DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement(s) filed 09/20/2024, 12/20/2024 and 08/25/2026 has/have been considered by the Examiner.
Response to Arguments
Claims 26 and 36 are newly cancelled. Claims 21-25, 27-35, 37-40 are pending in this action.
Claim Rejections - 35 USC § 103
Applicant's arguments filed 08/13/2026 have been fully considered but they are not persuasive.
Regarding independent claims 21, 31 and 40, Applicant argues:
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The primary reference of Dinsmoor (US 20190388692 A1 – hereinafter Dinsmoor), now used in the 35 USC 102 rejection below, teaches its system to determine, from a sensed evoked signal information, a characteristic value of the evoked signal (paragraph 0077 – “Processing circuitry 214 may receive, via an electrical signal sensed by sensing circuitry 212, information indicative of an ECAP signal (e.g., a numerical value indicating a characteristic of the ECAP in electrical units such as voltage or power) produced in response to the control stimulation”) that occurs at least 2 milliseconds after delivery of the stimulation pulse (paragraph 0042 – “Sensing can last for as long as necessary to detect at least some aspects of the shape and size of the resulting ECAP. For example, sensing can last for a long enough time to allow the polarization and refraction peaks in the ECAP to be detected, which may comprise up to 3 ms for example”), therefore sensing can last as long as 3 milliseconds or more for the system to detect characteristics such as polarization and refraction peaks of the ECAP signal. Dependent claims 22-25, 27-30, 32-35 and 37-39 are further rejected as stated in the rejection below.
Specification
Applicant’s arguments, filed 08/13/2026, with respect to the specification objections have been fully considered and are persuasive. The specification objections of 05/13/2026 have been withdrawn.
Claim Rejections - 35 USC § 101
Applicant’s arguments, filed 08/13/2026, with respect to the 35 USC § 101 rejection of claim 40 have been fully considered and are persuasive. The claim 40 rejection under 35 USC § 101 of 05/13/2026 has been withdrawn.
Double Patenting/Terminal Disclaimer
The terminal disclaimer filed on 08/13/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent 12,036412 B2, and U.S. Patent 11,707,626 B2 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Interpretation
In accordance to MPEP 2111.04, such term(s) as “configured to” in the claim(s) do not limit claim scope to the particular function performed, and merely suggest optional functionality since the claim does not introduce any structure that positively recites and limits the features of the invention for exclusive use as intended. Absent limiting structural features, limitations following said clauses will be interpreted as recitations of intended use, wherein prior art will be evaluated based on its capability of performing and its suitability for the intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim, Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
According to MPEP 2112.02, a prior art device anticipates a claimed process if the device carries out the process during normal operation. Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). Furthermore, where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, that the reference does not describe the recited effect in haec verba is of no significance as the reference meets the claim under the doctrine of inherency. Ex parte Novitski, 26 USPQ2d 1389, 1390-91 (BdPatApp & Inter 1993). Furthermore, the employment of the claimed steps must inherently produce the same intended results else the claims are incomplete for failing to recite a critical aspect of the invention.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 21, 25, 28-31, 35, 38-40 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Dinsmoor (US 20190388692 A1 – hereinafter Dinsmoor).
Re. claim 21, Dinsmoor teaches a system comprising:
processing circuitry (figure 2A, processing circuitry 214) configured to:
control stimulation circuitry (paragraph 0068 – “Processing circuitry 214 controls stimulation generator 211 to generate stimulation signals according to therapy stimulation programs 217…”) to deliver a stimulation pulse to a spinal cord of a patient (paragraph 0077 – “According to the techniques of the disclosure, stimulation generator 211 of IMD 200 receives, via telemetry circuitry 213, instructions to deliver electrical stimulation therapy according to therapy stimulation programs 217 to a target tissue site of the spinal cord of the patient via a plurality of electrode combinations of electrodes 232, 234 of leads 230 and/or a housing of IMD 200”);
receive evoked signal information representative of an evoked signal sensed by sensing circuitry (paragraph 0077 – “Processing circuitry 214 may receive, via an electrical signal sensed by sensing circuitry 212, information indicative of an ECAP signal (e.g., a numerical value indicating a characteristic of the ECAP in electrical units such as voltage or power) produced in response to the control stimulation”), the evoked signal being elicited by a stimulation pulse (paragraph 0077 – “Each pulse of a plurality of control pulses may elicit an ECAP that is sensed by sensing circuitry 212 via some of electrodes 232 and 234”);
determine, from the evoked signal information, a characteristic value of the evoked signal (paragraph 0077 – “Processing circuitry 214 may receive, via an electrical signal sensed by sensing circuitry 212, information indicative of an ECAP signal (e.g., a numerical value indicating a characteristic of the ECAP in electrical units such as voltage or power) produced in response to the control stimulation”)
occurring at least 2 milliseconds after delivery of the stimulation pulse (paragraph 0042 – “Sensing can last for as long as necessary to detect at least some aspects of the shape and size of the resulting ECAP. For example, sensing can last for a long enough time to allow the polarization and refraction peaks in the ECAP to be detected, which may comprise up to 3 ms for example”); and
control, based on application of the characteristic value to a closed-loop control policy, delivery of electrical stimulation (paragraph 0006 – “For example, in response to determining that a characteristic of the ECAP signal (e.g., a voltage amplitude) has deviated from a target ECAP characteristic, the system may change one or more stimulation parameters of the next one or more informed pulses and/or control pulses to be delivered to the patient”).
