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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/01/2026 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 07/01/2026. As directed by the amendment: Claims 1, 12, and 20 have been amended, claims 5 and 16 have been cancelled, and claims 21-22 have been added. Thus, claims 1-4, 6-15, and 17-22 are presently under consideration in this application.
Response to Arguments
Applicant's arguments, see pages 8-11, filed 07/01/2026, regarding 35 U.S.C. 103 have been fully considered but they are not persuasive. Applicant asserts on pages 8-9 that “The Office cited FIG. 5, including reference numeral 536A-N, and argued that it "shows a dashed square showing a start time of the window following a stimulation 538A-B." However, the Office has not cited any actual evidence to support this contention. In paragraph [0113], Dinsmoor (collectively "ECAPs 536"). According to this disclosure, Dinsmoor describes the dashed square as indicating ECAP signals. The Office has not cited any evidence that the dashed squares describe any sensing window.
The Office also argued that "Fig. 3 [of Dinsmoor] show[s] the delay following the control pulse and the beginning of the ECAP signal" and that "Dinsmoor teaches the delayed time from the control pulse to the start of the ECAP."³ Applicant respectfully notes that the Office has not cited any evidence to this contention. As shown below in FIG. 3 reproduced from Dinsmoor, it is unclear where any "delay" occurs between a control pulse and the ECAP signal. Instead of any delay, FIG. 3 indicates a continuous waveform. Since the Office has not cited any passage of Dinsmoor that discloses starting a sensing window after a delay from delivery of a stimulation pulse or a delay between a stimulation pulse and start of an ECAP”.
Applicant then asserts on 11 that “The applied references, alone or in any proper combination, do not disclose or suggest the subject matter recited by Applicant's claims, and there would have been no apparent reason that would have caused one of ordinary skill in the art to modify the techniques, systems, or devices described by the applied references to arrive at the claimed subject matter.”
Examiner disagrees because the Office Action cited the Abstract of Dinsmoor that teaches “The system may also be configured to sense, after one or more control pulses and prior to an immediately subsequent therapy pulse of the plurality of therapy pulses [sensing window], a respective evoked compound action potential (ECAP)” as the sensing window, which is used to adjust future stimulation parameters.
Examiner further disagrees because ECAP latency/delay is well-known in the art, as this is inherent to ECAP signals produced following a stimulation signal, which can be seen in Fig. 3 and [0101] of Dinsmoor. Since it is well-known that an ECAP starts after a delay, it would be obvious to one skilled in the art to make the start time of the sensing window being the delayed start of the ECAP signal, for the purpose of extracting of only ECAP features, 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 Aller, 105 USPQ 233.
Therefore, the rejection is maintained.
Applicant's arguments, see pages 11-12, filed 07/01/2026, regarding Double Patenting have been fully considered but they are persuasive. Amendments to the claim obviate the rejection of record. Therefore, the rejection is withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities: lines 8-9 repeats the phrase “wherein the processing circuitry is configured to” and should be removed as the phrase is recited in line 3. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: lines 8-9 repeats the phrase “wherein the instructions that cause the processing circuitry to select the sensing window comprises instructions that cause the processing circuitry to” and should be removed as the phrase is recited in line 2. Appropriate correction is required.
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)(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) 1, 7-9, 11-12, 18, and 20-22 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Jayakumar et al. (US 12403315)(Hereinafter Jayakumar).
