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 nonobviousness.
Claim(s) 1-5, 9-11, 13-16, 18-23, 25, 42-43, and 45-47 are rejected under 35 U.S.C. 103 as being unpatentable over Bourget(US 20210386991 A1) in view of ポール・エム・メドウズ(JP 2011500143 A), herein after referred to as Ref B (both cited previously), and further in view of Suri(US 20210052893 A1).
Regarding claim 1, Bourget discloses an implantable neuromodulation system comprising: a first housing configured for implantation in an anterior cervical region of a patient(IMB 110 is configured to deliver electrical stimulation therapy to patient 105 via selected combinations of electrodes carried by one or both of leads 130, alone or in combination with an electrode carried by or defined by an outer housing of IMD 110. Leads 130 may be introduced into spinal cord 120 in via any suitable region, such as the thoracic, cervical or lumbar regions[0063]); a first electrode lead coupled to the first housing and configured to be disposed in a submandibular region, wherein at least one electrode on the first electrode lead is configured to be disposed at or near a first branch of a hypoglossal nerve of the patient; a first sensor configured to provide a sensor signal that includes information about a patient response to a first electrostimulation therapy that is provided to the patient using the at least one electrode, (In some examples, IMD 110 receives a signal indicative of the ECAP from one or more sensors, e.g., one or more electrodes and circuitry, internal or external to patient 105. Such an example signal may include a signal indicating an ECAP of the tissue of patient 105[0073]); and a processor circuit disposed in the first housing and configured to update an electrostimulation therapy parameter based on the sensor signal, and to use the updated electrostimulation therapy parameter in a subsequent electrostimulation therapy that is configured to treat the sleep disorder or breathing disorder of the patient(Stimulation pulses 504 may be delivered according to test stimulation programs 216 stored in storage device 212 of IMD 200, and test stimulation programs 216 may be updated according to user input via an external programmer and/or may be updated according to a signal from sensor(s) 222[0130]). Bourget fails to disclose “wherein at least one electrode on the first electrode lead is configured to be disposed at or near a first branch of a hypoglossal nerve of the patient; and wherein the first electrostimulation therapy is configured to treat a sleep disorder or breathing disorder of the patient”. Bourget further fails to disclose “wherein the first sensor comprises an accelerometer disposed in or coupled to the first housing; and the sensor signal includes (i) information from the accelerometer about movement of or a position of a tongue of the patient or (ii) acoustic information from the accelerometer indicative of an airway openness”.
However, Ref B teaches “Submandibular IPG Transplant Member FIGS. 2A-2D illustrate a submandibular IPG implant 200 for treating obstructive sleep apnea (OSA). In this embodiment, the submandibular implant 200 stimulates the hypoglossal nerve (HGN), the peripheral nerve located below the lower jaw, and the peripheral nerve located behind the lower jaw(see attached translation, page 7, paragraph 3)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the system for controlling electrical stimulation of Bourget with the selective stimulation system of Ref B. Doing so would specify that the electrical stimulation could be used for sleep disorder treatment since the systems have the same components and Bourget already senses the body state during sleep.
However, Suri teaches “ In yet another embodiment, the feedback mechanism 90 comprises an inertial sensor (e.g., an accelerometer or gyroscope) that measures the movement of the tongue in response to electrical stimulation of the HGN 12. The inertial sensor may be incorporated into an oral appliance or mouth guard (not shown). Based on the signals output by the inertial sensor, the clinician programmer 56 can compute a score of the therapy provided by the current set up of the system 50, and in particular, the currently selected set of electrode contacts and corresponding stimulation parameters. That is, the motion activity sensed by the inertial sensor in synchronization with the stimulation of the HGN 12 is indicative of movement of the tongue. If the magnitude of the signals is relatively high, indicating a strong activation of the tongue protrusor muscles, the therapy score assigned to the current set up may be relatively high, whereas if the magnitude of the signals is relatively low, indicating no or weak activation of the tongue protrusor muscles, the therapy score assigned to the current set up may be relatively low[0151]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the system for controlling electrical stimulation of Bourget with the stimulator systems of Suri. Doing so would specify that the accelerometer in the system is used to measure tongue movement and positioning based on signals so the system can measure how effective the stimulation is.
