DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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) 1-2, 5-8, 10-14, 17-20, 22-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mishra (WO 2022/103774) view Moffitt et al. (US 2019/0329051) and one of ordinary skill in the art.
Mishra discloses;
1.
A method of treating a target region of a subject’s body with an alternating electric field, the method comprising: applying an alternating electric field to the target region during a course of treatment, wherein the alternating electric field has a frequency;
E.G. via the disclosed apparatus for delivering stimulation energy to patient tissue [0007] via one or more stimulation waveforms with characteristics defined by amplitude, frequency, duty cycle and/or pulse with ([0081]-[0082]]) via controller 250 that is configured to produce said stimulation signal comprising a waveform pattern having a plurality of frequency ranges as claimed ([0162]-[0163]).
Note: The examiner is interpreting the stimulation waveforms as defined by waveform pattern as being the claimed applied alternating electric field ([162]-[0163]).
measuring nerve or muscle activity that is generated by the subject’s body in response to the application of the alternating electric field; and modifying the course of treatment based on the measured nerve or muscle activity.
E.G. via at least one sensor and/or functional element 599 that measures a neural response, such as muscle activity [0007], wherein said data measured is analyzed by a controller 250 to assess/modify one or more stimulation parameters ([0125]-[0129]).
Mishra does not explicitly disclose measuring nerve or muscle activity generated by the subject in response to the applied field; and modifying the course of treatment based on the measured nerve or muscle activity; and the specific frequency range of 75 kHz to 300 kHz.
Moffitt et al. teaches a closed-loop neuromodulation system including: sensing physiological signal, including neural activity, indicative of patient condition or response, using sensed physiological signals for feedback control of neuromodulation (e.g., sensing for ‘ feedback control of the neuromodulation [0084]), automatically modifying stimulation parameters based on sensed signal and adjusting stimulation without manual intervention to optimize therapy (e.g., via the disclosed closed loop system for automatic selection, [0096]).
It would have been obvious to apply Moffitt et al. feedback control to Mishra’s adjustable stimulation parameters, including amplitude, as amplitude is a known parameter of electrical stimulation. Mishra discloses applying an alternating electric field having a frequency suitable for therapeutic stimulation, including frequencies up to approximately 50 kHz [0163]. Mishra thus teaches that the frequency is a parameter of the applied electric field that affects treatment. Mishra does not explicitly disclose a frequency within the claimed range 75 kHz to 300 kHz.
However, it would have been obvious to a person of ordinary skill in the art to select and/or optimize the frequency of the alternating electric field within a broader workable range, including the claimed range of 75 kHz to 300 kHz, because:
Frequency is a recognized result-effective variable in electrical stimulation therapies.
Adjusting frequency affects; tissue response, stimulation efficacy, patient comfort and avoidance of adverse sensations.
Selecting an appropriate frequency within a workable range would have involved routine experimentation and optimization, which is within the level of ordinary skill in the art. KSR Int’l CO. v. Teleflex Inc., 550 U.S. 398 (2007). In re Aller, 220 F,2d454 (CCPA 1955).
2.
The method of claim 1, wherein the nerve or muscle activity comprises nerve activity and wherein the nerve activity is measured using a passive array of ECAP electrodes (Moffitt, sensing physiological signals including neural activity, [0084].
Note: ECAP-type sensing via implanted or external electrodes is well-known in neuromodulation systems
It would have been obvious to implement Moffitt’s sensing using ECAP electrodes because:
electrodes are standard for neural signal acquisition
selection of specific electrode configuration is a design choice.
5.
The method of claim 1, wherein the modifying comprises adjusting an amplitude of the alternating electric field that is applied to the target region based on the measured nerve or muscle activity (e.g., Mishra, teaches amplitude as a controllable parameter, [0162]-[0163]; Moffitt, teaches modifying stimulation parameters based on sensed signals [0084], [0096], i.e. combination of the references explicitly suggest: amplitude adjustment based on measured activity)
6.
