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 .
Response to Arguments
The Applicant filed Amendments to the Claims and Remarks on December 16, 2025 in response to the Examiner’s Non-Final Office Action, mailed September 16, 2025.
Amendments to the Claims
At this time, claims 1-20 are pending. Claims 1, 8-9, 11-12, 17, and 19 have been amended. The Applicant asserts that no new matter is added. (Remarks, pg. 7)
Claim Rejections - 35 U.S.C. § 102 and 103
Claims 1, 4-9, 11-13, and 15-20 were previously rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent Publication No. 2019/0321641 to Baldoni et al. ("Baldoni"). Claims 2-3, 10, and 14 were previously rejected under 35 U.S.C.103 as being unpatentable over Baldoni in view of EP 2651431 to Perryman ("Perryman") and further in view of U.S. Patent Publication No. 2016/0287182 to Single ("Single"). (Remarks, pg. 7-9)
Applicant’s arguments with respect to claims 1-20 have been fully considered and are persuasive. The 35 U.S.C. § 102 and 103 rejections of September 16, 2025 has been withdrawn.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4-9, 11-13, and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Baldoni et al. (US 2019/0321641, hereinafter referred to as Baldoni) (cited previously) in view of Single (US 2017/0361101, hereinafter referred to as Single '101).
Regarding amended, independent claim 1, Baldoni discloses systems and methods for treating a patient having a blood glucose abnormality, such as type 2 diabetes (T2D), using an electrical signal. Baldoni further discloses a system ([0028]: “The present technology is directed generally to spinal cord modulation and associated systems and methods for treating blood glucose abnormalities, including metabolic syndrome, type 2 diabetes (T2D)… via waveforms with therapeutic electrical signal elements or components that provide therapeutic results.”), comprising:
a device (system 100 in Fig. 1A) comprising:
a signal generator ([0046]: “The signal generator 101 can transmit signals (e.g., electrical signals) to the signal delivery elements 110 that excite and/or suppress target nerves (e.g., sympathetic nerves).”); and
at least one processor (one or more processor(s) 107 in Fig. 1A; [0115]: “…the patient can use a constant glucose monitor that continuously monitors the patient's blood glucose level and communicates the measurements to an internal or external processor (e.g., an implanted pulse generator, or a phone-based app or other external device).”) configured to:
monitor a value of a medical parameter of a patient that is associated with type 2 diabetes, a condition of metabolic syndrome, pancreatis, or any combination thereof ([0028]: “…systems and methods for treating blood glucose abnormalities, including metabolic syndrome, type 2 diabetes (T2D), and/or reducing HbA1c levels via waveforms with therapeutic electrical signal elements or components that provide therapeutic results.”);
determine one or more stimulation parameters ([0017]: “As used herein, the term “electrical signal” refers generally to an electrical signal that may be characterized by one or more parameters, for example, frequency, pulse width, and/or amplitude.”) for stimulating at least one spinal nerve of the patient with an electrical signal ([0034]: “…therapeutic modulation signals are directed to the target location that generally includes the patient's spinal cord, e.g., the dorsal column of the patient's spinal cord. The modulation signals can be directed to the …dorsal root ganglion...”); and
control the signal generator to generate the electrical signal based on the one or more stimulation parameters ([0017]; [0095]: “…if a change in the patient's blood glucose level is detected, the systems, devices, and methods described herein can automatically deliver therapeutic electrical signals.”), the electrical signal being introduced to the at least one spinal nerve ([0034]: “…therapeutic modulation signals are directed to the target location that generally includes the patient's spinal cord, e.g., the dorsal column of the patient's spinal cord. The modulation signals can be directed to the …dorsal root ganglion...”) by the one or more stimulating electrodes (first and second leads 111a, 111b of signal delivery devices 110 in FIG. 1A), which causes a response by at least one anatomical element of the patient ([0031]: “…inhibiting at least a portion of the patient's sympathetic nervous system, such as one or more sympathetic nerves corresponding to one or more of the patient's …pancreas, …may result in the therapeutic effect by … altering insulin production...”) that changes the value of the medical parameter for the patient ([0095]: “…if a change in the patient's blood glucose level is detected, the systems, devices, and methods described herein can automatically deliver therapeutic electrical signals. Representative systems and methods described herein can include one or more sensors configured to monitor the patient's blood glucose levels by detecting an amount of glucose in the patient's blood.”).