Regarding claim 2, Bourget in view of Ref B and Suri teaches the implantable neuromodulation system of claim 1, wherein the sensor signal includes information about a neural response to the first electrostimulation therapy(Such a switch circuit may be a switch array, switch matrix, multiplexer, or any other type of switching circuit configured to selectively couple stimulation energy to selected electrodes 232, 234 and to selectively sense bioelectrical neural signals of a spinal cord of the patient (not shown in FIG. 2) with selected electrodes 232, 234[0098]).
Regarding claim 3, Bourget in view of Ref B and Suri teaches the implantable neuromodulation system of claim 2, wherein the information about the neural response to the first electrostimulation therapy includes information about an evoked compound action potential (ECAP)( Sensing circuitry 206 monitors signals from any combination of electrodes 232, 234. In some examples, sensing circuitry 206 includes one or more amplifiers, filters, and analog-to-digital converters. Sensing circuitry 206 may be used to sense physiological signals, such as ECAPs[0095]).
Regarding claim 4, Bourget in view of Ref B and Suri teaches the implantable neuromodulation system of claim 3,wherein the information about the ECAP includes information about a peak magnitude characteristic of an ECAP signal, and wherein the first and subsequent electrostimulation therapies are configured to evoke different ECAP signal peak magnitude characteristics(In some examples, the characteristic monitored by IMD 110 may be an ECAP amplitude. The ECAP amplitude may, in some examples, be given by a voltage difference between an N1 ECAP peak and a P2 ECAP peak. More description related to the N1 ECAP peak, and other ECAP peaks may be found below in the FIG. 4 description[0077]).
Regarding claim 5, Bourget in view of Ref B and Suri teaches the implantable neuromodulation system of claim 2, but Bourget fails to disclose wherein the first sensor comprises one or more electrodes on the first electrode lead or on a different lead disposed at or near the hypoglossal nerve of the patient.
However, Ref B teaches “Submandibular IPG Transplant Member FIGS. 2A-2D illustrate a submandibular IPG implant 200 for treating obstructive sleep apnea (OSA). In this embodiment, the submandibular implant 200 stimulates the hypoglossal nerve (HGN), the peripheral nerve located below the lower jaw, and the peripheral nerve located behind the lower jaw(see attached translation, page 7, paragraph 3)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the system for controlling electrical stimulation of Bourget with the selective stimulation system of Ref B. Doing so would specify that the electrical stimulation could be used for sleep disorder treatment since the systems have the same components and Bourget already senses the body state during sleep.
Regarding claim 9, Bourget in view of Ref B and Suri teaches the implantable neuromodulation system of claim 8, but Bourget fails to disclose wherein the sensor signal includes acoustic information indicative of an airway openness, and the acoustic information indicates whether the patient is snoring. However, Ref B teaches “In yet another embodiment, the IPG electronic function can include an acoustic pickup and a voice processor to identify snoring( see attached translation, page 6, paragraph 2). The IPG implant or the external control device is stimulated when the index is reduced or when snoring is detected, such as when the flow rate is reduced by 10% from the average flow rate of an unobstructed sleeping patient. Is slowly increased to improve the monitored indicator (eg, increased air flow and / or decreased snore)(see attached translation, page 20, paragraph 1)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the system for controlling electrical stimulation of Bourget with the selective stimulation system of Ref B. Doing so would specify that the electrical stimulation could be used for sleep disorder treatment since the systems have the same components and Bourget already senses the body state during sleep.
Regarding claim 10, Bourget in view of Ref B and Suri teaches the implantable neuromodulation system of claim 1, but Bourget fails to disclose wherein the processor circuit is configured to update the electrostimulation therapy parameter to change a position of a tongue or induce a movement of the tongue. However, Suri teaches “ In yet another embodiment, the feedback mechanism 90 comprises an inertial sensor (e.g., an accelerometer or gyroscope) that measures the movement of the tongue in response to electrical stimulation of the HGN 12. The inertial sensor may be incorporated into an oral appliance or mouth guard (not shown). Based on the signals output by the inertial sensor, the clinician programmer 56 can compute a score of the therapy provided by the current set up of the system 50, and in particular, the currently selected set of electrode contacts and corresponding stimulation parameters. That is, the motion activity sensed by the inertial sensor in synchronization with the stimulation of the HGN 12 is indicative of movement of the tongue. If the magnitude of the signals is relatively high, indicating a strong activation of the tongue protrusor muscles, the therapy score assigned to the current set up may be relatively high, whereas if the magnitude of the signals is relatively low, indicating no or weak activation of the tongue protrusor muscles, the therapy score assigned to the current set up may be relatively low[0151]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the system for controlling electrical stimulation of Bourget with the stimulator systems of Suri. Doing so would specify that the accelerometer in the system is used to measure tongue movement and positioning based on signals so the system can measure how effective the stimulation is.
