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 .
Claim Objections
Claims 5 & 16 are objected to for clarity of record. Claims recite order of execution as inversely proportional to spatial distances between respective electrodes. Examiner interprets this as the first subsequent execution of stimulation and ER collection tests via respective electrodes have the largest spatial distance between respective electrodes and first stimulating electrodes. However, in the instance wherein the smallest spatial distance is executed first, the order of execution could still remain inversely proportional.
Claim Interpretation
Under broadest reasonable interpretation and in light of the written description, the term “quality” is interpreted as but not limited to a comparison between a subject matter characteristic and a reasonably related reference subject matter characteristic. This comparison is used to characterize differences and to evaluate said subject matter characteristics.
Under broadest reasonable interpretation and in light of the written description, the term “ambulatory medical device” is interpreted to include at least wearable devices, implantable devices, drug delivery devices, and/or devices capable of performing the claimed functions.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1, 6, 9-10, 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sinclair et al (US Pre Grant Publication 2022/0192579 A1).
Regarding claim 1, Sinclair teaches a neuromodulation system, comprising:
an electrostimulator (DBS system 90, Fig. 13) configured to provide electrostimulation to a neural target of a patient via one or more stimulating electrodes (70, Fig. 11) on at least one lead (3387 DBS electrode lead from Medtronic) ([0225], [0229]);
a sensing circuit (96, Fig. 13) configured to sense evoked responses (ERs) to electrostimulation via one or more sensing electrodes (70, Fig. 11) on the at least one lead ([0189], [0225], Fig. 1 & 11; “FIG. 1 graphically illustrates a response from a neural circuit stimulated by a 130 Hz signal delivered from a neurostimulator via an electrode lead”); and
a controller circuit (processing unit 92, Fig. 13) operably connected to the electrostimulator (90) and the sensing circuit (96) [0231], the controller circuit configured to:
in response to electrostimulation of the neural target (step 172, Fig. 22) through first one or more stimulating electrodes (72c, Fig. 16) in accordance with a stimulation setting [0245], collect first ERs (step 174, Fig. 22) sensed from a group of sensing electrodes (72a, 72b, 72d, Fig. 16) on the at least one lead ([0245], Fig. 16; third electrode 72c delivers patterned stimulation; first, second, and fourth electrodes, 72a, 72b, and 72d, respectively, measures responses evoked by electrode 72c, Fig. 22; first cycle of steps 170-176);
perform a quality check (step 176, Fig. 22) of the first ERs ([0275], Fig. 22);
based on a result of the quality check of the first ERs, determine or update an ER sampling routine (step 170, Fig. 22) including one or more of timings ([0260], [0269-0271], [0275]; adjustments to length of continuous stimulation blocks and/or durations of probe bursts necessitates updates to timings; at step 176, when the system determines evoked response is not in a preferred state, process repeats from step 170 with updated parameters) or an order of performing multiple stimulation and ER collection tests subsequent to the electrostimulation through the first one or more stimulating electrodes (examiner notes the limitation regarding order of performing multiple stimulation is optional); and
sequentially execute the multiple stimulation and ER collection tests (2nd cycle of step 172, Fig. 22) and collect second ERs (second cycle of step 174, Fig. 22) in accordance with the determined or updated ER sampling routine ([0275], Fig. 22; step 172 & step 174 apply sequential stimulations and measure evoked responses; if responses not in preferred state, then step 176 repeats process and measures second set of evoked responses).
Regarding claims 6 & 19, Sinclair teaches the neuromodulation system of claim 1 as well as the method of claim 13, and further teaches wherein the electrostimulation of the neural target includes a plurality of stimulation bursts, and the first ERs include temporal ER portions corresponding to the plurality of stimulation bursts ([0192], Fig. 2; time window t2 corresponds to single pulse from burst),
wherein the controller circuit is configured to perform the quality check of the first ERs at one or more distinct time scales with respect to the electrostimulation, including at least one of:
a first quality check of one of the temporal ER portions corresponding to an individual burst of the plurality of stimulation bursts ([0279], Fig. 26a; continuous stimulation block 190 corresponds to individual pulse; step 170, Fig. 22 determines if block 190 is in preferred state); or
a second quality check of a plurality of the temporal ER portions corresponding to multiple distinct bursts of the plurality of stimulation bursts (examiner notes this limitation is optional).
