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 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, 3-11, 16, 19, and 20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Dinsmoor (US PGPUB 2024/0307690).
Regarding claims 1 and 19, Dinsmoor discloses a system and method comprising:
a stimulator device comprising a lead with a plurality of electrodes for providing stimulation (Fig. 2A: implantable medical device (IMD) 200, leads 230A-B, electrodes 232,234); and
an external device for optimizing stimulation for a patient having a stimulation device (Fig. 2B: external programmer 290),
wherein the stimulator device comprises a lead with a plurality of electrodes for providing stimulation, the method providing test stimulation 1006 at a plurality of different combinations of a position on the lead (Fig. 10) and a value of at least one stimulation parameter, the method comprising:
providing test stimulation at initial of the combinations, and measuring a neural potential in response to the test stimulation for each of the initial combinations (Fig. 10: select set of candidate recording electrode configurations 1004, deliver stimulation pulse and receive ECAP signal information resulting from stimulation pulse 1006);
determining at least one score for each of the initial combinations, wherein one of the at least one scores comprises a neural response score based on a feature of the measured neural potential (Fig. 10: determine ECAP characteristic value 1008);
determining a next combination 1012 using at least all previously determined neural response scores 1008 (Fig. 10: adjust electrode configuration for next pulse 1012 based on ECAP signal information);
repeating the steps prescribed in steps (a)-(c) for the next combination to determine and test further next combinations until a stopping criterium is met (Fig. 10: ECAP characteristic value satisfies ECAP metric 1010; Par. 135: “The processing circuitry 210 may control stimulation to iterate through the recording electrode combinations until, for example, a threshold is satisfied (e.g., exceeded or met).”); and
using at least the neural response scores to determine optimal therapeutic stimulation for the patient (Fig. 10: deliver stimulation using electrode configuration 1014).
Regarding 3, Dinsmoor discloses wherein the lead is implanted in a brain of the patient (Par. 69: “Although in one example IMD 110 takes the form of an SCS device, in other examples, IMD 110 takes the form of any combination of deep brain stimulation (DBS) device…”.
Regarding claim 4, Dinsmoor discloses wherein the at least one stimulation parameter comprises stimulation amplitude (Par. 71: “each stored therapy stimulation program, or set of stimulation parameter values, of stimulation parameter settings 242 defines values for a set of electrical stimulation parameters (e.g., a stimulation parameter set), such as a stimulation electrode combination, electrode polarity, current or voltage amplitude….”).
Regarding claim 5, Dinsmoor discloses wherein neural potentials are measured in step (a) using at least one of the electrodes (Par. 61: “IMD 110, via two or more electrodes interposed on leads 130, senses electrical potentials of tissue of the spinal cord 120 of patient 105 to measure the electrical activity of the tissue. IMD 110 senses ECAPs from the target tissue of patient 105, e.g., with electrodes on one or more leads 130 and associated sense circuitry”).
Regarding claim 6, Dinsmoor discloses wherein the positions vary longitudinally about the lead (Par. 79: “one or both of leads 230 may include one or more electrodes at each longitudinal location along the length of the lead, such as one electrode at different perimeter locations around the perimeter of the lead at each of the locations A, B, C, and D”).
Regarding claim 7, Dinsmoor discloses wherein the positions vary rotationally around the lead (Par. 48: “In some examples, electrode arrays include electrode segments, which are arranged at respective positions around a periphery of a lead, e.g., arranged in the form of one or more segmented rings around a circumference of a cylindrical lead. In other examples, one or more of leads 130 are linear leads having eight ring electrodes along the axial length of the lead, in another example, the electrodes are segmented rings arranged in a linear fashion along the axial length of the lead and at the periphery of the lead”).
Regarding claim 8, Dinsmoor discloses wherein determining the optimal therapeutic stimulation in step (e) comprises determining an optimal combination of a position and a value of the at least one stimulation parameter (Par. 139: “As illustrated in FIG. 10, processing circuitry 210 of IMD 200, or via an external programmer, selects stimulation parameters desired to elicit an ECAP signal (1002), and selects a candidate set of recording electrode combinations (1004)”).
Regarding claim 9, Dinsmoor discloses wherein determining the next combination in step (c) comprises determining at least one factor at each possible combination of positions and values of the at least one stimulation parameter, wherein the at least one factor at each possible combination is computed using all previously determined the neural response scores (Par. 144: “At block 1012, processing circuitry 210 adjusts the electrode combination for the next pulse. Stimulation is delivered to elicit an ECAP signal, and the processing circuitry 210 receives ECAP signal information resulting from the stimulation pulse using the adjusted electrode combination, where the adjusted electrode combination is different than the previous electrode combination. In some examples, other stimulation parameters may be modified, such as increased or decreased amplitudes. The ECAP characteristic values may be further evaluated to determine if the value satisfies an ECAP metric, as discussed above. The ECAP characteristic values may be evaluated until an entire predetermined set or subset of electrode combinations have been tested”).
