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 .
Election/Restrictions
Claims 22-43 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/08/2026.
Applicant's election with traverse of the Unity of Invention and Species Restriction Requirement in the reply filed on 06/08/2026 is acknowledged. The traversal is on the ground(s) that Peterson does not disclose “to modulate” or “modulating” a voltage on the regulation electrode and that Peterson does not disclose “about half the supply voltage”. This argument has been fully considered and found persuasive as Peterson’s disclosure of “differential voltage between the anode and cathode” is not the same as the supply voltage in the instant application.
The restriction requirement has been withdrawn. Accordingly claims 1-43 are being examined.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/27/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
In re claim 1, the limitation “a corresponding voltage on each stimulus electrode varies substantially symmetrically around a value” is interpreted to comprise voltages that are not exactly symmetrically (above and below) around a value and/or comprise values that are voltages symmetrically around a value.
Claim 3 and 25 repeat the limitation “substantially symmetrical around a value” which will be interpreted as in claim 1 (see above Claim Interpretations, In re claim 1).
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 1-43 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.
In re claim 1:
On line 2, “the electrodes comprising” lacks antecedent basis. Examiner suggests replacing with “the plurality of electrodes comprising”
On line 4 and 6, “the stimulus electrodes” lacks antecedent basis. For purposes of examination, this is interpreted to refer to both of the previously mentioned “a first stimulus electrode” and “a second stimulus electrode”, such that “an electrode array comprising a plurality of electrodes, the plurality of electrodes comprising stimulus electrodes, the stimulus electrodes comprising a first stimulus electrode and a second stimulus electrode”.
Claims 7, 8, 11, 16, 20, 29, 30, 33, 37, and 41 all recite the limitation “the stimulus electrodes” as in claim 1 and thus lack antecedent basis (see above 35 U.S.C. 112(b) Rejection, In re claim 1 regarding “the stimulus electrodes”).
In re claim 1, the limitation “a value which is about half the supply voltage” is unclear. Specifically, the word “about” is indefinite in this context. About half the supply voltage could be interpreted to mean within 1%, 5%, 10%, or 15% of the supply voltage. For purposes of examination, about half the supply voltage will be interpreted under broadest reasonable interpretation in light of the specification to mean a range greater than between 40 and 60% of the supply voltage, such as between 35 and 65% the supply voltage.
Claims 2, 7, 11, 23, 24, 29, and 33 have the same indefiniteness issue regarding the repeated limitation “a value which is about half the supply voltage” as recited in claim 1. See above 35 U.S.C. 112(b) rejection, In re claim 1, substantially the same reasoning applies.
In re claim 20, the limitation “wherein the controller is configured to adjust the supply voltage to at least an amplitude of the subsequent multiphasic stimulus pulse multiplied by a sum of tissue resistances at the stimulus electrodes” is unclear. Specifically, “an amplitude” could refer to either an amplitude of a voltage of the subsequent multiphasic stimulus pulse or to an amplitude of a current of the subsequent multiphasic stimulus pulse. For purposes of examination, the claim will be interpreted under broadest reasonable interpretation in light of the specification as meaning “wherein the controller is configured to adjust the supply voltage to at least an amplitude of a current of the subsequent multiphasic stimulus pulse multiplied by a sum of tissue resistances at the stimulus electrodes”.
Claim 41 has the same indefiniteness issue regarding the repeated limitation “an amplitude” as recited in claim 20. See above 35 U.S.C. 112(b) rejection, In re claim 20, substantially the same reasoning applies.
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 24 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. The limitation of claim 24, “wherein the voltage on each stimulus electrode varies symmetrically around a value which is about half the supply voltage over the multiphasic stimulus pulse” does not further limit claim 23, from which claim 24 depends, as claim 23 contains the limitation “such that a corresponding voltage on each stimulus electrode varies symmetrically around a value which is about half the supply voltage over the multiphasic stimulus pulse”. 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 9-10, 14, 23-28, and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Single (US 20150313487) [in view of Marnfeldt (US 20190299006)].
