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 .
Response to Pre-Appeal Brief Conference Request
This Office Action is responsive to the Pre-Appeal Brief Conference Request filed 29 Oct 2025. Prosecution is reopened. Thus, claims 1-20 filed on 24 Apr 2025 are presently pending in this application.
Applicant’s arguments, see Pre-Appeal Brief Conference Request, filed 29 Oct 2025, with respect to the rejection(s) of claims 1, 17, and 20 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, new grounds of rejection are made in view of Clark et al. (US 20180154156 A1), hereinafter Clark, and Schepis et al. (US 20200179697 A1), hereinafter Schepis.
Regarding claims 1, 17, and 20, Applicant argues that “Zhang does not show or suggest, among other things, ‘identifying an electrode configuration that, when used to deliver neuromodulation to the target peripheral nerve, stimulates fibers from an inhibitory surround receptive field’ and ‘delivering sub-perception therapy for the identified electrode configuration’ as recited in claims 1, 17, and
20” (Pre-Appeal Brief Request For Review, page 1). Examiner agrees, as Zhang discloses a spinal cord stimulation system, and does not disclose stimulation of a peripheral nerve.
However, as explained in further detail below, Clark et al. (US 20180154156 A1), hereinafter Clark the method recited in claims 1, 17, and 20.
Dependent claims 2-16 and 18-19 are also rejected under 35 U.S.C. 102 and 103, as explained in further detail below.
Claim Objections
Claims 4 and 10 are objected to because of the following informalities:
Claim 4: “a threshold amplitude” in line 1 should read “the threshold amplitude”.
Claim 10: “from features the evoked neural response” should read “from features in the evoked neural response”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 9-12 and 16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 9 recites “an algorithm to distinguish between stimulation of fibers from a center receptive field or the inhibitory surround receptive field based on a relation among patient sensation, pain, and the evoked neural response including features in the evokes neural response”. Claims 10-12 disclose that “the algorithm is configured to infer” that the fibers are stimulated based on various features in the received inputs. Claim 16 recites “an algorithm to distinguish between stimulation of fibers from a center receptive field or the inhibitory surround receptive field based on the patient input and the evoked neural response”. The specification mentions these algorithms in paragraphs [0014]-[0017], [0030]-[0033], [0037], and [0099], but does not describe how the algorithms accomplish the required tasks. Because the specification does not explain the algorithms in detail, claims 9-12 and 16 lack written description per MPEP 2161.01(I).
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-3, 9-12, and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 2 and 18 recite “a process to identify a neuromodulation configuration that stimulates the fibers from the inhibitory surround receptive field around a localized pain region”, which is indefinite because the process is not described in the claims. The process is described by its results, not by how the process achieves the claimed results. For the purposes of examination, claim 9 will be interpreted as “The method of claim 1, wherein identifying the electrode configuration that stimulates the fibers from the inhibitory surround receptive field around a localized pain region includes delivering neuromodulation energy, and wherein the identified neuromodulation configuration includes: waveform parameters, and the identified electrode configuration.”
Claim 3 is also rejected because it is dependent on claim 2.
Claim 9 recites “an algorithm to distinguish between stimulation of fibers”, which is indefinite because the algorithm is not described in the claim. The algorithm is defined by its results, not by how the algorithm achieves the claimed results.
Claims 10-12 are also rejected because they are dependent on claim 9.
Claim 10 recites “wherein the algorithm is configured to infer from an overlap in the patient sensation and the pain and from features of the evoked neural response”. It is unclear what is being inferred from the patient sensation, pain, and features of the evoked neural response. For the purposes of examination, this limitation will be interpreted as “wherein the algorithm is configured to distinguish between stimulation of fibers from the center receptive field or the inhibitory surround receptive field based on an overlap in the patient sensation and the pain and from features of the evoked neural response”.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 9, 16-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Clark et al. (US 20180154156 A1), hereinafter Clark, in view of Schepis et al. (US 20200179697 A1), hereinafter Schepis.
