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 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 30, 2025 has been entered.
Response to Amendment
The amendment filed December 30, 2025 has been entered. Claims 1-2, 5-6 have been amended. Claims 7, 15, 21 are canceled. Currently, claims 1-6, 8-14, 16-20 and 22 are pending for examination.
Response to Arguments
Applicant’s arguments, see pages 9-15, filed December 30, 2025, with respect to the rejection(s) of claim(s) 1-6, 8-14, 16-20 and 22 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Faltys et al. (US 2009/0222064).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of co-pending Application No. 19/184,338 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the application claim 1 is an apparatus equivalent of co-ending method claim 2. The additionally recited elements of a signal generator, controller comprising a processor and memory are all recited at a high level of generality, are known components in the art, and it would have been obvious to one of ordinary skill in the art to implement these known components with the recited limitations in the manner claimed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 1-6, 8-14, 16-20 and 22 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 1 has been amended to recite, “assign a subset of the frequency bands to a corresponding section of the electrode array, wherein the section of the electrode array is associated with a corresponding anatomical region of the patient”. This limitation is indefinite because the phrasing of is such that there is no clear association between it and the rest of the limitations. For example, “the frequency bands” is not necessarily referring to, “the discrete frequency bands” having a corresponding bandwidth (lines 11-13). Additionally, “the a corresponding section of the electrode array” is not associated with the randomly selected respective electrode configuration” (lines 18-24 and 28-30). Therefore the limitation, “instruct the signal generator to deliver the adjusted electrical stimulation signal…” (lines 28-30) is also indefinite because it is unclear of the stimulation signal… via the randomly selected respective electrical configuration is limited by the “assign a subset of the frequency bands…”.
Claim 5 has been amended to recite, “assign a subset of the frequency bands to a corresponding section of the electrode array, wherein the section of the electrode array is associated with a corresponding anatomical region of the patient”. This limitation is indefinite because the phrasing of is such that there is no clear association between it and the rest of the limitations. For example, “the a corresponding section of the electrode array” is not associated with the randomly selected respective electrode configuration” (lines 18-24 and 28-30). Therefore the limitation, “instruct the signal generator to deliver the adjusted electrical stimulation signal…” (lines 28-30) is also indefinite because it is unclear of the stimulation signal… via the randomly selected respective electrical configuration is limited by the “assign a subset of the frequency bands…”.
Claims 2-4, 6, 8-14, 16-20 and 22 are rejected to for being dependent on and failing to remedy the deficiencies of either claims 1 or 5.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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) 1-4, 6, 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Molnar et al. (US 2022/0080200) in view of Zhang et al. (US 2020/0139127), Fitzgerald et al. (US 2021/0299447), Wundrich et al. (US 2016/0199662) and Faltys et al. (US 2009/0222064).
Regarding claims 1, 6, Molnar et al. discloses an electrical stimulation system for providing electrical stimulation therapy to a patient while preventing accommodation by delivering spatially random electrical stimulation to a patient through an electrical lead that includes an electrode array, the electrical stimulation system comprising: an electrode array (fig. 1a-d) comprising a plurality of electrodes spaced apart from one another ([0041-0043]); a signal generator (“IPG”) electrically coupled to the electrode array and configured to deliver an electrical stimulation signal ([0059]), wherein the electrical stimulation signal is a pulse-based electrical signal (“pulse width” [0086]; “pulses” [0088]); the signal generator configured to: randomly select, at periodic intervals based on a predefined period of time (“a first waveform may be programmed to be delivered to a target stimulation site for a first predetermined amount of time and then a second waveform may be programmed to be delivered to the target stimulation site for a second predetermined amount of time” [0084]), a respective electrical configuration from the plurality of electrodes of the electrode array during the electrical stimulation therapy, wherein to randomly select the electrical configuration comprises to randomly select a first set of electrodes of the plurality of electrodes to function as anodes and a second set of electrodes of the plurality of electrodes, different from the first set of electrodes, to function as cathodes (“select a different pair of electrodes along the lead to effective shift or field steer the electrical field to a new location… random designation of cathode and anode pairs” [0070]); and instruct the signal generator to deliver the electrical stimulation signal to the patient for the predefined period of time ([0084]) via the randomly selected electrical configuration ([0070]) to improve a condition of the patient ([0003]).
