DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 05, 2026 has been entered.
Response to Arguments
Claims 1 and 21 are amended. Claims 1-4, 7-12, 14-16, and 20-21 are pending in this action.
Double Patenting
No attempt was made to overcome the non-statutory double-patenting rejection. Applicant’s filing of a Terminal Disclaimer when the statutory rejections are withdrawn is acknowledged. However, to provide clarity, the double patenting rejection is presented again in this office action.
Claim Rejections - 35 USC § 102/103
Applicant’s arguments with respect to claim(s) 1-2, 7-12, 14 and 20-21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, the newly cited reference as taught by Doan (US 20140364920 A1 – hereinafter Doan) teaches a system/method for stimulating neural tissue, and delivering sub-threshold stimulation pulses of an intensity below an initial excitation threshold of the nerve or neuron for about 2 OR more minutes, as stated in the rejection below.
Furthermore, the newly cited combination of Mishra and Doan does not expressly teach the limitations of thereby producing a block of nerve conduction or neuron excitation and increasing the initial excitation threshold to a first increased excitation threshold. However, this limitation is considered a functional limitation and is not comprised of any structural element to patentably distinguish from apparatus claim 1. This limitation does not further require any positively recited steps for method claims 12 and 21, but is considered to comprise an intended result of the stimulation; the positively recited steps as claimed in claims 12 and 21 are met under the combination of Mishra and Doan as stated in the rejection below, and would thus yield any intended results under the principles of inherency, (see MPEP 2111.04. I). Thus, claims 1, 12 and 21 are considered to be sufficiently met over the combination of Mishra and Doan as stated in the rejection below.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 7-12, 14, and 20-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8-9, and 13-18 U.S. Patent No. 11,865,346 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the U.S. Application 18/490,822 and U.S. Patent 11,865,346 B2 both teach stimulation methods/devices configured to apply an electrical stimulation comprising charge-balanced, biphasic, symmetric electrical pulses of an intensity below an initial excitation threshold of the nerve or neuron for a at least 2 minutes to produce a block of nerve conduction or neuron excitation and to increase the initial excitation threshold to a first increased excitation threshold.
Claims 12 and 14-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-10 of U.S. Patent No. 11,826,572 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the U.S. Application 18/490,822 and the U.S. Patent 11,826,572 B2 both teach stimulation methods comprising applying charge-balanced, biphasic, symmetric electrical pulses to a nerve or neuron at an intensity below the initial excitation threshold of the nerve or neuron for at least 2 minutes to cause an increase of the initial excitation threshold of the nerve or neuron to a first excitation threshold.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The term “about” in claims 1, 12 and 21 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, the degree in which the term “about” could be met is unclear in claims 1, 12 and 21 regarding the stimulation pulse duration, and stimulation frequency. Dependent claims 2, 7-11, and 20 are further rejected for the same reasons.
Claim Interpretation
In accordance to MPEP 2111.04, such term(s) as “configured to” in the claim(s) do not limit claim scope to the particular function performed, and merely suggest optional functionality if the claim does not introduce any structure that positively recites and limits the features of the invention for exclusive use as intended. Absent limiting structural features, limitations following said clauses will be interpreted as recitations of intended use, wherein prior art will be evaluated based on its capability of performing and its suitability for the intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim, Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
According to MPEP 2112.02, a prior art device anticipates a claimed process if the device carries out the process during normal operation. Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). Furthermore, where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, that the reference does not describe the recited effect in haec verba is of no significance as the reference meets the claim under the doctrine of inherency. Ex parte Novitski, 26 USPQ2d 1389, 1390-91 (BdPatApp & Inter 1993). Furthermore, the employment of the claimed steps must inherently produce the same intended results else the claims are incomplete for failing to recite a critical aspect of the invention.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-2, 11-12, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mishra (WO 2017142948 A1 – hereinafter Mishra) in view of Doan (US 20140364920 A1 – hereinafter Doan, NEW).