Regarding claims 1, 12, and 20, Jayakumar teaches A system/method/computer readable storage medium (Claims 1, 10, and 16 “A system/method/computer readable storage medium”) comprising:
stimulation circuitry configured to deliver electrical stimulation (Col. 4 lines 58-62 “The implantable pulse generator 14 can have multiple stimulation channels which may be independently programmable to control the magnitude of the current stimulus from each channel. In some embodiments, the implantable pulse generator 14”);
processing circuitry (Claim 10 “at least one processor configured to perform actions”) configured to:
determine a value of a stimulation parameter that at least partially defines an electrical stimulation pulse (Claim 10 “receiving, from a user, at least one limit for each of at least three stimulation parameters, each of the at least three stimulation parameters being different…selecting a one of the at least three stimulation parameters, stimulating tissue of the patient, by the stimulation device, using different first values for the selected one of the at least three stimulation parameters constrained by the at least one limit for the one of the at least three stimulation parameters”);
select, based on the value of the stimulation parameter, a sensing window defining a time for detecting one or more features of a single sensed evoked compound action potential (ECAP) signal elicited by the electrical stimulation pulse (Claim 10 “for each of the different first values, sensing one or more first effects arising in response to the corresponding stimulation including sensing a signal from the stimulated tissue, wherein the signal is an evoked compound action potential (ECAP), evoked resonant neural activity (ERNA), or local field potential (LFP), wherein at least one of the one or more effects is a feature of the signal over a selected range of time, wherein the feature comprises at least one of a range of amplitude of the signal over the selected range of time, an amount of time between a maximum amplitude of the signal and a minimum amplitude of the signal for the selected range of time, an area under a curve of the signal for the selected range of time, or a length of the curve of the signal for the selected range of time”); wherein the processing circuitry is configured to select the sensing window to start after a delay from delivery of the electrical stimulation pulse (Claim 10 “an amount of time between a maximum amplitude of the signal and a minimum amplitude of the signal for the selected range of time, an area under a curve of the signal for the selected range of time, or a length of the curve of the signal for the selected range of time” Examiner notes all of these examples are after a delay from electrical stimulation pulse, and that it is inherent to have a latency following a stimulation for an ECAP.).
determine a value of each of the one or more features within the sensing window and from the single sensed ECAP signal (Claim 10 “selecting a coarse value from the different first values of the one of the at least three stimulation parameters based on the sensed one or more first effects”); and
control, based on the value of each of the one or more features, the stimulation circuitry to deliver subsequent electrical stimulation to a patient (Claim 10 “directing stimulation of tissue of the patient, by the stimulation device, using different second values for the selected one of the at least three stimulation parameters that are within a predefined relative range around the selected coarse value of the one of the at least three stimulation parameters constrained by the at least one limit for the one of the at least three stimulation parameters…after the fine-tuned value is selected for any one of the at least three stimulation parameters, that fine-tuned value is used in subsequent stimulations when performing the actions for another one of the at least three stimulation parameters.”).
Regarding claim 7, Jayakumar teaches wherein the stimulation parameter comprises a current amplitude (Col. 19 lines 1-3 “The implantable pulse generator 14 can have multiple stimulation channels which may be independently programmable to control the magnitude of the current stimulus from each channel.”).
Regarding claim 8, Jayakumar teaches wherein the stimulation parameter comprises a pulse width (Col. 10 lines 26-33 “a treating physician may wish to tailor the stimulation parameters (such as which one or more of the stimulating electrodes to use, the stimulation pulse amplitude (such as current or voltage amplitude depending on the stimulator being used,) the stimulation pulse width, the stimulation frequency, the duty cycle, the stimulation phase, or the like or any combination thereof) for a particular patient.”).
Regarding claims 9 and 18, Jayakumar teaches wherein the processing circuitry is configured to determine, based on the value of the one or more features, an ECAP characteristic value representative of the single sensed ECAP signal (Claim 10 “selecting a coarse value from the different first values of the one of the at least three stimulation parameters based on the sensed one or more first effects”).
Regarding claim 11, Jayakumar teaches further comprising an implantable medical device comprising the processing circuitry and stimulation circuitry configured to generate the electrical stimulation deliverable to the patient (Col. 4 lines 58-62 “The implantable pulse generator 14 can have multiple stimulation channels which may be independently programmable to control the magnitude of the current stimulus from each channel. In some embodiments, the implantable pulse generator 14”).
Regarding claim 21, Jayakumar teaches wherein the processing circuitry is configured to select the sensing window to capture a single peak of the ECAP signal instead of other peaks of the ECAP signal (Col. 2 lines 7-13 “the signal is an evoked compound action potential (ECAP), evoked resonant neural activity (ERNA), or local field potential (LFP). In at least some aspects, at least one of the one or more effects is a feature of the signal, wherein the feature is a range of the signal, an area under a curve of the signal, a length of the curve of the signal, a maximum of the signal, or a minimum of the signal.” Col. 16 lines 4-5 “a range of time is selected or predefined for the extraction of the feature(s).”).
