DETAILED ACTION
Applicant’s arguments, filed on 01/20/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed on 01/20/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-20 are the current claims hereby under examination.
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 Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor (US 20200171313) in view of Tass (US 20170333711).
Regarding independent claim 1, Dinsmoor teaches a system for electrical stimulation delivery (Abstract: “This disclosure relates to methods, devices, and systems for delivering and adjusting stimulation therapy. In one example, a method comprising delivering, by a stimulation electrode, electrical stimulation as a candidate therapy to a patient according to a set of candidate therapy parameters”), the system comprising:
stimulation generation circuitry ([0008]: “the disclosure describes a system comprising: one or more electrodes; a stimulation generator configured to apply stimulation therapy via the one or more electrodes based on a set of stimulation therapy parameters”);
sensing circuitry configured to sense one or more biomarker signals ([0007]: “sensing, by a sensing electrode, an electrically evoked compound action potential (eECAP) signal”. The eECAP signal is the biomarker signals.); and
processing circuitry ([0011]: “the disclosure describes a non-transitory computer readable medium comprising instructions for causing a programmable processor to perform any of the methods described herein”) configured to:
cause the stimulation generation circuitry to deliver a first electrical stimulation with a patient in a first patient state ([0157]: “IMD 14 delivers electrical stimulation as a therapeutic or a diagnostic intervention (stimulation therapy) to a patient”; [0059]: “In response to a posture state indication by the posture state module, IMD 14 may change a program group, program, stimulation amplitude, pulse width, pulse rate, and/or one or more other parameters, groups or programs to maintain therapeutic efficacy”; [0056]: “Example posture states may include “Upright,” “Upright and Active,” “Lying Down,” and so forth.”. Any of the posture states such as “upright”, “upright and active”, “lying down”, etc. can be the first patient state.);
receive a first instance of a biomarker signal of the sensed one or more biomarker signals in presence of the first electrical stimulation from the stimulation generation circuitry delivering the first electrical stimulation with the patient in the first patient state ([0055]: “IMD 14 may include a posture state module that detects the posture state of patient 12 and causes the IMD 14 to automatically detect an eECAP response to stimulation in response to a change in posture state”; [0157]: “IMD 14 delivers electrical stimulation as a therapeutic or a diagnostic intervention (stimulation therapy) to a patient”; [0056]: “The IMD may then detect an eECAP biomarker in response to the adjusted stimulation parameters to determine if the adjustment was effective. In other examples, the IMD may detect an eECAP biomarker in response to stimulation when a change in posture is detected prior to making an adjustment to the stimulation parameters. IMD 14 may analyze the detected eECAP biomarker to determine the appropriate adjustment to the stimulation parameters”. The IMD detects the eECAP levels (the biomarker levels) when the user is in a first patient state (the posture state) and deliver specific stimulation parameters based on the posture state and the eECAP levels.);
cause the stimulation generation circuitry to deliver a second electrical stimulation with the patient in a second patient state ([0056]: “The IMD may then detect an eECAP biomarker in response to the adjusted stimulation parameters to determine if the adjustment was effective. In other examples, the IMD may detect an eECAP biomarker in response to stimulation when a change in posture is detected prior to making an adjustment to the stimulation parameters. IMD 14 may analyze the detected eECAP biomarker to determine the appropriate adjustment to the stimulation parameters”. The stimulation parameters are changed when a change in position is determined, which is the second patient state.);
receive a second instance of the biomarker signal of the sensed one or more biomarker signals in presence of the second electrical stimulation from the stimulation generation circuitry delivering the second electrical stimulation with the patient in the second patient state ([0055]: “IMD 14 may include a posture state module that detects the posture state of patient 12 and causes the IMD 14 to automatically detect an eECAP response to stimulation in response to a change in posture state”);
determine whether a difference between the first instance of the biomarker signal and the second instance of the biomarker signal satisfies a threshold ([0055]: “Based on the detected eECAP, IMD 14 determines whether an adjustment to the stimulation parameters is recommended or otherwise appropriate. For example, a posture state module may include a posture state sensor, such as an accelerometer, that detects when patient 12 lies down, stands up, or otherwise changes posture.”; [0060]: “IMD 14 may periodically detect eECAP generated in response to current stimulation parameters and adjust the current stimulation parameters if there has been a significant change, i.e., greater than a predetermined threshold change, to the detected eECAP biomarker relative to a desired or reference eECAP biomarker”; [0032]: “eECAP detection may allow a system to provide closed-loop stimulation control”).
However, Dinsmoor teaches applying closed-loop therapy in response to the biomarker signal ([0032]: “eECAP detection may allow a system to provide closed-loop stimulation control”), however Dinsmoor does not teach selecting a therapy mode from a plurality of different types of closed-loop therapy modes based on whether the difference between the first instance of the biomarker signal and the second instance of the biomarker signal satisfies the threshold.
Tass discloses a device for effective neurostimulation. Specifically, Tass teaches select a therapy mode from a plurality of different types of closed-loop therapy modes based on whether the difference between the first instance of the biomarker signal and the second instance of the biomarker signal satisfies the threshold (Abstract: “a measuring unit records measurement signals reflecting the neuron activity of the stimulated neurons and a control and analysis unit controls the stimulation unit to administer stimuli, check the success of stimulation based on the measurement, and, if the stimulation success is not sufficient, insert one or more stimulation breaks in the application of the stimuli or extend one or more stimulation breaks, where no stimuli that could suppress the pathological synchronous and oscillatory neuron activity are applied during the stimulation breaks.”; [0049]: “The stimulation success can in particular be checked by means of a threshold value comparison”. The eECAP biomarker signals can be used as a measurement signal reflecting the neuron activity. The device only implements pauses when the success of the stimulation is not sufficient, which is determined through a threshold, and therefore implements a different type of closed-loop therapy based on whether the biomarker signal satisfies the threshold or not.). Dinsmoor and Tass are analogous art as they are both related to devices to control neurostimulation.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the different types of closed-loop therapy from Tass into the system from Dinsmoor as it allows for different types of therapy to be applied dependent on the user’s response to the therapy, which can create a more personalized and effective treatment.
The Dinsmoor/Tass combination teaches causing the stimulation generation circuitry to deliver a third electrical stimulation (Dinsmoor, [0032]: “As discussed herein, systems, devices, and methods are described for adjusting electrical stimulation parameters based on a detected electrically evoked compound action potential (eECAP). The eECAP may be evoked in response to the application of electrical stimulation therapy that is defined according to a set of stimulation parameters. Adjustments to the electrical stimulation parameters based on the detected eECAP may provide more objective information than patient feedback. In addition, eECAP detection may allow a system to provide closed-loop stimulation control. Incorporation of eECAP into adjustment, and/or titration, of stimulation parameters may allow for stimulation systems to provide stimulation therapy that uses less energy, more targeted stimulation delivery to desired tissues, and/or improved therapeutic efficacy as compared to techniques that do not incorporate eECAP detection”) in accordance with the selected therapy mode (Tass, Abstract: “a measuring unit records measurement signals reflecting the neuron activity of the stimulated neurons and a control and analysis unit controls the stimulation unit to administer stimuli, check the success of stimulation based on the measurement, and, if the stimulation success is not sufficient, insert one or more stimulation breaks in the application of the stimuli or extend one or more stimulation breaks, where no stimuli that could suppress the pathological synchronous and oscillatory neuron activity are applied during the stimulation breaks.”. Determining whether to apply the third electrical stimulation immediately or after a stimulation break is dependent on the selected therapy mode.).
