stimulation parameter of the electrical stimulation pulses, and/or (ii) a duration of the period of modulation, by a multiple based on the number of times that the signal is detected, when the number of times that the signal is detected within a preset window of time exceeds a threshold ([0230] Data sensed by the pressure sensor 620, is processed by a button sensing module 622 which is configured to assess the number and duration of button presses over a given time period. This permits user input to include durations and patterns of button presses which serve as command signals that cause different adjustments of operation (e.g., pressing for two short durations can cause intensity to decrease). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Kolafa with Yoo because there is some teaching, suggestion, or motivation to do so. Yoo teaches that being perceptive to user requests to increase the stimulation multiple times during the session allows the treatment to be more dynamic and therefore effective. Specifically, Yoo teaches “The information from both assessment procedures is stored and used to set or adjust subsequent treatment. If one or more thresholds assessed at the end of therapy are different than those at the beginning then this information can be used to set or adjust stimulation intensity dynamically during a session” ([0191]).
Regarding claim 2, Kolafa teaches the at least one stimulation parameter comprises a pulse amplitude ([0038] three activations of sensor 260 in quick succession may cause the IMD 110 to deliver a larger stimulation level (stimulation level = amplitude) than two activations of sensor 260 in quick succession).
Regarding claim 3, Kolafa teaches the system for VNS of claim 2, wherein the controller is configured to modulate the at least one stimulation parameter in response to the predefined pattern of tactile input from the human subject, wherein the tactile input comprises one or more taps that are detected by the sensor ([0030], [0038] user input sensor 260 comprises an implanted tap sensor such as an accelerometer; three activations of sensor 260 in quick succession may cause the IMD 110 to deliver a larger stimulation level than two activations of sensor 260 in quick succession- triple tap).
Regarding claim 4, Kolafa teaches the system for VNS of claim 2, wherein the sensor comprises a motion sensor and the predefined pattern of tactile input comprises a double-tap detected by the motion sensor ([0030],[0038] user input sensor 260 comprises an implanted tap sensor such as an accelerometer; three activations of sensor 260 in quick succession may cause the IMD 110 to deliver a larger stimulation level than two activations of sensor 260 in quick succession (double-tap)).
Regarding claim 5, Kolafa and Yoo teach the system for VNS of claim 2. Kolafa further teaches the sensor comprises a motion sensor and the predefined pattern of tactile input comprises a triple-tap detected by the motion sensor ([0030], [0038] user input sensor 260 comprises an implanted tap sensor such as an accelerometer; three activations of sensor 260 in quick succession may cause the IMD 110 to deliver a larger stimulation level than two activations of sensor 260 in quick succession- triple tap).
Regarding claim 6, Kolafa and Yoo teach the system of claim 2. Yoo further teaches the sensor comprises an acoustic sensor ([0065] microphone 93), and the controller is configured to modulate the at least one stimulation parameter in response to the voice command from the human subject (microphone 93 allows processing of voice commands by the user interface module 44; [0065],[0080] allowing user control of adjustment of therapy), wherein the acoustic sensor is located in or on the VNS stimulator or is located on an external device (fig 5 part 93). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Kolafa with Yoo because there is some teaching, suggestion or motivation to do so. Yoo states that either accelerometer, EMG, or microphone data can measure user activity and, embodiments that use one sensor may be substituted with another in different embodiments [0230]. Kolafa already has an accelerometer so using the microphone to collect commands instead would have been obvious.
Regarding claim 7, Kolafa and Yoo teaches the system of claim 2. Kolafa fails to teach a voice command. Yoo teaches the controller is configured to modulate the at least one stimulation parameter based at least in part on the predefined pattern of tactile input ([0243], [0245] a gesture such as a "strong tap" can be sensed which is processed by a gesture module 624 having an accelerometer) and the voice command from the human subject ([0065],[0080] processing of voice commands). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Kolafa with Yoo because there is some teaching, suggestion or motivation to do so. Yoo states that either accelerometer, EMG, or microphone data can measure user activity and, embodiments that use one sensor may be substituted with another in different embodiments [0230]. Kolafa already has an accelerometer so using the microphone to collect commands instead would have been obvious.