In re claim 1, Single discloses an implantable neural stimulation device (Fig. 1: 100; [0061]: “Controls application of a sequence of neural stimuli”), the device comprising:
an electrode array (120) comprising a plurality of electrodes (122),
the electrodes comprising
a first stimulus electrode (Fig. 1: one of 122; Fig. 14: first electrode on right; [0061, 0093]: “each of which may be selectively used as the stimulus electrode”) and
a second stimulus electrode (Fig. 1: another one of 122; Fig. 14: second electrode on right; [0061, 0093]: “each of which may be selectively used as the stimulus electrode”));
a pulse generator (Fig. 14: balanced current drivers; [0095]: matched positive and negative current drivers) connectable to the stimulus electrodes (current generators connect to the electrodes),
the pulse generator configured to
generate a multiphasic stimulus pulse of current from a supply voltage (([0061]: “Device 100 comprises an implanted control unit 110, which controls application of a sequence of neural stimuli”; 0062]: “The stimuli can comprise monophasic or biphasic pulses”, [0092]) and
deliver the multiphasic stimulus pulse via the stimulus electrodes [0062] to an electrically excitable tissue ([0067]: “spinal cord”) in order to evoke a neural response on a neural pathway in the electrically excitable tissue ([0021, 0067] “an appropriate electrical stimulus 202 will induce nerves to fire, and thereby produces an evoked neural response 206”); and
modulation circuitry (Fig. 14: feedback loop with input connected to the supply voltage and ground; [0095]) connectable to a regulation electrode (Fig. 14: third electrode on the left connected to feedback amplifier; [0061]: “compensation electrode”) of the plurality of electrodes [0061],
the modulation circuitry configured to modulate a voltage on the regulation electrode during the delivery of the multiphasic stimulus pulse ([0031]: “during application of the neural stimulus, for example during the entire period of stimulation, the feedback amplifier may operate and be in connection with the feedback sense electrode and compensation electrode”) such that a corresponding voltage on each stimulus electrode are substantially symmetrical with each other ([0062]: “a charge-balanced biphasic pulse”; [0095]: “matched positive and negative current drivers”) around a value which is about half the supply voltage over the multiphasic stimulus pulse (Fig. 14: feedback amplifier is input with Vdd/2, i.e. half the supply voltage; [0095]; note: this would bias the voltage on the stimulus electrodes at a value of half the supply voltage).
*Single suggests but is silent in explicitly disclosing:
a corresponding voltage on each stimulus electrode varies substantially symmetrically around a value which is about half the supply voltage over the multiphasic stimulus pulse.
Single discloses wherein the stimulus current applied by two stimulus electrodes is a charge-balanced biphasic pulse ([0062]; note: a positive voltage is matched by an equal amplitude negative voltage, i.e. substantially symmetrical around a value). Additionally, in another embodiment, Single discloses wherein the stimulus electrodes swing in opposite direction (Fig. 8b and 8c; [0084]; i.e. substantially symmetrically around a value) resulting from the circuit of Fig. 6 wherein the electrodes can switch current source (i.e. switch polarity; Fig. 6; [0076]) and the virtual ground (similar in function to the applied value which is about half the supply voltage) is enabled [0084].
It would be obvious to try before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the implantable device of Single by providing wherein a corresponding voltage on each stimulus electrode varies substantially symmetrically around a value which is about half the supply voltage over the multiphasic stimulus pulse as suggested by Single as it would provide electrode with charge balancing (Single: [0062]), ensuring no excess of current being discharged to the tissue and, in the case of the other embodiment, would leave the potential on a measurement electrode unchanged by stimulation improving conditions for measurement of an evoked response (Single: [0078]).
However, in the event that Single lacks a corresponding voltage on each stimulus electrode varies substantially symmetrically around a value which is about half the supply voltage over the multiphasic stimulus pulse, claim 1 is additionally rejected under 35 U.S.C. 103 as follows:
Marnfeldt discloses an implantable pulse generator (abstract) that, like the implantable neural stimulation device of Single, utilizes stimulation electrodes ([0004, 0125]; Fig. 15: E1 and E2) to deliver a biphasic (i.e. multiphasic) pulse [0014] to evoke and sense a neural response on neural fibers [0126] while maintaining a common mode voltage [0023]. In addition, Marnfeldt discloses wherein the pulse delivered to each electrode is biphasic ([0014, 0057-0061]; Fig. 7B: E1 and E2 pulses are biphasic and symmetrical with respect to each other; i.e. a corresponding voltage on each stimulus electrode varies symmetrically around a value) and wherein a capacitor is placed in each electrode current path.