Baldoni is silent to the at least one processor being configured to: select, from a group of electrodes, one or more stimulating electrodes based on measurements of compound action potentials (CAPs), wherein unselected electrodes in the group of electrodes are non-stimulating electrodes.
However, Single ‘101 teaches a method and device for feedback control of neural stimulation. Single ‘101 further teaches at least one processor (controller 116 with electrode selection module 126 in Fig. 3) being configured to: select, from a group of electrodes (electrode array 150 in Fig. 3), one or more stimulating electrodes based on measurements of compound action potentials (CAPs) (feedback variable f in Fig. 4; [0067]: “Electrode selection module 126 selects a stimulation electrode 2 of electrode array 150 to deliver an electrical current pulse to surrounding tissue including nerve 180, and also selects a return electrode 4 of the array 150 for stimulus current recovery to maintain a zero net charge transfer.”; [0071]: “Referring to FIG. 4, the feedback loop 400 comprises stimulator A which takes a stimulation current value and converts it into a stimulation pattern defining a pulse width, number of electrodes and the like, to produce an electrical pulse on the stimulation electrodes 2 and 4. …the stimulus parameters are: alternating phase on/off, number of phases, number of stimulus electrode poles (bipolar, tripolar etc.)…”), wherein unselected electrodes in the group of electrodes are non-stimulating electrodes ([0069]: “The device 100 is further configured to sense the existence and intensity of compound action potentials (CAPs) propagating along nerve 180, whether such CAPs are evoked by the stimulus from electrodes 2 and 4, or otherwise evoked. To this end, any electrodes of the array 150 may be selected by the electrode selection module 126 to serve as measurement electrode 6 and measurement reference electrode 8.”).
Single ‘101 is of a similar pursuit to that of Baldoni and the instant application in teaching a control system for an implantable stimulator. Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Baldoni to include an electrode selection process or module, such as that of Single ‘101, in order to identify which electrodes are optimal for stimulation and which electrodes should be used for sensing.
Regarding claim 4, in view of the Baldoni/Single '101 combination, Baldoni discloses that the medical parameter being monitored comprises a blood glucose level of the patient, an inflammatory marker associated with pancreatis, or both ([0028]: “…systems and methods for treating blood glucose abnormalities, including metabolic syndrome, type 2 diabetes (T2D), and/or reducing HbA1c levels via waveforms with therapeutic electrical signal elements or components that provide therapeutic results.”).
Regarding claim 5, in view of the Baldoni/Single '101 combination, Baldoni discloses that the at least one processor (one or more processor(s) 107 in Fig. 1A) is configured to select the one or more stimulation parameters ([0017]; [0028]: “…systems and methods for treating blood glucose abnormalities, including metabolic syndrome, type 2 diabetes (T2D), and/or reducing HbA1c levels via waveforms with therapeutic electrical signal elements or components that provide therapeutic results.”) further based on activity information about activity of the patient that is known to affect the value of the medical parameter ([0111]: “In still further representative systems and methods, the therapy signal may be delivered in accordance with a schedule that is tied to the patient's eating behavior. For example, the patient can receive therapy for one hour before and after a meal, as well as during the meal.”).
Regarding claim 6, in view of the Baldoni/Single '101 combination, Baldoni discloses that the activity information includes information about past patient activity, current patient activity, predicted patient activity, or any combination thereof ([0111]: “In still further representative systems and methods, the therapy signal may be delivered in accordance with a schedule that is tied to the patient's eating behavior. For example, the patient can receive therapy for one hour before and after a meal, as well as during the meal.”).
Regarding claim 7, in view of the Baldoni/Single '101 combination, Baldoni discloses that the past patient activity includes patient intake of food or patient intake of a drug, wherein the current patient activity includes current patient exercise, and wherein the predicted patient activity includes predicted patient exercise and predicted patient intake of food or predicted patient intake of a drug ([0111]: “In still further representative systems and methods, the therapy signal may be delivered in accordance with a schedule that is tied to the patient's eating behavior. For example, the patient can receive therapy for one hour before and after a meal, as well as during the meal.”).
