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 Amendment
This Office Action is responsive to the amendment filed on 16 Apr 2026. As directed by the amendment: claims 4 and 9-10 have been amended, no claims have been canceled, and no claims have been added. Thus, claims 1-20 are presently pending in this application.
Response to Arguments
Claim Objections
Applicant’s arguments, see Remarks, filed 16 Apr 2026, with respect to the objections to claims 4 and 10 have been fully considered and are persuasive in light of the claim amendments. The objections to claims 4 and 10 have been withdrawn.
The Rejection of Claims Under § 112
Applicant's arguments filed 16 Apr 2026 have been fully considered but they are not persuasive.
Applicant argues that claim 9 “defines the algorithm by its inputs, its function, and its output, not solely by its result” (Remarks, page 11). Examiner respectfully disagrees. Claim 9 currently 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 evoked neural response”. The inputs to the algorithm are the patient sensation, pain, and the evoked neural response. The output of the algorithm is distinguishing which fibers were stimulated. Neither the claim nor the specification discloses details of how the algorithm achieves the desired output using the inputs. Paragraph [0099] of the specification and dependent claims 10-12 recite further inputs to the algorithm and that those inputs are used to generate the output, but do not provide details about how the inputs are used to infer the outputs.
Therefore, the rejections of claims 9-12 and 16 under 35 U.S.C. 112(a) are maintained.
Applicant argues that claims 2-3 and 18 “define a process by its steps, not merely by its result” (Remarks, page 12). Examiner respectfully disagrees. Claim 2 recites “a process to identify a neuromodulation configuration that stimulates the fibers from the inhibitory surround receptive field around a localized pain region”, but does not recite the steps of the process, only that the process is done.
The Rejection of Claims Under § 103
Applicant's arguments filed 16 Apr 2026 have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “stimulates fibers from an inhibitory surround receptive field”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The term “inhibitory surround receptive field” is not explicitly defined in the claims. Furthermore, the claim does not require the stimulation to be any specific value or have any specific effect on these fibers or on downstream neurons. Therefore, the neuromodulation delivered to the target peripheral nerve can radiate through the body to stimulate the inhibitory surround receptive field.
Examiner recommends explicitly defining the inhibitory surround receptive field in the claim, and altering the limitation “identifying an electrode configuration that, when used to deliver the neuromodulation to the target peripheral nerve, stimulates fibers from an inhibitory surround perceptive field” to specifically recite that this configuration directly “delivers the neuromodulation to the target peripheral nerve, and stimulates fibers from an inhibitory surround perceptive field”.
Applicant further argues that Schepis does not teach stimulating fibers from an inhibitory surround receptive field (Remarks, pages 12-13). Examiner respectfully disagrees. Schepis discloses that “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 [0149]). Schepis further discloses, “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)” (paragraph [0159]). Schepis discloses that “’modulate’ refers to modifying or changing the transmission of information. For example, this includes both excitation, pacing, and inhibition/interruption of the passage of impulses along a neuron's axon within a nerve” (paragraph [0124], emphasis added). Therefore, Schepis teaches applying neuromodulation to a peripheral nerve that stimulates fibers from an inhibitory surround receptive field.
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 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 9-12 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 Crosby et al. (US 20220241589 A1), hereinafter Crosby.
Regarding claim 9, Clark discloses the method of claim 1, 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, Crosby teaches systems and methods of applying electrical stimulation to target peripheral nerve fibers in order to achieve sustained relief of chronic pain (Abstract), comprising an algorithm to distinguish between stimulation of fibers from a receptive field or the inhibitory surround receptive field (paragraph [0181], "The present system may use, create, induce, or cause incoming non-painful information on afferent fibers of peripheral nerves, such as electrical stimulation-evoked activation of large diameter fibers (e.g., Type Ia, Ib, and II fibers, or A-alpha, A-beta fibers) and/or other fibers, to inhibit, reduce, or attenuate the projection of pain signals to the brain") based on a relation among patient sensation, pain (paragraphs [0209], [0211], [0213]-[0214]), and the evoked neural response including features in the evoked neural response (paragraph [0266], "if stimulation when the electrode(s) are placed at a location near the nerve does not produce the desired, wanted, or optimal response, such as sufficient activation of the target fiber population (e.g., large diameter A fibers (also known as A-alpha fibers, A-beta fibers, non-pain fibers, Type Ia, Ib, and/or II fibers) ... while avoiding activation of non-target fibers ... and/or the compound action potential peak corresponding to the target fiber population has reached a sufficient size ... while avoiding activating non-target fibers as indicated by the absence of a compound action potential peak corresponding to the non-target fibers, the electrode(s) may be relocated or another electrode may be selected").
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 Crosby to implement 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, because doing so provides sustained relief of chronic pain that effectively produces both focal and robust sensory signals in target fibers, is easy to implement, and is cost effective for a patient (Crosby, paragraph [0004]).
