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, Amendments to the Drawings, Amendments to the Specification, and Remarks on January 20, 2026 in response to the Examiner’s Non-Final Office Action, mailed October 17, 2025.
Amendments to the Claims
At this time, claims 1, 3-5, 8-16, 18-20, and 22-23 are pending, with claims 2 and 17 previously withdrawn from consideration. Claims 1, 3-5, 8-10, 14, 16, 18-20, and 22-23 have been amended. Claims 6, 7, and 21 have been cancelled. The Applicant asserts that no new matter is added. (Remarks, pg. 9)
Objections to the Drawings
The drawings were previously objected to due to reference numbers. Due to Amendments, Applicant’s arguments, see Remarks, pg. 9, with respect to the drawings have been fully considered and are persuasive. The objection of October 17, 2025 has been withdrawn.
Objections to the Specification
The Specification was previously objected to due to minor typographical errors. Due to Amendments, the Applicant’s arguments, see Remarks, pg. 9, with respect to the Specification have been fully considered and are persuasive. The objection of October 17, 2025 has been withdrawn.
Objections to the Claims
Claim 1 was previously objected to due to a minor typographical error. Due to Amendments, Applicant’s arguments, see Remarks, pg. 9, with respect to claim1 have been fully considered and are persuasive. The objection of October 17, 2025 has been withdrawn.
Claim Rejections - 35 U.S.C. § 102
Claims 1, 3-9, 11, 14-16, and 18-23 were previously rejected under 35 U.S.C. 102(a)(2). (Remarks, pg. 10-12)
Applicant’s arguments, with respect to 1, 3-9, 11, 14-16, and 18-23 have been fully considered and are persuasive. The 35 U.S.C. 102(a)(2) rejection of October 17, 2025 has been withdrawn.
Claim Rejections - 35 U.S.C. § 103
Claims 10, 12, and 13 were previously rejected under 35 U.S.C. 103. (Remarks, pg. 10-12)
Applicant’s arguments, with respect to claims 10, 12, and 13 have been fully considered and are persuasive. The 35 U.S.C. 103 rejections of October 17, 2025 have been withdrawn.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, 3-5, 8-9, 11, 14-16, 18-20, and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Arcot-Krishnamurthy et al. (US 2012/0172742, hereinafter referred to as Arcot-Krishnamurthy) (cited previously) in view of Yoo et al. (US 2011/0301659, hereinafter referred to as Yoo).
Regarding amended, independent claim 1, Arcot-Krishnamurthy discloses a device embodiment configured to deliver vagal stimulation therapy (VST) to a vagus nerve of a patient. Arcot-Krishnamurthy further discloses a system for vagus nerve stimulation (VNS) ([0002]: “…systems, devices and methods for delivering neural stimulation…”), comprising:
a VNS stimulator (pulse generator 128 in Fig. 16; implantable medical device (IMD) 142 in Fig. 17; [0067]: “…pulse generator 128 to provide VST [vagal stimulation therapy]…”) implanted in a patient ([0067]: “An implantable device may provide the entire VST system. Some embodiments use external devices to provide the monitoring functions, such as during implantation of an implantable vagus nerve stimulator. Some embodiments use implanted leads and external stimulators.”) and configured to transmit periodic or episodic electrical stimulation pulses ([0054]: “A simple [stimulation] burst pattern with one burst duration and burst interval can continue periodically for a programmed period or can follow a more complicated schedule.”) to a vagus nerve of the patient ([0006]: “An embodiment of a method includes delivering a vagal stimulation therapy (VST) to the vagus nerve of a patient…”); and
one or more sensors (sensor(s) 133 in Fig. 16), each configured to detect a biological signal from the patient ( [0067]: “…sensor(s) 133 to sense a parameter that is affected by the neural stimulation. Physiological parameter(s) that quickly respond to VST can be used in closed loop systems or during the implantation process. Examples of such parameters include heart rate, laryngeal vibrations, blood pressure, respiration, and electrogram parameters.”);
wherein the VNS stimulator comprises a controller (modulator 129 in Fig. 16) configured to automatically titrate upward one or more of a stimulus pulse width, a stimulus amplitude, a stimulus frequency or a duty cycle of the electrical stimulation pulses ([0071]: “Various modulator embodiments adjust VST intensity by changing an amplitude of a stimulation signal used to provide VST, by changing a frequency of a stimulation signal used to provide VST, by changing a burst frequency of a stimulation signal used to provide VST, by changing a pulse width of a stimulation signal used to provide VST, by changing a duty cycle of a stimulation signal used to provide VST, or various combinations of two or more of these stimulation signal characteristics.”), over a period of time.