The method of claim 1, wherein the modifying comprises reducing an amplitude of the alternating electric field that is applied to the target region when the measured nerve or muscle activity indicates that electrosensation is expected (Moffit, automatic adjustment based on detected patient state, [0096], sensing signals indicative of patient response [0084]; Mishra, amplitude is adjustable [0125]-[0129]).
It would have been obvious to one having ordinary skill in the art to have reduce amplitude when undesirable effects (i.e. electrosensation) are detected and/or increase the amplitudewhen tolerated because Moffit et al. is a basic closed loop system [0096] that is known to optimize efficacy vs. side effects which is a core purpose of feedback system.
In view of these teaches, it would have further been obvious to one having ordinary skill to select between increasing or decreasing amplitude in response to detected patient conditions in order to optimize therapeutic efficacy while reducing undesirable effects such as electrosensation. Such a modification represents the application of a known technique, i.e. feedback-based parameter adjustment, to a known device, i.e. stimulation system, yielding predictable results, namely improved control of therapy delivery. KSR v. Teleflex, 550 U.S. 398, 421 (2007).
7.
The method of claim 1, wherein the modifying comprises increasing an amplitude of the alternating electric field that is applied to the target region when the measured nerve or muscle activity indicates that the amplitude can be increased without causing electrosensation (Moffit, automatic adjustment based on detected patient state, [0096], sensing signals indicative of patient response [0084]; Mishra, amplitude is adjustable [0125]-[0129]).
Note: Same as claim 6. Claim 7 is an obvious subset/routine implementation of control logic.
8.
The method of claim 1, wherein the modifying comprises adjusting a frequency of the alternating electric field that is applied to the target region based on the measured nerve or muscle activity.
Mishra teaches that the alternating electric field may be applied at a selectable frequency, thereby identifying frequency as a controllable parameter of the stimulation signal, [0162]-[0163]; Moffitt teaches adjusting the stimulation parameters based on sensed physiological signals indicative of a patient condition [0084], [0096].
It would have been obvious to a person of ordinary skill in the art to adjust the frequency of the alternating current field based on the measured nerve or muscle activity in order to optimize therapeutic efficacy and minimize undesirable effects, as this represents the application of known feedback-based control to a known parameter of a stimulation system, yielding predictable results. KSR v. Teleflex, 550 U.S. 398, 421 (2007).
10.
The method of claim 1, wherein the modifying comprises applying an electrical signal to the subject’s body during each of a plurality of time intervals during the course of treatment, wherein the electrical signal is configured to reduce electrosensation when the alternating electric field is applied during the course of treatment,
and wherein decisions of when to apply the electrical signal are based on the measured nerve or muscle activity.
Moffitt teaches that neuromodulation therapy may be adjusted based on sensed physiological signals indicative of a patient condition and may include switching between different stimulation configurations or modes (e.g., [0062]-[0063], [0096]). Such configurations include different stimulation patterns, pulse characteristics and operational modes of the stimulation device.
It would have been obvious to a person of ordinary skill in the art to apply an additional or alternative electrical signal during intervals of treatment in response to measured nerve or muscle activity, in order to reduce undesirable effects such as electrosensation while maintaining therapeutic efficacy. This represents the use of known alternative stimulation modes triggered by sensed conditions, yielding predictable results. See KSR, 550 U.S. 417.
11.
The method of claim 10, wherein the decisions of when to apply the electrical signal are based on when the measured nerve or muscle activity indicates that electrosensation is expected.
As discussed above with respect to claim 10, Moffitt teaches adjusting stimulation based on detected patient conditions. Therefore, it would have been obvious to trigger the application of the electrical signal when the measured activity indicates an undesirable condition (e.g. electrosensation), as a predictable implementation of feedback-based control.
12.
The method of claim 11, wherein the electrical signal comprises a train of at least 10 pulses.
Moffitt teaches delivery of stimulation pulses and pulse patterns. The specific number of pulses in a pulse train represents a routine design choice and result-effective variable that may be selected to achieve a desired therapeutic outcome. See In re Boesch, 617 F. 2d 272, 205 USPQ 215 (CCPA 1980).
13.