Regarding claim 22, Jayakumar teaches wherein the processing circuitry is configured to select the sensing window to have a duration that ends prior to at least one feature of the single ECAP signal (Col. 2 lines 7-13 “the signal is an evoked compound action potential (ECAP), evoked resonant neural activity (ERNA), or local field potential (LFP). In at least some aspects, at least one of the one or more effects is a feature of the signal, wherein the feature is a range of the signal, an area under a curve of the signal, a length of the curve of the signal, a maximum of the signal, or a minimum of the signal.” Col. 16 lines 4-5 “a range of time is selected or predefined for the extraction of the feature(s).” Examiner notes that the time interval selected can end prior to the minimum peak value of Fig. 8 (880). ).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-2, 6-9, 11-13, 17-18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor et al. (US 20190388695) (IDS) (Hereinafter Dinsmoor).
Regarding claims 1, 12, and 20, Dinsmoor teaches A system/method/computer readable storage medium ([0065] “Memory 215 may store computer-readable instructions that, when executed by processing circuitry 214, cause IMD 200 to perform various functions.”) comprising:
stimulation circuitry configured to deliver electrical stimulation ([0077] “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”);
processing circuitry ([0065] “processing circuitry 214”) configured to:
determine a value of a stimulation parameter that at least partially defines an electrical stimulation pulse ([0008] “the electrical stimulation therapy comprising a plurality of informed pulses at a predetermined pulse frequency over a period of time, wherein the plurality of informed pulses are at least partially defined by a first set of parameter values” [0031] “Parameters of the electrical stimulation therapy (e.g., electrode combination, voltage or current amplitude, pulse width, pulse frequency, etc.)”);
select, based on the value of the stimulation parameter, a sensing window defining a time for detecting one or more features of a single sensed evoked compound action potential (ECAP) signal elicited by the electrical stimulation pulse ([0082] “an ECAP elicited from to a control pulse delivered during a time event may be recorded by sensing circuitry 212 during the same time event. In another example, two or more ECAPs responsive to two or more respective control pulses delivered during a time event may be recorded by sensing circuitry 212 during the same time event.” Abstract “The system may also be configured to sense, after one or more control pulses and prior to an immediately subsequent therapy pulse of the plurality of therapy pulses [sensing window], a respective evoked compound action potential (ECAP)”. See [0082]-[0084], specifically [0084] where a previous ECAP signal, based on predefined control pulse parameters (including pulse amplitude) that produced this previous ECAP signal, is selected to determine if that previous ECAP signal amplitude is greater than an upper-bound amplitude value. Based on the determination that the previous (selected) ECAP signal is above or below the upper-bound amplitude value will allow the system to determine whether to increase or decrease the current amplitude of the control pulse for future control pulses, thereby inherently changing the strength/shape/appearance of future ECAP signals and its features.
Each defined control pulse window that elicits an ECAP signal/response, in which Examiner interprets the entire ECAP signal, following a control pulse, as the sensing window, which reads on the claimed “sensing window” because features P1, P2, N1, and N2 can be extracted during a time following the control pulse, as noted in Fig. 5 where the control pulse induces the ECAP signal and the Abstract of the instant specification “a sensing window for sensing a feature of an evoked compound action potential (ECAP)” and [0070] “may measure ECAP signals elicited by some stimulation pulses (e.g., control pulses) and use the ECAP characteristic value derived thereof to inform adjustments to subsequent stimulation pulses (e.g., informed pulses) that have different stimulation parameters.” Likewise, Dinsmoor teaches in Fig. 3 and the Abstract teaches “The system may also be configured to sense, after one or more control pulses and prior to an immediately subsequent therapy pulse of the plurality of therapy pulses [sensing window], a respective evoked compound action potential (ECAP)”. Examiner further notes that following each ECAP is an independent and different ECAP signal produced based on the stimulation parameters (e.g. pulse frequency, current amplitude, pulse width) of the control pulse, as noted in Fig. 5 of the instant specification. In that regard, for an adjustment of stimulation to occur, as described in [0070] of the instant specification, and [0084] of Dinsmoor, a previous ECAP signal, based on predefined control pulse parameters (including pulse amplitude) that produced this previous ECAP signal, is selected to determine if that previous ECAP signal amplitude is greater than an upper-bound amplitude value. Based on the determination that the previous (selected) ECAP signal is above or below the upper-bound amplitude value will allow the system to determine whether to increase or decrease the current amplitude of the control pulse for future control pulses, thereby inherently changing the strength/shape/appearance of future ECAP signals and its features.); wherein the processing circuitry is configured to select the sensing window to start after a delay from delivery of the electrical stimulation pulse ([0101] “latency” Fig. 5(536A-N) that shows a dashed square showing a start time of the window following a stimulation 538A-B. Abstract “The system may also be configured to sense, after one or more control pulses and prior to an immediately subsequent therapy pulse of the plurality of therapy pulses, a respective evoked compound action potential (ECAP)” See Fig. 3 showing the delay following the control pulse and the beginning of the ECAP signal.).