Regarding claim 2, the Dinsmoor/Tass combination teaches the system of claim 1, wherein at least one of: (1) the first patient state is the patient not moving, and the second patient state is the patient moving (Dinsmoor, [0056]: “Example posture states may include “Upright,” “Upright and Active””. The first patient state can be upright, which is not moving, and the second patient state can be upright and active, which is the moving.), and (2) the first patient state is the patient having taken medication, and the second patient state is one of a steady state of the medication or when medication is no longer effective.
Regarding claim 3, the Dinsmoor/Tass combination teaches the system of claim 1.
However, the Dinsmoor/Tass combination is silent on the steps used to determine what type of therapy to use.
Tass teaches wherein to determine whether the difference between the first instance of the biomarker signal and the second instance of the biomarker signal satisfies the threshold, the processing circuitry is configured to determine that the difference between the first instance of the biomarker signal and the second instance of the biomarker signal satisfied the threshold ([0049]: “The stimulation success can in particular be checked by means of a threshold value comparison. Depending on which signals are used for determining the stimulation success, different threshold value comparisons result. If e.g. the pathologically neuronal synchronization is measured via the sensors of the measuring unit 12 … experience has shown that the lowering of the synchronization by e.g. at least 20% in comparison with the situation without stimulation is sufficient to determine a sufficient stimulation success”. If the measured signals from sensors, such as sensors used to measure the eECAP signals (Dinsmoor, [0006]: “The eECAP signal can be sensed by a sensor”), are above a threshold such as above 20%, the simulation is sufficient and the simulation breaks are not implemented.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the selection step from Tass into the Dinsmoor/Tass combination since the combination is silent on how the therapy modes are selected, and Tass discloses suitable steps in an analogous device.
The Dinsmoor/Tass combination teaches wherein to select the therapy mode, the processing circuitry is configured to select a normal closed-loop therapy mode, wherein the normal closed-loop therapy mode is one type of the plurality of different types of closed-loop therapy modes, and wherein to cause the stimulation generation circuitry to deliver the third electrical stimulation in accordance with the selected therapy mode, the processing circuitry is configured to: cause the stimulation generation circuitry to transition between delivering the first electrical stimulation having a first parameter set based on the patient being in the first patient state and delivering the third electrical stimulation having a second parameter set based on the patient being in the second patient state (Dinsmoor, [0032]: “As discussed herein, systems, devices, and methods are described for adjusting electrical stimulation parameters based on a detected electrically evoked compound action potential (eECAP). The eECAP may be evoked in response to the application of electrical stimulation therapy that is defined according to a set of stimulation parameters. Adjustments to the electrical stimulation parameters based on the detected eECAP may provide more objective information than patient feedback. In addition, eECAP detection may allow a system to provide closed-loop stimulation control. Incorporation of eECAP into adjustment, and/or titration, of stimulation parameters may allow for stimulation systems to provide stimulation therapy that uses less energy, more targeted stimulation delivery to desired tissues, and/or improved therapeutic efficacy as compared to techniques that do not incorporate eECAP detection”. This closed loop therapy methods describe a normal closed loop therapy, therefore teaching on this limitation.).
Regarding claim 4, the Dinsmoor/Tass combination teaches the system of claim 1.
However, the Dinsmoor/Tass combination is silent on the steps used to determine what type of therapy to use.
Tass teaches wherein to determine whether the difference between the first instance of the biomarker signal and the second instance of the biomarker signal satisfies the threshold, the processing circuitry is configured to determine that the difference between the first instance of the biomarker signal and the second instance of the biomarker signal does not satisfy the threshold ([0049]: “The stimulation success can in particular be checked by means of a threshold value comparison. Depending on which signals are used for determining the stimulation success, different threshold value comparisons result. If e.g. the pathologically neuronal synchronization is measured via the sensors of the measuring unit 12 … experience has shown that the lowering of the synchronization by e.g. at least 20% in comparison with the situation without stimulation is sufficient to determine a sufficient stimulation success”. If the measured signals from sensors, such as sensors used to measure the eECAP signals (Dinsmoor, [0006]: “The eECAP signal can be sensed by a sensor”), are below a threshold such as below 20%, the simulation is insufficient and the simulation breaks are implemented.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the selection step from Tass into the Dinsmoor/Tass combination since the combination is silent on how the therapy modes are selected, and Tass discloses suitable steps in an analogous device.
The Dinsmoor/Tass combination teaches wherein to select the therapy mode, the processing circuitry is configured to select a polling closed-loop therapy mode, wherein the polling closed-loop therapy mode is one type of the plurality of different types of closed-loop therapy modes (Tass, Abstract: “a measuring unit records measurement signals reflecting the neuron activity of the stimulated neurons and a control and analysis unit controls the stimulation unit to administer stimuli, check the success of stimulation based on the measurement, and, if the stimulation success is not sufficient, insert one or more stimulation breaks in the application of the stimuli or extend one or more stimulation breaks”. This closed-loop therapy mode describes the steps of a polling closed-loop therapy mode, therefore teaching on this limitation.), and wherein to cause the stimulation generation circuitry to deliver the third electrical stimulation in accordance with the selected therapy mode, the processing circuitry is configured to: cause the stimulation generation circuitry to deliver the first electrical stimulation having a first parameter set based on the patient being in the first patient state (Dinsmoor, [0157]: “IMD 14 delivers electrical stimulation as a therapeutic or a diagnostic intervention (stimulation therapy) to a patient”; [0059]: “In response to a posture state indication by the posture state module, IMD 14 may change a program group, program, stimulation amplitude, pulse width, pulse rate, and/or one or more other parameters, groups or programs to maintain therapeutic efficacy”; [0056]: “Example posture states may include “Upright,” “Upright and Active,” “Lying Down,” and so forth.”. Any of the posture states such as “upright”, “upright and active”, “lying down”, etc. can be the first patient state.); determine that the patient transition to the second patient state (Dinsmoor, [0056]: “The IMD may then detect an eECAP biomarker in response to the adjusted stimulation parameters to determine if the adjustment was effective. In other examples, the IMD may detect an eECAP biomarker in response to stimulation when a change in posture is detected prior to making an adjustment to the stimulation parameters. IMD 14 may analyze the detected eECAP biomarker to determine the appropriate adjustment to the stimulation parameters”. The stimulation parameters are changed when a change in position is determined, which is the second patient state.); cause the stimulation generation circuitry to deliver the third electrical stimulation having a second parameter set based on the patient being in the second patient state (Dinsmoor, [0056]: “The IMD may then detect an eECAP biomarker in response to the adjusted stimulation parameters to determine if the adjustment was effective. In other examples, the IMD may detect an eECAP biomarker in response to stimulation when a change in posture is detected prior to making an adjustment to the stimulation parameters. IMD 14 may analyze the detected eECAP biomarker to determine the appropriate adjustment to the stimulation parameters”. The stimulation parameters are changed when a change in position is determined, which is the second patient state.); after the stimulation generation circuitry delivers the third electrical stimulation having the second parameter set, temporally cause the stimulation generation circuitry to cease delivery of the third electrical stimulation or to deliver the first electrical stimulation having the first parameter set (Tass, Abstract: “a measuring unit records measurement signals reflecting the neuron activity of the stimulated neurons and a control and analysis unit controls the stimulation unit to administer stimuli, check the success of stimulation based on the measurement, and, if the stimulation success is not sufficient, insert one or more stimulation breaks in the application of the stimuli or extend one or more stimulation breaks, where no stimuli that could suppress the pathological synchronous and oscillatory neuron activity are applied during the stimulation breaks.”; [0049]: “The stimulation success can in particular be checked by means of a threshold value comparison”).
