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 .
Claim Objections
Claim 13 is objected to because of the following informalities: The phrase "rides on a return portion" in line 2 of claim 13 is idiomatic. While a person skilled in the art and familiar with the vernacular usage of th Appropriate correction is required.
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 following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4 & 16 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The limitation in claims 4 & 16 “wherein the waveform includes positive-going pulses and negative-going pulses” does not further limit “The portable TES applicator device of claim 1” or “The portable TES applicator device of claim 14” as claims 1 & 14 already contains the limitation “wherein the waveform includes positive-going pulses and/or negative-going pulses” in line 7 of claim 1 and line 9 of claim 14. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
The examiner notes that claims 5 & 17 depend from claims 4 & 16 respectively. Claims 5 & 17 do further limited the subject matter and are therefore not rejected under 35 U.S.C. 112(d), but if applicant chooses to cancel claims 4 and/or 16 without amending 5 and/or 17, these later claims would then improperly depend from cancelled claims.
Claim rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 12 and 18, the term “starts to plateau” is a relative term which renders the claim indefinite. The term “starts to plateau” 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. It is unclear both what is considered a plateau and at what point the system “starts to plateau,” particularly in cases such as Fig. 5M where the applied positive and genitive going pulses are not square waves. For example, in figure 33A (annotated version below) there are two places that broadest reasonable interpretation could describe as a voltage plateau. In figure 33B there is only one apparent plateau but no voltage change occurs at that point. There is nothing in the specification that clarifies how it is determined that a plateau is occurring or at what point in time that plateau is considered to “start” such as an amount of time without a certain degree of voltage change or a percentage of return to the baseline intensity.
For the purpose of examination “after a voltage of each positive-going pulse and/or each negative-going pulse starts to plateau” is interpreted to mean “during the positive-going pulse and/or negative-going pulse”
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, 7, 14, & 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim1, 2, 10, & 13 of U.S. Patent No. 10426945. Although the claims at issue are not identical, they are not patentably distinct from each other as laid out in the table below.
Table 1
Instant Application18/979530
Conflicting
Patent
US 10814131
Conflicting
Patent
US 10426945
Differences
Claim 1
A portable transdermal electrical stimulation (TES) applicator device, comprising:
Claim 1
A transdermal electrical stimulation (TES) device, the device comprising:
Claim 1
A wearable pinna transdermal electrical stimulation
US 10814131
portable
a first electrode configured to be secured to a first portion of a subject’s skin; a second electrode configured to be secured to a second portion of the subject’s skin;
Claim 7
The device of claim 1, further comprising a first electrode connected to the first connector and a second electrode connected to the second connector.
Claim 13
The device of claim 1, wherein the first or second electrodes are on an outer surface of a wearable applicator and configured to deliver TES from the TES controller to the subject's pinna and wherein the wearable applicator is in contact with at least one region of the wearer's pinna.
and a control module including a waveform generator that is configured to deliver a waveform that causes an electrical stimulation to be delivered between the first and second electrodes when the first and second electrodes are secured to the respective first and second portions of the subject’s skin,
Claim 1
a waveform generator configured to deliver a pulsed, asymmetric, biphasic electrical stimulation signal between the first and second connectors
Claim 1
the TES controller is adapted to deliver an asymmetric biphasic electrical stimulation signal of 10 seconds or longer between the first and second electrodes
wherein the waveform includes positive-going pulses and/or negative-going pulses,
Claim 1
a waveform generator configured to deliver a pulsed, asymmetric, biphasic electrical stimulation signal
Claim 1
asymmetric biphasic electrical stimulation
wherein the control module includes capacitance discharging circuitry that is configured to deliver a capacitive discharge current at an end of each positive-going pulse and/or at an end of each negative-going pulse,
Claim 1
a capacitive discharge circuit triggered by the controller and connected to one or both of the first and second connectors and configured to deliver a capacitive discharging pulse between a positive pulse and a negative pulse of the biphasic electrical stimulation signal
Claim 10
The device of claim 1, further comprising a capacitive discharge circuit, wherein the TES controller is configured to occasionally trigger the capacitive discharge circuit to discharge capacitance on the electrodes during the delivery of the electrical stimulation,
wherein the capacitive discharge current corresponds to a spike in current.
Claim 1
to discharge a capacitive charge on either or both the first electrode and the second electrode.
Claim 10
wherein the capacitive discharge circuit is configured to generate a gradual capacitive discharging pulse with controlled time constant and peak value.
Claim 7
The portable TES applicator device of claim 1, wherein the waveform has a duty cycle of greater than 10 percent.
Claim 2
having a duty cycle of between 20 and 50
US 10814131
duty cycle of greater than 10 percent.
Claim 14
A portable transdermal electrical stimulation (TES) applicator device, comprising:
Claim 1
A transdermal electrical stimulation (TES) device, the device comprising:
Claim 1
A wearable pinna transdermal electrical stimulation
US 10814131
portable
a first electrode configured to be secured to a first portion of a subject's skin; a second electrode configured to be secured to a second portion of the subject's skin;
Claim 7
The device of claim 1, further comprising a first electrode connected to the first connector and a second electrode connected to the second connector.
