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 .
Status of Claims
Claims 1, 5-11, 18, 24-29, 31, and 33-36 are currently pending and under examination. As per the amendments filed on 06/18/2025, claims 1, 18, and 29 are amended. Claims 4, 23, 30, and 32 are canceled. Claims 33-36 are newly added.
Response to Arguments
Applicant’s arguments, see Remarks page 7 (§ 112 Rejection), filed 06/18/2025, with respect to the rejections of claims 1 and 18 under 35 U.S.C. § 112(b) have been fully considered and are persuasive. Therefore, the rejections of claims 1 and 18 (and dependent claims) are withdrawn.
Applicant’s arguments, see Remarks pages 7-9 (§ 103 Rejections), filed 06/18/2025, with respect to the 35 U.S.C. § 103 rejections of claims 1, 4-11, 18, and 23-32 over Carbunaru (U.S. 9,415,223 B2), Mishra (US PG Pub No. 2019/0001139 A1), Zottola (US PG Pub 2016/0220820 A1), and Kronberg (US PG Pub 2008/0039901 A1) have been fully considered but they are not persuasive. Claims 4, 23, 30, and 32 are canceled. Specifically, Applicant argues:
None of the cited references teach or suggest making, by a processor, a determination or estimation of an unrecovered charge during delivery of the first stimulation pulse; during delivery of the first stimulation pulse, when the determined or estimated unrecovered charge achieves a predetermined threshold amount, applying a charge recovery pulse to interrupt the delivery of the first stimulation pulse. Contrary to these recitations of steps occurring during delivery of the first stimulation pulse, Carbunaru, Kronberg, Mishra, and Zottola all disclose programming stimulation pulses and charge recovery pulses prior to beginning stimulation (Page 8)
In commenting on the 04/11/2025 office action, the Applicant argues:
In view of these comments in the Office Action, claims 1 and 18 have been amended to clarify that a determination or estimation of the unrecovered charge is made during delivery of the first stimulation pulse. None of the cited references teach or suggest making such a determination or estimation during delivery of a stimulation pulse. For example, Figures 8 and 9 of Zottola demonstrate that the charge recovery scheme is added to the waveform before stimulation parameters are generated and delivered to a neurostimulation device for providing therapy. Accordingly, Carbunaru, Mishra, and Zottola fail to teach or suggest all of the elements of claims 1 and 18. For at least these reasons, claims 1 and 18, as well as the remainder of the claims which depend therefrom, are patentable over the cited references. The Applicant respectfully requests withdrawal of the rejection of these claims. (Page 9)
The Examiner recognizes the main argument stems from different interpretations between the Examiner and Applicant with respect to the chronology of claimed events that occur “during delivery of the first stimulation pulse.” Zottola teaches a means for automatically adjusting waveforms to add charge recovery phases to achieve a specified level of charge balancing ([0006] – “The waveform adjuster may be configured to identify a need for recovering charges injected during the charge injection phases and adjust the received stimulation waveform by automatically inserting charge recovery phases into the received stimulation waveform based on the identified need for recovering the injected charges and the received charge recovery scheme”). These waveform adjustments are estimations during programming which are implemented by hardware during delivery of the first stimulation pulse where charge imbalances have been detected and corrected with added charge recovery phases ([0069] – “In various embodiments, charge recovery module 622 can monitor whether an acceptable level of charge balance can be achieved based on the stimulation waveform and the charge recovery scheme entered by the user, and warn the user when the acceptable level of charge balance cannot be achieved … In various embodiments, waveform definition circuit 620, including charge recovery module 622, reduces or removes the burden of considering charge recovery phases during the creation of a stimulation waveform, thereby allowing the user to focus on defining the charge injection phases that provide the desired pattern of evoked action potentials in the target tissue of the neurostimulation”).
The “acceptable level of charge balance” (such as presented in [0088-0089]) is interpreted as a charge threshold to be achieved.
While the broadest reasonable interpretation of Zottolahas been assessed, it should be noted that an interpretation of instantaneous charge monitoring via measurements is represented in prior art such as Harkema (WO 2019/204677 A1, see “Notice of References Cited”). Harkema teaches monitoring charge buildup and releasing the charge when a threshold is reached ([0017] – “In some embodiments, waveforms are optimized by shorting the electrodes if the charge or charge density reaches or exceeds a predetermined threshold. The predetermined threshold is preferably selected to short the electrodes before reaching a charge or charge density that may be damaging to the patient, the electrodes, or both”) where the recovery phase can be either passive or active ([0033]). Therefore, the rejections of claims 1, 5-11, 28-29, and 31 are maintained. Due to the inclusion of new claim 33 (where the stimulation parameters in Harkema and Kronberg conflict with respect to pulse duration), the rejections of claims 18 and 24-27 are withdrawn. New rejections over Carbunaru in view of Mishra and Zottola are added (using the same basis as the corresponding apparatus claims). Newly added claims 33-36 are rejected over combinations of Carbunaru, Mishra, Zottola, and Harkema (see “Claim Rejections - 35 USC § 103”).