Regarding claim 11, Bourget in view of Ref B and Suri teaches the implantable neuromodulation system of claim 1, wherein the processor circuit is configured to determine a patient posture status using information from the sensor signal and update the electrostimulation therapy parameter based on the patient posture status(For example, to measure a physiological effect indicative of a compound action potential, the one or more sensors may be an accelerometer, a pressure sensor, a bending sensor, a sensor configured to detect a posture of patient 105, or a sensor configured to detect a respiratory function of patient 105. In this manner, although the ECAP may be indicative of a posture change or other patient action, other sensors may also detect similar posture changes or movements using modalities separate from the ECAP[0073]).
Regarding claim 13, Bourget in view of Ref B and Suri teaches the implantable neuromodulation system of claim 1, wherein the processor circuit is configured to establish a target therapy signature for the patient, and wherein the processor circuit is configured to change the electrostimulation therapy parameter to achieve the target therapy signature based on information from the sensor signal(The techniques of this disclosure may provide one or more advantages. For example, it may be beneficial to change the rate at which the medical device decreases and subsequently increases the one or more parameters of the stimulation pulses delivered to the target tissue in response to a transient patient action or in response to a change in control policy. For example, processing circuitry may execute an algorithm which generates one or more recommendations or automatically changes one or more parameters that define a control policy which controls how the medical device changes stimulation parameters based on a physiological signal such as an ECAP characteristic value[0045]).
Regarding claim 14, Bourget in view of Ref B and Suri teaches the implantable neuromodulation system of claim 13, wherein the target therapy signature includes an evoked compound action potential (ECAP) signal magnitude(In some examples, the zone between upper threshold ECAP amplitude 1206 and lower threshold ECAP amplitude 1208 may have a predetermined magnitude and/or be adjustable by a patient or physician[0175]).
Regarding claim 15, Bourget in view of Ref B and Suri teaches the implantable neuromodulation system of claim 14, but Bourget fails to disclose wherein the target therapy signature includes a specified tongue displacement or specified tongue position. However, Ref B teaches “This independent simultaneous stimulation produces the desired tongue movement without the need to sense breathing related events to achieve the desired result(see attached translation, page 17, paragraph 6)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the system for controlling electrical stimulation of Bourget with the selective stimulation system of Ref B. Doing so would specify that the electrical stimulation could be used for sleep disorder treatment since the systems have the same components and Bourget already senses the body state during sleep.
Regarding claim 16, Bourget in view of Ref B and Suri teaches the implantable neuromodulation system of claim 14, but Bourget fails to disclose wherein the target therapy signature includes an acoustic profile indicative of an unobstructed airway. However, Ref B teaches “In another embodiment, snoring can be detected internally using an acoustic sensor and an acoustic processing device. In yet another embodiment, snoring can be detected externally using, for example, a nasal cannula or a microphone placed in the ear. The air flow rate can be measured externally using a nasal cannula or thermistor and can be used as a trigger or closed loop feedback signal(see attached translation, page 19, paragraph 3)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the system for controlling electrical stimulation of Bourget with the selective stimulation system of Ref B. Doing so would specify that the electrical stimulation could be used for sleep disorder treatment since the systems have the same components and Bourget already senses the body state during sleep.
Regarding claim 18, Bourget in view of Ref B and Suri teaches the implantable neuromodulation system of claim 1, wherein the processor circuit is configured to update the electrostimulation therapy by changing one or more of a pulse width, pulse amplitude, waveform shape, stimulation frequency, burst pattern, or electrode configuration used for the subsequent electrostimulation therapy(Electrical stimulation may be delivered to a patient by the medical device in a train of electrical pulses, and parameters of the electrical pulses may include a frequency, an amplitude, a pulse width, and a pulse shape[0004]).