Regarding claim 1, Clark discloses a method performed using a plurality of neuromodulation electrode contacts (Fig. 3, paragraph [0048], electrodes 334) configured and arranged for use in delivering neuromodulation to a target peripheral nerve (paragraph [0048], "the cuff 350 permits stimulation of a target nerve (not shown), for example a peripheral nerve"; paragraph [0076]), wherein the plurality of neuromodulation electrode contacts is configurable into a plurality of electrode configurations (paragraphs [0082]-[0083], “Any other suitable selection of the initial set of electrode combinations can be used … It will be recognized that other selections of electrode combinations can be made”), the method comprising:
identifying an electrode configuration (Fig. 6, paragraphs [0079]-[0080], step 604; paragraphs [0103]-[0105], step 610) that produces beneficial stimulation or side effects (paragraph [0079]);
identifying a threshold amplitude (paragraphs [0081], [0084]-[0085]; Fig. 6, paragraph [0087], step 606; paragraphs [0099]-[0101], step 608) corresponding to a perception threshold (paragraph [0084], "Examples of stop criteria include, but are not limited to, a side effect is observed, the beneficial impact of the therapy has plateaued, a tolerance is reached or exceeded"; paragraph [0085], "when the therapy becomes uncomfortable (e.g., produces a discomfort side effect above a subjective threshold.)"), a motor or an EMG threshold (paragraph [0075], "muscle electrical potentials"), or an evoked neural threshold (paragraph [0075], "nerve action potentials") for the identified electrode configuration; and
delivering sub-perception therapy for the identified electrode configuration using a therapeutic amplitude that is set based on the threshold amplitude (Fig. 6, paragraph [0108], step 618).
Although Clark discloses that “Multi-electrode leads may enable greater selectivity of nerve fibers which may be modulated, for example, by using current steering to target areas of nerve bundles” (paragraph [0065]), Clark does not explicitly disclose that the plurality of neuromodulation electrode contacts is configurable into a plurality of electrode configurations for stimulating different subsets of fibers within a plurality of fibers of the target peripheral nerve. Clark also does not explicitly disclose that the identified electrode configuration stimulates fibers from an inhibitory surround receptive field.
However, Schepis teaches a device and method to selectively and reversibly modulate targeted neural- and non-neural tissue of a nervous structure by the application of an electrical signal to inhibit pain while preserving other sensory and motor function, and proprioception (paragraph [0131]). Schepis teaches targeting peripheral nerves (paragraph [0134]) that include a plurality of fibers (paragraph [0136], “Peripheral nerve axons which generally transmit information from the periphery toward the central nervous system (e.g. sensory information including pain) are often referred to as afferent fibers, while axons which generally transmit information from the central nervous system toward the periphery (e.g. motor information) are often referred to as efferent fibers”). Schepis further teaches that the plurality of electrode configurations can stimulate different subsets of fibers within the plurality of fibers (paragraph [0147]). Schepis further teaches identifying an electrode configuration that, when used to deliver the neuromodulation to the target peripheral nerve, stimulates fibers from an inhibitory surround receptive field (paragraph [0149], “the electrical signal disrupts the transmission of pain signals that originate in the periphery from reaching the brain by inhibiting nerve signal transmission through nerve fibers that are responsible for the transmission of pain. This … can be achieved by indirect inhibition of other downstream neurons responsible for transmitting pain signals to the brain, such as neurons of the central nervous system (e.g. spinal cord and the brain)”; paragraph [0159], “For example, where the targeted nervous structure is a large peripheral nerve, e.g., a nerve having a diameter greater than about 2.5 mm, the electrical stimulation can modulate activity or function of neural or non-neural tissues which results in activation of a bio-chemical signaling cascade which causes a decrease in activation of spinal or cortical neurons representing pain (for example, via modulation of synaptic signaling)”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Clark with the teachings of Schepis so that the targeted peripheral nerve includes a plurality of fibers, the plurality of electrode configurations is for stimulating different subsets of fibers within the plurality of fibers, and the method includes identifying an electrode configuration that, when used to deliver the neuromodulation to the target peripheral nerve, stimulates fibers from an inhibitory surround receptive field, because doing so preserves the function of central nervous system and peripheral nervous system neurons involved in detection, transmission, processing, and generation of non-painful touch, motor control, and proprioception (Schepis, paragraph [0159]).
Regarding claim 2, the method of claim 1 is obvious over Clark and Schepis, as explained above. Clark further discloses that identifying the electrode configuration (Fig. 6, paragraphs [0079]-[0080], step 604; paragraphs [0103]-[0105], step 610) includes delivering neuromodulation energy in a process to identify a neuromodulation configuration that stimulates the fibers from the inhibitory surround receptive field around a localized pain region (paragraph [0084], "At each stimulation amplitude, the presence or absence (and, optionally, quantitative or subjective level) of a beneficial stimulation effect, side effect(s), or both may be determined"), wherein the identified neuromodulation configuration includes: waveform parameters (paragraph [0084], stimulation amplitude), and the identified electrode configuration (paragraph [0084], "Each electrode combination is tested with one electrode acting as the anode and the other electrode acting as the cathode. In at least some embodiments, the electrode combination may be tested at different stimulation amplitudes.").