Regarding claim 10, the method of claim 9 is obvious over Clark, Schepis, and Crosby, as explained above. Crosby further teaches that the algorithm is configured to infer from an overlap in the patient sensation and the pain and from features in the evoked neural response that low-threshold fibers from the center receptive field or the inhibitory surround receptive field are stimulated (paragraph [0188], "The number of target fibers activated may therefore be sufficient if the non-painful sensory information produced in the target fibers shifts the balance (e.g., the ratio, balance, or relative number of action potentials per second, minute, hour, or day, and/or the number of activated fibers and/or the intensity of the activation as measured by the frequency of action potentials, bursts of action potentials, or temporal shifts in the pattern(s) of action potentials) of painful and non-painful information reaching the somatosensory cortex from the region of pain to include more non-painful information than painful information (i.e., a positive balance)"; paragraph [0225], "the present system may identify one or more peripheral nerves located proximal to (e.g., closer to the spinal cord), distal to (e.g., closer to the periphery), and/or in, overlapping with, on, or around the region where pain is manifested, through which neural impulses comprising the pain pass").
Regarding claim 11, the method of claim 9 is obvious over Clark, Schepis, and Crosby, as explained above. Crosby further teaches that the algorithm is configured to infer from discordance among the patient sensation and the pain, and from distinctions in the evoked neural response that the fibers from the inhibitory surround receptive field is stimulated (paragraph [0217], " the present system, it is advantageous for the activation of a large proportion of target fibers to use a pulse width identified empirically using an optimization strategy that maximizes the difference between the activation thresholds of target fibers and non-target fibers. Stimulating at an intensity that generates the maximum comfortable sensations in the patient's region of pain can be achieved at wider pulse widths (i.e., >10 μs, for example 15-200 μs) to selectively activate a larger number of target fibers without activating non-target fibers compared to the number of target fibers activated using conventional programming and optimization methods that use the minimum pulse width to achieve comfortable sensations and are unable to activate a sufficient number of target fibers to promote beneficial cortical plasticity for the sustained relief of chronic pain").
Regarding claim 12, the method of claim 9 is obvious over Clark, Schepis, and Crosby, as explained above. Crosby further teaches that the algorithm is configured to infer from at least one of a sensation or a distinction in the evoked neural response that the inhibitory surround receptive field or a different receptive field is stimulated (paragraphs [0209], [0211], [0213]-[0214]).
Regarding claim 16, Clark discloses the method of claim 1, as explained above.
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, Crosby teaches systems and methods of applying electrical stimulation to target peripheral nerve fibers in order to achieve sustained relief of chronic pain (Abstract), comprising an algorithm to distinguish between stimulation of fibers from a receptive field or the inhibitory surround receptive field (paragraph [0181], "The present system may use, create, induce, or cause incoming non-painful information on afferent fibers of peripheral nerves, such as electrical stimulation-evoked activation of large diameter fibers (e.g., Type Ia, Ib, and II fibers, or A-alpha, A-beta fibers) and/or other fibers, to inhibit, reduce, or attenuate the projection of pain signals to the brain") based on a relation among patient sensation, pain (paragraphs [0209], [0211], [0213]-[0214]), and the evoked neural response including features in the evoked neural response (paragraph [0266], "if stimulation when the electrode(s) are placed at a location near the nerve does not produce the desired, wanted, or optimal response, such as sufficient activation of the target fiber population (e.g., large diameter A fibers (also known as A-alpha fibers, A-beta fibers, non-pain fibers, Type Ia, Ib, and/or II fibers) ... while avoiding activation of non-target fibers ... and/or the compound action potential peak corresponding to the target fiber population has reached a sufficient size ... while avoiding activating non-target fibers as indicated by the absence of a compound action potential peak corresponding to the non-target fibers, the electrode(s) may be relocated or another electrode may be selected").
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 Crosby to implement 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, because doing so provides sustained relief of chronic pain that effectively produces both focal and robust sensory signals in target fibers, is easy to implement, and is cost effective for a patient (Crosby, paragraph [0004]).
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 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]).
Claims 14-15 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 Huertas Fernandez et al. (US 20200009394 A1, previously cited), hereinafter Huertas Fernandez.
Regarding claim 14, the method of claim 1 is obvious over Clark and Schepis, as explained above. Clark further discloses that the neuromodulation configuration includes a pulse frequency within a range of 50 Hz to 100 Hz (paragraph [0116], "less than 100 Hz for stimulation").
Clark does not explicitly disclose that the neuromodulation configuration includes a pulse width within a range of 210-230 microseconds.
However, Huertas Fernandez teaches a method for programming a patient's stimulator device (Abstract) for an implantable neurostimulator (paragraph [0003]) wherein the neuromodulation configuration includes a pulse with within a range of 210-230 µs (paragraph [0125]).
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 Huertas Fernandez so that the pulse width is within a range of 210-230 µs, because at frequencies between 50 and 100 Hz, the optimal pulse width for treatment falls between 195 and 230 µs (Huertas Fernandez, Fig. 12A, paragraph [0124], Table 1).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a pulse width of 210-230 µs, for the purpose of delivering effective neuromodulation while ensuring patient safety, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 15, the method of claim 14 is obvious over Clark, Schepis, and Huertas Fernandez, as explained above. Although Clark further discloses that the pulse frequency is less than 100 Hz for stimulation (paragraph [0116]), Clark does not explicitly disclose that the pulse frequency is 90 Hz. However, Huertas Fernandez further discloses that the pulse frequency is 90 Hz (paragraph [0088]).
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 Huertas Fernandez so that the pulse frequency is 90 Hz, because doing so provides supra-perception therapy, which can be used to determine the electrode configuration for sub-perception neuromodulation (Huertas Fernandez, paragraph [0088]).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a pulse frequency of 90 Hz, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CHRISTINE SISON/Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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