Molnar et al. does not expressly disclose a controller comprising a processor and a memory having a plurality of instructions stored thereon that, in response to execution by the processor, causes the controller to perform the random selection of the electrical configuration and instruct the signal generator to deliver the electrical stimulation signal. Nor does Molnar et al. state that the selected electrodes to function as anodes are electrical sources and the selected electrodes to function as cathodes are electrical sinks. However, it is known in the art for implantable stimulation devices to include a controller, processor and a memory as evidenced by Zhang et al., teaching a typical implantable pulse generator comprises a controller 316 comprising a processor (“microprocessor”) and a memory ([0093]) having a plurality of instructions stored thereon that, in response to execution by the processor, causes the controller to perform device functions. Zhang et al. further teaches it is known in the art that anodic electrodes are regarded in the art as sourcing current, and cathodic electrodes are sinking current ([0094]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include these conventional controller, processor, memory components in order to perform their respective functions such a modification being reasonably predictable without altering the overall operation of the device; and to consider Molnar et al. as selecting electrical sources and sinks as described in Zhang et al., with these specific limitations are not regarded as patentable over the prior art.
Molnar et al. does not expressly disclose instructions to partition a frequency range of the electrical stimulation signal into a plurality of discrete frequency bands, each of the discrete frequency bands having a corresponding bandwidth; adjust an amplitude of one or more of a voltage or a current of the electrical stimulation signal within a selected frequency band of the plurality of discrete frequency bands, for each of one or more of the plurality of discrete frequency bands, to generate an adjusted electrical signal based on feedback received from the patient; and instruct the signal generator to deliver the adjusted electrical signal to the patient via the randomly selected electrical configuration. Fitzgerald et al. delivery of an electrical stimulation signal via a plurality of discrete frequency bands, each of the discrete frequency bands having a corresponding bandwidth for delivery to the patient ([0041], [0113]) is known in the art, these discrete frequency bands useful for the generation and adjusting of the stimulation signal as they can be individually matched and optimized for a best fit with feedback from the patient ([0076], [0116]). These frequency bands are partitioned into a plurality of discrete frequency bands, each having a corresponding bandwidth ([0042]) and the amplitude of one or more of the voltage or a current of the electrical signal within a selected frequency band of the plurality of discrete frequency bands is adjusted (“adjusting the set of first oscillation parameters in at least one frequency band that corresponds to a frequency band in which the second oscillation parameters were determined” [0041]; “The set of first oscillation parameters can comprise the… amplitude of the generated stimulation” [0107]). Wundrich et al. teaches adjusting an amplitude of the voltage or current of an electrical stimulation signal based on feedback received from the patient ([0021-0025], [0062-0063]) within a selected frequency band of a plurality of discrete frequency bands ([0049-0050]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Molnar et al. to partition the electrical stimulation signal into a plurality of discrete frequency bands for delivery as taught by Fitzgerald et al. in order to enable the ability to apply a range of frequencies that can each be individually matched and optimized for best fit, and to adjust an amplitude of the voltage/current of the electrical stimulation signal as taught by Fitzgerald et al. and based on feedback received from the patient within the selected frequency band of the plurality of discrete frequency bands as taught by Wundrich et al. in order to provide a stimulation that “can be dynamically adapted to the patient and therefore optimized” ([0013]).
Molnar et al. does not expressly disclose the limitation, assign a subset of the frequency bands to a corresponding section of the electrode array, wherein the section of the electrode array is associated with a corresponding anatomical region of the patient. Faltys et al. teaches it is known in the art for a processor of an electrical stimulation system to assign certain frequency bands to a corresponding section (“each electrode”) of an electrode array (“The speech processor then assigns certain frequency bands to each electrode of the array such that each electrode is associated with a particular channel that represents a frequency or range of frequencies” [0005]), wherein the section of the electrode array is associated with a corresponding anatomical region of the patient (“electrode array's particular placement in the patient's cochlea” [0005]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Molnar et al. to try assigning a subset of the frequency bands to a corresponding section of the electrode array, wherein the section of the electrode array is associated with a corresponding anatomical region of the patient as taught by Faltys et al. as it is a known technique in the art to take a stimulation signal’s discrete frequency bands and preferentially assign a subset to a section of an electrode array that is positioned against a preferential anatomical region of the patient, such a modification being reasonably predictable in the art.
