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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 17 June 2026 has been entered.
Response to Amendment
This Office Action is responsive to the RCE filed 17 June 2025, which includes an information disclosure statement. No claims have been amended, cancelled, or added. Thus, claims 1-16 are presently under consideration in this application.
Additionally, the amendments made to the specification and the drawings filed 26 May 2026 have been accepted and any previous objects have been withdrawn.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-3 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radke (US Patent 4,595,010 A), hereinafter Radke in view of Carter et al. (US Patent 6,792,315 B2), hereinafter Carter.
Regarding claim 1, Radke discloses an electrical stimulation apparatus (an electrical muscle stimulator 1) comprising:
A pulse generator circuit (a pulse generating circuit 7, 185, 186) including at least a microprocessor to generate at least a first series of pulses and a second series of pulses (Column 3, lines 12-15: “A pulse generating circuit 7 includes an astable multivibrator 8 connected to two monostable multivibrators 9 and 10 to provide a first pulse signal 11 at an output 12 and a second pulse signal 13 at an output 14.”)
A control circuit portion for controlling at least the frequency of the first series of pulses and the second series of pulses (Column 3, lines 42-47: “The frequency of the output pulses supplied at 29 is established by the selection of the circuit components 3-34. The movable tap 35 of potentiometer 34 may be selectively adjusted to vary the frequency of the periodic pulses appearing at output circuit 29.”, frequency modifying circuit 190, Column 7, lines 39-66: “the FET 191 operates as a variable resistance to selectively control the operating frequency of the pulses generated by the NOR circuits 15' and 16'.”)
A modulator circuit portion (a summing and magnitude unbalance control 80) for modulating the first series of pulses and the second series of pulses into a combined waveform (Column 1, lines 62-66: “A summing circuit operatively combines the first and second pulse outputs to provide a combined pulse which operatively controls the supply of electricity to an electrode to stimulate one or more muscles.”, Column 4, lines 53-60: “The pulses 75 and 77 are supplied to a summing and magnitude unbalance control 80 which includes a pair of diodes 81 and 82, a fixed resistor 83 and a variable potentiometer 84 having a movable tap 85. In that pulse 13 is formed in response to the termination of pulse 11, the summation of pulses 75 and 77 at potentiometer 84 provides a combined pulse 86 at tap 85, as illustrated by wave form 87 in FIG. 3D.”)
An output circuit portion (An output control circuit 110) comprising a plurality of output channels (Column 5, lines 38-40: “An output control circuit 110 provides output terminals 111 and 112 which are connected to electrodes 5 and 6 through connecting leads 3 and 4, respectively.)
A load engaging portion comprising a plurality of electrodes each connected in signal receiving relation to one of said output channels, for delivering the combined waveform pulses to the body of a person (Column 5, lines 38-40: “An output control circuit 110 provides output terminals 111 and 112 which are connected to electrodes 5 and 6 through connecting leads 3 and 4, respectively”, Claim 6: “means operatively connected to said summing means and to said electrode for selectively supplying electricity to said electrode in response to said combined pulse to stimulate one or more of said muscles.”)
Radke fails to disclose an amplifier circuit portion for amplifying the combined waveform; a feedback signal generating portion for generating feedback signals received from the output circuit portion; and, a feedback circuit portion to provide feedback based on said first series of pulses and said second series of pulses to preclude output current from the output circuit portion from going above a maximum current.