Re. claim 25, Dinsmoor further teaches wherein the processing circuitry is configured to select the additional peak by at least selecting at least one of the P2 peak, the N2 peak, or the N3 peak based on temporal proximity of a stimulus artifact in the evoked signal to at least one of P2 peak, the N2, P3 peak, OR the N3 peak (P2 peak may be selected near a stimulus artifact to identify characteristics of the P2 signal, paragraph 0101 – “In contrast to ECAP signal 392, ECAP signal 394 represents the voltage amplitude detected from a supra-threshold control pulse. Peaks 396 of ECAP signal 394 are detected and represent the artifact of the delivered control pulse. After peaks 396, ECAP signal 394 also includes peaks P1, N1, and P2, which are three typical peaks representative of propagating action potentials from an ECAP…When detecting the ECAP of ECAP signal 394, different characteristics may be identified…In other examples, the characteristic of ECAP signal 394 may be the area under one or more of peaks P1, N1, and/or P2”).
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Re. claim 28, Dinsmoor further teaches wherein the processing circuitry is configured to determine the characteristic value of the evoked signal by at least determining the characteristic value of the evoked signal according to an area under at least one peak of the evoked signal (paragraph 0037 – “In one example, a system may adjust one or more parameters of informed pulses based on sensed ECAP signals. The medical device may determine a representative amplitude of at least one respective ECAP signal. The medical device may then compare the representative amplitude to a target ECAP characteristic (e.g., a target ECAP amplitude or other characteristics such as frequency content, area under one or more peaks”).
Re. claim 29, Dinsmoor further teaches wherein the processing circuitry is configured to: determine a difference between the characteristic value of the evoked signal and a target characteristic value (paragraph 0038 – “A growth curve may be determined for the patient that is determined based on the slope of the relationship between detected values of a characteristic of ECAP signals for respective different stimulation pulse amplitudes. Therefore, the medical device may determine a difference between the target ECAP characteristic value (e.g., an amplitude value, area under one or more peaks, frequency content, or maximum and/or minimum peak timing) and a measured ECAP value and multiply the difference by the gain value”);
and calculate, based on the difference, at least one parameter value that at least partially defines the electrical stimulation (paragraph 0038 – “The resulting value can then be used to increase or decrease the previous parameter value that defined the control pulse that resulted in the measured ECAP value”; paragraph 0085 – “Processing circuitry 214, in one example, may change the amplitude of the informed pulses and the control pulses following the at least one respective ECAP inversely proportional to the difference between target ECAP amplitude and the representative amplitude of the at least one respective ECAP”; paragraph 0089 – “For example, ECAP feedback rules 221 may specify that the percentage difference between the representative ECAP amplitude and the target ECAP amplitude is used to inversely adjust the current amplitude of informed pulses to the same proportion as the percentage difference, such as the technique described in FIG. 9”).
Re. claim 30, Dinsmoor further teaches a stimulation generator configured to deliver the electrical stimulation to a patient (figure 2A, stimulation generator 211; paragraph 0065 – “For example, processing circuitry 214 may include fixed-function or programmable circuitry, stimulation generator 211 may include circuitry configured to generate stimulation signals such as pulses or continuous waveforms on one or more channels…”);
the sensing circuitry configured to sense the evoked signal (figure 2A, sensing circuitry 212; paragraph 0077 – “Processing circuitry 214 may receive, via an electrical signal sensed by sensing circuitry 212, information indicative of an ECAP signal (e.g., a numerical value indicating a characteristic of the ECAP in electrical units such as voltage or power) produced in response to the control stimulation”); and an implantable medical device comprising the processing circuitry, the stimulation generator, and the sensing circuitry (figure 2A, IMD 200).