determine a value of each of the one or more features within the sensing window and from the single sensed ECAP signal ([0032] “Changes in a characteristic (e.g., an amplitude of a portion of the signal, an area under one or more peaks, frequency content, and/or maximum and/or minimum peak timing) of an ECAP signals occur as a function of how many axons have been activated by the delivered stimulation pulse.” The example of [0084] recites that if the amplitude of the selected ECAP is greater than the upper-bound of the adjustment window, the therapy stimulation adjusts to a decreased pulse amplitude.); and
control, based on the value of each of the one or more features, the stimulation circuitry to deliver subsequent electrical stimulation to a patient ([0008] “adjusting, based on at least one respective ECAP, one or more parameter values of the first set of parameter values that at least partially defines the plurality of informed pulses of the electrical stimulation therapy, and delivering the electrical stimulation therapy to the patient according to the adjusted one or more parameter values of the first set of parameter values” [0032] “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.”).
Although Dinsmoor teaches the delayed time from the control pulse to the start of the ECAP, Dinsmoor does not explicitly teach the start time of the sensing window being the delayed start of the ECAP signal. Nevertheless, allowing for the start time of the sensing window being the delayed start of the ECAP signal would allow for the extracting of only ECAP features ([0101]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the start time of the sensing window being the delayed start of the ECAP signal, for the purpose of extracting of only ECAP features, 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 Aller, 105 USPQ 233
Regarding claims 2 and 13, Dinsmoor teaches further comprising a memory storing a relationship between the stimulation parameter and the sensing window, wherein the processing circuitry is configured to select the sensing window based on the value of the stimulation parameter and the relationship stored in the memory ([0086] “processing circuitry 214 may determine the amplitude of a respective ECAP signal sensed by sensing circuitry 212. In response to a comparison between the amplitude of the respective ECAP signal and the target ECAP amplitude stored in patient ECAP characteristics 222” [0064] “The maximum target ECAP characteristic value, the minimum target ECAP characteristic value, and the predetermined frequency may be stored in the memory of IMD 110”).
Regarding claims 6 and 17, Dinsmoor teaches wherein the one or more features of the single sensed ECAP signal comprises one of a P1, an N1, or a P2 peak of the ECAP signal ([0101] “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. The example duration of the artifact and peaks P1, N1, and P2 is approximately 1 millisecond (ms). 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.”).
Regarding claim 7, Dinsmoor teaches wherein the stimulation parameter comprises a current amplitude ([0031] “Parameters of the electrical stimulation therapy (e.g., electrode combination, voltage or current amplitude, pulse width, pulse frequency, etc.)”).
Regarding claim 8, Dinsmoor teaches wherein the stimulation parameter comprises a pulse width ([0031] “Parameters of the electrical stimulation therapy (e.g., electrode combination, voltage or current amplitude, pulse width, pulse frequency, etc.)”).
Regarding claims 9 and 18, Dinsmoor teaches wherein the processing circuitry is configured to determine, based on the value of the one or more features, an ECAP characteristic value representative of the single sensed ECAP signal ([0073] “electrodes 232 and 234 may sense the voltage amplitude of a portion of the ECAP signals, where the sensed voltage amplitude is a characteristic the ECAP signal.”).