Arcot-Krishnamurthy is silent to that the one or more sensors comprises an electromyography (EMG) sensor configured to be positioned on or proximate to a larynx of the patient and to detect stimulation of the laryngeal branch of the vagus nerve; and automatically titrate upward one or more of a stimulus pulse width, a stimulus amplitude, a stimulus frequency or a duty cycle of the electrical stimulation pulses, over a period of time, until a larynx muscle contraction is identified based on the biological signal detected by the EMG sensor.
However, Yoo teaches neurostimulation and more particularly to spatially selective vagus nerve stimulation for substantially activating one or more target nerve branches without substantially activating one or more non-target nerve branches (Abstract). Yoo further teaches that the one or more sensors comprises an electromyography (EMG) sensor ([0040]: “A myoelectric sensing circuit 550 is electrically coupled to electrode 556 and senses a stimulation-evoked EMG signal indicative of the response to the electrical stimulation pulses delivered to [thoracic vagus nerve] tVN 104 and the electrical stimulation pulses delivered to [recurrent laryngeal nerve] RLN 106.”) configured to be positioned on or proximate to a larynx of the patient and to detect stimulation of the laryngeal branch of the vagus nerve ([0039]: “…an electrode 556 including a pair of insulated stainless steel wires was inserted into laryngeal muscle 107 (e.g., the posterior cricoarytenoid muscle) to measure laryngeal EMG.”); and
automatically titrate upward one or more of a stimulus pulse width, a stimulus amplitude, a stimulus frequency or a duty cycle of the electrical stimulation pulses, over a period of time, until a larynx muscle contraction is identified based on the biological signal detected by the EMG sensor ([0047]: “The contraction of a laryngeal muscle is not considered to be occurring, or the RLN is not considered to be activated, when the amplitude of the EMG signal does not exceed a specified EMG threshold. In one embodiment, the process of selecting the one or more contacts includes sweeping through various contacts and/or combination of contacts of the multi-contact electrode and observing the effect of the adjustment on the amplitude of the ENG signal and the amplitude of the EMG signal.”).
Yoo teaches a similar pursuit to that of the instant application in teaching an electrical therapeutic system with output controlled by sensor responsive to body or interface condition. 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 system of Arcot-Krishnamurthy to include an electromyography (EMG) sensor to detect stimulation of the laryngeal branch of the vagus nerve and use larynx muscle contraction as an upper threshold for the controller.
Regarding amended claim 3, in view of the Arcot-Krishnamurthy/Yoo combination, Arcot-Krishnamurthy discloses that the biological signal detected by at least one of the one or more sensors comprises a predetermined electrical activity in a patient's brain ([0067]: “…sensor(s) 133 to sense a parameter that is affected by the neural stimulation. Physiological parameter(s) that quickly respond to VST can be used in closed loop systems or during the implantation process. Examples of such parameters include …electrogram parameters.”).
Regarding amended claim 4, in view of the Arcot-Krishnamurthy/Yoo combination, Arcot-Krishnamurthy discloses that at least one of the one or more sensors the sensor comprises an electrocardiogram (EKG) sensor (sensor(s) 133 in Fig. 16; [0067]; [0077]: “…an electrogram signal (i.e., a voltage sensed by an electrode representing cardiac electrical activity)…”).
Regarding amended claim 5, in view of the Arcot-Krishnamurthy/Yoo combination, Arcot-Krishnamurthy discloses that the biological signal detected by at least one of the one or more sensors comprises one or both of an intensity or frequency of ictal tachycardia or bradycardia events ([0077]: “The intrinsic atrial and/or ventricular rates can be measured by measuring the time intervals between atrial and ventricular senses, respectively, and used to detect atrial and ventricular tachyarrhythmias”; [0062]: “According to various embodiments, the physiological response is detected by detecting a change in impedance characteristics (e.g. detecting a change in absolute impedance values, detecting a change in a mean of the sensed impedance values, and/or detecting a change in variability of the sensed impedance values)… FIG. 15 illustrates a step up in the variability of the sensed impedance when cough occurs. By way of example and not limitation, some system embodiments monitor a trend of the variability of the sensed impedance as the intensity is increased and detects the physiological response if the trend changes by more than threshold.”).
