DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/20/2025 has been entered.
Response to Arguments
Applicant’s arguments filed 2/20/2025 with respect to the rejection of Claims 1-4 under 35 U.S.C. 103 as being unpatentable over U.S. 2018/0229038 A1 to Burdick et al. (“Burdick”) in view of US 2017/0354831 A1 to Burnett (“Burnett”) have been fully considered and are persuasive. The Examiner agrees that the combination of Burdick and Burnett does not disclose “receiving, directly from the at least one sensor, data describing the physiological state” as recited by amended Claim 1. The Examiner finds Applicant’s reasoning regarding Burnett’s single controller persuasive in this respect. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of WO 2018187241 A1.
Applicant’s arguments with respect to the rejection of Claims 5-9 35 U.S.C. 103 as being unpatentable over Burdick in view of U.S. Patent Publication No. 2018/0229036 A1 to Harkema et al. (“Harkema”) have been fully considered and are persuasive. The Examiner agrees that the combination of Burdick and Harkema does not disclose “modifying the second scES configuration based at least in part on the second physiological state” as recited by amended Claim 5. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of WO 2018187241 A1.
Applicant’s arguments regarding the rejection of Claims 13-22 under 35 U.S.C. 102(a)(1) as being anticipated by Burdick have been fully considered and are persuasive. The Examiner agrees that Burdick does not disclose “receiving, directly from at least one sensor, data describing a physiological state of a subject” as recited by Claim 13 as amended. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of WO 2018187241 A1.
Applicant’s arguments regarding the rejection of Claim 23 under 35 U.S.C. 103 as being unpatentable over Burdick view of U.S. Patent No. 9,358,394 B2 to Steinke et al. have been fully considered and are persuasive for the same reasons as explained above with respect to Claim 13, from which Claim 23 depends. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of WO 2018187241 A1.
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.
Claims 1-7 and 13-22 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2018/0229038 A1 to Burdick et al. (“Burdick”) in view of WO2018187241A1 to Hamner et al. (“Hamner”).
Regarding Independent Claim 1, Burdick discloses:
“A control system for spinal cord epidural stimulation (scES), comprising:” (Abstract, “An example neurostimulator device includes a stimulation assembly connectable to a plurality of electrodes, wherein the plurality of electrodes are configured to stimulate a spinal cord. The neurostimulator device also includes an interface and at least one processor configured to modify at least one complex stimulation pattern deliverable by the plurality of electrodes by integrating data from the interface and performing a machine learning algorithm on the at least one complex stimulation pattern;” Para. [0068], “For example, the electrode array 140 may provide epidural stimulation to the spinal cord 110.”);
“a neurostimulator configured to apply scES to a subject;” (Fig. 2, “neurostimulator device 120;” Para. [0062], “The neurostimulator device 120 generates electrical stimulation that is delivered to the electrode array 140 by the one or more leads 130;” Para. [0068], “For example, the electrode array 140 may provide epidural stimulation to the spinal cord 110.”);
“at least one sensor for monitoring a physiological state of the subject;” (Para. [0027], “The neurostimulator device may be connected to the one or more sensors, and configured to transmit the physiological data collected by the one or more sensors to the computing device. The computing device may be connected to the one or more sensors, and configured to receive the physiological data from the one or more sensors.”)
“a first controller in direct electronic communication with the neurostimulator, the first controller being configured to control the scES applied by the neurostimulator;” Para. [0031], “The first computing device is connected to the network and configured to transmit stimulation parameters to the neurostimulator device. The neurostimulator device is configured to generate the complex stimulation patterns based at least in part on the stimulation parameters received from the first computing device.”);
“and a second controller in … electronic communication with the at least one sensor and [direct electronic communication with] the first controller;” (Para. [0031], “The first computing device is being configured to transmit the physiological data collected by the one or more sensors to the second computing device. The second computing device is configured to determine the stimulation parameters based at least in part on the physiological data collected by the one or more sensors, and transmit the stimulation parameters to the first computing device. In some embodiments, the first computing device is configured to receive instructions from the second computing device and transmit them to the neurostimulator device.);
Burdick’s second controller is in direct electronic communication with Burdick’s first controller, and is in electronic communication with Burdick’s sensor. However, Burdick’s second controller is not in direct electronic communication with Burdick’s sensor.
