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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 18/530,659, filed on 12/06/2023. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 1 and 12 are objected to because of the following informalities:
Regarding claim 1, in the fifth to last line, the claim reads “wherein the measurement unit is configured to acquire a measurement of at least a neural signal propagating in the brain and/or the nerve; a processing unit…”. However, the claim is missing a requisite “and” such that the claim reads “wherein the measurement unit is configured to acquire a measurement of at least a neural signal propagating in the brain and/or the nerve; and a processing unit…”. In the second to last line and last line, the claim reads “configured to control brain stimulation and/or nerve stimulation based on the determined phase relation” and seems to be missing a requisite “the” before “brain” and “nerve” such that the claim reads “configured to control the brain stimulation and/or the nerve stimulation based on the determined phase relation”.
Regarding claim 12, in the second to last line, the claim reads “controlling brain stimulation and/or nerve stimulation based on the determined phase relation” and seems to be missing a requisite “the” before “brain” and “nerve” such that the claim reads “controlling the brain stimulation and/or the nerve stimulation based on the determined phase relation”. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“A stimulation generating unit” in claim 1. For the purposes of examination, Examiner interprets “a stimulation generating unit” to refer to “any type of unit which is able to controllably output an electrical signal which may comprise a current generator” as stated on Pages 12 and 13 of Applicant’s specification.
“A measurement unit” in claim 1. For the purposes of examination, Examiner interprets “a measurement unit” to refer to “at least two sensing electrodes” as stated on Page 14 of Applicant’s specification.
“A processing unit” in claim 1. For the purposes of examination, Examiner interprets “a processing unit” to refer to “a general-purpose processing unit, such as a central processing unit (CPU), which may execute instructions and may alternatively be implemented as firmware arranged e.g., in an embedded system, or as a specifically designed processing unit, such as an Application-Specific Integrated Circuit (ASIC) or a Field-Programmable Gate Array (FPGA)” as stated on Page 15 of Applicant’s specification.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 6 is 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 6 recites the limitation "a phase relation" in line 5. It is unclear as to whether this is the same phase relation as previously mentioned in claim 1. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, Examiner interprets “a phase relation” and “the phase relation” as claimed in claim 1.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 6-8, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (hereinafter “Zhang”) (U.S. Pub. No. 2020/0324119 A1, IDS Reference A4 from IDS Dated 12/06/2023) in view of Raike et al. (hereinafter “Raike”) (U.S. Pub. No. 2019/0290912 A1).
Regarding claim 1, Zhang teaches a device for providing brain stimulation and/or nerve stimulation of a living being (¶[0002], where “This document relates generally to medical devices and more particularly to a neuromodulation method and system providing for asynchronous and/or non-regular activation of neural fibers using interferential stimulation,” ¶[0056], where “the neuromodulation system can include an implantable device configured to deliver neurostimulation (also referred to as neuromodulation) therapies, such as deep brain stimulation (DBS), spinal cord stimulation (SCS), peripheral nerve stimulation (PNS), and vagus nerve stimulation (VNS)”), said device comprising:
a stimulation generating unit (¶[0068], where “FIG. 2 illustrates an embodiment of a stimulation device 204,” ¶[0097], where “Stimulation device 904 can be included in any of the stimulation devices discussed in this document, including but not limited to stimulation devices (including implantable stimulators and IPGs) 104, 204, 404, 504, 604, and 704,” ¶[0098], where “Stimulation device 904 includes a stimulation output circuit 914 and a stimulation control circuit 914”) configured to generate at least a first high frequency stimulation signal and a second high frequency stimulation signal (Figure 16, where carrier frequency 1 is 2000 Hz and carrier frequency 2 is 2000 Hz, which Examiner interprets as a high frequency stimulation signal and Examiner would like to note that Applicant’s specification defines a high frequency as “at least 1 kHz or even larger” on Page 13, ¶[0061], where “In various embodiments, the frequencies f1(t) and f2(t) are functions varying with time. To produce waveforms with the frequencies f1(t) and f2(t), sinusoidal carrier waveforms with frequencies F1 and F2 can be modulated,” ¶[0101], where “stimulation output circuit 912 produces the first waveform using a first carrier waveform having a first carrier frequency and to produce the second waveform using a second carrier waveform having a second carrier frequency … The waveform parameters including the first and second carrier frequencies, the modulation range, the modulation rate, and the modulation type are further discussed below, with references to FIG. 16”) for stimulating a brain and/or a nerve of the living being (¶0068], where “FIG. 2 illustrates an embodiment of a stimulation device 204 and a lead system 208, such as may be implemented in neurostimulation system 100”), wherein a difference between a first frequency of the first high frequency stimulation signal and a second frequency of the second high frequency stimulation signal defines a beat frequency (¶[0059], where “Interferential stimulation can activate neural tissue using two or more waves having sinusoidal frequencies offset by a “beat frequency” and applied through multiple electrode pairs to create time and directionally varying electric fields. For example, applying two sinusoidal waveforms having frequencies f1 and f2 to tissue through two pairs of electrodes … The beat frequency (fb) is equal to the absolute value of the difference of the two carrier frequencies (i.e., fb =|f2−f1|). This beat frequency determines neural activation by producing “pulses” and stands in for an effective temporal pattern of pulses,” ¶[0100], where “Parameter modulation circuit 962 can modulate at least one of the first waveform, the second waveform, the first electrode configuration, or the second electrode configuration to result in the pattern of interferential stimulation including a time-varying beat frequency capable of effecting asynchronous and/or non-regular activation of the nerve fibers when the first and second stimulation currents are delivered simultaneously. The beat frequency being a difference between the first and second frequencies”); and
a set of electrodes (¶[0099], where “Stimulation output circuit 912 can include stimulation channels 960-1 to 960-N each producing a stimulation current and delivering that stimulation current using electrodes selected from the plurality of electrodes”) configured to receive the first high frequency stimulation signal and the second high frequency stimulation signal (¶[0099], where “In a 2-channel example, 2 of the stimulation channels 960-1 to 960-N are used for interferential stimulation. A first stimulation channel (e.g., stimulation channel 960-1) can be configured to produce a first stimulation current and to deliver the first stimulation current to the tissue using a first electrode configuration, and a second stimulation channel (e.g., stimulation channel 960-2) can be configured to produce a second stimulation current and to deliver the second stimulation current to the tissue using a second electrode configuration. The first stimulation current has a first waveform with a first frequency. The second stimulation current has a second waveform with a second frequency”) and configured to be arranged in relation to the brain and/or the nerve (¶[0102], where “FIG. 10 illustrates an embodiment of electrodes 1006 on a lead 1008 placed on or adjacent to a spinal cord 1065 for use with a stimulation device such as stimulation device 904,” ¶[0103], where “While FIGS. 10 and 11 illustrate leads with placements for SCS, the present application matter can be applied to stimulation of any neural tissue with leads and electrodes placed according to the intended target”) for transmitting the first high frequency stimulation signal and the second high frequency stimulation signal into the brain and/or the nerve (¶[0097], where “stimulation devices 904 can deliver neurostimulation energy to a neural target including nerve fibers using a plurality of electrodes, such as electrodes selected from those discussed in this document, including but not limited to electrodes 106, 206, 207, 406, 426, 428, 506, 606, 706, and 707”), wherein the set of electrodes are configured to cause interferential stimulation in the brain and/or the nerve by an interferential stimulation signal having the beat frequency (¶[0059], where “Interferential stimulation can activate neural tissue using two or more waves having sinusoidal frequencies offset by a “beat frequency” and applied through multiple electrode pairs to create time and directionally varying electric fields. For example, applying two sinusoidal waveforms having frequencies f1 and f2 to tissue through two pairs of electrodes results in activation functions (AFs) in X and Y directions,” where Examiner notes that an interferential stimulation signal is a stimulation signal), wherein the interferential stimulation signal is formed through interference by the first high frequency stimulation signal and the second high frequency stimulation signal (¶[0099], where “In a 2-channel example, 2 of the stimulation channels 960-1 to 960-N are used for interferential stimulation. A first stimulation channel (e.g., stimulation channel 960-1) can be configured to produce a first stimulation current and to deliver the first stimulation current to the tissue using a first electrode configuration, and a second stimulation channel (e.g., stimulation channel 960-2) can be configured to produce a second stimulation current and to deliver the second stimulation current to the tissue using a second electrode configuration. The first stimulation current has a first waveform with a first frequency. The second stimulation current has a second waveform with a second frequency,” ¶[0100], where “Parameter modulation circuit 962 can modulate at least one of the first waveform, the second waveform, the first electrode configuration, or the second electrode configuration to result in the pattern of interferential stimulation including a time-varying beat frequency capable of effecting asynchronous and/or non-regular activation of the nerve fibers when the first and second stimulation currents are delivered simultaneously.” Examiner interprets that since the electrode frequencies cross to create an interferential stimulation pattern, that the two stimulation signals interfere with one another, especially since signal interference is inherent to interferential stimulation.).