Regarding claim 2, Molnar et al. discloses directing an electrical stimulation signal to pass through a subset of the first set of electrodes and a subset of the second set of electrodes (“select a different pair of electrodes along the lead to effective shift or field steer the electrical field to a new location… random designation of cathode and anode pairs” [0070]), but does not expressly disclose wherein to deliver the adjusted electrical stimulation signal to the patient via the randomly selected respective electrical configuration comprises to direct a set of frequency components. Faltys et al. teaches it is known in the art to use a selected electrodes to direct frequency components ([0005]). Given that it is known in the art to program different electrodes with different frequency components, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Molnar et al. to try delivering a set of frequency components to a subset of the first set of electrodes and the second set of electrodes as taught by Faltys et al. in order to optimize various electrode combinations to provide therapy to the patient.
Regarding claim 3, Molnar et al. discloses the first set of electrodes comprises a first number of electrodes and the second set of electrodes comprises a second number of electrodes different from the first number (“a single cathode, e.g., electrode 4 designated as cathode 16 in FIG. 2a may be coupled with two anodes 14, both adjacent designated cathode 16” [0070]).
Regarding claim 4, Molnar et al. discloses wherein to randomly select the first set of electrodes comprises to randomly select a first number of electrodes in the first set of electrodes; and wherein to randomly select the second set of electrodes comprises to randomly select a second number of electrodes in the second set of electrodes ([0070]).
Regarding claim 8, Molnar et al. in view of Wundrich et al. disclose one or more sensors (“EEG electrodes” [0026]) configured to measure one or more physiological outcomes of the patient and generate sensor data (“EEG signal”); and wherein the feedback comprises feedback based on the sensor data ([0021-0025]).
Regarding claim 9, Molnar et al. in view of Wundrich et al. disclose wherein the feedback comprises feedback data received from a machine learning system ([0051-0052]).
Claim(s) 5, 10-14, 16-18, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Molnar et al. (US 2022/0080200) in view of Zhang et al. (US 2020/0139127) and Faltys et al. (US 2009/0222064).
Regarding claim 5, Molnar et al. discloses an electrical stimulation system for providing electrical stimulation therapy to a patient while preventing accommodation by delivering spatially random electrical stimulation to a patient through an electrical lead that includes an electrode array, the electrical stimulation system comprising: an electrode array (fig. 1a-d) comprising a plurality of electrodes spaced apart from one another ([0041-0043]); a signal generator (“IPG”) electrically coupled to the electrode array and configured to deliver an electrical stimulation signal ([0059]), wherein the electrical stimulation signal is a pulse-based electrical signal (“pulse width” [0086]; “pulses” [0088]); the signal generator configured to: randomly select, at periodic intervals based on a predefined period of time (“a first waveform may be programmed to be delivered to a target stimulation site for a first predetermined amount of time and then a second waveform may be programmed to be delivered to the target stimulation site for a second predetermined amount of time” [0084]), a respective electrical configuration from the plurality of electrodes of the electrode array during the electrical stimulation therapy, wherein to randomly select the electrical configuration comprises to randomly select a first set of electrodes of the plurality of electrodes to function as anodes and a second set of electrodes of the plurality of electrodes, different from the first set of electrodes, to function as cathodes (“select a different pair of electrodes along the lead to effective shift or field steer the electrical field to a new location… random designation of cathode and anode pairs” [0070]); and instruct the signal generator to deliver the electrical stimulation signal to the patient for the predefined period of time ([0084]) via the randomly selected electrical configuration ([0070]) to improve a condition of the patient ([0003]).
