DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claim(s) 1-4, 9-15, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wah (US 11191966 B2) (cited previously) in view of Waataja(US 20210146136 A1).
Regarding claim 1, Wah teaches a system for stimulating an anatomical element of a patient, comprising: a pulse generator configured to generate a current; a first electrode device electrically coupled to the pulse generator, the first electrode device comprising one or more electrodes configured for placement on or around the patient; a second electrode device electrically coupled to the pulse generator, the second electrode device comprising one or more electrodes configured for placement on or around the patient; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: transmit instructions to the pulse generator to apply the current to the patient via the first electrode device, wherein the current is applied using a set of parameters that correspond to an expected physiological response; receive a response measurement recorded via the second electrode device based at least in part on applying the current via the first electrode device(Module controller 116 has an associated memory 118 storing patient settings 120, control programs 122 and the like. Controller 116 controls a pulse generator 124 to generate stimuli in the form of current pulses in accordance with the patient settings 120 and control programs 122. Electrode selection module 126 switches the generated pulses to the appropriate electrode(s) of electrode array 150, for delivery of the current pulse to the tissue surrounding the selected electrode(s). Measurement circuitry 128 is configured to capture measurements of neural responses sensed at sense electrode(s) of the electrode array as selected by electrode selection module 126[Description of preferred embodiments, paragraph 3]); and adjust one or more parameters of the set of parameters for the implantable pulse generator to apply the current based at least in part on the response measurement being different than the expected physiological response(A feedback loop is completed by using the feedback variable to control the at least one stimulus parameter value for a future stimulus. The method adaptively compensates for changes in a gain of the feedback loop caused by electrode movement relative to the neural pathway[Abstract]). Wah fails to disclose electrode placement on or around an anterior sub-diaphragmatic hepatic vagal trunk, the pulse generator affecting a desired glycemic response in the patient, and the electrode device upregulating neural activity.
However, Waataja teaches “ For example, the electrodes 212, 212a may be individually placed on the celiac nerve, the vagal nerve, the hepatic branches of the vagal nerve, or some combination of these, respectively, of a patient. For example, the leads 106, 106a have distal electrodes 212, 212a which are individually placed on the ventral and dorsal vagal nerves VVN, DVN, respectively, of a patient, for example, just below the patient's diaphragm[0052]”, “activate the pulse generator and thereby cause the application of the desired modulating signal to the electrodes. Another form of treatment of may be implemented by programming the pulse generator to periodically deliver the vagal activity modulation productive of glycemic control at programmed intervals[0089]”, and “In some embodiments, the electrical signal is selected for frequency, pulse width, amplitude and timing to upregulate neural activity as described herein[0095]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the feedback control stimulation system of Wah with the neuromodulation control system of Waataja. Doing so would specify stimulation being administered in order to regulate glycemic levels in a patient.
Regarding claim 2, Wah in view of Waataja teaches the system of claim 1, wherein the data stored in the memory that, when processed causes the processor to adjust the one or more parameters causes the system to: adjust an amplitude, frequency, charge density, or a combination thereof for the current(In some embodiments of the invention k can be determined clinically, using a recruitment datum. A recruitment datum can be used as a reference point to adjust the stimulus intensity and achieve the same level of neural recruitment in different postures. Suitable data may include the patient's perceptual threshold, discomfort threshold, coverage of a certain area or body part, or any qualitative characteristic of the patient's perception of a stimulation such as optimal comfort. Electrophysiological measures may also be used, such as the onset of muscle response/twitching, or some measure of neural activity. Such measures may use the amplitude, latency or other characteristic(s) of responses evoked by the stimulus, which may appear in the spine, the peripheral nerves, the brain, or elsewhere in the body[description of embodiments, paragraph 46]).
Regarding claim 3, Wah in view of Waataja the system of claim 1, wherein the response measurement comprises an evoked compound action potential (eCAP) measurement, an electromyography (EMG) measurement, a glucose level measurement, or a combination thereof(From the measured evoked response a feedback variable such as observed ECAP voltage (V) is derived[abstract]).
