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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 07, 2025 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.
Specification
Applicant’s arguments, filed 01/13/2026, with respect to the specification objection have been fully considered and are persuasive. The specification objection of 11/05/2025 has been withdrawn.
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 Applicant’s filing of a Terminal Disclaimer when the statutory rejections are withdrawn is acknowledged.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) 1-4, 7-12, 14-16 and 20-21 have been considered but they are not persuasive.
Regarding the Mishra (WO 2017142948 A1 – hereinafter Mishra) reference, Examiner maintains that Mishra, under the broadest reasonable interpretation of the claims, sufficiently teaches the claim limitations as stated in the rejection below, including applying an electrical stimulation comprising 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),
of 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”),
for a length of time sufficient (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)…”) to produce 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…”).
As stated in the rejection, even if the parameters stated by Mishra are broadly stated, the device of Mishra sufficiently teaches that sub-threshold pulses which are charge-balanced, biphasic, symmetric electrical can be delivered to produce a block of nerve conduction as reasonably and broadly interpreted in claims 1 and 21. Since Mishra sufficiently anticipates the steps/parameters as claimed, any intended result is irrelevant to the claims. Furthermore, 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) (MPEP 2114 I, II). Therefore, it is considered that Mishra is capable of delivering the necessary stimulation parameters to achieve the intended result of blocking nerve conduction.
Second, paragraphs 0353-0354 are merely relied upon to teach the known technique of delivering stimulation for a length of time (claims 1, 7-9, 12, 20-21), specifically for a duration of from 100 milliseconds to 14 days (claims 4 and 16). The claims, under their broadest reasonable interpretation, only require stimulations to be delivered for these durations, which paragraphs 0353-0354 sufficiently teaches.
With regard to the Holsheimer (US 20020128694 A1 – hereinafter Holsheimer) reference, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In the instant case, Mishra, as stated above and in the rejection below, teaches the known technique of applying sub-threshold electrical stimulation parameters comprising charge-balanced, biphasic, symmetric electrical pulses. Mishra does not teach the result of increasing the initial excitation threshold to a first increased excitation threshold. Holsheimer is then merely relied upon as a similar system/method for stimulating neural tissue (abstract – “The invention applies hyperpolarizing pre-pulses and depolarizing pre-pulses to neural tissue, such as spinal cord tissue…”; figure 5) which teaches the known technique of delivering sub-threshold stimulation pulses of an intensity below an initial excitation threshold of the nerve or neuron, to increase an excitation threshold for a nerve as required by the claims (Holsheimer paragraph 0016 – “…an appropriate sub-threshold depolarizing (cathodic) pre-pulse (DPP) is applied to neural tissue in advance of a cathodic stimulation pulse, the nerve membrane 5 will be slightly depolarized, causing a reduction of the (small) number of open sodium channels 11 (FIG. 2). As a result, the excitation threshold of the axon 4 will increase and a stronger stimulus is needed to evoke an action potential than without a DPP”). Under the broadest reasonable interpretation of the claims, the combination of Mishra and Holsheimer sufficiently teaches the required limitations of the claims without any further clarification in the claims which would teach away from the cited prior art, and one of ordinary skill in the art would reasonably arrive at the combined invention since such modification would predictably result in, for example, mitigating pain by blocking pain signals from the increased neural excitation threshold.
With regard to claims 7-8 and 21, the Chomenky (US 20030149451 A1 – hereinafter Chomenky) reference is merely relied upon to teach a similar system/method for neural stimulation (abstract), which teaches the known technique of 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 AND to cause an increase of the second excitation threshold of the nerve or neuron to a third increased excitation threshold, as required by the claims. As stated in the rejection below, Chomenky further teaches in figure 2, a curve of excitation thresholds which increase excitation thresholds with the decrease in the electrical pulse duration to nerve tissue (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). The graph of figure 2 then shows that different excitation thresholds can be increased or decreased depending on the duration of stimulation, in which excitation thresholds can be increased to second and third increased thresholds with shorter stimulation durations, and decreased with longer durations.
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Therefore, under the broadest reasonable interpretation of the claims, the combination of Mishra, Holsheimer and Chomenky, all of which are analogous to neural stimulation devices/methods, sufficiently teaches the required limitations of the claims without any further clarification in the claims which would teach away from the cited prior art, and one of ordinary skill in the art would reasonably arrive at the combined invention 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”).
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 1-4, 7-12, 14-16, and 20-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8-10, 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 length of time sufficient to produce a block of nerve conduction or neuron excitation and to increase the initial excitation threshold to a first increased excitation threshold, as shown in the comparison table below.