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Re. claim 31, Dinsmoor teaches a method comprising:
controlling, by processing circuitry, stimulation circuitry (paragraph 0068 – “Processing circuitry 214 controls stimulation generator 211 to generate stimulation signals according to therapy stimulation programs 217…”) to deliver a stimulation pulse to a spinal cord of a patient (paragraph 0077 – “According to the techniques of the disclosure, stimulation generator 211 of IMD 200 receives, via telemetry circuitry 213, instructions to deliver electrical stimulation therapy according to therapy stimulation programs 217 to a target tissue site of the spinal cord of the patient via a plurality of electrode combinations of electrodes 232, 234 of leads 230 and/or a housing of IMD 200”);
receiving, by processing circuitry, signal information representative of an evoked signal sensed by sensing circuitry (paragraph 0077 – “Processing circuitry 214 may receive, via an electrical signal sensed by sensing circuitry 212, information indicative of an ECAP signal (e.g., a numerical value indicating a characteristic of the ECAP in electrical units such as voltage or power) produced in response to the control stimulation”),
the evoked signal being elicited by a stimulation pulse (paragraph 0077 – “Each pulse of a plurality of control pulses may elicit an ECAP that is sensed by sensing circuitry 212 via some of electrodes 232 and 234”);
determining, by the processing circuitry and from the evoked signal information, a characteristic value of the evoked signal (paragraph 0077 – “Processing circuitry 214 may receive, via an electrical signal sensed by sensing circuitry 212, information indicative of an ECAP signal (e.g., a numerical value indicating a characteristic of the ECAP in electrical units such as voltage or power) produced in response to the control stimulation”)
occurring at least 2 milliseconds after delivery of the stimulation pulse (paragraph 0042 – “Sensing can last for as long as necessary to detect at least some aspects of the shape and size of the resulting ECAP. For example, sensing can last for a long enough time to allow the polarization and refraction peaks in the ECAP to be detected, which may comprise up to 3 ms for example”);
and controlling, by the processing circuitry and based on application of the characteristic value to a closed-loop control policy, delivery of electrical stimulation (paragraph 0006 – “For example, in response to determining that a characteristic of the ECAP signal (e.g., a voltage amplitude) has deviated from a target ECAP characteristic, the system may change one or more stimulation parameters of the next one or more informed pulses and/or control pulses to be delivered to the patient”).
Re. claim 35, Dinsmoor further teaches wherein selecting the additional peak by at least selecting at least one of the P2 peak, the N2 peak, or the N3 peak based on temporal proximity of a stimulus artifact in the evoked signal to at least one of P2 peak, the N2, P3 peak, OR the N3 peak (P2 peak may be selected near a stimulus artifact to identify characteristics of the P2 signal, paragraph 0101 – “In contrast to ECAP signal 392, ECAP signal 394 represents the voltage amplitude detected from a supra-threshold control pulse. Peaks 396 of ECAP signal 394 are detected and represent the artifact of the delivered control pulse. After peaks 396, ECAP signal 394 also includes peaks P1, N1, and P2, which are three typical peaks representative of propagating action potentials from an ECAP…When detecting the ECAP of ECAP signal 394, different characteristics may be identified…In other examples, the characteristic of ECAP signal 394 may be the area under one or more of peaks P1, N1, and/or P2”).
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Re. claim 38, Dinsmoor further teaches wherein determining the characteristic value of the evoked signal comprises determining the characteristic value of the evoked signal according to an area under at least one peak of the evoked signal (paragraph 0037 – “In one example, a system may adjust one or more parameters of informed pulses based on sensed ECAP signals. The medical device may determine a representative amplitude of at least one respective ECAP signal. The medical device may then compare the representative amplitude to a target ECAP characteristic (e.g., a target ECAP amplitude or other characteristics such as frequency content, area under one or more peaks”).
Re. claim 39, Dinsmoor further teaches determining a difference between the characteristic value of the evoked signal and a target characteristic value (paragraph 0038 – “A growth curve may be determined for the patient that is determined based on the slope of the relationship between detected values of a characteristic of ECAP signals for respective different stimulation pulse amplitudes. Therefore, the medical device may determine a difference between the target ECAP characteristic value (e.g., an amplitude value, area under one or more peaks, frequency content, or maximum and/or minimum peak timing) and a measured ECAP value and multiply the difference by the gain value”);
and calculating, based on the difference, at least one parameter value that at least partially defines the electrical stimulation (paragraph 0038 – “The resulting value can then be used to increase or decrease the previous parameter value that defined the control pulse that resulted in the measured ECAP value”; paragraph 0085 – “Processing circuitry 214, in one example, may change the amplitude of the informed pulses and the control pulses following the at least one respective ECAP inversely proportional to the difference between target ECAP amplitude and the representative amplitude of the at least one respective ECAP”; paragraph 0089 – “For example, ECAP feedback rules 221 may specify that the percentage difference between the representative ECAP amplitude and the target ECAP amplitude is used to inversely adjust the current amplitude of informed pulses to the same proportion as the percentage difference, such as the technique described in FIG. 9”).