An apparatus for treating a target region of a subject’s body with an alternating electric field, the apparatus comprising: an AC voltage generator having an AC output that operates at a frequency between 50 kHz and 1 MHz and at least one control input;
and a controller configured to (a) accept signals from at least one sensor that measures nerve or muscle activity that is generated by the subject’s body in response to the application of the alternating electric field and (b) modify a course of treatment based on the measured nerve or muscle activity.
Mishra teaches a stimulation system including a signal generator capable of delivering an alternating electric field and a controller for adjusting stimulation parameters. Moffitt teaches a controller configured to receive signals from sensing circuitry and adjust stimulation parameters based on sensed physiological signals [0084]. Accordingly, the combination of Mishra and Moffitt teaches or suggests the claimed apparatus, including a controller to modify treatment based on measured nerve or muscle activity.
14.
The apparatus of claim 13, wherein the at least one sensor comprises a set of ECAP electrodes, and wherein the controller is configured to accept signals that represent nerve activity from the set of ECAP electrodes (Moffitt, sensing physiological signals including neural activity, [0084].
Note: ECAP-type sensing via implanted or external electrodes is well-known in neuromodulation systems
It would have been obvious to implement Moffitt’s sensing using ECAP electrodes because:
electrodes are standard for neural signal acquisition
selection of specific electrode configuration is a design choice.
17.
The apparatus of claim 13, further comprising at least one first electrode element configured for positioning on or in the subject’s body and at least one second electrode element configured for positioning on or in the subject’s body, wherein the AC output is applied between the at least one first electrode element and the at least one second electrode element.
Mishra teaches applying an electric field via electrodes positioned on or within the subject’s body. The use of multiple electrode elements to define the applied field represent a known and conventional implementation of stimulation systems ([0162]-[0163]).
18.
The apparatus of claim 13, wherein the controller is programmed to send signals to the at least one control input that cause the AC voltage generator to adjust an amplitude of the AC output based on the measured nerve or muscle activity.
E.G. via the disclosed apparatus configured to provide increased neural response magnitudes by modifying the amplitude and pulse width of stimulation pulses delivered (Mishra, [0018]-[0020] & [0163]).
19.
The apparatus of claim 13, wherein the controller is programmed to send signals to the at least one control input that cause the AC voltage generator to reduce an amplitude of the AC output when the measured nerve or muscle activity indicates that electrosensation is expected.
As discussed with respect to claim 6, Mishra teaches amplitude as a controllable parameter and Moffitt teaches adjusting stimulation parameters based on sensed physiological signals. It would have been obvious to configure the controller to increase or decrease amplitude based on measured nerve or muscle activity as a predictable application of feedback control.
20.
The apparatus of claim 13, wherein the controller is programmed to send signals to the at least one control input that cause the AC voltage generator to increase an amplitude of the AC output when the measured nerve or muscle activity indicates that the amplitude can be increased without causing electrosensation.
As discussed with respect to claim 6, Mishra teaches amplitude as a controllable parameter and Moffitt teaches adjusting stimulation parameters based on sensed physiological signals. It would have been obvious to configure the controller to increase or decrease amplitude based on measured nerve or muscle activity as a predictable application of feedback control.
22.
The apparatus of claim 13, wherein the controller is programmed to send signals to the at least one control input that cause the AC voltage generator to reduce a frequency of the AC output when the measured nerve or muscle activity indicates that electrosensation is expected.
As discussed with respect to claim 8, frequency is a controllable parameter of the stimulation signal. It would have been obvious to reduce frequency based on measured nerve or muscle activity as part of feedback-based optimization of therapy.
23.
The apparatus of claim 13, further comprising a signal generator that generates an electrical signal configured to reduce electrosensation when the alternating electric field is applied to the subject’s body,
wherein the controller is programmed to activate the signal generator based on the measured nerve or muscle activity.
Moffitt teaches systems capable of operating in multiple stimulations modes and adjusting such modes based on sensed physiological signals. It would have been obvious to include a signal generator configured to provide an alternative electrical signal to reduce undesirable effects (e.g., electrosensation) based on measured activity, as a predictable implementation of feedback-controlled therapy.