However, the Dinsmoor/Tass combination is silent on whether the system determines whether the patient transitioned to the first patient state during the cessation.
Tass teaches during the cessation of the third electrical stimulation or the stimulation generation circuitry delivering the first electrical stimulation having the first parameter set, determine whether the patient transitioned to the first patient state ([0057]: “Chronically or intermittently used EEG electrodes or accelerometers can e.g. be used as non-invasive sensors for the detection of characteristic movement patterns”. The device monitors movement patterns throughout all measurements, therefore this includes during the stimulation breaks, and since Dinsmoor teaches using motion signals to determine patient state (Dinsmoor, “In response to a posture state indication by the posture state module, IMD 14 may change a program group, program, stimulation amplitude, pulse width, pulse rate, and/or one or more other parameters, groups or programs to maintain therapeutic efficacy”; [0056]: “A posture state module may include, for example, one or more accelerometers”), it is obvious that the patient state is monitored during cessation.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the system determining patient state during the cessation from Tass into the Dinsmoor/Tass combination as the combination is silent on whether the patient state is monitored during the cessation, and Tass teaches this limitation in an analogous device.
The Dinsmoor/Tass combination teaches causing the stimulation generation circuitry to deliver the first electrical stimulation having the first parameter set or deliver the third electrical stimulation having the second parameter set based on the determination of whether the patient transitioned to the first patient state (Dinsmoor, [0032]: “As discussed herein, systems, devices, and methods are described for adjusting electrical stimulation parameters based on a detected electrically evoked compound action potential (eECAP). The eECAP may be evoked in response to the application of electrical stimulation therapy that is defined according to a set of stimulation parameters. Adjustments to the electrical stimulation parameters based on the detected eECAP may provide more objective information than patient feedback. In addition, eECAP detection may allow a system to provide closed-loop stimulation control. Incorporation of eECAP into adjustment, and/or titration, of stimulation parameters may allow for stimulation systems to provide stimulation therapy that uses less energy, more targeted stimulation delivery to desired tissues, and/or improved therapeutic efficacy as compared to techniques that do not incorporate eECAP detection”).
Regarding claim 5, the Dinsmoor/Tass combination teaches the system of claim 4, wherein prior to selecting the polling closed-loop therapy mode, the processing circuitry is configured to: reduce intensity of the first electrical stimulation (Dinsmoor, [0056]: “A posture state module may include, for example, one or more accelerometers that detect when patient 12 occupies a posture state in which it may be appropriate to decrease the stimulation amplitude, e.g., when patient 12 lies down.”. If the first or second patient state is when the user is lying down, the simulation amplitude is decreased, which occurs before the therapy mode is selected.); and determine that the first electrical stimulation having the reduced intensity is not therapeutic, and wherein to select the polling closed-loop therapy mode, the processing circuitry is configured to select the polling closed-loop therapy mode based on the determination that the first electrical stimulation having reduced intensity is not therapeutic (Tass, Abstract: “a measuring unit records measurement signals reflecting the neuron activity of the stimulated neurons and a control and analysis unit controls the stimulation unit to administer stimuli, check the success of stimulation based on the measurement, and, if the stimulation success is not sufficient, insert one or more stimulation breaks in the application of the stimuli or extend one or more stimulation breaks, where no stimuli that could suppress the pathological synchronous and oscillatory neuron activity are applied during the stimulation breaks.”).
Regarding claim 6, the Dinsmoor/Tass combination teaches the system of claim 1, wherein the first instance of the biomarker signal and the second instance of the biomarker signal comprise one of a local field potential (LFP) signal, an evoked compound action potential (ECAP) signal, and an electromyography (EMG) signal (Dinsmoor, [0007]: “sensing, by a sensing electrode, an electrically evoked compound action potential (eECAP) signal”. The eECAP signal is the biomarker signals.).
Regarding claim 7, the Dinsmoor/Tass combination teaches the system of claim 1, the system further comprising an implantable medical device (IMD) (Dinsmoor, [0045]: “Although the techniques described in this disclosure may be generally applicable to a variety of medical devices including external and implantable medical devices (IMDs), application of such techniques to IMDs and, more particularly, implantable electrical stimulators such as neurostimulators will be described for purposes of illustration”), wherein the IMD includes the stimulation generation circuitry, the sensing circuitry, and the processing circuitry (Dinsmoor, [0053]: “IMD 14 may deliver stimulation therapy according to one or more programs.”; [0055]: “To avoid or reduce possible disruptions in effective therapy due to posture state changes, IMD 14 may include a posture state module that detects the posture state of patient 12 and causes the IMD 14 to automatically detect an eECAP response to stimulation in response to a change in posture state”; [0084]: “Processing circuitry 80 controls stimulation generator 84 to deliver electrical stimulation via electrode combinations formed by electrodes in one or more electrode arrays. For example, stimulation generator 84 may deliver electrical stimulation therapy via electrodes on one or more leads 16, e.g., as stimulation pulses or continuous waveforms. Components described as processing circuitry within IMD 14, external programmer 20 or any other device described in this disclosure may each comprise one or more processors, such as one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), programmable logic circuitry, or the like, either alone or in any suitable combination”).
Regarding claim 8, the Dinsmoor/Tass combination teaches the system of clam 1, the system further comprising an implantable medical device (IMD) and an external programmer (Dinsmoor, [0046]: “system 10 includes an IMD 14 and external programmer”), wherein the IMD includes the stimulation generation circuitry and the sensing circuitry, and wherein the external programmer or a combination of the external programmer and the IMD include the processing circuitry (Dinsmoor, [0053]: “IMD 14 may deliver stimulation therapy according to one or more programs.”; [0055]: “To avoid or reduce possible disruptions in effective therapy due to posture state changes, IMD 14 may include a posture state module that detects the posture state of patient 12 and causes the IMD 14 to automatically detect an eECAP response to stimulation in response to a change in posture state”; [0084]: “Processing circuitry 80 controls stimulation generator 84 to deliver electrical stimulation via electrode combinations formed by electrodes in one or more electrode arrays. For example, stimulation generator 84 may deliver electrical stimulation therapy via electrodes on one or more leads 16, e.g., as stimulation pulses or continuous waveforms. Components described as processing circuitry within IMD 14, external programmer 20 or any other device described in this disclosure may each comprise one or more processors, such as one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), programmable logic circuitry, or the like, either alone or in any suitable combination”; [0061]: “external programmer 20 may transmit programs, parameter adjustments, program selections, group selections, or other information to control the operation of IMD”).
