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 .
Information Disclosure Statement
The information disclosure statement(s) filed 01/03/2025 has/have been considered by the Examiner.
Claim Interpretation
According to MPEP 2112.02, a prior art device anticipates a claimed process if the device carries out the process during normal operation. Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). Furthermore, where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, that the reference does not describe the recited effect in haec verba is of no significance as the reference meets the claim under the doctrine of inherency. Ex parte Novitski, 26 USPQ2d 1389, 1390-91 (BdPatApp & Inter 1993). Furthermore, the employment of the claimed steps must inherently produce the same intended results else the claims are incomplete for failing to recite a critical aspect of the invention.
In accordance to MPEP 2111.04, such term(s) as “configured to” in the claim(s) do not limit claim scope to the particular function performed, and merely suggest optional functionality since the claim does not introduce any structure that positively recites and limits the features of the invention for exclusive use as intended. Absent limiting structural features, limitations following said clauses will be interpreted as recitations of intended use, wherein prior art will be evaluated based on its capability of performing and its suitability for the intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim, Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
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.
Claim(s) 1-2, 6-7, 9-10, 12, 16-18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feldman (US 20180140831 A1 – hereinafter Feldman) in view of Doan (US 20200147392 A1 – hereinafter Doan).
Re. claim 1, Feldman teaches a method, comprising:
delivering neurostimulation (paragraph 0003 – “Implantable stimulation devices are devices that generate and deliver electrical stimuli to body nerves and tissues for the therapy of various biological disorders…However, the present invention may find applicability in any implantable medical device system, including a Deep Brain Stimulation (DBS) system”) using a neurostimulator having a plurality of electrodes (paragraph 0004 – “The IPG 10 is coupled to electrodes 16 via one or more electrode leads 18, such that the electrodes 16 form an electrode array 20. The electrodes 16 are carried on a flexible body 22, which also houses the individual signal wires 24 coupled to each electrode”),
including delivering neurostimulation pulses of a first polarity to a neural target using at least one stimulation electrode from the plurality of electrodes (paragraph 0020 – “In the example waveform shown in FIG. 3A, the pulses provided at the electrodes are biphasic, meaning that each pulse comprises a first phase 94a of a first polarity, followed by a second phase 94b of an opposite polarity”),
and passively recovering charge using a first number of one or more passive electrodes from the plurality of electrodes (paragraph 0029 – “FIGS. 6A and 6B show improved passive charge recovery circuitry for the IPG, and passive recovery logic for closing passive recovery switches coupled to each of the electrode nodes”; paragraph 0021 – “Passive charge recovery is implemented within the stimulation circuitry block 170, and includes use of passive recovery switches (e.g., transistors) 96(x), each connected between one of the electrode nodes (Ex′ and Ec′) 61a and a common reference voltage, as shown in FIG. 3B”).
Feldman does not expressly teach receiving a user input at a user interface of a programmer for changing a number of passive electrodes used to passively recover charge from the first number to a second number; and controlling the neurostimulator, using the programmer, to passively recover charge using the second number of passive electrodes.
Doan teaches a similar neuromodulation system/method (paragraph 0043 – “FIG. 1 shows an Implantable Pulse Generator (IPG) useable for Spinal Cord Stimulation (SC S)…”), which includes a plurality of electrodes (paragraph 0010 – “In the illustrated IPG 10, there are thirty-two electrodes (E1-E32)...”), and a user interface (figure 6),
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Which receives a user input at a user interface of a programmer for changing a number of passive electrodes used to passively recover charge from the first number to a second number (paragraph 0030 – “A cursor 94 (or other selection means such as a mouse pointer) can be used to select a particular electrode in the leads interface 92. Buttons in the electrode parameter interface 86 allow the selected electrode (including the case electrode, Ec) to be designated as an anode, a cathode, or off”),
And allows controlling the neurostimulator, using the programmer, to passively recover charge using the second number of selected passive electrodes (paragraph 0030 – “For example, electrodes E3 and E4 can both be selected to act as anode electrodes, with E3 receiving 30% of +A, and E4 receiving 70% of +A. GUI 64 can include other advanced options not shown as well, which for example allow for setting of a duty cycle (on/off time) for the stimulation pulses, setting a ramp-up time over which stimulation pulses will reach its programmed amplitude (A), options to specify the use of biphasic waveforms and/or passive charge recovery, etc.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the passive charge recovery system/method of Feldman, to incorporate the electrode selection as taught by Doan as stated above, since such modification would predictably result in more efficient charge recovery and increased energy efficiency.