Re. claim 40, Dinsmoor teaches a non-transitory computer-readable medium (figure 2A, memory 215) comprising instructions that, when executed, causes processing circuitry (paragraph 0010 – “…a computer-readable storage medium comprising instructions that, when executed, cause one or more processors to…”) to:
control stimulation circuitry (paragraph 0068 – “Processing circuitry 214 controls stimulation generator 211 to generate stimulation signals according to therapy stimulation programs 217…”) to deliver a stimulation pulse to a spinal cord of a patient (paragraph 0077 – “According to the techniques of the disclosure, stimulation generator 211 of IMD 200 receives, via telemetry circuitry 213, instructions to deliver electrical stimulation therapy according to therapy stimulation programs 217 to a target tissue site of the spinal cord of the patient via a plurality of electrode combinations of electrodes 232, 234 of leads 230 and/or a housing of IMD 200”);
receive signal information representative of an evoked signal sensed by sensing circuitry (paragraph 0077 – “Processing circuitry 214 may receive, via an electrical signal sensed by sensing circuitry 212, information indicative of an ECAP signal (e.g., a numerical value indicating a characteristic of the ECAP in electrical units such as voltage or power) produced in response to the control stimulation”),
the evoked signal being elicited by a stimulation pulse (paragraph 0077 – “Each pulse of a plurality of control pulses may elicit an ECAP that is sensed by sensing circuitry 212 via some of electrodes 232 and 234”);
determine, from the evoked signal information, a characteristic value of the evoked signal (paragraph 0077 – “Processing circuitry 214 may receive, via an electrical signal sensed by sensing circuitry 212, information indicative of an ECAP signal (e.g., a numerical value indicating a characteristic of the ECAP in electrical units such as voltage or power) produced in response to the control stimulation”)
occurring at least 2 milliseconds after delivery of the stimulation pulse (paragraph 0042 – “Sensing can last for as long as necessary to detect at least some aspects of the shape and size of the resulting ECAP. For example, sensing can last for a long enough time to allow the polarization and refraction peaks in the ECAP to be detected, which may comprise up to 3 ms for example”);
and control, based on application of the characteristic value to a closed-loop control policy, delivery of electrical stimulation (paragraph 0006 – “For example, in response to determining that a characteristic of the ECAP signal (e.g., a voltage amplitude) has deviated from a target ECAP characteristic, the system may change one or more stimulation parameters of the next one or more informed pulses and/or control pulses to be delivered to the patient”).
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) 22-24 and 32-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor (US 20190388692 A1 – hereinafter Dinsmoor) in view of Schwarz (US 20160199642 A1 – hereinafter Schwarz).
Re. claim 22, Dinsmoor teaches the system of claim 21 as stated above, including sensing ECAP signals comprising a P2 peak (figure 3) and determining, from the evoked signal information, the characteristic value of the evoked signal (paragraph 0013 – “In another example, a computer-readable storage medium comprising instructions that, when executed, causes one or more processors to control delivery of a control stimulation pulse to a patient, the control stimulation pulse having a first pulse width, sense an evoked compound action potential (ECAP) signal elicited by the control stimulation pulse, identify a characteristic of the ECAP signal…”; see also paragraph 0077 - “Processing circuitry 214 may receive, via an electrical signal sensed by sensing circuitry 212, information indicative of an ECAP signal (e.g., a numerical value indicating a characteristic of the ECAP in electrical units such as voltage or power) produced in response to the control stimulation”),
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but does not expressly include the P3 peak of the ECAP signal.
Schwarz similarly teaches an ECAP signal measurement system (abstract – “A system for frequency matching a cochlear implant during fitting includes a tissue stimulation device configured to generate a tonal stimulus to mask efferent nerve fibers in a subject, one or more response measurement contacts configured to measure CAP signals during and outside of a refractory period, a frequency matching module in communication with the response measurement contacts and configured to receive the CAP signals …”),
and further teaches the known technique of measuring ECAP signals comprising P2 AND P3 peaks (paragraph 0008 – “These recordings show characteristic minima (N1, N2) and maxima (P1, P2, P3), where the difference in amplitude between P2−N1 (eCAP-amplitude) of the recorded signal is of special interest”).
Dinsmoor and Schwarz all teach within the field of ECAP sensing systems, with Dinsmoor teaching the sensed ECAP signal including a P2 peak and ECAP signal characteristic determination, while Schwarz teaches the known technique of sensing ECAP signals comprising an P2 peak AS WELL AS a P3 peak. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensed ECAP signal and ECAP characteristic determination of Dinsmoor, to try incorporating the sensed ECAP signal including the P3 peak as taught by Schwarz, since such modification would predictably result in allowing optimized stimulation parameters based on the ECAP signals according to a P3 peak.
Re. claim 23, Dinsmoor further teaches the processing circuitry is configured to determine the characteristic value of the evoked signal, and determining the characteristic value of the evoked signal based on the evoked signal instead of an N1 peak of the evoked signal or a P2 peak of the evoked signal as stated above (paragraph 0077 – “Processing circuitry 214 may receive, via an electrical signal sensed by sensing circuitry 212, information indicative of an ECAP signal (e.g., a numerical value indicating a characteristic of the ECAP in electrical units such as voltage or power) produced in response to the control stimulation”), but does not expressly include the P3 peak of the ECAP signal.