Summary: The 35 U.S.C. § 103 rejections for claims 1, 5-11, 28-29, and 31 are maintained. The 35 U.S.C. § 103 rejections for claims 18 and 24-27 are withdrawn. New 35 U.S.C. § 103 rejections for claims 18 and 24-27 over Carbunaru in view of Mishra and Zottola are added. New 35 U.S.C. § 103 rejections for claims 33-36 over Carbunaru, Mishra, Zottola, and Harkema are added (see “Claim Rejections - 35 USC § 103”).
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1, 5-11, 18, 24-29, 31, and 33-35 are rejected under U.S.C 103 as being unpatentable over Carbunaru (U.S. No. 9,415,223 B2, see previously cited) in view of Mishra (US PG Pub 2019/0001139 A1, see previously cited) and Zottola (U.S. PG Pub 2016/0220820 A1, see IDS filed on 11/30/2022).
Regarding Claim 1, Carbunaru discloses an electrical stimulation system (Col. 1, Lines 17-19), comprising:
-at least one electrical stimulation lead, each of the at least one electrical stimulation lead comprising a plurality of stimulation electrodes (Col. 1, Lines 50-54); and
-a processor (114, 130) coupled to the at least one electrical stimulation lead (Col. 2, Lines 8-17), wherein the processor executes instructions that perform actions, comprising:
-directing delivery of at least one stimulation pulse through at least one of the stimulation electrodes of the at least one electrical stimulation lead to tissue of a patient during each of a plurality of charge injection phases (Col. 2, Lines 41-46), wherein each consecutive pair of the charge injection phases is separated by a charge recovery phase (Col. 2, Lines 47-54), wherein the plurality of charge injection phases comprises a first charge injection phase and the at least one stimulation pulse for delivery during the first charge injection phase comprises a first stimulation pulse (Fig 9a, Col 12, Lines 38-59 – shows the waveform with charge injection and charge recovery phases), wherein the first stimulation pulse is predetermined (Col 38, Lines 36-46);
Carbunaru does not teach wherein the directing delivery comprises:
during delivery of the first stimulation pulse, making, by the processor, a determination or estimation of an unrecovered charge;
during delivery of the first stimulation pulse, when the determined or estimated unrecovered charge achieves a predetermined threshold amount, directing, during the delivery of the first stimulation pulse, application of a charge recovery pulse to interrupt the delivery of the first stimulation pulse, wherein the charge recovery pulse has a relative amplitude that is larger in magnitude than an amplitude of the first stimulation pulse;
after application of the charge recovery pulse, directing resumption of the delivery of the first stimulation pulse at the amplitude of the first stimulation pulse; and
repeating steps i) to iii) at least once during the delivery of the first stimulation pulse.
Mishra, in the same field of charge-balanced electrical stimulation, teaches an implantable stimulator control which applies pulse trains in burst patterns (Fig. 30A, [0393]) made up of biphasic pulses ([0393] – “the trains of FIG. 30A are illustrated as comprising multiple bi-phasic pulses (pulses comprising alternating phases of energy delivery)”). The train-on periods featuring bi-phasic pulses are separated by non-stimulation train-off periods ([0393] – “In FIG. 30A, apparatus 10 can deliver a series of narrow pulses (e.g. between 2 and 1000 pulses, 8 biphasic pulses shown) for a train-on period Ton (e.g. a time period of between 1 μsec to 100 msec), after which no energy is delivered for a train-off period Toff (e.g. a time period of between 1 μsec to 100 msec)”). The biphasic pulses can facilitate full charge balancing ([0388] – “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”) by generating stimulation and charge recovery pulses with different amplitude and pulse width combinations based on the current and time constraints of the stimulation signal where charge recovery pulses can have a greater amplitude (and shorter pulse width) than the corresponding stimulation pulse ([0388-0399]).
Mishra additionally teaches the utility of applying bursts of pulse trains to reducing power consumption while able to generate an appropriate therapeutic effect ([0393] – “In some embodiments, apparatus 10 is configured to provide ‘compliance optimized burst’, for example when one or more implantable devices 200 deliver a repeated series of short stimulation pulses comprising voltage compliance optimized narrow pulses providing reduced power consumption while providing therapeutic efficacy”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Carbunara’s charge recovery control device by incorporating the pulse train burst mode in Mishra. This would have been obvious because both Carbunara and Mishra discuss charge-balanced electrical stimulation and Mishra provides a solution/improvement with the beneficial effects burst pulsing can have on power consumption and therapeutic efficacy. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Carbunara by incorporating the pulse train burst mode in Mishra.