Regarding claim 4, Wah in view of Waataja teaches system of claim 1, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: receive a plurality of response measurements recorded via the second electrode device over a period of time, the period of time coinciding at least with a duration of the current being applied to the anterior sub-diaphragmatic hepatic vagal trunk of the patient; and generate one or more growth curves based at least in part on the plurality of response measurements, wherein the one or more parameters are adjusted based at least in part on the one or more growth curves(Thus, a method for estimating k is to place the patient in a range of postures i, and in each posture, sweep the stimulus intensity and record a growth curve. From each growth curve, a line is fitted determining the threshold T.sub.i and growth slope M.sub.i.[Description of the Preferred Embodiments, paragraph 60]. I-V control can thus be implemented as a feedback loop in the manner shown. The setpoint is a unitless value determined by the patient's desired level of stimulation. A discrete-time controller G(z) is used to control the stimulus current based on the error signal; this may take the form of a simple gain or a more complex system such as a PID controller[Description of the Preferred Embodiments, paragraph 61]). Wah fails to explicitly disclose the current being applied to the anterior sub-diaphragmatic hepatic vagal trunk of the patient.
However, Waataja teaches “ For example, the electrodes 212, 212a may be individually placed on the celiac nerve, the vagal nerve, the hepatic branches of the vagal nerve, or some combination of these, respectively, of a patient. For example, the leads 106, 106a have distal electrodes 212, 212a which are individually placed on the ventral and dorsal vagal nerves VVN, DVN, respectively, of a patient, for example, just below the patient's diaphragm[0052]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the feedback control stimulation system of Wah with the neuromodulation control system of Waataja. Doing so would specify stimulation being administered in order to regulate glycemic levels in a patient.
Regarding claim 9, Wah in view of Waataja teaches the system of claim 1, but Wah fails to disclose herein the one or more electrodes of the first electrode device comprises: a first electrode for applying the current to the anterior sub-diaphragmatic hepatic vagal trunk of the patient as a first current; and a second electrode configured for placement on or around a posterior sub-diaphragmatic celiac vagal trunk of the patient, and wherein the memory stores further data for processing by the processor that, when processed, causes the processor to transmit the instructions to the pulse generator to effect the desired glycemic response in the patient by: applying a second current via the second electrode to the posterior sub-diaphragmatic celiac vagal trunk of the patient to downregulate neural activity thereof.
However, Waataja teaches “In an embodiment, the lead assemblies 106, 106a include distal electrodes 212, 212a, which are placed on one or more nerves or organs of a patient. For example, the electrodes 212, 212a may be individually placed on the celiac nerve, the vagal nerve, the hepatic branches of the vagal nerve, or some combination of these, respectively, of a patient. For example, the leads 106, 106a have distal electrodes 212, 212a which are individually placed on the ventral and dorsal vagal nerves VVN, DVN, respectively, of a patient, for example, just below the patient's diaphragm[0052]. In embodiments, a system comprises at least two electrodes operably connected to an implantable pulse generator, wherein one of the electrodes is adapted to be placed on a target nerve; an implantable pulse generator that comprises a power module and a programmable therapy delivery module, wherein the programmable therapy delivery module is configured to deliver at least one therapy program comprising an electrical signal treatment applied intermittently multiple times in a day and over multiple days to the target nerve[0049]. The neuroregulator 104 also may include memory in which treatment instructions and/or patient data can be stored. In some embodiments, the neuroregulator comprises a power module and a programmable therapy delivery module. For example, the neuroregulator 104 can store one or more therapy programs in the programmable therapy delivery module indicating what therapy should be delivered to the patient[0061]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the feedback control stimulation system of Wah with the neuromodulation control system of Waataja. Doing so would specify stimulation being administered in order to regulate glycemic levels in a patient.
Regarding claim 10, Wah in view of Waataja teaches the system of claim 1, but fails to disclose the memory stores further data for processing by the processor that, when processed, causes the processor to transmit the instructions to the pulse generator to effect the desired glycemic response in the patient by applying the second current to the posterior sub-diaphragmatic celiac vagal trunk of the patient concurrently with applying the first current to the anterior sub-diaphragmatic hepatic vagal trunk of the patient.