However, Carter an apparatus for providing therapeutic electric current to a treatment site of a patient (Abstract) comprising: an amplifier circuit portion for amplifying the combined waveform (view Figure 6A: power amplifier 67, Column 9, lines 23-25: “In the preferred embodiment of the electrotherapeutic apparatus, the Feed Signals are summed at a low level before the power amplifier.”, Column 11, lines 25-29); a feedback signal generating portion for generating feedback signals received from the output circuit portion; and, a feedback circuit portion to provide feedback based on said first series of pulses and said second series of pulses to preclude output current from the output circuit portion from going above a maximum current (Column 3, lines 46-49: “A feedback control system for patient electro therapy includes a generator for outputting a pair of therapeutic currents feeding a single feed electrode and a return electrode.”, Column 9, lines 6-17: “it is necessary that some form of feedback be employed to insure that the applied signal levels are appropriate for a given load. The feedback network consists of two functional parts: 1) a circuit (Hardware), that monitors the patient-applied current and voltage and 2) software that determines if the values measured require an output level change (Software). The parameter derived from the current and voltage is the impedance across the patient-applied electrodes. This parameter has been found by studies to be essentially invariant at a particular frequency (frequency interval for this device) and over the range of applied potentials used clinically.”, Column 10, lines 38-40: “The output of post divider 32 is coupled to a feedback input of the phase lock loop”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Radke to incorporate the teachings of Carter to have an amplifier circuit portion for amplifying the combined waveform; a feedback signal generating portion for generating feedback signals received from the output circuit portion; and, a feedback circuit portion to provide feedback based on said first series of pulses and said second series of pulses to preclude output current from the output circuit portion from going above a maximum current, as these prior art references are directed to electrical stimulation devices. One would be motivated to do this to make sure an appropriate load is applied, as recognized by Carter (Column 9, lines 6-17).
Regarding claim 2, Radke in view of Carter teaches the electrical stimulation apparatus according to claim 1 (as shown above). Radke fails to explicitly disclose wherein said feedback signal generating portion further comprises a plurality of resistors of known impedance, said resistors each being disposed between one of said output channels and the corresponding electrode.
However, Carter discloses wherein said feedback signal generating portion further comprises a plurality of resistors of known impedance, said resistors each being disposed between one of said output channels and the corresponding electrode (Column 12, lines 54-56: “A feedback system is illustrated in FIG. 10 as 200. The current level through the patient is monitored by a precision 5 ohm resistor 202”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Radke to incorporate the teaching of Carter to have said feedback signal generating portion further comprises a plurality of resistors of known impedance, said resistors each being disposed between one of sad output channels and the corresponding electrode, as these prior art references are directed to electrical therapy devices. One would be motivated to do this as resistors can improve safety, control, and performance.
Regarding claim 3, Radke in view of Carter teaches the electrical stimulation apparatus according to claim 2 (as shown above). Radke fail to disclose wherein said feedback circuit portion comprises a plurality of amplifiers, said amplifiers being operatively connected across a respective one of said resistors for receiving feedback signals.
However, Carter teaches wherein said feedback circuit portion comprises a plurality of amplifiers, said amplifiers being operatively connected across a respective one of said resistors for receiving feedback signals (Column 12, lines 54-58: “A feedback system is illustrated in FIG. 10 as 200. The current level through the patient is monitored by a precision 5 ohm resistor 202. A voltage is developed by the current through this resistor and is differentially detected by an amplifier 204.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Radke to incorporate the teaching of Carter to have said feedback circuit portion comprises a plurality of amplifiers, said amplifiers being operatively connected across a respective one of said resistors for receiving feedback signals, as these prior art references are directed to electrical therapy devices. One would be motivated to do this to ensure the correct intensity and shape of waveform is outputted.
Regarding claim 9, Radke in view of Carter teaches the electrical stimulation apparatus according to claim 1 (as shown above). Radke fails to disclose wherein said amplifier circuit portion comprises a DC-coupled amplifier circuit portion.
However, Carter teaches wherein said amplifier circuit portion comprises a DC-coupled amplifier circuit portion (Column 11, lines 26-39: “The power stage consists of one or more amplifiers 67, 69 capable of supplying a wide range of voltages into any physiological and electrode load over the frequency ranges used. Depending on the desired level of system integration and/or portability required, this amplifier stage can be either of the linear Classes A or AB, or the nonlinear switching Class D type. For the linear amplifiers a high power operational amplifier is operated in either a ground-referenced mode or in a bridge configuration. In the bridge configuration the load is connected differentially to the outputs of two power amplifiers that operate 180 degrees out-of-phase with respect to one another. In either configuration the amplifier's DC offset is nulled by a servo correction amplifier.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Radke to incorporate the teachings of Carter to have said amplifier circuit portion comprises a DC-coupled amplifier circuit portion, as these prior art references are directed to electrical stimulation device. One would be motivated to do this ensure the correct waveform is being applied.