Regarding claim 3, Clark discloses the method of claim 2, as explained above. Clark further discloses independently controlling current to each of the plurality of neuromodulation electrode contacts to control fractionalized current contributions to individual electrode contacts within the identified electrode configuration (paragraph [0077], "A multi-electrode lead with multiple independent current control, offers the capability to target specific locations within a structure"; paragraph [0103], "the anodic or cathodic current could be distributed between two or more electrodes where the division between electrodes can be equal (e.g., 50% on each) or unequal (e.g., split 10%/90%; 20%/80%; 33%/67%; 33%/33%/33%; or any other arrangement.)").
Regarding claim 4, the method of claim 1 is obvious over Clark and Schepis, as explained above. Clark further discloses that identifying the threshold amplitude includes performing a threshold process, wherein the threshold process includes:
stepping up the adjustable amplitude until a neural response is evoked or suppressed (paragraph [0084], "the electrode combination may be tested at different stimulation amplitudes. For example, the stimulation amplitude may be stepped up from an initial value by regular (or irregular) increments. At each stimulation amplitude, the presence or absence (and, optionally, quantitative or subjective level) of a beneficial stimulation effect, side effect(s), or both may be determined. ... the stimulation amplitude is increased until a stop criterion is met. Examples of stop criteria include, but are not limited to, a side effect is observed, the beneficial impact of the therapy has plateaued, a tolerance is reached or exceeded"; paragraphs [0081], [0084]-[0085]); or
stepping up the adjustable amplitude until a muscle twitch or an EMG signal is evoked or suppressed (paragraph [0084], "At each stimulation amplitude, the presence or absence (and, optionally, quantitative or subjective level) of a beneficial stimulation effect, side effect(s), or both may be determined."; paragraph [0096], "Alternatively or additionally, one or more physiological responses (for example, measured using one or more of the sensors described above) can be monitored or observed."; paragraph [0075], "Examples of physiological or other responses that can be measured or observed include ... muscle electrical potential, ... accelerometer measurements (e.g., to observe epilepsy, Parkinsonism, or tremor), posture, gait").
Regarding claim 9, the method of claim 1 is obvious over Clark and Schepis, as explained above. Clark further discloses that identifying the electrode configuration includes:
applying super-perception neuromodulation (paragraph [0085], "each of the electrode combinations (twenty electrode combinations in the illustrated example) is sequentially tested with the stimulation amplitude increasing incrementally");
receiving patient input regrading paresthesia and pain (paragraph [0085], "For each electrode combination, the user taps the button 882 when the therapy becomes uncomfortable (e.g., produces a discomfort side effect above a subjective threshold.)").
receiving input regarding evoked neural response in fibers of the peripheral nerve (paragraph [0075], "Examples of physiological or other responses that can be measured or observed include, but are not limited to, muscle electrical potentials, nerve action potentials").
Clark does not explicitly disclose implementing an algorithm to distinguish between stimulation of fibers from the center receptive field or the inhibitory surround receptive field based on a relation among patient sensation, pain, and the evoked neural response including features in the evoked neural response.
However, Schepis further teaches that the method distinguishes between stimulation of fibers from the inhibitory surround receptive field based on a relation among patient sensation, pain, and the evoked neural response including features in the evoked neural response (paragraph [0243], “the control and/or operation of the controller 130 can be adjusted varying a parameter of the electrical stimulation based on a measured feedback of the inhibition of nerve signal transmission (e.g., confirmation of no or limited nerve signal transmission from/through the target nerve), and/or a measured feedback of the temperature at the treatment site, and/or feedback from the patient regarding pain perception. Confirmation of no/limited nerve signal transmission can be achieved via intraoperative monitoring techniques including, for example, recorded EMG, direct neural recordings that demonstrate pain fiber response change in latency and/or amplitude or burst area.”; paragraph [0160], “at least one parameter of the electrical stimulation can be adjusted to differentially inhibit downstream or secondary effects of pain originating from myelinated Aδ fibers such that the downstream or secondary effects from myelinated Aδ fibers are inhibited to a greater extent than the downstream or secondary effects from unmyelinated C fibers.”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Clark and Schepis with the teachings of Schepis so that the method distinguishes between stimulation of fibers from the inhibitory surround receptive field based on a relation among patient sensation, pain, and the evoked neural response including features in the evoked neural response, because doing so preserves the function of central nervous system and peripheral nervous system neurons involved in detection, transmission, processing, and generation of non-painful touch, motor control, and proprioception (Schepis, paragraph [0159]).