Regarding claim 9, Sinclair teaches the neuromodulation system of claim 1, and further teaches a system comprising a programming device (108, Fig. 13, [0234]) and an ambulatory medical device (AMD) (signal generator 94 and/or lead 70, Fig. 22) communicatively coupled to the programming device ([0234]; input device 108 wired or wirelessly connected to processing unit 92), the AMD including at least a portion of the controller circuit configured to sequentially execute the multiple stimulation and ER collection tests and collect the second ERs ([0231]; measurement circuit 96 can be external or integrated within processing unit 92, [0235]; processing unit 92 may be implanted along with signal generator 94, lead 70, and/or any combination thereof, [0275], Fig. 22; step 172 & step 174 apply sequential stimulations and measure evoked responses; if responses not in preferred state, then step 176 repeats process and measures second set of evoked responses).
Regarding claim 10, Sinclair teaches the neuromodulation system of claim 1, and further teaches a system comprising a programming device (108, Fig. 13, [0234]) and an ambulatory medical device (AMD) communicatively coupled to the programming device (signal generator 94 and/or lead 70, Fig. 22) ([0234]; input device 108 wired or wirelessly connected to processing unit 92), the programming device including at least a portion of the controller circuit configured to sequentially execute the multiple stimulation and ER collection tests and collect the second ERs ([0234]; input device 108 can be configured as a patient controller, [0275], Fig. 22; step 172 & step 174 apply sequential stimulations and measure evoked responses; if responses not in preferred state, then step 176 repeats process and measures second set of evoked responses).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 2, 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sinclair et al (US Pre Grant Publication 2022/0192579 A1).
Regarding claim 2, Sinclair teaches the neuromodulation system of claim 1, and further teaches when the second ERs satisfy an acceptance criterion ([0275], Fig. 22; “In some embodiments, the determination of whether or not the ERNA is in a preferred or therapeutic state may be performed by comparing the measured response with a template ERNA response, or by comparing a measured ERNA characteristic with a desired range.”), but does not disclose wherein the controller circuit is configured to, provide a recommendation to a user to reposition the at least one lead or to set or adjust the stimulation setting, as claimed.
However, Sinclair teaches an embodiment for electrode implantation wherein the controller circuit (processing unit 92, Fig. 13) is configured to, provide a recommendation to a user to reposition the at least one lead or to set or adjust the stimulation setting ([0243-0244]; recommendation for the preferred electrode is part of the stimulation settings).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system, as taught by Sinclair, with the controller circuit that is configured to, provide a recommendation to a user to reposition the at least one lead or to set or adjust the stimulation setting. One of ordinary skill in the art would have been motivated to make these modifications to improve targeted evoked response activity by determining which electrodes are within the target neural structure (Sinclair, [0244]).
Regarding claim 13, Sinclair teaches a method of providing neurostimulation to a neural target of a patient via a neuromodulation system that comprises an electrostimulator and at least one lead coupled thereto, the method comprising:
delivering electrostimulation to the neural target in accordance with a stimulation setting via first one or more stimulating electrodes on the at least one lead;
collecting first evoked responses (ERs) from each of a group of sensing electrodes on the at least one lead via a sensing circuit;
performing a quality check of the first ERs;
based on a result of the quality check of the first ERs, determining or updating an ER sampling routine including one or more of timings or an order of performing multiple stimulation and ER collection tests subsequent to the electrostimulation through the first one or more stimulating electrodes;
sequentially executing the multiple stimulation and ER collection tests and collecting second ERs in accordance with the determined or updated ER sampling routine;
when the second ERs satisfy an acceptance criterion,
as claimed.