Regarding claim 19, Bourget in view of Ref B and Suri teaches the implantable neuromodulation system of claim 1, wherein the processor circuit is configured to determine whether a magnitude of an ECAP signal response to the subsequent electrostimulation therapy is different than a magnitude of an ECAP signal response to the first electrostimulation therapy, and wherein the processor circuit is configured to use information about the difference in ECAP signal responses to select a parameter for use in a further subsequent electrostimulation therapy(When detecting the ECAP of ECAP signal 406, different characteristics may be identified. For example, the characteristic of the ECAP may be the amplitude between N1 and P2. This N1-P2 amplitude may be easily detectable even if the artifact impinges on P1, a relatively large signal, and the N1-P2 amplitude may be minimally affected by electronic drift in the signal. In other examples, the characteristic of the ECAP used to control subsequent control pulses and/or informed pulses may be an amplitude of P1, N1, or P2 with respect to neutral or zero voltage. In some examples, the characteristic of the ECAP used to control subsequent control pulses or informed pulses is a sum of two or more of peaks P1, N1, or P2. In other examples, the characteristic of ECAP signal 406 may be the area under one or more of peaks P1, N1, and/or P2[0127]).
Regarding claim 20, Bourget in view of Ref B and Suri teaches the implantable neuromodulation system of claim 1, however Bourget fails to disclose wherein the processor circuit is configured to determine whether a tongue excursion or displacement response to the subsequent electrostimulation therapy is different than a tongue excursion or displacement response to the first electrostimulation therapy, and wherein the processor circuit is configured to use information about the difference in tongue excursion or displacement to select a parameter for use in a further subsequent electrostimulation therapy.
However, Ref B teaches “In addition, the position of the tongue can be used as a trigger using, for example, a proximity sensor, and the tongue can be used as a trigger using, for example, an accelerometer. These triggers can be used at any time, including initial placement, program, and / or IPG implant configuration(see attached translation, page 19, paragraph 3)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the system for controlling electrical stimulation of Bourget with the selective stimulation system of Ref B. Doing so would specify that the electrical stimulation could be used for sleep disorder treatment since the systems have the same components and Bourget already senses the body state during sleep.
Regarding claim 21, Bourget in view of Ref B and Suri teaches the implantable neuromodulation system of claim 1, but Bourget fails to disclose wherein the processor circuit is configured to determine whether an acoustic response following the first electrostimulation therapy is different than an acoustic response following the subsequent electrostimulation therapy, wherein the acoustic responses indicate different levels of airway obstruction for the patient, and wherein the processor circuit is configured to use information about the difference in acoustic responses to select a parameter for use in a further subsequent electrostimulation therapy.
However, Ref B teaches “The IPG implant or the external control device is stimulated when the index is reduced or when snoring is detected, such as when the flow rate is reduced by 10% from the average flow rate of an unobstructed sleeping patient. Is slowly increased to improve the monitored indicator (eg, increased air flow and / or decreased snore). When the sensor is connected to the IPG implant, the IPG implant changes the stimulation parameter. If the sensor is connected to an external controller, the controller changes the stimulation parameter or triggers a preprogrammed increase in the IPG implant(see attached translation, page 20, paragraph 1)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the system for controlling electrical stimulation of Bourget with the selective stimulation system of Ref B. Doing so would specify that the electrical stimulation could be used for sleep disorder treatment since the systems have the same components and Bourget already senses the body state during sleep.
Regarding claim 22, Bourget in view of Ref B and Suri teaches the implantable neuromodulation system of claim 1, but Bourget fails to disclose wherein the first sensor is configured to provide the sensor signal with information about a concentricity of collapse of a patient airway. However, Ref B teaches “In the embodiment shown in FIG. 3A, at least one electrode lead 341 and an electrode are permanently attached to the submandibular implant 200 at one of its corners. Another through lead 240 having an implant member female connector 350 can be used for attachment between another electrode lead 342 and the electrode. The embodiment shown in FIG. 3A is typically used for unilateral transplant patients, where a single electrode lead 341 is sufficient to achieve the desired therapeutic results(see attached translation, page 9, paragraph 3)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the system for controlling electrical stimulation of Bourget with the selective stimulation system of Ref B. Doing so would specify that the electrical stimulation could be used for sleep disorder treatment since the systems have the same components and Bourget already senses the body state during sleep.