Regarding amended claim 8, in view of the Arcot-Krishnamurthy/Yoo combination, Arcot-Krishnamurthy discloses the controller is configured to automatedly use the biological signal ([0051]) detected by at least one of the one or more sensors to determine a unique stimulation threshold ([0058]: “FIG. 11 illustrates an embodiment of a routine that increases the intensity of the NCT therapy over a period of time. The intensity is increased in increments 124. In the illustrated embodiments, a threshold determination routine 125 is performed to detect a lower boundary physiologic response to the neural stimulation such as a laryngeal vibration response. In various embodiments, a cough detection routine 126 or other side effect detection routine is performed to detect an upper boundary physiologic response to the neural stimulation. Some embodiments decrease the intensity of the NCT therapy over a period of time to detect the physiologic responses (e.g. lower and/or upper boundaries) to the neural stimulation.”; [0067]: “Other parameter(s) that have a slower response may be used to confirm that a therapeutically-effective dose is being delivered.”) for at least one electrode (electrode(s) 132 in Fig. 16) of the VNS stimulator when the VNS stimulator is configured using either a single electrode, or configured using a multi-electrode stimulation cuff or lead ([0052]: “…multi-electrode cuff…”; [0067]: “The sensor(s) and electrode(s) can be integrated on a single lead or can use multiple leads.”).
Regarding amended claim 9, in view of the Arcot-Krishnamurthy/Yoo combination, Arcot-Krishnamurthy discloses that the controller is configured to determine a VNS stimulation threshold by increasing the VNS pulse amplitude at one or more intervals over time until at least one of the one or more sensors detects a biological signal from the patient relevant to an acceptable amplitude of the stimulation pulses ([0058]: “FIG. 11 illustrates an embodiment of a routine that increases the intensity of the NCT therapy over a period of time. The intensity is increased in increments 124. In the illustrated embodiments, a threshold determination routine 125 is performed to detect a lower boundary physiologic response to the neural stimulation such as a laryngeal vibration response. In various embodiments, a cough detection routine 126 or other side effect detection routine is performed to detect an upper boundary physiologic response to the neural stimulation. Some embodiments decrease the intensity of the NCT therapy over a period of time to detect the physiologic responses (e.g. lower and/or upper boundaries) to the neural stimulation.”; [0067]: “Other parameter(s) that have a slower response may be used to confirm that a therapeutically-effective dose is being delivered.”).
Regarding claim 11, in view of the Arcot-Krishnamurthy/Yoo combination, Arcot-Krishnamurthy discloses that the controller (modulator 129 in Fig. 16) is configured to determine an efficacy of the VNS stimulator based on measurements from an EKG sensor or an EEG sensor (sensor(s) 133 in Fig. 16; [0067]; [0077]: “…an electrogram signal (i.e., a voltage sensed by an electrode representing cardiac electrical activity)…”; [0067]: “Other parameter(s) that have a slower response may be used to confirm that a therapeutically-effective dose is being delivered.”),
wherein the measurements from the EKG sensor include any one or more of heart rate variability (HRV) measurements, bradycardia events, or tachycardia and fibrillation events ([0068]: “A comparator 136 receives the first and second feedback signals 134 and 135 and determines a detected change in the parameter value based on these signals. Additionally, the comparator compares the detected change with an allowed change, which can be programmed into the device. For example, the device can be programmed to allow a heart rate reduction during VST to be no less than a percentage (e.g. on the order of 95%) of heart rate without stimulation. The device may be programmed with a quantitative value to allow a heart rate reduction during VST to be no less than that quantitative value (e.g. 5 beats per minute) than heart rate without stimulation. A comparison of the detected change (based on signals 134 and 135) and the allowed change provide a comparison result 141, which is used to appropriately control the modulator to adjust the applied VST.”; [0079]: “Sensor(s) 171 are used by the microprocessor to determine capture (e.g. laryngeal vibrations), the efficacy of therapy (e.g. heart rate, blood pressure) and/or detect events (e.g. cough) or states (e.g. activity sensors).”).
Regarding amended, independent claim 14, Arcot-Krishnamurthy discloses a method for vagus nerve stimulation (VNS) ([0006]: “An embodiment of a method includes delivering a vagal stimulation therapy (VST) to the vagus nerve of a patient…”), comprising:
transmitting periodic electrical stimulation pulses ([0054]: “A simple [stimulation] burst pattern with one burst duration and burst interval can continue periodically for a programmed period or can follow a more complicated schedule.”) from a VNS stimulator (pulse generator 128 in Fig. 16; implantable medical device (IMD) 142 in Fig. 17; [0067]: “…pulse generator 128 to provide VST [vagal stimulation therapy]…”) implanted in a patient to a vagus nerve ([0006]: “…delivering a vagal stimulation therapy (VST) to the vagus nerve of a patient…”);
receiving, from at least one sensor (sensor(s) 133 in Fig. 16) external to the patient, data comprising at least one biological signal from the patient ([0067]: “Some embodiments use external devices to provide the monitoring functions, such as during implantation of an implantable vagus nerve stimulator.”); and
automatically titrating an amplitude of the pulses upward based at least in part on the data ([0019]: “FIG. 9 illustrates a memory, according to various embodiments, that includes instructions, operable on by the stimulation control circuitry, for controlling an up-titration routine by progressively stepping up through defined parameter sets (e.g. parameter set 1 through parameter set N), where each set incrementally increases the stimulation dose or intensity of the stimulation therapy.”; [0051]; Figs. 9 and 10).