Schwarz similarly teaches an ECAP signal measurement system (abstract – “A system for frequency matching a cochlear implant during fitting includes a tissue stimulation device configured to generate a tonal stimulus to mask efferent nerve fibers in a subject, one or more response measurement contacts configured to measure CAP signals during and outside of a refractory period, a frequency matching module in communication with the response measurement contacts and configured to receive the CAP signals …”),
and further teaches the known technique of measuring ECAP signals comprising P2 AND P3 peaks (paragraph 0008 – “These recordings show characteristic minima (N1, N2) and maxima (P1, P2, P3), where the difference in amplitude between P2−N1 (eCAP-amplitude) of the recorded signal is of special interest”).
Dinsmoor and Schwarz all teach within the field of ECAP sensing systems, with Dinsmoor teaching the sensed ECAP signal including a P2 peak and ECAP signal characteristic determination, while Schwarz teaches the known technique of sensing ECAP signals comprising an P2 peak AS WELL AS a P3 peak. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensed ECAP signal and ECAP characteristic determination of Dinsmoor, to try incorporating the sensed ECAP signal including the P3 peak as taught by Schwarz, since such modification would predictably result in allowing optimized stimulation parameters based on the ECAP signals according to a P3 peak.
Re. claim 24, Dinsmoor further teaches the processing circuitry is configured to select an additional peak from at least one of a P2 peak, an N2 peak, OR an N3 peak (paragraph 0101 – “When detecting the ECAP of ECAP signal 394, different characteristics may be identified. For example, the characteristic of the ECAP may be the amplitude between N1 and P2…In some examples, the characteristic of the ECAP used to control informed pulses may be a sum of two or more of peaks P1, N1, or P2. In other examples, the characteristic of ECAP signal 394 may be the area under one or more of peaks P1, N1, and/or P2. In other examples, the characteristic of the ECAP may be a ratio of one of peaks P1, N1, or P2 to another one of the peaks”),
based on a pulse width of a stimulation pulse that elicited the evoked signal (paragraph 0032 – “A system can monitor changes in the characteristic of the ECAP signal and use that change in the characteristic to adjust one or more stimulation parameter of the informed pulses and/or control pulses delivered to the patient. For example, the system can reduce the intensity of stimulation pulses (e.g., reduce a current amplitude and/or pulse width) in response to detecting an increase in an amplitude of an ECAP signal”; paragraph 0059 – “The amount of action potentials (e.g., number of neurons propagating action potential signals) that are evoked may be based on the various parameters of electrical stimulation pulses such as amplitude, pulse width…”),
and the processing circuitry is configured to determine the characteristic value by at least determining the characteristic value of the evoked signal based on the additional peak (paragraph 0101 – “When detecting the ECAP of ECAP signal 394, different characteristics may be identified. For example, the characteristic of the ECAP may be the amplitude between N1 and P2…In some examples, the characteristic of the ECAP used to control informed pulses may be a sum of two or more of peaks P1, N1, or P2. In other examples, the characteristic of ECAP signal 394 may be the area under one or more of peaks P1, N1, and/or P2. In other examples, the characteristic of the ECAP may be a ratio of one of peaks P1, N1, or P2 to another one of the peaks”).
Dinsmoor does not expressly include the P3 peak of the ECAP signal.
Schwarz similarly teaches an ECAP signal measurement system (abstract – “A system for frequency matching a cochlear implant during fitting includes a tissue stimulation device configured to generate a tonal stimulus to mask efferent nerve fibers in a subject, one or more response measurement contacts configured to measure CAP signals during and outside of a refractory period, a frequency matching module in communication with the response measurement contacts and configured to receive the CAP signals …”),
and further teaches the known technique of measuring ECAP signals comprising P2 AND P3 peaks (paragraph 0008 – “These recordings show characteristic minima (N1, N2) and maxima (P1, P2, P3), where the difference in amplitude between P2−N1 (eCAP-amplitude) of the recorded signal is of special interest”).
Dinsmoor and Schwarz all teach within the field of ECAP sensing systems, with Dinsmoor teaching the sensed ECAP signal including a P2 peak and ECAP signal characteristic determination, while Schwarz teaches the known technique of sensing ECAP signals comprising an P2 peak AS WELL AS a P3 peak. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensed ECAP signal and ECAP characteristic determination of Dinsmoor, to try incorporating the sensed ECAP signal including the P3 peak as taught by Schwarz, since such modification would predictably result in allowing optimized stimulation parameters based on the ECAP signals according to a P3 peak.
Re. claim 32, Dinsmoor teaches the method of claim 31 as stated above, and further teaches sensing ECAP signals comprising a P2 peak (figure 3) and determining, from the evoked signal information, the characteristic value of the evoked signal (paragraph 0013 – “In another example, a computer-readable storage medium comprising instructions that, when executed, causes one or more processors to control delivery of a control stimulation pulse to a patient, the control stimulation pulse having a first pulse width, sense an evoked compound action potential (ECAP) signal elicited by the control stimulation pulse, identify a characteristic of the ECAP signal…”; see also paragraph 0077 - “Processing circuitry 214 may receive, via an electrical signal sensed by sensing circuitry 212, information indicative of an ECAP signal (e.g., a numerical value indicating a characteristic of the ECAP in electrical units such as voltage or power) produced in response to the control stimulation”),
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but does not expressly include the P3 peak of the ECAP signal.