Regarding claim 13, Kolafa and Yoo teach the system for VNS of claim 2. Kolafa further teaches wherein the sensor comprises a motion sensor and the tactile input comprises a double-tap or a triple-tap detected by the motion sensor; and wherein the controller is configured to modulate the at least one stimulation parameter differently based upon whether a double-tap or a triple-tap is detected ([0030],[0038] user input sensor 260 comprises an implanted tap sensor such as an accelerometer; three activations of sensor 260 in quick succession may cause the IMD 110 to deliver a larger stimulation level than two activations of sensor 260 in quick succession (double-tap)).
Regarding claim 14, Kolafa and Yoo teaches the system of claim 2. Kolafa fails to teach providing feedback. Yoo teaches the system is further configured to provide audio, visual, and/or haptic feedback ([0234] implantable neurostimulator is configured to provide notification signal 304) :
a) in response to the detection of the tactile input and/or the voice command from the human subject ([0234] stimulation contingently provided based upon assessment of sensed data).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Kolafa with Yoo because there is some teaching, suggestion, or motivation to do so. Yoo teaches that starting stimulation as a person is engaged in an activity such as driving a car may lead to trouble in accurate control of the gas or brake pedal ([0008]). Therefore, it would be obvious to provide a notification before stimulation.
Regarding claim 15, the combination of Kolafa and Yoo teaches the system of claim 14. Yoo further teaches the audio, visual, and/or haptic feedback is provided by the VNS stimulator or an external device ([0245] notification protocol can be programmed to attempt to provide notification by an external device).
Regarding claim 16, Kolafa and Yoo teach the system of claim 1. Kolafa further teaches wherein the controller is configured to store one or more profiles comprising a setting for the modulation of the at least one stimulation parameter ([0028] the storage 240 or other storage in the pulse generator 232 may be used to store the parameter settings that define a therapy protocol or program).
Regarding claim 17, Kolafa and Yoo teach the system of claim 16. Kolafa further teaches wherein the setting for the modulation of the at least one stimulation parameter comprises a pulse amplitude, pulse width, and/or pulse frequency setting for the stimulation parameter ([0017] parameters comprise pulse frequency, pulse width, current amplitude, on-time, and off-time).
Regarding claim 18, Kolafa and Yoo teach the system of claim 16. Kolafa further teaches wherein the controller is configured to allow the human subject and/or a remote operator to adjust the setting for the modulation of the at least one stimulation parameter ([0036] switching from one therapy protocol to the next = adjusting the setting for modulation, can be based on a rate at which the user activates sensor 260).
Regarding claim 20, Kolafa and Yoo teach the system of claim 1. Kolafa further teaches wherein the modulation of the at least one stimulation parameter comprises increasing the pulse amplitude ([0030], [0038] larger stimulation level).
Regarding claim 21, Kolafa teaches the modulation of the at least one stimulation parameter comprises changing the pulse amplitude ([0030], [0038] larger stimulation level).