Re. claim 1, Mishra teaches a device (figure 2, apparatus 10)
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comprising:
a controller (figure 3, housing 210 with controller 250);
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a pulse generator in communication with the controller (figure 3, waveform generator 255 within the controller 250);
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and an electrode configured to encircle or be placed in proximity to a sensory nerve or neuron (paragraph 0179 – “In some embodiments, one or more functional elements 260 are configured to deliver energy (e.g. electrical energy)…”; paragraph 0349 – “…one or more leads 265 can be implanted such that one or more functional elements 260 stimulate one or more nerves in the leg, arm, torso and/or sacrum”; paragraph 0266 – “In some embodiments, functional element 260 comprises one or more elements positioned proximate and/or within one or more tissue types and/or locations selected from the group consisting of: one or more nerves; one or more locations along, in and/or proximate to the spinal cord; peripheral nerves of the spinal cord including locations around the back; the tibial nerve (and/or sensory fibers that lead to the tibial nerve)…”; figure 2 shows the electrodes 260),
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the electrode in electrical communication with the pulse generator (paragraph 0246 – “One or more controllers 250 (singly or collectively controller 250) can be configured to control one or more functional elements 260…”; paragraph 0375 – “Implantable device 200 of Fig.3 further comprises controller 250 which can comprise waveform generator 255”; all shown in figures 2-3),
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wherein the controller is configured to instruct the pulse generator to:
apply an electrical stimulation comprising charge-balanced, biphasic, symmetric electrical pulses at a frequency of about 1 Hz to about 50 kHz (paragraph 0032 – “The pulse rate will vary depending on the duration of each phase, but will be in range of 0.5 Hz up to, 10 kHz”; paragraph 0042 – “The microprocessor is programmed to continue to generate the waveform for a prescribed period of time (e.g., 1 minute) to block the spasm…”),
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and an intensity below an initial excitation threshold of the nerve or neuron (paragraph 0401 – “…non-zero energy is delivered, such as a delivery of monophasic or multiphasic (e.g. biphasic, triphasic, etc.) sub-threshold pulses (e.g. of insufficient magnitude to elicit a neuronal response)”; paragraph 0402 – “In some embodiments, apparatus 10 is configured to deliver burst stimulation in which one or more burst-off periods comprise delivery of energy at a level insufficient to cause neuronal firing. For example, a stimulation waveform can include one or more sub-threshold pulses that are delivered during a burst-off period as shown in Fig.30C”).
Mishra teaches delivering charge-balanced, biphasic, symmetric electrical pulses and of an intensity below an initial excitation threshold of the nerve or neuron as stated above, but does not explicitly teach stimulation pulse delivery of an intensity below an initial excitation threshold of the nerve or neuron for about 2 or more minutes.
Doan similarly teaches a system/method for stimulating neural tissue (abstract – “A neuromodulation system and method of providing therapy to a patient. Electrical energy is delivered to the patient in accordance with a modulation parameter, thereby providing therapy to the patient, and the modulation parameter of the delivered electrical energy is varied over a period of time, such that the delivered electrical energy is continually maintained at a sub-threshold level throughout the period of time”; figure 3),
and further teaches sub-threshold nerve stimulation (paragraph 0018 – “The neuromodulation system further comprises control circuitry configured for controlling the modulation output circuitry in an automated manner that varies the modulation parameters(s) over a period of time, such that the delivered electrical energy is continually maintained at a sub-threshold level throughout the period of time. The sub-threshold level may be referred to as a patient-perception threshold, which may be referred to as a boundary below which a patient does not sense delivery of the electrical energy”).
Doan further teaches the known technique of delivering sub-threshold stimulation pulses of an intensity below an initial excitation threshold of the nerve or neuron for about 2 OR more minutes (Doan teaches delivery of sub-threshold stimulation pulses for about 50 minutes, paragraph 0098 – “One way of ensuring that nerve fibers are not being constantly stimulated is to vary the burst rate of electrical stimulation, providing the nerve fibers a respite from continuous stimulation. For example, referring to FIGS. 6a and 6b, the nerve fibers are stimulated from 9:00 AM at the start of the sub-threshold modulation program until "Burst OFF Time" at 9:50 AM, and again stimulated at 10:00 AM until 10:50 AM, giving a 10-minute break from electrical stimulation”).
Mishra and Doan all teach within the field of neurostimulation systems/methods with sub-threshold stimulation. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system/method of Mishra, specifically the sub-threshold stimulation, to try incorporating the sub-threshold stimulation delivery for about at least 2 minutes, as taught by Doan, since such modification would predictably result in, for example, mitigating pain by blocking pain signals from the increased neural excitation threshold.
The combination of Mishra and Doan (hereinafter the combined invention) does not expressly teach the limitation of thereby producing a block of nerve conduction or neuron excitation and increasing the initial excitation threshold to a first increased excitation threshold. However, the combined invention as stated above meets all the positively recited steps of the claimed invention and thus should inherently yield any intended results, unless the claims are incomplete for failing to include aspects that are essential to achieving the claimed intended results.
Re. claim 2, the combined invention of Mishra and Doan (hereinafter the combined invention) further teaches wherein the pulse generator is configured to deliver electrical stimulation through the electrode at an intensity of 0.01 mA to 10 mA and/or 1 mV to 10,000 mV (Mishra paragraph 026 – “…the stimulation waveform comprises a series of amplitude modulated pulses. The amplitude of the stimulation waveform can be varied continuously. The amplitude modulated pulses can sweep from 2mA to 3mA. The amplitude of the stimulation waveform can be varied between 2mA and 3mA every second. The amplitude of the stimulation waveform can be varied between 1mA and 3mA. The stimulation waveform can be varied between 0mA and 3mA”).