Schwarz similarly teaches an ECAP signal measurement system (abstract – “A system for frequency matching a cochlear implant during fitting includes a tissue stimulation device configured to generate a tonal stimulus to mask efferent nerve fibers in a subject, one or more response measurement contacts configured to measure CAP signals during and outside of a refractory period, a frequency matching module in communication with the response measurement contacts and configured to receive the CAP signals …”),
and further teaches the known technique of measuring ECAP signals comprising P2 AND P3 peaks (paragraph 0008 – “These recordings show characteristic minima (N1, N2) and maxima (P1, P2, P3), where the difference in amplitude between P2−N1 (eCAP-amplitude) of the recorded signal is of special interest”).
Dinsmoor and Schwarz all teach within the field of ECAP sensing systems, with Dinsmoor teaching the sensed ECAP signal including a P2 peak and ECAP signal characteristic determination, while Schwarz teaches the known technique of sensing ECAP signals comprising an P2 peak AS WELL AS a P3 peak. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensed ECAP signal and ECAP characteristic determination of Dinsmoor, to try incorporating the sensed ECAP signal including the P3 peak as taught by Schwarz, since such modification would predictably result in allowing optimized stimulation parameters based on the ECAP signals according to a P3 peak.
Re. claim 33, Dinsmoor further teaches determining the characteristic value of the evoked signal, and determining the characteristic value of the evoked signal based on the evoked signal instead of an N1 peak of the evoked signal or a P2 peak of the evoked signal as stated above (paragraph 0077 – “Processing circuitry 214 may receive, via an electrical signal sensed by sensing circuitry 212, information indicative of an ECAP signal (e.g., a numerical value indicating a characteristic of the ECAP in electrical units such as voltage or power) produced in response to the control stimulation”), but does not expressly include the P3 peak of the ECAP signal.
Schwarz similarly teaches an ECAP signal measurement system (abstract – “A system for frequency matching a cochlear implant during fitting includes a tissue stimulation device configured to generate a tonal stimulus to mask efferent nerve fibers in a subject, one or more response measurement contacts configured to measure CAP signals during and outside of a refractory period, a frequency matching module in communication with the response measurement contacts and configured to receive the CAP signals …”),
and further teaches the known technique of measuring ECAP signals comprising P2 AND P3 peaks (paragraph 0008 – “These recordings show characteristic minima (N1, N2) and maxima (P1, P2, P3), where the difference in amplitude between P2−N1 (eCAP-amplitude) of the recorded signal is of special interest”).
Dinsmoor and Schwarz all teach within the field of ECAP sensing systems, with Dinsmoor teaching the sensed ECAP signal including a P2 peak and ECAP signal characteristic determination, while Schwarz teaches the known technique of sensing ECAP signals comprising an P2 peak AS WELL AS a P3 peak. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensed ECAP signal and ECAP characteristic determination of Dinsmoor, to incorporate the sensed ECAP signal including the P3 peak as taught by Schwarz, since such modification would predictably result in allowing optimized stimulation parameters based on the ECAP signals according to a P3 peak.
Re. claim 34, Dinsmoor further teaches selecting an additional peak from at least one of a P2 peak, an N2 peak, OR an N3 peak (paragraph 0101 – “When detecting the ECAP of ECAP signal 394, different characteristics may be identified. For example, the characteristic of the ECAP may be the amplitude between N1 and P2…In some examples, the characteristic of the ECAP used to control informed pulses may be a sum of two or more of peaks P1, N1, or P2. In other examples, the characteristic of ECAP signal 394 may be the area under one or more of peaks P1, N1, and/or P2. In other examples, the characteristic of the ECAP may be a ratio of one of peaks P1, N1, or P2 to another one of the peaks”),
based on a pulse width of a stimulation pulse that elicited the evoked signal (paragraph 0032 – “A system can monitor changes in the characteristic of the ECAP signal and use that change in the characteristic to adjust one or more stimulation parameter of the informed pulses and/or control pulses delivered to the patient. For example, the system can reduce the intensity of stimulation pulses (e.g., reduce a current amplitude and/or pulse width) in response to detecting an increase in an amplitude of an ECAP signal”; paragraph 0059 – “The amount of action potentials (e.g., number of neurons propagating action potential signals) that are evoked may be based on the various parameters of electrical stimulation pulses such as amplitude, pulse width…”),
and determining the characteristic value by at least determining the characteristic value of the evoked signal based on the additional peak (paragraph 0101 – “When detecting the ECAP of ECAP signal 394, different characteristics may be identified. For example, the characteristic of the ECAP may be the amplitude between N1 and P2…In some examples, the characteristic of the ECAP used to control informed pulses may be a sum of two or more of peaks P1, N1, or P2. In other examples, the characteristic of ECAP signal 394 may be the area under one or more of peaks P1, N1, and/or P2. In other examples, the characteristic of the ECAP may be a ratio of one of peaks P1, N1, or P2 to another one of the peaks”).
