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 .
This action is non-final.
Response to Amendment
This Office Action is responsive to the amendment filed on 03/23/2026. As directed by the amendment: Claims 1 and 11 have been amended, claims 10, 16, and 21-49 have been cancelled, and no claims have been added. Thus, claims 1-9, 11-15, and 17-20 are presently under consideration in this application.
Response to Arguments
Applicant’s arguments, see pages 7-9, filed 03/23/2026, with respect to the rejection(s) of the claim(s) under 35 U.S.C. 103 have been fully considered and are persuasive. Amendments to the claim obviate the rejection of record. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Self (US 20150306383)(Hereinafter Self).
Claim Objections
Claims 2-9, 12-15, and 18-20 are objected to because of the following informalities: the phrase “The neuromodulation of Claim X” should be lowercase and should recite “The neuromodulation of claim X”. Appropriate correction is required.
Claims 1 and 11 are objected to because of the following informalities: the phrase “the safety control unit to verify…” should be amended to recite “the safety control unit configured to verify…”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9, 12-13, and 17-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the control unit" in line 12. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 1, it is unclear if the “operations” of line 21 is the same or different than the “operations” of line 6.
Claim 9 recites the limitation "the failure events" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 12, it is unclear if the “threshold condition” of line 1 is the same or different than the “operations” of line 23 of claim 11.
Regarding claim 13, it is unclear if the “threshold condition” of line 1 is the same or different than the “operations” of line 23 of claim 11.
Regarding claim 17, it is unclear if the “direct current” of line 19 is the same or different than the “direct current” of line 13.
Claim 17 recites the limitation "the current" in line 20. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the current" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-9 and 18-20 are rejected for being dependent on a rejected independent claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 9 fails to further limit the claim because the one failure event cannot be any failure event described, as this broadens the claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 7-9, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Self (US 20150306383)(Hereinafter Self) in view of Schulman et al. (US 6035237)(Hereinafter Schulman).
Regarding claims 1 and 11, Self teaches A neuromodulation device configured to operate in a plurality of waveform generation modes ([0029] “IMD 4 may deliver, for example, deep brain stimulation (DBS) or cortical stimulation (CS) therapy to patient 6 via the electrodes carried by, i.e., located on, lead segments 12 to treat any of a variety of neurological disorders or diseases.” [0043] “a user may select individual programs for delivery on an individual basis, or combinations of programs for delivery on a simultaneous or interleaved basis. In addition, a user may adjust parameters associated with the programs.”), comprising:
a power source (Fig. 2 (4));
a main control unit in communication with the power source (Fig. 2 (30) which is communicating with 40.);
a safety control unit in communication with the main control unit, the safety control unit to verify operations of the neuromodulation device ([0039] “Implantable stimulator 4 includes a processor 30, memory 32, stimulation generator 34, telemetry circuit 38, and power source 40. Simulation generator 34 includes protection element 36. Memory 32 may store instructions for execution by processor 30, stimulation therapy program data, sensor data, operational and status data, and any other electronic information regarding therapy or patient 6. Such information in memory 32 may assist in determining whether implantable stimulator 4 is currently in a state wherein protection element 36 [safety control unit] may be effective.”);
a bipolar current generator in communication with the main control unit and an input of a switching unit ([0041] “Stimulation generator 34 may include stimulation generation circuitry to generate stimulation pulses or waveforms and switching circuitry to switch the stimulation across different electrode combinations, e.g., in response to control by processor 30.”);
a plurality of electrodes, each in communication with a unique output of the switching unit, wherein the switching unit is configured to provide electrical communication between the bipolar current generator and a selected one of the plurality of electrodes in response to a control signal from the control unit ([0041] “Stimulation generator 34 may include stimulation generation circuitry to generate stimulation pulses or waveforms and switching circuitry to switch the stimulation across different electrode combinations, e.g., in response to control by processor 30... processor 30 may control the switching circuitry on a selective basis to cause stimulation generator 34 to deliver electrical stimulation to selected electrode combinations and to shift the electrical stimulation to different electrode combinations.” [0050] “During a stimulation mode, node 318 of transistor is a drain. During the stimulation mode, the switch 320 is open. Further, during the stimulation mode, the body node 316 is connected to the source 314 through a switch”);
wherein the bipolar current generator is configured to deliver alternating current to at least one working electrode of the plurality of electrodes during a first waveform generation mode, and wherein the bipolar current generator is further configured to deliver a direct current to the at least one working electrode during a second waveform generation mode ([0041] “stimulation generator 30 may deliver electrical stimulation therapy via electrodes of one or more leads 12, e.g., as stimulation pulses [DC] or continuous [AC] waveforms.” [0007] “generated by a first voltage across the first implantable electrode and the second implantable electrode; to flow from the first implantable electrode to an internal node in of the circuit, wherein the internal node is configured to allow a second voltage [second generation mode] of the internal node to raise in response to the current generated by the first voltage [first generation mode]” [0043] “a user may select individual programs for delivery on an individual basis, or combinations of programs for delivery on a simultaneous or interleaved basis. In addition, a user may adjust parameters associated with the programs.” [0044] “processor 30 may control stimulation generator 34 to deliver stimulation according to the programs in the groups, e.g., simultaneously or on a time-interleaved basis. A group may include a single program or multiple programs, each of which specifies an electrode combination.”); and