Regarding amended claim 8, in view of the Baldoni/Single '101 combination, Baldoni discloses that the measurements of CAPs include measurements of CAP conduction velocity ([0105]: “The sensing element can detect one or more neural signal(s) and/or neural response(s) (e.g., electrical signals corresponding to action potentials) from the nerve or neural population, and the system (e.g., the system 100 referenced in FIG. 1A) can use the detected neural signal(s) and/or neural response(s) to identify the patient's blood glucose level at a particular moment in time.”; [0106]: “The detected neural signal(s) and/or response(s) can include characteristics that may be measured… Characteristics can include, for example, signal strength (e.g., whether a value of the signal is above a pre-determined threshold value), frequency (e.g., number of action potentials fired in a given time), amplitude and/or velocity, amongst other measurable characteristics.”).
Regarding amended claim 9, in view of the Baldoni/Single '101 combination, Baldoni discloses that the measurements of CAPs include measurements of CAP signal amplitude ([0105]: “The sensing element can detect one or more neural signal(s) and/or neural response(s) (e.g., electrical signals corresponding to action potentials) from the nerve or neural population, and the system (e.g., the system 100 referenced in FIG. 1A) can use the detected neural signal(s) and/or neural response(s) to identify the patient's blood glucose level at a particular moment in time.”; [0106]: “The detected neural signal(s) and/or response(s) can include characteristics that may be measured… Characteristics can include, for example, signal strength (e.g., whether a value of the signal is above a pre-determined threshold value), frequency (e.g., number of action potentials fired in a given time), amplitude and/or velocity, amongst other measurable characteristics.”).
Regarding amended claim 11, in view of the Baldoni/Single '101 combination, Baldoni discloses that the one or more stimulating electrodes (first and second leads 111a, 111b of signal delivery devices 110 in FIG. 1A) are selected from the group of electrodes further based on a detected patient position ([0047]: “The signal generator 101 can also receive and respond to an input signal received from one or more sources. The input signals can direct or influence the manner in which the therapy, charging, and/or process instructions are selected, executed, updated, and/or otherwise performed. The input signals can be received from one or more sensors …The sensors and/or other input devices 112 can provide inputs that depend on or reflect patient state (e.g., patient position, patient posture, and/or patient activity level), and/or inputs that are patient-independent (e.g., time).”).
Regarding amended claim 12, in view of the Baldoni/Single '101 combination, Baldoni discloses the system further comprising:
the group of electrodes (first and second leads 111a, 111b of signal delivery devices 110 in FIG. 1A); and
a monitoring device (sensors and/or other input devices 112 in Fig. 1A) configured to provide data that enables the at least one processor (one or more processor(s) 107 in Fig. 1A) to monitor the value of the medical parameter ([0104]: “Monitoring a patient's blood glucose level can be performed on a continuous basis using one or more sensing elements (referred to herein as a “sensing element”) for detecting neural signals, neural responses, and/or other physiological parameters of the patient before, during and/or after the application of electrical stimulation signals to the patient.”; [0105]: “The neural response(s) can be detected frequently enough such that an upward or downward trend of the data corresponding to the blood glucose levels can be determined, or at least estimated.”).
Regarding claim 13, in view of the Baldoni/Single '101 combination, Baldoni discloses that the one or stimulation parameters ([0017]: “As used herein, the term “electrical signal” refers generally to an electrical signal that may be characterized by one or more parameters, for example, frequency, pulse width, and/or amplitude.”) are selected from a list of stimulation parameters ([0111]: “Block 802 [of Fig. 8] includes establishing the signal delivery parameters, including the signal delivery schedule.”), and wherein the one or more stimulation parameters comprise values for duty cycle of the electrical signal ([0109]: “Adjusting the electrical therapy signal can include adjusting one or more signal delivery parameters (e.g., frequency, amplitude, pulse width, duty cycle, and normal slow wave frequency) of the subsequent electrical signal to be applied to the target location.”), current level of the electrical signal ([0102]: “The signal amplitude may refer to the electrical current level…”), frequency of the electrical signal ([0017]), pulse width of the electrical signal ([0017]), or any combination thereof.
