Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. This action is responsive to the amendments filed 11/12/2025. Claims 8-9 have been amended. Claims 16-17 were newly added. No claims have been canceled.
Response to Arguments
3. Applicant’s arguments with respect to the rejections under 35 USC 112(b) have been considered and are withdrawn in light of the amendments.
4. Applicant’s arguments filed on 11/12/2025 with respect to the rejections under 35 USC 102, and 35 USC 103 have been fully considered but they are not persuasive. In substance, applicant argues that A) Zhang fails to disclose a first, second, and third pair of electrodes and B) Zhang fails to disclose three pair of electrodes where a third pair comprises a third waveform comprising a third frequency to the third pair of electrodes, wherein the third frequency is related to the beat frequency of the other two electrodes by an integer number.
5. In response to A), the examiner respectfully disagrees.Zhang clearly discloses several pairs of electrodes arranged and operating in combination or in conjunction with each other. The claim requires three pairs of electrodes with three waveforms. Zhang discloses this in column 9 lines 57-67, “the placement of electrode pairs 129A-1, 129A-2 and 129B-1, 129B-2, and electrode pairs 141A-1, 141A-2 and 1418-1, 141B-2…”. In addition, applicant asserts that the electrodes that the examiner cited operate on a different part of the subject and therefore cannot work in combination with one another. Examiner notes that the claim language specifically requires three different locations relative to a nerve. The claims do not specify a particular location that each electrode must be placed on. Zhang is clear in disclosing that each pair of electrodes is used as part of a therapy (see column 9, lines 57-67).Therefore, Zhang still meets the scope of the claims as currently claimed.
6. In response to B), the examiner respectfully disagrees.At the onset, the proper scope of the claims should be realized. The instant claim states wherein the third frequency is related to the beat frequency of the other two electrodes by an integer number (emphasis added). The claim requires the beat frequency of the other two electrodes and the third frequency to be related in some manner by an integer. However, the claim does not specify or limit further the specific manner in which the frequencies must be related. As such, the broadest reasonable interpretation of the limitation is that the frequencies may not be based on one another and can merely be related due to inclusion in a therapy. Zhang specifically teaches, “various electrode placement configurations relative to the location of a target tissue, the number of input waveforms and associated electrode pairs as well as the parametrics of the source waveforms as such as, e.g., amplitudes, frequencies, etc., may be varied and combined in myriad arrangements to achieve different T/STI patterns such that the resulting modulated fields can be steered to specific target neural tissues of a patient” (see column 6, lines 59-67). With respect to the claim’s recitation of an integer number, the source wave-form characteristics are adjustable or they can all be synched yielding an integer difference of zero (see column 6, lines 49-67; column 13, lines 38-50). This number is adjustable and customizable and thus can have a greater range as well (see column 6, lines 49-67). Furthermore, Zhang teaches at column 8, lines 21-48 the concept of "waveform engineering" which is generating a resultant waveform by incorporating parameters of two or more source input waveforms. Column 15, lines 48-50 further describes the beat waveform having a beat frequency due to the interference from two input source waveforms. Equation 4 shows the relationship of the waveform engineering of the third waveform which requires the resultant waveform “having a frequency twice as much” as the two source waveforms. Thus, the third waveform is related by a factor of two which is an integer. Therefore, Zhang meets the scope of the limitations as currently claimed.
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 1-11 and 14-15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zhang et al. (US Patent No. 11,931,572, – Previously Cited).