Regarding claim 11, Dinsmoor teaches further comprising an implantable medical device comprising the processing circuitry and stimulation circuitry configured to generate the electrical stimulation deliverable to the patient ([0008] “delivering the electrical stimulation therapy to the patient according to the adjusted one or more parameter values of the first set of parameter values”).
Claim(s) 3 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor et al. (US 20190388695) (IDS)(Hereinafter Dinsmoor) in view of Zhang et al. (US 20220266027)(Hereinafter Zhang).
Regarding claim 3 and 14, Dinsmoor teaches the invention of claim 1. Dinsmoor teaches the sensing of one first feature within the sensing window ([0101] “This N1-P2 amplitude may be easily detectable even if the artifact impinges on P1”) but does not teach a second feature that does not fall within the sensing window. Zhang, in the same field of endeavor, teaches features from the evoked compound action potentials in a closed-loop feedback system (Abstract), similar to the device of Dinsmoor, and further teaches wherein the relationship indicates one or more parameters defining the sensing window such that a first feature of the one or more features of the single ECAP signal falls within the sensing window and a second feature of the single ECAP signal does not fall within the sensing window ( [0025] “the first feature comprises one or more of an amplitude of any peak of the sensed neural responses, and area under a curve, a curve length, and a difference between amplitudes of any two peaks [observed within the sensing window] of the sensed neural responses. According to some embodiments, the second feature comprises one or more of a duration of a portion of the sensed neural responses, a conduction velocity, a latency of a feature of the sensed neural responses, a number of extrema, skew, and kurtosis. According to some embodiments, using the second value to determine whether to adjust the stimulation comprises determining a difference between the second value and a baseline value and adjusting the stimulation only if the difference exceeds a threshold” It is noted that the threshold for the second value may not be exceeded.) to adjust the stimulation based on feedback from the signal ([0025]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Dinsmoor, with the second feature that does not fall within the sensing window of Zhang, because such a modification would allow to adjust the stimulation based on feedback from the signal.
Claim(s) 10 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor et al. (US 20190388695) (IDS) (Hereinafter Dinsmoor) in view of Chakravarthy et al. (“Sensing Evoked Compound Action Potentials from the Spinal Cord: Novel Preclinical and Clinical Considerations for the Pain Management Researcher and Clinician” J Pain Res. 2020; 13: 3269–3279. Published online 2020 Dec 4. doi: 10.2147/JPR.S289098) (Hereinafter Chakravarthy) and Adenis et al. (“ECAP growth function to increasing pulse amplitude or pulse duration demonstrates large inter-animal variability that is reflected in auditory cortex of the guinea pig” PLOS One; Pgs. 1-25; Published: August 2, 2018 https://doi.org/10.1371/journal.pone.0201771)(Hereinafter Adenic).
Regarding claims 10 and 19, Dinsmoor teaches the invention of claim 1. However, Dinsmoor does not teach the determining a latency curve, determine a relationship between the stimulation parameter and parameter of the sensing window for controlling a subsequent electrical stimulation. Chakravarthy, in the same field of endeavor, teaches providing a stimulation for recording ECAPs and characterizing its parameters (Abstract), similar the device of Dinsmoor, and further teaches determine a latency curve between the amplitude values of the stimulation parameter and a latency of the one or more features of respective ECAP signals elicited by respective electrical stimulation pulses of the plurality of electrical stimulation pulses (Fig. 4B “ECAP latency differences are plotted versus pulse width with median and 10th–90th percentile range for Subjects #1 and #2, as well as #3 (gray), #4 (red) and #5 (blue); not all pulse widths were tried in all subjects.”);
determine, based on the latency curve, a relationship between values of the stimulation parameter and one or more parameters of the sensing window (Fig. 4B Pg. 3276 left col. lines 5-9 “The latency of an ECAP resulting from a stimulation pulse with higher amplitude and shorter pulse width will be shorter than that of an ECAP resulting from a stimulation pulse with lower amplitude and longer pulse width, assuming constant charge.”); and
control, based on the relationship and the first value of the stimulation parameter, the stimulation circuitry to deliver the subsequent electrical stimulation to the patient (Pg. 3276 left col. lines 14-18 “biphasic stimulation with a phase pulse width of under 200 µs on 1×8 percutaneous SCS leads provides a reasonable range of pulse width choices for the newest stimulation paradigms, such as those applied in recent bioinformatics work in SCS in preclinical models, while simultaneously providing for high-fidelity resolution of the N1/P2 features of the ECAP”) to optimize the stimulation pulse at a stable latency (Pg. 3276 left col. lines 9-14). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Dinsmoor, with the determining a latency curve, determine a relationship between the stimulation parameter and parameter of the sensing window for controlling a subsequent electrical stimulation of Chakravarthy, because such a modification would allow to optimize the stimulation pulse at a stable latency.