U.S. Application 18/490,822
U.S. Patent 11,865,346 B2
A device comprising:
a controller;
a pulse generator in communication with the controller;
and an electrode configured to encircle or be placed in proximity to a nerve or neuron, the electrode in electrical communication with the pulse generator,
wherein the controller is configured to instruct the pulse generator
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 length of time sufficient to produce a block of nerve conduction or neuron excitation
and to increase the initial excitation threshold to a first increased excitation threshold.
A device comprising:
a controller;
a pulse generator in communication with the controller;
and one or more skin surface electrodes or magnetic coils in electrical communication with the pulse generator,
wherein the controller is programmed or configured to cause the pulse generator, through the one or more skin surface electrodes or magnetic coils,
to apply an electrical stimulation to a nerve or neuron, wherein the electrical stimulation comprises charge-balanced, biphasic, symmetric electrical pulses and is of an intensity below an initial excitation threshold of the nerve or neuron, for a length of time sufficient to produce a block of nerve conduction or neuron excitation.
Claim 16. The device of claim 13,
wherein the controller is further programmed or configured to cause the pulse generator, through the one or more skin surface electrodes or magnetic coils, to apply electrical stimulation at an intensity below the initial excitation threshold of the nerve or neuron for a length of time sufficient to cause an increase of the initial excitation threshold of the nerve or neuron to a first increased excitation threshold.
The device of claim 1, 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.
The device of claim 13, wherein the controller is programmed or configured to cause the pulse generator, through the one or more skin surface electrodes or magnetic coils, to deliver electrical stimulation through the one or more skin surface electrodes or magnetic coils at an intensity of 0.01 mA to 10 mA and/or 1 mV to 10,000 mV.
The device of claim 1, wherein the pulse generator is configured to deliver electrical stimulation through the electrode at a frequency of 1 Hz to 50 kHz.
The device of 13, wherein the controller is programmed or configured to cause the pulse generator, through the one or more skin surface electrodes or magnetic coils, to deliver electrical stimulation through the one or more skin surface electrodes or magnetic coils at a frequency of 1 Hz to 50 kHz, for from 100 milliseconds to 14 days, wherein the electrical stimulation comprises biphasic, charge-balanced electrical pulses.
The device of claim 1, wherein the pulse generator is configured to deliver electrical stimulation through the electrode for a duration of from 100 milliseconds to 14 days.
The device of claim 1, 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
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.
The device of claim 16, wherein the controller is further programmed or configured to cause 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 increased excitation threshold of the nerve or neuron
for a length of time sufficient to cause an increase of the first increased excitation threshold of the nerve or neuron to a second increased excitation threshold.
The device of claim 7, 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 excitation threshold of the nerve or neuron and below the second excitation threshold of the nerve or neuron
for a length of time sufficient to cause an increase of the second excitation threshold of the nerve or neuron to a third excitation threshold.
18. The device of claim 17, wherein the controller is further programmed or configured to cause 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
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.
A method of blocking a nerve or neuron, comprising:
applying, through an electrode configured to encircle or be placed in proximity to a nerve or neuron, the electrode in electrical communication with a pulse generator, an electrical stimulation to the nerve or neuron,
wherein the electrical stimulation comprises charge-balanced, biphasic symmetric electrical pulses of an intensity that does not cause nerve or neuron excitation for a length of time sufficient to produce a block of nerve conduction or neuron excitation, and
wherein the stimulation is applied at an intensity below the initial excitation threshold of the nerve or neuron for a length of time sufficient to cause an increase of the initial excitation threshold of the nerve or neuron to a first excitation threshold.
A method of blocking a nerve or neuron, comprising:
applying an electrical stimulation to the nerve or neuron,
wherein the electrical stimulation comprises charge-balanced, biphasic, symmetric electrical pulses and is of an intensity that does not cause nerve or neuron excitation, for a length of time sufficient to produce a block of nerve conduction or neuron excitation.
Claim 2. The method of claim 1,
wherein the intensity of the electrical stimulation is below an initial excitation threshold of the nerve or neuron.
Claim 3. The method of claim 2,
wherein the stimulation is applied at an intensity below the initial excitation threshold of the nerve or neuron for a length of time sufficient to cause an increase of the initial excitation threshold of the nerve or neuron to a first increased excitation threshold.
The method of claim 12, wherein the electrical stimulation is delivered at an intensity of 0.01 mA to 10 mA and/or 1 mV to 10,000 mV.
The method of claim 1, wherein the electrical stimulation is delivered at an intensity of 0.01 mA to 10 mA and/or 1 mV to 10,000 mV.