Arcot-Krishnamurthy is silent to sensor data comprising an electromyography (EMG) data obtained from a laryngeal branch of the vagus nerve; and automatically titrating an amplitude of the pulses upward based at least in part on the EMG data until a larynx muscle contraction is identified based on the EMG data.
However, Yoo teaches sensor data comprising an electromyography (EMG) data obtained from a laryngeal branch of the vagus nerve ([0040]: “A myoelectric sensing circuit 550 is electrically coupled to electrode 556 and senses a stimulation-evoked EMG signal indicative of the response to the electrical stimulation pulses delivered to [thoracic vagus nerve] tVN 104 and the electrical stimulation pulses delivered to [recurrent laryngeal nerve] RLN 106.”; [0039]: “…an electrode 556 including a pair of insulated stainless steel wires was inserted into laryngeal muscle 107 (e.g., the posterior cricoarytenoid muscle) to measure laryngeal EMG.”); and
automatically titrating an amplitude of the pulses upward based at least in part on the EMG data until a larynx muscle contraction is identified based on the EMG data ([0047]: “The contraction of a laryngeal muscle is not considered to be occurring, or the RLN is not considered to be activated, when the amplitude of the EMG signal does not exceed a specified EMG threshold. In one embodiment, the process of selecting the one or more contacts includes sweeping through various contacts and/or combination of contacts of the multi-contact electrode and observing the effect of the adjustment on the amplitude of the ENG signal and the amplitude of the EMG signal.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the system of Arcot-Krishnamurthy to include an electromyography (EMG) sensor to detect stimulation of the laryngeal branch of the vagus nerve and use larynx muscle contraction as an upper threshold for the controller.
Regarding claim 15, in view of the Arcot-Krishnamurthy/Yoo combination, Arcot-Krishnamurthy discloses that the received data is included in a wireless signal ([0081]: “Wireless technology could be substituted for the leads, such that a leadless electrode is adapted to stimulate a vagus nerve and is further adapted to wirelessly communicate with an implantable system for use in controlling the VST.”).
Regarding amended, independent claim 16, Arcot-Krishnamurthy discloses a device for automatically titrating a-vagus nerve stimulation (VNS) ([0006]: “An embodiment of a method includes delivering a vagal stimulation therapy (VST) to the vagus nerve of a patient…”; [0050]: “FIG. 9 illustrates …an up-titration routine by progressively stepping up through defined parameter sets …Various embodiments provide a neural stimulation routine that automatically finds the desirable combination of therapy parameters (e.g. amplitude, pulse width, duty cycle) that provides a desired therapy intensity level.”), comprising:
a VNS stimulator implanted in a patient (pulse generator 128 in Fig. 16; implantable medical device (IMD) 142 in Fig. 17; [0067]: “…pulse generator 128 to provide VST [vagal stimulation therapy]…”) and configured to transmit electrical stimulation pulses to a vagus nerve of the patient ([0006]: “…delivering a vagal stimulation therapy (VST) to the vagus nerve of a patient…”), the VNS stimulator comprising a controller (modulator 129 in Fig. 16) configured to:
receive data from one or more sensors (sensor(s) 133 in Fig. 16; [0067]: “Some embodiments use external devices to provide the monitoring functions, such as during implantation of an implantable vagus nerve stimulator.”), each configured to detect a biological signal from the patient ([0067]: “…sensor(s) 133 to sense a parameter that is affected by the neural stimulation.”); and
automatically titrate an amplitude of the stimulation pulses upward based in part on the received data ([0019]: “FIG. 9 illustrates a memory, according to various embodiments, that includes instructions, operable on by the stimulation control circuitry, for controlling an up-titration routine by progressively stepping up through defined parameter sets (e.g. parameter set 1 through parameter set N), where each set incrementally increases the stimulation dose or intensity of the stimulation therapy.”; [0051]; Figs. 9 and 10).
