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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 18/871,340, filed on 12/03/2024.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 21, 25, 27, 33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weerakoon (US 20200305744 A1).
Regarding claim 21, Weerakoon teaches a neural stimulation system comprising: an implantable neuromodulation device ([0040] Also shown in FIG. 4 is circuitry for an IPG 100) for controllably delivering neural stimuli ([0040] Also shown in FIG. 4 is circuitry for an IPG 100 (or an ETS) that is capable of providing stimulation and sensing a resulting ECAP or other neural response or signal), an electrode assembly electrically coupled to the implantable neuromodulation device (Fig 4-5; [0058] electrode array 17), the electrode assembly including a set of electrodes proximal to a distal end of the electrode assembly (Fig 5; electrodes 16), the implantable neuromodulation device comprising: stimulation circuitry for applying the neural stimuli to at least one target nerve ([0041] The IPG 100 also includes stimulation circuitry 28 to produce stimulation at the electrodes 16, which may comprise the stimulation circuitry 28 shown earlier (FIG. 3)), wherein the neural stimuli elicit a neural potential from a target nerve ([0039] One such neural response is an Evoked Compound Action Potential (ECAP). An ECAP comprises a cumulative response provided by neural fibers that are recruited by the stimulation, and essentially comprises the sum of the action potentials of recruited fibers when they “fire.” An ECAP is shown in FIG. 4, and comprises a number of peaks that are conventionally labeled with P for positive peaks and N for negative peaks, with P1 comprising a first positive peak, N1 a first negative peak, P2 a second positive peak and so on); measurement circuitry ([0042] IPG 100 also includes sensing circuitry 115) configured to process signals sensed subsequent to respective neural stimuli at a pair of sensing electrodes of the set of electrodes ([0042] IPG 100 also includes sensing circuitry 115, and one or more of the electrodes 16 can be used to sense neural responses such as the ECAPs described earlier); and a control unit configured to control the stimulation circuitry to apply the neural stimuli ([0041] A bus 118 provides digital control signals from the control circuitry 102 (and possibly from an ECAP algorithm 124, described below) to one or more PDACs 40.sub.i or NDACs 42.sub.i to produce currents or voltages of prescribed amplitudes (I) for the stimulation pulses, and with the correct timing (PW, f)); and a processor ([0069] Processing circuitry 147 may be considered part of the control circuitry 102) configured to: configure a plurality of electrodes of the set of electrodes in at least one of a simulation mode ([0041] The IPG 100 also includes stimulation circuitry 28 to produce stimulation at the electrodes 16, which may comprise the stimulation circuitry 28 shown earlier (FIG. 3)) ([0057] FIGS. 5A and 5B show a percutaneous lead 15, and show the stimulation program example of FIG. 2A in which electrodes E4 and E5 are used to produce pulses in a bipolar mode of stimulation, with (during the first phase 30a) E4 comprising an anode and E5 a cathode, although other electrode arrangements (e.g., tripoles, etc.) could be used as well) and a sensing mode ([0042] IPG 100 also includes sensing circuitry 115, and one or more of the electrodes 16 can be used to sense neural responses such as the ECAPs described earlier. In this regard, each electrode node 39 is further coupleable to a sense amp circuit 110. Under control by bus 114, a multiplexer 108 can select one or more electrodes to operate as sensing electrodes by coupling the electrode(s) to the sense amps circuit 110 at a given time) ([0058] In FIG. 5B, two lead-based electrodes are used for sensing, with such electrodes either being adjacent or at least relatively close to one another. Specifically, in this example, electrode E8 is again used for sensing (S+), with adjacent electrode E9 providing the reference (S−). This could also be flipped, with E8 providing the reference (S−) for sensing at electrode E9 (S+)), wherein the electrodes configured in the stimulation mode are connected to the stimulation circuitry (Fig 5; [0057]) and the electrodes configured in the sensing mode are connected to the measurement circuitry (Fig 5; [0058]), wherein the plurality of electrodes configured in the sensing mode comprise a reference electrode ([0058] FIG. 5A, a single electrode E8 on the lead 15 is used for sensing (S+), with another signal being used as a reference (S−). Electrode E9 providing the reference (S−)); and select an electrode from the set of electrodes as the reference electrode ([0058] the sensing reference S− comprises a more distant electrode in the electrode array 17 or (as shown) the case electrode Ec) ([0060] The relatively large-signal background stimulation artifact 134 can make resolution and sensing of the small-signal ECAP difficult at the sense amp circuit 110. To ameliorate this concern, it can be beneficial to use a sensing electrode S+ that is far away from the stimulating electrodes) such that the reference electrode senses an insubstantial amount of the elicited neural potential ([0060] This can be beneficial because the stimulation artifact 134 would be smaller at a distant sensing electrode, and because the ECAP would pass a distant sensing electrode at a later time when the stimulation artifact 134 might have dissipated (e.g., ECAP2 in FIG. 5C)).