24.
The apparatus of claim 23, wherein a decision to activate the signal generator is based on when the measured nerve or muscle activity indicates that electrosensation is expected.
It would have been obvious to activate the signal generator when the measured activity indicates an undesirable condition, as a straightforward application of feedback-based control logic as taught by Moffitt.
25.
The apparatus of claim 24, wherein the electrical signal comprises a train of at least 10 pulses.
Moffitt teaches delivery of stimulation pulses and pulse patterns. The specific number of pulses in a pulse train represents a routine design choice and result-effective variable that may be selected to achieve a desired therapeutic outcome. See In re Boesch, 617 F. 2d 272, 205 USPQ 215 (CCPA 1980).
26.
The apparatus of claim 23, further comprising: at least one first electrode element configured for positioning on or in the subject’s body and at least one second electrode element configured for positioning on or in the subject’s body,
wherein the AC output is applied between the at least one first electrode element and the at least one second electrode element;
and a third electrode element configured for positioning on or in the subject’s body and a fourth electrode element configured for positioning on or in the subject’s body, wherein the electrical signal is applied between the third electrode element and the fourth electrode element.
Mishra teaches applying an electric field via electrodes, and Moffitt teaches multiple stimulation configurations. This use of multiple electrode pairs to deliver different electrical signals represents a predictable implementation of known stimulation techniques.
Response to Arguments
Applicant's arguments filed February 20, 2026 have been fully considered but they are not persuasive. The applicant argues the following points in which the examiner provides a reason(s) as to why the arguments are not persuasive:
The applicant argues that the primary reference, Mishra, does not modify amplitude based on measured activity.
The applicant argues that Mishra modifies stimulation amplitude based on predetermined timing rather than based on measured nerve or muscle activity. This argument is persuasive with respect to Mishra alone; however, it is not persuasive as to rejection under 35 U.S.C §103, which is based on the combination of Mishra and Moffitt.
Moffitt teaches sensing physiological signals, including neural activity indicative of a patient condition, and using such sensed signals for feedback control of neuromodulation (e.g., [0084]). Moffitt further teaches automatically adjusting stimulation parameters based on detected patient state (e.g., ]0096]).
Accordingly, while Mishra does not disclose feedback-based control, Moffitt explicitly provides the above teaching. Therefore, the rejection relies on the combination of references.
The applicant argues that there is no modification based on measured nerve of muscle activity.
The applicant further argues that the cited reference(s) fails to disclose modifying the course of treatment based on measured nerve or muscle activity. This argument is not persuasive. Moffitt teaches sensing physiological signals, including neural signals indicative of patient response [0084] and using such signals for feedback control of stimulation parameters. Such feedback control necessarily requires that stimulation parameters are modified in response to the sensed signals.
The claim does not require a specific type of neural measurement beyond “nerve or muscle activity.” Moffitt’s disclosure of sensing neural activity and using that information to adjust stimulation parameters meets this limitation when combined with Mishra’s stimulation system.
The applicant argues that there is no disclosure of increasing vs. decreasing amplitude based on measured activity.
The applicant’s argues that the cited prior art does not disclose reducing amplitude when electrosensation is expected and increasing amplitude when it is not, based on measured activity. This arguments is not persuasive.
Mishra teaches that amplitude is a controllable parameter of the applied electric field. Moffitt teaches adjusting stimulation parameters based on sensed physiological signals indicative of patient condition. Once a system is configured to measure physiological activity, and adjust a stimulation parameter based on that activity, the selection of whether to increase or decrease that parameter represents a finite and predictable set of control options available to a person of ordinary skill in the art. In particular if sensed activity indicates an undesirable condition, it would have been obvious to reduce amplitude, and if such condition is not present, it would have been obvious to increase amplitude to improve efficacy. Such bidirectional adjustment reflects the predictable application of feedback control to a known adjustable parameter. See KSR Int’l Co. vs. Teleflex Inc., 550 U.S. 398, 421 (2007).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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/NICOLE F JOHNSON/ Primary Examiner, Art Unit 3796
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