Sinclair does not disclose providing a recommendation to a user to reposition the at least one lead or to set or adjust the stimulation setting.
However, Sinclair teaches an embodiment for electrode implantation for providing a recommendation to a user to reposition the at least one lead or to set or adjust the stimulation setting ([0243-0244]; recommendation for the preferred electrode is part of the stimulation settings).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system, as taught by Sinclair, for providing a recommendation to a user to reposition the at least one lead or to set or adjust the stimulation setting. One of ordinary skill in the art would have been motivated to make these modifications to improve targeted evoked response activity by determining which electrodes are within the target neural structure (Sinclair, [0244]).
Claim(s) 3, ,8, 11, 14, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sinclair et al (US Pre Grant Publication 2022/0192579 A1), in view of Williams et al (US Pre Grant Publication 2025/0050110 A1).
Regarding claims 3 & 14, Sinclair teaches the neuromodulation system of claim 1 as well as the method of claim 13, but does not disclose wherein to perform the quality check includes to determine that the first ERs pass the quality check when each of the first ERs falls within a specific ER value range, or fail the quality check when one or more of the ERs fall outside of the specific ER value range,
wherein the controller circuit is configured to determine the specific ER value range based on a statistical distribution model of the first ERs,
as claimed.
However, Williams teaches a system and a method for controlling neural stimulation from captured signal data. Williams is analogous to the claimed invention as it is reasonably pertinent to the problem of analyzing signal windows to determine and affect stimulation quality.
Williams further teaches wherein to perform the quality check (820, Fig. 8) includes to determine that the first ERs pass the quality check when each of the first ERs falls within a specific ER value range, or fail the quality check when one or more of the ERs fall outside of the specific ER value range ([0124-0131], Fig. 8; step 820 comprises noise departure detector (NDD); NDD calculates r metric that is mapped to a quality score between 0 and 1; quality scores greater than 0.5 and less than 1 indicates statistically significant departure from noise model and likely an evoked response; quality scores outside of 0.5-1 range falls outside of the statistically significant range of values and likely noise),
wherein the controller circuit is configured to determine the specific ER value range based on a statistical distribution model of the first ERs ([0124-0129]; NDD calibration applies a statistical distribution noise model to sampled signal windows; NDD determines estimates of parameters such as mean and standard deviation; logistic function maps NDD metric r to a quality score between 0 and 1; applying a logit function to the quality scores between 0.5 and 1, remaps them to a specific value range correlated with the sampled ER signals).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system and method of Sinclair to perform the quality check includes to determine that the first ERs pass the quality check when each of the first ERs falls within a specific ER value range, or fail the quality check when one or more of the ERs fall outside of the specific ER value range and to determine the specific ER value range based on a statistical distribution model of the first ERs as taught by Williams. One of ordinary skill in the art would have been motivated to make these modifications to differentiate evoked responses from noise by implementing statistical models that identify a range of signal values that are correlated to evoked responses (Williams, [0124-0125]).
Regarding claim 8, Sinclair teaches the neuromodulation system of claim 7, and further teaches wherein the controller circuit is configured to repeat the identified at least one test at a scheduled time ([0193]; “For example, the multi-pulse burst may be repeated each second.”; when multi-pulse burst is repeated each second then test is performed at a scheduled time of one second).
Sinclair does not disclose including:
to repeat the identified at least one failed test prior to executing any other of the multiple stimulation and ER collection tests; or to append the identified at least one failed test to the end of the multiple stimulation and ER collection tests, and repeat the identified at least one test after executing every other of the multiple stimulation and ER collection tests,
as claimed.