Regarding claim 25, Weerakoon teaches the neural stimulation system of any of claim 21, further comprising a remote device in communication with the implantable neuromodulation device ([0006] IPG 10 can include an antenna 27a allowing it to communicate bi-directionally with a number of external devices used to program or monitor the IPG, such as a hand-held patient controller or a clinician's programmer).
Regarding claim 27, Weerakoon teaches the neural stimulation system of any one of claim 21, wherein the processor forms part of the implantable neuromodulation device ([0040] The IPG 100 includes control circuitry 102, which may comprise a microcontroller) ([0040] Other types of controller circuitry may be used in lieu of a microcontroller as well, such as microprocessors, FPGAs, DSPs, or combinations of these, etc) ([0069] Processing circuitry 147 may be considered part of the control circuitry 102).
Regarding claim 33, Weerakoon teaches a method of selecting a reference electrode ([0060] The relatively large-signal background stimulation artifact 134 can make resolution and sensing of the small-signal ECAP difficult at the sense amp circuit 110. To ameliorate this concern, it can be beneficial to use a sensing electrode S+ that is far away from the stimulating electrodes), the method comprising: providing stimulation circuitry ([0041] The IPG 100 also includes stimulation circuitry 28 to produce stimulation at the electrodes 16, which may comprise the stimulation circuitry 28 shown earlier (FIG. 3)) and measurement circuitry ([0042] IPG 100 also includes sensing circuitry 115); providing a processing unit configured to control the stimulation circuitry and the measurement circuitry ([0069] Processing circuitry 147 may be considered part of the control circuitry 102); providing for a lead body having a proximal end and a distal end (Fig 5; electrodes 16), the lead body having a set of electrodes proximal to the distal end (Fig 5; electrodes 16); wherein the set of electrodes are configurable in at least one of a stimulation mode ([0041] The IPG 100 also includes stimulation circuitry 28 to produce stimulation at the electrodes 16, which may comprise the stimulation circuitry 28 shown earlier (FIG. 3)) ([0057] FIGS. 5A and 5B show a percutaneous lead 15, and show the stimulation program example of FIG. 2A in which electrodes E4 and E5 are used to produce pulses in a bipolar mode of stimulation, with (during the first phase 30a) E4 comprising an anode and E5 a cathode, although other electrode arrangements (e.g., tripoles, etc.) could be used as well) and a sensing mode ([0042] IPG 100 also includes sensing circuitry 115, and one or more of the electrodes 16 can be used to sense neural responses such as the ECAPs described earlier. In this regard, each electrode node 39 is further coupleable to a sense amp circuit 110. Under control by bus 114, a multiplexer 108 can select one or more electrodes to operate as sensing electrodes by coupling the electrode(s) to the sense amps circuit 110 at a given time) ([0058] In FIG. 5B, two lead-based electrodes are used for sensing, with such electrodes either being adjacent or at least relatively close to one another. Specifically, in this example, electrode E8 is again used for sensing (S+), with adjacent electrode E9 providing the reference (S−). This could also be flipped, with E8 providing the reference (S−) for sensing at electrode E9 (S+)); wherein the electrodes configured in the stimulation mode are connected to the stimulation circuitry (Fig 5; [0057]), wherein the electrodes configured in the stimulation mode apply an electrical stimulus to a target nerve, wherein the electrical stimulus elicits a neural potential (Fig 5; [0057]); and wherein the electrodes configured in the sensing mode are connected to the measurement circuitry configured to measure the elicited neural potential (Fig 5; [0058]), wherein the electrodes configured in the sensing mode include at least one reference electrode ([0058] FIG. 5A, a single electrode E8 on the lead 15 is used for sensing (S+), with another signal being used as a reference (S−). Electrode E9 providing the reference (S−)); and selecting an electrode from the set of electrodes as the reference electrode ([0058] the sensing reference S− comprises a more distant electrode in the electrode array 17 or (as shown) the case electrode Ec) ([0060] The relatively large-signal background stimulation artifact 134 can make resolution and sensing of the small-signal ECAP difficult at the sense amp circuit 110. To ameliorate this concern, it can be beneficial to use a sensing electrode S+ that is far away from the stimulating electrodes) such that the reference electrode senses an insubstantial amount of the elicited neural potential ([0060] This can be beneficial because the stimulation artifact 134 would be smaller at a distant sensing electrode, and because the ECAP would pass a distant sensing electrode at a later time when the stimulation artifact 134 might have dissipated (e.g., ECAP2 in FIG. 5C)).