an indifferent electrode configured to provide a return path for the alternating current, the direct current, or both ([0036] “Generally, system 2 delivers stimulation therapy to patient 6 in the form of constant current [DC current] or voltage waveforms or constant current or voltage pulses…implantable stimulator 4 regulates current that is sourced or sunk by one or more electrodes, referred to as regulated electrodes. In some examples, one of the electrodes may be unregulated. In such configurations, either the housing electrode 13 or a lead electrode 11 may be the unregulated electrode.” [0037] “A source current, i.e., an anodal current, may refer to a positive current, i.e., a current having a positive polarity, that flows out of an electrode, e.g., from a regulated current source via a regulated current path to surrounding tissue, or from a reference voltage via an unregulated current path.’);
wherein the safety control unit is configured to detect at least one failure event related to operations of the neuromodulation device and prevent, alter, or stop operation of the bipolar current generator in response to the at least one detected failure event ([0046] “The automatic switching between a stimulation mode and a non-stimulation mode may prevent damage by an unexpected electrical pulse delivered to patient 6. In the non-stimulation mode mode, according to some examples, IMD 4 remains awake (operational) but does not actively deliver electrical stimulation to the patient, and the overvoltage protection circuitry 36 is in a state to be activated upon detection of an electrical pulse…processor 30 may control the components of IMD 4 to automatically switch back [alter] to the non-stimulation mode, in which overvoltage protection circuitry 36 may be activated, between each stimulation pulse from stimulation generator 34.” [0061] “FIG. 6 is a flow chart illustrating an example triggering of the overvoltage protection element consistent with this disclosure. A high voltage or current event (200) [failure event] results in a large voltage or current across two electrodes 52 and 54 of IMD 4. The current or voltage from the high voltage or current event charges a capacitor (202) within the circuitry of IMD 4…Once capacitor 74 is charged above a predetermined level, the voltage as the protection array is enough to trigger the protection array (204). For example, the protection array may be triggered when the voltage at the trigger node is between 17 and 24 V [failure event]… When protection array 56 is triggered, protection array 56 clamps the voltage of the circuit at 3V [alters]… once the protection array is turned on or “breaks over” the protection array stays on as long at the current is maintained above a predetermined level by the voltage source 50.” Examiner notes that the high voltage of [0061] trigging failure event alters the generator to enter non-stimulation mode, from the stimulation mode, allowing to prevent damage.)
wherein the safety control unit is configured to monitor the operations of the neuromodulation device including a current flowing to a power supply of the switching unit and to deactivate the bipolar current generator when the monitored current violates a threshold condition ([0058] “switch 62 is closed and switch 64 is open. This allows current provided by battery 70 to flow to electrode 52. However, if an electrical pulse was applied across electrodes 52 and 54 while switch 64 was open, the current would not be able to charge capacitor 74, and therefore overvoltage protection circuitry 56 may not fire. In this configuration additional current sources 66 and 76 also help control and provide current for stimulation pulses. In the configuration shown, with switch 68 closed, a capacitor (not shown) associated with current source 66 is being charged.” The current is flowing to the capacitor (power supply) of the switching unit. [0046] “The automatic switching between a stimulation mode and a non-stimulation mode may prevent damage by an unexpected electrical pulse delivered to patient 6. In the non-stimulation mode mode, according to some examples, IMD 4 remains awake (operational) but does not actively deliver electrical stimulation to the patient, and the overvoltage protection circuitry 36 is in a state to be activated upon detection of an electrical pulse…processor 30 may control the components of IMD 4 to automatically switch back [alter] to the non-stimulation mode, in which overvoltage protection circuitry 36 may be activated, between each stimulation pulse from stimulation generator 34.” [0061] “FIG. 6 is a flow chart illustrating an example triggering of the overvoltage protection element consistent with this disclosure. A high voltage or current event (200) [failure event] results in a large voltage or current across two electrodes 52 and 54 of IMD 4. The current or voltage from the high voltage or current event charges a capacitor (202) within the circuitry of IMD 4…Once capacitor 74 is charged above a predetermined level, the voltage as the protection array is enough to trigger the protection array (204). For example, the protection array may be triggered when the voltage at the trigger node is between 17 and 24 V [failure event]… When protection array 56 is triggered, protection array 56 clamps the voltage of the circuit at 3V [alters]… once the protection array is turned on or “breaks over” the protection array stays on as long at the current is maintained above a predetermined level by the voltage source 50.” Examiner notes that the high voltage of [0061] trigging failure event alters the generator to enter non-stimulation mode, from the stimulation mode, allowing to prevent damage.).