Although Zhang discloses a sensing circuit to allow for a sensing capability (¶[0086], where “Implantable stimulator 704 may include a sensing circuit 742 that is optional and required only when the stimulator needs a sensing capability … Sensing circuit 742, when included and needed, senses one or more physiological signals for purposes of patient monitoring and/or feedback control of the neurostimulation”) and modulation of the first and second waveforms utilizing a processor (¶[0072], where “circuits of neurostimulation 100, including its various embodiments discussed in this document, may be implemented using a combination of hardware and software ... Such a general-purpose circuit includes, but is not limited to, a microprocessor or a portion thereof, a microcontroller or portions thereof, and a programmable logic circuit or a portion thereof,” ¶[0101], where “Parameter modulation circuit 962 modulates at least one of the first waveform or the second waveform so that at least one parameter of the at least one of the first waveform or the second waveform is time-varying”), Zhang does not explicitly teach a measurement unit, comprising at least two sensing electrodes, wherein the measurement unit is configured to acquire a measurement of at least a neural signal propagating in the brain and/or the nerve nor a processing unit, configured to receive the measurement from the measurement unit and configured to determine a phase relation between the neural signal and the stimulation signal and configured to control brain stimulation and/or nerve stimulation based on the determined phase relation.
Raike teaches a medical device that is in the same field of endeavor of electrical stimulation to the brain (Abstract), and further teaches a measurement unit, comprising at least two sensing electrodes (¶[0039], where “the sensing circuitry of IMD 16 may receive the bioelectrical signals from electrodes 24, 26 or other electrodes positioned to monitored brain signals of patient 12 … IMD 16 can also use separate sensing electrodes to sense the bioelectrical brain signals,” ¶[0061], where “Sensing circuitry 46 includes circuitry for determining a voltage difference between two electrodes 24, 26, which generally indicates the electrical activity within the particular region of brain 24”), wherein the measurement unit is configured to acquire a measurement of at least a neural signal propagating in the brain and/or the nerve (¶[0039], where “Electrodes 24, 26 may … sense brain signals within brain 28. However, IMD 16 can also use separate sensing electrodes to sense the bioelectrical brain signals. In some examples, the sensing circuitry of IMD 16 may sense bioelectrical brain signals via one or more of the electrodes 24, 26”); and
a processing unit, configured to receive the measurement from the measurement unit (¶[0038], where “processing circuitry of IMD 16 may sense the bioelectrical signals within brain 28 of patient 12 and controls delivery of electrical stimulation therapy to brain 28,” ¶[0062], where “The output of sensing circuitry 46 may be received by processing circuitry 40. In some cases, processing circuitry 40 may apply additional processing to the bioelectrical signals, e.g., convert the output to digital values for processing and/or amplify the bioelectrical brain signal”) and configured to determine a phase relation between the neural signal and the stimulation signal and configured to control brain stimulation and/or nerve stimulation based on the determined phase relation (¶[0055], where “IMD 16 generates a plurality of electrical stimulation pulses and delivers the electrical stimulation pulses at a pulse frequency that is slightly less than that of the one or more oscillations, e.g., at 17 Hertz or 20 Hertz and 180 degrees (e.g., π radians) out of phase with the one or more oscillations. … the electrical stimulation may disrupt (e.g., destructively interfere with) at least a portion of the peaks of the oscillations of the bioelectrical brain signal a majority of the time. In some examples, modulating or shifting the frequency of the one or more pathologic oscillations may adjust or alter a relationship between the oscillations of the pathologic bioelectrical brain signals and oscillations of bioelectrical brain signals within other regions of the brain such that in a manner that suppresses one or more symptoms of a disease of the patient that result from the relationship.” Examiner interprets that modulating the frequency controls the stimulation and that the modulation is based on the phase relation since a specific phase is sought.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Raike, which teaches a measurement unit, comprising at least two sensing electrodes, wherein the measurement unit is configured to acquire a measurement of at least a neural signal propagating in the brain and/or the nerve nor a processing unit, configured to receive the measurement from the measurement unit and configured to determine a phase relation between the neural signal and the stimulation signal and configured to control brain stimulation and/or nerve stimulation based on the determined phase relation, with the invention of Zhang in order to sense the bioelectrical brain signals (Raike ¶[0039]) and to suppress one or more symptoms of a disease of the patient (Raike ¶[0055]).
Regarding claim 2, Zhang in combination with Raike teaches all limitations of claim 1 as described in the rejection above.
Raike teaches that the neural signal exhibits a neural frequency (¶[0038], where “IMD 16 may include sensing circuitry that senses bioelectrical brain signals within one or more regions of brain 28 … processing circuitry of IMD 16 may sense the bioelectrical signals within brain 28 of patient 12 and controls delivery of electrical stimulation therapy to brain 28 via electrodes 24, 26 when the bioelectrical brain signals are oscillating at a pathological frequency,” ¶[0039], where “Electrodes 24, 26 may … sense brain signals within brain 28”) and wherein the processing unit is configured to determine the phase relation at the neural frequency (¶[0038], where “IMD 16 may include sensing circuitry that senses bioelectrical brain signals within one or more regions of brain 28 … processing circuitry of IMD 16 may sense the bioelectrical signals within brain 28 of patient 12 and controls delivery of electrical stimulation therapy to brain 28 via electrodes 24, 26 when the bioelectrical brain signals are oscillating at a pathological frequency,” ¶[0055], where “IMD 16 generates a plurality of electrical stimulation pulses and delivers the electrical stimulation pulses at a pulse frequency that is slightly less than that of the one or more oscillations, e.g., at 17 Hertz or 20 Hertz and 180 degrees (e.g., π radians) out of phase with the one or more oscillations. … the electrical stimulation may disrupt (e.g., destructively interfere with) at least a portion of the peaks of the oscillations of the bioelectrical brain signal a majority of the time,” ¶[0075], where “processing circuitry 40 controls stimulation generator 44 to generate electrical stimulation comprising a frequency that is different from that of the one or more oscillations of the electrical signals of the brain and out of phase with the one or more oscillations so as to destructively interfere with the one or more oscillations present in the electrical signals of the brain.” Examiner interprets that the phase relation is determined since it must be known in order for an out of phase stimulation to be applied.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Raike, which teaches that the neural signal exhibits a neural frequency and wherein the processing unit is configured to determine the phase relation at the neural frequency, with the invention of Zhang in order to reduce the amplitude of the one or more oscillations experienced at local tissue regions of brain and suppress or reduce the symptoms of the pathological disease of the patient (Raike ¶[0076]).
Regarding claim 3, Zhang in combination with Raike teaches all limitations of claim 2 as described in the rejection above.
Zhang teaches that the stimulation generating unit is configured to generate the first high frequency stimulation signal and the second high frequency stimulation signal for defining the beat frequency (¶[0059], where “Interferential stimulation can activate neural tissue using two or more waves having sinusoidal frequencies offset by a “beat frequency” and applied through multiple electrode pairs to create time and directionally varying electric fields. For example, applying two sinusoidal waveforms having frequencies f1 and f2 to tissue through two pairs of electrodes … The beat frequency (fb) is equal to the absolute value of the difference of the two carrier frequencies (i.e., fb =|f2−f1|). This beat frequency determines neural activation by producing “pulses” and stands in for an effective temporal pattern of pulses,” ¶[0098], where “Stimulation device 904 includes a stimulation output circuit 914 and a stimulation control circuit 914,” ¶[0100], where “Stimulation control circuit 914 includes a parameter modulation circuit 962 … Parameter modulation circuit 962 can modulate at least one of the first waveform, the second waveform, the first electrode configuration, or the second electrode configuration to result in the pattern of interferential stimulation including a time-varying beat frequency capable of effecting asynchronous and/or non-regular activation of the nerve fibers when the first and second stimulation currents are delivered simultaneously. The beat frequency being a difference between the first and second frequencies.” Additionally, Examiner interprets that the beat frequency is a stimulation signal.).