Re. claim 11, the combined invention further teaches wherein the controller is programmed or configured to:
once block of nerve conduction or neuron excitation is achieved, instruct the pulse generator to change the intensity and/or frequency of the electrical stimulation, optionally by reducing the intensity of the electrical stimulation or increasing the frequency of the electrical stimulation (Mishra paragraph 094 – “…the medical apparatus is configured to vary at least one of the one or more stimulation parameters to increase charge to be delivered to a patient. The medical apparatus can be configured to allow a patient and/or other operator to vary the at least one of the one or more stimulation parameters”; paragraph 059 – “The apparatus can randomly vary a parameter selected from the group consisting of: amplitude; voltage amplitude; current amplitude; average amplitude; peak amplitude; frequency; average frequency; period; phase; polarity; pulse shape; a duty cycle parameter; duty cycle frequency, duty cycle pulse width; duty cycle off time; inter-pulse gap; polarity; burst-on period; burst-off period; inter-burst period; pulse train; train-on period; train- off period; inter-train period; drive impedance; duration of pulse; duration of amplitude level; duration of stimulation waveform; repetition of stimulation waveform; an amplitude modulation parameter; a frequency modulation parameter…”).
Re. claim 12, Mishra teaches a method of blocking a sensory nerve or neuron (paragraph 0168 – “In some embodiments, a medical apparatus comprises a stimulation apparatus for activating, blocking, affecting or otherwise stimulating (hereinafter “stimulate” or “stimulating”) tissue of a patient, such as nerve tissue or nerve root tissue (hereinafter “nerve”, “nerves”, “nerve tissue” or “nervous system tissue”)”), comprising:
applying, through an electrode configured to encircle or be placed in proximity to a sensory nerve or neuron (paragraph 0179 – “In some embodiments, one or more functional elements 260 are configured to deliver energy (e.g. electrical energy)…”; paragraph 0349 – “…one or more leads 265 can be implanted such that one or more functional elements 260 stimulate one or more nerves in the leg, arm, torso and/or sacrum”; paragraph 0266 – “In some embodiments, functional element 260 comprises one or more elements positioned proximate and/or within one or more tissue types and/or locations selected from the group consisting of: one or more nerves; one or more locations along, in and/or proximate to the spinal cord; peripheral nerves of the spinal cord including locations around the back; the tibial nerve (and/or sensory fibers that lead to the tibial nerve)…”; figure 2 shows the electrodes 260),
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the electrode in electrical communication with a pulse generator (paragraph 0246 – “One or more controllers 250 (singly or collectively controller 250) can be configured to control one or more functional elements 260…”; paragraph 0375 – “Implantable device 200 of Fig.3 further comprises controller 250 which can comprise waveform generator 255”; all shown in figures 2-3),
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an electrical stimulation to the nerve or neuron, wherein the electrical stimulation comprises charge-balanced, biphasic symmetric electrical pulses (paragraph 0387 – “In some embodiments, a charge recovery (e.g. anodal phase) is varied to maintain charge balance, such as a charge recovery performed by one or more implantable devices 200. Referring additionally to Figs.29A-D, charge recovery can be accomplished through delivery of a biphasic signal, comprising sequential pairs (symmetric or asymmetric) of cathodic and anodic pulses”; figure 29 below shows charge-balanced, biphasic, symmetric electrical pulses),
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at a frequency of about 1 Hz to about 50 kHz (paragraph 0032 – “The pulse rate will vary depending on the duration of each phase, but will be in range of 0.5 Hz up to, 10 kHz”; paragraph 0042 – “The microprocessor is programmed to continue to generate the waveform for a prescribed period of time (e.g., 1 minute) to block the spasm…”),
and of an intensity that does not cause nerve or neuron excitation (paragraph 0401 – “…non-zero energy is delivered, such as a delivery of monophasic or multiphasic (e.g. biphasic, triphasic, etc.) sub-threshold pulses (e.g. of insufficient magnitude to elicit a neuronal response)”; paragraph 0402 – “In some embodiments, apparatus 10 is configured to deliver burst stimulation in which one or more burst-off periods comprise delivery of energy at a level insufficient to cause neuronal firing. For example, a stimulation waveform can include one or more sub-threshold pulses that are delivered during a burst-off period as shown in Fig.30C”),
thereby producing a block of nerve conduction or neuron excitation (paragraph 0279 - “Functional elements 260 can be positioned to: depolarize, hyperpolarize and/or block innervated sections of the muscle that will then propagate an activating and/or inhibiting stimulus along the nerve fibers recruiting muscle tissue remote from the site of stimulation and/or modulate nerve activity (including inhibiting nerve conduction…”).