Regarding claim 15, in view of the Baldoni/Single '101 combination, Baldoni discloses that the at least one spinal nerve comprises one or more dorsal root ganglions at one or more of thoracic levels T7 thru T12 of the patient ([0080]: “In representative systems and methods, one or more therapeutic modulation signals can be delivered to a target location proximate to or at one or more of T7 to T12.”), wherein the medical parameter being monitored is one of a glucose level, a triglyceride level, or a cholesterol level ([0095]: “Representative systems and methods described herein can include one or more sensors configured to monitor the patient's blood glucose levels by detecting an amount of glucose in the patient's blood.”), and wherein the response by the anatomical element causes reduction of the glucose level, the triglyceride level, or the cholesterol level ([0031]: “…inhibiting at least a portion of the patient's sympathetic nervous system, such as one or more sympathetic nerves corresponding to one or more of the patient's …pancreas, …may result in the therapeutic effect by … altering insulin production...”; [0028]: “…systems and methods for treating blood glucose abnormalities, including metabolic syndrome, type 2 diabetes (T2D), and/or reducing HbA1c levels via waveforms with therapeutic electrical signal elements or components that provide therapeutic results.”).
Regarding claim 16, in view of the Baldoni/Single '101 combination, Baldoni discloses that the response by the anatomical element comprises an increase in insulin production, an increase in urinary excretion, or both ([0031]: “…inhibiting at least a portion of the patient's sympathetic nervous system, such as one or more sympathetic nerves corresponding to one or more of the patient's …pancreas, …may result in the therapeutic effect by … altering insulin production...”).
Regarding amended, independent claim 17, Baldoni discloses a system for treating type 2 diabetes ([0028]: “The present technology is directed generally to spinal cord modulation and associated systems and methods for treating blood glucose abnormalities, including metabolic syndrome, type 2 diabetes (T2D)… via waveforms with therapeutic electrical signal elements or components that provide therapeutic results.”), comprising:
a device (system 100 in Fig. 1A) comprising:
a signal generator ([0046]: “The signal generator 101 can transmit signals (e.g., electrical signals) to the signal delivery elements 110 that excite and/or suppress target nerves (e.g., sympathetic nerves).”); and
at least one processor (one or more processor(s) 107 in Fig. 1A; [0115]: “…the patient can use a constant glucose monitor that continuously monitors the patient's blood glucose level and communicates the measurements to an internal or external processor (e.g., an implanted pulse generator, or a phone-based app or other external device).”) configured to:
monitor a value of a medical parameter of a patient that is associated with type 2 diabetes ([0028]: “…systems and methods for treating blood glucose abnormalities, including… type 2 diabetes (T2D)…”);
determine one or more stimulation parameters ([0017]: “As used herein, the term “electrical signal” refers generally to an electrical signal that may be characterized by one or more parameters, for example, frequency, pulse width, and/or amplitude.”) for stimulating at least one spinal nerve of the patient with an electrical signal ([0034]: “…therapeutic modulation signals are directed to the target location that generally includes the patient's spinal cord, e.g., the dorsal column of the patient's spinal cord. The modulation signals can be directed to the …dorsal root ganglion...”); and
control the signal generator to generate the electrical signal based on the one or more stimulation parameters ([0017]), the electrical signal being introduced to the at least one spinal nerve ([0034]) by the one or more stimulating electrodes (first and second leads 111a, 111b of signal delivery devices 110 in FIG. 1A), which causes a response by at least one anatomical element of the patient ([0031]: “…inhibiting at least a portion of the patient's sympathetic nervous system, such as one or more sympathetic nerves corresponding to one or more of the patient's …pancreas, …may result in the therapeutic effect by … altering insulin production...”) that changes the value of the medical parameter for the patient ([0028]; [0031]).
Baldoni is silent to the at least one processor being configured to: select, from a group of electrodes, one or more stimulating electrodes based on measurements of compound action potentials (CAPs), wherein unselected electrodes in the group of electrodes are non-stimulating electrodes.