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.
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) 22, 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weerakoon (US 20200305744 A1) in view of Eder (US 20140249646 A1) and Giftakis (US 20060229686 A1).
Regarding claim 22, Weerakoon teaches the neural stimulation system of claim 21, but fails to teach wherein the plurality of electrodes configured in the sensing mode comprise a recording electrode, and wherein the reference electrode senses an insubstantial amount of the elicited neural potential if the reference electrode senses less than 5% of the magnitude of the elicited neural potential sensed at the recording electrode.
However, Eder teaches wherein the plurality of electrodes configured in the sensing mode comprise a recording electrode ([0005] FIG. 2, shows the setup for a monopolar recording with a single electrode placed around the nerve. The reference electrode is arranged far away from the recording electrode) ([0006] The monopolar configuration has the disadvantage that other biological interference--as for instance caused by adjacent muscle activity--will be indistinguishably picked up between recording and reference electrode…inter-electrode distance cannot be made arbitrary small, because the wavelength of the action potentials increases with the nerve conduction velocity, and thus requires a larger inter-electrode distance for proper spatial sampling especially for fast conducting nerve fibers). It would have been obvious to one of ordinary skill in the art before ethe effective filling date to have modified the invention of Weerakoon to include wherein the plurality of electrodes configured in the sensing mode comprise a recording electrode. Doing so allows the electrodes to switch modes depending on the desired operation.
Further, Giftakis teaches wherein the reference electrode senses an insubstantial amount of the elicited neural potential if the reference electrode senses less than 5% of the magnitude of the elicited neural potential sensed at the recording electrode ([0005] The second electrode, referred to as the reference, is typically placed outside of the cranium away from the desired source of electrical activity. For example, the reference electrode may be attached to the ear or mastoid, or at the back of the head. Such locations are considered "inactive" since sensing from these areas produces a potential that is close to zero) ([0006] The reference electrode is carefully positioned such that ECG and movement artifacts are not present in the measured signals) ([0006] it is desirable to have a single electrode positioned away from the active electrodes, which can function as a reference for EEG sensing and/or function as an indifferent electrode for monopolar stimulation). It would have been obvious to one of ordinary skill in the art before ethe effective filling date to have modified the invention of Weerakoon to include wherein the reference electrode senses an insubstantial amount of the elicited neural potential if the reference electrode senses less than 5% of the magnitude of the elicited neural potential sensed at the recording electrode. Doing so allows for the reference electrode to be at a distance to not interfere with the sensing.
Regarding claim 34, Weerakoon teaches the method of claim 33, but fails to teach wherein the electrodes configured in the sensing mode comprise a recording electrode, and wherein the reference electrode senses an insubstantial amount of the elicited neural potential if the reference electrode senses less than 5% of the magnitude of the elicited neural potential sensed at the recording electrode.
However, Eder teaches wherein the electrodes configured in the sensing mode comprise a recording electrode ([0005] FIG. 2, shows the setup for a monopolar recording with a single electrode placed around the nerve. The reference electrode is arranged far away from the recording electrode) ([0006] The monopolar configuration has the disadvantage that other biological interference--as for instance caused by adjacent muscle activity--will be indistinguishably picked up between recording and reference electrode…inter-electrode distance cannot be made arbitrary small, because the wavelength of the action potentials increases with the nerve conduction velocity, and thus requires a larger inter-electrode distance for proper spatial sampling especially for fast conducting nerve fibers). It would have been obvious to one of ordinary skill in the art before ethe effective filling date to have modified the invention of Weerakoon to include wherein the electrodes configured in the sensing mode comprise a recording electrode. Doing so allows the electrodes to switch modes depending on the desired operation.