Mishra further teaches wherein the stimulation is applied at an intensity below the initial excitation threshold of the nerve or neuron neuron (paragraph 0401 – “…non-zero energy is delivered, such as a delivery of monophasic or multiphasic (e.g. biphasic, triphasic, etc.) sub-threshold pulses (e.g. of insufficient magnitude to elicit a neuronal response)”; paragraph 0402 – “In some embodiments, apparatus 10 is configured to deliver burst stimulation in which one or more burst-off periods comprise delivery of energy at a level insufficient to cause neuronal firing. For example, a stimulation waveform can include one or more sub-threshold pulses that are delivered during a burst-off period as shown in Fig.30C”), for lengths of time of up to 1 year (paragraph 0353 – “…stimulation (e.g. stimulation energy and/or a stimulation agent) can be delivered to one or more locations within a patient for an extended time period (e.g. at least 1 hour, at least 1 day, at least 1 month or at least 1 year) …”) as stated above, but does not explicitly teach the stimulation pulse delivery of an intensity below an initial excitation threshold of the nerve or neuron for about 2 or more minutes.
Doan similarly teaches a system/method for stimulating neural tissue (abstract – “A neuromodulation system and method of providing therapy to a patient. Electrical energy is delivered to the patient in accordance with a modulation parameter, thereby providing therapy to the patient, and the modulation parameter of the delivered electrical energy is varied over a period of time, such that the delivered electrical energy is continually maintained at a sub-threshold level throughout the period of time”; figure 3),
and further teaches sub-threshold nerve stimulation (paragraph 0018 – “The neuromodulation system further comprises control circuitry configured for controlling the modulation output circuitry in an automated manner that varies the modulation parameters(s) over a period of time, such that the delivered electrical energy is continually maintained at a sub-threshold level throughout the period of time. The sub-threshold level may be referred to as a patient-perception threshold, which may be referred to as a boundary below which a patient does not sense delivery of the electrical energy”).
Doan further teaches the known technique of delivering sub-threshold stimulation pulses of an intensity below an initial excitation threshold of the nerve or neuron for about 2 OR more minutes (Doan teaches delivery of sub-threshold stimulation pulses for about 50 minutes, paragraph 0098 – “One way of ensuring that nerve fibers are not being constantly stimulated is to vary the burst rate of electrical stimulation, providing the nerve fibers a respite from continuous stimulation. For example, referring to FIGS. 6a and 6b, the nerve fibers are stimulated from 9:00 AM at the start of the sub-threshold modulation program until "Burst OFF Time" at 9:50 AM, and again stimulated at 10:00 AM until 10:50 AM, giving a 10-minute break from electrical stimulation”).
Mishra and Doan all teach within the field of neurostimulation systems/methods with sub-threshold stimulation. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system/method of Mishra, specifically the sub-threshold stimulation, to try incorporating the sub-threshold stimulation delivery for about at least 2 minutes, as taught by Doan, since such modification would predictably result in, for example, mitigating pain by blocking pain signals from the increased neural excitation threshold.
The combination of Mishra and Doan (hereinafter the combined invention) does not expressly teach the limitation of thereby producing a block of nerve conduction or neuron excitation and wherein the stimulation causes an increase the initial excitation threshold to a first increased excitation threshold. However, the combined invention as stated above meets all the positively recited steps of the claimed invention and thus should inherently yield any intended results, unless the claims are incomplete for failing to include aspects that are essential to achieving the claimed intended results.
Re. claim 14, the combined invention of Mishra and Doan (hereinafter the combined invention) further teaches wherein the electrical stimulation is delivered at an intensity of 0.01 mA to 10 mA and/or 1 mV to 10,000 mV (Mishra paragraph 026 – “…the stimulation waveform comprises a series of amplitude modulated pulses. The amplitude of the stimulation waveform can be varied continuously. The amplitude modulated pulses can sweep from 2mA to 3mA. The amplitude of the stimulation waveform can be varied between 2mA and 3mA every second. The amplitude of the stimulation waveform can be varied between 1mA and 3mA. The stimulation waveform can be varied between 0mA and 3mA”).
Claim(s) 7-9 and 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mishra (WO 2017142948 A1 – hereinafter Mishra) in view of Doan (US 20140364920 A1 – hereinafter Doan, NEW), and in further view of Chomenky (US 20030149451 A1 – hereinafter Chomenky) (cited previously).
Re. claim 7, the combined invention of Mishra and Doan (hereinafter the combined invention) further teaches wherein the controller is further programmed or configured to:
instruct the pulse generator to increase the intensity of the electrical stimulation to a first increased intensity electrical stimulation above the initial excitation threshold of the nerve or neuron and below the first excitation threshold of the nerve or neuron (Mishra paragraph 094 – “…the medical apparatus is configured to vary at least one of the one or more stimulation parameters to increase charge to be delivered to a patient. The medical apparatus can be configured to allow a patient and/or other operator to vary the at least one of the one or more stimulation parameters”; paragraph 0368 – “The amplitude of the signal contained in these quiescent period may be from 0% to 99% of the signal amplitude during the train-on and/or burst-on period, such as a signal with an amplitude less than 50% of the signal amplitude during the train-on and/or burst-on period or another amplitude below a neuronal excitation threshold”) for a length of time (Mishra paragraph 0353 – “…stimulation (e.g. stimulation energy and/or a stimulation agent) can be delivered to one or more locations within a patient for an extended time period (e.g. at least 1 hour, at least 1 day, at least 1 month or at least 1 year) …”; paragraph 0323 – “…delivers intermittent electrical stimulation energy, such as with a period between 8 seconds and 24 seconds and/or an on time between 8 seconds and 16 seconds”).