Dinsmoor does not expressly include the P3 peak of the ECAP signal.
Schwarz similarly teaches an ECAP signal measurement system (abstract – “A system for frequency matching a cochlear implant during fitting includes a tissue stimulation device configured to generate a tonal stimulus to mask efferent nerve fibers in a subject, one or more response measurement contacts configured to measure CAP signals during and outside of a refractory period, a frequency matching module in communication with the response measurement contacts and configured to receive the CAP signals …”),
and further teaches the known technique of measuring ECAP signals comprising P2 AND P3 peaks (paragraph 0008 – “These recordings show characteristic minima (N1, N2) and maxima (P1, P2, P3), where the difference in amplitude between P2−N1 (eCAP-amplitude) of the recorded signal is of special interest”).
Dinsmoor and Schwarz all teach within the field of ECAP sensing systems, with Dinsmoor teaching the sensed ECAP signal including a P2 peak and ECAP signal characteristic determination, while Schwarz teaches the known technique of sensing ECAP signals comprising an P2 peak AS WELL AS a P3 peak. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensed ECAP signal and ECAP characteristic determination of Dinsmoor, to incorporate the sensed ECAP signal including the P3 peak as taught by Schwarz, since such modification would predictably result in allowing optimized stimulation parameters based on the ECAP signals according to a P3 peak.
Claim(s) 27 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor (US 20190388692 A1 – hereinafter Dinsmoor) in view of Esteller (US 20190099602 A1 – hereinafter Esteller), and in further view of Schwarz (US 20160199642 A1 – hereinafter Schwarz).
Re. claim 27, Dinsmoor teaches the claimed invention of claim 21 as stated above, but does not expressly teach wherein the processing circuitry is configured to determine the characteristic value of the evoked signal by at least determining the characteristic value of the evoked signal as an amplitude of an N2 peak.
Esteller teaches a similar ECAP measuring system (paragraph 0086 – “…an ECAP algorithm 124b is included in the external device, which can receive information from the IPG 100 (or ETS 170) regarding the ECAPs it measures, process the ECAP…”; paragraph 0089 – “Once at received at the external device, ECAP algorithm 124b will process the received ECAP information as necessary…”) comprising processing circuitry (paragraph 0031 – “Other types of control circuitry may be used in lieu of a microcontroller as well, such as microprocessors, FPGAs, DSPs, or combinations of these, etc.”), and further teaches determining that the ECAP signal includes the N2 peak (figure 13 shows the N2 peak);
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And teaches wherein the processing circuitry is configured to:
determine the characteristic value of the ECAP signal by at least determining the characteristic value of the ECAP signal as an amplitude between the N2 peak and another peak (features of any peak(s) in the ECAP, including the amplitude between N2 peak and another peak, can be determined as discussed in paragraph 0066 – “Next, at least one ECAP feature is determined (step 148) from the measured ECAP(s) indicative of the size and shape of the ECAP. Various features for an ECAP are shown in FIG. 13. These include (but are not limited to)…[0067] a height of any peak (e.g., H_N1) present in the ECAP; [0068] a peak-to-peak height between any two peaks (such as H_PtoP from N1 to P2); [0069] a ratio of peak heights (e.g., H_N1/H_P2); [0070] a peak width of any peak (e.g., the full width half maximum of a N1, FWHM_N1); [0071] an area under any peak (e.g., A_N1); [0072] a total area (A_tot) comprising the area under positive peaks with the area under negative peaks subtracted or added; ; [0073] a length of any portion of the curve of the ECAP (e.g., the length of the curve from P1 to N2, L_P1to N2) [0074] any time defining the duration of at least a portion of the ECAP (e.g., the time from P1 to N2, t_P1 to N2)”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ECAP measuring system of Dinsmoor, to incorporate the characteristic value determination based on the N2 peak of the ECAP signal including the peak-to-peak height as taught by Esteller, since such modification would predictably result in optimizing stimulation parameters based on the P2 peak of the sensed ECAP signal (Esteller figure 11, steps 152 and 154).
The combined invention of Dinsmoor and Esteller (hereinafter the combined invention) shows the N2 and P2 peaks (Esteller figure 13), but does not expressly teach the P3 peak.