Zottola, in the same field of charge-balanced electrical stimulation, provides a waveform adjuster which can make a determination to automatically adjust application of charge recovery waveforms for charge-balancing concerns ([0006] – “The waveform adjuster may be configured to identify a need for recovering charges injected during the charge injection phases and adjust the received stimulation waveform by automatically inserting charge recovery phases into the received stimulation waveform based on the identified need for recovering the injected charges and the received charge recovery scheme”). These waveform adjustments are programming which are implemented during delivery of the first stimulation pulse where charge imbalances have been detected and corrected with charge recovery phases ([0069] – “In various embodiments, charge recovery module 622 can monitor whether an acceptable level of charge balance can be achieved based on the stimulation waveform and the charge recovery scheme entered by the user, and warn the user when the acceptable level of charge balance cannot be achieved … In various embodiments, waveform definition circuit 620, including charge recovery module 622, reduces or removes the burden of considering charge recovery phases during the creation of a stimulation waveform, thereby allowing the user to focus on defining the charge injection phases that provide the desired pattern of evoked action potentials in the target tissue of the neurostimulation”). The “acceptable level of charge balance” (such as presented in [0088-0089]) is interpreted as a charge threshold to be achieved.
The Examiner is focused on the use of the term “automatically inserting charge recovery phases into the received stimulation waveform” ([0006]) in the sense that the processor makes a determination to inject charge recover phases once the charge imbalance has reached a point deemed unacceptable (which could be interpreted as a charge imbalance threshold). The BRI of “during delivery of the first stimulation pulse, making a determination by the processor to apply a charge recovery pulse” could be a reference to the determination to apply a charge recovery pulse during the first stimulation pulse (e.g. applying the automatically inserted charge recovery in Zottola during the stimulation phase due to an excessive charge imbalance) in a repeatable fashion.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Carbunara’s charge recovery control device by incorporating the automated charge recovery determination in Zottola. This would have been obvious because both Carbunara and Zottola discuss charge-balanced electrical stimulation and Zottola provides a solution/improvement to automatically add charge recovery waveforms to prevent excessive charge imbalance. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Carbunara by incorporating the automated charge recovery determination in Zottola.
Therefore, Claim 1 is obvious over Carbunaru in view of Mishra and Zottola.
Regarding Claim 5, the electrical stimulation system in Claim 1 is obvious over Carbunaru in view of Mishra and Zottola, as indicated hereinabove. Carbunaru discloses charge injection phases separated by charge recovery phases (Col. 2, Lines 41-54). However, Carbunaru does not disclose the charge recovery pulses recover at least 10% of charge delivered by the first stimulation pulse of the first charge injection phase.
Mishra, in the same field of charge-balanced electrical stimulation, teaches the charge recovery pulses applied in the biphasic pulses can facilitate full charge balancing ([0388] – “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”). A fully charge balanced stimulation pulse (100% recovered) would be higher than 10% recovery.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Carbunara’s charge recovery control device by incorporating the pulse train burst mode in Mishra. This would have been obvious because both Carbunara and Mishra discuss charge-balanced electrical stimulation and Mishra provides a solution/improvement with the beneficial effects burst pulsing can have on power consumption and therapeutic efficacy. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Carbunara by incorporating the pulse train burst mode in Mishra.
Therefore, Claim 5 is obvious over Carbunaru in view of Mishra and Zottola.
Regarding Claim 6, the electrical stimulation system in Claim 1 is obvious over Carbunaru in view of Mishra and Zottola, as indicated hereinabove. Carbunaru further discloses the actions further comprise, during the charge recovery phase, providing at least one active recovery phase (Col 12, Lines 38-59).
Therefore, Claim 6 is obvious over Carbunaru in view of Mishra and Zottola.
Regarding Claim 7, the electrical stimulation system in Claim 1 is obvious over Carbunaru in view of Mishra and Zottola, as indicated hereinabove. Carbunaru further discloses the actions further comprise, during the charge recovery phase, providing at least one passive recovery phase (Col 12, Lines 38-59).
Therefore, Claim 7 is obvious over Carbunaru in view of Mishra and Zottola.
Regarding Claim 8, the electrical stimulation system in Claim 1 is obvious over Carbunaru in view of Mishra and Zottola, as indicated hereinabove. Carbunaru further discloses a programming unit configured to communicate with the processor to program the processor (Col 9, Lines 6-37).
Therefore, Claim 8 is obvious over Carbunaru in view of Mishra and Zottola.