Re. claim 2, Feldman of the combined invention further teaches wherein the plurality of electrodes includes segmented electrodes (Feldman figure 1 shows segmented electrodes 20 on two leads) on a deep brain stimulation (DBS) lead (Feldman paragraph 0003 – “However, the present invention may find applicability in any implantable medical device system, including a Deep Brain Stimulation (DBS) system”).
Re. claim 6, Doan of the combined invention further teaches wherein the programmer automatically controls the neurostimulator to passively recover charge using the second number based on the received user input (Doan paragraph 0030 – “For example, electrodes E3 and E4 can both be selected to act as anode electrodes, with E3 receiving 30% of +A, and E4 receiving 70% of +A. GUI 64 can include other advanced options not shown as well, which for example allow for setting of a duty cycle (on/off time) for the stimulation pulses, setting a ramp-up time over which stimulation pulses will reach its programmed amplitude (A), options to specify the use of biphasic waveforms and/or passive charge recovery, etc.”; paragraph 0083 – “If as most relevant here option 152 is chosen, the software 66 will take those same parameters and automatically derive a waveform with first and second pulses 130 and 140 of opposite polarities, with each of the pulses 130 and 140 having actively-driven monophasic pulses 132 and 142 followed by passive charge recovery pulses 134 and 144 as previously explained”).
Re. claim 7, Feldman of the combined invention further teaches wherein each of the one or more passive electrodes used to passively recover charge is also one of the at least one stimulation electrode used to deliver neurostimulation (Feldman paragraph 0034 – “As noted earlier, an IPG 10 may include circuitry and techniques designed to remove the charge from DC-blocking capacitors 55 in the electrode output paths that provide stimulation to a patient's tissue, Rt. An IPG 10 may issue biphasic pulses, with the second pulse phase 94b (FIG. 3A) designed to actively recover charge stored on the DC-blocking capacitors 55. Beyond this, a passive charge recovery phase 98 may be implemented to recover any remaining charge that was not recovered during active charge recovery (at the end of second pulse phase 94b)”; figure 4A also shows electrodes E1-E2 which delivers pulses 94a-94b, which also provide a passive charge recovery phase 98).
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Re. claim 9, Doan of the combined invention further teaches further comprising receiving a user selection of which of the plurality of electrodes are used to passively recover charge (Doan paragraph 0030 – “For example, electrodes E3 and E4 can both be selected to act as anode electrodes, with E3 receiving 30% of +A, and E4 receiving 70% of +A. GUI 64 can include other advanced options not shown as well, which for example allow for setting of a duty cycle (on/off time) for the stimulation pulses, setting a ramp-up time over which stimulation pulses will reach its programmed amplitude (A), options to specify the use of biphasic waveforms and/or passive charge recovery, etc.”).
Re. claim 10, Doan of the combined invention further teaches using an algorithm to determine which of the plurality of electrodes are used to passively recover charge (Doan paragraph 0065 – “As explained in the '569 Publication, an electrode configuration algorithm 120 programmed into control circuitry 70 of the clinician programmer 50 (FIG. 5) can compute from these positions and from other tissue modeling information which physical electrodes 16 will need to be selected and with what relative amplitudes to form the virtual anode and virtual cathode at the designated positions”).
Re. claim 12, Doan of the combined invention further teaches wherein the programmer is configured to automatically suggest the plurality of electrodes determined by the algorithm to be used to passively recover charge (Doan paragraph 0065 – “As explained in the '569 Publication, an electrode configuration algorithm 120 programmed into control circuitry 70 of the clinician programmer 50 (FIG. 5) can compute from these positions and from other tissue modeling information which physical electrodes 16 will need to be selected and with what relative amplitudes to form the virtual anode and virtual cathode at the designated positions”),
and enable a user to use the programmer to program the neurostimulator with the plurality of electrodes determined by the algorithm to be used to passively recover charge (Doan paragraph 0030 – “For example, electrodes E3 and E4 can both be selected to act as anode electrodes, with E3 receiving 30% of +A, and E4 receiving 70% of +A. GUI 64 can include other advanced options not shown as well, which for example allow for setting of a duty cycle (on/off time) for the stimulation pulses, setting a ramp-up time over which stimulation pulses will reach its programmed amplitude (A), options to specify the use of biphasic waveforms and/or passive charge recovery, etc.”).