Regarding claim 16, the method of claim 1 is obvious over Clark and Schepis, as explained above. Clark further discloses that identifying the electrode configuration includes:
applying neuromodulation (paragraph [0085], "each of the electrode combinations (twenty electrode combinations in the illustrated example) is sequentially tested with the stimulation amplitude increasing incrementally");
receiving patient input regarding pain (paragraph [0085], "For each electrode combination, the user taps the button 882 when the therapy becomes uncomfortable (e.g., produces a discomfort side effect above a subjective threshold.)"); and
receiving input regarding a motor or electromyogram response or an evoked neural response in fibers of the peripheral nerve (paragraph [0075], "Examples of physiological or other responses that can be measured or observed include, but are not limited to, muscle electrical potentials, nerve action potentials").
Clark does not explicitly disclose implementing an algorithm to distinguish between stimulation of fibers from the center receptive field or the inhibitory surround receptive field based on a relation among patient sensation, pain, and the evoked neural response including features in the evoked neural response.
However, Schepis further teaches that the method distinguishes between stimulation of fibers from the inhibitory surround receptive field based on the patient input and the evoked neural response (paragraph [0243], “the control and/or operation of the controller 130 can be adjusted varying a parameter of the electrical stimulation based on a measured feedback of the inhibition of nerve signal transmission (e.g., confirmation of no or limited nerve signal transmission from/through the target nerve), and/or a measured feedback of the temperature at the treatment site, and/or feedback from the patient regarding pain perception. Confirmation of no/limited nerve signal transmission can be achieved via intraoperative monitoring techniques including, for example, recorded EMG, direct neural recordings that demonstrate pain fiber response change in latency and/or amplitude or burst area.”; paragraph [0160], “at least one parameter of the electrical stimulation can be adjusted to differentially inhibit downstream or secondary effects of pain originating from myelinated Aδ fibers such that the downstream or secondary effects from myelinated Aδ fibers are inhibited to a greater extent than the downstream or secondary effects from unmyelinated C fibers.”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Clark and Schepis with the teachings of Schepis so that the method distinguishes between stimulation of fibers from the inhibitory surround receptive field based on a relation among patient sensation, pain, and the evoked neural response including features in the evoked neural response, because doing so preserves the function of central nervous system and peripheral nervous system neurons involved in detection, transmission, processing, and generation of non-painful touch, motor control, and proprioception (Schepis, paragraph [0159]).
Regarding claim 17, Clark discloses a non-transitory machine-readable medium including instructions (Fig. 5, paragraph [0071], memory 504; paragraphs [0118]-[0119]), which when executed by a machine, cause the machine to perform a method using a plurality of neuromodulation electrode contacts (Fig. 3, paragraph [0048], electrodes 334) configured and arranged for use in delivering neuromodulation to a target peripheral nerve (paragraph [0048], "the cuff 350 permits stimulation of a target nerve (not shown), for example a peripheral nerve"; paragraph [0076]), wherein the plurality of neuromodulation electrode contacts is configurable into a plurality of electrode configurations (paragraphs [0082]-[0083], “Any other suitable selection of the initial set of electrode combinations can be used … It will be recognized that other selections of electrode combinations can be made”), the method comprising:
identifying an electrode configuration (Fig. 6, paragraphs [0079]-[0080], step 604; paragraphs [0103]-[0105], step 610) that produces beneficial stimulation or side effects (paragraph [0079]);
identifying a threshold amplitude (paragraphs [0081], [0084]-[0085]; Fig. 6, paragraph [0087], step 606; paragraphs [0099]-[0101], step 608) corresponding to a perception threshold (paragraph [0084], "Examples of stop criteria include, but are not limited to, a side effect is observed, the beneficial impact of the therapy has plateaued, a tolerance is reached or exceeded"; paragraph [0085], "when the therapy becomes uncomfortable (e.g., produces a discomfort side effect above a subjective threshold.)"), a motor or an EMG threshold (paragraph [0075], "muscle electrical potentials"), or an evoked neural threshold (paragraph [0075], "nerve action potentials") for the identified electrode configuration; and
delivering sub-perception therapy for the identified electrode configuration using a therapeutic amplitude that is set based on the threshold amplitude (Fig. 6, paragraph [0108], step 618).