It would be obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the implantable device of Single by providing wherein a corresponding voltage on each stimulus electrode varies symmetrically around a value and providing each electrode with a capacitor as taught by Marnfeldt because this charge balancing would recover any charge that might be stored on capacitive elements in the electrode current paths by the end of the second phase and allow for charge balancing at each electrode location (Marnfeldt: [0014-0015, 0060-0061]). The proposed combination would yield the modulation circuitry configured to modulate a voltage on the regulation electrode during the delivery of the multiphasic stimulus such that a corresponding voltage on each stimulus electrode varies substantially symmetrically around a value which is about half the supply voltage over the multiphasic stimulus pulse.
In re claim 2, see 35 U.S.C. 103, In re claim 1 regarding the limitation “wherein the voltage on each stimulus electrode varies symmetrically around a value which is about half the supply voltage over the multiphasic stimulus pulse”.
In re claim 3, Single discloses wherein the voltage on each stimulus varies substantially symmetrically about a value which is half (i.e. 50%) of the supply voltage over the multiphasic stimulus pulse (See 35 U.S.C. 103, In re claim 1).
Single lacks:
wherein the voltage on each stimulus electrode varies substantially symmetrically about a value which is between 40 and 60% of the supply voltage over the multiphasic stimulus pulse.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the voltage on each stimulus electrode varies substantially symmetrically about a value which is between 40 and 60% of the supply voltage of the multiphasic stimulus pulse, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. One having ordinary skill in the art would know to optimize the voltage of each stimulus electrode to a desired electrical value [0035, 0036] to properly stimulate neural tissue and the evoke a neural response [0003-0005; 0072] without applying too high of an amplitude, as Single describes when discussing Daly US 20070225767, who applied the entire supply voltage at stimulus and sense electrodes [0011]. In re Aller, 105 USPQ 233.
In re claim 4, see above 35 U.S.C. 103 Rejection, In re claim 3. It would have been obvious to one having ordinary skill in the art at the time the invention was made to wherein the value is between 45% and 55% of the supply voltage over the multiphasic stimulus pulse, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
In re claim 5, see above 35 U.S.C. 103 Rejection, In re claim 3. It would have been obvious to one having ordinary skill in the art at the time the invention was made to wherein the value is between 48% and 52% of the supply voltage over the multiphasic stimulus pulse, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
In re claim 6, see above 35 U.S.C. 103 rejection, In re claim 1 regarding the limitation “wherein the value is 50% of the supply voltage over the multiphasic stimulus pulse”.
In re claim 9, Single discloses,
measurement circuitry comprising a measurement amplifier (Fig. 3: amplifier),
the measurement circuitry being configured to process a signal sensed at a first sense electrode and a second sense electrode of the plurality of electrodes (amplifier has inputs of the two electrodes on the right) subsequent to the delivered multiphasic stimulus pulse (Fig. 2: 210; the measurement amplifier detects a voltage after the stimulus current).
In re claim 10, Single lacks wherein the measurement circuitry comprises one or more shields around respective leads to the measurement amplifier ([0032]: “the operation of the feedback amplifier acts to spatially shield the measurement electrode from the stimulus field”).
In re claim 14, Single discloses a controller ([0041]: “an implanted processor execute a procedure for controlling electrical conditions of neural tissue”).
In re claim 23, a method of stimulating electrically excitable tissue [0021, 0067], the method comprising:
delivering a multiphasic stimulus pulse of current (([0061]: “Device 100 comprises an implanted control unit 110, which controls application of a sequence of neural stimuli”; 0062]: “The stimuli can comprise monophasic or biphasic pulses”, [0092]) from a supply voltage ([0095]: “a single supply”) via two stimulus electrodes (Fig. 1: 122; Fig. 14: two electrodes on right; [0061, 0093]: “each of which may be selectively used as the stimulus electrode”) of a plurality of electrodes (Fig. 1: 122; Fig. 14: the five electrodes) to the electrically excitable tissue ([0067]: “spinal cord”) in order to evoke a neural response on a neural pathway in the electrically excitable tissue ([0021, 0067] “an appropriate electrical stimulus 202 will induce nerves to fire, and thereby produces an evoked neural response 206”); and
modulating, with modulation circuitry (Fig. 14: feedback loop with input connected to the supply voltage and ground; [0095]), a voltage on a regulation electrode (Fig. 14: third electrode on the left connected to feedback amplifier;s [0061]: “compensation electrode”) of the plurality of electrodes [0061] during the multiphasic stimulus pulse ([0031]: “during application of the neural stimulus, for example during the entire period of stimulation, the feedback amplifier may operate and be in connection with the feedback sense electrode and compensation electrode”) such that a corresponding voltage on each stimulus electrode is symmetrical to each other ([0095]: “matched positive and negative current drivers”) around a value which is about half the supply voltage over the multiphasic stimulus pulse (Fig. 14: feedback amplifier is input with Vdd/2, i.e. half the supply voltage; [0095]; note: this would bias the voltage on the stimulus electrodes at a value of half the supply voltage).