Regarding independent claim 9, Dinsmoor teaches a method for electrical stimulation delivery (Abstract: “This disclosure relates to methods, devices, and systems for delivering and adjusting stimulation therapy. In one example, a method comprising delivering, by a stimulation electrode, electrical stimulation as a candidate therapy to a patient according to a set of candidate therapy parameters”), the method comprising:
causing, with processing circuitry ([0011]: “the disclosure describes a non-transitory computer readable medium comprising instructions for causing a programmable processor to perform any of the methods described herein”), a stimulation generation circuitry ([0008]: “the disclosure describes a system comprising: one or more electrodes; a stimulation generator configured to apply stimulation therapy via the one or more electrodes based on a set of stimulation therapy parameters”) to deliver a first electrical stimulation with a patient in a first patient state ([0157]: “IMD 14 delivers electrical stimulation as a therapeutic or a diagnostic intervention (stimulation therapy) to a patient”; [0059]: “In response to a posture state indication by the posture state module, IMD 14 may change a program group, program, stimulation amplitude, pulse width, pulse rate, and/or one or more other parameters, groups or programs to maintain therapeutic efficacy”; [0056]: “Example posture states may include “Upright,” “Upright and Active,” “Lying Down,” and so forth.”. Any of the posture states such as “upright”, “upright and active”, “lying down”, etc. can be the first patient state.);
receiving, with the processing circuitry, a first instance of a biomarker signal sensed by a sensing circuitry in presence of the first electrical stimulation from the stimulation generation circuitry delivering the first electrical stimulation with the patient in the first patient state ([0055]: “IMD 14 may include a posture state module that detects the posture state of patient 12 and causes the IMD 14 to automatically detect an eECAP response to stimulation in response to a change in posture state”; [0157]: “IMD 14 delivers electrical stimulation as a therapeutic or a diagnostic intervention (stimulation therapy) to a patient”; [0056]: “The IMD may then detect an eECAP biomarker in response to the adjusted stimulation parameters to determine if the adjustment was effective. In other examples, the IMD may detect an eECAP biomarker in response to stimulation when a change in posture is detected prior to making an adjustment to the stimulation parameters. IMD 14 may analyze the detected eECAP biomarker to determine the appropriate adjustment to the stimulation parameters”. The IMD detects the eECAP levels (the biomarker levels) when the user is in a first patient state (the posture state) and deliver specific stimulation parameters based on the posture state and the eECAP levels.);
causing, with the processing circuitry, the stimulation generation circuitry to deliver a second electrical stimulation with the patient in a second patient state ([0056]: “The IMD may then detect an eECAP biomarker in response to the adjusted stimulation parameters to determine if the adjustment was effective. In other examples, the IMD may detect an eECAP biomarker in response to stimulation when a change in posture is detected prior to making an adjustment to the stimulation parameters. IMD 14 may analyze the detected eECAP biomarker to determine the appropriate adjustment to the stimulation parameters”. The stimulation parameters are changed when a change in position is determined, which is the second patient state.);
receiving, with the processing circuitry, a second instance of the biomarker signal sensed by the sensing circuitry in presence of the second electrical stimulation from the stimulation generation circuitry delivering the second electrical stimulation with the patient in the second patient state ([0055]: “IMD 14 may include a posture state module that detects the posture state of patient 12 and causes the IMD 14 to automatically detect an eECAP response to stimulation in response to a change in posture state”);
determining, with the processing circuitry, whether a difference between the first instance of the biomarker signal and the second instance of the biomarker signal satisfies a threshold ([0055]: “Based on the detected eECAP, IMD 14 determines whether an adjustment to the stimulation parameters is recommended or otherwise appropriate. For example, a posture state module may include a posture state sensor, such as an accelerometer, that detects when patient 12 lies down, stands up, or otherwise changes posture.”; [0060]: “IMD 14 may periodically detect eECAP generated in response to current stimulation parameters and adjust the current stimulation parameters if there has been a significant change, i.e., greater than a predetermined threshold change, to the detected eECAP biomarker relative to a desired or reference eECAP biomarker”; [0032]: “eECAP detection may allow a system to provide closed-loop stimulation control”).
However, Dinsmoor teaches applying closed-loop therapy in response to the biomarker signal ([0032]: “eECAP detection may allow a system to provide closed-loop stimulation control”), however Dinsmoor does not teach selecting a therapy mode from a plurality of different types of closed-loop therapy modes based on whether the difference between the first instance of the biomarker signal and the second instance of the biomarker signal satisfies the threshold.
Tass discloses a device for effective neurostimulation. Specifically, Tass teaches selecting, with the processing circuitry, a therapy mode from a plurality of different types of closed-loop therapy modes based on whether the difference between the first instance of the biomarker signal and the second instance of the biomarker signal satisfies the threshold (Abstract: “a measuring unit records measurement signals reflecting the neuron activity of the stimulated neurons and a control and analysis unit controls the stimulation unit to administer stimuli, check the success of stimulation based on the measurement, and, if the stimulation success is not sufficient, insert one or more stimulation breaks in the application of the stimuli or extend one or more stimulation breaks, where no stimuli that could suppress the pathological synchronous and oscillatory neuron activity are applied during the stimulation breaks.”; [0049]: “The stimulation success can in particular be checked by means of a threshold value comparison”. The eECAP biomarker signals can be used as a measurement signal reflecting the neuron activity. The device only implements pauses when the success of the stimulation is not sufficient, which is determined through a threshold, and therefore implements a different type of closed-loop therapy based on whether the biomarker signal satisfies the threshold or not.). Dinsmoor and Tass are analogous art as they are both related to devices to control neurostimulation.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the different types of closed-loop therapy from Tass into the method from Dinsmoor as it allows for different types of therapy to be applied dependent on the user’s response to the therapy, which can create a more personalized and effective treatment.
The Dinsmoor/Tass combination teaches causing, with the processing circuitry, the stimulation generation circuitry to deliver a third electrical stimulation (Dinsmoor, [0032]: “As discussed herein, systems, devices, and methods are described for adjusting electrical stimulation parameters based on a detected electrically evoked compound action potential (eECAP). The eECAP may be evoked in response to the application of electrical stimulation therapy that is defined according to a set of stimulation parameters. Adjustments to the electrical stimulation parameters based on the detected eECAP may provide more objective information than patient feedback. In addition, eECAP detection may allow a system to provide closed loop stimulation control. Incorporation of eECAP into adjustment, and/or titration, of stimulation parameters may allow for stimulation systems to provide stimulation therapy that uses less energy, more targeted stimulation delivery to desired tissues, and/or improved therapeutic efficacy as compared to techniques that do not incorporate eECAP detection”) in accordance with the selected therapy mode (Tass, Abstract: “a measuring unit records measurement signals reflecting the neuron activity of the stimulated neurons and a control and analysis unit controls the stimulation unit to administer stimuli, check the success of stimulation based on the measurement, and, if the stimulation success is not sufficient, insert one or more stimulation breaks in the application of the stimuli or extend one or more stimulation breaks, where no stimuli that could suppress the pathological synchronous and oscillatory neuron activity are applied during the stimulation breaks.”. Determining whether to apply the third electrical stimulation immediately or after a stimulation break is dependent on the selected therapy mode.).
Regarding claim 10, the Dinsmoor/Tass combination teaches the method of claim 9, wherein at least one of: (1) the first patient state is the patient not moving, and the second patient state is the patient moving (Dinsmoor, [0056]: “Example posture states may include “Upright,” “Upright and Active””. The first patient state can be upright, which is not moving, and the second patient state can be upright and active, which is the moving.), and (2) the first patient state is the patient having taken medication, and the second patient state is one of a steady state of the medication or when medication is no longer effective.
Regarding claim 11, the Dinsmoor/Tass combination teaches the method of claim 9.
However, the Dinsmoor/Tass combination is silent on the steps used to determine what type of therapy to use.
Tass teaches wherein determining whether the difference between the first instance of the biomarker signal and the second instance of the biomarker signal satisfies the threshold comprises determining that the difference between the first instance of the biomarker signal and the second instance of the biomarker signal satisfies the threshold ([0049]: “The stimulation success can in particular be checked by means of a threshold value comparison. Depending on which signals are used for determining the stimulation success, different threshold value comparisons result. If e.g. the pathologically neuronal synchronization is measured via the sensors of the measuring unit 12 … experience has shown that the lowering of the synchronization by e.g. at least 20% in comparison with the situation without stimulation is sufficient to determine a sufficient stimulation success”. If the measured signals from sensors, such as sensors used to measure the eECAP signals (Dinsmoor, [0006]: “The eECAP signal can be sensed by a sensor”), are above a threshold such as above 20%, the simulation is sufficient and the simulation breaks are not implemented.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the selection step from Tass into the Dinsmoor/Tass combination since the combination is silent on how the therapy modes are selected, and Tass discloses suitable steps in an analogous device.