However, Williams teaches a system including:
to repeat the identified at least one failed test prior to executing any other of the multiple stimulation and ER collection tests ([0121], Fig. 8; step 840 mitigation action may suspend operation of feedback controller after quality score fails to meet one or more criteria such as ten consecutive iterations); or to append the identified at least one failed test to the end of the multiple stimulation and ER collection tests, and repeat the identified at least one test after executing every other of the multiple stimulation and ER collection tests (examiner notes this limitation is optional).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Sinclair to repeat the identified at least one failed test prior to executing any other of the multiple stimulation and ER collection tests as taught by Williams. One of ordinary skill in the art would have been motivated to make these modifications to optimize feedback control by ensuring the system delivers an appropriate stimulus to the patient (Williams, [0117]).
Regarding claim 11, Sinclair teaches the neuromodulation system of claim 1, but does not disclose wherein the sensing circuit includes a dedicated sensing channel electrically coupled to two or more sensing electrodes on the lead to concurrently sense ERs therefrom in response to electrostimulation through each of two or more distinct stimulation electrodes, as claimed.
However, Williams teaches a system wherein the sensing circuit includes a dedicated sensing channel (128, Fig. 2 & 3) electrically coupled to two or more sensing electrodes on the lead (electrode array 150, Fig. 3; electrodes 6 & 8 measure evoked responses) to concurrently sense ERs [0091], therefrom in response to electrostimulation through each of two or more distinct stimulation electrodes (electrode array 150, Fig. 3; electrodes 2 & 4 provide stimulus) [0091].
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Sinclair with the sensing circuit includes a dedicated sensing channel electrically coupled to two or more sensing electrodes on the lead to concurrently sense ERs therefrom in response to electrostimulation through each of two or more distinct stimulation electrodes, as taught by Williams. One of ordinary skill in the art would have been motivated to make these modifications to measure conduction velocity of an evoked response by measuring the response at different locations (Williams, [0087], [0089]).
Regarding claim 18, Sinclair teaches the method of claim 17, and further teaches wherein repeating the identified at least one test occurs at a scheduled time ([0193]; “For example, the multi-pulse burst may be repeated each second.”; when multi-pulse burst is repeated each second then test is performed at a scheduled time of one second).
Sinclair does not disclose prior to executing any other of the multiple stimulation and ER collection tests, or after executing every other of the multiple stimulation and ER collection tests.
However, Williams teaches a method prior to executing any other of the multiple stimulation and ER collection tests ([0121], Fig. 8; step 840 mitigation action may suspend operation of feedback controller after quality score fails to meet one or more criteria such as ten consecutive iterations), or after executing every other of the multiple stimulation and ER collection tests (examiner notes this limitation is optional).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Sinclair with prior to executing any other of the multiple stimulation and ER collection tests as taught by Williams. One of ordinary skill in the art would have been motivated to make these modifications to optimize feedback control by ensuring the system delivers an appropriate stimulus to the patient (Williams, [0117]).
Claim(s) 12, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sinclair et al (US Pre Grant Publication 2022/0192579 A1), in view of Williams et al (US Pre Grant Publication 2025/0050110 A1), and in further view of Nguyen et al (US Pre Grant Publication 2024/0066289 A1).
Regarding claim 12, Sinclair in view of Williams, teaches the neuromodulation system of claim 11, but does not disclose wherein the two or more sensing electrodes are at least temporarily electrically shorted to each other when coupled to the dedicated sensing channel, the dedicated sensing channel configured to sense the ERs from the electrically shorted electrodes.
However, Nguyen teaches a system and a method for endovascular deep brain stimulation with expandable electrode loops. Nguyen is analogous to the claimed invention as it is reasonably pertinent to the problem of delivering neural stimulation using various electrode configurations.
Nguyen further teaches wherein the two or more sensing electrodes are at least temporarily electrically shorted to each other when coupled to the dedicated sensing channel (sensing circuitry 36, Fig. 3), the dedicated sensing channel configured to sense the ERs from the electrically shorted electrodes ([0121-0122], Fig. 4D; “…shorting electrodes together may enable directional delivery of electric fields through various combinations of electrodes 17 and direction sensing through various combinations of electrodes 17.”).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system, as taught by Sinclair and Williams, with the two or more sensing electrodes are at least temporarily electrically shorted to each other when coupled to the dedicated sensing channel, the dedicated sensing channel configured to sense the ERs from the electrically shorted electrodes as taught by Nguyen. One of ordinary skill in the art would have been motivated to make these modifications to enable directional sensing of evoked responses by shorting individual electrodes together (Nguyen, [0121]).