Regarding claim 1, Zhang teaches a device for stimulating a nerve or a part of a nervous system of a living being (e.g. column 1, lines 8-12), said device comprising:
a stimulation generating unit configured to generate stimulation signals for stimulating the nerve or the part of the nervous system (e.g. Fig. 1B; Fig. 7 – multi-channel output circuitry; column 9, line 57 to column 10, line 3);
a first pair of electrodes configured to be arranged in a first location in relation to the nerve or the part of the nervous system (e.g. Fig. 1B – electrode pairs 129A-1 and 129A-2); a second pair of electrodes configured to be arranged in a second location in relation to the nerve or the part of the nervous system (e.g. Fig. 1B – electrode pairs 129B-1 and 129 B-2);
and a third pair of electrodes configured to be arranged in a third location in relation to the nerve or the part of the nervous system (e.g. Fig. 1B – electrode pairs 141A-1 and 141A-2); wherein the stimulation generating unit is configured to generate a first waveform comprising a first frequency to the first pair of electrodes (e.g. Fig. 1B; Fig. 7; column 9, lines 57-66; column 16, lines 41-47 and lines 62-67);
a second waveform comprising a second frequency to the second pair of electrodes, and a third waveform comprising a third frequency to the third pair of electrodes (e.g. Fig. 1B; Fig. 7; column 9, lines 57-66; column 16, lines 41-47 and lines 62-67);
wherein the first frequency and the second frequency define a beat frequency corresponding to a difference between the first frequency and the second frequency and wherein the third frequency is related to the beat frequency by an integer number (e.g. Fig. 1B; column 6, lines 35-58; column 7, lines 1-11), wherein the stimulation generating unit 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. Fig. 1B; Fig. 7; column 6, lines 35-58; column 15, lines 47-53).
Regarding claim 2, Zhang teaches the device according to claim 1 as
discussed above, and Zhang further teaches wherein the device is configured to be at least partially implanted in the living being with the first pair of electrodes, the second pair of electrodes, and the third pair of electrodes arranged at different locations in relation to the nerve or the part of the nervous system (e.g. column 1, lines 64-67; column 3, lines 44-49; column 9, lines 57-67).
Regarding claim 3, Zhang teaches the device according to claim 2 as
discussed above, and Zhang further teaches wherein the device comprises a carrier configured to be arranged in relation to the nerve or the part of the nervous system, 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. column 11, lines 20-24; column 17, lines 12-22).
Regarding claim 4, Zhang teaches the device according to claim 1 as
discussed above, and Zhang further teaches wherein the beat frequency is two times larger than the third frequency (e.g. column 6 lines 32-49; column 7 lines 1-17).
Regarding claim 5, Zhang teaches the device according to claim 1 as
discussed above, and Zhang further teaches 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, by modulating an amplitude of the first waveform, the second waveform, and the third waveform, respectively, and/or by modulating a time instant for start of the first waveform, the second waveform, and the third waveform, respectively, for controlling the interferential stimulation of the nerve or the part of the nervous system (e.g. Fig. 7; column 6, lines 45-57; column 11, lines 27-43; column 12, lines 33-63; column 17, lines 1-11).
Regarding claim 6, Zhang teaches the device according to claim 1 as
discussed above, and Zhang further teaches further comprising at least a fourth pair of electrodes configured to be arranged in a fourth location in relation to the nerve or the part of the nervous system (e.g. Fig. 1B – electrode pairs 141B-1 and 141B-2), wherein the stimulation generating unit is configured to generate a fourth waveform comprising a fourth frequency to the fourth pair of electrodes, wherein the fourth frequency is related to the beat frequency by an integer number (e.g. Figs. 1B; 7; column 6, lines 35-58; column 7, lines 1-11; column 9, lines 57-66; column 16, lines 62-67).
Regarding claim 7, Zhang teaches the device according to claim 6 as
discussed above, and Zhang further teaches wherein the stimulation generating unit is configured to be controlled to selectively output the third waveform to the third pair of electrodes or the fourth waveform to the fourth pair of electrodes for controlling the interferential stimulation in the nerve or the part of the nervous system (e.g. Figs. 1B; 7; column 6, lines 41-58; column 11, lines 27-35).
Regarding claim 8, Zhang teaches the device according to claim 1 as discussed above, and Zhang further teaches wherein the stimulation generating unit is configured to generate a first frequency and a second frequency, respectively, being in a range of 500 Hz - 1 MHz (e.g. column 12, lines 34-63, –
1000 Hz, 2000 Hz, etc.).
Regarding claim 9, Zhang teaches the device according to claim 1 as discussed above, and Zhang further teaches wherein the stimulation generating unit 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. column 12, lines 34-63, – 1000 Hz, 2000 Hz, etc.).
Regarding claim 10, Zhang teaches the device according to claim 1 as discussed above, and Zhang further teaches wherein the stimulation generation unit 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. Fig. 7; column 11, lines 20-21; column 16, lines 44-53 and lines 62-65; column 17, lines 2-12).