Although Self teaches multiple stimulation programs, Self does not explicitly teach wherein the bipolar current generator is configured to deliver alternating current to at least one working electrode of the plurality of electrodes during a first waveform generation mode, and wherein the bipolar current generator is further configured to deliver a direct current to the at least one working electrode during a second waveform generation mode. Schulman, in the same field of endeavor, teaches the implantable pulse generator with stimulation using coupling capacitors (Abstract), and further teaches wherein the bipolar current generator is configured to deliver alternating current to at least one working electrode of the plurality of electrodes during a first waveform generation mode, and wherein the bipolar current generator is further configured to deliver a direct current to the at least one working electrode during a second waveform generation mode (Col. 8 lines 1-5 “Such function can be achieved by adjusting the second pulse of a biphasic pulse pair, in amplitude and/or width, to precisely cancel out any dc component resulting from the first pulse of the biphasic pulse pair. Likewise, the amplitude of the positive or negative components of an ac signal can be increased or decreased independently to prevent any dc components.” Col. 10 lines 30-35 “current mirror circuit 1005, comprising transistors Q2 and M2, samples a small amount of current flowing in the other direction on line 77, and detects the average dc current by measuring the voltage V.sub.2 that builds up on the capacitor/resistor parallel circuit made up of capacitor CM2 and resistor R2.”) to prevent buildup of a block (Col. 4 lines 45-54). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Self, with the bipolar current generator is configured to deliver alternating current to at least one working electrode of the plurality of electrodes during a first waveform generation mode, and wherein the bipolar current generator is further configured to deliver a direct current to the at least one working electrode during a second waveform generation mode of Schulman, because such a modification would allow to prevent buildup of a block.
Regarding claim 7, claim 1 is obvious over Self and Schulman. Self does not teach direct current comprises an anodic current and a cathodic current, and wherein the at least one failure event comprises the anodic current not being (1) equal to and (2) opposite in sign to the cathodic current. Schulman, in the same field of endeavor, teaches the implantable pulse generator with stimulation using coupling capacitors (Abstract), and further teaches wherein the direct current comprises an anodic current and a cathodic current, and wherein the at least one failure event comprises the anodic current not being (1) equal to and (2) opposite in sign to the cathodic current (Col. 10 lines 14-19 “two coulomb counters may be used, one for determining an integrated coulomb count for coulombs flowing in one direction through the current path, and another for determining another integrated coulomb count for coulombs flowing in the other direction in the current path.” Col. 12 lines 55-60 “if there is a small mismatch between the positive and negative phases of each biphasic stimuli, the small build up of charge on the capacitance from the phase with the larger amplitude will be discharged through the switch (60A) and will never get a chance to build up to a value that could cause breakdown to occur.” Col. 9 lines 44-50 “Whenever the output voltage signal v(t), which is proportional to the current i(t), drops below the minimum reference level R(min), the switch 76 is opened, and the output terminal 62 is shorted to ground through the switch S3. Hence, the second comparator circuit 82 provides a fail-safe step to assure that small currents, e.g., currents below a defined threshold, are not allowed to flow through the living tissue.”) to prevent buildup of a block (Col. 4 lines 45-54). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Self, with the direct current comprises an anodic current and a cathodic current, and wherein the at least one failure event comprises the anodic current not being (1) equal to and (2) opposite in sign to the cathodic current of Schulman, because such a modification would allow to prevent buildup of a block.
Regarding claim 8, claim 1 is obvious over Self and Schulman. Self does not teach the direct current comprises an anodic current and a cathodic current, and wherein the at least one failure event comprises the anodic current not being (1) less than a threshold amount different from and (2) opposite in sign to the cathodic current. Schulman, in the same field of endeavor, teaches the implantable pulse generator with stimulation using coupling capacitors (Abstract), and further teaches wherein the direct current comprises an anodic current and a cathodic current, and wherein the at least one failure event comprises the anodic current not being (1) less than a threshold amount different from and (2) opposite in sign to the cathodic current (Col. 10 lines 14-19 “two coulomb counters may be used, one for determining an integrated coulomb count for coulombs flowing in one direction through the current path, and another for determining another integrated coulomb count for coulombs flowing in the other direction in the current path.” Col. 12 lines 55-60 “if there is a small mismatch between the positive and negative phases of each biphasic stimuli, the small build up of charge on the capacitance from the phase with the larger amplitude will be discharged through the switch (60A) and will never get a chance to build up to a value that could cause breakdown to occur.” Col. 9 lines 44-50 “Whenever the output voltage signal v(t), which is proportional to the current i(t), drops below the minimum reference level R(min), the switch 76 is opened, and the output terminal 62 is shorted to ground through the switch S3. Hence, the second comparator circuit 82 provides a fail-safe step to assure that small currents, e.g., currents below a defined threshold, are not allowed to flow through the living tissue.”) to prevent buildup of a block (Col. 4 lines 45-54). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Self, with the direct current comprises an anodic current and a cathodic current, and wherein the at least one failure event comprises the anodic current not being (1) less than a threshold amount different from and (2) opposite in sign to the cathodic current of Schulam, because such a modification would allow to prevent buildup of a block.