However, Waataja teaches “ A second therapy program may comprise an electrical signal treatment applied intermittently multiple times in a day and over multiple days, wherein the electrical signal has a frequency selected to upregulate or down regulate activity on second target nerve or organ, and has an on time and an off time, wherein the off time is selected to allow at least a partial recovery of the activity of the target nerve. The first and/or second therapy programs may be applied at the same time, at different times, or at overlapping times. The first and/or second therapy programs may be delivered at specific times of the day, and or in response to a signal from a sensor[0062], “activate the pulse generator and thereby cause the application of the desired modulating signal to the electrodes. Another form of treatment of may be implemented by programming the pulse generator to periodically deliver the vagal activity modulation productive of glycemic control at programmed intervals[0089]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the feedback control stimulation system of Wah with the neuromodulation control system of Waataja. Doing so would specify stimulation being administered in order to regulate glycemic levels in a patient.
Regarding claim 11, Wah in view of Waataja teaches the system of claim 1, but Wah fails to disclose when processed by the processor, the data stored in the memory causes the processor to transmit instructions to the pulse generator to apply the current to the anterior sub-diaphragmatic hepatic vagal trunk of the patient as a square wave signal.
However, Waataja teaches “Such a signal has a preferred pulse width of 100 micro-seconds (associated with a frequency of 5,000 Hz). It is believed this frequency and pulse width best avoid neural recovery from blocking and avoid repolarization of the nerve by avoiding periods of no signal in the pulse cycle. A short “off” time in the pulse cycle (e.g., between cycles or within a cycle) could be acceptable as long as it is short enough to avoid nerve repolarization. The waveform may be a square or sinusoidal waveform or other shape[0131]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the feedback control stimulation system of Wah with the neuromodulation control system of Waataja. Doing so would specify stimulation being administered in order to regulate glycemic levels in a patient.
Regarding claim 12, Wah discloses a system for stimulating an anatomical element of a patient, comprising: a pulse generator configured to generate a current; a first electrode device comprising: a first body; and a first plurality of electrodes disposed on the first body and configured to apply the current; a second electrode device comprising: a second body; and a second plurality of electrodes disposed on the second body and configured to record measurements corresponding to the current when the current is applied; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: transmit instructions to the pulse generator to apply the current to the patient via the first electrode device, wherein the current is applied using a set of parameters that correspond to an expected physiological response; receive a response measurement recorded via the second electrode device based at least in part on applying the current via the first electrode device; and adjust one or more parameters of the set of parameters for the pulse generator to apply the current based at least in part on the response measurement being different than the expected physiological response(Module controller 116 has an associated memory 118 storing patient settings 120, control programs 122 and the like. Controller 116 controls a pulse generator 124 to generate stimuli in the form of current pulses in accordance with the patient settings 120 and control programs 122. Electrode selection module 126 switches the generated pulses to the appropriate electrode(s) of electrode array 150, for delivery of the current pulse to the tissue surrounding the selected electrode(s). Measurement circuitry 128 is configured to capture measurements of neural responses sensed at sense electrode(s) of the electrode array as selected by electrode selection module 126[Description of preferred embodiments, paragraph 3]. Both the stimulus transfer function and the recording transfer function describe a physical process where a first element (stimulation electrode or nerve, respectively) radiates an electric field in a volume conductor, and some of this field is sensed by a second element (nerve or sense electrode, respectively)[Description of preferred embodiments, paragraph 16]). A feedback loop is completed by using the feedback variable to control the at least one stimulus parameter value for a future stimulus. The method adaptively compensates for changes in a gain of the feedback loop caused by electrode movement relative to the neural pathway[Abstract]. According to a third aspect the present invention provides a non-transitory computer readable medium for controllably applying a neural stimulus, comprising the following instructions for execution by one or more processors[Summary of Invention, paragraph 11]). Wah fails to disclose electrode placement on or around an anterior sub-diaphragmatic hepatic vagal trunk pr the posterior sub-diaphragmatic celiac vagal trunk, the pulse generator affecting a desired glycemic response in the patient, and the electrode device upregulating or downregulating neural activity.