Re. claim 16, Feldman teaches non-transitory machine-readable medium including instructions (memory, paragraphs 0007, 0009, 0015), which when executed by a machine, cause the machine to perform a method for controlling a neurostimulator having a plurality of electrodes (paragraph 0004 – “The IPG 10 is coupled to electrodes 16 via one or more electrode leads 18, such that the electrodes 16 form an electrode array 20. The electrodes 16 are carried on a flexible body 22, which also houses the individual signal wires 24 coupled to each electrode”),
to deliver neurostimulation (paragraph 0003 – “Implantable stimulation devices are devices that generate and deliver electrical stimuli to body nerves and tissues for the therapy of various biological disorders…However, the present invention may find applicability in any implantable medical device system, including a Deep Brain Stimulation (DBS) system”)
including deliver neurostimulation pulses of a first polarity to a neural target using at least one stimulation electrode from the plurality of electrodes (paragraph 0020 – “In the example waveform shown in FIG. 3A, the pulses provided at the electrodes are biphasic, meaning that each pulse comprises a first phase 94a of a first polarity, followed by a second phase 94b of an opposite polarity”),
and passively recover charge using a first number of one or more passive electrodes from the plurality of electrodes (paragraph 0029 – “FIGS. 6A and 6B show improved passive charge recovery circuitry for the IPG, and passive recovery logic for closing passive recovery switches coupled to each of the electrode nodes”; paragraph 0021 – “Passive charge recovery is implemented within the stimulation circuitry block 170, and includes use of passive recovery switches (e.g., transistors) 96(x), each connected between one of the electrode nodes (Ex′ and Ec′) 61a and a common reference voltage, as shown in FIG. 3B”).
Feldman does not expressly teach the method performed by the machine executing the instructions including: receiving a user input at a user interface of a programmer for changing a number of passive electrodes used to passively recover charge from the first number to a second number; and controlling the neurostimulator, using the programmer, to passively recover charge using the second number of passive electrodes.
Doan teaches a similar neuromodulation system/method (paragraph 0043 – “FIG. 1 shows an Implantable Pulse Generator (IPG) useable for Spinal Cord Stimulation (SC S)…”), which includes a plurality of electrodes (paragraph 0010 – “In the illustrated IPG 10, there are thirty-two electrodes (E1-E32)...”), and a user interface (figure 6),
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Which receives a user input at a user interface of a programmer for changing a number of passive electrodes used to passively recover charge from the first number to a second number (paragraph 0030 – “A cursor 94 (or other selection means such as a mouse pointer) can be used to select a particular electrode in the leads interface 92. Buttons in the electrode parameter interface 86 allow the selected electrode (including the case electrode, Ec) to be designated as an anode, a cathode, or off”),
And allows controlling the neurostimulator, using the programmer, to passively recover charge using the second number of passive electrodes (paragraph 0030 – “For example, electrodes E3 and E4 can both be selected to act as anode electrodes, with E3 receiving 30% of +A, and E4 receiving 70% of +A. GUI 64 can include other advanced options not shown as well, which for example allow for setting of a duty cycle (on/off time) for the stimulation pulses, setting a ramp-up time over which stimulation pulses will reach its programmed amplitude (A), options to specify the use of biphasic waveforms and/or passive charge recovery, etc.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the passive charge recovery system/method of Feldman, to incorporate the electrode selection as taught by Doan as stated above, since such modification would predictably result in more efficient charge recovery and increased energy efficiency.
Re. claim 17, Feldman teaches a system, comprising:
a neurostimulator having a plurality of electrodes (paragraph 0004 – “The IPG 10 is coupled to electrodes 16 via one or more electrode leads 18, such that the electrodes 16 form an electrode array 20. The electrodes 16 are carried on a flexible body 22, which also houses the individual signal wires 24 coupled to each electrode”),
wherein the neurostimulator is configured to deliver neurostimulation (paragraph 0003 – “Implantable stimulation devices are devices that generate and deliver electrical stimuli to body nerves and tissues for the therapy of various biological disorders…However, the present invention may find applicability in any implantable medical device system, including a Deep Brain Stimulation (DBS) system”) by delivering neurostimulation pulses of a first polarity to a neural target using at least one stimulation electrode from the plurality of electrodes (paragraph 0020 – “In the example waveform shown in FIG. 3A, the pulses provided at the electrodes are biphasic, meaning that each pulse comprises a first phase 94a of a first polarity, followed by a second phase 94b of an opposite polarity”),
and passively recovering charge using a first number of one or more passive electrodes from the plurality of electrodes (paragraph 0029 – “FIGS. 6A and 6B show improved passive charge recovery circuitry for the IPG, and passive recovery logic for closing passive recovery switches coupled to each of the electrode nodes”; paragraph 0021 – “Passive charge recovery is implemented within the stimulation circuitry block 170, and includes use of passive recovery switches (e.g., transistors) 96(x), each connected between one of the electrode nodes (Ex′ and Ec′) 61a and a common reference voltage, as shown in FIG. 3B”).