Arcot-Krishnamurthy is silent to one or more sensors comprising an electromyography (EMG) sensor configured to be positioned on or proximate to a larynx of the patient and to detect stimulation of the laryngeal branch of the vagus nerve; and automatically titrate an amplitude of the stimulation pulses upward based in part on the received EMG data, until a larynx muscle contraction is identified based on the biological signal detected by the EMG sensor.
However, Yoo teaches one or more sensors comprising an electromyography (EMG) sensor configured to be positioned on or proximate to a larynx of the patient and to detect stimulation of the laryngeal branch of the vagus nerve ([0040]: “A myoelectric sensing circuit 550 is electrically coupled to electrode 556 and senses a stimulation-evoked EMG signal indicative of the response to the electrical stimulation pulses delivered to [thoracic vagus nerve] tVN 104 and the electrical stimulation pulses delivered to [recurrent laryngeal nerve] RLN 106.”; [0039]: “…an electrode 556 including a pair of insulated stainless steel wires was inserted into laryngeal muscle 107 (e.g., the posterior cricoarytenoid muscle) to measure laryngeal EMG.”); and
automatically titrate an amplitude of the stimulation pulses upward based in part on the received EMG data, until a larynx muscle contraction is identified based on the biological signal detected by the EMG sensor ([0047]: “The contraction of a laryngeal muscle is not considered to be occurring, or the RLN is not considered to be activated, when the amplitude of the EMG signal does not exceed a specified EMG threshold. In one embodiment, the process of selecting the one or more contacts includes sweeping through various contacts and/or combination of contacts of the multi-contact electrode and observing the effect of the adjustment on the amplitude of the ENG signal and the amplitude of the EMG signal.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the system of Arcot-Krishnamurthy to include an electromyography (EMG) sensor to detect stimulation of the laryngeal branch of the vagus nerve and use larynx muscle contraction as an upper threshold for the controller.
Regarding amended claim 18, in view of the Arcot-Krishnamurthy/Yoo combination, Arcot-Krishnamurthy discloses that the biological signal detected by at least one of the one or more sensors comprises electrical activity in a patient's brain ( [0067]: “…sensor(s) 133 to sense a parameter that is affected by the neural stimulation. Physiological parameter(s) that quickly respond to VST can be used in closed loop systems or during the implantation process. Examples of such parameters include …electrogram parameters.”).
Regarding amended claim 19, in view of the Arcot-Krishnamurthy/Yoo combination, Arcot-Krishnamurthy discloses that at least one of the one or more sensors the sensor comprises an electrocardiogram (EKG) sensor (sensor(s) 133 in Fig. 16; [0067]; [0077]: “…an electrogram signal (i.e., a voltage sensed by an electrode representing cardiac electrical activity)…”).
Regarding amended claim 20, in view of the Arcot-Krishnamurthy/Yoo combination, Arcot-Krishnamurthy discloses that the biological signal detected by at least one of the one or more sensors (sensor(s) 133 in Fig. 16; [0067]; [0077]: “…an electrogram signal (i.e., a voltage sensed by an electrode representing cardiac electrical activity)…”) is indicative of one or both of an intensity or frequency of ictal tachycardia or bradycardia events ([0077]: “The intrinsic atrial and/or ventricular rates can be measured by measuring the time intervals between atrial and ventricular senses, respectively, and used to detect atrial and ventricular tachyarrhythmias”).