Thus, Burdick discloses:
“…a second controller in … electronic communication with the at least one sensor”
“and a second controller in direct electronic communication with … the first controller”
“wherein the second controller includes a processor and a non-transitory computer readable storage medium having computer program instructions stored thereon that, when executed by the processor, cause the processor to perform the following instructions:” (Para. [0206], “…instructions for performing the method may be stored in a non-transitory memory storage hardware device of at least one of the computing device 152, the neurostimulator device 220, the neurostimulator device 320, and the neurostimulator device 420;” Para. [0209], “The computing device 152 and/or the remote computing device 157 may be substantially identical to the computing device 12. The computing device 12 includes a system memory 22, the processing unit 21, and a system bus 23 that operatively couples various system components, including the system memory 22, to the processing unit 21.”);
“receiving, … from the at least one sensor, data describing the physiological state;” (Para. [0031], “The second computing device is configured to determine the stimulation parameters based at least in part on the physiological data collected by the one or more sensors, and transmit the stimulation parameters to the first computing device.”);
“generating a scES configuration based at least in part on the received data;” (Para. [0031], “The second computing device is configured to determine the stimulation parameters based at least in part on the physiological data collected by the one or more sensors, and transmit the stimulation parameters to the first computing device.”);
“and transmitting the scES configuration to the first controller.” (Para. [0031], “The first computing device is being configured to transmit the physiological data collected by the one or more sensors to the second computing device. The second computing device is configured to determine the stimulation parameters based at least in part on the physiological data collected by the one or more sensors, and transmit the stimulation parameters to the first computing device. In some embodiments, the first computing device is configured to receive instructions from the second computing device and transmit them to the neurostimulator device.”).
Burdick does not disclose:
“and a second controller in direct electronic communication with the at least one sensor…” (i.e., Burdick discloses a second controller that is in electronic communication with the at least one sensor, but does not disclose “wherein the electronic communication with the at least one sensor is direct electronic communication”);
“receiving, directly from the at least one sensor…”
Hamner describes “Systems, methods and devices for peripheral neuromodulation for treating diseases related to overactive bladder” (Title). Hamner is analogous art.
Hamner teaches:
“and a second controller in direct electronic communication with the at least one sensor…” (Claim 147, “wherein the first controller and the second controller each comprise a processor and a memory for receiving the real-time feedback information from the input source that…’” Claim 148, “…wherein the at least one input source comprises at least one biomedical sensor…”);
“receiving, directly from the at least one sensor, data describing the physiological state” (Claim 147; Claim 148; Para. [0028], “The first controller and the second controller can each include a processor and a memory for receiving the real-time feedback information from the input source that, when executed by the processor, cause the device to adjust one or more parameters of the first electrical stimulus based at least in part on the feedback information and/or adjust one or more parameters of the second electrical stimulus based at least in part on the feedback information independent from the first electrical stimulus. The input source can include, for example, at least one biomedical sensor.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Burdick with the teachings of Hamner (i.e., to modify the second controller of Burdkick such that it is configured in the manner of Hamner and is thus in direct electronic communication with and receives data directly from a sensor) in order to enable sensor data to be used as closed loop feedback input for modifying stimulation parameters on a realtime basis (Hamner at Para. [0078]).
Regarding Claim 2, the combination of Burdick and Hamner renders obvious the entirety of Claim 1 as explained above.
Burdick additionally discloses:
“wherein the at least one sensor includes a first sensor for monitoring a first physiological state of the subject and a second sensor for monitoring a second physiological state of the subject, and wherein the first physiological state and second physiological state are not identical.” (Para. [0194], “In the clinical setting, numerous and sensitive EMG sensors 190, as well as foot pressure sensors (not shown), accelerometers 192, and motion tracking systems (not shown) can be used to gather extensive data on the performance of the subject 102 in response to specific stimuli. These assessments of performance can be used by the learning system to determine suitable and/or optimal stimulation parameters.”).
Regarding Claim 3, the combination of Burdick and Hamner renders obvious the entirety of Claim 2 as explained above.