The Dinsmoor/Tass combination teaches wherein selecting the therapy mode comprises selecting a normal closed-loop therapy mode, wherein the normal closed-loop therapy mode is one type of the plurality of different types of closed-loop therapy modes, and wherein causing the stimulation generation circuitry to deliver the third electrical stimulation in accordance with the selected therapy mode comprises: causing the stimulation generation circuitry to transition between delivering the first electrical stimulation having a first parameter set based on the patient being in the first patient state and delivering the third electrical stimulation having a second parameter set based on the patient being in the second patient state (Dinsmoor, [0032]: “As discussed herein, systems, devices, and methods are described for adjusting electrical stimulation parameters based on a detected electrically evoked compound action potential (eECAP). The eECAP may be evoked in response to the application of electrical stimulation therapy that is defined according to a set of stimulation parameters. Adjustments to the electrical stimulation parameters based on the detected eECAP may provide more objective information than patient feedback. In addition, eECAP detection may allow a system to provide closed-loop stimulation control. Incorporation of eECAP into adjustment, and/or titration, of stimulation parameters may allow for stimulation systems to provide stimulation therapy that uses less energy, more targeted stimulation delivery to desired tissues, and/or improved therapeutic efficacy as compared to techniques that do not incorporate eECAP detection”. This closed loop therapy methods describe a normal closed loop therapy, therefore teaching on this limitation.).
Regarding claim 12, the Dinsmoor/Tass combination teaches the method of claim 9.
However, the Dinsmoor/Tass combination is silent on the steps used to determine what type of therapy to use.
Tass teaches wherein determining whether the difference between the first instance of the biomarker signal and the second instance of the biomarker signal satisfies the threshold comprises determining that the difference between the first instance of the biomarker signal and the second instance of the biomarker signal does not satisfy the threshold ([0049]: “The stimulation success can in particular be checked by means of a threshold value comparison. Depending on which signals are used for determining the stimulation success, different threshold value comparisons result. If e.g. the pathologically neuronal synchronization is measured via the sensors of the measuring unit 12 … experience has shown that the lowering of the synchronization by e.g. at least 20% in comparison with the situation without stimulation is sufficient to determine a sufficient stimulation success”. If the measured signals from sensors, such as sensors used to measure the eECAP signals (Dinsmoor, [0006]: “The eECAP signal can be sensed by a sensor”), are below a threshold such as below 20%, the simulation is insufficient and the simulation breaks are implemented.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the selection step from Tass into the Dinsmoor/Tass combination since the combination is silent on how the therapy modes are selected, and Tass discloses suitable steps in an analogous device.
The Dinsmoor/Tass combination teaches wherein selecting the therapy mode comprises selecting a polling closed-loop therapy mode, wherein the polling closed-loop therapy mode is one type of the plurality of different types of closed-loop therapy modes (Tass, Abstract: “a measuring unit records measurement signals reflecting the neuron activity of the stimulated neurons and a control and analysis unit controls the stimulation unit to administer stimuli, check the success of stimulation based on the measurement, and, if the stimulation success is not sufficient, insert one or more stimulation breaks in the application of the stimuli or extend one or more stimulation breaks”. This closed-loop therapy mode describes the steps of a polling closed-loop therapy mode, therefore teaching on this limitation.), and wherein causing the stimulation generation circuitry to deliver the third electrical stimulation in accordance with the selected therapy mode comprises: causing the stimulation generation circuitry to deliver the first electrical stimulation having a first parameter set based on the patient being in the first patient state (Dinsmoor, [0157]: “IMD 14 delivers electrical stimulation as a therapeutic or a diagnostic intervention (stimulation therapy) to a patient”; [0059]: “In response to a posture state indication by the posture state module, IMD 14 may change a program group, program, stimulation amplitude, pulse width, pulse rate, and/or one or more other parameters, groups or programs to maintain therapeutic efficacy”; [0056]: “Example posture states may include “Upright,” “Upright and Active,” “Lying Down,” and so forth.”. Any of the posture states such as “upright”, “upright and active”, “lying down”, etc. can be the first patient state.); determining that the patient transitioned to the second patient state (Dinsmoor, [0056]: “The IMD may then detect an eECAP biomarker in response to the adjusted stimulation parameters to determine if the adjustment was effective. In other examples, the IMD may detect an eECAP biomarker in response to stimulation when a change in posture is detected prior to making an adjustment to the stimulation parameters. IMD 14 may analyze the detected eECAP biomarker to determine the appropriate adjustment to the stimulation parameters”. The stimulation parameters are changed when a change in position is determined, which is the second patient state.); causing the stimulation generation circuitry to deliver the third electrical stimulation having a second parameter set based on the patient being in the second patient state (Dinsmoor, [0056]: “The IMD may then detect an eECAP biomarker in response to the adjusted stimulation parameters to determine if the adjustment was effective. In other examples, the IMD may detect an eECAP biomarker in response to stimulation when a change in posture is detected prior to making an adjustment to the stimulation parameters. IMD 14 may analyze the detected eECAP biomarker to determine the appropriate adjustment to the stimulation parameters”. The stimulation parameters are changed when a change in position is determined, which is the second patient state.); after the stimulation generation circuitry delivers the third electrical stimulation having the second parameter set, temporally causing the stimulation generation circuitry to cease delivery of the third electrical stimulation or to deliver the first electrical stimulation having the first parameter set (Tass, Abstract: “a measuring unit records measurement signals reflecting the neuron activity of the stimulated neurons and a control and analysis unit controls the stimulation unit to administer stimuli, check the success of stimulation based on the measurement, and, if the stimulation success is not sufficient, insert one or more stimulation breaks in the application of the stimuli or extend one or more stimulation breaks, where no stimuli that could suppress the pathological synchronous and oscillatory neuron activity are applied during the stimulation breaks.”; [0049]: “The stimulation success can in particular be checked by means of a threshold value comparison”).
However, the Dinsmoor/Tass combination is silent on whether the system determines whether the patient transitioned to the first patient state during the cessation.
Tass teaches during the cessation of the third electrical stimulation or stimulation generation circuitry delivering the first electrical stimulation having the first parameter set, determining whether the patient transitioned to the first patient state ([0057]: “Chronically or intermittently used EEG electrodes or accelerometers can e.g. be used as non-invasive sensors for the detection of characteristic movement patterns”. The device monitors movement patterns throughout all measurements, therefore this includes during the stimulation breaks, and since Dinsmoor teaches using motion signals to determine patient state (Dinsmoor, “In response to a posture state indication by the posture state module, IMD 14 may change a program group, program, stimulation amplitude, pulse width, pulse rate, and/or one or more other parameters, groups or programs to maintain therapeutic efficacy”; [0056]: “A posture state module may include, for example, one or more accelerometers”), it is obvious that the patient state is monitored during cessation.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the system determining patient state during the cessation from Tass into the Dinsmoor/Tass combination as the combination is silent on whether the patient state is monitored during the cessation, and Tass teaches this limitation in an analogous device.