However, Waataja teaches “ For example, the electrodes 212, 212a may be individually placed on the celiac nerve, the vagal nerve, the hepatic branches of the vagal nerve, or some combination of these, respectively, of a patient. For example, the leads 106, 106a have distal electrodes 212, 212a which are individually placed on the ventral and dorsal vagal nerves VVN, DVN, respectively, of a patient, for example, just below the patient's diaphragm[0052]”, “activate the pulse generator and thereby cause the application of the desired modulating signal to the electrodes. Another form of treatment of may be implemented by programming the pulse generator to periodically deliver the vagal activity modulation productive of glycemic control at programmed intervals[0089]”, and “In one aspect of the disclosure a reversible intermittent (or continuous) modulating signal is applied to a target nerve or organ in order to downregulate and/or upregulate neural activity on the nerve[0103]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the feedback control stimulation system of Wah with the neuromodulation control system of Waataja. Doing so would specify stimulation being administered in order to regulate glycemic levels in a patient.
Regarding claim 13, Wah in view of Waataja teaches the system of claim 12, wherein the data stored in the memory that, when processed causes the processor to adjust the one or more parameters causes the system to: adjust an amplitude, frequency, charge density, or a combination thereof for the current(In some embodiments of the invention k can be determined clinically, using a recruitment datum. A recruitment datum can be used as a reference point to adjust the stimulus intensity and achieve the same level of neural recruitment in different postures. Suitable data may include the patient's perceptual threshold, discomfort threshold, coverage of a certain area or body part, or any qualitative characteristic of the patient's perception of a stimulation such as optimal comfort. Electrophysiological measures may also be used, such as the onset of muscle response/twitching, or some measure of neural activity. Such measures may use the amplitude, latency or other characteristic(s) of responses evoked by the stimulus, which may appear in the spine, the peripheral nerves, the brain, or elsewhere in the body[Description of Preferred Embodiments, paragraph 46]).
Regarding claim 14, Wah in view of Waataja teaches the system of claim 12, wherein the response measurement comprises an evoked compound action potential (eCAP) measurement, an electromyography (EMG) measurement, a glucose level measurement, or a combination thereof(From the measured evoked response a feedback variable such as observed ECAP voltage (V) is derived[abstract]).
Regarding claim 15, Wah in view of Waataja teaches the system of claim 14, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: receive a plurality of response measurements recorded via the second electrode device over a period of time, the period of time coinciding at least with a duration of the current being applied; and generate one or more growth curves based at least in part on the plurality of response measurements, wherein the one or more parameters are adjusted based at least in part on the one or more growth curves(Thus, a method for estimating k is to place the patient in a range of postures i, and in each posture, sweep the stimulus intensity and record a growth curve. From each growth curve, a line is fitted determining the threshold T.sub.i and growth slope M.sub.i.[Description of the Preferred Embodiments, paragraph 60]. I-V control can thus be implemented as a feedback loop in the manner shown. The setpoint is a unitless value determined by the patient's desired level of stimulation. A discrete-time controller G(z) is used to control the stimulus current based on the error signal; this may take the form of a simple gain or a more complex system such as a PID controller[Description of the Preferred Embodiments, paragraph 61]). Wah fails to explicitly disclose the current being applied to the anterior or posterior sub-diaphragmatic hepatic vagal trunk of the patient.
However, Waataja teaches “ For example, the electrodes 212, 212a may be individually placed on the celiac nerve, the vagal nerve, the hepatic branches of the vagal nerve, or some combination of these, respectively, of a patient. For example, the leads 106, 106a have distal electrodes 212, 212a which are individually placed on the ventral and dorsal vagal nerves VVN, DVN, respectively, of a patient, for example, just below the patient's diaphragm[0052]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the feedback control stimulation system of Wah with the neuromodulation control system of Waataja. Doing so would specify stimulation being administered in order to regulate glycemic levels in a patient.
