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 final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/2/2026 has been entered.
Response to Amendment
3. This action is responsive to the amendments filed 6/2/2026. Claims 1, 3, 14, and 16-17 have been amended. Claim 2 was canceled.
Response to Arguments
Applicant’s response with respect to art rejections have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-11, and 14-17 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Carroll et al. (US Pub.: 2021/0138245 A1).
Regarding claim 1, Carroll discloses a device for stimulating a nerve or a part of a nervous system of a living being (e.g. paragraphs 0002, 0029), said device comprising:
a stimulation generating unit (e.g. Fig. 1 – electrical stimulator 100) configured to generate stimulation signals for interferential stimulation of stimulating the nerve or the part of the nervous system (e.g. paragraph 0033);
a first pair of electrodes (e.g. Fig. 5A – electrodes 108a and 108b) configured to be arranged in a first location in relation to the nerve or the part of the nervous system (e.g. paragraphs 0042, 0055);
a second pair of electrodes (e.g. Fig. 5A – electrodes 108c and 108d) configured to be arranged in a second location in relation to the nerve or the part of the nervous system (e.g. paragraphs 0042, 0055);
and a third pair of electrodes (e.g. Fig. 5A – electrodes 108e and 108f) configured to be arranged in a third location in relation to the nerve or the part of the nervous system (e.g. paragraphs 0046, 0055);
wherein the first pair of electrodes (108a and 108b), the second pair of electrodes (108c and 108d) and the third pair of electrodes (108e and 108f) are arranged in relation to the nerve or part of the nervous system to output a first waveform, a second waveform and a third waveform (e.g. paragraphs 0054-0055) with an electric field of the output first waveform overlapping with the electric field of the output second waveform (e.g. Fig. 5A; paragraph 0056) and with the electric field of the output third waveform overlapping with both the electric field of the output first waveform and the electric field of the output second waveform (e.g. Fig. 5A; paragraphs 0058, 0064);
wherein the stimulation generating unit (100) is configured to generate a first waveform comprising a first frequency to the first pair of electrodes (e.g. paragraphs 0056, 0059);
a second waveform comprising a second frequency to the second pair of electrodes (e.g. paragraphs 0056, 0059),
and a third waveform comprising a third frequency to the third pair of electrodes (e.g. paragraphs 0057, 0059);
wherein the first frequency and the second frequency are configured to interfere along the nerve to define a beat frequency corresponding to a difference between the first frequency and the second frequency forming an interferential signal (e.g. Fig. 5A – first beat signal 130; paragraph 0059),
and wherein the third frequency is configured to modulate the interferential signal to cause interferential stimulation within a particular location of the nerve (e.g. paragraphs 0054, 0064), wherein the third frequency is from one to four times larger than the beat frequency, or wherein the beat frequency is two times larger than the third frequency (e.g. paragraphs 0059-0060 – the combinations of the first, second, third, fourth, and the beat frequencies are adjustable/customizable. In one exemplary combination, the third frequency is 20 kHz (i.e. 20,000 Hz) and the first beat frequency is 5 kHz (i.e. 5,000 Hz)).
and wherein the stimulation generating unit (100) is configured to output the first waveform, the second waveform, and the third waveform for causing interferential stimulation in the nerve or the part of the nervous system (e.g. paragraphs 0029, 0053).
Regarding claim 3, Carroll discloses the device according to claim 1 as discussed above, and Carroll further teaches wherein the device comprises a carrier configured to be arranged in relation to the nerve or the part of the nervous system (e.g. paragraphs 0033, 0070), wherein the first pair of electrodes, the second pair of electrodes, and the third pair of electrodes are mounted in or on the carrier (e.g. paragraph 0070).
Regarding claim 4, Carroll discloses the device according to claim 1 as discussed above, and Carroll further teaches wherein the beat frequency is two times larger than the third frequency (e.g. paragraphs 0059-0060 – the combinations of the first, second, third, fourth, and the beat frequencies are adjustable/customizable. In an exemplary combination, the first beat frequency is 2 kHz (i.e. 2,000 Hz) and the third frequency is 1 kHz (i.e. 1,000 Hz).
Regarding claim 5, Carroll discloses the device according to claim 1 as discussed above, and Carroll further teaches further comprising a control unit configured to modulate the first waveform, the second waveform, and the third waveform by modulating the first frequency, the second frequency, and the third frequency, respectively, (e.g. paragraphs 0036, 0066) by modulating an amplitude of the first waveform, the second waveform, and the third waveform, respectively (e.g. paragraphs 0036, 0066), and/or by modulating a time instant for start of the first waveform, the second waveform, and the third waveform, respectively (e.g. paragraph 0037), for controlling the interferential stimulation of the nerve or the part of the nervous system (e.g. paragraph 0031, 0051).
Regarding claim 6, Carroll discloses the device according to claim 1 as discussed above, and Carroll further teaches further comprising at least a fourth pair of electrodes (e.g. Fig. 5A – electrodes 108g and 108h) configured to be arranged in a fourth location in relation to the nerve or the part of the nervous system (e.g. paragraphs 0046, 0055), wherein the stimulation generating unit (100) is configured to generate a fourth waveform comprising a fourth frequency to the fourth pair of electrodes (e.g. paragraphs 0057, 0059), wherein the fourth frequency is related to the beat frequency by an integer number (e.g. paragraphs 0059-0060).
Regarding claim 7, Carroll discloses the device according to claim 6 as discussed above, and Carroll further teaches wherein the stimulation generating unit (100) is configured to be controlled to selectively output the third waveform to the third pair of electrodes (electrodes 108e and 108f) or the fourth waveform to the fourth pair of electrodes (electrodes 108g and 108h) for controlling the interferential stimulation in the nerve or the part of the nervous system (e.g. paragraphs 0034, 0048, 0064).