Feldman does not expressly teach a programmer having a user interface configured to receive a user input for changing a number of passive electrodes used to passively recover charge from the first number to a second number, wherein the programmer is configured to control the neurostimulator to passively recover charge using the second number of passive electrodes.
Doan teaches a similar neuromodulation system/method (paragraph 0043 – “FIG. 1 shows an Implantable Pulse Generator (IPG) useable for Spinal Cord Stimulation (SC S)…”), which includes a plurality of electrodes (paragraph 0010 – “In the illustrated IPG 10, there are thirty-two electrodes (E1-E32)...”), and a programmer having a user interface user interface (figure 6, GUI 64),
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Which receives a user input at a user interface of a programmer for changing a number of passive electrodes used to passively recover charge from the first number to a second number (paragraph 0030 – “A cursor 94 (or other selection means such as a mouse pointer) can be used to select a particular electrode in the leads interface 92. Buttons in the electrode parameter interface 86 allow the selected electrode (including the case electrode, Ec) to be designated as an anode, a cathode, or off”),
And allows controlling the neurostimulator, using the programmer, to passively recover charge using the second number of selected passive electrodes (paragraph 0030 – “For example, electrodes E3 and E4 can both be selected to act as anode electrodes, with E3 receiving 30% of +A, and E4 receiving 70% of +A. GUI 64 can include other advanced options not shown as well, which for example allow for setting of a duty cycle (on/off time) for the stimulation pulses, setting a ramp-up time over which stimulation pulses will reach its programmed amplitude (A), options to specify the use of biphasic waveforms and/or passive charge recovery, etc.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the passive charge recovery system/method of Feldman, to incorporate the electrode selection as taught by Doan as stated above, since such modification would predictably result in more efficient charge recovery and increased energy efficiency.
Re. claim 18, Feldman of the combined invention further teaches wherein the plurality of electrodes includes segmented electrodes (Feldman figure 1 shows segmented electrodes 20 on two leads) on a deep brain stimulation (DBS) lead (Feldman paragraph 0003 – “However, the present invention may find applicability in any implantable medical device system, including a Deep Brain Stimulation (DBS) system”).
Re. claim 20, Doan of the combined invention further teaches wherein the programmer is configured to automatically control the neurostimulator to passively recover charge using the second number based on the received user input (Doan paragraph 0030 – “For example, electrodes E3 and E4 can both be selected to act as anode electrodes, with E3 receiving 30% of +A, and E4 receiving 70% of +A. GUI 64 can include other advanced options not shown as well, which for example allow for setting of a duty cycle (on/off time) for the stimulation pulses, setting a ramp-up time over which stimulation pulses will reach its programmed amplitude (A), options to specify the use of biphasic waveforms and/or passive charge recovery, etc.”; paragraph 0083 – “If as most relevant here option 152 is chosen, the software 66 will take those same parameters and automatically derive a waveform with first and second pulses 130 and 140 of opposite polarities, with each of the pulses 130 and 140 having actively-driven monophasic pulses 132 and 142 followed by passive charge recovery pulses 134 and 144 as previously explained”).
Claim(s) 3, 5 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feldman (US 20180140831 A1 – hereinafter Feldman) in view of Doan (US 20200147392 A1 – hereinafter Doan), in further view of Moore (US 20220355115 A1 – hereinafter Moore).
Re. claim 3, the combined invention of Feldman and Doan (hereinafter the combined invention) teaches the claimed invention of claim 1 as stated above, but does not expressly teach wherein the received user input includes a progressive input to progressively change the number of electrodes.
Moore teaches a similar neuromodulation system/method (abstract – “Systems and methods for creating, maintaining, and remotely modifying stimulation settings for a neuromodulation therapy are discussed”), and further teaches a user input (figure 6A, GUI 600), which selects whether passive charge recovery is used (paragraph 0099 – “In some examples, the waveform interface 604 may allow a user to select biphasic or monophasic pulses, and to select whether passive charge recovery will be used (not shown)”),
And selects AND modifies electrode selection to progressively change the number of electrodes (paragraph 0100 – “The GUI 600 may include an electrode configuration interface 605 which allows the user to select and modify a particular electrode configuration, such as specifying which electrodes are active electrodes (ON) to provide stimulation, and which electrodes are inactive electrodes (OFF) to refrain from providing stimulation”).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the user input of the combined invention, to incorporate the modified electrode selection user input as taught by Moore, since such modification would predictably result in more efficient charge recovery and increased energy efficiency.