*Single suggests but is silent in explicitly disclosing:
a corresponding voltage on each stimulus electrode varies substantially symmetrically around a value which is about half the supply voltage over the multiphasic stimulus pulse.
Single discloses wherein the stimulus current applied by two stimulus electrodes is a charge-balanced biphasic pulse ([0062]; note: a positive voltage is matched by an equal amplitude negative voltage, i.e. substantially symmetrical around a value). Additionally, in another embodiment, Single discloses wherein the stimulus electrodes swing in opposite direction (Fig. 8b and 8c; [0084]; i.e. substantially symmetrically around a value) resulting from the circuit of Fig. 6 wherein the electrodes can switch current source (i.e. switch polarity; Fig. 6; [0076]) and the virtual ground (similar in function to the applied value which is about half the supply voltage) is enabled [0084].
It would be obvious to try before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the implantable device of Single by providing wherein a corresponding voltage on each stimulus electrode varies substantially symmetrically around a value which is about half the supply voltage over the multiphasic stimulus pulse as suggested by Single as it would provide electrode with charge balancing (Single: [0062]), ensuring no excess of current being discharged to the tissue and, in the case of the other embodiment, would leave the potential on a measurement electrode unchanged by stimulation improving conditions for measurement of an evoked response (Single: [0078]).
However, in the event that Single lacks a corresponding voltage on each stimulus electrode varies substantially symmetrically around a value which is about half the supply voltage over the multiphasic stimulus pulse, claim 1 is additionally rejected under 35 U.S.C. 103 as follows:
Marnfeldt discloses an implantable pulse generator (abstract) that, like the implantable neural stimulation device of Single, utilizes stimulation electrodes ([0004, 0125]; Fig. 15: E1 and E2) to deliver a biphasic (i.e. multiphasic) pulse [0014] to evoke and sense a neural response on neural fibers [0126] while maintaining a common mode voltage [0023]. In addition, Marnfeldt discloses wherein the pulse delivered to each electrode is biphasic ([0014, 0057-0061]; Fig. 7B: E1 and E2 pulses are biphasic and symmetrical with respect to each other; i.e. a corresponding voltage on each stimulus electrode varies symmetrically around a value) and wherein a capacitor is placed in each electrode current path.
It would be obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the implantable device of Single by providing wherein a corresponding voltage on each stimulus electrode varies symmetrically around a value and providing each electrode with a capacitor as taught by Marnfeldt because this charge balancing would recover any charge that might be stored on capacitive elements in the electrode current paths by the end of the second phase and allow for charge balancing at each electrode location (Marnfeldt: [0014-0015, 0060-0061]). The proposed combination would yield the modulation circuitry configured to modulate a voltage on the regulation electrode during the delivery of the multiphasic stimulus such that a corresponding voltage on each stimulus electrode varies substantially symmetrically around a value which is about half the supply voltage over the multiphasic stimulus pulse.
In re claim 24, see above 35 U.S.C. 103 Rejections, In re claim 2 and 23 as well as 35 U.S.C. 112(d) Rejection, In re claim 24.
In re claim 25, see above 35 U.S.C. 103 Rejection, In re claim 3.
In re claim 26, see above 35 U.S.C. 103 Rejection, In re claim 4.
In re claim 27, see above 35 U.S.C. 103 Rejection, In re claim 5.
In re claim 28, see above 35 U.S.C. 103 Rejection, In re claim 6.
In re claim 31, see above 35 U.S.C. 103 Rejection, In re claim 9.
In re claim 32, see above 35 U.S.C. 103 Rejection, In re claim 10.
Claims 7-8, 11, 15-16, 19-29, 29-30, 33, 36-37, and 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over Single (US 20150313487) in view of Marnfeldt (US 20190299006).