Molnar et al. does not expressly disclose a controller comprising a processor and a memory having a plurality of instructions stored thereon that, in response to execution by the processor, causes the controller to perform the random selection of the electrical configuration and instruct the signal generator to deliver the electrical stimulation signal. Nor does Molnar et al. state that the selected electrodes to function as anodes are electrical sources and the selected electrodes to function as cathodes are electrical sinks. However, it is known in the art for implantable stimulation devices to include a controller, processor and a memory as evidenced by Zhang et al., teaching a typical implantable pulse generator comprises a controller 316 comprising a processor (“microprocessor”) and a memory ([0093]) having a plurality of instructions stored thereon that, in response to execution by the processor, causes the controller to perform device functions. Zhang et al. further teaches it is known in the art that anodic electrodes are regarded in the art as sourcing current, and cathodic electrodes are sinking current ([0094]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include these conventional controller, processor, memory components in order to perform their respective functions such a modification being reasonably predictable without altering the overall operation of the device; and to consider Molnar et al. as selecting electrical sources and sinks as described in Zhang et al., with these specific limitations are not regarded as patentable over the prior art.
Molnar et al. does not expressly disclose the limitation, assign a subset of the frequency bands to a corresponding section of the electrode array, wherein the section of the electrode array is associated with a corresponding anatomical region of the patient. Faltys et al. teaches it is known in the art for a processor of an electrical stimulation system to assign certain frequency bands to a corresponding section (“each electrode”) of an electrode array (“The speech processor then assigns certain frequency bands to each electrode of the array such that each electrode is associated with a particular channel that represents a frequency or range of frequencies” [0005]), wherein the section of the electrode array is associated with a corresponding anatomical region of the patient (“electrode array's particular placement in the patient's cochlea” [0005]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Molnar et al. to try assigning a subset of the frequency bands to a corresponding section of the electrode array, wherein the section of the electrode array is associated with a corresponding anatomical region of the patient as taught by Faltys et al. as it is a known technique in the art to take a stimulation signal’s discrete frequency bands and preferentially assign a subset to a section of an electrode array that is positioned against a preferential anatomical region of the patient, such a modification being reasonably predictable in the art.
Regarding claims 10-11, Molnar et al. further discloses randomly select a new electrical configuration from the plurality of electrodes of the electrode array in response to a determination that a threshold period of time has been met, the threshold defined as a predefined period of time elapsed since randomly selecting the electrical configuration (“the neuromodulation field is defined by the electrode position, spacing, designation as anode or cathode, and ratio of activation” [0079]; “the designated cathode and related anode pair and generated spherical electrical field, may be designated in a… random designation of cathode and anode pairs” [0070]; “after a period of time, the desired patient and performance outcomes may be sustained, or improved or minimally diminished by again varying from a current waveform to a new waveform” [0081]; “In another embodiment, a sensing window is used, wherein a predetermined time of sensed electrical information is received by sensing electrodes 20 of the first electrode 10 and such pattern is then delivered in a repeating fashion to the stimulating electrodes 22 of the second lead 10′ for either a predetermined period of time at which time the process repeats with a new sensing time frame for new stimulation pattern creation” [0098]).
Regarding claim 12, Molnar et al. discloses directing an electrical stimulation signal to pass through a subset of the first set of electrodes and a subset of the second set of electrodes (“select a different pair of electrodes along the lead to effective shift or field steer the electrical field to a new location… random designation of cathode and anode pairs” [0070]), but does not expressly disclose wherein to deliver the adjusted electrical stimulation signal to the patient via the randomly selected respective electrical configuration comprises to direct a set of frequency components. Faltys et al. teaches it is known in the art to use a selected electrodes to direct frequency components ([0005]). Given that it is known in the art to program different electrodes with different frequency components, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Molnar et al. to try delivering a set of frequency components to a subset of the first set of electrodes and the second set of electrodes as taught by Faltys et al. in order to optimize various electrode combinations to provide therapy to the patient.
Regarding claim 13, Molnar et al. discloses wherein the electrical stimulation signal comprises a pulse waveform ([0086], [0088]).