Burdick additionally discloses:
“wherein said receiving comprises receiving, from the first sensor, data describing the first physiological state and receiving, from the second sensor, data describing the second physiological states;” (Para. [0011], “The neurostimulator device may also include a sensor interface connectable to the one or more sensors. The sensor interface is configured to receive signals from the one or more sensors when the sensor interface is connected to the one or more sensors. The neurostimulator device may further include at least one processor connected to both the stimulation assembly and the sensor interface. The at least one processor is configured to direct the stimulation assembly to deliver at least one complex stimulation pattern to the selected ones of the plurality of electrodes, and to receive the signals from the sensor interface. The at least one processor is further configured to modify the at least one complex stimulation pattern delivered by the stimulation assembly based on the signals received from the sensor interface.;” Para. [0016], “The plurality of sensors may include at least one of an Electromyography sensor, a joint angle sensor, an accelerometer, a gyroscope sensor, a flow sensor, a pressure sensor, and a load sensor;” Para. [0194], “In the clinical setting, numerous and sensitive EMG sensors 190, as well as foot pressure sensors (not shown), accelerometers 192, and motion tracking systems (not shown) can be used to gather extensive data on the performance of the subject 102 in response to specific stimuli. These assessments of performance can be used by the learning system to determine suitable and/or optimal stimulation parameters.”);
“and wherein said generating comprises generating a first scES configuration based at least in part on the received data describing the first physiological state and generating a second scES configuration based at least in part on the received data describing the second physiological state;” (Para. [0023], “The neurostimulator device may be configured to generate the complex stimulation patterns based at least in part on the stimulation parameters received from the computing device. The computing device may be further configured to determine the stimulation parameters based on at least in part on the physiological data collected by the one or more sensors;” Para. [0192], “Information received from the electrodes 142, the connections 194, and/or the external adjunctive devices may be used to tune and/or adjust the complex stimulation pattern delivered by the neurostimulator devices 220, 320, and 420;” Para. [0194], “n the clinical setting, numerous and sensitive EMG sensors 190, as well as foot pressure sensors (not shown), accelerometers 192, and motion tracking systems (not shown) can be used to gather extensive data on the performance of the subject 102 in response to specific stimuli. These assessments of performance can be used by the learning system to determine suitable and/or optimal stimulation parameters.”);
“and wherein transmitting the scES comprises transmitting the first scES configuration to the first controller and transmitting and the second scES to the first controller.” (Para. [0031], “The first computing device is being configured to transmit the physiological data collected by the one or more sensors to the second computing device. The second computing device is configured to determine the stimulation parameters based at least in part on the physiological data collected by the one or more sensors, and transmit the stimulation parameters to the first computing device. In some embodiments, the first computing device is configured to receive instructions from the second computing device and transmit them to the neurostimulator device.”).
Regarding Claim 4, the combination of Burdick and Hamner renders obvious discloses the entirety of Claim 1 as explained above.
Burdick additionally discloses:
“wherein the computer program instructions, when executed by the processor, cause the processor to perform the following additional instructions: receiving, from the at least one sensor, data describing the physiological state after application of scES by the neurostimulator; and modifying the scES configuration based at least in part on the data describing the physiological state after application of scES by the neurostimulator.” (Para. [0189], “The neurostimulator device 420 may be configured to provide feedback (received from the sensor 188, recording electrodes, and/or the electrodes 142) to the controller 422, which the controller may use to modify or adjust the stimulation pattern or waveform. In embodiments in which the controller 422 is implemented using a FPGA, the FPGA may be configured to modify the complex stimulation patterns delivered to the subject 102 in near real-time.”).
Regarding Independent Claim 5, Burdick discloses:
“A method of improving bladder function in a subject with impaired bladder control, the method comprising:” (Para. [0018], “In some embodiments, when at least partially activated, the at least one selected spinal circuit produces improved neurological function including at least one of improved autonomic control of at least one of voiding the subject's bladder….”);
“applying spinal cord epidural stimulation (scES) to the subject according to a first scES configuration;” Para. [0012], “The at least one complex stimulation pattern may include a first stimulation pattern followed by a second stimulation pattern;” Para. [0068], “For example, the electrode array 140 may provide epidural stimulation to the spinal cord 110.”);
“applying scES to the subject according to a second scES configuration;” (Para. [0012], “The at least one complex stimulation pattern may include a first stimulation pattern followed by a second stimulation pattern;” Para. [0068], “For example, the electrode array 140 may provide epidural stimulation to the spinal cord 110.”);
“monitoring a first physiological state of the subject after applying scES according to the first scES configuration;” (Para. [0192], “ The learning system receives input from one or more of the sensors 188 and/or external adjunctive devices, which may be implanted along with the neurostimulator device 220, 320, or 420 and/or temporarily applied to the subject 102 (e.g., in a clinical setting). Examples of such sensors include the EMG sensors 190, joint angle sensors 191, accelerometers 192, and the like. … Information received from the electrodes 142, the connections 194, and/or the external adjunctive devices may be used to tune and/or adjust the complex stimulation pattern delivered by the neurostimulator devices 220, 320, and 420;” Para. [0194], “…numerous and sensitive EMG sensors 190, as well as foot pressure sensors (not shown), accelerometers 192, and motion tracking systems (not shown) can be used to gather extensive data on the performance of the subject 102 in response to specific stimuli. These assessments of performance can be used by the learning system to determine suitable and/or optimal stimulation parameters. Soon after the subject 102 is implanted with one of the neurostimulator devices 220, 320, and 420, the subject 102 will begin physical training in a clinical setting (e.g., walking on the treadmill 170), which will continue for a few months during which the learning system can tune the stimulation parameters;” Para. [0195], “…the neurostimulator devices 220, 320, and 420 receive signals from on-board, implanted, and external sensing systems (e.g., the electrodes 142, the sensors 188, and the like). This information may be used by the one of the neurostimulator devices 220, 320, and 420 to tune the stimulation parameters.”);