Raike teaches that the stimulation signal is equal to the neural frequency (¶[0085], where “electrical stimulation 401 comprises an amplitude that is about equal to an amplitude of oscillations of bioelectrical signal 400 of brain 28,” ¶[0086], where “because electrical stimulation 401 is out of phase with the one or more oscillations of bioelectrical brain signal 400 of brain 28, electrical stimulation 401 destructively interferes with the one or more oscillations of bioelectrical brain signal 400”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Raike, which teaches that the stimulation signal is equal to the neural frequency, with the invention of Zhang in order to reduce the amplitude of the one or more oscillations of the bioelectrical brain signals of the brain associated with the pathological disease and suppress or reduce the symptoms of the pathological disease of the patient (Raike ¶[0086]).
Regarding claim 6, Zhang in combination with Raike teaches all limitations of claim 2 as described in the rejection above.
Zhang teaches the first high frequency stimulation signal and the second high frequency stimulation signal (Figure 16, where carrier frequency 1 is 2000 Hz and carrier frequency 2 is 2000 Hz, which Examiner interprets as a high frequency stimulation signal, ¶[0061], where “In various embodiments, the frequencies f1(t) and f2(t) are functions varying with time. To produce waveforms with the frequencies f1(t) and f2(t), sinusoidal carrier waveforms with frequencies F1 and F2 can be modulated,” ¶[0101], where “stimulation output circuit 912 produces the first waveform using a first carrier waveform having a first carrier frequency and to produce the second waveform using a second carrier waveform having a second carrier frequency … The waveform parameters including the first and second carrier frequencies, the modulation range, the modulation rate, and the modulation type are further discussed below, with references to FIG. 16”).
Although Zhang teaches an interferential stimulation signal and specific pulse trains or patterns (“The electronic circuitry of IPG 404 can include a control circuit that controls delivery of the neurostimulation energy … Examples of pulse parameters include, among other things, … parameters associated with a pulse train or pattern such as burst rate (e.g., an “on” modulation time followed by an “off” modulation time)”), Zhang does not explicitly teach that the stimulation generating unit is configured to generate a sequence of bursts of the stimulation signal defining a repetition frequency of the bursts in the sequence, wherein the processing unit is configured to control a phase relation such that onset of a burst of the stimulation signal is in desired phase relation with the neural signal at the neural frequency.
Raike teaches that the stimulation generating unit is configured to generate a sequence of bursts of the stimulation signal defining a repetition frequency of the bursts in the sequence (¶[0052], where “IMD 16 generates electrical stimulation comprising a frequency approximating that of the one or more oscillations and out of phase with the one or more oscillations … the waveform comprises regularly-spaced electrical stimulation pulses, regular bursts of electrical stimulation pulses, or irregular patterns of electrical stimulation. In such examples, IMD 16 delivers the bursts or patterns in the frequency and phase relationships to the oscillations of the bioelectrical signal of interest,” ¶[0053], where “burst electrical stimulation describes a type of electrical stimulation comprising a first period of time wherein electrical stimulation is delivered as two or more closely spaced electrical stimulation pulses (e.g., a “burst” of one or more electrical stimulation pulses) and a period of time in which electrical stimulation is not delivered. Each “burst” of electrical stimulation comprises closely spaced electrical stimulation pulses. Burst electrical stimulation typically may be defined by an intra-burst frequency (e.g., a frequency of each of the one or more electrical stimulation pulses that make up the “burst”) and an inter-burst frequency (e.g., a frequency of each of the bursts of stimulation)”), wherein the processing unit is configured to control a phase relation (¶[0038], where “processing circuitry of IMD 16 may sense the bioelectrical signals within brain 28 of patient 12 and controls delivery of electrical stimulation therapy to brain 28 via electrodes 24, 26 when the bioelectrical brain signals are oscillating at a pathological frequency,” ¶[0075], where “processing circuitry 40 controls stimulation generator 44 to generate electrical stimulation comprising a frequency that is different from that of the one or more oscillations of the electrical signals of the brain and out of phase with the one or more oscillations so as to destructively interfere with the one or more oscillations present in the electrical signals of the brain.” Examiner interprets that the processing unit is configured to control a phase relation since the processing circuitry generates stimulation that is out of phase with the brain signals and control is required to generate an appropriate waveform.) such that onset of a burst of the stimulation signal is in desired phase relation with the neural signal at the neural frequency (¶[0052], where “IMD 16 generates electrical stimulation comprising a frequency that is different from that of the one or more oscillations and out of phase with the one or more oscillations such that the electrical stimulation inter-burst frequency is different from the oscillations and occurs substantially out of phase with the frequency of the oscillations of the brain signals … IMD 16 delivers the bursts or patterns in the frequency and phase relationships to the oscillations of the bioelectrical signal of interest.” Examiner interprets that the burst is within the desired phase relation with the neural signal since the burst patterns is based on the relationship with the bioelectrical signal and is designed to be out of phase with said signal.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Raike, which teaches that the stimulation generating unit is configured to generate a sequence of bursts of the stimulation signal defining a repetition frequency of the bursts in the sequence, wherein the processing unit is configured to control a phase relation such that onset of a burst of the stimulation signal is in desired phase relation with the neural signal at the neural frequency, with the invention of Zhang in order to reduce the amplitude of the one or more oscillations experienced at local tissue regions of brain and suppress or reduce the symptoms of the pathological disease of the patient (Raike ¶[0076]).
Regarding claim 7, Zhang in combination with Raike teaches all limitations of claim 1 as described in the rejection above.
Zhang teaches that the stimulation generating unit is configured to generate the first high frequency stimulation signal and the second high frequency stimulation signal during a period of time (¶[0061], where “In various embodiments, the frequencies f1(t) and f2(t) are functions varying with time. To produce waveforms with the frequencies f1(t) and f2(t), sinusoidal carrier waveforms with frequencies F1 and F2 can be modulated, respectively.” Examiner interprets that, since the waveforms vary with time, that the first and second high frequency stimulation signals inherently occur during a period of time.).
Raike teaches that the measurement unit is configured to acquire the measurement during the period of time (¶[0066], where “sensing circuitry 46 may sense brain signals substantially at the same time that IMD 16 delivers therapy to patient 14”) and that the processing unit is configured to determine the phase relation during the period of time (¶[0038], where “processing circuitry of IMD 16 may sense the bioelectrical signals within brain 28 of patient 12 and controls delivery of electrical stimulation therapy to brain 28 via electrodes 24, 26 when the bioelectrical brain signals are oscillating at a pathological frequency”, ¶[0055], where “IMD 16 generates a plurality of electrical stimulation pulses and delivers the electrical stimulation pulses at a pulse frequency that is slightly less than that of the one or more oscillations, e.g., at 17 Hertz or 20 Hertz and 180 degrees (e.g., π radians) out of phase with the one or more oscillations. … the electrical stimulation may disrupt (e.g., destructively interfere with) at least a portion of the peaks of the oscillations of the bioelectrical brain signal a majority of the time. In some examples, modulating or shifting the frequency of the one or more pathologic oscillations may adjust or alter a relationship between the oscillations of the pathologic bioelectrical brain signals and oscillations of bioelectrical brain signals within other regions of the brain such that in a manner that suppresses one or more symptoms of a disease of the patient that result from the relationship.” Examiner interprets that the modulation is based on the phase relation since a specific phase is sought and that the processing unit determines the phase relation during the time period since the IMD, which includes the processing circuitry, determines an out of phase signal and relationships between the oscillations of the pathologic bioelectrical brain signals and oscillations of bioelectrical brain signals.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Raike, which teaches that the measurement unit is configured to acquire the measurement during the period of time and that the processing unit is configured to determine the phase relation during the period of time, with the invention of Zhang in order to measure the electrical activity of a particular region (Raike ¶[0060]) and to suppress one or more symptoms of a disease of the patient (Raike ¶[0055]).
Regarding claim 8, Zhang in combination with Raike teaches all limitations of claim 1 as described in the rejection above.
Zhang teaches the first high frequency stimulation signal and the second high frequency stimulation signal (¶[0061], where “In various embodiments, the frequencies f1(t) and f2(t) are functions varying with time. To produce waveforms with the frequencies f1(t) and f2(t), sinusoidal carrier waveforms with frequencies F1 and F2 can be modulated, respectively.” Examiner interprets that the first and second high frequency stimulation signals are stimulation signals.) as well as an interferential stimulation signal (¶[0059]).