The combined invention further teaches increasing an excitation threshold for a nerve as stated above, but does not explicitly teach delivering stimulation for a length of time sufficient to cause an increase of the first excitation threshold of the nerve or neuron to a second excitation threshold.
Chomenky similarly teaches systems/methods for neural stimulation (Chomenky abstract – “Low voltage pulses, delivered to the same or individual electrodes provide transcutaneous electrical nerve stimulation (TENS), blocking the signals of discomfort or pain that may arise from the high voltage pulsing”).
Chomenky further teaches in figure 2, a curve of excitation thresholds, which increase the excitation thresholds with the decrease in the electrical pulse duration to nerve tissue (Chomenky paragraph 0057 – “An excitation threshold of a nerve depends not only upon the duration of the stimulating pulse but also upon the immediate local excitation history of the nerve”; paragraph 0056 – “The curves illustrate the relative increase in the threshold of excitation with the decrease in the duration of the electrical pulses for different excitable tissues. As can be seen from the middle curve, the threshold of excitation of sensory nerves (the middle curve of the three shown on the Figure) for 10-20 microsecond pulses is 20-50 times higher than that for 1 ms pulses”), and therefore teaches causing an increase of first excitation threshold of the nerve or neuron to a second excitation threshold by delivering stimulating electrical pulses at lower durations, as shown in the various arrow points below.
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The combined invention and Chomenky all teach within the field of neurostimulation systems/methods. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined invention, specifically the stimulation length of time, to incorporate the decreased stimulation duration to increase to a second excitation threshold, as taught by Chomenky as stated above, since such modification would predictably result in, for example, to block excitation of nerve signals from transmitting pain signals (Chomenky paragraph 0048 – “…the excitation of which actually blocks the transmittance of the pain signals”).
Re. claim 8, the newly combined invention including Chomenky further teaches wherein the controller is further programmed or configured to:
instruct the pulse generator to increase the intensity of the first increased intensity electrical stimulation to a second increased intensity electrical stimulation above the first increased excitation threshold of the nerve or neuron and below the second increased excitation threshold of the nerve or neuron (Mishra paragraph 094 – “…the medical apparatus is configured to vary at least one of the one or more stimulation parameters to increase charge to be delivered to a patient. The medical apparatus can be configured to allow a patient and/or other operator to vary the at least one of the one or more stimulation parameters”) for a length of time sufficient to cause an increase of the second excitation threshold of the nerve or neuron to a third increased excitation threshold (Chomenky figure 2 shows decreased durations [length of time] sufficient to induce increases in excitation thresholds, paragraph 0056 – “The curves illustrate the relative increase in the threshold of excitation with the decrease in the duration of the electrical pulses for different excitable tissues”).
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Re. claim 9, the newly combined invention including Chomenky further teaches wherein the controller is further programmed or configured to increase the intensity of the second increased intensity electrical stimulation one or more additional times (Mishra paragraph 094 – “…the medical apparatus is configured to vary at least one of the one or more stimulation parameters to increase charge to be delivered to a patient. The medical apparatus can be configured to allow a patient and/or other operator to vary the at least one of the one or more stimulation parameters”) for a length of time sufficient to further increase the excitation threshold of the nerve or neuron (Chomenky figure 2 shows decreased durations [length of time] sufficient to induce increases in excitation thresholds, paragraph 0056 – “The curves illustrate the relative increase in the threshold of excitation with the decrease in the duration of the electrical pulses for different excitable tissues”).
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Re. claim 20, the combined invention of Mishra and Doan (hereinafter the combined invention) further teaches the method further comprising:
increasing the intensity of the electrical stimulation to a first increased intensity electrical stimulation above the initial excitation threshold of the nerve or neuron and below the first excitation threshold of the nerve or neuron (Mishra paragraph 094 – “…the medical apparatus is configured to vary at least one of the one or more stimulation parameters to increase charge to be delivered to a patient. The medical apparatus can be configured to allow a patient and/or other operator to vary the at least one of the one or more stimulation parameters”; paragraph 0368 – “The amplitude of the signal contained in these quiescent period may be from 0% to 99% of the signal amplitude during the train-on and/or burst-on period, such as a signal with an amplitude less than 50% of the signal amplitude during the train-on and/or burst-on period or another amplitude below a neuronal excitation threshold”) for a length of time (Mishra paragraph 0353 – “…stimulation (e.g. stimulation energy and/or a stimulation agent) can be delivered to one or more locations within a patient for an extended time period (e.g. at least 1 hour, at least 1 day, at least 1 month or at least 1 year) …”; paragraph 0323 – “…delivers intermittent electrical stimulation energy, such as with a period between 8 seconds and 24 seconds and/or an on time between 8 seconds and 16 seconds”).