However, Single ‘101 teaches a method and device for feedback control of neural stimulation. Single ‘101 further teaches at least one processor (controller 116 with electrode selection module 126 in Fig. 3) being configured to: select, from a group of electrodes (electrode array 150 in Fig. 3), one or more stimulating electrodes based on measurements of compound action potentials (CAPs) (feedback variable f in Fig. 4; [0067]: “Electrode selection module 126 selects a stimulation electrode 2 of electrode array 150 to deliver an electrical current pulse to surrounding tissue including nerve 180, and also selects a return electrode 4 of the array 150 for stimulus current recovery to maintain a zero net charge transfer.”; [0071]: “Referring to FIG. 4, the feedback loop 400 comprises stimulator A which takes a stimulation current value and converts it into a stimulation pattern defining a pulse width, number of electrodes and the like, to produce an electrical pulse on the stimulation electrodes 2 and 4. …the stimulus parameters are: alternating phase on/off, number of phases, number of stimulus electrode poles (bipolar, tripolar etc.)…”), wherein unselected electrodes in the group of electrodes are non-stimulating electrodes ([0069]: “The device 100 is further configured to sense the existence and intensity of compound action potentials (CAPs) propagating along nerve 180, whether such CAPs are evoked by the stimulus from electrodes 2 and 4, or otherwise evoked. To this end, any electrodes of the array 150 may be selected by the electrode selection module 126 to serve as measurement electrode 6 and measurement reference electrode 8.”).
Single ‘101 is of a similar pursuit to that of Baldoni and the instant application in teaching a control system for an implantable stimulator. Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Baldoni to include an electrode selection process or module, such as that of Single ‘101, in order to identify which electrodes are optimal for stimulation and which electrodes should be used for sensing.
Regarding claim 18, in view of the Baldoni/Single '101 combination, Baldoni discloses that the at least one spinal nerve ([0034]) comprises one or more dorsal root ganglions at thoracic level T9 or T10 of the patient ([0080]: “In representative systems and methods, one or more therapeutic modulation signals can be delivered to a target location proximate to or at one or more of T7 to T12.”).
Regarding amended, independent claim 19, Baldoni discloses a system for treating metabolic syndrome ([0028]: “…systems and methods for treating blood glucose abnormalities, including metabolic syndrome, type 2 diabetes (T2D), and/or reducing HbA1c levels via waveforms with therapeutic electrical signal elements or components that provide therapeutic results.”), comprising:
a signal generator ([0046]: “The signal generator 101 can transmit signals (e.g., electrical signals) to the signal delivery elements 110 that excite and/or suppress target nerves (e.g., sympathetic nerves).”); and
at least one processor (one or more processor(s) 107 in Fig. 1A) configured to:
monitor a value of a medical parameter of a patient that is associated with metabolic syndrome ([0028]: “…systems and methods for treating blood glucose abnormalities, including metabolic syndrome, type 2 diabetes (T2D), and/or reducing HbA1c levels via waveforms with therapeutic electrical signal elements or components that provide therapeutic results.”);
determine one or more stimulation parameters ([0017]: “As used herein, the term “electrical signal” refers generally to an electrical signal that may be characterized by one or more parameters, for example, frequency, pulse width, and/or amplitude.”) for stimulating at least one spinal nerve of the patient with an electrical signal ([0034]: “…therapeutic modulation signals are directed to the target location that generally includes the patient's spinal cord, e.g., the dorsal column of the patient's spinal cord. The modulation signals can be directed to the …dorsal root ganglion...”); and
control the signal generator to generate the electrical signal based on the one or more stimulation parameters ([0017]; [0095]: “…if a change in the patient's blood glucose level is detected, the systems, devices, and methods described herein can automatically deliver therapeutic electrical signals.”), the electrical signal being introduced to the at least one spinal nerve ([0034]: “…therapeutic modulation signals are directed to the target location that generally includes the patient's spinal cord, e.g., the dorsal column of the patient's spinal cord. The modulation signals can be directed to the …dorsal root ganglion...”) by the one or more stimulating electrodes (first and second leads 111a, 111b of signal delivery devices 110 in FIG. 1A), which causes a response by at least one anatomical element of the patient ([0031]: “…inhibiting at least a portion of the patient's sympathetic nervous system, such as one or more sympathetic nerves corresponding to one or more of the patient's …pancreas, …may result in the therapeutic effect by … altering insulin production...”) that changes the value of the medical parameter for the patient ([0095]: “…if a change in the patient's blood glucose level is detected, the systems, devices, and methods described herein can automatically deliver therapeutic electrical signals. Representative systems and methods described herein can include one or more sensors configured to monitor the patient's blood glucose levels by detecting an amount of glucose in the patient's blood.”).
Baldoni is silent to the at least one processor being configured to: select, from a group of electrodes, one or more stimulating electrodes based on measurements of compound action potentials (CAPs), wherein unselected electrodes in the group of electrodes are non-stimulating electrodes.