The method of claim 12, wherein the electrical stimulation is delivered at a frequency of 1 Hz to 50 kHz.
The method of claim 1, wherein the electrical stimulation is delivered at a frequency of 1 Hz to 50 kHz.
The method of claim 12, wherein the electrical stimulation is delivered for a period of from 1 minute to 14 days.
The method of claim 1, wherein the electrical stimulation is delivered for a period of from 1 minute to 14 days.
The method of claim 12, 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
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.
The method of claim 3, 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 increased excitation threshold of the nerve or neuron
for a length of time sufficient to cause an increase of the first increased excitation threshold of the nerve or neuron to a second increased excitation threshold.
A method of blocking nerve conduction or neuron excitation in a patient, comprising:
applying, through an electrode implanted within the patient and configured to encircle or be placed in proximity to a nerve or neuron, the electrode in electrical communication with a pulse generator, an electrical stimulation to the nerve or neuron,
wherein the electrical stimulation comprises charge-balanced, biphasic symmetric electrical pulses having a frequency of 1 Hz to 50 kHz and an intensity of 0.01 mA to 10 mA and/or 1 mV to 10,000 mV,
wherein the stimulation does not cause nerve or neuron excitation,
and wherein the stimulation is delivered for a length of time sufficient to produce a block of nerve conduction or neuron excitation,
wherein the stimulation is applied at an intensity below the initial excitation threshold of the nerve or neuron for a length of time sufficient to cause an increase of the initial excitation threshold of the nerve or neuron to a first excitation threshold;
and 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
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.
A method of blocking a nerve or neuron, comprising:
applying an electrical stimulation to the nerve or neuron,
wherein the electrical stimulation comprises charge-balanced, biphasic, symmetric electrical pulses
and is of an intensity that does not cause nerve or neuron excitation,
for a length of time sufficient to produce a block of nerve conduction or neuron excitation.
Claim 3. The method of claim 2,
wherein the stimulation is applied at an intensity below the initial excitation threshold of the nerve or neuron for a length of time sufficient to cause an increase of the initial excitation threshold of the nerve or neuron to a first increased excitation threshold.
Claim 4. The method of claim 3, 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 increased excitation threshold of the nerve or neuron
for a length of time sufficient to cause an increase of the first increased excitation threshold of the nerve or neuron to a second 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 a length of time sufficient to cause an increase of the initial excitation threshold of the nerve or neuron to a first excitation threshold, as shown in the comparison table below.
U.S. Application 18/490,822
U.S. Patent 11,826,572 B2
A method of blocking a nerve or neuron, comprising:
applying, through an electrode configured to encircle or be placed in proximity to a nerve or neuron, the electrode in electrical communication with a pulse generator, an electrical stimulation to the nerve or neuron,
wherein the electrical stimulation comprises charge-balanced, biphasic symmetric electrical pulses of an intensity that does not cause nerve or neuron excitation for a length of time sufficient to produce a block of nerve conduction or neuron excitation,
and wherein the stimulation is applied at an intensity below the initial excitation threshold of the nerve or neuron
for a length of time sufficient to cause an increase of the initial excitation threshold of the nerve or neuron to a first excitation threshold.
6. A method of reducing pain in a patient comprising:
applying a subthreshold electrical stimulation to a nerve or neuron,
wherein the subthreshold electrical stimulation is biphasic, symmetric electrical pulses
of an intensity that is below both an initial excitation threshold of the nerve or neuron and a pain threshold of the patient,
for a length of time sufficient to cause an increase of the initial excitation threshold and the initial pain threshold to first increased thresholds; and increasing the intensity of the subthreshold electrical stimulation to an intensity that is above the initial excitation threshold of the nerve or neuron and is below a first the increased excitation threshold and a first increased pain threshold of the patient, Wherein the applying and increasing are repeated to further increase the intensity of the subthreshold electrical stimulation until the pain is reduced.
Claim 10: The method according to claim 6, wherein the subthreshold electrical stimulation comprises electrical pulses that are charge-balanced.
The method of claim 12, wherein the electrical stimulation is delivered at an intensity of 0.01 mA to 10 mA and/or 1 mV to 10,000 mV.
The method according to claim 6, wherein the subthreshold electrical stimulation is delivered at an intensity of 0.01 mA to 10 mA and/or 1 mV to 10,000 mV.
The method of claim 12, wherein the electrical stimulation is delivered at a frequency of 1 Hz to 50 kHz.
The method according to claim 6, wherein the subthreshold electrical stimulation is delivered at a frequency of 1 Hz to 50 kHz.