Regarding claim 23, Bourget in view of Ref B and Suri teaches the implantable neuromodulation system of claim 1, but Bourget fails to disclose wherein the processor circuit is configured to update the electrostimulation therapy parameter by changing a stimulation mode from a unilateral stimulation configuration to a bilateral stimulation configuration, and wherein the unilateral and bilateral stimulation configurations are configured to stimulate at least a portion of the same neural target tissue.
However, Ref B teaches “The embodiment shown in FIG. 3A is typically used for unilateral transplant patients, where a single electrode lead 341 is sufficient to achieve the desired therapeutic results, but the second electrode lead 342 and the electrode are It is still possible to add for bilateral applications(see attached translation, page 9, paragraph 3)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the system for controlling electrical stimulation of Bourget with the selective stimulation system of Ref B. Doing so would specify that the electrical stimulation could be used for sleep disorder treatment since the systems have the same components and Bourget already senses the body state during sleep.
Regarding claim 25, Bourget in view of Ref B and Suri teaches the implantable neuromodulation system of claim 1, but Bourget fails to disclose wherein the first sensor is configured to provide the sensor signal with information about an airway obstruction bias direction, and wherein the updated electrostimulation therapy parameter includes a bilateral electrostimulation therapy parameter.
However, Ref B teaches “In the embodiment shown in FIG. 3A, at least one electrode lead 341 and an electrode are permanently attached to the submandibular implant 200 at one of its corners. Another through lead 240 having an implant member female connector 350 can be used for attachment between another electrode lead 342 and the electrode. The embodiment shown in FIG. 3A is typically used for unilateral transplant patients, where a single electrode lead 341 is sufficient to achieve the desired therapeutic results(see attached translation, page 9, paragraph 3)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the system for controlling electrical stimulation of Bourget with the selective stimulation system of Ref B. Doing so would specify that the electrical stimulation could be used for sleep disorder treatment since the systems have the same components and Bourget already senses the body state during sleep.
Regarding claim 42, Bourget discloses an implantable neuromodulation system comprising: a first electrode lead coupled to an electrostimulation signal generator circuit(IMB 110 is configured to deliver electrical stimulation therapy to patient 105 via selected combinations of electrodes carried by one or both of leads 130, alone or in combination with an electrode carried by or defined by an outer housing of IMD 110. Leads 130 may be introduced into spinal cord 120 in via any suitable region, such as the thoracic, cervical or lumbar regions[0063]); a first sensor configured to provide a sensor signal that includes information about a patient response to the first electrostimulation therapy(Stimulation pulses 504 may be delivered according to test stimulation programs 216 stored in storage device 212 of IMD 200, and test stimulation programs 216 may be updated according to user input via an external programmer and/or may be updated according to a signal from sensor(s) 222[0130]), wherein the patient response includes at least one of an acoustic profile of an airway of the patient, a change in a position of a tongue of the patient; a posture sensor configured to provide a posture signal that includes information about a patient posture; and a processor circuit configured to use information from each of the sensor signal and the posture signal to select a subsequent electrostimulation therapy to treat the sleep disorder or breathing disorder of the patient(In some examples, IMD 110 receives a signal indicative of the ECAP from one or more sensors, e.g., one or more electrodes and circuitry, internal or external to patient 105. Such an example signal may include a signal indicating an ECAP of the tissue of patient 105[0073]. For example, to measure a physiological effect indicative of a compound action potential, the one or more sensors may be an accelerometer, a pressure sensor, a bending sensor, a sensor configured to detect a posture of patient 105, or a sensor configured to detect a respiratory function of patient 105. In this manner, although the ECAP may be indicative of a posture change or other patient action, other sensors may also detect similar posture changes or movements using modalities separate from the ECAP[0073]). Bourget fails to disclose “the first electrode lead comprising a first electrode configured to be disposed at or near a first branch of a hypoglossal nerve of a patient and configured to provide a first electrostimulation therapy to treat a sleep disorder or breathing disorder of the patient”. Bourget further fails to disclose “wherein the first sensor comprises an accelerometer disposed in or coupled to the first housing; and the sensor signal includes (i) information from the accelerometer about movement of or a position of a tongue of the patient or (ii) acoustic information from the accelerometer indicative of an airway openness”.