Claim(s) 2-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radke in view of Carter as applied to claim 1 above, and further in view of Dernebo et al. (US 2019/0209831 A1), hereinafter Dernebo.
Alternatively, regarding claim 2, Radke in view of Carter teaches the electrical stimulation apparatus according to claim 1 (as shown above). Radke and Carter, alone or in combination, fail to explicitly teach wherein said feedback signal generating portion further comprises a plurality of resistors of known impedance, said resistors each being disposed between one of said output channels and the corresponding electrode.
However, Dernebo teaches an electrical stimulation system wherein said feedback signal generating portion further comprises a plurality of resistors of known impedance (figure 23: each feedback circuit has a resistor and an amplifier, which are shown in detail in fig.10), said resistors each being disposed between one of said output channels and the corresponding electrode (figure 23: feedback circuit, which generates the feedback signal, is between the electrodes and the pulse out channel and [0189] “The CPU 531 can set the current limit by sending the signal 759’ to the comparator 756’ and a feedback signal 752’ is sent back to CPU 531 to inform the CPU 531 about the current level.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Radke and Carter to incorporate the teachings of Dernebo to have wherein said feedback signal generating portion further comprises a plurality of resistors of known impedance, said resistors each being disposed between one of said output channels and the corresponding electrode, as these prior art references are directed to electrical stimulation devices. One would be motivated to do this to achieve a feedback loop that monitors and ensures that a constant current is achieved thereby providing a more consistent stimulation pulse to the patient, as recognized by Dernebo ([0146]).
Regarding claim 3, Radke in view of Carter in view of Dernebo teaches the electrical stimulation apparatus according to claim 2 (as shown above). Radke and Carter, alone or in combination, fail to teach wherein said feedback circuit portion comprises a plurality of amplifiers, said amplifiers being operatively connected across a respective one of said resistors for receiving feedback signals.
However, Dernebo teaches wherein said feedback circuit portion comprises a plurality of amplifiers (fig. 23: feedback circuits 118a-118d, [0190] “each feedback circuit includes a switch and amplifier to switch the amplifier in and out that measures the natural voltage signals from the muscles”), said amplifiers being operatively connected across a respective one of said resistors for receiving feedback signals ([0146] “the estimated current is calculated from the delta voltage of the voltage-drop divided by the resistance of resistor R1 and the gain from amplifier 767”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Radke and Carter to incorporate the teachings of Dernebo to have wherein said feedback circuit portion comprises a plurality of amplifiers, said amplifiers being operatively connected across a respective one of said resistors for receiving feedback signals, as these prior art references are directed to electrical stimulation devices. One would be motivated to do this to achieve a feedback loop that monitors and ensures that a constant current is achieved thereby providing a more consistent stimulation pulse to the patient, as recognized by Dernebo ([0146]).
Regarding claim 4, Radke in view of Carter teaches the electrical stimulation apparatus according to claim 1 (as shown above). Radke fails to explicitly disclose wherein said feedback circuit portion further comprises a feedback loop current circuit that receives the feedback signals from the feedback signal generating portion.
However, Dernebo teaches wherein said feedback circuit portion further comprises a feedback loop current circuit that receives the feedback signals from the feedback signal generating portion ([0103] “it would also be possible to apply the arrangement in a closed-loop controlled simulation therapy where the applied stimulation energy is adapted in dependence of sensed electrical signals”, [0146] “The arrangement is thus self-learning or automatic and makes the necessary adjustments of the stimulation signals based on the feedback in the pulse current value signal 752 that is an input to the master CPU.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Radke and Carter to incorporate the teachings of Dernebo to have said feedback circuit portion further comprises a feedback loop current circuit that receives the feedback signals from the feedback signal generating portion, as these prior art referees are directed to electrical stimulation devices. One would be motivated to do this to have a feedback lip for a constant current output stimulation thereby administering a more consistent pulse to the patient, as recognized by Dernebo ([0046]).
Regarding claim 5, Radke in view of Carter in view of Dernebo teaches the electrical stimulation apparatus according to claim 4 (as shown above). Ross and Carter, alone or in combination, fail to teach wherein outputs of said amplifiers are connected to a common input of the feedback loop current circuit.
