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 .
This response is non-final.
Response to Amendment
This Office Action is responsive to the amendment filed on 02/17/2026. As directed by the amendment: Claims 1, 7, 21, and 28 have been amended, claims 4, 12-20, 22, and 27 have been cancelled, and no claims have been added. Thus, claims 1-3, 5-11, 21, 23-26, and 28 are presently under consideration in this application.
Response to Arguments
Applicant’s arguments, see pages 7-9, filed 02/17/2026, with respect to the rejection(s) of claim(s) 1-3, 5-11, 21, 23-26, and 28 under 35 U.S.C. 103 have been fully considered and are persuasive. Applicant’s argument that the amendment where the microcontroller cannot power up and down the telemetry when the medical device is in deep sleep mode is persuasive. The amendments recite that the processor contains no power during hibernation mode and is controlled by the switch by the hibernation control circuit of the medical device, and is power upped when the hibernation mode changes from the hibernation control circuitry. In other words, the processor and hibernation control circuitry are separate components within the same device, where the hibernation control circuitry receives the power up or down from telemetry or sensor to control with the processor for power up and down, via the switch. As noted by the Applicant, Chen teaches the processor is powered up by the external signal sent to the processor, which differs with the instant claims because 1) as argued on pages 8-9, the processor of the instant claims does not have power and would be impossible to then receive the external signal, and 2) the hibernation control circuitry is different than the processor, and the hibernation control circuitry, as claimed, is controlling the switch to power on and off the processor, which Chen does not teach. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Jeon et al. (US 10652828).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5, 9, 23, and 25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites the limitation "the expiration" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 9, it is unclear if the “sensor” of claim 9, is the same or different than the sensor of claim 1 line 11.
Regarding claim 23, it is unclear of the “isolation interface circuitry” of claim 23, is the same or different than the isolation interface circuitry of claim 21 line 17.
Regarding claim 25, it is unclear if the “sensor” of claim 25, is the same or different than the sensor of claim 21 line 10.
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.
Claim(s) 1, 21, and 28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jeon et al. (US 10652828)(Hereinafter Jeon).
Regarding claims 1, 21, and 28, Jeon teaches A medical device/method (Col. 1 lines 47-50 “wearable electronic devices, in order to provide a function using one of the sensors of the wearable device (for example, displaying the time when the wearable electronic device detects wrist lifting by the user),” Col. 7 lines 32-35 “The electronic device may, for example, include at least one of…a portable medical device”) comprising:
processor circuitry (Fig. 3(320)),
a battery configured to provide power to the medical device (Fig. 3(389));
stimulation circuitry configured to generate an electrical stimulation signal (Col. 5 lines 14-15 “The haptic module 179 may include, for example, a motor, a piezoelectric element, or an electrical stimulation device.”);
hibernation control circuitry configured to cause the medical device to enter a hibernation mode in response to a hibernation trigger signal and exit the hibernation mode in response to a wake-up trigger signal (Col. 10 lines 5-15 and 35-47 “the power management module 388 [hibernation control circuitry] may cut off the power supply to the processor 320 through the switch 381 disposed on power supply wiring between the power management module 388 and the processor 320. According to one embodiment, the switch 381, which controls the power supply to the processor 320, may be located within the power management module 388…changes from the first mode to the second mode [sleep signal] and from the second mode to the first mode [wake up signal] may be performed according to whether a preset mode change condition is satisfied…the mode change condition may include a case in which the motion of the electronic device 301 detected through a motion sensor (e.g., at least one or more of a gyro sensor, an acceleration sensor, an inertial measurement unit (IMU), and a gyro compass) of the sensor module 376 has a magnitude greater than or equal to the threshold value, a case in which the location of the electronic device 301 detected through a location sensor (e.g., a GPS sensor) of the sensor module 376 is within a predetermined region/area, a case in which the motion of the electronic device 301 indicates a preset gesture, a case in which a user input occurs through a key/button, a microphone, or a display (or a touch panel), a case in which a