Raike teaches that the processing unit is configured to control the stimulation generating unit to adapt the stimulation signal (¶[0038], where “processing circuitry of IMD 16 may sense the bioelectrical signals within brain 28 of patient 12 and controls delivery of electrical stimulation therapy to brain 28 via electrodes 24, 26 when the bioelectrical brain signals are oscillating at a pathological frequency”) in order to change the phase relation between the neural signal and the stimulation signal (¶[0055], where “modulating or shifting the frequency of the one or more pathologic oscillations may adjust or alter a relationship between the oscillations of the pathologic bioelectrical brain signals and oscillations of bioelectrical brain signals within other regions of the brain such that in a manner that suppresses one or more symptoms of a disease of the patient that result from the relationship,” ¶[0068], where “based on the monitoring of such parameter(s), IMD 16 may deliver electrical stimulation selected to entrain brain signals oscillating at a frequency associated with the detected symptoms, and then adjust the frequency to modulate the oscillation frequency of the brain signals to a frequency not associated with the detected symptoms.” Examiner interprets that by changing the frequency of the applied stimulation that the phase relation changes as well since there will be a different phase relation between the signals.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Raike, which teaches that the processing unit is configured to control the stimulation generating unit to adapt the stimulation signal in order to change the phase relation between the neural signal and the stimulation signal, with the invention of Zhang in order to suppress one or more symptoms of a disease of the patient that result from the relationship (Raike ¶[0055]).
Regarding claim 12, since the claim is directed to a method comprising substantially the same subject matter of claim 1, see the rejection of claim 1 above. However, claim 12 adds “A method for providing brain stimulation and/or nerve stimulation of a living being”.
Zhang teaches a method for providing brain stimulation and/or nerve stimulation of a living being (¶[0002], where “This document relates generally to … a neuromodulation method and system providing for asynchronous and/or non-regular activation of neural fibers using interferential stimulation,” ¶[0056], where “the neuromodulation system can include an implantable device configured to deliver neurostimulation (also referred to as neuromodulation) therapies, such as deep brain stimulation (DBS), spinal cord stimulation (SCS), peripheral nerve stimulation (PNS), and vagus nerve stimulation (VNS)”).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang and Raike as applied to claim 2 above, and further in view of Dinsmoor et al. (hereinafter “Dinsmoor”) (U.S. Pub. No. 2024/0139521 A1).
Regarding claim 4, Zhang in combination with Raike teaches all limitations of claim 2 as described in the rejection above.
Zhang teaches the first frequency of the first high frequency stimulation signal or the second frequency of the second high frequency stimulation signal (Figure 16, where carrier frequency 1 is 2000 Hz and carrier frequency 2 is 2000 Hz, which Examiner interprets as a high frequency stimulation signal, ¶[0061], where “In various embodiments, the frequencies f1(t) and f2(t) are functions varying with time. To produce waveforms with the frequencies f1(t) and f2(t), sinusoidal carrier waveforms with frequencies F1 and F2 can be modulated,” ¶[0101], where “stimulation output circuit 912 produces the first waveform using a first carrier waveform having a first carrier frequency and to produce the second waveform using a second carrier waveform having a second carrier frequency … The waveform parameters including the first and second carrier frequencies, the modulation range, the modulation rate, and the modulation type are further discussed below, with references to FIG. 16”).
Raike teaches that the measurement unit is configured to acquire a measurement of the neural signal (¶[0039], where “Electrodes 24, 26 may … sense brain signals within brain 28. However, IMD 16 can also use separate sensing electrodes to sense the bioelectrical brain signals. In some examples, the sensing circuitry of IMD 16 may sense bioelectrical brain signals via one or more of the electrodes 24, 26”), wherein the processing unit is configured to determine the phase relation based on analysis of the neural frequency and at the stimulation signal (¶[0038], where “IMD 16 may include sensing circuitry that senses bioelectrical brain signals within one or more regions of brain 28 … processing circuitry of IMD 16 may sense the bioelectrical signals within brain 28 of patient 12 and controls delivery of electrical stimulation therapy to brain 28 via electrodes 24, 26 when the bioelectrical brain signals are oscillating at a pathological frequency,” ¶[0055], where “IMD 16 generates a plurality of electrical stimulation pulses and delivers the electrical stimulation pulses at a pulse frequency that is slightly less than that of the one or more oscillations, e.g., at 17 Hertz or 20 Hertz and 180 degrees (e.g., π radians) out of phase with the one or more oscillations. … the electrical stimulation may disrupt (e.g., destructively interfere with) at least a portion of the peaks of the oscillations of the bioelectrical brain signal a majority of the time,” ¶[0075], where “processing circuitry 40 controls stimulation generator 44 to generate electrical stimulation comprising a frequency that is different from that of the one or more oscillations of the electrical signals of the brain and out of phase with the one or more oscillations so as to destructively interfere with the one or more oscillations present in the electrical signals of the brain.” Examiner interprets that the phase relation is determined since it must be known in order for an out of phase stimulation to be applied. Additionally, the phase relation is based on the neural frequency and the stimulation signal since the respective signals are designed to destructively interfere with one another, where the brain signal and stimulation signal will need to be known in order to generate a proper electrical stimulation that interferes with the brain signal.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Raike, which teaches that the measurement unit is configured to acquire a measurement of the neural signal, wherein the processing unit is configured to determine the phase relation based on analysis of the neural frequency and at the stimulation signal, with the invention of Zhang in order to reduce the amplitude of the one or more oscillations experienced at local tissue regions of brain and suppress or reduce the symptoms of the pathological disease of the patient (Raike ¶[0076]).
Neither Zhang nor Raike teaches that the measurement unit is configured to acquire a measurement of the interferential stimulation signal.
Dinsmoor teaches a device configured for independently modulating two or more concurrent signals of electrical stimulation therapy (Abstract), and further teaches that the measurement unit is configured to acquire a measurement of the interferential stimulation signal (¶[0118], where “Stimulation interference signals 638A, 638B, and 638N (e.g., the artifact of the stimulation pulses) may be sensed by leads 230 and may be sensed during the same period of time as the delivery of control pulses 612 and informed pulses 624”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Dinsmoor, which teaches that the measurement unit is configured to acquire a measurement of the interferential stimulation signal, with the modified invention of Zhang in order to adequately sense ECAP signals which may not be adequately sensed when occurring at the same time as a stimulation interference signal (Dinsmoor ¶[0118]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang, Raike, and Dinsmoor as applied to claim 4 above, and further in view of Feinstein (U.S. Pub. No. 2019/0366087 A1, IDS Reference A3 from IDS Dated 12/06/2023).
Regarding claim 5, Zhang in combination with Raike and Dinsmoor teaches all limitations of claim 4 as described in the rejection above.
Zhang teaches the interferential stimulation signal based on at least one of the first frequency of the first high frequency stimulation signal or the second frequency of the second high frequency stimulation signal (¶[0059], where “Interferential stimulation can activate neural tissue using two or more waves having sinusoidal frequencies offset by a “beat frequency” and applied through multiple electrode pairs to create time and directionally varying electric fields. For example, applying two sinusoidal waveforms having frequencies f1 and f2 to tissue through two pairs of electrodes … The beat frequency (fb) is equal to the absolute value of the difference of the two carrier frequencies (i.e., fb =|f2−f1|). This beat frequency determines neural activation by producing “pulses” and stands in for an effective temporal pattern of pulses,” ¶[0098], where “Stimulation device 904 includes a stimulation output circuit 914 and a stimulation control circuit 914,” ¶[0100], where “Stimulation control circuit 914 includes a parameter modulation circuit 962 … Parameter modulation circuit 962 can modulate at least one of the first waveform, the second waveform, the first electrode configuration, or the second electrode configuration to result in the pattern of interferential stimulation including a time-varying beat frequency capable of effecting asynchronous and/or non-regular activation of the nerve fibers when the first and second stimulation currents are delivered simultaneously. The beat frequency being a difference between the first and second frequencies.” Additionally, Examiner interprets that the interferential stimulation signal is a stimulation signal.).