However, Ref B teaches “Submandibular IPG Transplant Member FIGS. 2A-2D illustrate a submandibular IPG implant 200 for treating obstructive sleep apnea (OSA). In this embodiment, the submandibular implant 200 stimulates the hypoglossal nerve (HGN), the peripheral nerve located below the lower jaw, and the peripheral nerve located behind the lower jaw(see attached translation, page 7, paragraph 3)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the system for controlling electrical stimulation of Bourget with the selective stimulation system of Ref B. Doing so would specify that the electrical stimulation could be used for sleep disorder treatment since the systems have the same components and Bourget already senses the body state during sleep.
However, Suri teaches “ In yet another embodiment, the feedback mechanism 90 comprises an inertial sensor (e.g., an accelerometer or gyroscope) that measures the movement of the tongue in response to electrical stimulation of the HGN 12. The inertial sensor may be incorporated into an oral appliance or mouth guard (not shown). Based on the signals output by the inertial sensor, the clinician programmer 56 can compute a score of the therapy provided by the current set up of the system 50, and in particular, the currently selected set of electrode contacts and corresponding stimulation parameters. That is, the motion activity sensed by the inertial sensor in synchronization with the stimulation of the HGN 12 is indicative of movement of the tongue. If the magnitude of the signals is relatively high, indicating a strong activation of the tongue protrusor muscles, the therapy score assigned to the current set up may be relatively high, whereas if the magnitude of the signals is relatively low, indicating no or weak activation of the tongue protrusor muscles, the therapy score assigned to the current set up may be relatively low[0151]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the system for controlling electrical stimulation of Bourget with the stimulator systems of Suri. Doing so would specify that the accelerometer in the system is used to measure tongue movement and positioning based on signals so the system can measure how effective the stimulation is.
Regarding claim 43, Bourget in view of Ref B and Suri teaches the implantable neuromodulation system of claim 42, further comprising a first housing configured for implantation in an anterior cervical region of the patient, wherein the first electrode lead, the first sensor, the posture sensor, and the processor circuit are coupled to the first housing(IMB 110 is configured to deliver electrical stimulation therapy to patient 105 via selected combinations of electrodes carried by one or both of leads 130, alone or in combination with an electrode carried by or defined by an outer housing of IMD 110. Leads 130 may be introduced into spinal cord 120 in via any suitable region, such as the thoracic, cervical or lumbar regions[0063]. In some examples, IMD 110 receives a signal indicative of the ECAP from one or more sensors, e.g., one or more electrodes and circuitry, internal or external to patient 105. Such an example signal may include a signal indicating an ECAP of the tissue of patient 105[0073]. Stimulation pulses 504 may be delivered according to test stimulation programs 216 stored in storage device 212 of IMD 200, and test stimulation programs 216 may be updated according to user input via an external programmer and/or may be updated according to a signal from sensor(s) 222[0130]. For example, to measure a physiological effect indicative of a compound action potential, the one or more sensors may be an accelerometer, a pressure sensor, a bending sensor, a sensor configured to detect a posture of patient 105, or a sensor configured to detect a respiratory function of patient 105. In this manner, although the ECAP may be indicative of a posture change or other patient action, other sensors may also detect similar posture changes or movements using modalities separate from the ECAP. [0073]).
Regarding claim 45, Bourget in view of Ref B and Suri teaches the implantable neuromodulation system of claim 42, wherein the first sensor comprises one or more electrodes configured to sense the evoked compound action potential (ECAP) and wherein the patient response includes information about the (ECAP) of a portion of the hypoglossal nerve (Sensing circuitry 206 monitors signals from any combination of electrodes 232, 234. In some examples, sensing circuitry 206 includes one or more amplifiers, filters, and analog-to-digital converters. Sensing circuitry 206 may be used to sense physiological signals, such as ECAPs[0095]. An evoked compound action potential (ECAP) is synchronous firing of a population of neurons which occurs in response to the application of a stimulus including, in some cases, an electrical stimulus by a medical device. The ECAP may be detectable as being a separate event from the stimulus itself, and the ECAP may reveal characteristics of the effect of the stimulus on the nerve fibers[0004]). Bourget fails to disclose “electrode disposed at or near the first branch of the hypoglossal nerve”.