“monitoring a second physiological state of the subject after applying scES according to the second scES configuration;” (Para. [0192], “ The learning system receives input from one or more of the sensors 188 and/or external adjunctive devices, which may be implanted along with the neurostimulator device 220, 320, or 420 and/or temporarily applied to the subject 102 (e.g., in a clinical setting). Examples of such sensors include the EMG sensors 190, joint angle sensors 191, accelerometers 192, and the like. … Information received from the electrodes 142, the connections 194, and/or the external adjunctive devices may be used to tune and/or adjust the complex stimulation pattern delivered by the neurostimulator devices 220, 320, and 420;” Para. [0194], “…numerous and sensitive EMG sensors 190, as well as foot pressure sensors (not shown), accelerometers 192, and motion tracking systems (not shown) can be used to gather extensive data on the performance of the subject 102 in response to specific stimuli. These assessments of performance can be used by the learning system to determine suitable and/or optimal stimulation parameters. Soon after the subject 102 is implanted with one of the neurostimulator devices 220, 320, and 420, the subject 102 will begin physical training in a clinical setting (e.g., walking on the treadmill 170), which will continue for a few months during which the learning system can tune the stimulation parameters;” Para. [0195], “…the neurostimulator devices 220, 320, and 420 receive signals from on-board, implanted, and external sensing systems (e.g., the electrodes 142, the sensors 188, and the like). This information may be used by the one of the neurostimulator devices 220, 320, and 420 to tune the stimulation parameters.”);
“modifying the first scES configuration based at least in part on the first physiological state” (Para. [0195], “…the neurostimulator devices 220, 320, and 420 receive signals from on-board, implanted, and external sensing systems (e.g., the electrodes 142, the sensors 188, and the like). This information may be used by the one of the neurostimulator devices 220, 320, and 420 to tune the stimulation parameters;” Para. [0013], “The at least one processor may be configured to perform a machine learning method (based on the signals received from the sensor interface) to determine a set of stimulation parameters. In such embodiments, the at least one processor may modify the at least one complex stimulation pattern based at least in part on the set of stimulation parameters. Optionally, the at least one processor may be configured to receive and record electrical signals from the plurality of electrodes. The at least one processor may modify the at least one complex stimulation pattern based at least in part on the electrical signals received from the plurality of electrodes.”).
“wherein modifying the first scES configuration based at least in part on the first physiological state comprises modifying the first scES if the first physiological state is not within a predetermined range for the first physiological state or if the first physiological state is above or below a threshold value for the first physiological state,” (Para. [0016], “The subject has a spinal cord with at least one selected spinal circuit that has a first stimulation threshold representing a minimum amount of stimulation required to activate the at least one selected spinal circuit, and a second stimulation threshold representing an amount of stimulation above which the at least one selected spinal circuit is fully activated. When the at least one complex stimulation pattern is applied to a portion of a spinal cord of the patient, the at least one complex stimulation pattern is below the second stimulation threshold such that the at least one selected spinal circuit is at least partially activatable by the addition of at least one of (a) neurological signals originating from the portion of the patient's body having the paralysis, and (b) supraspinal signals;” Para. [0061], “The electrical stimulation delivered is configured to be below the second stimulation threshold such that the selected spinal circuit is at least partially activatable by the addition of (a) induced neurological signals (e.g., neurological signals induced through physical training), and/or (b) supraspinal signals.”);
“wherein modifying the second scES configuration based at least in part on the second physiological state comprises modifying the second scES if the second physiological state is not within a predetermined range for the second physiological state or if the second physiological state is above or below a threshold value for the second physiological state,” (Para. [0016], “The subject has a spinal cord with at least one selected spinal circuit that has a first stimulation threshold representing a minimum amount of stimulation required to activate the at least one selected spinal circuit, and a second stimulation threshold representing an amount of stimulation above which the at least one selected spinal circuit is fully activated. When the at least one complex stimulation pattern is applied to a portion of a spinal cord of the patient, the at least one complex stimulation pattern is below the second stimulation threshold such that the at least one selected spinal circuit is at least partially activatable by the addition of at least one of (a) neurological signals originating from the portion of the patient's body having the paralysis, and (b) supraspinal signals;” Para. [0061], “The electrical stimulation delivered is configured to be below the second stimulation threshold such that the selected spinal circuit is at least partially activatable by the addition of (a) induced neurological signals (e.g., neurological signals induced through physical training), and/or (b) supraspinal signals.”);
Burdick does not disclose:
“and modifying the second scES configuration based at least in part on the second physiological state”
“and wherein one of the first physiological state and the second physiological state is selected from the group consisting of blood pressure, heart rate, detrusor filling pressure, and detrusor voiding pressure.”