preset event (e.g., an incoming call, an incoming message, etc.) occurs in the electronic device 301, and/or a case in which the state of certain component(s) of the electronic device 301 is switched (e.g., a case in which the processor 320, a communication processor (CP), or another component is switched from the wake up state to the sleep state).” Col. 13 lines 34-40 “the processor 320 configured to be functionally or electrically connected to the motion detection sensor circuit 376 and the display 360 and to be electrically connected to the power management circuit 388 through the switch 381 that is turned on when the processor is in a first mode [awake mode] and turned off when the processor 320 (e.g., the processor 120) is in a second mode [hibernation mode]”), wherein the hibernation trigger signal comprises a sensor signal or a timer signal, the timer signal indicative of the end of a period of stimulation therapy or the beginning of a period of withholding of stimulation therapy (Col. 10 lines 12-15 and 35-47 “changes from the first mode to the second mode [sleep signal] and from the second mode to the first mode [wake up signal] may be performed according to whether a preset mode change condition is satisfied…the mode change condition may include a case in which the motion of the electronic device 301 detected through a motion sensor (e.g., at least one or more of a gyro sensor, an acceleration sensor, an inertial measurement unit (IMU), and a gyro compass) of the sensor module 376 has a magnitude greater than or equal to the threshold value, a case in which the location of the electronic device 301 detected through a location sensor (e.g., a GPS sensor) of the sensor module 376 is within a predetermined region/area, a case in which the motion of the electronic device 301 indicates a preset gesture, a case in which a user input occurs through a key/button, a microphone, or a display (or a touch panel), a case in which a preset event (e.g., an incoming call, an incoming message, etc.) occurs in the electronic device 301, and/or a case in which the state of certain component(s) of the electronic device 301 is switched (e.g., a case in which the processor 320, a communication processor (CP), or another component is switched from the wake up state to the sleep state).”) and wherein the hibernation control circuitry is further configured to power up and power down telemetry circuitry or a sensor when the medical device is in the hibernation mode (Col. 10 lines 5-11 “the power management module 388 may cut off the power supply to the processor 320 through the switch 381 disposed on power supply wiring between the power management module 388 and the processor 320. According to one embodiment, the switch 381, which controls the power supply to the processor 320, may be located within the power management module 388.” Col. 1 lines 64-67 “electrically connected to the power management circuit through a switch that is turned on when the processor is in a first mode and turned off when the processor is in a second mode” Col. 13 lines 40-44 “wherein the motion detection sensor circuit 376 detects a motion associated with the electronic device 301 in the second mode and provides image data to the display 360 in response to the detection of the motion [Examiner notes the sensor is powered up during the second mode(hibernation mode)].” Col. 19 lines 54-60 “the power management module may be turned off in the second mode. In the second mode, some functions (e.g., measurement of at least one of a remaining amount of the battery 389 and a voltage, a current, or a temperature during charging) of the power management module may be performed by the sensor module.” Col. 5 lines 34-37 “The communication module 190 may include one or more communication processors that support wired communication or wireless communication, which is operated independently of the processor 120 (e.g., an application processor).” Examiner notes that since the power management module is electrically connected to the processor and controls the powering up and down the processor, and the processor is also electrically connected to the communication module 190, therefore, when the processor is powered off, the communication module 190 is also powered off.);
a switch configured to open in response to the hibernation control circuitry causing the medical device to enter the hibernation mode and close in response to the hibernation control circuitry causing the medical device to exit the hibernation mode (Fig. 3(381) Col. 9 lines 5-11 “the processor 320 may be functionally or electrically connected to the power management module 388 through the switch 381 (e.g., a hardware switch or a software switch). The switch 381 may be in an ON state (or closed state) when the processor 320 is in the first mode and is in an OFF state (or opened state) when the processor 320 is in the second mode.”) and configured to cause power to not be delivered to the processor circuitry when the switch is open and the medical device