Raike teaches that the processing unit is configured to determine phase information of the stimulation signal (¶[0055], where “IMD 16 generates a plurality of electrical stimulation pulses and delivers the electrical stimulation pulses at a pulse frequency that is slightly less than that of the one or more oscillations, e.g., at 17 Hertz or 20 Hertz and 180 degrees (e.g., π radians) out of phase with the one or more oscillations. … the electrical stimulation may disrupt (e.g., destructively interfere with) at least a portion of the peaks of the oscillations of the bioelectrical brain signal a majority of the time,” ¶[0075], where “processing circuitry 40 controls stimulation generator 44 to generate electrical stimulation comprising a frequency that is different from that of the one or more oscillations of the electrical signals of the brain and out of phase with the one or more oscillations so as to destructively interfere with the one or more oscillations present in the electrical signals of the brain.” Examiner interprets that the phase relation is determined based on the stimulation signal since the respective neural and stimulation signals are designed to destructively interfere with one another, where the brain signal and stimulation signal will need to be known in order to generate a proper electrical stimulation within a certain phase that interferes with the brain signal.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Raike, which teaches that the processing unit is configured to determine phase information of the stimulation signal, with the modified invention of Zhang in order to reduce the amplitude of the one or more oscillations experienced at local tissue regions of brain and suppress or reduce the symptoms of the pathological disease of the patient (Raike ¶[0076]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang and Raike as applied to claim 1 above, and further in view of Feinstein.
Regarding claim 9, Zhang in combination with Raike teaches all limitations of claim 1 as described in the rejection above.
Zhang teaches that the stimulation generating unit is configured to generate a third high frequency stimulation signal and a fourth high frequency stimulation signal (¶[0060], where “Interferential stimulation using two sinusoidal waveforms with frequencies f1(t) and f2(t) are specifically discussed as examples for illustration and discussion. However, the present subject matter is neither limited to two waveforms nor limited to sinusoidal waveforms. In various embodiments, the interferential stimulation according to the present subject matter can use two or more waveforms to produce activation functions with a beat frequency that varies with time,” ¶[0061], where “In various embodiments, the frequencies f1(t) and f2(t) are functions varying with time. To produce waveforms with the frequencies f1(t) and f2(t), sinusoidal carrier waveforms with frequencies F1 and F2 can be modulated,” ¶[0099], where “Stimulation output circuit 912 can include stimulation channels 960-1 to 960-N each producing a stimulation current and delivering that stimulation current using electrodes selected from the plurality of electrodes. In a 2-channel example, 2 of the stimulation channels 960-1 to 960-N are used for interferential stimulation. A first stimulation channel (e.g., stimulation channel 960-1) can be configured to produce a first stimulation current and to deliver the first stimulation current to the tissue using a first electrode configuration, and a second stimulation channel (e.g., stimulation channel 960-2) can be configured to produce a second stimulation current and to deliver the second stimulation current to the tissue using a second electrode configuration … While the 2-channel example is discussed below as a specific example for illustrative rather than restrictive purposes, the number N can be two or larger in various embodiments. In other words, n channels (2≤n≤N) can be selected for interferential stimulation. Each selected stimulation channel i (1≤i≤N) is configured to produce an ith stimulation current having an ith waveform with an ith frequency and to deliver the ith stimulation current to the tissue using an ith electrode configuration specified for effecting a distribution of the ith stimulation current in each electrode of the plurality of electrodes.” Examiner interprets that, since the device can include stimulation channels for N channels, that the device includes a third and fourth high frequency stimulation signal.) for stimulating a brain and/or a nerve of the living being (¶0068], where “FIG. 2 illustrates an embodiment of a stimulation device 204 and a lead system 208, such as may be implemented in neurostimulation system 100”), wherein a difference between a third frequency of the third high frequency stimulation signal and a fourth frequency of the fourth high frequency stimulation signal defines a beat frequency (¶[0059], where “Interferential stimulation can activate neural tissue using two or more waves having sinusoidal frequencies offset by a “beat frequency” and applied through multiple electrode pairs to create time and directionally varying electric fields. For example, applying two sinusoidal waveforms having frequencies f1 and f2 to tissue through two pairs of electrodes … The beat frequency (fb) is equal to the absolute value of the difference of the two carrier frequencies (i.e., fb =|f2−f1|). This beat frequency determines neural activation by producing “pulses” and stands in for an effective temporal pattern of pulses,” ¶[0060], where “Interferential stimulation using two sinusoidal waveforms with frequencies f1(t) and f2(t) are specifically discussed as examples for illustration and discussion. However, the present subject matter is neither limited to two waveforms nor limited to sinusoidal waveforms. In various embodiments, the interferential stimulation according to the present subject matter can use two or more waveforms to produce activation functions with a beat frequency that varies with time,” ¶[0100], where “Parameter modulation circuit 962 can modulate at least one of the first waveform, the second waveform, the first electrode configuration, or the second electrode configuration to result in the pattern of interferential stimulation including a time-varying beat frequency capable of effecting asynchronous and/or non-regular activation of the nerve fibers when the first and second stimulation currents are delivered simultaneously. The beat frequency being a difference between the first and second frequencies.” Examiner interprets that the beat frequency is the difference between the third and fourth high frequency stimulation signals since the device is not limited to two waveforms and the beat frequency is applied to electrode pairs, such that the beat frequency applies in the same manner to the third and fourth signals as the first and second signals as described in claim 1.);
wherein the set of electrodes comprises a first sub-set of electrodes configured to receive the first high frequency stimulation signal and the second high frequency stimulation signal (¶[0099], where “Stimulation output circuit 912 can include stimulation channels 960-1 to 960-N each producing a stimulation current and delivering that stimulation current using electrodes selected from the plurality of electrodes. In a 2-channel example, 2 of the stimulation channels 960-1 to 960-N are used for interferential stimulation. A first stimulation channel (e.g., stimulation channel 960-1) can be configured to produce a first stimulation current and to deliver the first stimulation current to the tissue using a first electrode configuration, and a second stimulation channel (e.g., stimulation channel 960-2) can be configured to produce a second stimulation current and to deliver the second stimulation current to the tissue using a second electrode configuration … While the 2-channel example is discussed below as a specific example for illustrative rather than restrictive purposes, the number N can be two or larger in various embodiments. In other words, n channels (2≤n≤N) can be selected for interferential stimulation. Each selected stimulation channel i (1≤i≤N) is configured to produce an ith stimulation current having an ith waveform with an ith frequency and to deliver the ith stimulation current to the tissue using an ith electrode configuration specified for effecting a distribution of the ith stimulation current in each electrode of the plurality of electrodes.” Examiner interprets that since more than two stimulation channels can be utilized, where each stimulation channel includes a pair of electrodes and electrode configurations are chosen from a plurality of electrodes, and since a first and second channel are described, that the first and second channel are a subset of electrodes within the two or larger group of electrodes from the plurality of electrodes.) and configured to be arranged at a first location in relation to the brain and/or the nerve for causing interferential stimulation (Examiner interprets that since Zhang teaches a first sub-set of electrodes in ¶[0099] that the electrodes of the first sub-set are inherently arranged at a first location in relation to the brain and/or nerve in order to stimulate the proper area.), wherein the device further comprises a second sub-set of electrodes configured to receive the third frequency stimulation signal and the fourth stimulation signal (¶[0060], ¶[0061], ¶[0099], where “Stimulation output circuit 912 can include stimulation channels 960-1 to 960-N each producing a stimulation current and delivering that stimulation current using electrodes selected from the plurality of electrodes. In a 2-channel example, 2 of the stimulation channels 960-1 to 960-N are used for interferential stimulation. A first stimulation channel (e.g., stimulation channel 960-1) can be configured to produce a first stimulation current and to deliver the first stimulation current to the tissue using a first electrode configuration, and a second stimulation channel (e.g., stimulation channel 960-2) can be configured to produce a second stimulation current and to deliver the second stimulation current to the tissue using a second electrode configuration … While the 2-channel example is discussed below as a specific example for illustrative rather than restrictive purposes, the number N can be two or larger in various embodiments. In other words, n channels (2≤n≤N) can be selected for interferential stimulation. Each selected stimulation channel i (1≤i≤N) is configured to produce an ith stimulation current having an ith waveform with an ith frequency and to deliver the ith stimulation current to the tissue using an ith electrode configuration specified for effecting a distribution of the ith stimulation current in each electrode of the plurality of electrodes.” Examiner interprets that, since the device can include stimulation channels for N channels, that the device includes a third and fourth high frequency stimulation signal with respective electrodes. Additionally, each stimulation channel includes a pair of electrodes and electrode configurations are chosen from a plurality of electrodes, and since the device includes a third and fourth channel, the third and fourth channel are a second subset of electrodes within the two or larger group of electrodes from the plurality of electrodes.) and configured to be arranged at a second location different from the first location in relation to the brain and/or the nerve for transmitting the third frequency stimulation signal and the fourth frequency stimulation signal into the brain and/or the nerve (Examiner interprets that the second subset is arranged at a different location from the first subset since each subset contains different electrodes and since the two subsets cannot occupy the same space.).