Hamner describes “Systems, methods and devices for peripheral neuromodulation for treating diseases related to overactive bladder” (Title). Hamner is analogous art.
Hamner teaches:
“and modifying the second scES configuration based at least in part on the second physiological state” (Claim 147, “…wherein the first controller and the second controller each comprise a processor and a memory for receiving the real-time feedback information from the input source that, when executed by the processor, cause the device to: adjust one or more parameters of the first electrical stimulus based at least in part on the feedback information; adjust one or more parameters of the second electrical stimulus based at least in part on the feedback information independent from the first electrical stimulus.”);
“and wherein one of the first physiological state and the second physiological state is selected from the group consisting of blood pressure, heart rate, detrusor filling pressure, and detrusor voiding pressure.” (Para. [0135], “In some embodiments, sympathetic activity can also be assessed using more traditional techniques, such as measuring blood pressure changes before release and before starting a hand grip exercise, or measuring blood pressure changes before and after immersing the hand in a bath of cold water (e.g., cold pressor test). Parasympathetic activity can be assessed by measuring heart rate response during deep breathing, or heart rate response to standing from lying or seated position (orthostatics).”)
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Burdick with the teachings of Hamner (i.e., to configure the second controller of Burdick in the manner of Hamner, thereby causing it to modify Burdick’s second scES configuration based on the second physiological state in the manner of Hamner) in order to enable sensor data to be used as closed loop feedback input for modifying stimulation parameters on a realtime basis (Hamner at Para. [0078]).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Burdick with the teachings of Hamner (i.e., to modify the method of Burdick such that it uses blood pressure as its first or second physiological state) in order to assess sympathetic activity (Hamner at Para. [0135]), which may be balanced with assessed parasympathetic activity to reduce urinary symptoms (Hamner at Para. [0026]).
Regarding Claim 6, the combination of Burdick and Hamner renders obvious the entirety of Claim 5 as explained above.
Burdick additionally discloses:
“wherein the first physiological state and second physiological state are not identical.” (Para. [0194], “In the clinical setting, numerous and sensitive EMG sensors 190, as well as foot pressure sensors (not shown), accelerometers 192, and motion tracking systems (not shown) can be used to gather extensive data on the performance of the subject 102 in response to specific stimuli. These assessments of performance can be used by the learning system to determine suitable and/or optimal stimulation parameters.”).
Regarding Claim 7, the combination of Burdick and Hamner renders obvious the entirety of Claim 5 as explained above.
Burdick additionally discloses:
“wherein applying scES according to the first scES configuration and applying scES according to the second scES configuration occur simultaneously” (Para. [0096], “The complex stimulation pattern may include at least one of tonic stimulation and intermittent stimulation. The stimulation applied may be pulsed. The electrical stimulation may include simultaneous or sequential stimulation….”).
Regarding Independent Claim 13, Burdick discloses:
“A non-transitory computer readable storage medium having computer program instructions stored thereon that, when executed by a processor, cause the processor to perform the following instructions:” (Para. [0206], “…instructions for performing the method may be stored in a non-transitory memory storage hardware device of at least one of the computing device 152, the neurostimulator device 220, the neurostimulator device 320, and the neurostimulator device 420;” Para. [0209], “The computing device 152 and/or the remote computing device 157 may be substantially identical to the computing device 12. The computing device 12 includes a system memory 22, the processing unit 21, and a system bus 23 that operatively couples various system components, including the system memory 22, to the processing unit 21.”);
“receiving, … from at least one sensor, data describing a physiological state of a subject;” (Para. [0031], “The second computing device is configured to determine the stimulation parameters based at least in part on the physiological data collected by the one or more sensors, and transmit the stimulation parameters to the first computing device.”);
“generating a spinal cord epidural stimulation (scES) configuration based at least in part on the received data;” (Para. [0031], “The second computing device is configured to determine the stimulation parameters based at least in part on the physiological data collected by the one or more sensors, and transmit the stimulation parameters to the first computing device;” Para. [0068], “For example, the electrode array 140 may provide epidural stimulation to the spinal cord 110.”);
“and transmitting the scES configuration to a neurostimulator controller” (Para. [0031], “The first computing device is being configured to transmit the physiological data collected by the one or more sensors to the second computing device. The second computing device is configured to determine the stimulation parameters based at least in part on the physiological data collected by the one or more sensors, and transmit the stimulation parameters to the first computing device. In some embodiments, the first computing device is configured to receive instructions from the second computing device and transmit them to the neurostimulator device.”).