Regarding Claim 9, the electrical stimulation system in Claim 8 is obvious over Carbunaru in view of Mishra and Zottola, as indicated hereinabove. Carbunaru further teaches the programming unit is configured to receive user input or modification of a duration of charge recovery and to communicate the user input to the processor (Col 11, Lines 12-23). Carbunaru states “allowing the physician or clinician to readily determine the desired stimulation parameters to be programmed into the IPG 14, as 15 well as the RC 16. Thus, modification of the stimulation parameters in the programmable memory of the IPG 14 after implantation is performed by a clinician” (Col 11, Lines 13-18). Note the stimulation parameters in question are defined as pulse amplitude, pulse duration, pulse rate, and pulse shape (Col 7, Lines 46-57). Carbunaru does not disclose the charge recovery pulses as part of a burst stimulation pattern.
Mishra, in the same field of charge-balanced electrical stimulation, teaches an implantable stimulator control which applies pulse trains in burst patterns (Fig. 30A, [0393]) made up of biphasic pulses ([0393] – “the trains of FIG. 30A are illustrated as comprising multiple bi-phasic pulses (pulses comprising alternating phases of energy delivery)”). The train-on periods featuring bi-phasic pulses are separated by non-stimulation train-off periods ([0393]). The stimulation and charge recovery pulses in Mishra have definite durations ([0388-0399]), but Carbunaru has already demonstrated the ability to control waveform durations as noted above.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Carbunara’s charge recovery control device by incorporating the pulse train burst mode in Mishra. This would have been obvious because both Carbunara and Mishra discuss charge-balanced electrical stimulation and Mishra provides a solution/improvement with the beneficial effects burst pulsing can have on power consumption and therapeutic efficacy. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Carbunara by incorporating the pulse train burst mode in Mishra.
Therefore, Claim 9 is obvious over Carbunaru in view of Mishra and Zottola.
Regarding Claim 10, the electrical stimulation system in Claim 8 is obvious over Carbunaru in view of Mishra and Zottola, as indicated hereinabove. Carbunaru further discloses the programming unit is configured to receive user input or modification of an amplitude or a relative amplitude of the charge recovery and to communicate the user input to the processor (Col 11, Lines 12-23). Carbunaru states “allowing the physician or clinician to readily determine the desired stimulation parameters to be programmed into the IPG 14, as 15 well as the RC 16. Thus, modification of the stimulation parameters in the programmable memory of the IPG 14 after implantation is performed by a clinician” (Col 11, Lines 13-18). Note the stimulation parameters in question are defined as pulse amplitude, pulse duration, pulse rate, and pulse shape (Col 7, Lines 46-57). Carbunaru does not disclose the charge recovery pulses as part of a burst stimulation pattern.
Mishra, in the same field of charge-balanced electrical stimulation, teaches an implantable stimulator control which applies pulse trains in burst patterns (Fig. 30A, [0393]) made up of biphasic pulses ([0393] – “the trains of FIG. 30A are illustrated as comprising multiple bi-phasic pulses (pulses comprising alternating phases of energy delivery)”). The train-on periods featuring bi-phasic pulses are separated by non-stimulation train-off periods ([0393]). The stimulation and charge recovery pulses have definite amplitudes ([0388-0399]), but Carbunaru has already demonstrated the ability to control waveform amplitudes as noted above.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Carbunara’s charge recovery control device by incorporating the pulse train burst mode in Mishra. This would have been obvious because both Carbunara and Mishra discuss charge-balanced electrical stimulation and Mishra provides a solution/improvement with the beneficial effects burst pulsing can have on power consumption and therapeutic efficacy. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Carbunara by incorporating the pulse train burst mode in Mishra.
Therefore, Claim 10 is obvious over Carbunaru in view of Mishra and Zottola.
Regarding Claim 11, the electrical stimulation system in Claim 8 is obvious over Carbunaru in view of Mishra and Zottola, as indicated hereinabove. Carbunaru discloses charge injection phases separated by charge recovery phases (Col. 2, Lines 41-54). However, Carbunaru does not disclose each of the charge recovery pulses has a duration of no more than 20 microseconds.
Mishra, in the same field of charge-balanced electrical stimulation, teaches an implantable stimulator control which applies pulse trains in burst patterns (Fig. 30A, [0393]) made up of biphasic pulses ([0393] – “the trains of FIG. 30A are illustrated as comprising multiple bi-phasic pulses (pulses comprising alternating phases of energy delivery)”). The timing of the trains (containing multiple pulses) is established as between 1 μsec to 100 msec ([0393] – “In FIG. 30A, apparatus 10 can deliver a series of narrow pulses (e.g. between 2 and 1000 pulses, 8 biphasic pulses shown) for a train-on period Ton (e.g. a time period of between 1 μsec to 100 msec), after which no energy is delivered for a train-off period TOFF (e.g. a time period of between 1 μsec to 100 msec)”). MPEP 2144.05 states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” A train time between 1 μsec to 100 msec for multiple pulses would establish the ability of recovery pulses in the biphasic pulses in Mishra to be shorter than 20 μsec. There is no evidence of an “unexpected result or criticality” on the analysis from the discussed range interpretations.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Carbunara’s charge recovery control device by incorporating the pulse train burst mode in Mishra. This would have been obvious because both Carbunara and Mishra discuss charge-balanced electrical stimulation and Mishra provides a solution/improvement with the beneficial effects burst pulsing can have on power consumption and therapeutic efficacy. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Carbunara by incorporating the pulse train burst mode in Mishra.