Claim 13
The device of claim 1, wherein the first or second electrodes are on an outer surface of a wearable applicator and configured to deliver TES from the TES controller to the subject's pinna and wherein the wearable applicator is in contact with at least one region of the wearer's pinna.
and a control module including a waveform generator that is configured to deliver a waveform that causes an electrical stimulation to be delivered between the first and second electrodes when the first and second electrodes are secured to the respective first and second portions of the subject's skin,
Claim 1
a waveform generator configured to deliver a pulsed, asymmetric, biphasic electrical stimulation signal
Claim 1
the TES controller is adapted to deliver an asymmetric biphasic electrical stimulation signal of 10 seconds or longer between the first and second electrodes
wherein the waveform has a current frequency of 250 Hz or greater and an intensity of greater than 3 mA,
Claim 1
a frequency of between 3 kHz and 50 kHz
Claim 2
The device of claim 1 wherein the TES controller is adapted to deliver… a peak intensity of between 0.25 mA and 5 mA.
US 10814131
wherein the waveform has a current frequency of 250 Hz or greater and an intensity of greater than 3 mA,
wherein the waveform includes positive-going pulses and/or negative-going pulses,
Claim 1
a waveform generator configured to deliver a pulsed, asymmetric, biphasic electrical stimulation signal between the first and second connectors
Claim 1
asymmetric biphasic electrical stimulation
wherein the control module includes capacitance discharging circuitry that is configured to deliver a capacitive discharge current at an end of each positive-going pulse and/or at an end of each negative-going pulse,
Claim 1
a capacitive discharge circuit triggered by the controller and connected to one or both of the first and second connectors and configured to deliver a capacitive discharging pulse between a positive pulse and a negative pulse of the biphasic electrical stimulation signal
Claim 10
The device of claim 1, further comprising a capacitive discharge circuit, wherein the TES controller is configured to occasionally trigger the capacitive discharge circuit to discharge capacitance on the electrodes during the delivery of the electrical stimulation,
wherein the capacitive discharge current corresponds to a spike in current.
Claim 1
to discharge a capacitive charge on either or both the first electrode and the second electrode.
Claim 10
wherein the capacitive discharge circuit is configured to generate a gradual capacitive discharging pulse with controlled time constant and peak value.
Claim 15
The portable TES applicator device of claim 14, wherein the waveform has a duty cycle of greater than 10 percent.
Claim 2
having a duty cycle of between 20 and 50
US 10814131
duty cycle of greater than 10 percent.
Therefore, the claim of U.S. Patent No. 10426945 anticipate all instance of claims 1, 7, 14, & 15 on instant application as laid out in Table 1 above.
Claims 3-6, 8-9, 11-13, & 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 & 7 of U.S. Patent No. 10426945 in view of Demers et al. (US 2015/0335888 published Nov-26, 2015, hereinafter Demers).
Demers teaches a lightweight, wearable neurostimulator apparatuses that may be operated with an electrode assembly so that the neurostimulator apparatus may be comfortably and securely held to the user's body (e.g., head, neck, etc.) by attachment to the electrode assembly ([0014]). Demers explains that although there are some lightweight and presumably wearable neuromodulation devices have been described, none of these systems are adapted for use with electrodes (e.g., disposable electrode assemblies) for applying energy to a user's head ([0008]), and address a need for wearable neurostimulators that are configured to be comfortably wearable and will not fall off when a user is moving around ([0009]). Demers also teaches that capacitance might build up between the electrodes, causing pain and discomfort, which could reduce the cognitive effects of the TES. Therefore, there is a need for a neurostimulator to include stimulation circuits that may reduce discomfort, for example, neurostimulators that include a “short-circuiting” feature that is configured to reduce discomfort and accordingly increase the cognitive effects induced by TES ([0010]). The methods and apparatuses (e.g., devices and systems, and methods of operating such apparatuses) taught by Demers may address at least the needs identified above ([0012]).
The device taught by Demers may be connected to a microcontroller or other logic circuit. The microcontroller or other logic circuit may also incorporate a clock or other timing circuit. (wherein the control module further includes a processor and a timer) ([0237]), which can receive control may include control of the start, duration, and timing of stimulation (e.g., on/off, duration, etc.) and/or may also include controls for the waveforms to be applied to induce a cognitive effect in a subject (0152]). At least on embodiment of the TES includes a housing containing current control circuitry, fuse and other safety circuitry, wireless antenna and chipset, waveform generator, memory, microprocessor, and connector to first electrode ( wherein the control module is at least partially housed within a body of the portable TES applicator device). The TES device comprises a waveform generator configured to deliver a pulsed, asymmetric, biphasic current ([0084]) (wherein the waveform includes positive-going pulses and negative-going pulses, and wherein the control module is configured to deliver an asymmetric electrical waveform with regard to phases of the positive-going pulses and the negative-going pulses) and a control module that is adapted to deliver a biphasic electrical stimulation signal… having a frequency of 400 Hz or greater, a duty cycle of greater than 10 percent, an intensity of 3 mA or greater” in [0266]), and the capacitive discharging circuitry that can be triggered at the onset of each negative-going pulse ([0269]) (wherein the capacitance discharging circuitry is further configured to deliver a second capacitive discharge current at a start of each positive-going pulse and/or at a start of each negative-going pulse). Demers teaches multiple possible placements for electrodes including a pair of electrodes of a transdermal neurostimulator attached to subject's head, neck, or head and neck (wherein the first electrode is configured to be secured to a first location on the back of the subject’s neck, and the second electrode is configured to be secured to a second location on the back of the subject’s neck). In general, in any of the apparatuses and methods described, the electrodes (and particularly the second electrode) may be configured for placement in any appropriate region of the body, and are not limited to the mastoid and neck regions described in these examples. The examiner further notes that two electrodes attached to the subject’s neck, as opposed to their head and neck, would necessarily be connected to two different points on the subject’s neck ([0097]). Demers also gives a specific example of placing the first electrode in electrical contact with the skin at the temple region and the second electrode in contact with the mastoid region ([0214]) (wherein the first electrode is configured to be secured to the subject’s temple or forehead, and the second electrode is configured to be secured to the subject’s neck) In figure 12B, Demers shows and example of the controller triggering the capacitive discharge circuit to short the anode-cathode path at the time when the positive pulse ends ([0268]) (wherein the capacitive discharge is applied immediately after a voltage of each positive-going pulse and/or each negative-going pulse starts to plateau) and in Fig. 14A shows a negative going pulse that occurs during the return portion of an adjacent capacitive discharge, see annotated Fig 14A below) (wherein a time constant for return of the capacitive discharge is sufficiently long such that an adjacent negative-going pulse rides on a return portion of the capacitive discharge current).