Burdick does not disclose:
“receiving, directly from at least one sensor, data describing a physiological state of a subject;”
Hamner describes “Systems, methods and devices for peripheral neuromodulation for treating diseases related to overactive bladder” (Title). Hamner is analogous art.
Hamner teaches:
“receiving, directly from at least one sensor, data describing a physiological state of a subject;” (Claim 147; Claim 148; Para. [0028], “The first controller and the second controller can each include a processor and a memory for receiving the real-time feedback information from the input source that, when executed by the processor, cause the device to adjust one or more parameters of the first electrical stimulus based at least in part on the feedback information and/or adjust one or more parameters of the second electrical stimulus based at least in part on the feedback information independent from the first electrical stimulus. The input source can include, for example, at least one biomedical sensor.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Burdick with the teachings of Hamner (i.e., to modify the second controller of Burdkick such that it is configured in the manner of Hamner and is thus in direct electronic communication with and receives data directly from a sensor) in order to enable sensor data to be used as closed loop feedback input for modifying stimulation parameters on a realtime basis (Hamner at Para. [0078]).
Regarding Claim 14, the combination of Burdick and Hamner renders obvious the entirety of Claim 13 as explained above.
Burdick additionally discloses:
“wherein the receiving comprises receiving first sensor data from a first sensor, the first sensor data describing a first physiological state and receiving second sensor data from a second sensor, the second sensor data describing a second physiological state” (Para. [0194], “In the clinical setting, numerous and sensitive EMG sensors 190, as well as foot pressure sensors (not shown), accelerometers 192, and motion tracking systems (not shown) can be used to gather extensive data on the performance of the subject 102 in response to specific stimuli. These assessments of performance can be used by the learning system to determine suitable and/or optimal stimulation parameters.”).
Regarding Claim 15, the combination of Burdick and Hamner renders obvious the entirety of Claim 14 as explained above.
Burdick additionally discloses:
“wherein the first physiological state and second physiological state are not identical” (Para. [0194], “In the clinical setting, numerous and sensitive EMG sensors 190, as well as foot pressure sensors (not shown), accelerometers 192, and motion tracking systems (not shown) can be used to gather extensive data on the performance of the subject 102 in response to specific stimuli. These assessments of performance can be used by the learning system to determine suitable and/or optimal stimulation parameters.”).
Regarding Claim 16, the combination of Burdick and Hamner renders obvious the entirety of Claim 14 as explained above.
Burdick additionally discloses:
“wherein the generating a scES configuration comprises generating a first scES configuration based at least in part on the first sensor data and generating a second scES configuration based at least in part on the second sensor data.” (Para. [0023], “The neurostimulator device may be configured to generate the complex stimulation patterns based at least in part on the stimulation parameters received from the computing device. The computing device may be further configured to determine the stimulation parameters based on at least in part on the physiological data collected by the one or more sensors;” Para. [0192], “Information received from the electrodes 142, the connections 194, and/or the external adjunctive devices may be used to tune and/or adjust the complex stimulation pattern delivered by the neurostimulator devices 220, 320, and 420;” Para. [0194], “n the clinical setting, numerous and sensitive EMG sensors 190, as well as foot pressure sensors (not shown), accelerometers 192, and motion tracking systems (not shown) can be used to gather extensive data on the performance of the subject 102 in response to specific stimuli. These assessments of performance can be used by the learning system to determine suitable and/or optimal stimulation parameters.”).
Regarding Claim 17, the combination of Burdick and Hamner renders obvious the entirety of Claim 14 as explained above.
Burdick additionally discloses:
“wherein the first scES configuration is modified based on the first sensor data” (Para. [0189], “The neurostimulator device 420 may be configured to provide feedback (received from the sensor 188, recording electrodes, and/or the electrodes 142) to the controller 422, which the controller may use to modify or adjust the stimulation pattern or waveform. In embodiments in which the controller 422 is implemented using a FPGA, the FPGA may be configured to modify the complex stimulation patterns delivered to the subject 102 in near real-time.”).
Regarding Claim 18, the combination of Burdick and Hamner renders obvious the entirety of Claim 14 as explained above.