Although Zhang teaches generation of a third high frequency stimulation signal and a fourth high frequency stimulation signal utilizing a third and fourth electrode (¶[0060], ¶[0061], ¶[0099]), where the set of electrodes are configured to cause interferential stimulation in the brain and/or the nerve by an interferential stimulation signal having the beat frequency (¶[0059]), and where the first sub-set of electrodes is configured to be arranged at a first location in relation to the brain and/or the nerve for causing interferential stimulation and a second sub-set of electrodes configured to receive the third frequency stimulation signal and the fourth stimulation signal and configured to be arranged at a second location different from the first location in relation to the brain and/or the nerve for transmitting the third frequency stimulation signal and the fourth frequency stimulation signal into the brain and/or the nerve (¶[0059], ¶[0099]), Zhang does not explicitly teach the first sub-set of electrodes is configured to cause interferential stimulation by a first interferential stimulation signal forming said interferential signal, wherein the second set of electrodes are configured to cause interferential stimulation in the brain and/or the nerve by a second interferential stimulation signal having the beat frequency, wherein the second interferential stimulation signal is formed through interference by the third frequency stimulation signal and the fourth frequency stimulation signal, nor wherein the processing unit is configured to determine a phase relation between the neural signal and the first stimulation signal and wherein the processing unit is further configured to control the second stimulation signal based on the determined phase relation.
Feinstein teaches the first sub-set of electrodes (Figure 3B, first pair of electrodes 181 and 182) for causing interferential stimulation by a first interferential stimulation signal forming said interferential signal (¶[0034], where “an exemplary positioning of electrodes (181, 182) on the patient (50) is shown. In this exemplary embodiment, a first electrode (181) supplies transcutaneous electrical impulses at a first frequency and a second electrode (182) supplies transcutaneous electrical impulses at a second frequency different than the first frequency, the transcutaneous electrical impulses provided at the first and second frequencies giving rise to a first beat impulse having a first interference frequency. The first and second electrodes (181, 182) are positioned such that the therapeutic target area thereof is positioned to cause stimulation of a first desired nerve/tissue/organ with the first beat impulse having the first interference frequency”),
and wherein the device further comprises a second sub-set of electrodes (Figure 3B, second pair of electrodes 183 and 184) configured to receive the third frequency stimulation signal and the fourth stimulation signal (¶[0035], where “a third electrode (183) supplies transcutaneous electrical impulses at a third frequency and a fourth electrode (184) supplies transcutaneous electrical impulses at a fourth frequency different than the third frequency”) and configured to be arranged at a second location different from the first location in relation to the brain and/or the nerve for transmitting the third high frequency stimulation signal and the fourth high frequency stimulation signal into the brain and/or the nerve (Figure 3B, first pair of electrodes 181 and 182 and second pair of electrodes 183 and 184), wherein the second set of electrodes are configured to cause interferential stimulation in the brain and/or the nerve by a second interferential stimulation signal having the beat frequency (¶[0031], where “therapy generally utilizes two medium frequency currents which pass through the tissues simultaneously. They are set up so that their paths cross; and in simple terms they interfere with each other. This interference gives rise to an interference or beat frequency,” ¶[0035], where “a third electrode (183) supplies transcutaneous electrical impulses at a third frequency and a fourth electrode (184) supplies transcutaneous electrical impulses at a fourth frequency different than the third frequency, the transcutaneous electrical impulses provided at the third and fourth frequencies giving rise to a second beat impulse having a second interference frequency. The third and fourth electrodes (183, 184) are positioned such the therapeutic target area thereof is positioned to cause stimulation of a second desired nerve/tissue/organ with the second beat impulse having the second interference frequency”), wherein the second interferential stimulation signal is formed through interference by the third high frequency stimulation signal and the fourth high frequency stimulation signal (¶[0035], where “a third electrode (183) supplies transcutaneous electrical impulses at a third frequency and a fourth electrode (184) supplies transcutaneous electrical impulses at a fourth frequency different than the third frequency, the transcutaneous electrical impulses provided at the third and fourth frequencies giving rise to a second beat impulse having a second interference frequency. The third and fourth electrodes (183, 184) are positioned such the therapeutic target area thereof is positioned to cause stimulation of a second desired nerve/tissue/organ with the second beat impulse having the second interference frequency”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Feinstein, which teaches the first sub-set of electrodes for causing interferential stimulation by a first interferential stimulation signal forming said interferential signal, wherein the device further comprises a second sub-set of electrodes configured to receive the third frequency stimulation signal and the fourth stimulation signal, wherein the second set of electrodes are configured to cause interferential stimulation in the brain and/or the nerve by a second interferential stimulation signal having the beat frequency, wherein the second interferential stimulation signal is formed through interference by the third frequency stimulation signal and the fourth frequency stimulation signal, with the invention of Zhang in order to cause stimulation of a first desired nerve/tissue/organ with the first beat impulse (Feinstein ¶[0034]) and to cause stimulation of a second desired nerve/tissue/organ with the second beat impulse (Feinstein ¶[0035]).
Although Zhang and Feinstein teach a first and second interferential stimulation signal, neither Zhang nor Feinstein teach that the processing unit is configured to determine a phase relation between the neural signal and the first stimulation signal and wherein the processing unit is further configured to control the second stimulation signal based on the determined phase relation.
Raike teaches that the processing unit is configured to determine a phase relation between the neural signal and the first stimulation signal (¶[0055], where “IMD 16 generates a plurality of electrical stimulation pulses and delivers the electrical stimulation pulses at a pulse frequency that is slightly less than that of the one or more oscillations, e.g., at 17 Hertz or 20 Hertz and 180 degrees (e.g., π radians) out of phase with the one or more oscillations. … the electrical stimulation may disrupt (e.g., destructively interfere with) at least a portion of the peaks of the oscillations of the bioelectrical brain signal a majority of the time. In some examples, modulating or shifting the frequency of the one or more pathologic oscillations may adjust or alter a relationship between the oscillations of the pathologic bioelectrical brain signals and oscillations of bioelectrical brain signals within other regions of the brain such that in a manner that suppresses one or more symptoms of a disease of the patient that result from the relationship.” Examiner interprets that the processing unit determines a phase relation between the neural signal and the first stimulation signal since the stimulation signals are designed to be out of phase with the bioelectrical brain signal and the relationship between the two is determined in order to have this relationship.) and wherein the processing unit is further configured to control the second stimulation signal based on the determined phase relation (¶[0055], where “In some examples, modulating or shifting the frequency of the one or more pathologic oscillations may adjust or alter a relationship between the oscillations of the pathologic bioelectrical brain signals and oscillations of bioelectrical brain signals within other regions of the brain such that in a manner that suppresses one or more symptoms of a disease of the patient that result from the relationship.” Examiner interprets that modulating the frequency controls the stimulation signal and that the modulation is based on the phase relation since a specific phase is sought. Additionally, since Feinstein teaches a second interferential stimulation signal, and Raike teaches modulation of the stimulation signal, the combination teaches control and adjustment of the second stimulation signal based on the phase relation.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Raike, which teaches that the processing unit is configured to determine a phase relation between the neural signal and the first stimulation signal and wherein the processing unit is further configured to control the second stimulation signal based on the determined phase relation, with the modified invention of Zhang in order to suppress one or more symptoms of a disease of the patient (Raike ¶[0055]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang and Raike as applied to claim 1 above, and further in view of Zhang et al. (hereinafter “Zhang ‘686”) (U.S. Pub. No. 2024/0216686 A1).
Regarding claim 11, Zhang in combination with Raike teaches all limitations of claim 1 as described in the rejection above.
Raike teaches a measurement unit with electrodes that is attached to the main stimulation unit (¶[0039], where “the sensing circuitry of IMD 16 may receive the bioelectrical signals from electrodes 24, 26 or other electrodes positioned to monitored brain signals of patient 12 … IMD 16 can also use separate sensing electrodes to sense the bioelectrical brain signals,” ¶[0061], where “Sensing circuitry 46 includes circuitry for determining a voltage difference between two electrodes 24, 26, which generally indicates the electrical activity within the particular region of brain 24”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Raike, which teaches a measurement unit with electrodes that is attached to the main stimulation unit, with the invention of Zhang in order to sense the bioelectrical brain signals (Raike ¶[0039]).
Neither Zhang nor Raike explicitly teaches the structure of a cuff electrode, where the set of electrodes and the measurement unit are arranged in one or more cuffs configured to be arranged around a nerve for providing stimulation of the nerve.