Although Clark discloses that “Multi-electrode leads may enable greater selectivity of nerve fibers which may be modulated, for example, by using current steering to target areas of nerve bundles” (paragraph [0065]), Clark does not explicitly disclose that the plurality of neuromodulation electrode contacts is configurable into a plurality of electrode configurations for stimulating different subsets of fibers within a plurality of fibers of the target peripheral nerve. Clark also does not explicitly disclose that the identified electrode configuration stimulates fibers from an inhibitory surround receptive field.
However, Schepis teaches a device and method to selectively and reversibly modulate targeted neural- and non-neural tissue of a nervous structure by the application of an electrical signal to inhibit pain while preserving other sensory and motor function, and proprioception (paragraph [0131]). Schepis teaches targeting peripheral nerves (paragraph [0134]) that include a plurality of fibers (paragraph [0136], “Peripheral nerve axons which generally transmit information from the periphery toward the central nervous system (e.g. sensory information including pain) are often referred to as afferent fibers, while axons which generally transmit information from the central nervous system toward the periphery (e.g. motor information) are often referred to as efferent fibers”). Schepis further teaches that the plurality of electrode configurations can stimulate different subsets of fibers within the plurality of fibers (paragraph [0147]). Schepis further teaches identifying an electrode configuration that, when used to deliver the neuromodulation to the target peripheral nerve, stimulates fibers from an inhibitory surround receptive field (paragraph [0149], “the electrical signal disrupts the transmission of pain signals that originate in the periphery from reaching the brain by inhibiting nerve signal transmission through nerve fibers that are responsible for the transmission of pain. This … can be achieved by indirect inhibition of other downstream neurons responsible for transmitting pain signals to the brain, such as neurons of the central nervous system (e.g. spinal cord and the brain)”; paragraph [0159], “For example, where the targeted nervous structure is a large peripheral nerve, e.g., a nerve having a diameter greater than about 2.5 mm, the electrical stimulation can modulate activity or function of neural or non-neural tissues which results in activation of a bio-chemical signaling cascade which causes a decrease in activation of spinal or cortical neurons representing pain (for example, via modulation of synaptic signaling)”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Clark with the teachings of Schepis so that the targeted peripheral nerve includes a plurality of fibers, the plurality of electrode configurations is for stimulating different subsets of fibers within the plurality of fibers, and the method includes identifying an electrode configuration that, when used to deliver the neuromodulation to the target peripheral nerve, stimulates fibers from an inhibitory surround receptive field, because doing so preserves the function of central nervous system and peripheral nervous system neurons involved in detection, transmission, processing, and generation of non-painful touch, motor control, and proprioception (Schepis, paragraph [0159]).
Regarding claim 18, the non-transitory machine-readable medium of claim 17 is obvious over Clark and Schepis, as explained above. Clark further discloses that identifying the electrode configuration (Fig. 6, paragraphs [0079]-[0080], step 604; paragraphs [0103]-[0105], step 610) includes delivering neuromodulation energy in a process to identify a neuromodulation configuration that stimulates the fibers from the inhibitory surround receptive field around a localized pain region (paragraph [0084], "At each stimulation amplitude, the presence or absence (and, optionally, quantitative or subjective level) of a beneficial stimulation effect, side effect(s), or both may be determined"), wherein the identified neuromodulation configuration includes: waveform parameters (paragraph [0084], stimulation amplitude), and the identified electrode configuration (paragraph [0084], "Each electrode combination is tested with one electrode acting as the anode and the other electrode acting as the cathode. In at least some embodiments, the electrode combination may be tested at different stimulation amplitudes.").