Further, Giftakis teaches wherein the reference electrode senses an insubstantial amount of the elicited neural potential if the reference electrode senses less than 5% of the magnitude of the elicited neural potential sensed at the recording electrode ([0005] The second electrode, referred to as the reference, is typically placed outside of the cranium away from the desired source of electrical activity. For example, the reference electrode may be attached to the ear or mastoid, or at the back of the head. Such locations are considered "inactive" since sensing from these areas produces a potential that is close to zero) ([0006] The reference electrode is carefully positioned such that ECG and movement artifacts are not present in the measured signals) ([0006] it is desirable to have a single electrode positioned away from the active electrodes, which can function as a reference for EEG sensing and/or function as an indifferent electrode for monopolar stimulation). It would have been obvious to one of ordinary skill in the art before ethe effective filling date to have modified the invention of Weerakoon to include wherein the reference electrode senses an insubstantial amount of the elicited neural potential if the reference electrode senses less than 5% of the magnitude of the elicited neural potential sensed at the recording electrode. Doing so allows for the reference electrode to be at a distance to not interfere with the sensing.
Claim(s) 23, 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weerakoon (US 20200305744 A1) in view of Laird-Wah (US 20190168000 A1).
Regarding claim 23, Weerakoon teaches the neural stimulation system of any of claim 21, but fails to teach wherein the plurality of electrodes configured in the stimulation mode comprise a return electrode, and wherein the processor is further configured to select the return electrode based on a desired level of a field at the target nerve.
However, Laird-Wah teaches wherein the plurality of electrodes configured in the stimulation mode comprise a return electrode ([0061] return electrode 4 of the array 150), and wherein the processor is further configured to select the return electrode based on a desired level of a field at the target nerve ([0061] 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). It would have been obvious to one of ordinary skill in the art before ethe effective filling date to have modified the invention of Weerakoon to include wherein the plurality of electrodes configured in the stimulation mode comprise a return electrode, and wherein the processor is further configured to select the return electrode based on a desired level of a field at the target nerve. Doing so allows for a return electrode paired with the stimulation electrodes for effective treatment.
Regarding claim 35, Weerakoon teaches the method of any of claim 33, but fails to teach wherein the electrodes configured in the stimulation mode include a return electrode, further comprising selecting the return electrode based on a desired level of a field at the target nerve.
However, Laird-Wah teaches method of any of claim 33, wherein the electrodes configured in the stimulation mode include a return electrode ([0061] return electrode 4 of the array 150), further comprising selecting the return electrode based on a desired level of a field at the target nerve ([0061] 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). It would have been obvious to one of ordinary skill in the art before ethe effective filling date to have modified the invention of Weerakoon to include wherein the plurality of electrodes configured in the stimulation mode comprise a return electrode, and wherein the processor is further configured to select the return electrode based on a desired level of a field at the target nerve. Doing so allows for a return electrode paired with the stimulation electrodes for effective treatment.
Claim(s) 24, 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weerakoon (US 20200305744 A1) in view of Laird-Wah (US 20190168000 A1), further in view of Linden (US 20200306528 A1).
Regarding claim 24, Weerakoon teaches the neural stimulation system of any of claim 21, but fails to teach wherein the target nerve includes nerve fibers such as sacral nerve, vagus nerve, and nerve fibers in a dorsal column.
However, Linden teaches wherein the target nerve includes nerve fibers such as sacral nerve ([0295] stimulation element 260 comprises one or more elements positioned proximate and/or within one or more tissue types and/or locations selected from the group consisting of: one or more nerves; one or more locations along, in and/or proximate to the spinal cord…the sacral and/or pudendal nerve), vagus nerve ([0295] the vagus nerve). It would have been obvious to one of ordinary skill in the art before ethe effective filling date to have modified the invention of Weerakoon to include wherein the target nerve includes nerve fibers such as sacral nerve, vagus nerve. Doing so allows for effective treatment of the sacral and vagus nerve.
Further, Laird-Wah teaches nerve fibers in a dorsal column ([0061] FIG. 3 is a schematic illustrating interaction of the implanted stimulator 100 with a nerve 180, in this case the spinal cord however alternative embodiments may be positioned adjacent any desired neural tissue including a peripheral nerve, visceral nerve, parasympathetic nerve or a brain structure) [0003] When used to relieve neuropathic pain originating in the trunk and limbs, the electrical pulse is applied to the dorsal column (DC) of the spinal cord). It would have been obvious to one of ordinary skill in the art before ethe effective filling date to have modified the invention of Weerakoon to include wherein target nerve fibers include nerve fibers in a dorsal column. Doing so allows for effective treatment in the dorsal column.