Zhang ‘686 teaches a noninvasive/minimally invasive neuromodulation system and method for providing therapy to a target neural tissue of a patient. In one arrangement, an example method comprises applying at least two input waveforms to respective pairs of electrodes affixed on the patient's skin or subcutaneously disposed relative to the target neural tissue, wherein the frequencies of the input waveforms are configured such that they combine, when simultaneously applied, to generate a beat waveform having a beat frequency due to interference (Abstract), and further teaches that the set of electrodes and the measurement unit are arranged in one or more cuffs configured to be arranged around a nerve for providing stimulation of the nerve (¶[0041], where “another independent variation may involve additional hardware such as nerve cuff electrodes that may be added to further assist in steering and shaping of the TTI activation region in a patient as a further refinement in field waveform engineering,” ¶[0053], where “one or more electrode pairs 722A-1/722B-1 may comprise subcutaneous electrode pairs, wherein either or both types of temporal interference may be effectuated to generate suitable beat waveforms. In still further variations, a cuff electrode arrangement may also be provided.” Examiner interprets that since the measurement unit of Raike is attached to the electrodes, where the electrodes are utilized to measure signals, and since the electrodes are cuff electrodes, that both the electrodes and measurement unit are arranged in a cuff.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Zhang ‘686, which teaches that the set of electrodes and the measurement unit are arranged in one or more cuffs configured to be arranged around a nerve for providing stimulation of the nerve, with the modified invention of Zhang in order to assist in steering and shaping of the TTI activation region in a patient as a further refinement in field waveform engineering (Zhang ‘686 ¶[0041]).
Claims 1 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Carroll (U.S. Pub. No. 2021/0138245 A1) in view of Raike.
Regarding claim 1, Carroll teaches a device for providing brain stimulation and/or nerve stimulation of a living being (Abstract, where “An example method for spinal cord stimulation treatment includes … transmitting signals through the first and second circuits that interfere to produce a first beat signal, transmitting signals through the third and fourth circuits that interfere to produce a second beat signal, and interaction of the first and second beat signals results in a combined beat signal proximate to and/or within the subject's spinal cord”), said device comprising:
a stimulation generating unit (¶[0033], where “FIG. 1 illustrates an example of an electrical stimulator 100 for spinal cord stimulation treatment, according to an example implementation. The electrical stimulator 100 includes an interferential current generator 102 which generates an interferential alternating current output,” ¶[0036], where “the interferential current generator 102 includes a pulse generator 116 that generates digital signal pulse”) configured to generate at least a first high frequency stimulation signal and a second high frequency stimulation signal for stimulating a brain and/or a nerve of the living being (¶[0033], where “electrical stimulator 100 includes an interferential current generator 102 which generates an interferential alternating current output comprising first signals 104,” ¶[0056], where “transmitting the first signals 104 through the first circuit 120 and the second circuit 122 includes transmitting signals having a base frequency of about 15 kHz on the first channel, and transmitting signals having a base frequency of about 10 kHz on the second channel.” Examiner interprets that the frequencies are high frequencies and Examiner would like to note that Applicant’s specification defines a high frequency as “at least 1 kHz or even larger” on Page 13.), wherein a difference between a first frequency of the first high frequency stimulation signal and a second frequency of the second high frequency stimulation signal defines a beat frequency (¶[0034], where “The first signals 104 are transmitted through the first circuit and the second circuit so that the first signals interfere with each other to produce a first beat signal”);
a set of electrodes (¶[0033], where “The electrical stimulator 100 also includes at least eight implantable electrodes 108”) configured to receive the first high frequency stimulation signal and the second high frequency stimulation signal (¶[0033], where “(i) a first circuit is created between a first electrode and a second electrode of the eight implantable electrodes on a first channel,” ¶[0034], where “The first signals 104 are transmitted through the first circuit and the second circuit so that the first signals interfere with each other to produce a first beat signal”) and configured to be arranged in relation to the brain and/or the nerve for transmitting the first high frequency stimulation signal and the second high frequency stimulation signal into the brain and/or the nerve (¶[0033], where “each electrode has a first and a second end. The first ends are coupled to the interferential current generator 102 and the second ends are configured to be implanted to a dura matter 110 in an epidural space 112 at predetermined locations proximate to a subject's spinal cord 114”), wherein the set of electrodes are configured to cause interferential stimulation in the brain and/or the nerve by an interferential stimulation signal having the beat frequency, wherein the interferential stimulation signal is formed through interference by the first high frequency stimulation signal and the second high frequency stimulation signal (¶[0033], where “(i) a first circuit is created between a first electrode and a second electrode of the eight implantable electrodes on a first channel,” ¶[0034], where “The first signals 104 are transmitted through the first circuit and the second circuit so that the first signals interfere with each other to produce a first beat signal”);
a processing unit (¶[0036], where “the interferential current generator 102 includes a pulse generator 116 that generates digital signal pulses, and a processor 118 connected to the pulse generator 116 that processes the digital signal pulses to approximate a sine-wave-like output waveform for the first signals 104”).
Although Carroll teaches a processing unit, Carroll does not teach a measurement unit, comprising at least two sensing electrodes, wherein the measurement unit is configured to acquire a measurement of at least a neural signal propagating in the brain and/or the nerve; nor that the processing unit is configured to receive the measurement from the measurement unit and configured to determine a phase relation between the neural signal and the interferential stimulation signal and configured to control brain stimulation and/or nerve stimulation based on the determined phase relation.
Raike teaches a measurement unit, comprising at least two sensing electrodes (¶[0039], where “the sensing circuitry of IMD 16 may receive the bioelectrical signals from electrodes 24, 26 or other electrodes positioned to monitored brain signals of patient 12 … IMD 16 can also use separate sensing electrodes to sense the bioelectrical brain signals,” ¶[0061], where “Sensing circuitry 46 includes circuitry for determining a voltage difference between two electrodes 24, 26, which generally indicates the electrical activity within the particular region of brain 24”), wherein the measurement unit is configured to acquire a measurement of at least a neural signal propagating in the brain and/or the nerve (¶[0039], where “Electrodes 24, 26 may … sense brain signals within brain 28. However, IMD 16 can also use separate sensing electrodes to sense the bioelectrical brain signals. In some examples, the sensing circuitry of IMD 16 may sense bioelectrical brain signals via one or more of the electrodes 24, 26”); and
a processing unit, configured to receive the measurement from the measurement unit (¶[0038], where “processing circuitry of IMD 16 may sense the bioelectrical signals within brain 28 of patient 12 and controls delivery of electrical stimulation therapy to brain 28,” ¶[0062], where “The output of sensing circuitry 46 may be received by processing circuitry 40. In some cases, processing circuitry 40 may apply additional processing to the bioelectrical signals, e.g., convert the output to digital values for processing and/or amplify the bioelectrical brain signal”) and configured to determine a phase relation between the neural signal and the stimulation signal and configured to control brain stimulation and/or nerve stimulation based on the determined phase relation (¶[0055], where “IMD 16 generates a plurality of electrical stimulation pulses and delivers the electrical stimulation pulses at a pulse frequency that is slightly less than that of the one or more oscillations, e.g., at 17 Hertz or 20 Hertz and 180 degrees (e.g., π radians) out of phase with the one or more oscillations. … the electrical stimulation may disrupt (e.g., destructively interfere with) at least a portion of the peaks of the oscillations of the bioelectrical brain signal a majority of the time. In some examples, modulating or shifting the frequency of the one or more pathologic oscillations may adjust or alter a relationship between the oscillations of the pathologic bioelectrical brain signals and oscillations of bioelectrical brain signals within other regions of the brain such that in a manner that suppresses one or more symptoms of a disease of the patient that result from the relationship.” Examiner interprets that modulating the frequency controls the stimulation and that the modulation is based on the phase relation since a specific phase is sought.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Raike, which teaches a measurement unit, comprising at least two sensing electrodes, wherein the measurement unit is configured to acquire a measurement of at least a neural signal propagating in the brain and/or the nerve nor a processing unit, configured to receive the measurement from the measurement unit and configured to determine a phase relation between the neural signal and the stimulation signal and configured to control brain stimulation and/or nerve stimulation based on the determined phase relation, with the invention of Carroll in order to sense the bioelectrical brain signals (Raike ¶[0039]) and to suppress one or more symptoms of a disease of the patient (Raike ¶[0055]).
Regarding claim 9, Carroll in combination with Raike teaches all limitations of claim 1 as described in the rejection above.