Regarding claim 9, Self teaches wherein the at least one failure event is any of the failure events described herein ([0046] “The automatic switching between a stimulation mode and a non-stimulation mode may prevent damage by an unexpected electrical pulse delivered to patient 6. In the non-stimulation mode mode, according to some examples, IMD 4 remains awake (operational) but does not actively deliver electrical stimulation to the patient, and the overvoltage protection circuitry 36 is in a state to be activated upon detection of an electrical pulse…processor 30 may control the components of IMD 4 to automatically switch back [alter] to the non-stimulation mode, in which overvoltage protection circuitry 36 may be activated, between each stimulation pulse from stimulation generator 34.” [0061] “FIG. 6 is a flow chart illustrating an example triggering of the overvoltage protection element consistent with this disclosure. A high voltage or current event (200) [failure event] results in a large voltage or current across two electrodes 52 and 54 of IMD 4. The current or voltage from the high voltage or current event charges a capacitor (202) within the circuitry of IMD 4…Once capacitor 74 is charged above a predetermined level, the voltage as the protection array is enough to trigger the protection array (204). For example, the protection array may be triggered when the voltage at the trigger node is between 17 and 24 V [failure event]… When protection array 56 is triggered, protection array 56 clamps the voltage of the circuit at 3V [alters]… once the protection array is turned on or “breaks over” the protection array stays on as long at the current is maintained above a predetermined level by the voltage source 50.” Examiner notes that the high voltage of [0061] trigging failure event alters the generator to enter non-stimulation mode, from the stimulation mode, allowing to prevent damage.).
Regarding claim 12, Self teaches wherein violating a threshold condition corresponds to the monitored current exceeding a threshold level ([0061] “FIG. 6 is a flow chart illustrating an example triggering of the overvoltage protection element consistent with this disclosure. A high voltage or current event (200) [failure event] results in a large voltage or current across two electrodes 52 and 54 of IMD 4. The current or voltage from the high voltage or current event charges a capacitor (202) within the circuitry of IMD 4…Once capacitor 74 is charged above a predetermined level, the voltage as the protection array is enough to trigger the protection array (204). For example, the protection array may be triggered when the voltage at the trigger node is between 17 and 24 V [failure event]… When protection array 56 is triggered, protection array 56 clamps the voltage of the circuit at 3V [alters]… once the protection array is turned on or “breaks over” the protection array stays on as long at the current is maintained above a predetermined level by the voltage source 50.” Examiner notes that the high voltage of [0061] trigging failure event alters the generator to enter non-stimulation mode, from the stimulation mode, allowing to prevent damage.).
Claim(s) 2-3, and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Self (US 20150306383)(Hereinafter Self) in view of Schulman et al. (US 6035237)(Hereinafter Schulman) and Ranu et al. (US 9463326)(Hereinafter Ranu).
Regarding claim 2, claim 1 is obvious over Self and Schulman. Self does not teach at least one failure event comprises an actual stimulating current being unequal to a desired stimulating current, wherein the actual stimulating current is the alternating current or the direct current. Ranu, in the same field of endeavor, teaches an implantable stimulation device with a switch matrix for observing a failure (Abstract), and further teaches wherein the at least one failure event comprises an actual stimulating current being unequal to a desired stimulating current, wherein the actual stimulating current is the alternating current or the direct current (Abstract “A voltage drop across the active switches in the switch matrix is monitored and is compared to an expected voltage based upon the amplitude of the current and the known on resistance of the switch. If the monitored and expected voltages differ significantly, then a failure condition can be inferred, and an appropriate action can be taken, such shutting down stimulation”) to identify failures to provide safety for the patient (Col. 3 lines 61-65). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Self in view of Schulman, with the at least one failure event comprises an actual stimulating current being unequal to a desired stimulating current, wherein the actual stimulating current is the alternating current or the direct current of Ranu, because such a modification would allow to identify failures to provide safety for the patient.