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It would have been obvious to one of ordinary skill in the art at the time of filing of the instant application to include a control module further includes a processor and a timer at least partially housed within a body of the portable TES applicator device comprising a waveform generator wherein the waveform includes positive-going pulses and negative-going pulses, and wherein the control module is configured to deliver an asymmetric electrical waveform with regard to phases of the positive-going pulses and the negative-going pulses with a current frequency of 250 Hz or greater and an intensity of greater than 3 mA, wherein the waveform has a duty cycle of greater than 10 percent, including capacitance discharging circuitry wherein the capacitance discharging circuitry is further configured to deliver a second capacitive discharge current at a start of each positive-going pulse and/or at a start of each negative-going pulse, wherein the capacitive discharge is applied immediately after a voltage of each positive-going pulse and/or each negative-going pulse starts to plateau and wherein a time constant for return of the capacitive discharge is sufficiently long such that an adjacent negative-going pulse rides on a return portion of the capacitive discharge current and a first electrode is configured to be secured to a first location on the back of the subject’s neck or secured to the subject’s temple or forehead, and a second electrode is configured to be secured to a second location on the back of the subject’s neck taught by Demers in the portable TES applicator device taught by U.S. Patent No. 10426945 for the purpose of implementing a comfortably wearable TES device that features capacitive discharging circuitry configured to reduce discomfort and accordingly increase the cognitive effects induced by TES.
Claims 2 & 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 & 7 of U.S. Patent No. 10426945 in view of Diubaldi et al. (WO 2014163783, hereinafter Diubaldi).
With regard to claims 2 & 10, U.S. Patent No. 10426945 the portable TES applicator device of claim 1.
U.S. Patent No. 10426945 does not teach wherein the first electrode is configured to be secured to a medial portion of the subject’s neck, and the second electrode is configured to be secured above the first electrode and wherein the electrical stimulation is configured to suppress the subject’s sympathetic nervous system.
Diubaldi teaches, in one aspect, a device for providing transdermal electrical stimulation at an adjustable position on a head configured to be fixedly supported about an anatomical body part; the supporting member being adjustably positionable in only two directions substantially perpendicular to one another ([0005]). Figure 5 A is back view of the head of the human body showing an alternative embodiment of the present inventive transcutaneous external electrical stimulator system for simultaneous/staggered electrical stimulation of the occipital and trigeminal nerves with the patch disposed to stimulate the occipital nerve oriented in a substantially horizontal direction ([0015]), and Figure 5C is an alternative substantially vertical orientation of the patch for stimulation of the occipital nerve in accordance with the present inventive transcutaneous external electrical stimulator system for simultaneous electrical stimulation of the occipital and trigeminal nerves ([0017]). Patch 005 is depicted in Figure 5A & C with a pair of electrodes 505 and may be positioned with the orientation of the patch modified, as desired, for example, substantially horizontal direction as seen in Figure 5A or in a substantially vertical direction as seen in Figure 5C ([0049]) (wherein the first electrode is configured to be secured to a medial portion of the subject’s neck, and the second electrode is configured to be secured above the first electrode). Diubaldi goes on to explain that when the electrode patch is positioned at the back of the head such as in the various orientations depicted in Figures 5A & 5C, it is positioned to stimulate the occipital nerve (or one of its branches) and trigeminal nerves (or one of its superficial branches, for example, opthamalic nerve ([0049]). Instant application describes eliciting “a calm or relaxed mental state” by placing at least one of a pair of electrodes on or over the nerves of the cervical plexus (instant specification [0023]), and explains that the cervical plexus may be located in the neck, deep to sternocleidomastoideos formed from the cervical plexus also innervate the back of the head (instant specification [0292]) and includes, among others, the lesser occipital nerve (instant specification [0292]). By stimulating the occipital nerve at the back of the head and neck, Diubaldi reads on eliciting a calm or relaxed mental state, i.e. suppressing the sympathetic nervous system (wherein the electrical stimulation is configured to suppress the subject’s sympathetic nervous system).
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant application to combine the known method of configuring a first electrode to be secured to a medial portion of the subject’s neck and configuring a second electrode to be secured above the first electrode taught by Diubaldi to the wearable neurostimulator apparatuses taught by U.S. Patent No. 10426945 to yield the predictable result of stimulating nerves at the back of the head with parasympathetic output.
Claims 1 & 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 & 7 of U.S. Patent No. 10814131 in view of Demers.
Therefore, the claim of U.S. Patent No. 10814131 anticipate all instance of claims 1 & 14 on instant application as laid out in Table 1 above except for a portable TES device and wherein the waveform has a current frequency of 250 Hz or greater and an intensity of greater than 3 mA.