Therefore, Claim 11 is obvious over Carbunaru in view of Mishra and Zottola.
Regarding Claim 18, Carbunara discloses a method of delivering electrical stimulation (Abstract), the method comprising: providing an electrical stimulation system comprising at least one electrical stimulation lead implanted in tissue of a patient (Col 2, Lines 35-37), wherein each of the at least one electrical stimulation lead comprises a plurality of stimulation electrodes (Col 2, Lines 35-37); and delivering at least one stimulation pulse through at least one of the stimulation electrodes of the at least one electrical stimulation lead to the tissue of the patient during each of a plurality of charge injection phases (Col. 2, Lines 41-46), wherein each consecutive pair of the charge injection phases is separated by a charge recovery phase (Col. 2, Lines 47-54), wherein the plurality of charge injection phases comprises a first charge injection phase and the at least one stimulation pulse for delivery during the first charge injection phase comprises a first stimulation pulse, (Fig 9a, Col 12, Lines 38-59 – shows the waveform showing charge injection and charge recovery phases) wherein the first stimulation pulse is predetermined (Col 38, Lines 36-46). Carbunaru does not teach wherein the directing delivery comprises:
during delivery of the first stimulation pulse, making, by a processor, a determination or estimation of an unrecovered charge;
during delivery of the first stimulation pulse, when the determined or estimated unrecovered charge achieves a predetermined threshold amount, applying, a charge recovery pulse to interrupt the delivery of the first stimulation pulse, wherein the charge recovery pulse has a relative amplitude that is larger in magnitude than an amplitude of the first stimulation pulse;
after application of the charge recovery pulse, directing resumption of the delivery of the first stimulation pulse at the amplitude of the first stimulation pulse; and
repeating steps i) to iii) at least once during the delivery of the first stimulation pulse, wherein each of the charge recovery pulses has a duration of no more than 20 microseconds.
Mishra, in the same field of charge-balanced electrical stimulation, teaches an implantable stimulator control which applies pulse trains in burst patterns (Fig. 30A, [0393]) made up of biphasic pulses ([0393] – “the trains of FIG. 30A are illustrated as comprising multiple bi-phasic pulses (pulses comprising alternating phases of energy delivery)”). The train-on periods featuring bi-phasic pulses are separated by non-stimulation train-off periods ([0393] – “In FIG. 30A, apparatus 10 can deliver a series of narrow pulses (e.g. between 2 and 1000 pulses, 8 biphasic pulses shown) for a train-on period Ton (e.g. a time period of between 1 μsec to 100 msec), after which no energy is delivered for a train-off period Toff (e.g. a time period of between 1 μsec to 100 msec)”). The biphasic pulses can facilitate full charge balancing ([0388] – “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”) by generating stimulation and charge recovery pulses with different amplitude and pulse width combinations based on the current and time constraints of the stimulation signal where charge recovery pulses can have a greater amplitude (and shorter pulse width) than the corresponding stimulation pulse ([0388-0399]).
Mishra additionally teaches the utility of applying bursts of pulse trains to reducing power consumption while able to generate an appropriate therapeutic effect ([0393] – “In some embodiments, apparatus 10 is configured to provide ‘compliance optimized burst’, for example when one or more implantable devices 200 deliver a repeated series of short stimulation pulses comprising voltage compliance optimized narrow pulses providing reduced power consumption while providing therapeutic efficacy”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Carbunara’s charge recovery control method by incorporating the pulse train burst mode in Mishra. This would have been obvious because both Carbunara and Mishra discuss charge-balanced electrical stimulation and Mishra provides a solution/improvement with the beneficial effects burst pulsing can have on power consumption and therapeutic efficacy. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Carbunara by incorporating the pulse train burst mode in Mishra.