Regarding claim 3, claim 1 is obvious over Self and Schulman. Self does not teach at least one failure event comprises a monitored current signal from a power supply to the switching unit exceeding an expected current amount. Ranu, in the same field of endeavor, teaches an implantable stimulation device with a switch matrix for observing a failure (Abstract), and further teaches wherein the at least one failure event comprises a monitored current signal from a power supply to the switching unit exceeding an expected current amount (Claim 1 “wherein the first plurality of switches are selectable to distribute the at least one current to one or more of the electrodes; a second plurality of switches, wherein the second plurality of switches are selectable to distribute the at least one current from one or more of the electrodes; and monitoring circuitry configured to measure at least one first voltage, each at least one first voltage comprising a voltage only across one of the first switches, and at least one second voltage, each at least one second voltage comprising a voltage only across one of the second switches” Abstract “A voltage drop across the active switches in the switch matrix is monitored and is compared to an expected voltage based upon the amplitude of the current and the known on resistance of the switch. If the monitored and expected voltages differ significantly, then a failure condition can be inferred, and an appropriate action can be taken, such shutting down stimulation”) to identify failures to provide safety for the patient (Col. 3 lines 61-65). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Self in view of Schulman, with the at least one failure event comprises a monitored current signal from a power supply to the switching unit exceeding an expected current amount of Ranu, because such a modification would allow to identify failures to provide safety for the patient.
Regarding claim 13, claim 1 is obvious over Self and Schulman. Self does not teach violating a threshold condition corresponds to the monitored current falling below a threshold level. Ranu, in the same field of endeavor, teaches an implantable stimulation device with a switch matrix for observing a failure (Abstract), and further teaches wherein violating a threshold condition corresponds to the monitored current falling below a threshold level (Col. 7 lines 10-25 “Such ranges will comprise some function of the expected values Vdsp(exp) and Vdsn(exp), and can take several different forms. For example, it may only be of interest to know if the current through the switch is very low, or effectively zero. If so, Vdsp and Vdsn would necessarily be very small. To detect this condition, range_p for example might be set relative to a threshold, i.e., Vdsp>c*Vdsp(exp), where c is between 0 and 1. Using a scalar c to define the threshold is sensible given the variability in the system, particularly Rdsp(exp), which as noted earlier may not always perfectly reflect the on resistance of the switch. Thus, compare block 180 might assess for example whether Vdsp>0.7*Vdsp(exp), on the notion that values below this threshold could not be due to expected variability, but must instead be due to an unusually low current draw (Iout) through the switch, which would potentially indicate failure.”) to identify failures to provide safety for the patient (Col. 3 lines 61-65). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Self in view of Schulman, with the at violating a threshold condition corresponds to the monitored current falling below a threshold level of Ranu, because such a modification would allow to identify failures to provide safety for the patient.
Regarding claim 14, claim 1 is obvious over Self and Schulman. Self does not teach switching unit comprises a multiplexer. Ranu, in the same field of endeavor, teaches an implantable stimulation device with a switch matrix for observing a failure (Abstract), and further teaches wherein the switching unit comprises a multiplexer (Col. 10 lines 14-25 “if two switching matrices 50 and 50′ are used, it is not necessary to measure active switches in both of these matrices, although this is preferred to get a complete picture of where failure may be occurring in the IPG 100. It is further not necessary to measure active switches in both matrices 50 and 50′ at the same time. For example, the switches in switch matrix 50 could be measured during the issuance of even pulses, and the switches in switch matrix 50′ could be measured during the issuance of odd pulses. If this type of modification is used, one could modify the monitoring circuitry 200 of FIG. 5A or 5B to use a single multiplexer 70 and A/D converter 80.”) to identify failures to provide safety for the patient (Col. 3 lines 61-65). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Self in view of Schulman, with the switching unit comprises a multiplexer of Ranu, because such a modification would allow to identify failures to provide safety for the patient.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Self (US 20150306383)(Hereinafter Self) in view of Schulman et al. (US 6035237)(Hereinafter Schulman) and DeShazo et al. (US 11160984)(Hereinafter DeShazo).
Regarding claim 4, claim 1 is obvious over Self and Schulman. Self does not teach one failure event comprises a real time determination that at least one of a resistance or capacitance of the at least one working electrode is not equal to an expected resistance or expected capacitance of the at least one working electrode. DeShazo, in the same field of endeavor, teaches pulse generation circuitry to deliver pulses of neurostimulation therapy to electrodes (Abstract), and further teaches wherein the at least one failure event comprises a real time determination that at least one of a resistance or capacitance of the at least one working electrode is not equal to an expected resistance or expected capacitance of the at least one working electrode (Col. 12 lines 12-15 “By determining model 400 for a patient, IPG 402 can monitor shifts in resistance and capacitance (e.g., R.sub.F, C.sub.DL, or R.sub.S) over time during the life of the patient and device.” Col. 4 lines 3-6 “the calculating values comprises determining a resistance associated with tissue between electrodes using a voltage measurement captured at the beginning of a therapy waveform.” Col. 15 lines 32-38 “A current at an output of the current regulator is determined by a voltage of the programmable voltage source and a resistance of the programmable resistor. The current output of the current regulator may be decreased in precalculated steps to create the exponentially decreasing discharge current applied to the electrodes [not equal to expected resistance].”) to improve monitoring of lead integrity (Col. 12 lines 15-16). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Self in view of Schulman, with the least one failure event comprises a real time determination that at least one of a resistance or capacitance of the at least one working electrode is not equal to an expected resistance or expected capacitance of the at least one working electrode of DeShazo, because such a modification would allow to improve monitoring of lead integrity.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Self (US 20150306383)(Hereinafter Self) in view of Schulman et al. (US 6035237)(Hereinafter Schulman) and Ghiron et al. (US 10183172)(Hereinafter Ghiron).