However, attention is drawn to the Demers reference. Demers teaches a lightweight, wearable neurostimulator apparatuses that may be operated with an electrode assembly so that the neurostimulator apparatus may be comfortably and securely held to the user's body (e.g., head, neck, etc.) by attachment to the electrode assembly ([0014]) (a portable TES device). Demers explains that although there are some lightweight and presumably wearable neuromodulation devices have been described, none of these systems are adapted for use with electrodes (e.g., disposable electrode assemblies) for applying energy to a user's head ([0008]), and address a need for wearable neurostimulators that are configured to be comfortably wearable and will not fall off when a user is moving around ([0009]). Demers also teaches that capacitance might build up between the electrodes, causing pain and discomfort, which could reduce the cognitive effects of the TES. Therefore, there is a need for a neurostimulator to include stimulation circuits that may reduce discomfort, for example, neurostimulators that include a “short-circuiting” feature that is configured to reduce discomfort and accordingly increase the cognitive effects induced by TES ([0010]). In devices with an asymmetric waveform lower frequency stimulation at a fixed duty cycle will cause relatively more capacitance build-up per cycle ([0265]). Therefore, Demers teaches a system with a frequency of 400 Hz or greater, a duty cycle of greater than 10 percent, an intensity of 3 mA or greater (wherein the waveform has a current frequency of 250 Hz or greater and an intensity of greater than 3 mA).
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant application to apply making a portable TES device with a waveform that has a current frequency of 250 Hz or greater and an intensity of greater than 3 mA taught by Demers to the transdermal electrical stimulation (TES) device taught by U.S. Patent No. 10814131 in view of Demers for the purpose of addressing a need for wearable neurostimulators that are configured to be comfortably wearable and will not fall off with relatively less capacitance build-up per cycle.
Claims 3-9, 11-13, & 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 & 7 of U.S. Patent No. 10814131 in view of Demers.
Demers teaches a lightweight, wearable neurostimulator apparatuses that may be operated with an electrode assembly so that the neurostimulator apparatus may be comfortably and securely held to the user's body (e.g., head, neck, etc.) by attachment to the electrode assembly ([0014]). Demers explains that although there are some lightweight and presumably wearable neuromodulation devices have been described, none of these systems are adapted for use with electrodes (e.g., disposable electrode assemblies) for applying energy to a user's head ([0008]), and address a need for wearable neurostimulators that are configured to be comfortably wearable and will not fall off when a user is moving around ([0009]). Demers also teaches that capacitance might build up between the electrodes, causing pain and discomfort, which could reduce the cognitive effects of the TES. Therefore, there is a need for a neurostimulator to include stimulation circuits that may reduce discomfort, for example, neurostimulators that include a “short-circuiting” feature that is configured to reduce discomfort and accordingly increase the cognitive effects induced by TES ([0010]). The methods and apparatuses (e.g., devices and systems, and methods of operating such apparatuses) taught by Demers may address at least the needs identified above ([0012]).
The device taught by Demers may be connected to a microcontroller or other logic circuit. The microcontroller or other logic circuit may also incorporate a clock or other timing circuit. (wherein the control module further includes a processor and a timer) ([0237]), which can receive control may include control of the start, duration, and timing of stimulation (e.g., on/off, duration, etc.) and/or may also include controls for the waveforms to be applied to induce a cognitive effect in a subject (0152]). At least on embodiment of the TES includes a housing containing current control circuitry, fuse and other safety circuitry, wireless antenna and chipset, waveform generator, memory, microprocessor, and connector to first electrode ( wherein the control module is at least partially housed within a body of the portable TES applicator device). The TES device comprises a waveform generator configured to deliver a pulsed, asymmetric, biphasic current ([0084]) (wherein the waveform includes positive-going pulses and negative-going pulses, and wherein the control module is configured to deliver an asymmetric electrical waveform with regard to phases of the positive-going pulses and the negative-going pulses) and a control module that is adapted to deliver a biphasic electrical stimulation signal… having a frequency of 400 Hz or greater, a duty cycle of greater than 10 percent, an intensity of 3 mA or greater” in [0266]), (wherein the waveform has a current frequency of 250 Hz or greater and an intensity of greater than 3 mA, wherein the waveform has a duty cycle of greater than 10 percent) and the capacitive discharging circuitry that can be triggered at the onset of each negative-going pulse ([0269]) (wherein the capacitance discharging circuitry is further configured to deliver a second capacitive discharge current at a start of each positive-going pulse and/or at a start of each negative-going pulse). Demers teaches multiple possible placements for electrodes including a pair of electrodes of a transdermal neurostimulator attached to subject's head, neck, or head and neck (wherein the first electrode is configured to be secured to a first location on the back of the subject’s neck, and the second electrode is configured to be secured to a second location on the back of the subject’s neck). In general, in any of the apparatuses and methods described, the electrodes (and particularly the second electrode) may be configured for placement in any appropriate region of the body, and are not limited to the mastoid and neck regions described in these examples. The examiner further notes that two electrodes attached to the subject’s neck, as opposed to their head and neck, would necessarily be connected to two different points on the subject’s neck ([0097]). Demers also gives a specific example of placing the first electrode in electrical contact with the skin at the temple region and the second electrode in contact with the mastoid region ([0214]) (wherein the first electrode is configured to be secured to the subject’s temple or forehead, and the second electrode is configured to be secured to the subject’s neck) In figure 12B, Demers shows and example of the controller triggering the capacitive discharge circuit to short the anode-cathode path at the time when the positive pulse ends ([0268]) (wherein the capacitive discharge is applied immediately after a voltage of each positive-going pulse and/or each negative-going pulse starts to plateau) and in Fig. 14A shows a negative going pulse that occurs during the return portion of an adjacent capacitive discharge, see annotated Fig 14A below) (wherein a time constant for return of the capacitive discharge is sufficiently long such that an adjacent negative-going pulse rides on a return portion of the capacitive discharge current).