In re claim 7, The implantable device of claim 1, wherein the modulation circuitry comprises a feedback amplifier (Fig. 14: amplifier) with
an output connected to the regulation electrode (Fig. 14: output of feedback amplifier connects to the third electrode from the left),
a first input connected to a value which is about half the supply voltage (positive input of feedback amplifier connects to Vdd/2), and
a second input connected to a feedback sense electrode (Fig. 14: negative input).
Single lacks:
a second input connected to a node connecting the stimulus electrodes.
Marnfeldt discloses an implantable pulse generator (abstract) that, like the implantable neural stimulation device of Single, utilizes stimulation electrodes ([0004, 0125]; Fig. 15: E1 and E2) to deliver a biphasic (i.e. multiphasic) pulse [0014] to evoke and sense a neural response on neural fibers [0126] while maintaining a common mode voltage [0023]. In addition, Marnfeldt discloses wherein an amplifier receives a common mode voltage from a node connecting the stimulus electrode (Fig. 15: node labeled Vcm; [0072]) and an input containing a reference voltage which is between or equal to ground and the compliance voltage (note: compliance voltage must be less than a supply voltage) and can for example be set to VH/2, which is half the compliance voltage (i.e. a value which is about half the supply voltage; Fig. 15: Vref;[0072]).
It would be obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the implantable device of the proposed system by providing wherein a second input of the feedback amplifier is connected to a node connecting the stimulus electrodes as taught by Marnfeldt because it would allow the device to determine if the common mode voltage being output by a regulation electrode has exceeded an allowable maximum and restrict the output voltage of the amplifier accordingly ([0103-0107]).
In re claim 8, the proposed system lacks wherein the regulation electrode is one of the stimulus electrodes.
Single discloses in an alternative embodiment (Fig. 13) wherein a compensation electrode (i.e. regulation electrode) is one of the stimulation electrodes (Fig. 13: second electrode from the left receives negative current and the output of the feedback amplifier; [0095]; the negative current is for stimulation).
It would be obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the implantable device of the proposed system by providing wherein the regulation electrode is one of the stimulus electrodes as taught by the additional embodiment of Single because this would allow a feedback signal of the voltage at the tissue to be sensed separately from location of the applied modulated voltage, decreasing the artefact of the measured signal and allowing the feedback signal to better capture any evoked responses from tissue in addition to the modulated voltage of the regulation electrode (Single: [0075]).
In re claim 11, Single discloses
wherein the modulation circuitry comprises a feedback amplifier (amplifier) with
an output connected to the regulation electrode (Fig. 14: output of feedback amplifier connects to the third electrode from the left),
a first input connected to a value which is about half the supply voltage (positive input of feedback amplifier connects to Vdd/2), and
a second input connected to the regulation electrode (Fig. 14: negative input).
the one or more shields are driven by the feedback amplifier ([0032]: “the operation of the feedback amplifier acts to spatially shield the measurement electrode from the stimulus field”).
Single lacks:
the modulation circuitry comprises a feedback amplifier with
a second input connected to a node connecting the stimulus electrodes; and
Marnfeldt discloses an implantable pulse generator (abstract) that, like the implantable neural stimulation device of Single, utilizes stimulation electrodes ([0004, 0125]; Fig. 15: E1 and E2) to deliver a biphasic (i.e. multiphasic) pulse [0014] to evoke and sense a neural response on neural fibers [0126] while maintaining a common mode voltage [0023]. In addition, Marnfeldt discloses wherein an amplifier receives a common mode voltage from a node connecting the stimulus electrode (Fig. 15: node labeled Vcm; [0072]) and an input containing a reference voltage which is between or equal to ground and the compliance voltage (note: compliance voltage must be less than a supply voltage) and can for example be set to VH/2, which is half the compliance voltage (i.e. a value which is about half the supply voltage; Fig. 15: Vref; [0072]).
It would be obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the implantable device of the proposed system by providing wherein a second input of the feedback amplifier is connected to a node connecting the stimulus electrodes as taught by Marnfeldt because it would allow the device to determine if the common mode voltage being output by a regulation electrode has exceeded an allowable maximum and restrict the output voltage of the amplifier accordingly ([0103-0107]).
In re claim 15, Single lacks wherein the modulation circuitry comprises
a digital-to-analog converter connected to the regulation electrode,
the digital-to- analog converter being controlled by the controller.