Regarding amended, independent claim 22, Arcot-Krishnamurthy discloses a device for automatically titrating a vagus nerve stimulation (VNS) ([0006]: “An embodiment of a method includes delivering a vagal stimulation therapy (VST) to the vagus nerve of a patient…”; [0050]: “FIG. 9 illustrates …an up-titration routine by progressively stepping up through defined parameter sets …Various embodiments provide a neural stimulation routine that automatically finds the desirable combination of therapy parameters (e.g. amplitude, pulse width, duty cycle) that provides a desired therapy intensity level.”), comprising:
a VNS stimulator implanted in a patient (pulse generator 128 in Fig. 16; implantable medical device (IMD) 142 in Fig. 17; [0067]: “…pulse generator 128 to provide VST [vagal stimulation therapy]…”) and configured to transmit electrical stimulation pulses ([0054]: “A simple [stimulation] burst pattern with one burst duration and burst interval can continue periodically for a programmed period or can follow a more complicated schedule.”) to a vagus nerve of the patient ([0006]: “An embodiment of a method includes delivering a vagal stimulation therapy (VST) to the vagus nerve of a patient…”), the VNS stimulator comprising a controller (modulator 129 in Fig. 16) configured to:
receive data from an external sensor (sensor(s) 133 in Fig. 16; [0067]: “Some embodiments use external devices to provide the monitoring functions, such as during implantation of an implantable vagus nerve stimulator.”) configured to detect from the patient a physical event relevant to one or more stimulus parameters of the stimulation pulses ([0067]: “…sensor(s) 133 to sense a parameter that is affected by the neural stimulation.”; [0077]: “The intrinsic atrial and/or ventricular rates can be measured by measuring the time intervals between atrial and ventricular senses, respectively, and used to detect atrial and ventricular tachyarrhythmias”); and
titrate at least one or more stimulus parameters of the stimulation pulses to find one or more optimal parameters ([0052]) based in part on the received data (Figs. 9-11; [0050]: “FIG. 9 illustrates …an up-titration routine by progressively stepping up through defined parameter sets (e.g. parameter set 1 through parameter set N), where each set incrementally changes (increases or decreases) the stimulation dose or intensity of the stimulation therapy. This memory may be illustrated as part of a therapy titration/adjustment module 119 in FIG. 10. …Various embodiments provide a neural stimulation routine that automatically finds the desirable combination of therapy parameters (e.g. amplitude, pulse width, duty cycle) that provides a desired therapy intensity level.’).
Arcot-Krishnamurthy is silent to that the received data comprises electromyography (EMG) data for a laryngeal branch of the vagus nerve, and the titration is configured to automatically continue until a larynx muscle contraction is identified based on the EMG data
However, Yoo teaches that the received data comprises electromyography (EMG) data for a laryngeal branch of the vagus nerve ([0040]: “A myoelectric sensing circuit 550 is electrically coupled to electrode 556 and senses a stimulation-evoked EMG signal indicative of the response to the electrical stimulation pulses delivered to [thoracic vagus nerve] tVN 104 and the electrical stimulation pulses delivered to [recurrent laryngeal nerve] RLN 106.”; [0039]: “…an electrode 556 including a pair of insulated stainless steel wires was inserted into laryngeal muscle 107 (e.g., the posterior cricoarytenoid muscle) to measure laryngeal EMG.”), and the titration is configured to automatically continue until a larynx muscle contraction is identified based on the EMG data ([0047]: “The contraction of a laryngeal muscle is not considered to be occurring, or the RLN is not considered to be activated, when the amplitude of the EMG signal does not exceed a specified EMG threshold. In one embodiment, the process of selecting the one or more contacts includes sweeping through various contacts and/or combination of contacts of the multi-contact electrode and observing the effect of the adjustment on the amplitude of the ENG signal and the amplitude of the EMG signal.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the system of Arcot-Krishnamurthy to include an electromyography (EMG) sensor to detect stimulation of the laryngeal branch of the vagus nerve and use larynx muscle contraction as an upper threshold for the controller.
Regarding amended, independent claim 23, Arcot-Krishnamurthy discloses a device for automatically titrating a vagus nerve stimulation (VNS) ([0006]: “An embodiment of a method includes delivering a vagal stimulation therapy (VST) to the vagus nerve of a patient…”; [0050]: “FIG. 9 illustrates …an up-titration routine by progressively stepping up through defined parameter sets …Various embodiments provide a neural stimulation routine that automatically finds the desirable combination of therapy parameters (e.g. amplitude, pulse width, duty cycle) that provides a desired therapy intensity level.”), comprising:
a VNS stimulator implanted in a patient (pulse generator 128 in Fig. 16; implantable medical device (IMD) 142 in Fig. 17; [0067]: “…pulse generator 128 to provide VST [vagal stimulation therapy]…”) and configured to transmit electrical stimulation pulses ([0054]: “A simple [stimulation] burst pattern with one burst duration and burst interval can continue periodically for a programmed period or can follow a more complicated schedule.”) to a vagus nerve of the patient ([0006]: “An embodiment of a method includes delivering a vagal stimulation therapy (VST) to the vagus nerve of a patient…”);