Regarding claim 20, Clark discloses a system (Figs. 1 and 5, systems 100 and 500), comprising:
a plurality of neuromodulation electrode contacts (Fig. 3, paragraph [0048], electrodes 334) configured and arranged for use in delivering neuromodulation to a target peripheral nerve (paragraph [0048], "the cuff 350 permits stimulation of a target nerve (not shown), for example a peripheral nerve"; paragraph [0076]), wherein the plurality of neuromodulation electrode contacts is configurable into a plurality of electrode configurations (paragraphs [0082]-[0083], “Any other suitable selection of the initial set of electrode combinations can be used … It will be recognized that other selections of electrode combinations can be made”);
a waveform generator configured for use to generate neuromodulation energy (Fig. 1, paragraph [0033], stimulation circuitry 110); and
a controller (Fig. 1, paragraph [0031], control module 102) configured for use for:
identifying an electrode configuration (Fig. 6, paragraphs [0079]-[0080], step 604; paragraphs [0103]-[0105], step 610) that produces beneficial stimulation or side effects (paragraph [0079]);
identifying a threshold amplitude (paragraphs [0081], [0084]-[0085]; Fig. 6, paragraph [0087], step 606; paragraphs [0099]-[0101], step 608) corresponding to a perception threshold (paragraph [0084], "Examples of stop criteria include, but are not limited to, a side effect is observed, the beneficial impact of the therapy has plateaued, a tolerance is reached or exceeded"; paragraph [0085], "when the therapy becomes uncomfortable (e.g., produces a discomfort side effect above a subjective threshold.)"), a motor or an EMG threshold (paragraph [0075], "muscle electrical potentials"), or an evoked neural threshold (paragraph [0075], "nerve action potentials") for the identified electrode configuration; and
delivering sub-perception therapy for the identified electrode configuration using a therapeutic amplitude that is set based on the threshold amplitude (Fig. 6, paragraph [0108], step 618).
Although Clark discloses that “Multi-electrode leads may enable greater selectivity of nerve fibers which may be modulated, for example, by using current steering to target areas of nerve bundles” (paragraph [0065]), Clark does not explicitly disclose that the plurality of neuromodulation electrode contacts is configurable into a plurality of electrode configurations for stimulating different subsets of fibers within a plurality of fibers of the target peripheral nerve. Clark also does not explicitly disclose that the identified electrode configuration stimulates fibers from an inhibitory surround receptive field.
However, Schepis teaches a device and method to selectively and reversibly modulate targeted neural- and non-neural tissue of a nervous structure by the application of an electrical signal to inhibit pain while preserving other sensory and motor function, and proprioception (paragraph [0131]). Schepis teaches targeting peripheral nerves (paragraph [0134]) that include a plurality of fibers (paragraph [0136], “Peripheral nerve axons which generally transmit information from the periphery toward the central nervous system (e.g. sensory information including pain) are often referred to as afferent fibers, while axons which generally transmit information from the central nervous system toward the periphery (e.g. motor information) are often referred to as efferent fibers”). Schepis further teaches that the plurality of electrode configurations can stimulate different subsets of fibers within the plurality of fibers (paragraph [0147]). Schepis further teaches identifying an electrode configuration that, when used to deliver the neuromodulation to the target peripheral nerve, stimulates fibers from an inhibitory surround receptive field (paragraph [0149], “the electrical signal disrupts the transmission of pain signals that originate in the periphery from reaching the brain by inhibiting nerve signal transmission through nerve fibers that are responsible for the transmission of pain. This … can be achieved by indirect inhibition of other downstream neurons responsible for transmitting pain signals to the brain, such as neurons of the central nervous system (e.g. spinal cord and the brain)”; paragraph [0159], “For example, where the targeted nervous structure is a large peripheral nerve, e.g., a nerve having a diameter greater than about 2.5 mm, the electrical stimulation can modulate activity or function of neural or non-neural tissues which results in activation of a bio-chemical signaling cascade which causes a decrease in activation of spinal or cortical neurons representing pain (for example, via modulation of synaptic signaling)”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Clark with the teachings of Schepis so that the targeted peripheral nerve includes a plurality of fibers, the plurality of electrode configurations is for stimulating different subsets of fibers within the plurality of fibers, and the method includes identifying an electrode configuration that, when used to deliver the neuromodulation to the target peripheral nerve, stimulates fibers from an inhibitory surround receptive field, because doing so preserves the function of central nervous system and peripheral nervous system neurons involved in detection, transmission, processing, and generation of non-painful touch, motor control, and proprioception (Schepis, paragraph [0159]).
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Clark et al. (US 20180154156 A1), hereinafter Clark, in view of Schepis et al. (US 20200179697 A1), hereinafter Schepis, and further in view of Esteller et al. (US 20190209844 A1, previously cited), hereinafter Esteller.
Regarding claim 5, the method of claim 1 is obvious over Clark and Schepis, as explained above. Clark further discloses that identifying the electrode configuration includes:
using sensing electrode contacts (paragraph [0075], "at least one of the sensors 518 is part of the electrical stimulation system, for example, a sensor (e.g., an electrode) disposed on the lead 516 or within the control module 514 or a sensor coupled to the control module 514 through another lead or the like") to sense evoked neural responses (paragraph [0075], "Examples of physiological or other responses that can be measured or observed include, but are not limited to, muscle electrical potentials, nerve action potentials"), and
recording data corresponding to the sensed evoked neural responses (paragraph [0075], "The one or more sensors 518 can be any suitable sensor for measuring or observing physiological or other responses to the stimulation").