Regarding claim 36, Weerakoon teaches the teaches the neural stimulation system of any of claim 33, but fails to teach wherein the target nerve includes nerve fibers such as sacral nerve, vagus nerve, and nerve fibers in a dorsal column.
However, Linden teaches wherein the target nerve includes nerve fibers such as sacral nerve ([0295] stimulation element 260 comprises one or more elements positioned proximate and/or within one or more tissue types and/or locations selected from the group consisting of: one or more nerves; one or more locations along, in and/or proximate to the spinal cord…the sacral and/or pudendal nerve), vagus nerve ([0295] the vagus nerve). It would have been obvious to one of ordinary skill in the art before ethe effective filling date to have modified the invention of Weerakoon to include wherein the target nerve includes nerve fibers such as sacral nerve, vagus nerve. Doing so allows for effective treatment of the sacral and vagus nerve.
Further, Laird-Wah teaches nerve fibers in a dorsal column ([0061] FIG. 3 is a schematic illustrating interaction of the implanted stimulator 100 with a nerve 180, in this case the spinal cord however alternative embodiments may be positioned adjacent any desired neural tissue including a peripheral nerve, visceral nerve, parasympathetic nerve or a brain structure) [0003] When used to relieve neuropathic pain originating in the trunk and limbs, the electrical pulse is applied to the dorsal column (DC) of the spinal cord). It would have been obvious to one of ordinary skill in the art before ethe effective filling date to have modified the invention of Weerakoon to include wherein target nerve fibers include nerve fibers in a dorsal column. Doing so allows for effective treatment in the dorsal column.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weerakoon (US 20200305744 A1) in view of Molnar (US 20180110991 A1).
Regarding claim 26, Weerakoon teaches the neural stimulation system of claim 25, but fails to teach wherein the processor is part of the remote device.
However, Molnar teaches wherein the processor is part of the remote device ([0039] A controller 22, which can be accessed using, e.g., a remote control via transceiver 20, includes a processor and memory for storing instructions (to be executed by the processor) for processing data (such as sensed brain activity), initiating stimulation, etc). It would have been obvious to one of ordinary skill in the art before ethe effective filling date to have modified the invention of Weerakoon to include wherein the processor is part of the remote device. Doing so allows for processing to be remote to the device for effective monitoring of signals.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weerakoon (US 20200305744 A1) in view of Molnar (US 20180110991 A1) and Chow (US 20140200638 A1).
Regarding claim 28, Weerakoon teaches a remote device in communication with an implantable neuromodulation device ([0006] IPG 10 can include an antenna 27a allowing it to communicate bi-directionally with a number of external devices used to program or monitor the IPG, such as a hand-held patient controller or a clinician's programmer), wherein the electrodes configured in the sensing mode comprise a reference electrode ([0058] FIG. 5A, a single electrode E8 on the lead 15 is used for sensing (S+), with another signal being used as a reference (S−). Electrode E9 providing the reference (S−)); and select an electrode from the set of electrodes as the reference electrode to sense an insubstantial amount of the elicited neural potential ([0058] the sensing reference S− comprises a more distant electrode in the electrode array 17 or (as shown) the case electrode Ec) ([0060] The relatively large-signal background stimulation artifact 134 can make resolution and sensing of the small-signal ECAP difficult at the sense amp circuit 110. To ameliorate this concern, it can be beneficial to use a sensing electrode S+ that is far away from the stimulating electrodes) ([0060] This can be beneficial because the stimulation artifact 134 would be smaller at a distant sensing electrode, and because the ECAP would pass a distant sensing electrode at a later time when the stimulation artifact 134 might have dissipated (e.g., ECAP2 in FIG. 5C)).
Weerakoon fails to teach the remote device comprising: a processing unit configured to receive instructions from a user; a communication unit configured to send and receive instructions to and from the implantable neuromodulation device, the processing unit configured to send instructions to the implantable neuromodulation device to: configure a plurality of electrodes of a set of electrodes in at least one of a stimulation mode and a sensing mode.