a cuff arranged on the vagus nerve and coupled to the VNS stimulator via a lead wire ([0052]: “…multi-electrode cuff…”; [0067]: “The sensor(s) and electrode(s) can be integrated on a single lead or can use multiple leads.”);
electrodes coupled to the cuff, the electrodes contacting the vagus nerve at different positions ([0052]: “The therapy titration module 119, also referred to as a therapy adjustment module, can be programmed to change stimulation sites 121, such as changing the stimulation electrodes used for a neural target or changing the neural targets for the neural stimulation. For example, different electrodes of a multi-electrode cuff can be used to stimulate a neural target.”); and
a controller (modulator 129 in Fig. 16) coupled to the VNS stimulator and configured to:
receive data from one or more sensors (sensor(s) 133 in Fig. 16; [0067]: “Some embodiments use external devices to provide the monitoring functions, such as during implantation of an implantable vagus nerve stimulator.”), each configured to detect from the patient a biological signal ([0067]: “…sensor(s) 133 to sense a parameter that is affected by the neural stimulation.”) relevant to one or more acceptable stimulus parameters of the stimulation pulses ([0067]: “Other parameter(s) that have a slower response may be used to confirm that a therapeutically-effective dose is being delivered.”; [0068]: “…response monitor 130 monitors the parameter during a time with stimulation to provide a first feedback signal 134 indicative of a parameter value corresponding to a time with stimulation and during a time without stimulation to provide a second feedback signal 135 indicative of a parameter value corresponding to a time without stimulation. …A comparison of the detected change (based on signals 134 and 135) and the allowed change provide a comparison result 141, which is used to appropriately control the modulator to adjust the applied VST.”) from at least one of the electrodes (electrode(s) 132 in Fig. 16);
titrate one or more optimal parameters ([0067]) using different electrodes to find one or more optimal parameters and one or more optimal electrodes to activate as stimulating electrodes ([0052]) based in part on the received data ([0019]: “FIG. 9 illustrates a memory, according to various embodiments, that includes instructions, operable on by the stimulation control circuitry, for controlling an up-titration routine by progressively stepping up through defined parameter sets (e.g. parameter set 1 through parameter set N), where each set incrementally increases the stimulation dose or intensity of the stimulation therapy.”; [0051]; Figs. 9 and 10).
Arcot-Krishnamurthy is silent to that the received data comprises electromyography (EMG) data for a laryngeal branch of the vagus nerve, and the titration is configured to automatically continue until a larynx muscle contraction is identified based on the EMG data.
However, Yoo teaches that the received data comprises electromyography (EMG) data for a laryngeal branch of the vagus nerve ([0040]: “A myoelectric sensing circuit 550 is electrically coupled to electrode 556 and senses a stimulation-evoked EMG signal indicative of the response to the electrical stimulation pulses delivered to [thoracic vagus nerve] tVN 104 and the electrical stimulation pulses delivered to [recurrent laryngeal nerve] RLN 106.”; [0039]: “…an electrode 556 including a pair of insulated stainless steel wires was inserted into laryngeal muscle 107 (e.g., the posterior cricoarytenoid muscle) to measure laryngeal EMG.”), and the titration is configured to automatically continue until a larynx muscle contraction is identified based on the EMG data ([0047]: “The contraction of a laryngeal muscle is not considered to be occurring, or the RLN is not considered to be activated, when the amplitude of the EMG signal does not exceed a specified EMG threshold. In one embodiment, the process of selecting the one or more contacts includes sweeping through various contacts and/or combination of contacts of the multi-contact electrode and observing the effect of the adjustment on the amplitude of the ENG signal and the amplitude of the EMG signal.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the system of Arcot-Krishnamurthy to include an electromyography (EMG) sensor to detect stimulation of the laryngeal branch of the vagus nerve and use larynx muscle contraction as an upper threshold for the controller.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over the Arcot-Krishnamurthy/Yoo combination in view of Ternes et al. (US 2011/0015703, hereinafter referred to as Ternes) (cited previously).
Regarding amended claim 10, in view of the Arcot-Krishnamurthy/Yoo combination, Arcot-Krishnamurthy discloses that the sensor comprises a microphone, and the biological signal comprises a heart rate or an ictal tachycardia event (sensor(s) 133 in Fig. 16; [0067]: “…sensor(s) 133 to sense a parameter that is affected by the neural stimulation. Physiological parameter(s) that quickly respond to VST can be used in closed loop systems or during the implantation process. Examples of such parameters include heart rate…”; [0077]: “…an electrogram signal (i.e., a voltage sensed by an electrode representing cardiac electrical activity)…”).
Arcot-Krishnamurthy does disclose components for sensing biological signals comprising a heart rate or an ictal tachycardia event (sensor(s) 133 in Fig. 16; [0067]: “…sensor(s) 133 to sense a parameter that is affected by the neural stimulation. Physiological parameter(s) that quickly respond to VST can be used in closed loop systems or during the implantation process. Examples of such parameters include heart rate…”. However, Arcot-Krishnamurthy is silent to that the sensor comprises a microphone.