The method of claim 12, wherein the electrical stimulation is delivered for a period of from 1 minute to 14 days.
The method according to claim 6, wherein the subthreshold electrical stimulation is delivered for a period of from 100 ms to 14 days.
Claim Interpretation
The term(s) “for” and “configured to” in the claim(s) may be interpreted as intended use. Intended use/functional language does not require that references teach or disclose the intended use of an element. 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. See MPEP section 2114. II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART.
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) 1-4, 11-12, and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mishra (WO 2017142948 A1 – hereinafter Mishra) in view of Holsheimer (US 20020128694 A1 – hereinafter Holsheimer) (both cited previously).
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 (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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of 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”) for a length of time sufficient (paragraph 0354 – “ …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)…”) to produce 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 teaches delivering charge-balanced, biphasic, symmetric electrical pulses of an intensity below an initial excitation threshold of the nerve or neuron for length of time of up to 1 year as stated above, but does not explicitly teach for a length of time sufficient to increase the initial excitation threshold to a first increased excitation threshold.
Holsheimer similarly teaches a system/method for stimulating neural tissue (Holsheimer abstract – “The invention applies hyperpolarizing pre-pulses and depolarizing pre-pulses to neural tissue, such as spinal cord tissue…”; figure 5).
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Holsheimer also teaches delivering charge-balanced electrical pulses (Holsheimer paragraph 0047 – “The charge-balancing pulse has an amplitude and duration compensating for the charge injected by the stimulation pulse. This is usually accomplished by a charge-balancing pulse having a long duration and a low amplitude”), and further teaches the known technique of delivering sub-threshold stimulation pulses of an intensity below an initial excitation threshold of the nerve or neuron, to increase an excitation threshold for a nerve (Holsheimer paragraph 0016 – “…an appropriate sub-threshold depolarizing (cathodic) pre-pulse (DPP) is applied to neural tissue in advance of a cathodic stimulation pulse, the nerve membrane 5 will be slightly depolarized, causing a reduction of the (small) number of open sodium channels 11 (FIG. 2). As a result, the excitation threshold of the axon 4 will increase and a stronger stimulus is needed to evoke an action potential than without a DPP”).
Mishra and Holsheimer 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 for a time to increase an excitation threshold, as taught by Holsheimer, since such modification would predictably result in, for example, mitigating pain by blocking pain signals from the increased neural excitation threshold.
Re. claim 2, the combined invention of Mishra and Holsheimer (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 3, the combined invention further teaches wherein the pulse generator is configured to deliver electrical stimulation through the electrode at a frequency of 1 Hz to 50 kHz (Mishra paragraph 024 – “…the stimulation waveform comprises a high frequency carrier signal modulated with a low frequency envelope. The low frequency envelope can comprise a frequency between 0.1Hz and 1500Hz. The high frequency carrier can comprise a frequency between 1Hz and 10kHz”).
Re. claim 4, the combined invention further teaches wherein the pulse generator is configured to deliver electrical stimulation through the electrode for a duration of from 100 milliseconds to 14 days (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”).
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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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”) for a length of time sufficient (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)…”) to produce 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) …”), but does not explicitly teach delivering stimulation for a length of time sufficient to cause an increase of the initial excitation threshold of the nerve or neuron to a first excitation threshold.
Holsheimer similarly teaches a system/method for stimulating neural tissue (Holsheimer abstract – “The invention applies hyperpolarizing pre-pulses and depolarizing pre-pulses to neural tissue, such as spinal cord tissue…”; figure 5).
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Holsheimer also teaches delivering charge-balanced electrical pulses (Holsheimer paragraph 0047 – “The charge-balancing pulse has an amplitude and duration compensating for the charge injected by the stimulation pulse. This is usually accomplished by a charge-balancing pulse having a long duration and a low amplitude”), and further teaches the known technique of delivering sub-threshold stimulation pulses of an intensity below an initial excitation threshold of the nerve or neuron, to increase an excitation threshold for a nerve (Holsheimer paragraph 0016 – “…an appropriate sub-threshold depolarizing (cathodic) pre-pulse (DPP) is applied to neural tissue in advance of a cathodic stimulation pulse, the nerve membrane 5 will be slightly depolarized, causing a reduction of the (small) number of open sodium channels 11 (FIG. 2). As a result, the excitation threshold of the axon 4 will increase and a stronger stimulus is needed to evoke an action potential than without a DPP”).
Mishra and Holsheimer 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 for a time to increase an excitation threshold, as taught by Holsheimer, since such modification would predictably result in, for example, mitigating pain by blocking pain signals from the increased neural excitation threshold.