Marnfeldt discloses wherein each electrode, including an electrode that drives the common mode voltage; (i.e. modulation circuitry comprises a digital-to-analog converter connected to the regulation electrode) is connected to a PDAC and a NDAC (Fig. 3; [0057, 0075]; i.e. digital-to-analog converter) and wherein the DACs are controlled via control signals of control circuitry ([0051]; i.e. the digital-to-analog converted being controlled by a controller).
It would be obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the implantable device of Single by providing wherein each electrode is connected to DAC circuity, wherein the DACs are controlled by a controller as taught by Marnfeldt because the DAC circuits are able to be activated and digitally programmed to produce the desired current with the correct timing, and a compliance voltage (note: compliance voltage must be less than supply voltage) can be coupled to the PDAC and a ground voltage can be coupled to the NDACs such that the stimulation circuitry is coupled and powered between the compliance voltage and ground, providing a way to maintain the voltage at a value about half of the supply voltage and can for example be set to VH/2, which is half the compliance voltage (i.e. a value which is about half the supply voltage; Fig. 15: Vref;[0072]).
In re claim 16, Single lacks wherein the regulation electrode is one of the stimulus electrodes.
Single discloses in an alternative embodiment (Fig. 13) wherein a compensation electrode (i.e. regulation electrode) is one of the stimulation electrodes (Fig. 13: second electrode from the left receives negative current and the output of the feedback amplifier; [0095]; the negative current is for stimulation).
It would be obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the implantable device of the proposed system by providing wherein the regulation electrode is one of the stimulus electrodes as taught by the additional embodiment of Single because this would allow a feedback signal of the voltage at the tissue to be sensed separately from location of the applied modulated voltage, decreasing the artefact of the measured signal and allowing the feedback signal to better capture any evoked responses from tissue in addition to the modulated voltage of the regulation electrode (Single: [0075]).
In re claim 19, Single lacks wherein the controller is configured to adjust the supply voltage before the pulse generator generates a subsequent multiphasic stimulus pulse.
Marnfeldt discloses wherein a compliance voltage (i.e. supply voltage minus voltage drops) can be adjusted [0062-0063, 0066, 0087] by control circuitry [0112] to engaging in sensing for neural responses (Fig. 13B; [0113-0118]; note: sensing occurs prior to subsequent pulses).
It would be obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the proposed system by providing wherein a compliance voltage is adjusted by a controller before the pulse generator generates a subsequent multiphasic stimulus pulse as taught by Marnfeldt because adjusting the compliance voltage (i.e. supply voltage minus voltage drops; note: supply voltage would be adjusted to accommodate the compliance voltage adjustment; Fig. 19) when voltage drops drop below their minimum values, the DAC will become loaded and be unable to produce its prescribed current (Marnfeldt: [0062]).
In re claim 20, Single lacks:
wherein the controller is configured to adjust the supply voltage to at least an amplitude of the subsequent multiphasic stimulus pulse multiplied by a sum of tissue resistances at the stimulus electrodes.
Marnfeldt discloses wherein a compliance voltage (i.e. supply voltage) is adjusted according to prescribed (i.e. subsequent) amplitudes for a pulse [0092], and the compliance voltage has extra headroom (i.e. ensuring the compliance voltage is at least the determined value; [0092]), and wherein a compliance voltage (i.e. supply voltage) is selected by considering the resistance of the tissue and adjusting the compliance voltage to accommodate the value of the tissue resistance [0096].
It would be obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the proposed system by providing wherein a compliance voltage is adjusted according to prescribed (i.e. subsequent) amplitudes for a pulse, and the compliance voltage has extra headroom, and wherein a compliance voltage is selected by considering the resistance of the tissue and adjusting the compliance voltage to accommodate the value of the tissue resistance as taught by Marnfeldt because each of these factors would influence the amount of voltage required to provide stimulation, and if any/all of these factors required a voltage that exceeds the compliance/supply voltage it would make sense to adjust the supply voltage. Further, it would be obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the proposed system by providing wherein the supply voltage is adjusted to at least an amplitude of the subsequent multiphasic stimulus pulse multiplied by a sum of the tissue resistances a the stimulus electrodes because voltage is equal to current multiplied by resistance, in this case the resistance would be equal to the sum of the resistances by the tissue, and the supply voltage would need to be greater than the calculated voltage to account to voltage lost to voltage drops to be able to provide the compliance voltage required for stimulation [0078-0080].