However, Dernebo teaches wherein outputs of said amplifiers are connected to a common input of the feedback loop current circuit ([0146] “The arrangement is thus self-learning or automatic and makes the necessary adjustments of the stimulation signals based on the feedback in the pulsed current value signal 752 that is an input to the master CPU”: the input to master CPU is a common input).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Radke and Carter to incorporate the teachings of Dernebo to have outputs of said amplifiers connected to a common input of the feedback loop current circuit, as these prior art references are directed to electrical stimulation devices. One would be motivated to do this to have a feedback lip for a constant current output stimulation thereby administering a more consistent pulse to the patient, as recognized by Dernebo ([0046]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radke in view of Carter as applied to claim 1 above, and further in view of Madsen et al. (US Patent 5,776,173 A).
Regarding claim 7, Radke in view of Carter teaches the electrical stimulation apparatus according to claim 1 (as shown above). Radke and Carter, alone or in combination, fail to teach wherein said modulation circuit portion comprises a signal mixer.
However, Madsen teaches a programmable stimulator for administering neuromuscular electrotherapy (Abstract) wherein said modulator circuit portion comprises a signal mixer (Column 7, line 66-Column 8, line 8: “The output from both variable-frequency oscillator 124 and fixed-frequency oscillator 126 are provided at inputs of mixer 128…The output of mixer 128 is a single pulse string whose frequency is the sum of the frequencies of the two input signals.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Radke and Carter to incorporate the teachings of Madsen to have the modulator circuit portion comprise a signal mixer, as these prior art references are directed to electrical stimulation devices. One would be motivated to do this to produce a single modulated waveform for administration to a patient.
Claim(s) 6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radke in view of Carter as applied to claim 1 above, and further in view of Pfeifer (WO 2014/145239 A1), hereinafter Pfeifer.
Regarding claim 6, Radke in view of Carter teaches the electrical stimulation apparatus according to claim 1 (as shown above). Radke and Carter, alone or in combination, fail to teach wherein said load engaging portion receives the combined waveform of pulses from the amplifier circuit portion and delivers the combined waveform of pulses to said the body of a patient without passing the combined waveform of pulses through a transformer.
However, Pfeifer teaches an electro-therapy device delivering a combined waveform wherein said load engaging portion receives the combined waveform of pulses from the amplifier circuit portion and delivers the combined waveform of pulses to said the body of a patient without passing the combined waveform of pulses through a transformer ([0037] DC/DC step up converter 260, [0044] “Microprocessor 440 has output channels 450, 460 which are the channel electrodes forwarding the current signals to the subject. Various resistors/switches/controls 445 may be switched on/off via signals from microprocessor 440, to modulate/alter the output current to output channels 450, 460.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Radke and Carter to incorporate the teachings of Pfeifer to have said load engaging portion receives the combined waveform of pulses from the amplifier circuit portion and delivers the combined waveform of pulses to said the body of a patient without passing the combined waveform of pulses through a transformer, as these prior art references are directed to electrical stimulation devices. One would be motivated to do this to modulate the waveform as needed.
Regarding claim 8, Radke in view of Carter teaches the electrical stimulation apparatus according to claim 1 (as shown above). Radke and Carter, alone or in combination, fails to teach wherein said control circuit portion comprises a microprocessor and related software.
However, Pfeifer teaches wherein said control circuit portion comprises a microprocessor and related software ([0045] “This embodiment contemplates the frequency control to be part of the microprocessor 440. That is, frequency control actions are facilitated by software instructions.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Radke and Carter to incorporate the teachings of Pfeifer to have the control circuit portion comprise a microprocessor and related software, as these prior art references are directed to electrical stimulation devices. One would be motivated to do this to control the frequency, as recognized by Pfeifer ([0045]).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radke in view of Carter as applied to claim 1 above, and further in view of Karunasiri et al. (US Patent 6,195,585 B1).
Regarding claim 9, Radke in view of Carter teaches the electrical stimulation apparatus according to claim 1 (as shown above). Radke and Carter, alone or in combination, fail to teach wherein said amplifier circuit portion comprises a DC-coupled amplifier circuit portion.