Regarding claim 18, Wah in view of Waataja teaches the system of claim 12, but Wah fails to disclose herein the one or more electrodes of the first electrode device comprises: a first electrode for applying the current to the anterior sub-diaphragmatic hepatic vagal trunk of the patient as a first current; and a second electrode configured for placement on or around a posterior sub-diaphragmatic celiac vagal trunk of the patient, and wherein the memory stores further data for processing by the processor that, when processed, causes the processor to transmit the instructions to the pulse generator to effect the desired glycemic response in the patient by: applying a second current via the second electrode to the posterior sub-diaphragmatic celiac vagal trunk of the patient to upregulate neural activity thereof the anterior sub-diaphragmatic hepatic vagal trunk.
However, Waataja teaches “In an embodiment, the lead assemblies 106, 106a include distal electrodes 212, 212a, which are placed on one or more nerves or organs of a patient. For example, the electrodes 212, 212a may be individually placed on the celiac nerve, the vagal nerve, the hepatic branches of the vagal nerve, or some combination of these, respectively, of a patient. For example, the leads 106, 106a have distal electrodes 212, 212a which are individually placed on the ventral and dorsal vagal nerves VVN, DVN, respectively, of a patient, for example, just below the patient's diaphragm[0052]. In embodiments, a system comprises at least two electrodes operably connected to an implantable pulse generator, wherein one of the electrodes is adapted to be placed on a target nerve; an implantable pulse generator that comprises a power module and a programmable therapy delivery module, wherein the programmable therapy delivery module is configured to deliver at least one therapy program comprising an electrical signal treatment applied intermittently multiple times in a day and over multiple days to the target nerve[0049]. The neuroregulator 104 also may include memory in which treatment instructions and/or patient data can be stored. In some embodiments, the neuroregulator comprises a power module and a programmable therapy delivery module. For example, the neuroregulator 104 can store one or more therapy programs in the programmable therapy delivery module indicating what therapy should be delivered to the patient[0061]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the feedback control stimulation system of Wah with the neuromodulation control system of Waataja. Doing so would specify stimulation being administered in order to regulate glycemic levels in a patient.
Regarding claim 19, Wah discloses the a system for stimulating an anatomical element of a patient, comprising: a pulse generator configured to generate a current; a first electrode device electrically coupled to the pulse generator, the first electrode device comprising; a first set of or more electrodes for placement on or around the patient, wherein the first plurality of electrodes is configured to apply the current to the anatomical element; and a second electrode device electrically coupled to the pulse generator, the second electrode device comprising; at least one electrode for placement on or around the patient, and configured to record measurements corresponding to the first current when the first current is applied(Module controller 116 has an associated memory 118 storing patient settings 120, control programs 122 and the like. Controller 116 controls a pulse generator 124 to generate stimuli in the form of current pulses in accordance with the patient settings 120 and control programs 122. Electrode selection module 126 switches the generated pulses to the appropriate electrode(s) of electrode array 150, for delivery of the current pulse to the tissue surrounding the selected electrode(s). Measurement circuitry 128 is configured to capture measurements of neural responses sensed at sense electrode(s) of the electrode array as selected by electrode selection module 126[Description of preferred embodiments, paragraph 3]. Both the stimulus transfer function and the recording transfer function describe a physical process where a first element (stimulation electrode or nerve, respectively) radiates an electric field in a volume conductor, and some of this field is sensed by a second element (nerve or sense electrode, respectively)[Description of preferred embodiments, paragraph 16]). A feedback loop is completed by using the feedback variable to control the at least one stimulus parameter value for a future stimulus. The method adaptively compensates for changes in a gain of the feedback loop caused by electrode movement relative to the neural pathway[Abstract]. According to a third aspect the present invention provides a non-transitory computer readable medium for controllably applying a neural stimulus, comprising the following instructions for execution by one or more processors[Summary of Invention, paragraph 11]). Wah fails to disclose “anterior sub- diaphragmatic hepatic vagal trunk of a patient to upregulate its neural activity; and a second set of one or more electrodes for placement on or around a posterior sub- diaphragmatic celiac vagal trunk of the patient, and configured to effect a desired glycemic response in the patient by applying a second current the posterior sub-diaphragmatic celiac vagal trunk of the patient to downregulate its neural activity; anterior sub-diaphragmatic hepatic vagal trunk of a patient; and at least one additional electrode for placement on or around the posterior sub- diaphragmatic celiac vagal trunk of the patient and configured to record measurements corresponding to the second current when the second current is applied to the posterior sub- diaphragmatic celiac vagal trunk of the patient.”