In re claim 29, see above 35 U.S.C. 104 rejection, In re claim 7.
In re claim 30, see above 35 U.S.C. 103 Rejection, In re claim 8.
In re claim 33, see above 35 U.S.C. 103 Rejection, In re claim 11.
In re claim 36, see above 35 U.S.C. 103 Rejection, In re claim 15.
In re claim 37, see above 35 U.S.C. 103 Rejection, In re claim 16.
In re claim 40, see above 35 U.S.C. 103 Rejection, In re claim 19.
In re claim 41, see above 35 U.S.C. 103 Rejection, In re claim 20.
Claims 12 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Single (US 20150313487) [in view of Marnfeldt (US 20190299006)] in further view of US 20170105646.
In re claim 12, Single lacks wherein the one or more shields are driven by a tissue-connected electrode of the plurality of electrodes via a buffer.
Bryenton discloses a multi-parameter sensor system that, like the implantable neural stimulation device of Single, comprising a sensing electrode (Fig. 7: 702; i.e. a sense electrode of measurement circuitry) that senses physiological signals [0101] that has a protective shield (701). In addition, Bryenton discloses wherein the protective conducting driven shield electrode (701) is driven by a buffer amplifier (703) to be at the same potential as the sensing electrode (i.e. driven by a tissue-connected electrode of the plurality of electrodes).
It would be obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the implantable device of Single by providing wherein the one or more shields are driven by a tissue-connected electrode of the plurality of electrodes via buffer as taught by Bryenton because the buffer can shunt away noise sources from the sensing electrode and reduce the effect of the noise source (Bryenton: [0100]) and provide increased sensitivity and accuracy to measurement at various frequencies (Bryenton: [0101]).
In re claim 34, see above 35 U.S.C. 103 Rejection, In re claim 12.
Claims 13 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Single (US 20150313487) [in view of Marnfeldt (US 20190299006)] in further view of Vincent (WO 2023021633).
In re claim 13, Single lacks wherein the one or more shields are driven by a digital-to-analog-converted control signal.
Vincent discloses a capacitive sensor system for an electronic device configured to sense a contact between an object and a surface that, like the implantable neural stimulation device of Single, senses a signal that corresponds to changes in an amplitude and/or the phase of a reference signal [0003] that has a driven shield (Fig. 3: 308; [0004]). In addition, Vincent discloses wherein the shield is driven by a reference signal generator (312), specifically a DAC that is configured to generate a signal which is output to the driven signal (i.e. digital to analog converted control signal; [0021]).
It would be obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the proposed system by providing wherein the one or more shields are driven by a digital-to-analog converted control signal as taught by Vincent because the DAC can convert an input signal into an analog signal, generating a periodic signal and further vary the analog signal to ramp or step the reference signal driving the one or more shields (Vincent: [0029]; Fig. 4A and 4B) such that the shielding is not limited to one value.
In re claim 35, see above 35 U.S.C. rejection, In re claim 13.
Claims 17-18 and 38-39 are rejected under 35 U.S.C. 103 as being unpatentable over Single (US 20150313487) in view of Marnfeldt (US 20190299006) in further view of Karantonis (US 20190239768)
In re claim 17, Single lacks wherein the multiphasic stimulus pulse is triphasic.
Karantonis discloses an implantable device for delivering neural stimulus [0021], that, like the implantable device disclosed by Single, discloses an array of electrodes including a stimulus electrode to evoke and measure a neural response [0022-0023, 0068] and delivers a charge balanced stimulus [0072]. In addition, Karantonis discloses wherein the neural stimulus pulse is triphasic (Fig. 4: 400; [0072]) and wherein an interphase gap is introduced which allows for variations in the charges delivered between each phase [0088].
It would be obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the proposed system by providing wherein the stimulus pulse is triphasic as taught by Karantonis because triphasic stimuli provides further artefact rejection when combined with artefact reduction techniques in comparison to biphasic stimulus (such as the ones described in Single; [0082, 0085]).
In re claim 18, Single discloses wherein the modulation circuitry is configured to modulate the voltage on the regulation electrode in between stimulation to half the supply voltage ([0031]: feedback amplifier is disconnected from compensation electrode during application of neural stimulus; note: this would mean the feedback amplifier does not modulate a voltage on the compensation electrode during stimulation, and only in between stimulation pulses).