Zottola, in the same field of charge-balanced electrical stimulation, provides a waveform adjuster which can make a determination to automatically adjust application of charge recovery waveforms for charge-balancing concerns ([0006] – “The waveform adjuster may be configured to identify a need for recovering charges injected during the charge injection phases and adjust the received stimulation waveform by automatically inserting charge recovery phases into the received stimulation waveform based on the identified need for recovering the injected charges and the received charge recovery scheme”). These waveform adjustments are programming which are implemented during delivery of the first stimulation pulse where charge imbalances have been detected and corrected with charge recovery phases ([0069] – “In various embodiments, charge recovery module 622 can monitor whether an acceptable level of charge balance can be achieved based on the stimulation waveform and the charge recovery scheme entered by the user, and warn the user when the acceptable level of charge balance cannot be achieved … In various embodiments, waveform definition circuit 620, including charge recovery module 622, reduces or removes the burden of considering charge recovery phases during the creation of a stimulation waveform, thereby allowing the user to focus on defining the charge injection phases that provide the desired pattern of evoked action potentials in the target tissue of the neurostimulation”). The “acceptable level of charge balance” (such as presented in [0088-0089]) is interpreted as a charge threshold to be achieved.
The Examiner is focused on the use of the term “automatically inserting charge recovery phases into the received stimulation waveform” ([0006]) in the sense that the processor makes a determination to inject charge recover phases once the charge imbalance has reached a point deemed unacceptable (which could be interpreted as a charge imbalance threshold). The BRI of “during delivery of the first stimulation pulse, making a determination by the processor to apply a charge recovery pulse” could be a reference to the determination to apply a charge recovery pulse during the first stimulation pulse (e.g. applying the automatically inserted charge recovery in Zottola during the stimulation phase due to an excessive charge imbalance) in a repeatable fashion.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Carbunara’s charge recovery control method by incorporating the automated charge recovery determination in Zottola. This would have been obvious because both Carbunara and Zottola discuss charge-balanced electrical stimulation and Zottola provides a solution/improvement to automatically add charge recovery waveforms to prevent excessive charge imbalance. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Carbunara by incorporating the automated charge recovery determination in Zottola.
Therefore, Claim 18 is obvious over Carbunaru in view of Mishra and Zottola.
Regarding Claim 24, the method of delivering electrical stimulation in Claim 18 is obvious over Carbunaru in view of Mishra and Zottola, as indicated hereinabove. Carbunaru discloses charge injection phases separated by charge recovery phases (Col. 2, Lines 41-54). However, Carbunaru does not disclose the charge recovery pulses recover at least 10% of charge delivered by the first stimulation pulse of the first charge injection phase.
Mishra, in the same field of charge-balanced electrical stimulation, teaches the charge recovery pulses applied in the biphasic pulses can facilitate full charge balancing ([0388] – “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”). A fully charge balanced stimulation pulse (100% recovered) would be higher than 10% recovery.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Carbunara’s charge recovery control method by incorporating the pulse train burst mode in Mishra. This would have been obvious because both Carbunara and Mishra discuss charge-balanced electrical stimulation and Mishra provides a solution/improvement with the beneficial effects burst pulsing can have on power consumption and therapeutic efficacy. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Carbunara by incorporating the pulse train burst mode in Mishra.
Therefore, Claim 24 is obvious over Carbunaru in view of Mishra and Zottola.
Regarding Claim 25, the method of delivering electrical stimulation in Claim 18 is obvious over Carbunaru in view of Mishra and Zottola, as indicated hereinabove. Carbunaru further discloses the actions further comprise, during the charge recovery phase, providing at least one active recovery phase (Col 12, Lines 38-59).
Therefore, Claim 25 is obvious over Carbunaru in view of Mishra and Zottola.
Regarding Claim 26, the method of delivering electrical stimulation in Claim 18 is obvious over Carbunaru in view of Mishra and Zottola, as indicated hereinabove. Carbunaru further discloses the actions further comprise, during the charge recovery phase, providing at least one passive recovery phase (Col 12, Lines 38-59).
Therefore, Claim 26 is obvious over Carbunaru in view of Mishra and Zottola.
Regarding Claim 27, the method of delivering electrical stimulation in Claim 18 is obvious over Carbunaru in view of Mishra and Zottola, as indicated hereinabove. Carbunaru discloses charge injection phases separated by charge recovery phases (Col. 2, Lines 41-54). However, Carbunaru does not disclose each of the charge recovery pulses has a duration of no more than 20 microseconds.
Mishra, in the same field of charge-balanced electrical stimulation, teaches an implantable stimulator control which applies pulse trains in burst patterns (Fig. 30A, [0393]) made up of biphasic pulses ([0393] – “the trains of FIG. 30A are illustrated as comprising multiple bi-phasic pulses (pulses comprising alternating phases of energy delivery)”). The timing of the trains (containing multiple pulses) is established as between 1 μsec to 100 msec ([0393] – “In FIG. 30A, apparatus 10 can deliver a series of narrow pulses (e.g. between 2 and 1000 pulses, 8 biphasic pulses shown) for a train-on period Ton (e.g. a time period of between 1 μsec to 100 msec), after which no energy is delivered for a train-off period TOFF (e.g. a time period of between 1 μsec to 100 msec)”). MPEP 2144.05 states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” A train time between 1 μsec to 100 msec for multiple pulses would establish the ability of recovery pulses in the biphasic pulses in Mishra to be shorter than 20 μsec. There is no evidence of an “unexpected result or criticality” on the analysis from the discussed range interpretations.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Carbunara’s charge recovery control method by incorporating the pulse train burst mode in Mishra. This would have been obvious because both Carbunara and Mishra discuss charge-balanced electrical stimulation and Mishra provides a solution/improvement with the beneficial effects burst pulsing can have on power consumption and therapeutic efficacy. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Carbunara by incorporating the pulse train burst mode in Mishra.