The combined invention further teaches increasing an excitation threshold for a nerve as stated above, but does not explicitly teach delivering stimulation for a length of time sufficient to cause an increase of the first excitation threshold of the nerve or neuron to a second excitation threshold.
Chomenky similarly teaches systems/methods for neural stimulation (Chomenky abstract – “Low voltage pulses, delivered to the same or individual electrodes provide transcutaneous electrical nerve stimulation (TENS), blocking the signals of discomfort or pain that may arise from the high voltage pulsing”).
Chomenky further teaches in figure 2, a curve of excitation thresholds, which increase the excitation thresholds with the decrease in the electrical pulse duration to nerve tissue (Chomenky paragraph 0057 – “An excitation threshold of a nerve depends not only upon the duration of the stimulating pulse but also upon the immediate local excitation history of the nerve”; paragraph 0056 – “The curves illustrate the relative increase in the threshold of excitation with the decrease in the duration of the electrical pulses for different excitable tissues. As can be seen from the middle curve, the threshold of excitation of sensory nerves (the middle curve of the three shown on the Figure) for 10-20 microsecond pulses is 20-50 times higher than that for 1 ms pulses”), and therefore teaches causing an increase of first excitation threshold of the nerve or neuron to a second excitation threshold by delivering stimulating electrical pulses at lower durations, as shown in the various arrow points below.
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The combined invention and Chomenky all teach within the field of neurostimulation systems/methods. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined invention, specifically the stimulation length of time, to incorporate the decreased stimulation duration to increase to a second excitation threshold, as taught by Chomenky as stated above, since such modification would predictably result in, for example, to block excitation of nerve signals from transmitting pain signals (Chomenky paragraph 0048 – “…the excitation of which actually blocks the transmittance of the pain signals”).
Re. claim 21, Mishra teaches a method of blocking nerve conduction or neuron excitation in a patient (paragraph 0168 – “In some embodiments, a medical apparatus comprises a stimulation apparatus for activating, blocking, affecting or otherwise stimulating (hereinafter “stimulate” or “stimulating”) tissue of a patient, such as nerve tissue or nerve root tissue (hereinafter “nerve”, “nerves”, “nerve tissue” or “nervous system tissue”)”), comprising:
applying, through an electrode implanted within the patient and configured to encircle or be placed in proximity to a nerve or neuron (paragraph 0179 – “In some embodiments, one or more functional elements 260 are configured to deliver energy (e.g. electrical energy) …”; paragraph 0349 – “…one or more leads 265 can be implanted such that one or more functional elements 260 stimulate one or more nerves in the leg, arm, torso and/or sacrum”; figure 2 shows the electrodes 260),
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the electrode in electrical communication with a pulse generator (paragraph 0246 – “One or more controllers 250 (singly or collectively controller 250) can be configured to control one or more functional elements 260…”; paragraph 0375 – “Implantable device 200 of Fig.3 further comprises controller 250 which can comprise waveform generator 255”; all shown in figures 2-3),
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an electrical stimulation to the nerve or neuron, wherein the electrical stimulation comprises charge-balanced, biphasic symmetric electrical pulses (paragraph 0387 – “In some embodiments, a charge recovery (e.g. anodal phase) is varied to maintain charge balance, such as a charge recovery performed by one or more implantable devices 200. Referring additionally to Figs.29A-D, charge recovery can be accomplished through delivery of a biphasic signal, comprising sequential pairs (symmetric or asymmetric) of cathodic and anodic pulses”; figure 29)
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having a frequency of 1 Hz to 50 kHz (paragraph 0032 – “The pulse rate will vary depending on the duration of each phase, but will be in range of 0.5 Hz up to, 10 kHz”; paragraph 0042 – “The microprocessor is programmed to continue to generate the waveform for a prescribed period of time (e.g., 1 minute) to block the spasm…”),
and an intensity of 0.01 mA to 10 mA and/or 1 mV to 10,000 mV (Mishra paragraph 026 – “…the stimulation waveform comprises a series of amplitude modulated pulses. The amplitude of the stimulation waveform can be varied continuously. The amplitude modulated pulses can sweep from 2mA to 3mA. The amplitude of the stimulation waveform can be varied between 2mA and 3mA every second. The amplitude of the stimulation waveform can be varied between 1mA and 3mA. The stimulation waveform can be varied between 0mA and 3mA”),
wherein the stimulation does not cause nerve or neuron excitation, excitation (paragraph 0401 – “…non-zero energy is delivered, such as a delivery of monophasic or multiphasic (e.g. biphasic, triphasic, etc.) sub-threshold pulses (e.g. of insufficient magnitude to elicit a neuronal response)”; paragraph 0402 – “In some embodiments, apparatus 10 is configured to deliver burst stimulation in which one or more burst-off periods comprise delivery of energy at a level insufficient to cause neuronal firing. For example, a stimulation waveform can include one or more sub-threshold pulses that are delivered during a burst-off period as shown in Fig.30C”),
thereby producing a block of nerve conduction or neuron excitation (paragraph 0279 - “Functional elements 260 can be positioned to: depolarize, hyperpolarize and/or block innervated sections of the muscle that will then propagate an activating and/or inhibiting stimulus along the nerve fibers recruiting muscle tissue remote from the site of stimulation and/or modulate nerve activity (including inhibiting nerve conduction…”).