Regarding claim 5, claim 1 is obvious over Self and Schulman. Self does not teach one failure event comprises a real time determination that a peak-to-peak voltage of the at least one working electrode is above an expected voltage of the at least one working electrode. Ghiron, in the same field of endeavor, teaches the determining of failure of a stimulation therapy system (Abstract), and further teaches wherein the at least one failure event comprises a real time determination that a peak-to-peak voltage of the at least one working electrode is above an expected voltage of the at least one working electrode (Col. 17 lines 26-34 “The magnetic stimulation system may determine if a failure has occurred using the voltage difference, for example, by checking if the voltage difference is outside of the peak-to-peak acceptance window. For example, the peak-to-peak acceptance window may be 10%, meaning that the voltage difference of the signal may be plus/minus 10% of the expected voltage difference (e.g., as determined in accordance with the expected signal 500) to be within the peak-to-peak acceptance window.”) to determine a failure during treatment (Col. 16 lines 25-27). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Self in view of Schulman, with the one failure event comprises a real time determination that a peak-to-peak voltage of the at least one working electrode is above an expected voltage of the at least one working electrode of Ghiron, because such a modification would allow to determine a failure during treatment.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Self (US 20150306383)(Hereinafter Self) in view of Schulman et al. (US 6035237)(Hereinafter Schulman) and Boor et al. (US 11478644)(Hereinafter Boor).
Regarding claim 6, claim 1 is obvious over Self and Schulman. Self does not teach at least one failure event comprises a blocking capacitor is not properly functioning. Boor, in the same field of endeavor, teaches the implantable pulse generator with a switch circuit for providing DC power (Abstract), and further teaches wherein the at least one failure event comprises a blocking capacitor is not properly functioning (Col. 8 lines 9-10 “using two DC blocking capacitors 302 provides protection in the event that one of DC blocking capacitors 302 fails.”) to maintain the prevention of DC leakage (Col. 8 lines 21-24). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Self in view of Schulman, with the at least one failure event comprises a blocking capacitor is not properly functioning of Boor, because such a modification would allow to maintain the prevention of DC leakage.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Self (US 20150306383)(Hereinafter Self) in view of Schulman et al. (US 6035237)(Hereinafter Schulman) and Anderson et al. (US 20030105500)(Hereinafter Anderson).
Regarding claim 15, claim 1 is obvious over Self and Schulman. Self does not teach back- biasing diode in communication with at least one output of the switching unit, wherein the back- biasing diode is configured to prevent back-biasing of the switching unit at least one output. Anderson, in the same field of endeavor, teaches the implantable pulse generator with a switch cycles to stimulate tissue (Abstract), and further teaches further comprising a back- biasing diode in communication with at least one output of the switching unit, wherein the back- biasing diode is configured to prevent back-biasing of the switching unit at least one output ([0024] “Since the junction 58 between the inductor 50 and the anode of the diode 56 are effectively connected to ground because switch 52 is closed, the diode is back-biased and no load current passes through the inductor during this period.”) to terminate the load from passing for more stimulation ([0024]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Self in view of Schulman, with the back- biasing diode in communication with at least one output of the switching unit, wherein the back- biasing diode is configured to prevent back-biasing of the switching unit at least one output of Anderson, because such a modification would allow to terminate the load from passing for more stimulation.
Claim(s) 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Self (US 20150306383)(Hereinafter Self) in view of Schulman et al. (US 6035237)(Hereinafter Schulman) and Wilder et al. (US 20210346700)(Hereinafter Wilder).