The Dinsmoor/Tass combination teaches causing the stimulation generation circuitry to deliver the first electrical stimulation having the first parameter set or deliver the third electrical stimulation having the second parameter set based on the determination of whether the patient transitioned to the first patient state (Dinsmoor, [0032]: “As discussed herein, systems, devices, and methods are described for adjusting electrical stimulation parameters based on a detected electrically evoked compound action potential (eECAP). The eECAP may be evoked in response to the application of electrical stimulation therapy that is defined according to a set of stimulation parameters. Adjustments to the electrical stimulation parameters based on the detected eECAP may provide more objective information than patient feedback. In addition, eECAP detection may allow a system to provide closed loop stimulation control. Incorporation of eECAP into adjustment, and/or titration, of stimulation parameters may allow for stimulation systems to provide stimulation therapy that uses less energy, more targeted stimulation delivery to desired tissues, and/or improved therapeutic efficacy as compared to techniques that do not incorporate eECAP detection”).
Regarding claim 13, the Dinsmoor/Tass combination teaches the method of claim 12, further comprising: prior to selecting the polling closed-loop therapy mode: reducing intensity of the first electrical stimulation (Dinsmoor, [0056]: “A posture state module may include, for example, one or more accelerometers that detect when patient 12 occupies a posture state in which it may be appropriate to decrease the stimulation amplitude, e.g., when patient 12 lies down.”. If the first or second patient state is when the user is lying down, the simulation amplitude is decreased, which occurs before the therapy mode is selected.); and determining that the first electrical stimulation having reduced intensity is not therapeutic, and wherein selecting the polling closed-loop therapy mode comprises selecting the polling closed-loop therapy mode based on the determination that the first electrical stimulation having reduced intensity is not therapeutic (Tass, Abstract: “a measuring unit records measurement signals reflecting the neuron activity of the stimulated neurons and a control and analysis unit controls the stimulation unit to administer stimuli, check the success of stimulation based on the measurement, and, if the stimulation success is not sufficient, insert one or more stimulation breaks in the application of the stimuli or extend one or more stimulation breaks, where no stimuli that could suppress the pathological synchronous and oscillatory neuron activity are applied during the stimulation breaks.”).
Regarding claim 14, the Dinsmoor/Tass combination teaches the method of claim 9, wherein the first instance of the biomarker signal and the second instance of the biomarker signal comprise one of a local field potential (LFP) signal, an evoked compound action potential (ECAP) signal, and an electromyography (EMG) signal (Dinsmoor, [0007]: “sensing, by a sensing electrode, an electrically evoked compound action potential (eECAP) signal”. The eECAP signal is the biomarker signals.).
Regarding claim 15, the Dinsmoor/Tass combination teaches the method of claim 9, wherein an implantable medical device (IMD) includes the stimulation generation circuitry, the sensing circuitry, and the processing circuitry (Dinsmoor, [0053]: “IMD 14 may deliver stimulation therapy according to one or more programs.”; [0055]: “To avoid or reduce possible disruptions in effective therapy due to posture state changes, IMD 14 may include a posture state module that detects the posture state of patient 12 and causes the IMD 14 to automatically detect an eECAP response to stimulation in response to a change in posture state”; [0084]: “Processing circuitry 80 controls stimulation generator 84 to deliver electrical stimulation via electrode combinations formed by electrodes in one or more electrode arrays. For example, stimulation generator 84 may deliver electrical stimulation therapy via electrodes on one or more leads 16, e.g., as stimulation pulses or continuous waveforms. Components described as processing circuitry within IMD 14, external programmer 20 or any other device described in this disclosure may each comprise one or more processors, such as one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), programmable logic circuitry, or the like, either alone or in any suitable combination”).
Regarding claim 16, the Dinsmoor/Tass combination teaches the method of claim 9, wherein an implantable medical device (IMD) includes the stimulation generation circuitry and the sensing circuitry, and wherein an external programmer or a combination of the external programmer and the IIMD include the processing circuitry (Dinsmoor, [0053]: “IMD 14 may deliver stimulation therapy according to one or more programs.”; [0055]: “To avoid or reduce possible disruptions in effective therapy due to posture state changes, IMD 14 may include a posture state module that detects the posture state of patient 12 and causes the IMD 14 to automatically detect an eECAP response to stimulation in response to a change in posture state”; [0084]: “Processing circuitry 80 controls stimulation generator 84 to deliver electrical stimulation via electrode combinations formed by electrodes in one or more electrode arrays. For example, stimulation generator 84 may deliver electrical stimulation therapy via electrodes on one or more leads 16, e.g., as stimulation pulses or continuous waveforms. Components described as processing circuitry within IMD 14, external programmer 20 or any other device described in this disclosure may each comprise one or more processors, such as one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), programmable logic circuitry, or the like, either alone or in any suitable combination”; [0061]: “external programmer 20 may transmit programs, parameter adjustments, program selections, group selections, or other information to control the operation of IMD”).
Regarding independent claim 17, Dinsmoor teaches a computer-readable storage medium storing instructions thereon that when executed cause one or more processors to ([0180]: “For aspects implemented in software, at least some of the functionality ascribed to the systems and devices described in this disclosure may be embodied as instructions on a computer-readable storage medium such as random access memory (RAM), read-only memory (ROM), non-volatile random access memory (NVRAM), electrically erasable programmable read-only memory (EEPROM), FLASH memory, magnetic media, optical media, or the like that is tangible. The computer-readable storage media may be referred to as non-transitory.”):
cause a stimulation generation circuitry ([0008]: “the disclosure describes a system comprising: one or more electrodes; a stimulation generator configured to apply stimulation therapy via the one or more electrodes based on a set of stimulation therapy parameters” ) to deliver a first electrical stimulation with a patient in a first patient state ([0157]: “IMD 14 delivers electrical stimulation as a therapeutic or a diagnostic intervention (stimulation therapy) to a patient”; [0059]: “In response to a posture state indication by the posture state module, IMD 14 may change a program group, program, stimulation amplitude, pulse width, pulse rate, and/or one or more other parameters, groups or programs to maintain therapeutic efficacy”; [0056]: “Example posture states may include “Upright,” “Upright and Active,” “Lying Down,” and so forth.”. Any of the posture states such as “upright”, “upright and active”, “lying down”, etc. can be the first patient state.);
receive a first instance of a biomarker signal sensed by a sensing circuitry in presence of the first electrical stimulation from the stimulation generation circuitry delivering the first electrical stimulation with the patient in the first patient state ([0055]: “IMD 14 may include a posture state module that detects the posture state of patient 12 and causes the IMD 14 to automatically detect an eECAP response to stimulation in response to a change in posture state”; [0157]: “IMD 14 delivers electrical stimulation as a therapeutic or a diagnostic intervention (stimulation therapy) to a patient”; [0056]: “The IMD may then detect an eECAP biomarker in response to the adjusted stimulation parameters to determine if the adjustment was effective. In other examples, the IMD may detect an eECAP biomarker in response to stimulation when a change in posture is detected prior to making an adjustment to the stimulation parameters. IMD 14 may analyze the detected eECAP biomarker to determine the appropriate adjustment to the stimulation parameters”. The IMD detects the eECAP levels (the biomarker levels) when the user is in a first patient state (the posture state) and deliver specific stimulation parameters based on the posture state and the eECAP levels.);
cause the stimulation generation circuitry to deliver a second electrical stimulation with the patient in a second patient state ([0056]: “The IMD may then detect an eECAP biomarker in response to the adjusted stimulation parameters to determine if the adjustment was effective. In other examples, the IMD may detect an eECAP biomarker in response to stimulation when a change in posture is detected prior to making an adjustment to the stimulation parameters. IMD 14 may analyze the detected eECAP biomarker to determine the appropriate adjustment to the stimulation parameters”. The stimulation parameters are changed when a change in position is determined, which is the second patient state.);
receive a second instance of the biomarker signal sensed by the sensing circuitry in presence of the second electrical stimulation from the stimulation generation circuitry delivering the second electrical stimulation with the patient in the second patient state ([0055]: “IMD 14 may include a posture state module that detects the posture state of patient 12 and causes the IMD 14 to automatically detect an eECAP response to stimulation in response to a change in posture state”);
determine whether a difference between the first instance of the biomarker signal and the second instance of the biomarker signal satisfies a threshold ([0055]: “Based on the detected eECAP, IMD 14 determines whether an adjustment to the stimulation parameters is recommended or otherwise appropriate. For example, a posture state module may include a posture state sensor, such as an accelerometer, that detects when patient 12 lies down, stands up, or otherwise changes posture.”; [0060]: “IMD 14 may periodically detect eECAP generated in response to current stimulation parameters and adjust the current stimulation parameters if there has been a significant change, i.e., greater than a predetermined threshold change, to the detected eECAP biomarker relative to a desired or reference eECAP biomarker”; [0032]: “eECAP detection may allow a system to provide closed-loop stimulation control”).