Clark does not explicitly disclose that the sensing electrode contacts are configurable into a plurality of sensing configurations for sensing evoked neural responses in different subsets of fibers within the plurality of fibers.
However, Esteller teaches a method for measuring evoked neural responses and using them to maintain and adjust therapy (Abstract) wherein the sensing electrode contacts are configurable into a plurality of sensing configurations (paragraph [0079]), and wherein identifying the electrode configuration includes recording data corresponding to the received electrical signal (paragraphs [0009], [0042], [0084], [0088]-[0091]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Clark and Schepis with the teachings of Esteller so that the sensing electrode contacts are configurable into a plurality of sensing configurations for sensing evoked neural responses in different subsets of fibers within the plurality of fibers, and that the identifying the electrode configuration includes recording data corresponding to the received electrical signal, because doing so enables an understanding of which neurons are being recruited and the ability to activate different neural fiber types, thus allowing more accurate and effective adjustment of neuromodulation therapy (Esteller, paragraph [0064]).
Regarding claim 6, the method of claim 5 is obvious over Clark, Schepis, and Esteller, as explained above. Clark further discloses receiving a sensory input from a patient (paragraph [0085], "For each electrode combination, the user taps the button 882 when the therapy becomes uncomfortable (e.g., produces a discomfort side effect above a subjective threshold.)").
Clark does not explicitly disclose that the sensing electrode contacts are configured for sensing evoked responses on different sides of the peripheral nerve or distinct branches of the peripheral nerve, and that the method further comprises: displaying the sensed evoked responses and the received sensory input on a user interface.
However, Esteller further teaches that the sensing electrode contacts are configured for sensing evoked responses on different sides of the peripheral nerve or distinct branches of the peripheral nerve (paragraphs [0046], [0060]), and that the method further comprises:
receiving a sensory input from a patient (paragraph [0078], "the patient may find that their perception of the stimulation has changed and the patient can now perceive the stimulation at a particular body position"); and
displaying the sensed evoked responses and the received sensory input on a user interface (paragraph [0078], "The user ... is presented with a user interface, ... which is configured to present the user with a representation of the electrical signals sensed at the various available implanted electrodes (channels)").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Clark and Schepis with the teachings of Esteller so that the sensing electrode contacts are configured for sensing evoked responses on different sides of the peripheral nerve or distinct branches of the peripheral nerve, and that the method further comprises: displaying the sensed evoked responses and the received sensory input on a user interface, because doing so enables the user to recalibrate aspects of the neuromodulation (Esteller, paragraph [0078]).
Regarding claim 7, the method of claim 6 is obvious over Clark, Schepis, and Esteller, as explained above. Clark further discloses that the received sensory input from the patient includes patient sensation corresponding to test neuromodulation configurations (paragraph [0085], "For each electrode combination, the user taps the button 882 when the therapy becomes uncomfortable (e.g., produces a discomfort side effect above a subjective threshold.)").
Regarding claim 8, the method of claim 7 is obvious over Clark, Schepis, and Esteller, as explained above. Clark further discloses displaying the electrode configuration corresponding to the test neuromodulation configurations (paragraph [0088], "FIG. 9 illustrates one embodiment of an interface that can present the results of the testing"; paragraph [0095], "FIG. 10 illustrates an interface with the results of testing these electrode combinations").
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Clark et al. (US 20180154156 A1), hereinafter Clark, in view of Schepis et al. (US 20200179697 A1), hereinafter Schepis, and further in view of Saab (US 20130066394 A1, previously cited).
Regarding claim 10, the method of claim 9 is obvious over Clark and Schepis, as explained above. Clark does not explicitly disclose that the algorithm is configured to infer from an overlap in the patient sensation and the pain and from features the evoked neural response that low-threshold fibers from the center receptive field or the inhibitory surround receptive field is stimulated.