Carroll teaches that the stimulation generating unit is configured to generate a third high frequency stimulation signal and a fourth high frequency stimulation signal for stimulating a brain and/or a nerve of the living being (¶0033], where “The electrical stimulator 100 includes an interferential current generator 102 which generates an interferential alternating current output comprising … second signals 106,” ¶[0057], where “transmitting the second signals 106 through the third circuit 124 and the fourth circuit 126 includes transmitting signals having a base frequency of about 20 kHz on the third channel, and transmitting signals having a base frequency of about 14.9 kHz on the fourth channel.” Examiner interprets that the frequencies are high frequencies and Examiner would like to note that Applicant’s specification defines a high frequency as “at least 1 kHz or even larger” on Page 13), wherein a difference between a third frequency of the third high frequency stimulation signal and a fourth frequency of the fourth high frequency stimulation signal defines a beat frequency (¶[0034], where “the second signals 106 are transmitted through the third circuit and the fourth circuit so that the second signals interfere with each other to produce a second beat signal”);
wherein the set of electrodes comprises a first sub-set of electrodes (¶[0033], where “The electrical stimulator 100 also includes at least eight implantable electrodes 108, and each electrode has a first and a second end … (i) a first circuit is created between a first electrode and a second electrode of the eight implantable electrodes on a first channel”) configured to receive the first high frequency stimulation signal and the second high frequency stimulation signal (¶[0033], where “(i) a first circuit is created between a first electrode and a second electrode of the eight implantable electrodes on a first channel,” ¶[0034], where “The first signals 104 are transmitted through the first circuit and the second circuit so that the first signals interfere with each other to produce a first beat signal”) and configured to be arranged at a first location in relation to the brain and/or the nerve (¶[0033], where “each electrode has a first and a second end. The first ends are coupled to the interferential current generator 102 and the second ends are configured to be implanted to a dura matter 110 in an epidural space 112 at predetermined locations proximate to a subject's spinal cord 114.” Examiner interprets that since Carroll teaches a first sub-set of electrodes that the electrodes of the first sub-set are inherently arranged at a first location in relation to the brain and/or nerve in order to stimulate the proper area.) for causing interferential stimulation by a first interferential stimulation signal forming said interferential signal (¶[0033], where “(i) a first circuit is created between a first electrode and a second electrode of the eight implantable electrodes on a first channel,” ¶[0034], where “The first signals 104 are transmitted through the first circuit and the second circuit so that the first signals interfere with each other to produce a first beat signal”),
and wherein the device further comprises a second sub-set of electrodes (¶[0033], where “The electrical stimulator 100 also includes at least eight implantable electrodes 108, and each electrode has a first and a second end ... (ii) a second circuit is created between a third electrode and a fourth electrode of the eight implantable electrodes on a second channel”) configured to receive the third high frequency stimulation signal and the fourth stimulation signal (¶[0033], where “The electrical stimulator 100 also includes at least eight implantable electrodes 108, and each electrode has a first and a second end ... (ii) a second circuit is created between a third electrode and a fourth electrode of the eight implantable electrodes on a second channel,” ¶[0034], where “the second signals 106 are transmitted through the third circuit and the fourth circuit so that the second signals interfere with each other to produce a second beat signal”) and configured to be arranged at a second location different from the first location in relation to the brain and/or the nerve for transmitting the third high frequency stimulation signal and the fourth high frequency stimulation signal into the brain and/or the nerve (¶[0033], where “each electrode has a first and a second end. The first ends are coupled to the interferential current generator 102 and the second ends are configured to be implanted to a dura matter 110 in an epidural space 112 at predetermined locations proximate to a subject's spinal cord 114.” Examiner interprets that the second subset is arranged at a different location from the first subset since each subset contains different electrodes and since the two subsets cannot occupy the same space.), wherein the second set of electrodes are configured to cause interferential stimulation in the brain and/or the nerve by a second interferential stimulation signal having the beat frequency (¶[0033, where “The electrical stimulator 100 also includes at least eight implantable electrodes 108, and each electrode has a first and a second end ... (ii) a second circuit is created between a third electrode and a fourth electrode of the eight implantable electrodes on a second channel,” ¶[0034], where “the second signals 106 are transmitted through the third circuit and the fourth circuit so that the second signals interfere with each other to produce a second beat signal”), wherein the second interferential stimulation signal is formed through interference by the third high frequency stimulation signal and the fourth high frequency stimulation signal (¶[0034], where “the second signals 106 are transmitted through the third circuit and the fourth circuit so that the second signals interfere with each other to produce a second beat signal”).
Although Carroll teach a first and second interferential stimulation signal and a processing unit, Carroll does not teach that the processing unit is configured to determine a phase relation between the neural signal and the first stimulation signal and wherein the processing unit is further configured to control the second stimulation signal based on the determined phase relation.
Raike teaches that the processing unit is configured to determine a phase relation between the neural signal and the first stimulation signal (¶[0055], where “IMD 16 generates a plurality of electrical stimulation pulses and delivers the electrical stimulation pulses at a pulse frequency that is slightly less than that of the one or more oscillations, e.g., at 17 Hertz or 20 Hertz and 180 degrees (e.g., π radians) out of phase with the one or more oscillations. … the electrical stimulation may disrupt (e.g., destructively interfere with) at least a portion of the peaks of the oscillations of the bioelectrical brain signal a majority of the time. In some examples, modulating or shifting the frequency of the one or more pathologic oscillations may adjust or alter a relationship between the oscillations of the pathologic bioelectrical brain signals and oscillations of bioelectrical brain signals within other regions of the brain such that in a manner that suppresses one or more symptoms of a disease of the patient that result from the relationship.” Examiner interprets that the processing unit determines a phase relation between the neural signal and the first stimulation signal since the stimulation signals are designed to be out of phase with the bioelectrical brain signal and the relationship between the two is determined in order to have this relationship.) and wherein the processing unit is further configured to control the second stimulation signal based on the determined phase relation (¶[0055], where “In some examples, modulating or shifting the frequency of the one or more pathologic oscillations may adjust or alter a relationship between the oscillations of the pathologic bioelectrical brain signals and oscillations of bioelectrical brain signals within other regions of the brain such that in a manner that suppresses one or more symptoms of a disease of the patient that result from the relationship.” Examiner interprets that modulating the frequency controls the stimulation signal and that the modulation is based on the phase relation since a specific phase is sought. Additionally, since Carroll teaches a second interferential stimulation signal, and Raike teaches modulation of the stimulation signal, the combination teaches control and adjustment of the second stimulation signal based on the phase relation.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Raike, which teaches that the processing unit is configured to determine a phase relation between the neural signal and the first stimulation signal and wherein the processing unit is further configured to control the second stimulation signal based on the determined phase relation, with the invention of Carroll in order to suppress one or more symptoms of a disease of the patient (Raike ¶[0055]).
Regarding claim 10, Carroll in combination with Raike teaches all limitations of claim 9 as described in the rejection above.
Carroll teaches that the processing unit is configured to control the second interferential stimulation signal (¶[0036], where “the interferential current generator 102 includes a pulse generator 116 that generates digital signal pulses, and a processor 118 connected to the pulse generator 116 that processes the digital signal pulses to approximate a sine-wave-like output waveform for the first signals 104 and the second signals 106 … processor 118 then transmits the sine-wave-like output waveform as the first signals 104 and the second signals 106,” ¶[0046], where “second signals 106 are transmitted through the third circuit 124 and the fourth circuit 126 so that the second signals 106 interfere with each other to produce a second beat signal 132.” Examiner interprets that since the processor controls the second signal output that the processor is configured to control the second interferential signal.) for controlling blocking or strengthening a neural signal triggered by the first interferential stimulation signal (¶[0045], where “The first signals 104 are transmitted through the first circuit 120 and the second circuit 122 so that the first signals 104 interfere with each other to produce a first beat signal 130,” ¶[0046], where “The second signals 106 are transmitted through the third circuit 124 and the fourth circuit 126 so that the second signals 106 interfere with each other to produce a second beat signal 132,” ¶[0048], where “where the first circuit 120 and the second circuit 122 superimpose or overlap (and where the third circuit 124 and the fourth circuit 126 overlap), the resultant first beat signal 130 (and the second beat signal 132) will be the difference between the frequencies of the two circuits and the amplitude will be additive and greater than either circuit alone,” ¶[0053], where “the eight implantable electrodes 108a-h are implanted proximal to the spinal cord, and interaction of the first beat signal 130 and the second beat signal 132 results in a combined beat signal 134 proximate to the subject's spinal cord 114”).
Conclusion
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/SEFRA D. MANOS/Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796