However, Single ‘101 teaches a method and device for feedback control of neural stimulation. Single ‘101 further teaches at least one processor (controller 116 with electrode selection module 126 in Fig. 3) being configured to: select, from a group of electrodes (electrode array 150 in Fig. 3), one or more stimulating electrodes based on measurements of compound action potentials (CAPs) (feedback variable f in Fig. 4; [0067]: “Electrode selection module 126 selects a stimulation electrode 2 of electrode array 150 to deliver an electrical current pulse to surrounding tissue including nerve 180, and also selects a return electrode 4 of the array 150 for stimulus current recovery to maintain a zero net charge transfer.”; [0071]: “Referring to FIG. 4, the feedback loop 400 comprises stimulator A which takes a stimulation current value and converts it into a stimulation pattern defining a pulse width, number of electrodes and the like, to produce an electrical pulse on the stimulation electrodes 2 and 4. …the stimulus parameters are: alternating phase on/off, number of phases, number of stimulus electrode poles (bipolar, tripolar etc.)…”), wherein unselected electrodes in the group of electrodes are non-stimulating electrodes ([0069]: “The device 100 is further configured to sense the existence and intensity of compound action potentials (CAPs) propagating along nerve 180, whether such CAPs are evoked by the stimulus from electrodes 2 and 4, or otherwise evoked. To this end, any electrodes of the array 150 may be selected by the electrode selection module 126 to serve as measurement electrode 6 and measurement reference electrode 8.”).
Single ‘101 is of a similar pursuit to that of Baldoni and the instant application in teaching a control system for an implantable stimulator. Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Baldoni to include an electrode selection process or module, such as that of Single ‘101, in order to identify which electrodes are optimal for stimulation and which electrodes should be used for sensing.
Regarding claim 20, in view of the Baldoni/Single '101 combination, Baldoni discloses that the medical parameter being monitored ([0028]) comprises a level of a lipid level of the patient ([0031]: “Other effects (e.g., associated with blood glucose abnormalities) that can be reduced or eliminated include symptoms such as …abnormal cholesterol or triglyceride levels.”).
Claims 2, 3, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over the Baldoni/Single '101 combination, further in view of Perryman (EP 2654444).
Regarding claim 2, in view of the Baldoni/Single '101 combination, Baldoni discloses that the at least one processor (one or more processor(s) 107 in Fig. 1A) is configured to control the signal generator to generate the electrical signal (signal generator 101 and signal delivery elements 110 in Fig. 1A; [0095]: “…if a change in the patient's blood glucose level is detected, the systems, devices, and methods described herein can automatically deliver therapeutic electrical signals.”).
The Baldoni/Single '101 combination is silent to controlling the signal generator based on when the value of the medical parameter is not within an acceptable range of values, and to control the signal generator to cease generating the electrical signal when the value of the medical parameter is within the acceptable range of values.
However, Perryman teaches a system and apparatus for control of pancreatic beta cell function to improve glucose homeostasis and insulin production. Perryman further teaches controlling the signal generator based on when the value of the medical parameter is not within an acceptable range of values, and to control the signal generator to cease generating the electrical signal when the value of the medical parameter is within the acceptable range of values ([0065]: “If outside the desired or threshold range, the feedback controller can initiate adjustments to parameter settings of the electrical stimulation.”; [0075]: “The controller can send the signals to increase or decrease stimulation until glucose homeostasis is achieved… The controller can include a microprocessor that can instruct the system to produce an exciting or inhibiting stimulation signal or to cease electrical stimulation.”).
Perryman is considered analogous art to Baldoni as they each have a similar pursuit of controlling medical parameters using electrostimulation. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the stimulation system of the Baldoni/Single '101 combination to include an upper limit threshold limitation case for controlling the start of electrostimulation in order to keep the patient’s blood glucose levels from rising above a normal, healthy range.
Regarding claim 3, in view of the Baldoni/Single '101/Perryman combination, Baldoni discloses that the at least one processor (one or more processor(s) 107 in Fig. 1A) controls the signal generator to generate the electrical signal (generator 101 and signal delivery elements 110 in Fig. 1A; [0095]: “…if a change in the patient's blood glucose level is detected, the systems, devices, and methods described herein can automatically deliver therapeutic electrical signals.”).