However, Waataja teaches “ For example, the electrodes 212, 212a may be individually placed on the celiac nerve, the vagal nerve, the hepatic branches of the vagal nerve, or some combination of these, respectively, of a patient. For example, the leads 106, 106a have distal electrodes 212, 212a which are individually placed on the ventral and dorsal vagal nerves VVN, DVN, respectively, of a patient, for example, just below the patient's diaphragm[0052]”, “activate the pulse generator and thereby cause the application of the desired modulating signal to the electrodes. Another form of treatment of may be implemented by programming the pulse generator to periodically deliver the vagal activity modulation productive of glycemic control at programmed intervals[0089]”, and “ Another therapy program may comprise an electrical signal treatment applied continuously over multiple days, wherein the electrical signal has a frequency selected to downregulate or upregulate activity on the target nerve. A second therapy program may comprise an electrical signal treatment applied intermittently multiple times in a day and over multiple days, wherein the electrical signal has a frequency selected to upregulate or down regulate activity on second target nerve or organ, and has an on time and an off time, wherein the off time is selected to allow at least a partial recovery of the activity of the target nerve. The first and/or second therapy programs may be applied at the same time, at different times, or at overlapping times[0062]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the feedback control stimulation system of Wah with the neuromodulation control system of Waataja. Doing so would specify stimulation being administered in order to regulate glycemic levels in a patient.
Regarding claim 20, Wah in view of Waataja teaches the system of claim 19, but Wah fails to disclose first set of one or more electrodes is further configured to apply the first current to the anterior sub-diaphragmatic hepatic vagal trunk of a patient at a first frequency, and wherein the second set of one or more electrodes is further configured to apply the second current to the posterior sub-diaphragmatic celiac vagal trunk at a second frequency different from the first frequency. However, Waataja teaches “ Another therapy program may comprise an electrical signal treatment applied continuously over multiple days, wherein the electrical signal has a frequency selected to downregulate or upregulate activity on the target nerve. A second therapy program may comprise an electrical signal treatment applied intermittently multiple times in a day and over multiple days, wherein the electrical signal has a frequency selected to upregulate or down regulate activity on second target nerve or organ, and has an on time and an off time, wherein the off time is selected to allow at least a partial recovery of the activity of the target nerve. The first and/or second therapy programs may be applied at the same time, at different times, or at overlapping times[0062]. When the signal is selected to downregulate activity on the nerve, the electrical signal is applied at a frequency of about 200 Hz to 10,000 Hz. When the signal is selected to upregulate activity on the nerve, the electrical signal is applied at a frequency of about 0.01 Hz up to 200 Hz[0096]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the feedback control stimulation system of Wah with the neuromodulation control system of Waataja. Doing so would specify stimulation being administered in order to regulate glycemic levels in a patient.
Claim(s) 5-8 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Wah in view of Waataja and further in view of Bhavaraju(US 20190339224 A1) (cited previously).
Regarding claim 5, Wah in view of Waataja teaches the system of claim 4, but fails to explicitly disclose wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: receive values for one or more of the set of parameters used to apply the current to the anterior sub-diaphragmatic hepatic vagal trunk of the patient, the values recorded via the second electrode device at each instance that a response measurement of the plurality of response measurements is recorded.