Burdick additionally discloses:
“wherein the second scES configuration is modified based on the second sensor data” (Para. [0195], “…the neurostimulator devices 220, 320, and 420 receive signals from on-board, implanted, and external sensing systems (e.g., the electrodes 142, the sensors 188, and the like). This information may be used by the one of the neurostimulator devices 220, 320, and 420 to tune the stimulation parameters;” Para. [0013], “The at least one processor may be configured to perform a machine learning method (based on the signals received from the sensor interface) to determine a set of stimulation parameters. In such embodiments, the at least one processor may modify the at least one complex stimulation pattern based at least in part on the set of stimulation parameters. Optionally, the at least one processor may be configured to receive and record electrical signals from the plurality of electrodes. The at least one processor may modify the at least one complex stimulation pattern based at least in part on the electrical signals received from the plurality of electrodes;” Para. [0092], “Optionally, the neurostimulator device 120 may be connected to one or more sensors 188 (e.g., Electromyography (“EMG”) sensors 190, joint angle (or flex) sensors 191, accelerometers 192, gyroscopic sensors, pressure sensors, flow sensors, load sensors, and the like) via connections 194 (e.g., wires, wireless connections, and the like).”).
Regarding Claim 19, the combination of Burdick and Hamner renders obvious the entirety of Claim 13 as explained above.
Burdick additionally discloses:
“wherein the step of receiving data occurs both before and after the step of transmitting the scES configuration” (Para. [0015], “Optionally, the at least one processor may be configured to record the signals received from the sensor interface, transmit the recorded electrical signals to the computing device, and receive information from the computing device.”).
Regarding Claim 20, the combination of Burdick and Hamner renders obvious the entirety of Claim 13 as explained above.
Burdick additionally discloses:
“wherein the step of generating the scES configuration is based at least in part on the received data being inside or outside a predetermined range” (Para. [0017], “The subject has a spinal cord with at least one selected spinal circuit that has a first stimulation threshold representing a minimum amount of stimulation required to activate the at least one selected spinal circuit, and a second stimulation threshold representing an amount of stimulation above which the at least one selected spinal circuit is fully activated. When the at least one complex stimulation pattern is applied to a portion of a spinal cord of the patient, the at least one complex stimulation pattern is below the second stimulation threshold such that the at least one selected spinal circuit is at least partially activatable by the addition of at least one of (a) neurological signals originating from the portion of the patient's body having the paralysis, and (b) supraspinal signals.).
Regarding Claim 21, the combination of Burdick and Hamner renders obvious the entirety of Claim 13 as explained above.
Burdick additionally discloses:
“wherein the step of generating the scES configuration is based at least in part on the received data being above or below a threshold value.” (Para. [0016], “The subject has a spinal cord with at least one selected spinal circuit that has a first stimulation threshold representing a minimum amount of stimulation required to activate the at least one selected spinal circuit, and a second stimulation threshold representing an amount of stimulation above which the at least one selected spinal circuit is fully activated. When the at least one complex stimulation pattern is applied to a portion of a spinal cord of the patient, the at least one complex stimulation pattern is below the second stimulation threshold such that the at least one selected spinal circuit is at least partially activatable by the addition of at least one of (a) neurological signals originating from the portion of the patient's body having the paralysis, and (b) supraspinal signals;” Para. [0061], “The electrical stimulation delivered is configured to be below the second stimulation threshold such that the selected spinal circuit is at least partially activatable by the addition of (a) induced neurological signals (e.g., neurological signals induced through physical training), and/or (b) supraspinal signals.”).
Regarding Claim 22, the combination of Burdick and Hamner renders obvious the entirety of Claim 13 as explained above.
Burdick additionally discloses:
“wherein the computer program instructions, when executed by the processor, cause the processor to perform the following additional instructions: receiving, from the at least one sensor, data describing the physiological state after application of scES; and modifying the scES configuration based at least in part on the data describing the physiological state after application of scES” (Para. [0011], “The sensor interface is configured to receive signals from the one or more sensors when the sensor interface is connected to the one or more sensors;” Para. [0189], “The neurostimulator device 420 may be configured to provide feedback (received from the sensor 188, recording electrodes, and/or the electrodes 142) to the controller 422, which the controller may use to modify or adjust the stimulation pattern or waveform. In embodiments in which the controller 422 is implemented using a FPGA, the FPGA may be configured to modify the complex stimulation patterns delivered to the subject 102 in near real-time.”)
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited U.S. Patent Publication No. 2018/0229038 A1 to Burdick et al. (“Burdick”) in view of WO2018187241A1 to Hamner et al. (“Hamner”) as applied to Claim 5 above, and further in view of previously cited U.S. Patent Publication No. 2018/0229036 A1 to Harkema et al. (“Harkema”)
Regarding Claim 8, the combination of Burdick and Hamner renders obvious the entirety of Claim 5 as explained above.