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Schwarz teaches an ECAP signal measurement system (abstract – “A system for frequency matching a cochlear implant during fitting includes a tissue stimulation device configured to generate a tonal stimulus to mask efferent nerve fibers in a subject, one or more response measurement contacts configured to measure CAP signals during and outside of a refractory period, a frequency matching module in communication with the response measurement contacts and configured to receive the CAP signals …”),
and further teaches the known technique of measuring ECAP signals comprising N2 AND P3 peaks (paragraph 0008 – “These recordings show characteristic minima (N1, N2) and maxima (P1, P2, P3), where the difference in amplitude between P2−N1 (eCAP-amplitude) of the recorded signal is of special interest”).
The combined invention and Schwarz all teach within the field of ECAP sensing systems; Esteller of the combined invention in particular teaches the ECAP signals comprising the P2 and N2 peaks as well as determining the characteristic value of the ECAP signal as an amplitude between the N2 peak and another peak as stated above, while Schwarz teaches the known element of sensing ECAP signals comprising an N2 peak AS WELL AS a P3 peak. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method and sensed ECAP signal of the combined invention, to incorporate the sensed ECAP signal including the P3 peak as taught by Schwarz, since such modification would predictably result in allowing optimized stimulation parameters based on the ECAP signals.
Re. claim 37, Dinsmoor teaches the claimed invention of claim 31 as stated above, but does not expressly teach wherein determining the characteristic value of the evoked signal comprises determining the characteristic value of the evoked signal as an amplitude of an N2 peak.
Esteller teaches a similar ECAP measuring system (paragraph 0086 – “…an ECAP algorithm 124b is included in the external device, which can receive information from the IPG 100 (or ETS 170) regarding the ECAPs it measures, process the ECAP…”; paragraph 0089 – “Once at received at the external device, ECAP algorithm 124b will process the received ECAP information as necessary…”) comprising processing circuitry (paragraph 0031 – “Other types of control circuitry may be used in lieu of a microcontroller as well, such as microprocessors, FPGAs, DSPs, or combinations of these, etc.”), and further teaches determining that the ECAP signal includes the N2 peak (figure 13 shows the N2 peak);
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And determining the characteristic value of the ECAP signal by at least determining the characteristic value of the ECAP signal as an amplitude between the N2 peak and another peak (features of any peak(s) in the ECAP, including the amplitude between N2 peak and another peak, can be determined as discussed in paragraph 0066 – “Next, at least one ECAP feature is determined (step 148) from the measured ECAP(s) indicative of the size and shape of the ECAP. Various features for an ECAP are shown in FIG. 13. These include (but are not limited to)…[0067] a height of any peak (e.g., H_N1) present in the ECAP; [0068] a peak-to-peak height between any two peaks (such as H_PtoP from N1 to P2); [0069] a ratio of peak heights (e.g., H_N1/H_P2); [0070] a peak width of any peak (e.g., the full width half maximum of a N1, FWHM_N1); [0071] an area under any peak (e.g., A_N1); [0072] a total area (A_tot) comprising the area under positive peaks with the area under negative peaks subtracted or added; ; [0073] a length of any portion of the curve of the ECAP (e.g., the length of the curve from P1 to N2, L_P1to N2) [0074] any time defining the duration of at least a portion of the ECAP (e.g., the time from P1 to N2, t_P1 to N2)”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ECAP measuring system/method of Dinsmoor, to incorporate the characteristic value determination based on the N2 peak of the ECAP signal including the peak-to-peak height as taught by Esteller, since such modification would predictably result in optimizing stimulation parameters based on the P2 peak of the sensed ECAP signal (Esteller figure 11, steps 152 and 154).
The combined invention of Dinsmoor and Esteller (hereinafter the combined invention) shows the N2 and P2 peaks (Esteller figure 13), but does not expressly teach the P3 peak.
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Schwarz teaches an ECAP signal measurement system (abstract – “A system for frequency matching a cochlear implant during fitting includes a tissue stimulation device configured to generate a tonal stimulus to mask efferent nerve fibers in a subject, one or more response measurement contacts configured to measure CAP signals during and outside of a refractory period, a frequency matching module in communication with the response measurement contacts and configured to receive the CAP signals …”),
and further teaches the known technique of measuring ECAP signals comprising N2 AND P3 peaks (paragraph 0008 – “These recordings show characteristic minima (N1, N2) and maxima (P1, P2, P3), where the difference in amplitude between P2−N1 (eCAP-amplitude) of the recorded signal is of special interest”).
The combined invention and Schwarz all teach within the field of ECAP sensing systems; Esteller of the combined invention in particular teaches the ECAP signals comprising the P2 and N2 peaks as well as determining the characteristic value of the ECAP signal as an amplitude between the N2 peak and another peak as stated above, while Schwarz teaches the known element of sensing ECAP signals comprising an N2 peak AS WELL AS a P3 peak. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method and sensed ECAP signal of the combined invention, to incorporate the sensed ECAP signal including the P3 peak as taught by Schwarz, since such modification would predictably result in allowing optimized stimulation parameters based on the ECAP signals.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ANH-KHOA N DINH/Examiner, Art Unit 3796
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