However, Bhavaraju teaches the processor module 214 may control the processing performed by the sensor electronics 112. For example, the processor module 214 may be configured to process data (e.g., counts), from the sensor, filter the data, calibrate the data, perform fail-safe checking, and/or the like[0235]. For example, the processor module 214 including memory 218 may be used as the system's cache memory, where temporary storage is provided for recent sensor data received from the sensor[0240].
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the feedback control stimulation system of Wah with the calibration system of Bhavaraju. Doing so would clarify the processor and memory to obtain and store data from the electrodes in order to compare and generate a growth curve later on.
Regarding claim 6, Wah in view of Waataja and Bhavaraju teaches the system of claim 5, wherein a response measurement of the plurality of response measurements corresponds to optimal values for the set of parameters recorded at a same time instance that the response measurement is recorded, the optimal values for the set of parameters being optimal for applying the current to achieve a desired glycemic response in the patient(Wah - The stimulus current I can then be adjusted using any suitable feedback algorithm (such as is shown in FIG. 17, discussed further below) to maintain the relationship between I and V, with the desired value of y being driven to a chosen set-point. A higher value of y will result in higher recruitment.[Description of the Preferred Embodiments, paragraph 37]). Wah fails to disclose corresponding measurements to desired glycemic response and the anterior sub-diaphragmatic hepatic vagal trunk.
However, Waajata teaches “While patient comfort may be adequate as feedback for determining the proper parameters for duration of blocking and no blocking, more objective tests can be developed. For example, the duration of blocking and no blocking as well as combination with upregulating signals can be adjusted to achieve desired levels of glucose regulation. Such testing can be measured and applied on a per patient basis or performed on a statistical sampling of patients and applied to the general population of patients[0143]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the feedback control stimulation system of Wah with the neuromodulation control system of Waataja. Doing so would specify stimulation being administered in order to regulate glycemic levels in a patient.
Regarding claim 7, Wah in view of Waataja and Bhavaraju teaches the system of claim 6, but Wah fails to specify wherein the one or more parameters are adjusted based at least in part on the optimal values. However, Bhavaraju teaches “the estimative algorithm function may be formed by applying curve fitting techniques that regressively fit a curve to data points by adjusting the function (e.g., by adjusting constants of the function) until an optimal fit to the available data points is obtained. Simply put, a “curve” (i.e., a function sometimes referred to as a “model”) is fitted and generated that relates one data value to one or more other data values and selecting parameters of the curve such that the curve estimates the relationship between the data values. By way of example, selection of the parameters of the curve may involve selection of coefficients of a polynomial function. In some embodiments, the curve fitting process may involve evaluating how closely the curve determined in the curve fitting process estimates the relationship between the data values, to determine the optimal fit[0273]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the feedback control stimulation system of Wah with the calibration system of Bhavaraju. Doing so would clarify the processor and memory to obtain and store data from the electrodes to compare for optimal parameters in order to generate a growth curve later on.
Regarding claim 8, Wah in view of Waajata teaches the system of claim 1, but Wah fails to specify wherein the response measurement being different than the expected physiological response indicates an operational issue comprising a fibrous growth on the anterior sub-diaphragmatic hepatic vagal trunk of the patient that affects applying the current via the first electrode, the first electrode or the second electrode not being properly placed on the anterior sub-diaphragmatic hepatic vagal trunk of the patient, the anterior sub-diaphragmatic hepatic vagal trunk being too large for proper placement of the first electrode, or a combination thereof.
However, Bhavaraju teaches “variations in the manufacturing process may give rise to different values for various parameters that are measured (e.g., analyte sensitivity, baseline, impedance, capacitance, interferent sensitivity, etc.), and the errors resulting from these different parameter values are compounded into the error of the overall system. The more variations there are in the manufacturing setup, the more significant the consequences to the error introduced in the system[0014]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the feedback control stimulation system of Wah with the calibration system of Bhavaraju. Doing so would clarify the processor and memory to obtain and store data from the electrodes to compare for optimal parameters in order to generate a growth curve later on.