is in the hibernation mode and to cause power to be delivered to the processor circuitry when the switch is closed and the medical device is not in the hibernation mode (Fig. 3(381) Col. 9 lines 5-11 “the processor 320 may be functionally or electrically connected to the power management module 388 through the switch 381 (e.g., a hardware switch or a software switch). The switch 381 may be in an ON state (or closed state) when the processor 320 is in the first mode and is in an OFF state (or opened state) when the processor 320 is in the second mode.” Col. 10 lines 5-11 “the power management module 388 may cut off the power supply to the processor 320 through the switch 381 disposed on power supply wiring between the power management module 388 and the processor 320. According to one embodiment, the switch 381, which controls the power supply to the processor 320, may be located within the power management module 388.”);
isolation interface circuitry configured to prevent power leakage from the hibernation control circuitry to the stimulation circuitry when the medical device is in the hibernation mode (Col. 7 lines 11-20 “the battery 189 may include a protection circuit module (PCM) 240. The PCM 240 may perform various functions (e.g., a pre-shutdown function) to prevent degradation or burn-out of the battery 189. The PCM 240 may be additionally or alternatively configured as at least a portion of a battery management system (BMS) that performs cell balancing, battery capacity measurement, charging/discharging count measurement, temperature measurement, or voltage measurement.”),
wherein the stimulation circuitry is not powered by the battery when the medical device is in the hibernation mode (Col. 5 lines 14-15 “The haptic module 179 may include, for example, a motor, a piezoelectric element, or an electrical stimulation device.” Since the stimulation circuitry requires the microprocessor to produce stimulation, when the microprocessor contains no current or power, the stimulation circuitry is not powered.).
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) 2-3, 5, 7-8, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jeon et al. (US 10652828)(Hereinafter Jeon) in view of Chen et al. (US 9744347)(IDS 12/27/2023) (Hereinafter Chen).
Regarding claim 2, Jeon teaches the invention of claims 1 and 21. However, Jeon does not teach power consumption from the battery during the hibernation mode is less than 1 microamp. Chen, in the same field of endeavor, teaches a medical device that controls the power consumption of the device by enabling different modes and delivering stimulation (Abstract), and further teaches wherein power consumption from the battery during the hibernation mode is less than 1 microamp (Col. 28 lines 51-59 “The LPM4 mode is also referred to as a “deep sleep” mode, where the microcontroller 400 draws almost no current (i.e., consumes virtually no power). The microcontroller 400 has to be “woken up” from this deep sleep LPM4 mode by an external signal. By doing so, the deep sleep LPM4 mode allows the microcontroller 400 to not waste power in standby.”) to consume substantially less power (Abstract). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Jeon, with the power consumption from the battery during the hibernation mode is less than 1 microamp of Chen, because such a modification would allow to consume substantially less power.
Regarding claim 3, Jeon teaches the invention of claims 1 and 21. However, Jeon does not teach hibernation trigger signal is associated with the stimulation circuitry ceasing to generate the electrical stimulation signal. Chen, in the same field of endeavor, teaches a medical device that controls the power consumption of the device by enabling different modes and delivering stimulation (Abstract), and further teaches wherein the hibernation trigger signal is associated with the stimulation circuitry ceasing to generate the electrical stimulation signal (Col. 13 lines 45-51 “a crystal oscillator 430 is external to the microcontroller 400 and is coupled to the microcontroller 400. In some embodiments, the crystal oscillator 430 generates a 32.678 Khz clock that may be used when the microcontroller 400 enters a power-conservation operating mode (also referred to as a low-power mode or a sleep mode) to reduce power consumption.” Col. 28 lines 60-63 “the waveforms for the electrical stimulation pulses are generated by the microcontroller 400's internal DAC (digital-to-analog converter) in real-time for each pulse.” Since the stimulation circuitry requires the microprocessor to produce stimulation, when the microprocessor contains no current or power, the stimulation circuitry is not powered.) to consume substantially less power (Abstract). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Jeon, with the hibernation trigger signal is associated with the stimulation circuitry ceasing to generate the electrical stimulation signal of Chen, because such a modification would allow to consume substantially less power.