However, Dinsmoor does not teach sweep of pulses iteratively increasing amplitudes and a latency curve between the stimulated amplitudes and latency. Adenis, in the same field of endeavor, teaches the monitoring of ECAPs, similar to the device of Dinsmoor, and further teaches wherein the value of the stimulation parameter is a first value, and wherein the stimulation circuitry configured to deliver a plurality of electrical stimulation pulses at least partially defined by the stimulation parameter (Pg. 4 lines 39-42 “The first strategy used pulse amplitude (PA) to increase the injected charges. The protocol included 20 blocks of 128 stimulations [sweep]. Each block delivered a pulse of particular amplitude ranging from 100 μA [first value] to 1050 μA (increments of 50 μA between each block) with a fixed pulse duration of 30 μsec/phase and an interphase gap of 15 μsec”), wherein the processing circuitry is configured to:
control the stimulation circuitry to deliver the plurality of electrical stimulation pulses as a sweep of pulses comprising iteratively increasing amplitude values of the stimulation parameter (Pg. 4 lines 39-42 “The first strategy used pulse amplitude (PA) to increase the injected charges. The protocol included 20 blocks of 128 stimulations [sweep]. Each block delivered a pulse of particular amplitude ranging from 100 μA to 1050 μA (increments of 50 μA between each block) with a fixed pulse duration of 30 μsec/phase and an interphase gap of 15 μsec”); determine, based on the latency curve, a relationship between values of the stimulation parameter and one or more parameters of the sensing window (Fig. 1 D/E “. D-E. Latency of the N1 trough (D) and of the P2 peak (E) as a function of the stimulation intensity (pulse amplitude in blue and pulse duration in red). Note that the latencies decreased as the stimulus intensity increased.”) to promote larger eCAP and a decrease latency (Pg. 9 line 8). Although Chakravarthy is directed to pulse width, there is no difference in the growth function obtained between pulse duration and pulse amplitude (Pg. 9 lines 1-2). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Dinsmoor and substitute the pulse width of Charkravarthy, with the sweep of pulses iteratively increasing amplitudes and a latency curve between the stimulated amplitudes and latency of Adenis, because such a modification would allow to promote larger eCAP and a decrease latency.
Claim(s) 4 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor et al. (US 20190388695) (IDS) (Hereinafter Dinsmoor) in view of Parker et al. (US 20210121696)(Hereinafter Parker).
Regarding claims 4 and 15, Dinsmoor teaches the invention of claim 1. However, Dinsmoor does not teach selecting a sensing window based on a determined duration. Parker, in the same field of endeavor, teaches neuromodulation of a nerve using implantable electrode array for an ECAP signal (Abstract). Although Parker does not explicitly select a specific sensing window, Parker teaches wherein the processing circuitry is configured to [distinguish] the sensing window by at least determining, based on the value of the stimulation parameter, a duration of the sensing window (Fig. 7 and [0107] “at low currents only larger fibre types are recruited and the observed ECAP exhibits few peaks. As the current is increased, smaller fibres are recruited and the resulting ECAP starts to display additional peaks, in addition to the expected increase in peak amplitude.” Examiner notes the altering of the location of features on the ECAP signal based on the stimulation parameter.) to distinguish between responses of the ECAP ([0108]). Nevertheless, one skilled in the art would be able to select the sensing window based on the distinguished timeframes to target the specific response of a feature of choice for adjustment ([0108]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Dinsmoor, with the selecting a sensing window based on a determined duration of Parker, because such a modification would allow to target the specific response of a feature of choice for adjustment.