Single lacks:
wherein the modulation circuitry is configured to modulate the voltage on the regulation electrode in between phases of the triphasic stimulus pulse to half the supply voltage.
Karantonis discloses wherein an interphase gap is introduced which allows for variations in the charges delivered between each phase [0088].
It would be obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the proposed system by providing wherein the stimulus pulse is triphasic as taught by Karantonis because the interphase gap allows the charge to be adjusted to accomplish the required charge balancing and reduction in artefact experienced by the recording electrodes. In combination with Single, the voltage would be modulated during such an interphase gap to allow the charges at each electrode during each phase of the triphasic stimulation pulse to be charge balanced and reduce artefact. The proposed combination would yield wherein the modulation circuitry is configured to modulate the voltage on the regulation electrode in between phases of the triphasic stimulus pulse to half the supply voltage.
In re claim 38, see above 35 U.S.C. rejection, In re claim 17.
In re claim 39, see above 35 U.S.C. rejection, In re claim 18.
Claims 21 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Single (US 20150313487) in view of Marnfeldt (US 20190299006) in further view of Single (US 20050077872).
In re claim 21, Single lacks wherein the controller is configured to adjust the supply voltage using a digital-to-analog converter.
Single ‘872 discloses a method of charging a battery of an implantable auditory prosthesis and a corresponding control system (abstract) that, like the implantable device disclosed by Single ‘487, discloses wherein an implantable device outputs a stimulation signal to a nerve [0011, 0054], and that discloses adjusting the supply voltage [0073] as disclosed by Marnfeldt. In addition, Single discloses wherein an input voltage (i.e. supply voltage) can be adjusted via the control of a digital number if a digital to analog converter is used [0079], where the battery voltage is monitored and a number representing the battery voltage is fed to a controller [0073].
It would be obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the proposed system by providing wherein the controller is configured to adjust the supply voltage using a digital-to-analog converter as disclosed by Single because it allows the implantable device to monitor the battery voltage level and switch into a mode where the battery can charge (by closing a switch) when the battery voltage is too low (i.e. when the supply voltage needs to be adjusted; Single: [0036, 0073, 0079].
In re claim 42, see above 35 U.S.C. 103 Rejection, In re claim 21.
Claims 22 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Single (US 20150313487) in view of Marnfeldt (US 20190299006) in further view of Popovic (US 20130090712).
In re claim 22, Single lacks wherein the controller is configured to adjust the supply voltage by controlling a switched-mode power supply.
Popovic discloses a functional electrical stimulation device (abstract) that, like the implantable device of Signle, discloses providing sequential bipolar stimulation via electrodes [0015] and recording neural action potentials [0002], and further discloses adjusting a voltage supply [0082, 0113, 0139] as disclosed by Marnfeldt. In addition, Popovic discloses wherein the supply voltage is adjusted using a switched-mode power supply ([0077, 0139]; Claim 55).
It would be obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the proposed system by providing wherein the supply voltage is adjusted using a switched-mode power supply as taught by Popovic because the switched-mode power supply can lead to significant increases in battery life as compared to other available power supply architectures and allows for efficient DC-DC conversion while providing for potential galvanic isolation between the power source and output and switching on and off can also contribute to energy savings (Popovic: [0077-0078]).
In re claim 43, see above 35 U.S.C. 103 Rejection, In re claim 22.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Wagenbach (US 20200305745) discloses an implantable stimulator device (abstract) wherein a pulse delivered to each electrode is biphasic ([0015]; Fig. 6B: E4 and E5 pulses are symmetrical) to evoke a neural response on neural fibers [0025] and a voltage is maintained at a common mode voltage [].
Steinke (US 20220273953) discloses a compliance voltage management algorithm for a stimulator device (abstract) wherein a compliance voltage (i.e. supply voltage) is selected by taking into account the resistance of the tissue and how it changes over time and adjusting the compliance voltage to accommodate the value of the tissue resistance [0109, 0173] and adjusting the compliance voltage to correspond to the amplitude of prescribed (subsequent) pulses [0171] and wherein the compliance voltage accounts for voltage drop across tissue and across DC-blocking capacitors [0092].
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALLE M WELCH whose telephone number is (571)272-0168. The examiner can normally be reached Mon-Fri, 8:30 am to 5:00 pm..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HALLE MARGARET WELCH/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
Prosecution Insights