Therefore, Claim 27 is obvious over Carbunaru in view of Mishra and Zottola.
Regarding Claim 28, the electrical stimulation device in Claim 1 is obvious over Carbunaru in view of Mishra and Zottola, as indicated hereinabove. Carbunaru discloses charge injection phases separated by charge recovery phases (Col. 2, Lines 41-54). However, Carbunaru does not disclose each of the charge recovery pulses has a duration of no more than 1 microsecond.
Mishra, in the same field of charge-balanced electrical stimulation, teaches an implantable stimulator control which applies pulse trains in burst patterns (Fig. 30A, [0393]) made up of biphasic pulses ([0393] – “the trains of FIG. 30A are illustrated as comprising multiple bi-phasic pulses (pulses comprising alternating phases of energy delivery)”). The timing of the trains (containing multiple pulses) is established as between 1 μsec to 100 msec ([0393] – “In FIG. 30A, apparatus 10 can deliver a series of narrow pulses (e.g. between 2 and 1000 pulses, 8 biphasic pulses shown) for a train-on period Ton (e.g. a time period of between 1 μsec to 100 msec), after which no energy is delivered for a train-off period TOFF (e.g. a time period of between 1 μsec to 100 msec)”). MPEP 2144.05 states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” A train time of 1 μsec for multiple pulses would establish the ability of recovery pulses in the biphasic pulses in Mishra to be shorter than 1 μsec. There is no evidence of an “unexpected result or criticality” on the analysis from the discussed range interpretations.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Carbunara’s charge recovery control device by incorporating the pulse train burst mode in Mishra. This would have been obvious because both Carbunara and Mishra discuss charge-balanced electrical stimulation and Mishra provides a solution/improvement with the beneficial effects burst pulsing can have on power consumption and therapeutic efficacy. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Carbunara by incorporating the pulse train burst mode in Mishra.
Therefore, Claim 28 is obvious over Carbunaru in view of Mishra and Zottola.
Regarding Claim 29, the electrical stimulation device in Claim 1 is obvious over Carbunaru in view of Mishra and Zottola, as indicated hereinabove. Carbunaru discloses charge injection phases separated by charge recovery phases (Col. 2, Lines 41-54) where charge balancing is achieved (Col 15, Lines 2-13) and said charge balancing suggests a summation of charge. However, Carbunaru does not disclose making the determination or estimation comprises estimating charge delivered by the first stimulation pulse up to that point in time. Note: the determination step in Claim 1 is based on Mishra’s teaching of an implantable stimulator control which applies pulse trains in burst patterns (Fig. 30A, [0393]) made up of biphasic pulses ([0393]) and Zottola’s teaching of a waveform adjuster to determine the application of charge recovery ([0006]).
Zottola, in the same field of charge-balanced electrical stimulation, further teaches the estimation of the charge imbalance generated during a charge injection phase and the ability to adjust the stimulation waveform as necessary ([0085] – “At 973, a need for recovering charges injected during the charge injection phases is identified. This can include identifying the charge injection phases in the received stimulation waveform and determining whether the stimulation waveform has included charge recovery phases to properly recover the injected charges”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Carbunara’s charge recovery control device by incorporating the automated charge recovery determination in Zottola. This would have been obvious because both Carbunara and Zottola discuss charge-balanced electrical stimulation and Zottola provides a solution/improvement to automatically add charge recovery waveforms to prevent excessive charge imbalance. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Carbunara by incorporating the automated charge recovery determination in Zottola.
Therefore, Claim 29 is obvious over Carbunaru in view of Mishra and Zottola.
Regarding Claim 31, the electrical stimulation device in Claim 29 is obvious over Carbunaru in view of Mishra and Zottola, as indicated hereinabove. Carbunaru discloses charge injection phases separated by charge recovery phases (Col. 2, Lines 41-54) where charge balancing is achieved (Col 15, Lines 2-13) and said charge balancing suggests a summation of charge. However, Carbunaru does not disclose estimating the charge further comprises reducing the estimated charge by previous charge recovery during the first stimulation pulse. Note: the determination step in Claim 1 is based on Mishra’s teaching of an implantable stimulator control which applies pulse trains in burst patterns (Fig. 30A, [0393]) made up of biphasic pulses ([0393]) and Zottola’s teaching of a waveform adjuster to determine the application of charge recovery ([0006]).