Mishra further teaches: wherein the stimulation is applied at an intensity below the initial excitation threshold of the nerve or neuron (paragraph 0401 – “…non-zero energy is delivered, such as a delivery of monophasic or multiphasic (e.g. biphasic, triphasic, etc.) sub-threshold pulses (e.g. of insufficient magnitude to elicit a neuronal response)”; paragraph 0402 – “In some embodiments, apparatus 10 is configured to deliver burst stimulation in which one or more burst-off periods comprise delivery of energy at a level insufficient to cause neuronal firing. For example, a stimulation waveform can include one or more sub-threshold pulses that are delivered during a burst-off period as shown in Fig.30C”), for lengths of time of up to 1 year (paragraph 0353 – “…stimulation (e.g. stimulation energy and/or a stimulation agent) can be delivered to one or more locations within a patient for an extended time period (e.g. at least 1 hour, at least 1 day, at least 1 month or at least 1 year) …”) as stated above, but does not explicitly teach the stimulation pulse delivery of an intensity below an initial excitation threshold of the nerve or neuron for about 2 or more minutes.
Doan similarly teaches a system/method for stimulating neural tissue (abstract – “A neuromodulation system and method of providing therapy to a patient. Electrical energy is delivered to the patient in accordance with a modulation parameter, thereby providing therapy to the patient, and the modulation parameter of the delivered electrical energy is varied over a period of time, such that the delivered electrical energy is continually maintained at a sub-threshold level throughout the period of time”; figure 3),
and further teaches sub-threshold nerve stimulation (paragraph 0018 – “The neuromodulation system further comprises control circuitry configured for controlling the modulation output circuitry in an automated manner that varies the modulation parameters(s) over a period of time, such that the delivered electrical energy is continually maintained at a sub-threshold level throughout the period of time. The sub-threshold level may be referred to as a patient-perception threshold, which may be referred to as a boundary below which a patient does not sense delivery of the electrical energy”).
Doan further teaches the known technique of delivering sub-threshold stimulation pulses of an intensity below an initial excitation threshold of the nerve or neuron for about 2 OR more minutes (Doan teaches delivery of sub-threshold stimulation pulses for about 50 minutes, paragraph 0098 – “One way of ensuring that nerve fibers are not being constantly stimulated is to vary the burst rate of electrical stimulation, providing the nerve fibers a respite from continuous stimulation. For example, referring to FIGS. 6a and 6b, the nerve fibers are stimulated from 9:00 AM at the start of the sub-threshold modulation program until "Burst OFF Time" at 9:50 AM, and again stimulated at 10:00 AM until 10:50 AM, giving a 10-minute break from electrical stimulation”).
Mishra and Doan all teach within the field of neurostimulation systems/methods with sub-threshold stimulation. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system/method of Mishra, specifically the sub-threshold stimulation, to try incorporating the sub-threshold stimulation delivery for about at least 2 minutes, as taught by Doan, since such modification would predictably result in, for example, mitigating pain by blocking pain signals from the increased neural excitation threshold.
The combination of Mishra and Doan (hereinafter the combined invention) does not expressly teach the limitation of thereby producing a block of nerve conduction or neuron excitation and increasing the initial excitation threshold to a first increased excitation threshold. However, the combined invention as stated above meets all the positively recited steps of the claimed invention and thus should inherently yield any intended results, unless the claims are incomplete for failing to include aspects that are essential to achieving the claimed intended results.
The combined invention of Mishra and Doan (hereinafter the combined invention) further teaches increasing the intensity of the electrical stimulation to a first increased intensity electrical stimulation above the initial excitation threshold of the nerve or neuron and below the first excitation threshold of the nerve or neuron (Mishra paragraph 094 – “…the medical apparatus is configured to vary at least one of the one or more stimulation parameters to increase charge to be delivered to a patient. The medical apparatus can be configured to allow a patient and/or other operator to vary the at least one of the one or more stimulation parameters”; paragraph 0368 – “The amplitude of the signal contained in these quiescent period may be from 0% to 99% of the signal amplitude during the train-on and/or burst-on period, such as a signal with an amplitude less than 50% of the signal amplitude during the train-on and/or burst-on period or another amplitude below a neuronal excitation threshold”),
for a length of time (Mishra paragraph 0353 – “…stimulation (e.g. stimulation energy and/or a stimulation agent) can be delivered to one or more locations within a patient for an extended time period (e.g. at least 1 hour, at least 1 day, at least 1 month or at least 1 year) …”; paragraph 0323 – “…delivers intermittent electrical stimulation energy, such as with a period between 8 seconds and 24 seconds and/or an on time between 8 seconds and 16 seconds”), but does not explicitly teach delivering stimulation for a length of time sufficient to cause an increase of the first excitation threshold of the nerve or neuron to a second excitation threshold.