However, Saab teaches a method of electrical neuromodulation to prevent or reduce pain perception (paragraph [0005]), wherein the algorithm is configured to infer from an overlap in the patient sensation and the pain and from features the evoked neural response that low-threshold fibers from the center receptive field or the inhibitory surround receptive field is stimulated (paragraphs [0065]-[0066]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Clark and Schepis with the teachings of Saab so that the algorithm is configured to infer from an overlap in the patient sensation and the pain and from features the evoked neural response that low-threshold fibers from the center receptive field or the inhibitory surround receptive field is stimulated, because doing so improves the efficiency and lifetime of the neurostimulation device, targets physiologically relevant nervous system structures, reduces side effects of neuromodulation, and reduces the overall amount of delivered current while maintaining the effectiveness of the therapy (Saab, paragraph [0012]).
Regarding claim 11, the method of claim 9 is obvious over Clark and Schepis, as explained above. Clark does not explicitly disclose that the algorithm is configured to infer from slight discordance among the patient sensation and the pain, and from slight distinctions in the evoked neural response that the fibers from the inhibitory surround receptive field is stimulated.
However, Saab teaches a method of electrical neuromodulation to prevent or reduce pain perception (paragraph [0005]), wherein the algorithm is configured to infer from slight discordance among the patient sensation and the pain, and from slight distinctions in the evoked neural response that the fibers from the inhibitory surround receptive field is stimulated (paragraphs [0065]-[0066]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Clark and Schepis with the teachings of Saab so that the algorithm is configured to infer from slight discordance among the patient sensation and the pain, and from slight distinctions in the evoked neural response that the fibers from the inhibitory surround receptive field is stimulated, because doing so improves the efficiency and lifetime of the neurostimulation device, targets physiologically relevant nervous system structures, reduces side effects of neuromodulation, and reduces the overall amount of delivered current while maintaining the effectiveness of the therapy (Saab, paragraph [0012]).
Regarding claim 12, the method of claim 9 is obvious over Clark and Schepis, as explained above. Clark does not explicitly disclose that the algorithm is configured to infer from at least one of a strong sensation or a strong distinction in the evoked neural response that the inhibitory surround receptive field or a different receptive field is stimulated.
However, Saab teaches a method of electrical neuromodulation to prevent or reduce pain perception (paragraph [0005]), wherein the algorithm is configured to infer from a strong distinction in the evoked neural response that the inhibitory surround receptive field or a different receptive field is stimulated (paragraphs [0065]-[0066]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Clark and Schepis with the teachings of Saab so that the algorithm is configured to infer from a strong distinction in the evoked neural response that the inhibitory surround receptive field or a different receptive field is stimulated, because doing so improves the efficiency and lifetime of the neurostimulation device, targets physiologically relevant nervous system structures, reduces side effects of neuromodulation, and reduces the overall amount of delivered current while maintaining the effectiveness of the therapy (Saab, paragraph [0012]).
Claims 13 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Clark et al. (US 20180154156 A1), hereinafter Clark, in view of Schepis et al. (US 20200179697 A1), hereinafter Schepis, and further in view of Baynham et al. (US 20150032181 A1), hereinafter Baynham.
Regarding claim 13, the method of claim 1 is obvious over Clark and Schepis, as explained above. Clark does not explicitly disclose that the therapeutic amplitude is less than the threshold amplitude and is set as a percentage of the threshold amplitude.
However, Baynham teaches a peripheral nerve stimulation system (paragraph [0036]) that determines a therapeutic amplitude that is less than a perception threshold amplitude and is set as a percentage of the perception threshold amplitude (paragraph [0083], "If the eCAP comparison reveals that the perception threshold of the patient has been reached (step 314), the SCM system 10 computes a decreased amplitude value as a function of the amplitude value indicative of the perception threshold (step 318). As described above, such function can be, e.g., a percentage of the determined perception threshold").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Clark and Schepis with the teachings of Baynham so that the therapeutic amplitude is less than the threshold amplitude and is set as a percentage of the threshold amplitude, because doing so allows the system to provide therapy to the patient without the perception of paresthesia (Baynham, paragraph [0083]).
Regarding claim 19, the non-transitory machine-readable medium of claim 17 is obvious over Clark and Schepis, as explained above. Clark does not explicitly disclose that the therapeutic amplitude is less than the threshold amplitude and is set as a percentage of the threshold amplitude.
However, Baynham teaches a peripheral nerve stimulation system (paragraph [0036]) that determines a therapeutic amplitude that is less than a perception threshold amplitude and is set as a percentage of the perception threshold amplitude (paragraph [0083], "If the eCAP comparison reveals that the perception threshold of the patient has been reached (step 314), the SCM system 10 computes a decreased amplitude value as a function of the amplitude value indicative of the perception threshold (step 318). As described above, such function can be, e.g., a