Regarding claim 20, Sinclair in view of Williams teaches the method of claim 13, and further teaches wherein the first or the second ERs include ERs to electrostimulation through each of two or more distinct stimulation electrodes,
but does not disclose,
and sensed from two or more sensing electrodes at least temporarily electrically shorted to each other and coupled to a dedicated sensing channel,
as claimed.
However, Nguyen teaches,
and sensed from two or more sensing electrodes at least temporarily electrically shorted to each other ([0121-0122], Fig. 4D) and coupled to a dedicated sensing channel (sensing circuitry 36, Fig. 3).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method, as taught by Sinclair and Williams, with the first or the second ERs include ERs to electrostimulation through each of two or more distinct stimulation electrodes, as further taught by Williams, and sensed from two or more sensing electrodes at least temporarily electrically shorted to each other and coupled to a dedicated sensing channel, as taught by Nguyen. One of ordinary skill in the art would have been motivated to make these modifications to enable directional sensing of evoked responses by shorting individual electrodes together (Nguyen, [0121]).
Claim(s) 4-5, 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sinclair et al (US Pre Grant Publication 2022/0192579 A1), in view of Williams et al (US Pre Grant Publication 2025/0050110 A1), and in further view of Dinsmoor et al (US Pre Grant Publication 2024/0307690 A1).
Regarding claims 4 & 15, Sinclair in view of Williams teaches the neuromodulation system of claim 3 as well as the method of claim 14, and further teaches wherein, when one or more of the first ERs fail the quality check, the controller circuit is configured to determine or update the ER sampling routine (Fig. 22; step 176, system not in a preferred state) including a post-stimulation time delay before initiating a subsequent stimulation and ER collection test involving stimulation through second one or more stimulating electrodes different than the first one or more stimulating electrodes ([0107-0108], [0251]; optimization of stimulation frequency, when the system is not in a preferred state, updates post-stimulation time delay window t2), but does not disclose,
wherein the post-stimulation time delay is inversely related to a spatial distance between the first and the second stimulating electrodes.
However, Dinsmoor teaches a system and method for determining electrode combinations for sensing ECAPs. Dinsmoor is analogous to the claimed invention as it is reasonably pertinent to the problem of sensing neural stimulation using various electrode configurations.
Dinsmoor further teaches wherein the post-stimulation time delay is inversely related to a spatial distance between the first and the second stimulating electrodes ([0037], [0042], [0044]; signal with pulse width that is too long is sensed as an artifact by electrodes close to stimulation electrodes; large distances between stimulation electrodes and sensing electrodes avoid sensed artifacts but reduce signal fidelity; signal quality is inversely proportional to distance of signal propagation or effectively signal time delay; optimizing time delay to minimize artifacts necessitates a post-stimulation time delay inversely related to distance whereby smaller spatial distances require larger time delays to avoid sensed artifacts, [0054] sensing and stimulation can be performed by the same, overlapping, or different electrodes).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Sinclair and Williams with the system and method wherein the post-stimulation time delay is inversely related to a spatial distance between the first and the second stimulating electrodes as taught by Dinsmoor. One of ordinary skill in the art would have been motivated to make these modifications to optimize evoked response activity by adjusting the duration of stimulation blocks (Dinsmoor, [0271]).
Regarding claims 5 & 16, Sinclair in view of Williams teaches the neuromodulation system of claim 3 as well as the method of claim 14, but does not disclose wherein, when one or more of the first ERs fail the quality check, the controller circuit is configured to determine or update the ER sampling routine including an order of executing the subsequent multiple stimulation and ER collection tests involving stimulations via respective stimulating electrodes different than the first one or more stimulating electrodes,
Wherein the order of executing the subsequent multiple stimulation and ER collection tests is inversely related to spatial distances between the respective stimulating electrodes and the first one or more stimulating electrodes.