Regarding claim 14, Molnar et al. discloses wherein the electrical stimulation signal comprises a periodic waveform (“Waveforms may have a predetermined fixed, repeating,… non-random form” [0088]).
Regarding claim 16, Molnar et al. does not expressly disclose wherein to deliver the electrical stimulation signal to the patient via the randomly selected electrical configuration comprises to deliver high-frequency signal components of the electrical stimulation signal through only the distal section of the electrode array. Faltys et al. teaches it is known in the art to deliver discrete frequency bands of a stimulation signal to specific electrodes ([0005]). Given that it is known in the art to program different sets of electrodes with different frequency parameters, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Molnar et al. to try delivering a high frequency signal to a set of electrodes at a distal section of the electrode array and a low frequency signal to a set of electrodes at a proximal section of the electrode array as it is a matter of selecting an optimum electrode location along the electrode array, and since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 17, Molnar et al. does not expressly disclose wherein to deliver the electrical stimulation signal to the patient via the randomly selected electrical configuration comprises to amplify signals transmitted through the distal section at a different weight from signals transmitted through the proximal section. Faltys et al. teaches it is known in the art to deliver discrete frequency bands of a stimulation signal to specific electrodes ([0005]). Given that it is known in the art to program different sets of electrodes with different frequency parameters, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Molnar et al. to try delivering different amplification of signal to a set of electrodes at a distal section of the electrode array as compared to a different weight of signals transmitted to a set of electrodes at a proximal section of the electrode array as it is a matter of selecting an optimum electrode location along the electrode array, the specific location (distal vs proximal) for amplified signals being a matter of design choice and lacking any particular criticality (see applicant’s specification [0114]), and since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 18, Molnar et al. discloses to randomly select the first set of electrodes comprises to randomly select a first number of electrodes in the first set of electrodes; and wherein to randomly select the second set of electrodes comprises to randomly select a second number of electrodes in the second set of electrodes ([0070]).
Regarding claim 20, Molnar et al. discloses wherein at least one of the first set of electrodes or the second set of electrodes comprises at least two electrodes ([0070]).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Molnar et al. (US 2022/0080200) in view of Zhang et al. (US 2020/0139127) and Faltys et al. (US 2009/0222064), and further in view of Zhu (US 2020/0078593).
Regarding claim 19, Molnar et al. does not expressly disclose wherein the frequency range of the electrical stimulation signal is 0.05 Hz to 2 kHz to block action potential of the patient’s nerve cells from firing. Zhu teaches it is known in the art to deliver an electrical stimulation signal in the range claimed by the applicant (“1.5 KHz-50 KHz”) stating this is an attractive frequency range for pain management as it blocks naturally occurring action potentials within neural fibers ([0009]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Molnar et al. to try applying an electrical stimulation signal within the ranges as taught by Zhu as it is a known technique for a known and similar device and the results of such a modification would have been reasonably predictable, such a modification would better block action potentials within the nerve fibers in neuromodulation for pain management ([0009]).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Molnar et al. (US 2022/0080200) in view of Zhang et al. (US 2020/0139127), Fitzgerald et al. (US 2021/0299447), Wundrich et al. (US 2016/0199662)and Faltys et al. (US 2009/0222064), and further in view of DeShazo et al. (US 2020/0306550).
Regarding claim 22, Molnar et al. does not expressly disclose adjusting the electrical stimulation signal as a function of one or more impedance changes detected by a corresponding electrode of the electrode array to increase an efficacy of the electrical stimulation therapy to the patient. DeShazo et al. teaches it is known in the art to monitor impedance changes ([0024]) using corresponding electrodes ([0026]) to create an impedance model that is then used to adjust the stimulation therapy for a patient ([0027]; [0093]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Molnar et al. to detect impedance changes and to adjust the electrical stimulation signal based on the detected impedance changes as taught by DeShazo et al. in order to factor any changes in impedance that may occur at the electrode/tissue interface that may alter how stimulation is delivered to the patient ([0024]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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/ERICA S LEE/Primary Examiner, Art Unit 3796