Regarding claim 11, Zhang teaches the device according to claim 1 as discussed above, and Zhang further teaches wherein the first waveform, the second waveform, and the third waveform are sinusoidal signals (e.g. column 7, lines 1-5; column 16, lines 56-66).
Regarding claim 14, Zhang teaches a method for controlling stimulation of a nerve or a part of a nervous system of a living being (e.g. column 1, lines 8-12), said method comprising: providing a first control signal for controlling generation of a first waveform comprising a first frequency to a first pair of electrodes arranged in a first location in relation to the nerve or the part of the nervous system (e.g. Fig. 1B – electrode pairs 129A-1 and 129A-2; Fig. 7; column 9, lines 57-66; column 16, lines 41-47 and lines 62-67); providing a second control signal for controlling generation of a second waveform comprising a second frequency to a second pair of electrodes arranged in a second location in relation to the nerve or the part of the nervous system (e.g. Fig. 1B – electrode pairs 129B-1 and 129 B-2; Fig. 7; column 9, lines 57-66; column 16, lines 41-47 and lines 62-67); and providing a third control signal for controlling generation of a third waveform comprising a third frequency to a third pair of electrodes arranged in a third location in relation to the nerve or the part of the nervous system (e.g. Fig. 1B – electrode pairs 141A-1 and 141A-2; Fig. 7; column 9, lines 57-66; column 16, lines 41-47 and lines 62-67); wherein the control signals control generation of the first waveform and the second waveform with a difference between the first frequency and the second frequency defining a beat frequency and control generation of the third frequency being related to the beat frequency by an integer number (e.g. Fig. 1B; Fig. 7; column 6, lines 35-58; column 7, lines 1-11).
Regarding claim 15, Zhang teaches the method according to claim 14 as
discussed above, and Zhang further teaches modulating the first waveform, the second waveform, and the third waveform by modulating the first frequency, the second frequency, and the third frequency, respectively, by modulating an amplitude of the first waveform, the second waveform, and the third waveform, respectively, and/or by modulating a time instant for start of the first waveform, the second waveform, and the third waveform, respectively (e.g. Fig. 7; column 6, lines 45-57; column 11, lines 27-43; column 12, lines 33-63; column 17, lines 1-11).
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 Zhang and further in view of Parramon et al. (US Pub.: 2016/0256693 A1, – Previously Cited).
Regarding claim 12, Zhang teaches the device according to claim 1 as discussed above.
However, Zhang 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 similar 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 Zhang 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, Zhang 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 Zhang 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).
Claims 16-17 are rejected under 35 U.S.C 103 as being unpatentable over Zhang and further in view of Nemec et al. (US Patent No.: 4,023,574 A).
Regarding claim 16, Zhang teaches the device according to claim 1 as discussed above. However, Zhang does not explicitly teach wherein the third frequency is related to the beat frequency by an integer number from 1 to 4.
Nemec, in a same field of endeavor of electrical stimulation devices, discloses wherein the third frequency is related to the beat frequency by an integer number from 1 to 4 (e.g. column 2, lines 10-30).
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 Zhang to include wherein the third frequency is related to the beat frequency by an integer number from 1 to 4, as taught and suggested by Nemec, for the purpose of creating an exactly balanced and modulated electrical effect over a treatment area within a person (Nemec, column 2, lines 6-10).
Regarding claim 17, Zhang teaches the method according to claim 14 as discussed above. However, Zhang does not explicitly teach wherein the third frequency is related to the beat frequency by an integer number from 1 to 4.
Nemec, in a same field of endeavor of electrical stimulation devices, discloses wherein the third frequency is related to the beat frequency by an integer number from 1 to 4 (e.g. column 2, lines 10-30).
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 method of Zhang to include wherein the third frequency is related to the beat frequency by an integer number from 1 to 4, as taught and suggested by Nemec, for the purpose of creating an exactly balanced and modulated electrical effect over a treatment area within a person (Nemec, column 2, lines 6-10).
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 DANIEL TEHRANI whose telephone number is (571)270-0697. The examiner can normally be reached 9:00am-5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792