Regarding claim 8, Carroll discloses the device according to claim 1 as discussed above, and Carroll further teaches wherein the stimulation generating unit (100) is configured to generate a first frequency and a second frequency, respectively, being in a range of 500 Hz - 1 MHz (e.g. paragraphs 0059-0060).
Regarding claim 9, Carroll discloses the device according to claim 1 as discussed above, and Carroll further teaches wherein the stimulation generating unit (100) is configured to generate the first frequency and the second frequency with a difference between the first frequency and the second frequency being in a range of 1 Hz - 10 kHz (e.g. paragraphs 0038, 0059).
Regarding claim 10, Carroll discloses the device according to claim 1 as discussed above, and Carroll further teaches wherein the stimulation generation unit (100) is configured to generate the first waveform, the second waveform, and the third waveform with an amplitude of the third waveform being equal to or larger than an amplitude of the first waveform and an amplitude of the second waveform (e.g. paragraphs 0048, 0058).
Regarding claim 11, Carroll discloses the device according to claim 1 as discussed above, and Carroll further teaches wherein the first waveform, the second waveform, and the third waveform are sinusoidal signals (e.g. paragraphs 0036, 0038).
Regarding claim 14, Carroll discloses a method for controlling stimulation of a nerve or a part of a nervous system of a living being (e.g. paragraphs 0002, 0029), said method comprising: providing the device for stimulating a nerve or a part of a nervous system of a living being according to claim 1 (see rejection of claim 1 above),
providing a first control signal for controlling generation of the first waveform comprising the first frequency to the first pair of electrodes arranged in the first location in relation to the nerve or the part of the nervous system (e.g. Fig. 5A – electrodes 108a and 108b; paragraphs 033, 0042, 0055);
providing a second control signal for controlling generation of the second waveform comprising the second frequency to the second pair of electrodes arranged in the second location in relation to the nerve or the part of the nervous system (e.g. Fig. 5A – electrodes 108c and 108d; paragraphs 0033, 0042, 0055);
and providing a third control signal for controlling generation of the third waveform comprising the third frequency to the third pair of electrodes arranged in the third location in relation to the nerve or the part of the nervous system (e.g. Fig. 5A – electrodes 108e and 108f; paragraphs 0033, 0042, 0055).
Regarding claim 15, Carroll discloses the method according to claim 14 as discussed above, and Carroll further teaches further comprising modulating the first waveform, the second waveform, and the third waveform by modulating the first frequency, the second frequency, and the third frequency, respectively, (e.g. paragraphs 0036, 0066) by modulating an amplitude of the first waveform, the second waveform, and the third waveform, respectively (e.g. paragraphs 0036, 0066), and/or by modulating a time instant for start of the first waveform, the second waveform, and the third waveform, respectively (e.g. paragraph 0037).
Regarding claim 16, Carroll discloses the device according to claim 1 as discussed above, and Carroll further teaches wherein the third frequency is from one to four times larger than the beat frequency (e.g. paragraphs 0059-0060 – the first, second, third, fourth, and the beat frequencies are adjustable/customizable. In one exemplary combination, the third frequency is 20 kHz (i.e. 20,000 Hz) and the first beat frequency is 5 kHz (i.e. 5,000 Hz)).
Regarding claim 17, Carroll discloses the method according to claim 14 as discussed above, and Carroll further teaches wherein the third frequency is from one to four times larger than the beat frequency (e.g. paragraphs 0059-0060 – the combinations of the first, second, third, fourth, and the beat frequencies are adjustable/customizable. In one exemplary combination, the third frequency is 20 kHz (i.e. 20,000 Hz) and the first beat frequency is 5 kHz (i.e. 5,000 Hz)).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 12-13 are rejected under 35 U.S.C 103 as being unpatentable over Carroll and further in view of Parramon et al. (US Pub.: 2016/0256693 A1, – Previously Cited).
Regarding claim 12, Carroll discloses the device according to claim 1 as discussed above.
However, Carroll does not explicitly teach wherein the device comprises a feedback sensor configured to provide feedback on stimulation of the nerve or the part of the nervous system, wherein the stimulation generating unit is configured to be controlled in dependence of the feedback.
Parramon, in a same field of endeavor of electrical stimulation devices, discloses wherein the device comprises a feedback sensor configured to provide feedback on stimulation of the nerve or the part of the nervous system, wherein the stimulation generating unit is configured to be controlled in dependence of the feedback (e.g. paragraphs 0006-0007, 0084).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Carroll to include a feedback sensor configured to provide feedback on stimulation of the nerve or the part of the nervous system, wherein the stimulation generating unit is configured to be controlled in dependence of the feedback, as taught and suggested by Parramon, for the purpose of optimizing treatment for the patient.
Regarding claim 13, Carroll in view of Parramon teaches the device according to claim 12 as discussed above, and Parramon further teaches wherein the feedback sensor is configured to monitor an effect of stimulation of the nerve or the part of the nervous system by monitoring a specific biomarker (e.g. paragraphs 0006-0007, – adenosine sensor (a chemical biomarker sensor); 0084).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Carroll and Parramon to include an adenosine sensor (chemical biomarker sensor) to monitor an effect of stimulation of the nerve or the part of the nervous system, as taught and suggested by Parramon, because adenosine has been determined to be a chemical biomarker correlated with pain relief and the concentration or amount of adenosine, or changes in the concentration or amount of adenosine, can be correlated with the efficacy or effect of electrical stimulation (Parramon, paragraph 0032).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL TEHRANI whose telephone number is (571)270-0697. The examiner can normally be reached 9:00am-5:00pm.
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/D.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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