However, Molnar teaches the remote device comprising :a processing unit configured to receive instructions from a user ([0041] The IPG is preferably able to receive user input (such as instructions on when or how to initiate stimulation) wirelessly using its transceiver); a communication unit configured to send and receive instructions to and from the implantable neuromodulation device ([0039] A controller 22, which can be accessed using, e.g., a remote control via transceiver 20, includes a processor and memory for storing instructions (to be executed by the processor) for processing data (such as sensed brain activity), initiating stimulation, etc). It would have been obvious to one of ordinary skill in the art before ethe effective filling date to have modified the invention of Weerakoon to include the remote device comprising: a processing unit configured to receive instructions from a user; a communication unit configured to send and receive instructions to and from the implantable neuromodulation device. Doing so allows for processing to be remote to the device for effective monitoring of signals and remote input from the user to configure the device when implanted.
Further, Chow teaches the processing unit configured to send instructions to the implantable neuromodulation device to: configure a plurality of electrodes of a set of electrodes in at least one of a stimulation mode and a sensing mode ([0046] When the signal indicates an operational mode, the implantable medical device may enter an operational mode. For example, the implantable medical device may select a particular operational mode (e.g., a stimulation mode or a sensing mode), at 808) ([0046] When the selected operational mode is a first operational mode, at 810, such as a sensing mode, the implantable medical device may close at least one switch between the housing of the implantable medical device and one or more circuit elements, at 812. Additionally or alternatively, the implantable medical device may open at least one second switch, such as one or more switches between a stimulation circuit and one or more electrodes, at 814). It would have been obvious to one of ordinary skill in the art before ethe effective filling date to have modified the invention of Weerakoon to include the processing unit configured to send instructions to the implantable neuromodulation device to: configure a plurality of electrodes of a set of electrodes in at least one of a stimulation mode and a sensing mode. Doing so allows for remote input from the user to configure the device when implanted depending on the desired treatment.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weerakoon (US 20200305744 A1) in view of Molnar (US 20180110991 A1) and Chow (US 20140200638 A1), further in view of Eder (US 20140249646 A1) and Giftakis (US 20060229686 A1).
Regarding claim 29, Weerakoon teaches the remote device of claim 28, butf ails to teach wherein the plurality of electrodes configured in the sensing mode comprise a recording electrode, and wherein the reference electrode senses an insubstantial amount of the elicited neural potential if the reference electrode senses less than 5% of the magnitude of the elicited neural potential sensed at the recording electrode.
However, Eder teaches wherein the plurality of electrodes configured in the sensing mode comprise a recording electrode ([0005] FIG. 2, shows the setup for a monopolar recording with a single electrode placed around the nerve. The reference electrode is arranged far away from the recording electrode) ([0006] The monopolar configuration has the disadvantage that other biological interference--as for instance caused by adjacent muscle activity--will be indistinguishably picked up between recording and reference electrode…inter-electrode distance cannot be made arbitrary small, because the wavelength of the action potentials increases with the nerve conduction velocity, and thus requires a larger inter-electrode distance for proper spatial sampling especially for fast conducting nerve fibers). It would have been obvious to one of ordinary skill in the art before ethe effective filling date to have modified the invention of Weerakoon to include wherein the plurality of electrodes configured in the sensing mode comprise a recording electrode. Doing so allows the electrodes to switch modes depending on the desired operation.
Further, Giftakis teaches wherein the reference electrode senses an insubstantial amount of the elicited neural potential if the reference electrode senses less than 5% of the magnitude of the elicited neural potential sensed at the recording electrode ([0005] The second electrode, referred to as the reference, is typically placed outside of the cranium away from the desired source of electrical activity. For example, the reference electrode may be attached to the ear or mastoid, or at the back of the head. Such locations are considered "inactive" since sensing from these areas produces a potential that is close to zero) ([0006] The reference electrode is carefully positioned such that ECG and movement artifacts are not present in the measured signals) ([0006] it is desirable to have a single electrode positioned away from the active electrodes, which can function as a reference for EEG sensing and/or function as an indifferent electrode for monopolar stimulation). It would have been obvious to one of ordinary skill in the art before ethe effective filling date to have modified the invention of Weerakoon to include wherein the reference electrode senses an insubstantial amount of the elicited neural potential if the reference electrode senses less than 5% of the magnitude of the elicited neural potential sensed at the recording electrode. Doing so allows for the reference electrode to be at a distance to not interfere with the sensing.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weerakoon (US 20200305744 A1) in view of Molnar (US 20180110991 A1) and Chow (US 20140200638 A1), further in view of Laird-Wah (US 20190168000 A1).
Regarding claim 30, Weerakoon teaches the remote device of any of claim 28, but fails to teach wherein the electrodes configured in the stimulation mode comprise a return electrode, and wherein the processing unit is further configured to select the return electrode based on a desired level of a field at a target nerve.