Regarding claims 5 and 23, Jeon teaches the invention of claims 1 and 21. However, Jeon does not teach wake-up trigger signal comprises a timer trigger signal and wherein the medical device further comprises a timer communicatively coupled to the hibernation control circuitry and configured to generate the timer trigger at the expiration of a predetermined time period, wherein the isolation interface circuitry is further configured to prevent power leakage from the timer to the stimulation circuitry. Chen, in the same field of endeavor, teaches a medical device that controls the power consumption of the device by enabling different modes and delivering stimulation (Abstract), and further teaches wherein the wake-up trigger signal comprises a timer trigger signal and wherein the medical device further comprises a timer communicatively coupled to the hibernation control circuitry and configured to generate the timer trigger at the expiration of a predetermined time period, wherein the isolation interface circuitry is further configured to prevent power leakage from the timer to the stimulation circuitry (Col. 15 lines 10-14 “the stimulation driver 450 and the stimulation multiplexers 460) from the voltage up-converter 370 between consecutive stimulation pulses, thereby preserving energy stored in the voltage up-converter 370 for the next stimulation pulse.” Col. 33 lines 28-37 “the timer unit 425 (or the timer signals generated therefrom) may be used to control the timing for the micromanage tasks discussed above, i.e., switching the microcontroller 400 between the active mode and one of the power-conservation modes, enabling/disabling the voltage up-converter 370, the stimulation driver 450, and the multiplexers, disconnecting the load from the voltage up-converter 370, and/or writing to the DAC.” Col. 28 lines 51-59 “The LPM4 mode is also referred to as a “deep sleep” mode, where the microcontroller 400 draws almost no current (i.e., consumes virtually no power). The microcontroller 400 has to be “woken up” from this deep sleep LPM4 mode by an external signal. By doing so, the deep sleep LPM4 mode allows the microcontroller 400 to not waste power in standby.”) to consume substantially less power (Abstract). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Jeon, with the wake-up trigger signal comprises a timer trigger signal and wherein the medical device further comprises a timer communicatively coupled to the hibernation control circuitry and configured to generate the timer trigger at the expiration of a predetermined time period, wherein the isolation interface circuitry is further configured to prevent power leakage from the timer to the stimulation circuitry of Chen, because such a modification would allow to consume substantially less power.
Regarding claim 7, Jeon teaches the invention of claims 1 and 21. However, Jeon does not teach medical device further comprises the telemetry circuitry and wherein the wake-up trigger signal comprises a signal received by the telemetry circuitry from the external device. Chen, in the same field of endeavor, teaches a medical device that controls the power consumption of the device by enabling different modes and delivering stimulation (Abstract), and further teaches wherein the medical device further comprises the telemetry circuitry and wherein the wake-up trigger signal comprises a signal received by the telemetry circuitry from the external device (Col. 28 lines 51-59 “the microcontroller 400 may operate in the LPM4 power-conservation when the PNS device 200 is not in use. The LPM4 mode is also referred to as a “deep sleep” mode, where the microcontroller 400 draws almost no current (i.e., consumes virtually no power). The microcontroller 400 has to be “woken up” from this deep sleep LPM4 mode by an external signal [wake up trigger]. By doing so, the deep sleep LPM4 mode allows the microcontroller 400 to not waste power in standby.”) to consume substantially less power (Abstract). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Jeon, with the medical device further comprises the telemetry circuitry and wherein the wake-up trigger signal comprises a signal received by the telemetry circuitry from the external device of Chen, because such a modification would allow to consume substantially less power.
Regarding claim 8, Jeon teaches the invention of claims 1 and 21. However, Jeon does not teach signal is a radio frequency signal or an inductive coupling signal. Chen, in the same field of endeavor, teaches a medical device that controls the power consumption of the device by enabling different modes and delivering stimulation (Abstract), and further teaches wherein the signal is a radio frequency signal or an inductive coupling signal (Col. 15 lines 48-49 “the antenna 510 may receive telemetry signals that are in different radio bands” ) to consume substantially less power (Abstract). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Jeon, with the signal is a radio frequency signal or an inductive coupling signal of Chen, because such a modification would allow to consume substantially less power.