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It would have been obvious to one of ordinary skill in the art at the time of filing of the instant application to include a control module further includes a processor and a timer at least partially housed within a body of the portable TES applicator device comprising a waveform generator wherein the waveform includes positive-going pulses and negative-going pulses, and wherein the control module is configured to deliver an asymmetric electrical waveform with regard to phases of the positive-going pulses and the negative-going pulses with a current frequency of 250 Hz or greater and an intensity of greater than 3 mA, wherein the waveform has a duty cycle of greater than 10 percent, including capacitance discharging circuitry wherein the capacitance discharging circuitry is further configured to deliver a second capacitive discharge current at a start of each positive-going pulse and/or at a start of each negative-going pulse, wherein the capacitive discharge is applied immediately after a voltage of each positive-going pulse and/or each negative-going pulse starts to plateau and wherein a time constant for return of the capacitive discharge is sufficiently long such that an adjacent negative-going pulse rides on a return portion of the capacitive discharge current and a first electrode is configured to be secured to a first location on the back of the subject’s neck or secured to the subject’s temple or forehead, and a second electrode is configured to be secured to a second location on the back of the subject’s neck taught by Demers in the portable TES applicator device taught by U.S. Patent No. 10814131 in view of Demers for the purpose of implementing a comfortably wearable TES device that features capacitive discharging circuitry configured to reduce discomfort and accordingly increase the cognitive effects induced by TES.
Claims 2 & 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 & 7 of U.S. Patent No. 10814131 in view of Demers, in further view of Diubaldi.
With regard to claims 2 & 10, U.S. Patent No. 10814131 in view of Demers teaches the portable TES applicator device of claim 1.
U.S. Patent No. 10814131 in view of Demers does not teach wherein the first electrode is configured to be secured to a medial portion of the subject’s neck, and the second electrode is configured to be secured above the first electrode and wherein the electrical stimulation is configured to suppress the subject’s sympathetic nervous system.
Diubaldi teaches, in one aspect, a device for providing transdermal electrical stimulation at an adjustable position on a head configured to be fixedly supported about an anatomical body part; the supporting member being adjustably positionable in only two directions substantially perpendicular to one another ([0005]). Figure 5 A is back view of the head of the human body showing an alternative embodiment of the present inventive transcutaneous external electrical stimulator system for simultaneous/staggered electrical stimulation of the occipital and trigeminal nerves with the patch disposed to stimulate the occipital nerve oriented in a substantially horizontal direction ([0015]), and Figure 5C is an alternative substantially vertical orientation of the patch for stimulation of the occipital nerve in accordance with the present inventive transcutaneous external electrical stimulator system for simultaneous electrical stimulation of the occipital and trigeminal nerves ([0017]). Patch 005 is depicted in Figure 5A & C with a pair of electrodes 505 and may be positioned with the orientation of the patch modified, as desired, for example, substantially horizontal direction as seen in Figure 5A or in a substantially vertical direction as seen in Figure 5C ([0049]) (wherein the first electrode is configured to be secured to a medial portion of the subject’s neck, and the second electrode is configured to be secured above the first electrode). Diubaldi goes on to explain that when the electrode patch is positioned at the back of the head such as in the various orientations depicted in Figures 5A & 5C, it is positioned to stimulate the occipital nerve (or one of its branches) and trigeminal nerves (or one of its superficial branches, for example, opthamalic nerve ([0049]). Instant application describes eliciting “a calm or relaxed mental state” by placing at least one of a pair of electrodes on or over the nerves of the cervical plexus (instant specification [0023]), and explains that the cervical plexus may be located in the neck, deep to sternocleidomastoideos formed from the cervical plexus also innervate the back of the head (instant specification [0292]) and includes, among others, the lesser occipital nerve (instant specification [0292]). By stimulating the occipital nerve at the back of the head and neck, Diubaldi reads on eliciting a calm or relaxed mental state, i.e. suppressing the sympathetic nervous system (wherein the electrical stimulation is configured to suppress the subject’s sympathetic nervous system).
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant application to combine the known method of configuring a first electrode to be secured to a medial portion of the subject’s neck and configuring a second electrode to be secured above the first electrode taught by Diubaldi to the wearable neurostimulator apparatuses taught by U.S. Patent No. 10814131 in view Demers to yield the predictable result of stimulating nerves at the back of the head with parasympathetic output.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-9, & 11-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Demers.