Regarding claim 22, Kolafa teaches a method for vagus nerve stimulation (VNS), comprising ([0032] a method of vagus nerve stimulation):
a) providing a VNS stimulator implantable in a human subject and configured to transmit electrical stimulation pulses to a vagus nerve of the human subject ([0023] IMD is provided for implantation and stimulating the vagus nerve with electrical pulses);
b) detecting, by at least one sensor communicatively linked with the VNS stimulator, a signal corresponding to a predefined pattern of tactile input, a bodily gesture, and/or a voice command from the human subject, indicative of a request for increased VNS ([0030] implanted tap sensor), and
c) temporarily modulating, by a controller communicatively linked with the at least one sensor and the VNS stimulator, at least one parameter of the electrical stimulation pulses upward, in response to detecting the signal, ([0030], [0038] user input sensor 260 comprises an implanted tap sensor such as an accelerometer; three activations of sensor 260 in quick succession may cause the IMD 110 to deliver a larger stimulation level than two activations of sensor 260 in quick succession- triple tap),
Kolafa fails to teach that if multiple manual stimulation boost requests are made during a time window that the stimulation boost duration or other stimulation parameter may be increased. Yoo teaches a system that can track a number of times that the signal is detected within a preset window of time, and
increase (i) a magnitude of the temporary modulation of the at least one stimulation parameter of the electrical stimulation pulses, and/or (ii) a duration of the period of modulation, by a multiple based on the number of times that the signal is detected, when the number of times that the signal is detected within a preset window of time exceeds a threshold ([0230] Data sensed by the pressure sensor 620, is processed by a button sensing module 622 which is configured to assess the number and duration of button presses over a given time period. This permits user input to include durations and patterns of button presses which serve as command signals that cause different adjustments of operation (e.g., pressing for two short durations can cause intensity to decrease). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Kolafa with Yoo because there is some teaching, suggestion, or motivation to do so. Yoo teaches that being perceptive to user requests to increase the stimulation multiple times during the session allows the treatment to be more dynamic and therefore effective. Specifically, Yoo teaches “The information from both assessment procedures is stored and used to set or adjust subsequent treatment. If one or more thresholds assessed at the end of therapy are different than those at the beginning then this information can be used to set or adjust stimulation intensity dynamically during a session” ([0191]).
Regarding claim 23, Kolafa and Yoo teach the method of claim 22. Kolafa further teaches wherein the at least one sensor comprises a motion sensor and the tactile input comprises a double-tap or a triple-tap by the human subject ([0030], [0038] user input sensor 260 comprises an implanted tap sensor such as an accelerometer; three activations of sensor 260 in quick succession may cause the IMD 110 to deliver a larger stimulation level than two activations of sensor 260 in quick succession- triple tap).
Regarding claim 24, Kolafa and Yoo teaches the method of claim 22. Kolafa fails to teach an acoustic sensor. Yoo teaches the at least one sensor comprises an acoustic sensor ([0065] microphone 93). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Kolafa with Yoo because there is some teaching, suggestion, or motivation to do so. Yoo teaches either accelerometer, EMG, or microphone data can measure user activity and, embodiments that use one sensor may be substituted with another in different embodiments.
Regarding claim 25, Kolafa and Yoo teach the method of claim 22. Kolafa further teaches wherein the modulation of the at least one parameter of the electrical stimulation pulses comprises increasing or decreasing a pulse amplitude ([0030],[0038] deliver a larger stimulation level).
Regarding claim 26, Kolafa and Yoo teach the method of claim 22. Kolafa further teaches wherein the modulation of the at least one parameter of the electrical stimulation pulses comprises changing the pulse amplitude ([0038] larger stimulation level).
Regarding claim 19, Kolafa and Yoo teaches the system of claim 1. Kolafa fails to teach a voice command. Yoo teaches the controller is configured to stop and/or revert the modulation of the at least one stimulation parameter based at least in part on a second tactile input and/or second voice command from the human subject ([0188] if the device's accelerometer module 47 detects a strong tap or stamp by the patient it will immediately pause stimulation). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Kolafa with Yoo because there is some teaching, suggestion, or motivation to do so. Yoo teaches that giving the patient the ability to stop the stimulation deters patient discomfort ([0188]).
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kolafa in view of Yoo and Weng et al (US20170116986A1); hereinafter Weng (cited previously).
Regarding claim 8, the combination of Kolafa and Yoo teaches the system of claim 7. Yoo further teaches the system comprises a motion sensor ([0116],[0129] accelerometer 47) and an acoustic sensor ([0129] microphone 93),
the predefined pattern of tactile input comprises two or more taps detected by the motion sensor ([0245] when the device is provided with an accelerometer it is programmed to a sense a behavioral gesture such as striking or double tapping by a user), and
the voice command comprises an audible command provided by the human subject ([0065] processing of voice commands).