However, Ref B teaches “Submandibular IPG Transplant Member FIGS. 2A-2D illustrate a submandibular IPG implant 200 for treating obstructive sleep apnea (OSA). In this embodiment, the submandibular implant 200 stimulates the hypoglossal nerve (HGN), the peripheral nerve located below the lower jaw, and the peripheral nerve located behind the lower jaw(see attached translation, page 7, paragraph 3)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the system for controlling electrical stimulation of Bourget with the selective stimulation system of Ref B. Doing so would specify that the electrical stimulation could be used for sleep disorder treatment since the systems have the same components and Bourget already senses the body state during sleep.
Regarding claim 46, Bourget in view of Ref B and Suri teaches the implantable neuromodulation system of claim 42, wherein the posture signal indicates a particular posture type of an upright posture, a prone posture, a supine posture, a right recumbent posture, or a left recumbent posture, and wherein the processor circuit is configured to select the subsequent electrostimulation therapy from among multiple other therapies based on the particular posture type; and wherein the subsequent electrostimulation therapy differs from the multiple other therapies by at least one of an electrostimulation pulse width, pulse amplitude, waveform shape, stimulation frequency, burst pattern, or electrode configuration(Electrical stimulation may be delivered to a patient by the medical device in a train of electrical pulses, and parameters of the electrical pulses may include a frequency, an amplitude, a pulse width, and a pulse shape[0004]. A sensor configured to detect a posture of patient 105, or a sensor configured to detect a respiratory function of patient 105. In this manner, although the ECAP may be indicative of a posture change or other patient action, other sensors may also detect similar posture changes or movements using modalities separate from the ECAP[0073]).
Regarding claim 47, Bourget in view of Ref B and Suri teaches the implantable neuromodulation system of claim 42, but Bourget fails to disclose wherein the first electrostimulation therapy comprises one of a unilateral and a bilateral electrostimulation therapy and wherein the subsequent electrostimulation therapy comprises the other one of the unilateral and bilateral electrostimulation therapy.
However, Ref B teaches “The embodiment shown in FIG. 3A is typically used for unilateral transplant patients, where a single electrode lead 341 is sufficient to achieve the desired therapeutic results, but the second electrode lead 342 and the electrode are it is still possible to add for bilateral applications(see attached translation, page 9, paragraph 3)”. Ref B teaches stimulation for both unilateral and bilateral applications so one can assume the bilateral stimulation can occur after unilateral stimulation by adding an electrode.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the system for controlling electrical stimulation of Bourget with the selective stimulation system of Ref B. Doing so would specify that the electrical stimulation could be used for sleep disorder treatment since the systems have the same components and Bourget already senses the body state during sleep.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 42 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant primarily argues that the art of record fails to disclose amendment “the first sensor comprises an accelerometer disposed in or coupled to the first housing; and the sensor signal includes (i) information from the accelerometer about movement of or a position of a tongue of the patient or (ii) acoustic information from the accelerometer indicative of an airway openness”. However new art Suri teaches “ In yet another embodiment, the feedback mechanism 90 comprises an inertial sensor (e.g., an accelerometer or gyroscope) that measures the movement of the tongue in response to electrical stimulation of the HGN 12. Based on the signals output by the inertial sensor, the clinician programmer 56 can compute a score of the therapy provided by the current set up of the system 50, and in particular, the currently selected set of electrode contacts and corresponding stimulation parameters. That is, the motion activity sensed by the inertial sensor in synchronization with the stimulation of the HGN 12 is indicative of movement of the tongue[0151]. The IPG 52 comprises an outer case 66 for housing the electronic and other components (described in further detail below)[0089]. Referring now to FIG. 3, the components and circuitry housed in the outer case 66 comprise stimulation circuitry 68, control circuitry 70, communication circuitry 72, memory 74, sensing circuitry 76, a rechargeable power source 77, and power circuitry 79, which all may be conveniently mounted on a printed circuit board (PCB) (not shown)[0090]”. Suri teaches an accelerometer as sensing circuitry location in the housing of the implantable device where the accelerometer measures the movement of the patients tongue. Suri can be combined with Bourget and Ref B to teach all the claimed material. Therefore the 103 rejections for all claims stand.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The system and method for management of brain and body functions and sensory perception of Tyler(US 10589087 B2).
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 MARIA CATHERINE ANTHONY whose telephone number is (703)756-4514. The examiner can normally be reached 7:30 am - 4:30 pm, EST, M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CARL LAYNO can be reached at (571) 272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796