However, Karunasiri teaches a monitoring circuitry with an implantable stimulator wherein said amplifier circuit portion comprises a DC-coupled amplifier circuit portion (Column 15, lines 39-42: “In a preferred embodiment, the amplifier 160 (FIG. 3) that differentially amplifies the sensed signals preferably comprises a seven stage, dc coupled, amplifier having a maximum gain of about 60 dB.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Radke and Carter to incorporate the teaching of Karunasiri to have an amplifier circuit portion comprises a DC-coupled amplifier circuit portion, as these prior art references are directed to stimulation devices. One would be motivated to do this to allows the stimulation system to produce a smooth signal.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radke in view of Carter as applied to claim 1 above, and further in view of Chao (US 2017/0071823 A1), hereinafter Chao.
Regarding claim 10, Radke in view of Carter teaches the electrical stimulation apparatus according to claim 1 (as shown above). Radke and Carter, alone or in combination, fail to teach wherein a frequency of the second series of pulses is an integer multiple of a frequency of the first series of pulses.
However, Chao teaches an electrotherapy system wherein a frequency of the second series of pulses is an integer multiple of a frequency of the first series of pulses ([0021] “The modulation module 311 makes the reference frequency a fundamental frequency to perform frequency modulation, determines an integer according to the one of the twelve meridians with which the first user input is associated, and to generate the modulation signal having a frequency which is the integer multiple of the fundamental frequency.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Radke and Carter to incorporate the teachings of Chao to have a frequency of the second series of pulses is an integer multiple of a frequency of the first series of pulses, as these prior art references are directed to neurostimulation devices. One would be motivated to do this to achieve a meridian frequency that promotes healing and/or alleviation of symptoms.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radke in view of Carter as applied to claim 1 above, and further in view of Segel (US 2019/0168024 A1), hereinafter Segel.
Regarding claim 11, Radke in view of Carter teaches the electrical stimulation apparatus according to claim 1 (as shown above). Radke and Carter, alone or in combination, fail to teach the apparatus further comprising a display screen, the display screen being configured to display at least one of a maximum impedance factor, a minimum impedance factor, a desired impedance factor, a target impedance factor, and a standardized impedance factor.
However, Segel teaches a radiation device for treating biological tissue comprising a impedance display 42 ([0031]) which “indicates an impedance value for tissue in contact with it and can be calibrated to a baseline set for the patient by applying the wand 14 to surrounding non-damaged tissue and then when the wand 14 is applied to the damaged tissue, an impedance value (much higher than the baseline) will be indicated and hopefully reduced over time, through treatment, to the baseline value” ([0051]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Radke and Carter to incorporate the teachings of Segel to have a display screen, the display screen being configured to display at least one of a maximum impedance factor, a minimum impedance factor, a desired impedance factor, a target impedance factor, and a standardized impedance factor, as these prior art references are directed to stimulating tissue. One would be motivated to do this to determine if a tissue is being healed and adjusting the treatment accordingly, as recognized by Segel ([0040]).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radke in view of Carter as applied to claim 1 above, and further in view of Matsushita (US 2018/0296831 A1), Matsushita.
Regarding claim 12, Radke in Carter teaches the electrical stimulation apparatus according to claim 1 (as shown above). Radke and Carter, alone or in combination, fail to teach wherein the microprocessor is further configured to evaluate the feedback signals and reduce the voltage of the first series of pulses or the second series of pulses by 5% if the voltage of the first series of pulses or the second series of pulses reaches a maximum threshold.
However, Matsushita teaches a muscle electrostimulation device wherein “The output adjuster 401 adjusts an output voltage (output level) in the electrode unit 30. In this embodiment, a maximum output voltage is set to 40 V, and 100% output voltage is reduced by 2.0 V every time the output level is decreased by 1. The output levels include fifteen ranges of level 1 to level 15.” ([0122]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Radke and Carter to have the microprocessor is further configured to evaluate the feedback signals and reduce the voltage of the first series of pulses or the second series of pulses by 5% if the voltage of the first series of pulses or the second series of pulses reaches a maximum threshold, as these prior art references are directed to stimulation devices. One would be motivated to do prevent damage by high voltages and preserve battery.
Allowable Subject Matter
Claims 13-16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/ATTIYA SAYYADA HUSSAINI/Examiner, Art Unit 3792 /NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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