However, Ternes teaches a programmed neural stimulation therapy using a neural stimulator and using detected paced cardiac activity as an input for the neural stimulation therapy. Ternes further teaches a sensor comprising a microphone ([0064]: “‘Heart sounds’ include audible mechanical vibrations caused by cardiac activity that can be sensed with a microphone and audible and inaudible mechanical vibrations caused by cardiac activity that can be sensed with an accelerometer.”)
Ternes teaches a similar pursuit to the instant application of cardiac control via vagal stimulation. 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 Arcot-Krishnamurthy to include a microphone sensor for detecting a heart rate or an ictal tachycardia event of a patient in order to effectively mitigate the potentially dangerous effects of such an event via vagus nerve stimulation ([0059]-[0060]).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over the Arcot-Krishnamurthy/Yoo/Ternes combination in view of Osorio (US 2017/0157402) (cited previously).
Regarding claim 12, in view of the Arcot-Krishnamurthy/Yoo/Ternes combination, Arcot-Krishnamurthy discloses that the measurements from the EKG sensor (sensor(s) 133 in Fig. 16; [0067]; [0077]: “…an electrogram signal (i.e., a voltage sensed by an electrode representing cardiac electrical activity)…”) comprise one or more of a number of ictal tachycardia events, a number of bradycardia events, or a Heart Rate Variability (HRV) ([0068]; [0077]: “The sensing circuitry [of Fig. 18]… when an electrogram signal (i.e., a voltage sensed by an electrode representing cardiac electrical activity) generated by a particular channel exceeds a specified detection threshold… The intrinsic atrial and/or ventricular rates can be measured by measuring the time intervals between atrial and ventricular senses, respectively, and used to detect atrial and ventricular tachyarrhythmias.”); or the measurements from the EEG sensor (sensor(s) 133 in Fig. 16; [0067]: “…electrogram parameters.”).
Arcot-Krishnamurthy is silent to indications of a seizure event.
However, Osorio teaches methods, apparatus, and systems for performing vagus nerve stimulation (VNS) for treating epileptic seizures characterized by cardiac changes, including ictal tachycardia. Osorio further teaches indications of a seizure event ([0055]: “One or more of the heart rate sensor 130 and the kinetic sensor 140 may be used by a seizure detection algorithm in the system 100 to detect epileptic seizures. In alternative embodiments, other body signals (e.g., blood pressure, brain activity, blood oxygen/CO.sub.2 concentrations, temperature, skin resistivity, etc.) of the patient may be sensed and used by the seizure detection algorithm to detect epileptic seizures.”).
Osorio is of a similar pursuit to the instant application and the invention of Arcot-Krishnamurthy in providing vagus nerve stimulation to a patient in response to detected biological events. 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 Arcot-Krishnamurthy to include the detection of indications of a seizure event, so as to effectively mitigate the potentially dangerous effects of such an event via vagus nerve stimulation ([0003]; [0009]).
Regarding claim 13, in view of the Arcot-Krishnamurthy/Yoo/Ternes combination, Arcot-Krishnamurthy discloses that the controller is configured to automatically effect an optimal titration of the VNS stimulation amplitude such that …events are reduced with minimal stimulator use as determined based at least in part on the event (Figs. 9-11; [0050]: “FIG. 9 illustrates …an up-titration routine by progressively stepping up through defined parameter sets (e.g. parameter set 1 through parameter set N), where each set incrementally changes (increases or decreases) the stimulation dose or intensity of the stimulation therapy. This memory may be illustrated as part of a therapy titration/adjustment module 119 in FIG. 10. …Various embodiments provide a neural stimulation routine that automatically finds the desirable combination of therapy parameters (e.g. amplitude, pulse width, duty cycle) that provides a desired therapy intensity level.”).
Arcot-Krishnamurthy is silent to VNS stimulation such that seizure events are reduced.
However, Osorio teaches VNS stimulation such that seizure events ([0055]) are reduced ([0005]: “…electrical stimulation of a target tissue to reduce symptoms or effects of the disorder. Such therapeutic electrical signals have been successfully applied to brain, spinal cord, and cranial nerves tissues improve or ameliorate a variety of conditions. A particular example of such a therapy involves applying an electrical signal to the vagus nerve to reduce or eliminate epileptic seizures…”).
Osorio is of a similar pursuit to the instant application and the invention of Arcot-Krishnamurthy in providing vagus nerve stimulation to a patient in response to detected biological events. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the Arcot-Krishnamurthy/Ternes combination to include VNS stimulation such that seizure events are reduced, so as to effectively mitigate the potentially dangerous effects of such an event via vagus nerve stimulation ([0003]; [0009]).
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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/M.G.S./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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