However, Dinsmoor teaches applying closed-loop therapy in response to the biomarker signal ([0032]: “eECAP detection may allow a system to provide closed-loop stimulation control”), however Dinsmoor does not teach selecting a therapy mode from a plurality of different types of closed-loop therapy modes based on whether the difference between the first instance of the biomarker signal and the second instance of the biomarker signal satisfies the threshold.
Tass discloses a device for effective neurostimulation. Specifically, Tass teaches select a therapy mode from a plurality of different types of closed-loop therapy modes based on whether the difference between the first instance of the biomarker signal and the second instance of the biomarker signal satisfies the threshold (Abstract: “a measuring unit records measurement signals reflecting the neuron activity of the stimulated neurons and a control and analysis unit controls the stimulation unit to administer stimuli, check the success of stimulation based on the measurement, and, if the stimulation success is not sufficient, insert one or more stimulation breaks in the application of the stimuli or extend one or more stimulation breaks, where no stimuli that could suppress the pathological synchronous and oscillatory neuron activity are applied during the stimulation breaks.”; [0049]: “The stimulation success can in particular be checked by means of a threshold value comparison”. The eECAP biomarker signals can be used as a measurement signal reflecting the neuron activity. The device only implements pauses when the success of the stimulation is not sufficient, which is determined through a threshold, and therefore implements a different type of closed-loop therapy based on whether the biomarker signal satisfies the threshold or not.). Dinsmoor and Tass are analogous art as they are both related to devices to control neurostimulation.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the different types of closed-loop therapy from Tass into the system from Dinsmoor as it allows for different types of therapy to be applied dependent on the user’s response to the therapy, which can create a more personalized and effective treatment.
The Dinsmoor/Tass combination teaches cause the stimulation generation circuitry to deliver a third electrical stimulation (Dinsmoor, [0032]: “As discussed herein, systems, devices, and methods are described for adjusting electrical stimulation parameters based on a detected electrically evoked compound action potential (eECAP). The eECAP may be evoked in response to the application of electrical stimulation therapy that is defined according to a set of stimulation parameters. Adjustments to the electrical stimulation parameters based on the detected eECAP may provide more objective information than patient feedback. In addition, eECAP detection may allow a system to provide closed loop stimulation control. Incorporation of eECAP into adjustment, and/or titration, of stimulation parameters may allow for stimulation systems to provide stimulation therapy that uses less energy, more targeted stimulation delivery to desired tissues, and/or improved therapeutic efficacy as compared to techniques that do not incorporate eECAP detection”) in accordance with the selected therapy mode (Tass, Abstract: “a measuring unit records measurement signals reflecting the neuron activity of the stimulated neurons and a control and analysis unit controls the stimulation unit to administer stimuli, check the success of stimulation based on the measurement, and, if the stimulation success is not sufficient, insert one or more stimulation breaks in the application of the stimuli or extend one or more stimulation breaks, where no stimuli that could suppress the pathological synchronous and oscillatory neuron activity are applied during the stimulation breaks.”. Determining whether to apply the third electrical stimulation immediately or after a stimulation break is dependent on the selected therapy mode.).
Regarding claim 18, the Dinsmoor/Lass combination teaches the computer-readable storage medium of claim 17.
However, the Dinsmoor/Tass combination is silent on the steps used to determine what type of therapy to use.
Tass teaches wherein the instructions that cause the one or more processors to determine whether the difference between the first instance of the biomarker signal and the second instance of the biomarker signal satisfies the threshold comprise instructions that cause the one or more processors to determine that the difference between the first instance of the biomarker instance of the biomarker signal satisfies the threshold ([0049]: “The stimulation success can in particular be checked by means of a threshold value comparison. Depending on which signals are used for determining the stimulation success, different threshold value comparisons result. If e.g. the pathologically neuronal synchronization is measured via the sensors of the measuring unit 12 … experience has shown that the lowering of the synchronization by e.g. at least 20% in comparison with the situation without stimulation is sufficient to determine a sufficient stimulation success”. If the measured signals from sensors, such as sensors used to measure the eECAP signals (Dinsmoor, [0006]: “The eECAP signal can be sensed by a sensor”), are above a threshold such as above 20%, the simulation is sufficient and the simulation breaks are not implemented.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the selection step from Tass into the Dinsmoor/Tass combination since the combination is silent on how the therapy modes are selected, and Tass discloses suitable steps in an analogous device.
The Dinsmoor/Tass combination teaches wherein the instructions that cause the one or more processors to select a normal closed-loop therapy mode, wherein the normal closed-loop therapy mode is one type of the plurality of different types of closed-loop therapy modes, and wherein the instructions that cause the one or more processors to cause the stimulation generation circuitry to deliver the third electrical stimulation in accordance with the selected therapy mode comprise instructions that cause the one or more processors to: cause the stimulation generation circuitry to transition between delivering the first electrical stimulation having a first parameter set based on the patient being in the first patient state and delivering the third electrical stimulation having a second parameter set based on the patient being in the second patient state (Dinsmoor, [0032]: “As discussed herein, systems, devices, and methods are described for adjusting electrical stimulation parameters based on a detected electrically evoked compound action potential (eECAP). The eECAP may be evoked in response to the application of electrical stimulation therapy that is defined according to a set of stimulation parameters. Adjustments to the electrical stimulation parameters based on the detected eECAP may provide more objective information than patient feedback. In addition, eECAP detection may allow a system to provide closed-loop stimulation control. Incorporation of eECAP into adjustment, and/or titration, of stimulation parameters may allow for stimulation systems to provide stimulation therapy that uses less energy, more targeted stimulation delivery to desired tissues, and/or improved therapeutic efficacy as compared to techniques that do not incorporate eECAP detection”. This closed loop therapy methods describe a normal closed loop therapy, therefore teaching on this limitation.).
Regarding claim 19, the Dinsmoor/Lass combination teaches the computer-readable storage medium of claim 17.
However, the Dinsmoor/Tass combination is silent on the steps used to determine what type of therapy to use.