The combination of Kolafa and Yoo fails to teach authentication of the voice command. Weng teaches the controller is configured to modulate the at least one stimulation parameter based at least in part on the predefined pattern of tactile input or the voice command from the human subject, wherein in the case of a voice command the modulation occurs only if the voice command has been validated ([0050] voice command is authenticated). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination of Kolafa and Yoo with Weng because there is some teaching, suggestion, or motivation to do so. Weng teaches an advantage of making sure that only authorized users can provide commands to the device [0050].
Regarding claim 9, Kolafa and Yoo teaches the system of claim 2. Kolafa fails to teach an acoustic sensor. Yoo teaches the at least one sensor comprises an acoustic sensor ([0065] microphone 93). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Kolafa with Yoo because there is some teaching, suggestion, or motivation to do so. Yoo teaches either accelerometer, EMG, or microphone data can measure user activity and, embodiments that use one sensor may be substituted with another in different embodiments. The combination of Kolafa and Yoo fails to teach a training mode. Weng teaches the controller is configured to
a) place the system in a training mode wherein the system is configured to generate, transmit, and/or store a unique identifier associated with a voice of the human subject ([0050] the biometric data correspond to a voice pattern of the unique characteristics of the voice for the user that provide a biometric identifier for the user; wherein the characteristics of different acoustic events are trained); and
b) validate the voice command using the unique identifier ([0050] voice command is authenticated).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination of Kolafa and Yoo with Weng because there is some teaching, suggestion, or motivation to do so. Weng teaches that the training mode and unique identifiers is for the advantage of making sure that only authorized users can provide commands to the device [0050].
Regarding claim 10, the combination of Kolafa, Yoo, and Weng teaches the system of claim 9. Weng further teaches the validation is performed at least in part using a cloud-based service (the validation is performed using a cloud-based service, cloud servers 104B [0049],[0050]).
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kolafa and Yoo in view of Gozani et al (US2019/0022386A1); hereinafter Gozani (cited previously).
Regarding claim 11, Kolafa teaches the system of claim 2. Kolafa further teaches the at least one sensor comprises a motion sensor ([0030] user input sensor 260 comprises an implanted tap sensor such as an accelerometer). Kolafa fails to teach a training mode. Gozani teaches the controller is configured to:
a) place the system in a training mode wherein the system is configured to obtain training data based on a second predefined pattern of tactile input and/or bodily gesture, different from a first predefined pattern of tactile input and/or bodily gesture ([0179],[0180] processor 515 comprising a pulse analyzer puts the system into a training mode to obtain training data based on individual gesture patterns), for modulating the at least one stimulation parameter ([0145],[0179] the gesture includes taps used to adjust stimulation) optionally wherein the at least one stimulation parameter comprises an amplitude, pulse width, duty cycle, and/or pulse frequency of the electrical stimulation pulses, by the human subject ([0145] most actions are initiated by a simple tap, and the intensity of the stimulation is controlled by a flick wherein the direction associated with the change in the intensity)
b) validate the tactile input and/or bodily gesture using the training data, before modulating the at least one stimulation parameter ([0153],[0179] wave segments analyzed by pulse analyzer to determine presence of valid pulses (taps)).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Kolafa with Gozani because there is some teaching, suggestion, or motivation to do so. Gozani teaches the advantage of customizing the device to individual gesture patterns so as to improve the performance ([0179]).
Regarding claim 12, the combination of Kolafa and Gozani teaches the system of claim 11. Gozani further teaches the training data comprises timing (each person has a different preferred pace for the double tap) , based on a predefined pattern of taps that includes two or more taps by the human subject (multiple inbuilt gesture patterns), wherein the predefined pattern of taps is distinct from the predefined pattern of taps for modulating the at least one stimulation parameter ([0145], [0178]-[0179] there are multiple gesture patterns and thus the predefined pattern of taps is distinct from the predefined pattern of taps for modulating one stimulation parameter).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dhrasti SNEHAL Dalal whose telephone number is (571)272-0780. The examiner can normally be reached Monday - Thursday 8:30 am - 6:00 pm, Alternate Friday off, 8:30 am - 5:00 pm.
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/D.S.D./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796