However, Waataja teaches “Stimulation of vagus nerve fibers innervating the pancreas causes an increase in plasma insulin, however, blood glucose levels are either unchanged or increased. Blockade of neuronal fibers innervating the liver can also affect blood glucose possibly though disinhibition of vagal efferents innervating the pancreas, decreased hepatic sensitivity to glucagon and/or decreased insulin resistance through attenuation of PPARa. Little is known; however, of the effect on blood glucose with combined simulation of celiac fibers innervating the pancreas (increasing insulin secretion) and blockade of neuronal hepatic fibers innervating the liver in an animal model of Type 2 diabetes[0070].”
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the feedback control stimulation system of Wah with the neuromodulation control system of Waataja. Doing so would specify how anatomical growths or conditions could create issues or obstacles during stimulation.
Regarding claim 16, Wah in view of Waataja teaches the system of claim 15, but fails to explicitly disclose wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: receive values for one or more of the set of parameters used to apply the current to the posterior sub-diaphragmatic celiac vagal trunk, or the anterior sub-diaphragmatic hepatic vagal trunk, of the patient, the values recorded via the second electrode device at each instance that a response measurement of the plurality of response measurements is recorded.
However, Bhavaraju teaches the processor module 214 may control the processing performed by the sensor electronics 112. For example, the processor module 214 may be configured to process data (e.g., counts), from the sensor, filter the data, calibrate the data, perform fail-safe checking, and/or the like[0235]. For example, the processor module 214 including memory 218 may be used as the system's cache memory, where temporary storage is provided for recent sensor data received from the sensor[0240].
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the feedback control stimulation system of Wah with the calibration system of Bhavaraju. Doing so would clarify the processor and memory to obtain and store data from the electrodes in order to compare and generate a growth curve later on.
Regarding claim 17, Wah in view of Bhavaraju teaches the system of claim 16, wherein a response measurement of the plurality of response measurements corresponds to optimal values for the set of parameters recorded at a same time instance that the response measurement is recorded, the optimal values for the set of parameters being optimal for applying the current to achieve the desired glycemic response in the patient, and wherein the one or more parameters are adjusted based at least in part on the optimal values(Wah - The stimulus current I can then be adjusted using any suitable feedback algorithm (such as is shown in FIG. 17, discussed further below) to maintain the relationship between I and V, with the desired value of y being driven to a chosen set-point. A higher value of y will result in higher recruitment.[Description of the Preferred Embodiments, paragraph 37]. This is seen in FIG. 14. If recording on electrode 4, closest to the stimulus, the optimal k is approximately 0.45, but any value between 0 and 1 outperforms constant-amplitude feedback. For electrode 8, the optimal value is approximately 0.27, with values between 0 and 0.55 outperforming constant-amplitude[Description of the Preferred Embodiments, paragraph 43]). Wah fails to disclose corresponding measurements to desired glycemic response and the anterior or posterior sub-diaphragmatic hepatic vagal trunk.
However, Waajata teaches “While patient comfort may be adequate as feedback for determining the proper parameters for duration of blocking and no blocking, more objective tests can be developed. For example, the duration of blocking and no blocking as well as combination with upregulating signals can be adjusted to achieve desired levels of glucose regulation. Such testing can be measured and applied on a per patient basis or performed on a statistical sampling of patients and applied to the general population of patients[0143]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the feedback control stimulation system of Wah with the neuromodulation control system of Waataja. Doing so would specify stimulation being administered in order to regulate glycemic levels in a patient.
Response to Arguments
Applicant’s arguments, see Remarks, filed 10/17/2025, with respect to the rejection(s) of claim(s) 1-4, 12-15, and 19 under 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Waataja being incorporated with Wah for a 103 rejection for all claims. Applicant argues against Waataja because it teaches “upregulating a signal applied to the celiac vagal trunk” but claim 12 teaches “downregulating a signal applied to the celiac vagal trunk”. However, Waataja teaches the ability for the system to either downregulate or upregulate neural activity based on the needs of the patient as seen in paragraph [0012]. Therefore the 103 rejections for all claims stand.
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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/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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