The combination of Burdick and Hamner does not disclose:
“wherein applying scES according to the first scES configuration is applying at an intensity sufficient to enact one of the following: increase or decrease detrusor filling pressure, increase or decrease detrusor voiding pressure, increase or decrease blood pressure, and increase or decrease heart rate.”
Hamner does describe such application of spinal cord stimulation, but not in the context of scES. Hamner thus does not fairly teach “applying [scES] at an intensity sufficient to…,” as Hamner’s stimulation may ostensibly differ from scES in the propriety of certain intensities.
Harkema describes “methods for creating and applying specific configurations of epidural stimulation to assist or cause a patient to perform a complex motor function or to mitigate one or more secondary consequences of paralysis including, but not limited to, cardiovascular, respiratory, bladder, temperature and sexual dysfunction,” (Abstract). Harkema is thus analogous art.
Harkema teaches:
“wherein applying scES according to the first scES configuration is applying at an intensity sufficient to enact one of the following: increase or decrease detrusor filling pressure, increase or decrease detrusor voiding pressure, increase or decrease blood pressure, and increase or decrease heart rate.” (Para. [0033], “FIGS. 6A and 6B shows the effectiveness of the training and electrostimulation process described above. FIG. 6A depicts the systolic and diastolic blood pressure and the heart rate of a patient transitioning from a supine position to a sitting position and back to a supine position. FIG. 6B depicts the same characteristics of the same patient after eighty sessions of training in combination with epidural stimulation, including stimulation to regulate blood pressure and heart rate while transitioning between positions. As is clearly visible, the dramatic decrease in blood pressure in the sitting position has been substantially eliminated and the increase in heart rate has been substantially reduced.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of combined Burdick and Hamner with the teachings of Harkema (i.e., to apply scES at an intensity sufficient to increase or decrease blood pressure, and increase or decrease heart rate) in order to “provide an immediate therapeutic alternative to individuals who currently have no recourse for treatment” (Harkema at Para. [0005]).
Regarding Claim 9, the combination of Burdick and Hamner renders obvious the entirety of Claim 5 as explained above.
The combination of Burdick and Hamner does not disclose:
“wherein applying scES according to the second scES configuration is applying at an intensity sufficient to enact one of the following: increase or decrease detrusor filling pressure, increase or decrease detrusor voiding pressure, increase or decrease blood pressure, and increase or decrease heart rate”
Hamner differs from Claim 9 in the same way as explained above with respect to Claim 8.
Harkema is analogous art, as explained above at Claim 8.
Harkema teaches:
“wherein applying scES according to the second scES configuration is applying at an intensity sufficient to enact one of the following: increase or decrease detrusor filling pressure, increase or decrease detrusor voiding pressure, increase or decrease blood pressure, and increase or decrease heart rate” (Para. [0033], “FIGS. 6A and 6B shows the effectiveness of the training and electrostimulation process described above. FIG. 6A depicts the systolic and diastolic blood pressure and the heart rate of a patient transitioning from a supine position to a sitting position and back to a supine position. FIG. 6B depicts the same characteristics of the same patient after eighty sessions of training in combination with epidural stimulation, including stimulation to regulate blood pressure and heart rate while transitioning between positions. As is clearly visible, the dramatic decrease in blood pressure in the sitting position has been substantially eliminated and the increase in heart rate has been substantially reduced.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of combined Burdick and Hamner with the teachings of Harkema (i.e., to apply scES at an intensity sufficient to increase or decrease blood pressure, and increase or decrease heart rate) in order to “provide an immediate therapeutic alternative to individuals who currently have no recourse for treatment” (Harkema at Para. [0005]).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited U.S. Patent Publication No. 2018/0229038 A1 to Burdick et al. (“Burdick”) in view of WO2018187241A1 to Hamner et al. (“Hamner”) as applied to Claim 13 above, and further in view of previously cited U.S. Patent No. 9,358,394 B2 to Steinke et al. (“Steinke”).
Regarding Claim 23, the combination of Burdick and Hamner renders obvious the entirety of Claim 13 as explained above.
Burdick additionally discloses:
“wherein the computer program instructions, when executed by the processor, cause the processor to performed the following additional instructions: receiving, from the at least one sensor, data describing the physiological state after application of scES;” (Para. [0011], “The sensor interface is configured to receive signals from the one or more sensors when the sensor interface is connected to the one or more sensors;” Para. [0189], “The neurostimulator device 420 may be configured to provide feedback (received from the sensor 188, recording electrodes, and/or the electrodes 142) to the controller 422, which the controller may use to modify or adjust the s