Tass teaches wherein the instructions that cause the one or more processors to determine whether the difference between the first instance of the biomarker and the second instance of the biomarker signal satisfies the threshold comprise instructions that cause the one or more processors to determine that the difference between the first instance of the biomarker signal and the second instance of the biomarker signal does not satisfy the threshold ([0049]: “The stimulation success can in particular be checked by means of a threshold value comparison. Depending on which signals are used for determining the stimulation success, different threshold value comparisons result. If e.g. the pathologically neuronal synchronization is measured via the sensors of the measuring unit 12 … experience has shown that the lowering of the synchronization by e.g. at least 20% in comparison with the situation without stimulation is sufficient to determine a sufficient stimulation success”. If the measured signals from sensors, such as sensors used to measure the eECAP signals (Dinsmoor, [0006]: “The eECAP signal can be sensed by a sensor”), are below a threshold such as below 20%, the simulation is insufficient and the simulation breaks are implemented.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the selection step from Tass into the Dinsmoor/Tass combination since the combination is silent on how the therapy modes are selected, and Tass discloses suitable steps in an analogous device.
The Dinsmoor/Tass combination teaches wherein the instructions that cause the one or more processors to select the therapy mode comprise instructions that cause the one or more processors to select a polling closed-loop therapy mode, wherein the polling closed-loop therapy mode is one type of the plurality of different types of closed-loop therapy modes (Tass, Abstract: “a measuring unit records measurement signals reflecting the neuron activity of the stimulated neurons and a control and analysis unit controls the stimulation unit to administer stimuli, check the success of stimulation based on the measurement, and, if the stimulation success is not sufficient, insert one or more stimulation breaks in the application of the stimuli or extend one or more stimulation breaks”. This closed-loop therapy mode describes the steps of a polling closed-loop therapy mode, therefore teaching on this limitation.), and wherein the instructions that cause the one or more processors to cause the stimulation generation circuitry to deliver the third electrical stimulation in accordance with the selected therapy mode comprise instructions that cause the one or more processors to: cause the stimulation generation circuitry to deliver the first electrical stimulation having a first parameter set based on the patient being in the first patient state (Dinsmoor, [0157]: “IMD 14 delivers electrical stimulation as a therapeutic or a diagnostic intervention (stimulation therapy) to a patient”; [0059]: “In response to a posture state indication by the posture state module, IMD 14 may change a program group, program, stimulation amplitude, pulse width, pulse rate, and/or one or more other parameters, groups or programs to maintain therapeutic efficacy”; [0056]: “Example posture states may include “Upright,” “Upright and Active,” “Lying Down,” and so forth.”. Any of the posture states such as “upright”, “upright and active”, “lying down”, etc. can be the first patient state.); determine that the patient transitioned to the second patient state (Dinsmoor, [0056]: “The IMD may then detect an eECAP biomarker in response to the adjusted stimulation parameters to determine if the adjustment was effective. In other examples, the IMD may detect an eECAP biomarker in response to stimulation when a change in posture is detected prior to making an adjustment to the stimulation parameters. IMD 14 may analyze the detected eECAP biomarker to determine the appropriate adjustment to the stimulation parameters”. The stimulation parameters are changed when a change in position is determined, which is the second patient state.); cause the stimulation generation circuitry to deliver the third electrical stimulation having a second parameter set based on the patient being in the second patient state (Dinsmoor, [0056]: “The IMD may then detect an eECAP biomarker in response to the adjusted stimulation parameters to determine if the adjustment was effective. In other examples, the IMD may detect an eECAP biomarker in response to stimulation when a change in posture is detected prior to making an adjustment to the stimulation parameters. IMD 14 may analyze the detected eECAP biomarker to determine the appropriate adjustment to the stimulation parameters”. The stimulation parameters are changed when a change in position is determined, which is the second patient state.); after the stimulation generation circuitry delivers the third electrical stimulation having the second parameter set, temporally cause the stimulation generation circuitry to cease delivery of the third electrical stimulation or to deliver the first electrical stimulation having the first parameter set (Tass, Abstract: “a measuring unit records measurement signals reflecting the neuron activity of the stimulated neurons and a control and analysis unit controls the stimulation unit to administer stimuli, check the success of stimulation based on the measurement, and, if the stimulation success is not sufficient, insert one or more stimulation breaks in the application of the stimuli or extend one or more stimulation breaks, where no stimuli that could suppress the pathological synchronous and oscillatory neuron activity are applied during the stimulation breaks.”; [0049]: “The stimulation success can in particular be checked by means of a threshold value comparison”).
However, the Dinsmoor/Tass combination is silent on whether the system determines whether the patient transitioned to the first patient state during the cessation.
Tass teaches during the cessation of the third electrical stimulation or stimulation generation circuitry delivering the first electrical stimulation having the first parameter set, determine whether the patient transitioned to the first patient state ([0057]: “Chronically or intermittently used EEG electrodes or accelerometers can e.g. be used as non-invasive sensors for the detection of characteristic movement patterns”. The device monitors movement patterns throughout all measurements, therefore this includes during the stimulation breaks, and since Dinsmoor teaches using motion signals to determine patient state (Dinsmoor, “In response to a posture state indication by the posture state module, IMD 14 may change a program group, program, stimulation amplitude, pulse width, pulse rate, and/or one or more other parameters, groups or programs to maintain therapeutic efficacy”; [0056]: “A posture state module may include, for example, one or more accelerometers”), it is obvious that the patient state is monitored during cessation.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the system determining patient state during the cessation from Tass into the Dinsmoor/Tass combination as the combination is silent on whether the patient state is monitored during the cessation, and Tass teaches this limitation in an analogous device.
The Dinsmoor/Tass combination teaches cause the stimulation generation circuitry to deliver the first electrical stimulation having the first parameter set or deliver the third electrical stimulation having the second parameter set based on the determination of whether the patient transitioned to the first patient state (Dinsmoor, [0032]: “As discussed herein, systems, devices, and methods are described for adjusting electrical stimulation parameters based on a detected electrically evoked compound action potential (eECAP). The eECAP may be evoked in response to the application of electrical stimulation therapy that is defined according to a set of stimulation parameters. Adjustments to the electrical stimulation parameters based on the detected eECAP may provide more objective information than patient feedback. In addition, eECAP detection may allow a system to provide closed loop stimulation control. Incorporation of eECAP into adjustment, and/or titration, of stimulation parameters may allow for stimulation systems to provide stimulation therapy that uses less energy, more targeted stimulation delivery to desired tissues, and/or improved therapeutic efficacy as compared to techniques that do not incorporate eECAP detection”).
Regarding claim 20, the Dinsmoor/Tass combination teaches the computer-readable storage medium of claim 19, further comprising instructions that cause the one or more processors to: prior to selecting the polling closed-loop therapy mode: reduce intensity of the first electrical stimulation (Dinsmoor, [0056]: “A posture state module may include, for example, one or more accelerometers that detect when patient 12 occupies a posture state in which it may be appropriate to decrease the stimulation amplitude, e.g., when patient 12 lies down.”. If the first or second patient state is when the user is lying down, the simulation amplitude is decreased, which occurs before the therapy mode is selected.); and determine that the first electrical stimulation having reduced intensity is not therapeutic, and wherein the instructions that cause the one or more processors to select the polling closed-loop therapy mode comprise instructions that cause the one or more processors to select the polling closed-loop therapy mode based on the determination that the first electrical stimulation having reduced intensity is not therapeutic (Tass, Abstract: “a measuring unit records measurement signals reflecting the neuron activity of the stimulated neurons and a control and analysis unit controls the stimulation unit to administer stimuli, check the success of stimulation based on the measurement, and, if the stimulation success is not sufficient, insert one or more stimulation breaks in the application of the stimuli or extend one or more stimulation breaks, where no stimuli that could suppress the pathological synchronous and oscillatory neuron activity are applied during the stimulation breaks.”).
Response to Arguments
All of applicant’s argument regarding the rejections and objections previously set forth have been fully considered and are persuasive unless directly addressed subsequently.
Applicant’s arguments with respect to claims 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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