Chomenky similarly teaches systems/methods for neural stimulation (Chomenky abstract – “Low voltage pulses, delivered to the same or individual electrodes provide transcutaneous electrical nerve stimulation (TENS), blocking the signals of discomfort or pain that may arise from the high voltage pulsing”).
Chomenky further teaches in figure 2, a curve of excitation thresholds, which increase the excitation thresholds with the decrease in the electrical pulse duration to nerve tissue (Chomenky paragraph 0057 – “An excitation threshold of a nerve depends not only upon the duration of the stimulating pulse but also upon the immediate local excitation history of the nerve”; paragraph 0056 – “The curves illustrate the relative increase in the threshold of excitation with the decrease in the duration of the electrical pulses for different excitable tissues. As can be seen from the middle curve, the threshold of excitation of sensory nerves (the middle curve of the three shown on the Figure) for 10-20 microsecond pulses is 20-50 times higher than that for 1 ms pulses”), and therefore teaches causing an increase of first excitation threshold of the nerve or neuron to a second excitation threshold by delivering stimulating electrical pulses at lower durations, as shown in the various arrow points below.
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The combined invention and Chomenky all teach within the field of neurostimulation systems/methods. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined invention, specifically the stimulation length of time, to incorporate the decreased stimulation duration to increase to a second excitation threshold, as taught by Chomenky as stated above, since such modification would predictably result in, for example, to block excitation of nerve signals from transmitting pain signals (Chomenky paragraph 0048 – “…the excitation of which actually blocks the transmittance of the pain signals”).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mishra (WO 2017142948 A1 – hereinafter Mishra) in view of Doan (US 20140364920 A1 – hereinafter Doan, NEW), and in further view of Fetz (US 20090105786 A1 – hereinafter Fetz).
Re. claim 10, the combined invention of Mishra and Doan (hereinafter the combined invention) further teaches wherein the controller is programmed or configured to:
once block of nerve conduction or neuron excitation is achieved, instruct the pulse generator to stop application of the electrical stimulation for a period of at least 1 minute (Mishra paragraph 0323 – “…or an on time of several hours followed by an off time of several hours (such as 8 hours of stimulation ON and 16 hours of stimulation OFF or 16 hours on and 8 hours off, and 12 hour on and 12 hours off…”),
after the period has concluded, the controller is programmed or configured to:
resume electrical stimulation of the nerve or neuron at the same or a lower intensity to continue or prolong the block of nerve conduction or neuron excitation (Mishra paragraph 094 – “…the medical apparatus is configured to vary at least one of the one or more stimulation parameters to increase charge to be delivered to a patient. The medical apparatus can be configured to allow a patient and/or other operator to vary the at least one of the one or more stimulation parameters”).
The combined invention does not explicitly teach the block of nerve conduction or neuron excitation is maintained during the period of at least 1 minute.
Fetz teaches a similar neurostimulation system/method (Fetz abstract – “The invention provides a method and device for inducing a conditioned neural response in a subject. The method comprises detecting spike activity in a first neural site in the subject; and delivering a stimulus pulse to a second neural site in the subject”).
Fetz further teaches nerve blocking in monkeys (Fetz paragraph 0190 – “Nerve block. We blocked nerves leading to wrist muscles with local anesthetic to create temporary motor paralysis. Block onset typically occurred after 5-60 minutes, depending on anesthetic and block method”), which maintained nerve blocking after turning off stimulation for two 30 second increments and measuring torque in wrist muscles, showing 1 combined minute of blocked nerves in the wrist (Fetz paragraph 0191 – “To confirm continued nerve block during the practice session, the stimulator was turned off after every 10 minutes of FES to assure that the monkey could not acquire the peripheral target through volitional muscle contractions. FIGS. 5B & 11 illustrate the torques produced with the stimulator active compared to periods when the stimulator was turned off for 30 s”).
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The combined invention and Fetz all teach within the field of neurostimulation systems/methods. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined invention, specifically the stimulation off period of at least 1 minute, to incorporate the teachings of Fetz where the nerve block is maintained after the stimulator is turned off for two 30 second increments to combine 1 minute of blocked nerves, as taught by Fetz as stated above, since such modification would predictably result in allowing continued nerve blocking to treat pain, while conserving power/battery life.
Conclusion
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/ANH-KHOA N DINH/Examiner, Art Unit 3796
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