Zottola, in the same field of charge-balanced electrical stimulation, further teaches the estimation of the charge imbalance generated during a charge injection phase and the ability to adjust the stimulation waveform as necessary ([0085] – “At 973, a need for recovering charges injected during the charge injection phases is identified. This can include identifying the charge injection phases in the received stimulation waveform and determining whether the stimulation waveform has included charge recovery phases to properly recover the injected charges”). Zottola teaches a waveform adjuster which can make a determination to automatically adjust application of charge recovery waveforms for charge-balancing concerns ([0006] – “The waveform adjuster may be configured to identify a need for recovering charges injected during the charge injection phases and adjust the received stimulation waveform by automatically inserting charge recovery phases into the received stimulation waveform based on the identified need for recovering the injected charges and the received charge recovery scheme”) where a time-variable assessment of charge imbalance is interpreted as being necessary to determine where to apply charge recovery.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Carbunara’s charge recovery control device by incorporating the automated charge recovery determination in Zottola. This would have been obvious because both Carbunara and Zottola discuss charge-balanced electrical stimulation and Zottola provides a solution/improvement to automatically add charge recovery waveforms to prevent excessive charge imbalance. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Carbunara by incorporating the automated charge recovery determination in Zottola.
Therefore, Claim 31 is obvious over Carbunaru in view of Mishra and Zottola.
Regarding Claim 33, the method of delivering electrical stimulation in Claim 18 is obvious over Carbunaru in view of Mishra and Zottola, as indicated hereinabove. Carbunaru discloses charge injection phases separated by charge recovery phases (Col. 2, Lines 41-54). However, Carbunaru does not disclose each of the charge recovery pulses has a duration of no more than 1 microsecond.
Mishra, in the same field of charge-balanced electrical stimulation, teaches an implantable stimulator control which applies pulse trains in burst patterns (Fig. 30A, [0393]) made up of biphasic pulses ([0393] – “the trains of FIG. 30A are illustrated as comprising multiple bi-phasic pulses (pulses comprising alternating phases of energy delivery)”). The timing of the trains (containing multiple pulses) is established as between 1 μsec to 100 msec ([0393] – “In FIG. 30A, apparatus 10 can deliver a series of narrow pulses (e.g. between 2 and 1000 pulses, 8 biphasic pulses shown) for a train-on period Ton (e.g. a time period of between 1 μsec to 100 msec), after which no energy is delivered for a train-off period TOFF (e.g. a time period of between 1 μsec to 100 msec)”). MPEP 2144.05 states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” A train time of 1 μsec for multiple pulses would establish the ability of recovery pulses in the biphasic pulses in Mishra to be shorter than 1 μsec. There is no evidence of an “unexpected result or criticality” on the analysis from the discussed range interpretations.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Carbunara’s charge recovery control method by incorporating the pulse train burst mode in Mishra. This would have been obvious because both Carbunara and Mishra discuss charge-balanced electrical stimulation and Mishra provides a solution/improvement with the beneficial effects burst pulsing can have on power consumption and therapeutic efficacy. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Carbunara by incorporating the pulse train burst mode in Mishra.
Therefore, Claim 33 is obvious over Carbunaru in view of Mishra and Zottola.
Regarding Claim 34, the method of delivering electrical stimulation in Claim 18 is obvious over Carbunaru in view of Mishra and Zottola, as indicated hereinabove. Carbunaru discloses charge injection phases separated by charge recovery phases (Col. 2, Lines 41-54) where charge balancing is achieved (Col 15, Lines 2-13) and said charge balancing suggests a summation of charge. However, Carbunaru does not disclose making the determination or estimation comprises estimating charge delivered by the first stimulation pulse up to that point in time. Note: the determination step in Claim 1 is based on Mishra’s teaching of an implantable stimulator control which applies pulse trains in burst patterns (Fig. 30A, [0393]) made up of biphasic pulses ([0393]) and Zottola’s teaching of a waveform adjuster to determine the application of charge recovery ([0006]).
Zottola, in the same field of charge-balanced electrical stimulation, further teaches the estimation of the charge imbalance generated during a charge injection phase and the ability to adjust the stimulation waveform as necessary ([0085] – “At 973, a need for recovering charges injected during the charge injection phases is identified. This can include identifying the charge injection phases in the received stimulation waveform and determining whether the stimulation waveform has included charge recovery phases to properly recover the injected charges”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Carbunara’s charge recovery control method by incorporating the automated charge recovery determination in Zottola. This would have been obvious because both Carbunara and Zottola discuss charge-balanced electrical stimulation and Zottola provides a solution/improvement to automatically add charge recovery waveforms to prevent excessive charge imbalance. Therefore, a person of ord