Regarding claim 1, 2-9, & 11-13, Demers teaches a portable transdermal electrical stimulation (TES) applicator device, comprising: a first electrode configured to be secured to a first portion of a subject’s skin (Fig.s 1-8 & 24-29 and “described herein are lightweight, wearable neurostimulator apparatuses that may be operated with an electrode assembly so that the neurostimulator apparatus may be comfortably and securely held to the user's body (e.g., head, neck, etc.) by attachment to the electrode assembly” in [0014]); a second electrode configured to be secured to a second portion of the subject’s skin (133 & 135 in Fig 4D and “attaching a first electrode portion of an electrode assembly to the subject's temple and a second electrode portion of an electrode assembly to a second region on the subject's head or neck” in [0030]); and a control module including a waveform generator that is configured to deliver a waveform that causes an electrical stimulation to be delivered between the first and second electrodes when the first and second electrodes are secured to the respective first and second portions of the subject’s skin (2508 in Fig. 25 and “the controller comprises a waveform generator configured to deliver a biphasic electrical signal between the first electrode and the second electrode” in [0032]), wherein the waveform includes positive-going pulses and/or negative-going pulses (Fig. 9C & Fig. 12A-D and “a biphasic electrical signal” in [0032]), wherein the control module includes capacitance discharging circuitry that is configured to deliver a capacitive discharge current (“In some variations the circuitry includes capacitive discharge circuitry that is configured to controllably apply current to one or more electrical contacts (and therefore the electrodes they are connected to) to prevent or eliminate capacitive charge. ” in [0014]) at an end of each positive-going pulse and/or at an end of each negative-going pulse, wherein the capacitive discharge current corresponds to a spike in current (“configured to deliver a gradual capacitive discharging current pulse during a portion of a cycle of the biphasic electrical stimulation signal” in [0084]), wherein the control module further includes a processor and a timer (“the microcontroller or other logic circuit may also incorporate a clock or other timing circuit” in [0237]), wherein the control module is at least partially housed within a body of the portable TES applicator device (2512 in Fig. 25 and “TES housing 2512 containing current control circuitry 2505, fuse and other safety circuitry 2506, wireless antenna and chipset 2507, waveform generator 2508, memory 2509, microprocessor 2510, and connector to first electrode (2514) connected by electrically conductive cable 2511 to second durable TES housing 2513 containing a battery 2501, recharging circuitry 2502, connector to second electrode 2503, and other electrical components 2504” in [0220]), wherein the waveform includes positive-going pulses and negative-going pulses (Fig. 9C & Fig. 12A-D and “a biphasic electrical signal” in [0032]), wherein the control module is configured to deliver an asymmetric electrical waveform with regard to phases of the positive-going pulses and the negative-going pulses (Fig 10, Fig 12A and “a waveform generator configured to deliver a pulsed, asymmetric, biphasic current” in [0084]), wherein the waveform has a current frequency of 250 Hz or greater and an intensity of greater than 3 mA, wherein the waveform has a duty cycle of greater than 10 percent (“the TES control module is adapted to deliver a biphasic electrical stimulation signal… having a frequency of 400 Hz or greater, a duty cycle of greater than 10 percent, an intensity of 3 mA or greater” in [0266]), wherein the capacitance discharging circuitry is further configured to deliver a second capacitive discharge current at a start of each positive-going pulse and/or at a start of each negative-going pulse (Fig. 12E, Fig. 14B, and “the capacitive discharging pulse can be triggered at the onset of each negative-going pulse” in [0269]), wherein the first electrode is configured to be secured to a first location on the back of the subject’s neck, and the second electrode is configured to be secured to a second location on the back of the subject’s neck (“a pair of electrodes of a transdermal neurostimulator attached to subject's head, neck, or head and neck” the examiner notes that two electrodes attached to the subject’s neck, as opposed to their head and neck, would necessarily be connected to two different points on the subject’s neck, and “In general, in any of the apparatuses and methods described herein, the electrodes (and particularly the second electrode) may be configured for placement in any appropriate region of the body, and are not limited to the mastoid and neck regions described in these examples. Other locations include other face regions (e.g., central forehead, etc.), scalp regions, the body below the neck, etc.” in [0097]), wherein the first electrode is configured to be secured to the subject’s temple or forehead, and the second electrode is configured to be secured to the subject’s neck (Fig7A-D and “placing the first active region 433 of the first electrode portion 405 in electrical contact with the skin at the temple region… the second electrically active region 435 is in contact with the mastoid region” in [0214]), wherein the capacitive discharge is applied immediately after a voltage of each positive-going pulse starts to plateau (Fig. 12B and “as shown in FIG. 12B, at the time when the positive pulse ends, the controller triggers the capacitive discharge circuit to short the anode-cathode path” in [0268]), wherein a time constant for return of the capacitive discharge is sufficiently long such that an adjacent negative-going pulse rides on a return portion of the capacitive discharge current (Fig. 14A shows a negative going pulse that occurs during the return portion of an adjacent capacitive discharge, see annotated Fig 14A below).