Regarding claim 17, Self teaches A neuromodulation device configured to operate in a plurality of waveform generation modes ([0029] “IMD 4 may deliver, for example, deep brain stimulation (DBS) or cortical stimulation (CS) therapy to patient 6 via the electrodes carried by, i.e., located on, lead segments 12 to treat any of a variety of neurological disorders or diseases.” [0043] “a user may select individual programs for delivery on an individual basis, or combinations of programs for delivery on a simultaneous or interleaved basis. In addition, a user may adjust parameters associated with the programs.”), comprising:
a power source (Fig. 2 (4));
a main control unit in communication with the power source (Fig. 2 (30) which is communicating with 40.);
a safety control unit in communication with the main control unit, the safety control unit to verify operations of the neuromodulation device ([0039] “Implantable stimulator 4 includes a processor 30, memory 32, stimulation generator 34, telemetry circuit 38, and power source 40. Simulation generator 34 includes protection element 36. Memory 32 may store instructions for execution by processor 30, stimulation therapy program data, sensor data, operational and status data, and any other electronic information regarding therapy or patient 6. Such information in memory 32 may assist in determining whether implantable stimulator 4 is currently in a state wherein protection element 36 [safety control unit] may be effective.”);
a bipolar current generator in communication with the main control unit and an input of a switching unit ([0041] “Stimulation generator 34 may include stimulation generation circuitry to generate stimulation pulses or waveforms and switching circuitry to switch the stimulation across different electrode combinations, e.g., in response to control by processor 30.”);
a plurality of electrodes, each in communication with a unique output of the switching unit, wherein the switching unit is configured to provide electrical communication between the bipolar current generator and a selected one of the plurality of electrodes in response to a control signal from the control unit ([0041] “Stimulation generator 34 may include stimulation generation circuitry to generate stimulation pulses or waveforms and switching circuitry to switch the stimulation across different electrode combinations, e.g., in response to control by processor 30... processor 30 may control the switching circuitry on a selective basis to cause stimulation generator 34 to deliver electrical stimulation to selected electrode combinations and to shift the electrical stimulation to different electrode combinations.” [0050] “During a stimulation mode, node 318 of transistor is a drain. During the stimulation mode, the switch 320 is open. Further, during the stimulation mode, the body node 316 is connected to the source 314 through a switch”);
wherein the bipolar current generator is configured to deliver alternating current to at least one working electrode of the plurality of electrodes during a first waveform generation mode, and wherein the bipolar current generator is further configured to deliver a direct current to the at least one working electrode during a second waveform generation mode ([0041] “stimulation generator 30 may deliver electrical stimulation therapy via electrodes of one or more leads 12, e.g., as stimulation pulses [DC] or continuous [AC] waveforms.” [0007] “generated by a first voltage across the first implantable electrode and the second implantable electrode; to flow from the first implantable electrode to an internal node in of the circuit, wherein the internal node is configured to allow a second voltage [second generation mode] of the internal node to raise in response to the current generated by the first voltage [first generation mode]” [0043] “a user may select individual programs for delivery on an individual basis, or combinations of programs for delivery on a simultaneous or interleaved basis. In addition, a user may adjust parameters associated with the programs.” [0044] “processor 30 may control stimulation generator 34 to deliver stimulation according to the programs in the groups, e.g., simultaneously or on a time-interleaved basis. A group may include a single program or multiple programs, each of which specifies an electrode combination.”); and
an indifferent electrode configured to provide a return path for the alternating current, the direct current, or both ([0036] “Generally, system 2 delivers stimulation therapy to patient 6 in the form of constant current [DC current] or voltage waveforms or constant current or voltage pulses…implantable stimulator 4 regulates current that is sourced or sunk by one or more electrodes, referred to as regulated electrodes. In some examples, one of the electrodes may be unregulated. In such configurations, either the housing electrode 13 or a lead electrode 11 may be the unregulated electrode.” [0037] “A source current, i.e., an anodal current, may refer to a positive current, i.e., a current having a positive polarity, that flows out of an electrode, e.g., from a regulated current source via a regulated current path to surrounding tissue, or from a reference voltage via an unregulated current path.’).
Although Self teaches multiple stimulation programs, Self does not explicitly teach wherein the bipolar current generator is configured to deliver alternating current to at least one working electrode of the plurality of electrodes during a first waveform generation mode, and wherein the bipolar current generator is further configured to deliver a direct current to the at least one working electrode during a second waveform generation mode. Schulman, in the same field of endeavor, teaches the implantable pulse generator with stimulation using coupling capacitors (Abstract), and further teaches wherein the bipolar current generator is configured to deliver alternating current to at least one working electrode of the plurality of electrodes during a first waveform generation mode, and wherein the bipolar current generator is further configured to deliver a direct current to the at least one working electrode during a second waveform generation mode (Col. 8 lines 1-5 “Such function can be achieved by adjusting the second pulse of a biphasic pulse pair, in amplitude and/or width, to precisely cancel out any dc component resulting from the first pulse of the biphasic pulse pair. Likewise, the amplitude of the positive or negative components of an ac signal can be increased or decreased independently to prevent any dc components.” Col. 10 lines 30-35 “current mirror circuit 1005, comprising transistors Q2 and M2, samples a small amount of current flowing in the other direction on line 77, and detects the average dc current by measuring the voltage V.sub.2 that builds up on the capacitor/resistor parallel circuit made up of capacitor CM2 and resistor R2.”) to prevent buildup of a block (Col. 4 lines 45-54). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Self, with the bipolar current generator is configured to deliver alternating current to at least one working electrode of the plurality of electrodes during a first waveform generation mode, and wherein the bipolar current generator is further configured to deliver a direct current to the at least one working electrode during a second waveform generation mode of Schulman, because such a modification would allow to prevent buildup of a block.