Re. claim 5, Feldman of the combined invention further teaches wherein the received user input includes input of a value to provide the progressive input (Feldman teaches parameter values such as amplitude and duration values, paragraph 0016 – “Stimulation parameters define the shape and timing of stimulation pulses to be formed at the electrodes, and can include parameters such as which electrodes E1-E16 or Ec will be active; whether those active electrodes are to act as anodes that source current to a patient's tissue, or cathodes that sink current from the tissue; and the amplitude (A), duration (D), and frequency (f) of the pulses. Amplitude may comprise a voltage or current amplitude”).
Re. claim 19, the combined invention of Feldman and Doan (hereinafter the combined invention) teaches the claimed invention of claim 17 as stated above, but does not expressly teach wherein the received user input includes a progressive input to progressively change the number of electrodes.
Moore teaches a similar neuromodulation system/method (abstract – “Systems and methods for creating, maintaining, and remotely modifying stimulation settings for a neuromodulation therapy are discussed”), and further teaches a user input (figure 6A, GUI 600), which selects whether passive charge recovery is used (paragraph 0099 – “In some examples, the waveform interface 604 may allow a user to select biphasic or monophasic pulses, and to select whether passive charge recovery will be used (not shown)”),
And selects AND modifies electrode selection to progressively change the number of electrodes (paragraph 0100 – “The GUI 600 may include an electrode configuration interface 605 which allows the user to select and modify a particular electrode configuration, such as specifying which electrodes are active electrodes (ON) to provide stimulation, and which electrodes are inactive electrodes (OFF) to refrain from providing stimulation”).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the user input of the combined invention, to incorporate the modified electrode selection user input as taught by Moore, since such modification would predictably result in more efficient charge recovery and increased energy efficiency.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feldman (US 20180140831 A1 – hereinafter Feldman) in view of Doan (US 20200147392 A1 – hereinafter Doan), in further view of Moore (US 20220355115 A1 – hereinafter Moore) and Lee (US 20150005842 A1 – hereinafter Lee).
Re. claim 4, the combined invention of Feldman, Doan and Moore (hereinafter the combined invention) teaches the claimed invention of claim 3 as stated above, but does not expressly teach wherein the user interface includes a slider bar or dial, and the received user input includes movement of the slider bar or movement of the dial to provide the progressive input.
Lee teaches a similar neuromodulation system (abstract – “A neuromodulation system and method of providing sub-threshold therapy to a patient”), and further teaches a user interface (figure 8, user selection screen 200),
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Which includes a slider bar, and the received user input includes movement of the slider bar or movement of the dial to provide the progressive input (paragraph 0087 – “To this end, the electrode selection screen 200 includes an electrode panel 154 comprising an electrode selection control 156 for all the electrodes 26. The electrode selection control 156 may include a slider (or any other selection tool) that can be actuated to select a particular electrode… In the illustrated embodiment, the electrode selection control 156 includes all the electrodes 130 of graphical lead 128 out of which electrode E4 has been actuated”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the user interface of the combined invention, to incorporate the user interface slider as taught by Lee, since such modification would predictably result in ease of use during electrode selection.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feldman (US 20180140831 A1 – hereinafter Feldman) in view of Doan (US 20200147392 A1 – hereinafter Doan), in further view of Griffith (US 20110160810 A1 – hereinafter Griffith).
Re. claim 8, the combined invention of Feldman, Doan and Moore (hereinafter the combined invention) teaches the claimed invention of claim 1 as stated above, but does not expressly teach wherein at least one of the one or more passive electrodes used to passively recover charge is not also used as one of the at least one stimulation electrode used to deliver neurostimulation.