However, Dinsmoor and Parker do not teach the determining, based on the value of the stimulation parameter, a duration of the sensing window. Nevertheless, Parker teaches multiple stimulation parameters altering the location of each ECAP feature response based on the stimulation parameter (Fig. 7 and [0107]) and that determining, based on the value of the stimulation parameter, a duration of the sensing window would allow for the extracting of the specific ECAP feature of choice based on the change caused by the stimulation parameter ([0107]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to m determining, based on the value of the stimulation parameter, a duration of the sensing window, for the purpose of extracting of the specific ECAP feature of choice based on the change caused by the stimulation parameter, 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 Aller, 105 USPQ 233.
Claim(s) 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor et al. (US 20190388695) (IDS) (Hereinafter Dinsmoor) in view of Zhang et al. (US 20240139525)(Hereinafter Zhang).
Regarding claim 21, Dinsmoor teaches the invention of claim 1. However, Dinsmoor does not teach select the sensing window to capture a single peak of the ECAP signal instead of other peaks of the ECAP signal. Zhang, in the same field of endeavor, teaches a neurostimulation system for viewing features of an ECAP signal (Abstract and Fig. 10), and further teaches wherein the processing circuitry is configured to select the sensing window to capture a single peak of the ECAP signal instead of other peaks of the ECAP signal (Claim 16 “a selection of the ECAP parameter for the metric mode from a plurality of ECAP parameters using the user input device, the plurality of ECAP parameters including at least one of: a peak amplitude being an amplitude of a negative or positive peak of the ECAP in the ECAP portion of the ESG signal;” [0121] “A recommended end of the time window is determined based on the selected parameter and displayed to the user, who can specify the time window by moving the time winder slider for each of the selected sensing channels 1, 2, and 3. Area 1162 shows a segment of each of the ESG signals sensed through the selected sensing channels 1, 2, and 3. The three displayed segments provide for visualization of the signal property indicated by the N1-P2 amplitude measured from each of the ESG signals sensed through the selected sensing channels 1, 2, and 3 within the specified time window (showing only a segment of each ESG signal to focus the visualization on the signal property).”) to select the desired features ([0122]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Dinsmoor, with the select the sensing window to capture a single peak of the ECAP signal instead of other peaks of the ECAP signal of Zhang, because such a modification would allow to select the desired features.
Regarding claim 22, Dinsmoor teaches the invention of claim 1. However, Dinsmoor does not teach select the sensing window to have a duration that ends prior to at least one feature of the single ECAP signal. Zhang, in the same field of endeavor, teaches a neurostimulation system for viewing features of an ECAP signal (Abstract and Fig. 10), and further teaches wherein the processing circuitry is configured to select the sensing window to have a duration that ends prior to at least one feature of the single ECAP signal (Claim 16 “a selection of the ECAP parameter for the metric mode from a plurality of ECAP parameters using the user input device, the plurality of ECAP parameters including at least one of: a peak amplitude being an amplitude of a negative or positive peak of the ECAP in the ECAP portion of the ESG signal;” [0121] “A recommended end of the time window is determined based on the selected parameter and displayed to the user, who can specify the time window by moving the time winder slider for each of the selected sensing channels 1, 2, and 3. Area 1162 shows a segment of each of the ESG signals sensed through the selected sensing channels 1, 2, and 3. The three displayed segments provide for visualization of the signal property indicated by the N1-P2 amplitude measured from each of the ESG signals sensed through the selected sensing channels 1, 2, and 3 within the specified time window (showing only a segment of each ESG signal to focus the visualization on the signal property).”) to select the desired features ([0122]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Dinsmoor, with the select the sensing window to have a duration that ends prior to at least one feature of the single ECAP signal of Zhang, because such a modification would allow to select the desired features.
Conclusion
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/MOUSSA HADDAD/Examiner, Art Unit 3796
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