However, Self in view of Schulman does not teach a bipolar current generator calibration unit comprising a calibration load and a calibration load switch, wherein the control unit is configured to activate the calibration load switch to direct current from the bipolar current generator to the calibration load, measure the current directed to the calibration load, and calibrate the bipolar current generator in response to the measured current. Wilder, in the same field of endeavor, teaches a neurostimulation device with electrodes for measuring an overvoltage condition (Abstract), and further teaches a bipolar current generator calibration unit comprising a calibration load and a calibration load switch, wherein the control unit is configured to activate the calibration load switch to direct current from the bipolar current generator to the calibration load, measure the current directed to the calibration load, and calibrate the bipolar current generator in response to the measured current ([0043] “The switch matrix also allows the StimOut to be selectively connected to a Testing and Calibration Bus (TestBus), or the Elect_pad, or Vrest signal.” [0048] “A matrix of selectable impedances may be connected to the TestBus and is used to measure and calibrate individual channel stimulation current levels and stim current matching between different channels.” Fig. 10 shows the TestBus with 8 switches and resistors/calibration load, where the current is measured and calibrated.) to test for accuracy before connection to tissue ([0048]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Self in view of Schulman, with the bipolar current generator calibration unit comprising a calibration load and a calibration load switch, wherein the control unit is configured to activate the calibration load switch to direct current from the bipolar current generator to the calibration load, measure the current directed to the calibration load, and calibrate the bipolar current generator in response to the measured current of Wilder, because such a modification would allow to test for accuracy before connection to tissue.
Regarding claim 18, claim 17 is obvious over Self, Schulman, and Wilder. Self does not teach wherein the calibration load comprises a resistor. Wilder, in the same field of endeavor, teaches a neurostimulation device with electrodes for measuring an overvoltage condition (Abstract), and further teaches wherein the calibration load comprises a resistor (Fig. 10 resistors 330 and 1k.) to test for accuracy before connection to tissue ([0048]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Self in view of Schulman, with the bipolar current generator calibration unit comprising a calibration load and a calibration load switch, wherein the control unit is configured to activate the calibration load switch to direct current from the bipolar current generator to the calibration load, measure the current directed to the calibration load, and calibrate the bipolar current generator in response to the measured current of Wilder, because such a modification would allow to test for accuracy before connection to tissue.
Regarding claim 19, claim 17 is obvious over Self, Schulman, and Wilder. Self does not teach wherein the current sensor configured to measure the current directed to the calibration load. Wilder, in the same field of endeavor, teaches a neurostimulation device with electrodes for measuring an overvoltage condition (Abstract), and further teaches further comprising a current sensor configured to measure the current directed to the calibration load ([0029] “routing of appropriate excitation signals for electrode impedance measurement (e.g., using the impedance matrix [current sensor] illustrated in FIG. 10), using internal circuits for calibration for channel current source elements, as well as methods for detecting internal faults that may lead to undesirable DC electrode currents (e.g., the circuit illustrated in FIG. 9).”) to test for accuracy before connection to tissue ([0048]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Self in view of Schulman, with the current sensor configured to measure the current directed to the calibration load of Wilder, because such a modification would allow to test for accuracy before connection to tissue.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Self (US 20150306383)(Hereinafter Self) in view of Schulman et al. (US 6035237)(Hereinafter Schulman) , Wilder et al. (US 20210346700)(Hereinafter Wilder) and Mishra et al. (US 9539430)(Hereinafter Mishra).
Regarding claim 20, claim 17 is obvious over Self, Schulman, and Wilder. Self does not teach calibrating the bipolar current generator comprises adjusting a value of the control signal communicated to the bipolar current generator. Mishra, in the same field of endeavor, teaches (Abstract), and further teaches wherein calibrating the bipolar current generator comprises adjusting a value of the control signal communicated to the bipolar current generator (Col. 4 lines 17-22 “external control device 102 may be configured to dynamically adjust a transmit power level of the power signal in order to maintain an optimal compliance voltage within implantable stimulator 104 regardless of fluctuations in maximum stimulation current level requirements.” Col. 10 lines 66-67 and Col. 11 lines 1-5 “An example will now be given of a calibration procedure that utilizes shunt circuitry 800. Calibration facility 204 may first direct implantable stimulator 104 to close switch 816 in order to shunt a current path of current source 802 through shunt resistor 804. Calibration facility 204 may then select a target compliance voltage (e.g., 8 volts) and adjust a transmit power level”) to maintain a compliance voltage at which an implantable stimulator operates at an optimal level (Col. 1 lines 26-27). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Self in view of Schulman and Wilder, with calibrating the bipolar current generator comprises adjusting a value of the control signal communicated to the bipolar current generator of Mishra, because such a modification would allow to maintain a compliance voltage at which an implantable stimulator operates at an optimal level.
Conclusion
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/MOUSSA HADDAD/Examiner, Art Unit 3796
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