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Regarding claim 14-20, Demers teaches a portable transdermal electrical stimulation (TES) applicator device, comprising: a first electrode configured to be secured to a first portion of a subject’s skin (Fig.s 1-8 & 24-29 and “described herein are lightweight, wearable neurostimulator apparatuses that may be operated with an electrode assembly so that the neurostimulator apparatus may be comfortably and securely held to the user's body (e.g., head, neck, etc.) by attachment to the electrode assembly” in [0014]); a second electrode configured to be secured to a second portion of the subject’s skin (133 & 135 in Fig 4D and “attaching a first electrode portion of an electrode assembly to the subject's temple and a second electrode portion of an electrode assembly to a second region on the subject's head or neck” in [0030]); and a control module including a waveform generator that is configured to deliver a waveform that causes an electrical stimulation to be delivered between the first and second electrodes when the first and second electrodes are secured to the respective first and second portions of the subject’s skin (2508 in Fig. 25 and “the controller comprises a waveform generator configured to deliver a biphasic electrical signal between the first electrode and the second electrode” in [0032]), wherein the waveform has a current frequency of 250 Hz or greater and an intensity of greater than 3 mA(“the TES control module is adapted to deliver a biphasic electrical stimulation signal… having a frequency of 400 Hz or greater, a duty cycle of greater than 10 percent, an intensity of 3 mA or greater” in [0266]), wherein the waveform includes positive-going pulses and/or negative-going pulses (“the TES control module is adapted to deliver a biphasic electrical stimulation signal” in [0266]), wherein the control module includes capacitance discharging circuitry that is configured to deliver a capacitive discharge current at an end of each positive-going pulse and/or at an end of each negative-going pulse (“In some variations the circuitry includes capacitive discharge circuitry that is configured to controllably apply current to one or more electrical contacts (and therefore the electrodes they are connected to) to prevent or eliminate capacitive charge. ” in [0014]), wherein the capacitive discharge current corresponds to a spike in current(“configured to deliver a gradual capacitive discharging current pulse during a portion of a cycle of the biphasic electrical stimulation signal” in [0084]), wherein the waveform has a duty cycle of greater than 10 percent (a duty cycle of greater than 10 percent” in [0266]), wherein the waveform includes positive-going pulses and negative-going pulses (Fig. 9C & Fig. 12A-D and “a biphasic electrical signal” in [0032]), wherein the control module is configured to deliver an asymmetric electrical waveform with regard to phases of the positive-going pulses and the negative-going pulses (Fig 10, Fig 12A and “a waveform generator configured to deliver a pulsed, asymmetric, biphasic current” in [0084]), wherein the capacitive discharge is applied immediately after a voltage of each positive-going pulse and/or each negative-going pulse starts to plateau (Fig. 12B and “as shown in FIG. 12B, at the time when the positive pulse ends, the controller triggers the capacitive discharge circuit to short the anode-cathode path” in [0268]), wherein the first electrode is configured to be secured to a first location on the back of the subject’s neck, and the second electrode is configured to be secured to a second location on the back of the subject’s neck (“a pair of electrodes of a transdermal neurostimulator attached to subject's head, neck, or head and neck” the examiner notes that two electrodes attached to the subject’s neck, as opposed to their head and neck, would necessarily be connected to two different points on the subject’s neck, and “In general, in any of the apparatuses and methods described herein, the electrodes (and particularly the second electrode) may be configured for placement in any appropriate region of the body, and are not limited to the mastoid and neck regions described in these examples. Other locations include other face regions (e.g., central forehead, etc.), scalp regions, the body below the neck, etc.” in [0097]), wherein the first electrode is configured to be secured to the subject’s temple or forehead, and the second electrode is configured to be secured to the subject’s neck (Fig7A-D and “placing the first active region 433 of the first electrode portion 405 in electrical contact with the skin at the temple region… the second electrically active region 435 is in contact with the mastoid region” in [0214]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2 & 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diubaldi.
With regard to claims 2 & 10, Demers teaches the portable TES applicator device of claim 1.
Demers does not teach wherein the first electrode is configured to be secured to a medial portion of the subject’s neck, and the second electrode is configured to be secured above the first electrode and wherein the electrical stimulation is configured to suppress the subject’s sympathetic nervous system.
Diubaldi teaches, in one aspect, a device for providing transdermal electrical stimulation at an adjustable position on a head configured to be fixedly supported about an anatomical body part; the supporting member being adjustably positionable in only two directions substantially perpendicular to one another ([0005]). Figure 5 A is back view of the head of the human body showing an alternative embodiment of the present inventive transcutaneous external electrical stimulator system for simultaneous/staggered electrical stimulation of the occipital and trigeminal nerves with the patch disposed to stimulate the occipital nerve oriented in a substantially horizontal direction ([0015]), and Figure 5C is an alternative substantially vertical orientation of the patch for stimulation of the occipital nerve in accordance with the present inventive transcutaneous external electrical stimulator system for simultaneous electrical stimulation of the occipital and trigeminal nerves ([0017]). Patch 005 is depicted in Figure 5A & C with a pair of electrodes 505 and may be positioned with the orientation of the patch modified, as desired, for example, substantially horizontal direction as seen in Figure 5A or in a substantially vertical direction as seen in Figure 5C ([0049]) (wherein the first electrode is configured to be secured to a medial portion of the subject’s neck, and the second electrode is configured to be secured above the first electrode). Diubaldi goes on to explain that when the electrode patch is positioned at the back of the head such as in the various orientations depicted in Figures 5A & 5C, it is positioned to stimulate the occipital nerve (or one of its branches) and trigeminal nerves (or one of its superficial branches, for example, opthamalic nerve ([0049]). Instant application describes eliciting “a calm or relaxed mental state” by placing at least one of a pair of electrodes on or over the nerves of the cervical plexus (instant specification [0023]), and explains that the cervical plexus may be located in the neck, deep to sternocleidomastoideos formed from the cervical plexus also innervate the back of the head (instant specification [0292]) and includes, among others, the lesser occipital nerve (instant specification [0292]). By stimulating the occipital nerve at the back of the head and neck, Diubaldi reads on eliciting a calm or relaxed mental state, i.e. suppressing the sympathetic nervous system (wherein the electrical stimulation is configured to suppress the subject’s sympathetic nervous system).
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant application to combine the known method of configuring a first electrode to be secured to a medial portion of the subject’s neck and configuring a second electrode to be secured above the first electrode taught by Diubaldi to the wearable neurostimulator apparatuses taught by Demers to yield the predictable result of stimulating nerves at the back of the head with parasympathetic output.