However, Laird-Wah teaches wherein the electrodes configured in the stimulation mode comprise a return electrode ([0061] return electrode 4 of the array 150), and wherein the processing unit is further configured to select the return electrode based on a desired level of a field at a target nerve ([0061] 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). It would have been obvious to one of ordinary skill in the art before ethe effective filling date to have modified the invention of Weerakoon to include wherein the plurality of electrodes configured in the stimulation mode comprise a return electrode, and wherein the processor is further configured to select the return electrode based on a desired level of a field at the target nerve. Doing so allows for a return electrode paired with the stimulation electrodes for effective treatment.
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weerakoon (US 20200305744 A1) in view of Molnar (US 20180110991 A1) and Chow (US 20140200638 A1), further in view of Laird-Wah (US 20190168000 A1), further in view of Linden (US 20200306528 A1).
Regarding claim 31, Weerakoon teaches the teaches the neural stimulation system of any of claim 30, but fails to teach wherein the target nerve includes nerve fibers such as sacral nerve, vagus nerve, and nerve fibers in a dorsal column.
However, Linden teaches wherein the target nerve includes nerve fibers such as sacral nerve ([0295] stimulation element 260 comprises one or more elements positioned proximate and/or within one or more tissue types and/or locations selected from the group consisting of: one or more nerves; one or more locations along, in and/or proximate to the spinal cord…the sacral and/or pudendal nerve), vagus nerve ([0295] the vagus nerve). It would have been obvious to one of ordinary skill in the art before ethe effective filling date to have modified the invention of Weerakoon to include wherein the target nerve includes nerve fibers such as sacral nerve, vagus nerve. Doing so allows for effective treatment of the sacral and vagus nerve.
Further, Laird-Wah teaches nerve fibers in a dorsal column ([0061] FIG. 3 is a schematic illustrating interaction of the implanted stimulator 100 with a nerve 180, in this case the spinal cord however alternative embodiments may be positioned adjacent any desired neural tissue including a peripheral nerve, visceral nerve, parasympathetic nerve or a brain structure) [0003] When used to relieve neuropathic pain originating in the trunk and limbs, the electrical pulse is applied to the dorsal column (DC) of the spinal cord). It would have been obvious to one of ordinary skill in the art before ethe effective filling date to have modified the invention of Weerakoon to include wherein target nerve fibers include nerve fibers in a dorsal column. Doing so allows for effective treatment in the dorsal column.
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weerakoon (US 20200305744 A1) in view of Molnar (US 20180110991 A1) and Chow (US 20140200638 A1).
Regarding claim 32, Weerakoon teaches the remote device of any of claim 28, wherein the remote device is one of a remote control, a portable computing device, and an external device ([0006] IPG 10 can include an antenna 27a allowing it to communicate bi-directionally with a number of external devices used to program or monitor the IPG, such as a hand-held patient controller or a clinician's programmer).
Claim(s) 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weerakoon (US 20200305744 A1) in view of Prutchi (US 6152882 A).
Regarding claim 41, Weerakoon teaches a neural stimulation lead for applying stimulation to a tissue, the neural stimulation lead comprising: a lead body having a proximal end and a distal end (Fig 5; electrodes 16); the lead body having a first set of electrodes at the distal end (Fig 5; electrodes 16), wherein the first set of electrodes and the second set of electrodes are configurable in at least one of a stimulation mode ([0041] The IPG 100 also includes stimulation circuitry 28 to produce stimulation at the electrodes 16, which may comprise the stimulation circuitry 28 shown earlier (FIG. 3)) ([0057] FIGS. 5A and 5B show a percutaneous lead 15, and show the stimulation program example of FIG. 2A in which electrodes E4 and E5 are used to produce pulses in a bipolar mode of stimulation, with (during the first phase 30a) E4 comprising an anode and E5 a cathode, although other electrode arrangements (e.g., tripoles, etc.) could be used as well) and a sensing mode ([0042] IPG 100 also includes sensing circuitry 115, and one or more of the electrodes 16 can be used to sense neural responses such as the ECAPs described earlier. In this regard, each electrode node 39 is further coupleable to a sense amp circuit 110. Under control by bus 114, a multiplexer 108 can select one or more electrodes to operate as sensing electrodes by coupling the electrode(s) to the sense amps circuit 110 at a given time) ([0058] In FIG. 5B, two lead-based electrodes are used for sensing, with such electrodes either being adjacent or at least relatively close to one another. Specifically, in this example, electrode E8 is again used for sensing (S+), with adjacent electrode E9 providing the reference (S−). This could also be flipped, with E8 providing the reference (S−) for sensing at electrode E9 (S+)); wherein the electrodes configured in the stimulation mode are connected to stimulation circuitry (Fig 5; [0057]), wherein the electrodes configured in the stimulation mode apply an electrical stimulus to a target nerve, wherein the electrical stimulus elicits a neural potential (Fig 5; [0057]); wherein the electrodes configured in the sensing mode are connected to measurement circuitry (Fig 5; [0058]) configured to measure the elicited neural potential (Fig 5; [0058]), wherein the electrodes configured in the sensing mode include at least one reference electrode ([0058] FIG. 5A, a single electrode E8 on the lead 15 is used for sensing (S+), with another signal being used as a reference (S−). Electrode E9 providing the reference (S−)), wherein an electrode from the second set of electrodes is configured as the reference electrode ([0058] FIG. 5A, a single electrode E8 on the lead 15 is used for sensing (S+), with another signal being used as a reference (S−). Electrode E9 providing the reference (S−)).