However, Dinsmoor teaches wherein, when one or more of the first ERs fail the quality check, the controller circuit is configured to determine or update the ER sampling routine including an order of executing the subsequent multiple stimulation and ER collection tests involving stimulations via respective stimulating electrodes different than the first one or more stimulating electrodes ([0102]; “In some examples, the target ECAP characteristic may include one in which a stimulation artifact is minimized…”, [0125], Fig. 3A & 3B; “Processing circuitry 210 may generate the growth curve by controlling stimulation circuitry to deliver stimulation pulses sweeping the stimulation amplitude (e.g., iteratively increasing the amplitude) and/or testing different electrode combinations (FIGS. 3A, 3B) to sense respective ECAP signals and obtain ECAP characteristic values (e.g., data) which represents an estimated neural response.”; minimizing stimulation artifact necessitates changing order of electrode combination tests),
Wherein the order of executing the subsequent multiple stimulation and ER collection tests is inversely related to spatial distances between the respective stimulating electrodes and the first one or more stimulating electrodes ([0037], [0042], [0044]; signal with pulse width that is too long is sensed as an artifact by electrodes close to stimulation electrodes; large distances between stimulation electrodes and sensing electrodes avoid sensed artifacts but reduce signal fidelity; signal quality is inversely proportional to distance of signal propagation or effectively signal time delay; optimizing order to minimize artifacts necessitates an order of execution inversely related to distance whereby larger spatial distances can execute earlier in order without introducing artifacts, [0054]; sensing and stimulation can be performed by the same, overlapping, or different electrodes).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system and method, as taught by Sinclair and Williams, with when one or more of the first ERs fail the quality check, the controller circuit is configured to determine or update the ER sampling routine including an order of executing the subsequent multiple stimulation and ER collection tests involving stimulations via respective stimulating electrodes different than the first one or more stimulating electrodes and wherein the order of executing the subsequent multiple stimulation and ER collection tests is inversely related to spatial distances between the respective stimulating electrodes and the first one or more stimulating electrodes as taught by Dinsmoor. One of ordinary skill in the art would have been motivated to make these modifications to optimize evoked response activity by testing different electrode combinations (Dinsmoor, [0125]).
Claim(s) 7, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sinclair et al (US Pre Grant Publication 2022/0192579 A1), in view of Karamanoglu et al (US Pre Grant Publication 20130030496 A1).
Regarding claims 7 & 17, Sinclair teaches the neuromodulation system of claim 1 as well as the method of claim 13, and further teaches wherein the controller circuit is configured to:
perform the quality check of the second ERs (2nd cycle of step 174, Fig. 22);
identify, from the multiple stimulation and ER collection tests, at least one failed test with corresponding one or more ERs that fail the quality check (2nd cycle of step 176, Fig. 22),
repeat the identified at least one failed test (step 176, Fig. 22; continues to test responses until system reaches preferred state),
but does not disclose, up to a specific maximum number of attempts.
However, Karamanoglu teaches a system and a method for inducing respiration through cardiac neurostimulation. Karamanoglu is analogous to the claimed invention because it is reasonably pertinent to the problem of analyzing sensed evoked signals.
Karamanoglu further teaches to repeat the identified failed test that up to a specific maximum number of attempts ([0078-0079], Fig. 7; step 326 adjusts stimulation parameters and continues to cycle through test until step 324 maximum number of attempts is reached or stimulation adjustments meet testing thresholds).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system and method of Sinclair to repeat the identified at least one failed test up to a specific maximum number of attempts as taught by Karamanoglu. One of ordinary skill in the art would have been motivated to make these modifications to improve evoked response measurements by adjusting lead position and/or placing new leads or leads with different dimensions and electrode configurations (Karamanoglu, [0079]).
Conclusion
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/DWANE COLLARD/Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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