Griffith teaches a similar neurostimulation system (abstract – “A multi-channel neurostimulation system comprises a plurality of electrical terminals configured for being respectively coupled to a plurality of electrodes…”), and further teaches switching electrodes to ground to passively recover charge at the selected electrode(s) so that the selected electrode(s) is/are not also used as one of the at least one stimulation electrode used to deliver neurostimulation (paragraph 0088 – “In an optional embodiment, the stimulation output circuitry 50 further comprises a bank of recovery switches (not shown) respectively coupled between the electrodes and ground. In this case, a digital control signal comprising seventeen bits can be respectively input to the switches to selectively switch any of the electrodes to ground, thereby passively recovering charge at the selected electrode or electrodes”; it is further submitted by the Examiner that it is known that electrodes connected to ground do not carry stimulating current).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of the combined invention, to incorporate the selected passive charge recovery electrodes not used to deliver neurostimulation as taught by Griffith, since such modification would predictably result in more efficient charge recovery and increased energy efficiency.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feldman (US 20180140831 A1 – hereinafter Feldman) in view of Doan (US 20200147392 A1 – hereinafter Doan), in further view of Steinke (US 20220273953 A1 – hereinafter Steinke).
Re. claim 11, the combined invention of Feldman, Doan and Moore (hereinafter the combined invention) teaches the claimed invention of claim 1 as stated above, but does not expressly teach wherein the programmer is configured to automatically program the neurostimulator with the plurality of electrodes determined by the algorithm to be used to passively recover charge.
Steinke teaches a stimulation device (abstract – “A user can use a user interface associated with an external programming device to define a time-varying stimulation waveform to be programmed into the stimulator device”), which employs passive charge recovery (paragraph 0017),
And further teaches a programmer which automatically programs instructions to a stimulator using previously selected electrodes (paragraph 0022 – “…executing a computer-implementable algorithm to automatically determine one or more first of the plurality of contiguous blocks in each at least one group that will be used to determine the compliance voltage variable for each group; and automatically determining programming instructions configured to: program the current generation circuitry to produce the at least one group thereby producing the waveform at the selected ones of the electrodes…”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the programmer of the combined invention, to incorporate the automatic programming as taught by Steinke, since such modification would predictably result in ease of use for programming stimulation parameters.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feldman (US 20180140831 A1 – hereinafter Feldman) in view of Doan (US 20200147392 A1 – hereinafter Doan), in further view of Chen (US 20210346692 A1 – hereinafter Chen).
Re. claim 13, the combined invention of Feldman and Doan (hereinafter the combined invention) teaches the claimed invention of claim 1 as stated above, but does not expressly teach wherein the algorithm is configured to determine which of the plurality of electrodes are used to passively recover charge based on at least one of:
image guided information,
which of the plurality of electrodes when used to deliver neurostimulation pulses cause a quickest side effect,
which of the plurality of electrodes when used to deliver neurostimulation pulses has a smallest therapy window,
a location or distance to a stimulation target,
a location or distance to side effect tissue,
or electrode size,
Chen teaches a system for treating cancerous tumors (abstract) which uses an electrode selection algorithm to determine/select electrodes based on image guided information (paragraph 0012 – “The tumor profile can be acquired by using an imaging modality to capture the tumor and then generating a tumor profile based on the imaging data. The profile can then be used to select electrode configurations to create a desired Volume of Tissue Activation (VTA), which can be customizable to each patient's unique tumor… Electrode configurations and stimulation settings can be selected by a computer algorithm based on the desired effect on the tumor”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode selection algorithm of the combined invention, to incorporate the image guided information input to the electrode selection algorithm as taught by Chen, since such modification would predictably result in more accurate and efficient electrode selection.
Re. claims 14-15, the combined invention of Feldman and Doan (hereinafter the combined invention) teaches the claimed invention of claim 1 as stated above, including the received user input to change the number of passive electrodes as stated above, but does not expressly teach receiving one or more algorithm inputs used to determine which passive electrodes are used to passively recover charge, wherein the one or more algorithm inputs include at least one of: medical imaging information, a side effect, a clinical effect, a stimulation target, side effect tissue, or lead information.
Chen teaches a system for treating cancerous tumors (abstract) which uses an electrode selection algorithm to determine/select electrodes from input based on medical image information (paragraph 0012 – “The tumor profile can be acquired by using an imaging modality to capture the tumor and then generating a tumor profile based on the imaging data. The profile can then be used to select electrode configurations to create a desired Volume of Tissue Activation (VTA), which can be customizable to each patient's unique tumor… Electrode configurations and stimulation settings can be selected by a computer algorithm based on the desired effect on the tumor”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode selection algorithm of the combined invention, to incorporate the image guided information input to the electrode selection algorithm as taught by Chen, since such modification would predictably result in more accurate and efficient electrode selection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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/ANH-KHOA N DINH/Examiner, Art Unit 3796
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