Weerakoon fails to fully teach a plurality of anchoring elements proximal to first set of electrodes and a second set of electrodes proximal to the anchoring elements.
However, Prutchi teaches a plurality of anchoring elements proximal to first set of electrodes ([28] The catheter 50 also includes a fixation mechanism including a plurality of tines 56 for anchoring the end of the catheter to cardiac tissue. The tines 56 are preferable to "active fixation" screws, since they cause most of the tissue reaction at a certain distance from the probe electrode 52) and a second set of electrodes proximal to the anchoring elements (Fig 5; reference electrode 54) ([28] The catheter 50 also includes contact guards 58 for preventing the reference electrode 54 from closely approaching or contacting the cardiac tissue. The grommet-like contact guards 58 ensure that the reference electrode 54 is in contact with blood and inactive tissue (e.g. connective tissue) rather than with electrically-active myocardium so as not to contaminate the MAP signal. This prevents pick-up of unwanted signals from tissue regions other than the tissue subjacent the probe electrode 52). It would have been obvious to one of ordinary skill in the art before ethe effective filling date to have modified the invention of Weerakoon to include a plurality of anchoring elements proximal to first set of electrodes and a second set of electrodes proximal to the anchoring elements. Doing so allows for the device to be set in place during treatment and to separate the different electrodes for effective operation.
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weerakoon (US 20200305744 A1) in view of Prutchi (US 6152882 A), further in view of Eder (US 20140249646 A1).
Regarding claim 42, Weerakoon teaches the neural stimulation lead of claim 41, wherein an electrode from the first set of electrodes is configured as the recording electrode ([0058] FIG. 5A, a single electrode E8 on the lead 15 is used for sensing (S+)).
Weerakoon fails to fully teach wherein the electrodes configured in the sensing mode comprise a recording electrode.
However, Eder teaches wherein the electrodes configured in the sensing mode comprise a recording electrode ([0005] FIG. 2, shows the setup for a monopolar recording with a single electrode placed around the nerve. The reference electrode is arranged far away from the recording electrode). It would have been obvious to one of ordinary skill in the art before ethe effective filling date to have modified the invention of Weerakoon to include wherein the electrodes configured in the sensing mode comprise a recording electrode. Doing so allows for signals to be recorded at the sensing site.
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weerakoon (US 20200305744 A1) in view of Prutchi (US 6152882 A), further in view of Laird-Wah (US 20190168000 A1).
Regarding claim 43, Weerakoon teaches the neural stimulation lead of any of claim 41, but fails to teach wherein the electrodes configured in the stimulation mode include a return electrode, and wherein an electrode from the second set of electrodes is configured as the return electrode.
However, Laird-Wah teaches wherein the electrodes configured in the stimulation mode include a return electrode ([0061] return electrode 4 of the array 150), and wherein an electrode from the second set of electrodes is configured as the return electrode ([0061] 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). It would have been obvious to one of ordinary skill in the art before ethe effective filling date to have modified the invention of Weerakoon to include wherein the electrodes configured in the stimulation mode include a return electrode, and wherein an electrode from the second set of electrodes is configured as the return electrode. Doing so allows for a return electrode to be paired with the stimulation electrodes and for the return electrode to be separated for effective stimulation.
Conclusion
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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