Re. claim 14, the combined invention of Mishra and Holsheimer (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”).
Re. claim 15, the combined invention further teaches wherein the electrical stimulation is delivered at a frequency of 1 Hz to 50 kHz (Mishra paragraph 024 – “…the stimulation waveform comprises a high frequency carrier signal modulated with a low frequency envelope. The low frequency envelope can comprise a frequency between 0.1Hz and 1500Hz. The high frequency carrier can comprise a frequency between 1Hz and 10kHz”).
Re. claim 16, the combined invention further teaches wherein the electrical stimulation is delivered for a period of from 1 minute to 14 days (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”).
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 Holsheimer (US 20020128694 A1 – hereinafter Holsheimer), and in further view of Chomenky (US 20030149451 A1 – hereinafter Chomenky) (cited previously).
Re. claim 7, the combined invention of Mishra and Holsheimer (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 (Holsheimer paragraph 0016 – “…an appropriate sub-threshold depolarizing (cathodic) pre-pulse (DPP) is applied to neural tissue in advance of a cathodic stimulation pulse, the nerve membrane 5 will be slightly depolarized, causing a reduction of the (small) number of open sodium channels 11 (FIG. 2). As a result, the excitation threshold of the axon 4 will increase and a stronger stimulus is needed to evoke an action potential than without a DPP”), 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 Holsheimer (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 (Holsheimer paragraph 0016 – “…an appropriate sub-threshold depolarizing (cathodic) pre-pulse (DPP) is applied to neural tissue in advance of a cathodic stimulation pulse, the nerve membrane 5 will be slightly depolarized, causing a reduction of the (small) number of open sodium channels 11 (FIG. 2). As a result, the excitation threshold of the axon 4 will increase and a stronger stimulus is needed to evoke an action potential than without a DPP”), 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 (Mishra paragraph 024 – “…the stimulation waveform comprises a high frequency carrier signal modulated with a low frequency envelope. The low frequency envelope can comprise a frequency between 0.1Hz and 1500Hz. The high frequency carrier can comprise a frequency between 1Hz and 10kHz”),
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”),
and wherein the stimulation is delivered for a length of time for a length of time (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)…”),
sufficient to produce 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) …”), but does not explicitly teach delivering stimulation for a length of time sufficient to cause an increase of the initial excitation threshold of the nerve or neuron to a first excitation threshold.
Holsheimer similarly teaches a system/method for stimulating neural tissue (Holsheimer abstract – “The invention applies hyperpolarizing pre-pulses and depolarizing pre-pulses to neural tissue, such as spinal cord tissue…”; figure 5).
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Holsheimer also teaches delivering charge-balanced electrical pulses (Holsheimer paragraph 0047 – “The charge-balancing pulse has an amplitude and duration compensating for the charge injected by the stimulation pulse. This is usually accomplished by a charge-balancing pulse having a long duration and a low amplitude”), and further teaches the known technique of delivering sub-threshold stimulation pulses of an intensity below an initial excitation threshold of the nerve or neuron, to increase an excitation threshold for a nerve (Holsheimer paragraph 0016 – “…an appropriate sub-threshold depolarizing (cathodic) pre-pulse (DPP) is applied to neural tissue in advance of a cathodic stimulation pulse, the nerve membrane 5 will be slightly depolarized, causing a reduction of the (small) number of open sodium channels 11 (FIG. 2). As a result, the excitation threshold of the axon 4 will increase and a stronger stimulus is needed to evoke an action potential than without a DPP”).
Mishra and Holsheimer 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 for a time to increase an excitation threshold, as taught by Holsheimer, since such modification would predictably result in, for example, mitigating pain by blocking pain signals from the increased neural excitation threshold.
The combined invention of Mishra and Holsheimer (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”);
AND increasing an excitation threshold for a nerve (Holsheimer paragraph 0016 – “…an appropriate sub-threshold depolarizing (cathodic) pre-pulse (DPP) is applied to neural tissue in advance of a cathodic stimulation pulse, the nerve membrane 5 will be slightly depolarized, causing a reduction of the (small) number of open sodium channels 11 (FIG. 2). As a result, the excitation threshold of the axon 4 will increase and a stronger stimulus is needed to evoke an action potential than without a DPP”), 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 Holsheimer (US 20020128694 A1 – hereinafter Holsheimer), and in further view of Fetz (US 20090105786 A1 – hereinafter Fetz).
Re. claim 10, the combined invention of Mishra and Holsheimer (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
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CARL LAYNO can be reached on 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANH-KHOA N DINH/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796