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Claims 1 & 14 are rejected under 35 U.S.C. 103 as being unpatentable over Cook et al. (US 2014/0081353 published Mar-03 2014) in view of Zhu and Doan (US 2014/0243924 published Aug-28 2014, hereinafter Zhu).
With regard to claims 1 & 14, Cook teaches a portable transdermal electrical stimulation (TES) applicator device ((Fig 2A&B, “a device configured for stimulation of the sensory branches of the trigeminal nerve in the face and forehead” in [0032] and “in one embodiment, the generator 15 is portable and attached to the belt of the patient” in [0043]), comprising: a first electrode configured to be secured to a first portion of a subject’s skin; a second electrode configured to be secured to a second portion of the subject’s skin (10 in Fig. 2A&B and “the electrode assembly 10 may include a pair of electrodes for placement on a region of the patient's face” in [0043]); and a control module including a waveform generator that is configured to deliver a waveform that causes an electrical stimulation to be delivered between the first and second electrodes when the first and second electrodes are secured to the respective first and second portions of the subject’s skin (15 in Fig.s 2-4 and “the pulse generator as disclosed herein includes a programmable microcontroller which, in various embodiments, may implement some or all of the following features: produces electrical pulses of specific, programmable characteristics” in [0034]), wherein the waveform has a current frequency of 250 Hz (“in some embodiments, the operation includes 2-channels, and operates at the following parameters: frequency 1-300 Hz, pulse duration 50-500 µs, duty cycle 1-100%” in [0062]) or greater and an intensity of greater than 3 mA (“the microcontroller may be set to a range of outputs. In one embodiment, the range may be set to approximately between 2.5 mA and approximately 7 mA” in [0064]), wherein the waveform includes positive-going pulses and/or negative-going pulses (“In one embodiment, the electrode assembly 10 may be configured to deliver a symmetric biphasic pulse. In other embodiments, the pulse waveform may be asymmetric and/or multiphasic” in [0045]),
Cook does not teach wherein the control module includes capacitance discharging circuitry that is configured to deliver a capacitive discharge current at an end of each positive-going pulse and/or at an end of each negative-going pulse, wherein the capacitive discharge current corresponds to a spike in current.
However, attention is drawn to the Zhu reference. Zhu teaches a neuromodulation system comprises a plurality of electrical terminals configured for being respectively coupled to a plurality of electrodes, and modulation output circuitry configured for respectively outputting a plurality of individual electrical pulse trains in a plurality of timing channels to the plurality of electrical terminals. Each of the pulse trains has a modulation pulse, and at least one of the pulse trains has a charge recovery pulse associated with the modulation pulse of the at least one respective pulse train. ([0016]) Zhu explains that multiphasic electrical energy may include a series of biphasic pulses, with each biphasic pulse including a cathodic (negative) stimulation phase and an anodic (positive) charge recovery phase that is generated after the stimulation phase to prevent direct current charge transfer through the tissue, thereby avoiding cell trauma and electrode degradation via corrosion ([0010]). In Fig. 5A&B Zhu illustrates how multiphasic electrical energy may include a series of biphasic pulses, with each biphasic pulse including a cathodic (negative) modulation pulse (during a first phase) and an anodic (positive) charge recovery pulse (during a second phase) that is generated after the modulation pulse to prevent direct current charge transfer through the tissue, thereby avoiding electrode degradation and cell trauma ([0049]). Fig. 5A illustrates an active charge recovery pulse, wherein electrical current is actively conveyed through the electrode via current or voltage sources. Fig. 5B illustrates a passive charge recovery pulse, or the second phase may have a passive charge recovery pulse, wherein electrical current is passively conveyed through the electrode via redistribution of the charge flowing from coupling capacitances present in the circuit (wherein the control module includes capacitance discharging circuitry that is configured to deliver a capacitive discharge current at an end of each positive-going pulse and/or at an end of each negative-going pulse, wherein the capacitive discharge current corresponds to a spike in current)
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant application to incorporate the capacitance discharging circuitry taught by Zhu in to the portable transdermal electrical stimulation (TES) applicator device taught by Cook for the purpose of employing multiphasic energy while avoiding cell trauma and electrode degradation via corrosion that might occur without charge recovery.
Conclusion
US 20170157404 (effectively filed Dec-04 2015)
Overview: Methods, devices and systems for developing new therapy options for patient suffering from neurological disorders. An example may include the use of a therapy patterning and waveform selection system that allows significant freedom to program therapy patterns using 25 arbitrary shapes and functions. For such patterning to be implemented, a physician may identify a condition needing new and/or alternative therapy options, link the identified condition one or more therapy parameters, program, test and assess the therapy. The process may include multiple iterations to address an initial condition and then to mitigate side effects of the initial therapy. The process may also include identifying features of a neural network, identifying signals within the network, and modulating operation of the network, and/or parts of the network. Some embodiments comprise devices configured to deliver certain therapy patterns and combinations as well.
From [0040] As a result of such rulesets, a pattern as shown in Figure 11 and described above may include a first portion, as shown, which is the therapeutic design, and a second portion applicable across the various electrodes to address intermediate term and long term rules, with the second portion designed to apply at sub-threshold levels to avoid paresthesia, for example, or other stimulus, while balancing out charge on the electrode interfaces.
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/W.P.A./ Examiner, Art Unit 3792
/AMANDA L STEINBERG/ Examiner, Art Unit 3792
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