The Baldoni/Single '101 combination is silent to controlling the signal generator to generate the electrical signal in a manner that keeps the value of the medical parameter within an acceptable range of values.
However, Perryman teaches controlling the signal generator to generate the electrical signal in a manner that keeps the value of the medical parameter within an acceptable range of values ([0065]: “If outside the desired or threshold range, the feedback controller can initiate adjustments to parameter settings of the electrical stimulation.”; [0075]: “The controller can send the signals to increase or decrease stimulation until glucose homeostasis is achieved… The controller can include a microprocessor that can instruct the system to produce an exciting or inhibiting stimulation signal or to cease electrical stimulation.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the stimulation system of the Baldoni/Single '101 combination to include an upper limit threshold limitation case for controlling the start of electrostimulation in order to keep the patient’s blood glucose levels from rising above a normal, healthy range.
Regarding claim 14, in view of the Baldoni/Single '101/Perryman combination, Baldoni discloses that the at least one spinal nerve comprises one or more dorsal root ganglions at one or more of thoracic levels T6 thru L2 of the patient ([0080]: “In representative systems and methods, one or more therapeutic modulation signals can be delivered to a target location proximate to or at one or more of T7 to T12.”), wherein the medical parameter being monitored is a glucose level, an inflammatory marker associated with pancreatis, or both ([0095]: “Representative systems and methods described herein can include one or more sensors configured to monitor the patient's blood glucose levels by detecting an amount of glucose in the patient's blood.”), and wherein the response by the anatomical element causes reduction of the glucose level, the inflammatory marker, or both ([0031]: “…inhibiting at least a portion of the patient's sympathetic nervous system, such as one or more sympathetic nerves corresponding to one or more of the patient's …pancreas, …may result in the therapeutic effect by … altering insulin production...”; [0028]).
The Baldoni/Single '101 combination does not disclose that the multiple dorsal root ganglion nerves are at one or more of lumbar levels L1 and/or L2 of the patient.
However, Perryman teaches that the multiple dorsal root ganglion nerves are at one or more of lumbar levels L1 and/or L2 of the patient ([0014]: “FIG. 4 is a diagram of a cross sectional pathway overview of a spinal column segment 201 at which an electrode lead 202 is placed to stimulate the dorsal root ganglia 203 and/or spinal nerves 210 from in the dermatome regions from spinal segments T7 to L1, which are sensory nerve fibers 204 that lead to the pancreas 206.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the Baldoni stimulation locations to further include the lumbar levels taught by Perryman in order to cause the pancreas to increase insulin and/or glucagon production to lower the patient's blood glucose level, thereby providing an effective treatment for type 2 diabetes.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over the Baldoni/Single '101/Perryman combination, further in view of Single (US 2016/0287182, hereinafter referred to as Single '182) (cited previously).
Regarding claim 10, in view of the Baldoni/Single '101/Perryman combination, Baldoni discloses that the measurements of CAP conduction velocity and CAP signal amplitude ([0105]-[0106]).
The Baldoni/Single ‘101/Perryman combination is silent to the measurements being vectorized measurements.
Single ‘182 teaches a method and device for processing a neural measurement obtained in the presence of artifact, in order to detect whether a neural response is present in the neural measurement. Single further teaches the measurements being vectorized measurements ([0101]: “In contrast, the amplitude of the evoked response vector CAP changes relatively slowly as discussed in relation to FIG. 7b, but undergoes a change in phase as discussed in relation to FIG. 7a. Thus, as shown in FIG. 10b, the CAP vector rotates without undergoing a significant amplitude change. Thus, at one moment (FIG. 10a) the CAP vector can be orthogonal to V.sub.2, and at a later time (FIG. 10b) can be aligned with V.sub.2.”).
Single ‘182 can be considered analogous art as it has a similar pursuit to the Baldoni/Perryman combination of therapeutic stimulation with automatic adjustment. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the Baldoni/Single ‘101/Perryman combination to include the measurements of CAP conduction velocity and CAP signal amplitude being vectorized measurements, as taught by Single ‘182, to find the electrode(s) that maximize conduction velocity and maximize CAP amplitude (instant Specification [0110]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Hershey et al. (US 2017/0296823).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY G SCHLUETER whose telephone number is (703)756-4601. The examiner can normally be reached M-F 9:00am-5:30pm EST.
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/M.G.S./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796