Claim(s) 9-11 and 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jeon et al. (US 10652828)(Hereinafter Jeon) in view of Panken et al. (US 8380314) (Hereinafter Panken).
Regarding claims 9-11 and 25-26, Jeon teach the invention of claims 1 and 21. Although Jeon teaches that the motion sensor can turn on and off the device, it is not explicitly directed to the hibernation mode of the device in which a trigger wake up signal is a sensor signal from a sensor. Panken, in the same field of endeavor, teaches an implantable device containing sensors, that communicates with an external device and used for stimulation (Abstract), and further teaches further comprising a sensor communicatively coupled to the hibernation control circuitry, and wherein the wake-up trigger signal comprises a second sensor signal from the sensor (Col. 28 lines 45-50 “Biosignal detection module 66 monitors an EEG signal to determine whether the EEG signal includes a biosignal that indicates patient 12 provided a volitional input, such as a thought relating to a particular muscle movement, to initiate therapy (107). If biosignal detection module 66 does not detect the biosignal, IMD 18 remains in standby mode.” Examiner notes that when EEG shows an input for movement, therapy is initiated, which is a signal from the sensor to come out of standby mode. Examiner further notes that Col. 29 lines 4-5 uses the phrase “return to a standby” indicating the cycling between on and standby based on the sensor trigger signal.) wherein the sensor is further configured to sense a one or more physiological parameters of a patient, and wherein the sensor generates the second sensor signal in response to the sensing of the one or more physiological parameters of the patient (Col. 28 lines 45-50 “Biosignal detection module 66 monitors an EEG signal to determine whether the EEG signal includes a biosignal that indicates patient 12 provided a volitional input, such as a thought relating to a particular muscle movement, to initiate therapy (107). If biosignal detection module 66 does not detect the biosignal, IMD 18 remains in standby mode.”) wherein the sensor comprises a magnetic sensor or an accelerometer (Col. 28 lines 54-60 “Stimulation generator 64 may continue delivering therapy to patient 12 for a predetermined amount of time or until processor 60 detects a signal that indicates therapy should be adjusted (e.g., stopped). The signal may take the form of a patient input (e.g., via programmer 30, an implanted accelerometer or via a biosignal generated in response to a volitional patient though)… if IMD 18 determines that the biosignal directs the therapy module to stop therapy (110), IMD 18 stops therapy, and may return to a standby mode.”) to conserve the energy of the device when not in use. It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Jeon, with the hibernation mode of the device in which a trigger wake up signal is a sensor signal from a sensor of Panken, because such a modification would allow to conserve the energy of the device when not in use.
Claim(s) 6 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jeon et al. (US 10652828)(Hereinafter Jeon) in view of Kleckner et al. (US 20200269055) (Hereinafter Kleckner).
Regarding claims 6 and 24, Jeon teaches the invention of claims 1 and 21. Jeon does not teach a predetermined time period selectable for more than a year. Kleckner, in the same field of endeavor, teaches a medical device for conserving power by switching between normal state and power saving state (Abstract), and further teaches wherein the predetermined time period is a programmable time period, the programmable time period being a time period of a length that is selectable, wherein a maximum selectable length ([0081] “In some examples, control circuit 80 operates in the power saving state for a fixed time interval. Control circuit 80 may set a timer to a predetermined time interval, e.g., 1 minute, 10 minutes, 30 minutes, one hour, four hours, eight hours, 24 hours or other time interval ranging from several minutes to several hours or even days.”) to extend the life of the medical life to years ([0095]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Jeon, with the wherein the predetermined time period is a programmable time period, the programmable time period being a time period of a length that is selectable, wherein a maximum selectable length of Kleckner, because such a modification would allow to extend the life of the medical life to years.
However, Kleckner does not teach the selectable length of time to be more than a year. Allowing for more than a year time period that is selectable to that time range would allow for the extension of the lifetime of the device ([0095]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to select a time length over a year, for the purpose of extending the lifetime of the device ([0095]), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Suh (2021/0154482)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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