Regarding claim 10, Dinsmoor discloses wherein the at least one factor at each possible combination is further computed using a distance between each possible combination and each of the previously tested combinations (Par. 39: “Although the system may adjust one or more stimulation parameters according to the one or more characteristics of the sensed ECAP signal, for example, to compensate for the change in distance between electrodes and nerves, the precision of such adjustments is dependent on accurately determining the characteristics of the ECAP signal”).
Regarding claim 11, Dinsmoor discloses wherein the next combination is determined in step (c) as the possible combination having the best at least one factor (Par. 98: “The stimulation is provided while the processor iterates through different sensing electrode combinations. The resulting ECAP signal and related stimulation artifact are measured during stimulation. The stimulation is provided while the processor iterates through the electrode combinations until, in some examples an aspect of the stimulation artifact satisfies a threshold, such as until the amplitude of the stimulation artifact is under a threshold and/or sensitivity to neural activation satisfies a threshold, for example the amplitude of neural activation exceeds a threshold.” – The “best” factor could be identified as the combination in which the described thresholds are satisfied).
Regarding claim 16, Dinsmoor discloses wherein the second score is indicative of a patient symptom, a patient response, or a side effect in response to the test stimulation (Par. 83: “Sensor(s) 222 may output patient parameter values that may be used as feedback to control delivery of therapy”).
Claim Rejections - 35 USC § 103
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 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) 2 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor (US PGPUB 2024/0307690), in view of Sinclair (WO 2018/027259).
Regarding claims 2 and 20, Dinsmoor discloses the method and system of claims 1 and 19. Dinsmoor does not disclose wherein each measured neural potential comprises an Evoked Resonant Neural Response. However, Sinclair, in the same field of endeavor of deep brain stimulation systems, discloses “Processing the evoked responses may involve comparing different ERNA features, including relative differences between or spatial derivatives of amplitude, rate of decay, rate of change, and frequency, across different combinations of electrodes used for stimulation and measurement” (Par. 167). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to use a measure of an evoked resonant neural response, as taught and suggested by Sinclair, because “the measured ERNA provides information concerning the patient's natural state” (Par. 120).
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor (US PGPUB 2024/0307690), in view of Molnar (US PGPUB 2011/0264165).
Regarding claim 12, Dinsmoor discloses the method of claim 9. Dinsmoor does not disclose wherein a plurality of factors are determined at each possible combination, and wherein the factors are weighted to determine a weighted factor at each possible combination. However, Molnar, in the same field of endeavor of deep brain stimulation, discloses “processor 80 may assign different weights to a ranking based on the bioelectrical brain signals and the physiological model in order to order the therapy programs. For example, processor 80 may determine that the ranking of therapy programs based on a physiological model is entitled to more weight than the ranking determined based on bioelectrical brain signals because the physiological model may be more revealing of side effects resulting from stimulation according to a particular therapy program” (Par. 362), where a “therapy program” is a stimulation electrode combination. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to use weighted factors to determine electrode combinations, as taught and suggested by Molnar, for the purpose of “consider[ing] both the ranking based on the bioelectrical brain signals and the ranking based on the physiological model” (Par. 362).
Regarding claim 13, Dinsmoor in view of Molnar discloses the method of claim 12. Molnar further discloses wherein the next combination is determined in step (c) using the weighted factors (Par. 362: “processor 80 may assign different weights to a ranking based on the bioelectrical brain signals and the physiological model in order to order the therapy programs. For example, processor 80 may determine that the ranking of therapy programs based on a physiological model is entitled to more weight than the ranking determined based on bioelectrical brain signals because the physiological model may be more revealing of side effects resulting from stimulation according to a particular therapy program”). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to use weight factors, as taught and suggested by Molnar, for the reason that “physiological model indicates a particular therapy program programs stimulate tissue associated with a stimulation-induced side effect or a target tissue site, processor 80 may decrease the ranking of the therapy program, despite the characteristic (e.g., a frequency domain characteristic) of the bioelectrical brain signal indicating the electrodes of the therapy program are proximate the target tissue site.” (Par. 363).
Regarding claim 14, Dinsmoor in view of Molnar discloses the method of claim 12. Molnar further discloses wherein the next combination is determined in step (c) as the possible combination having the best weighted factor (Par. 362: “Processor 80 may then rank therapy programs based on a combined score that considers both the ranking based on the bioelectrical brain signals and the ranking based on the physiological model, whereby in the combined score applies a higher weight (e.g., 51%-99%) to the ranking based on the physiological model compared to the weight (e.g., 1%-49%) applied to the ranking based on the bioelectrical brain signal. However, in other examples, processor 80 may determine that the ranking of therapy programs based bioelectrical brain signals is entitled to more weight than the ranking of therapy programs based on a physiological model”). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to determine the combination with the best weighted factor, as taught and suggested by Molnar, for the purpose of “select[ing] stimulation electrode combination based on sensed bioelectrical brain signals and physiological model” (Fig. 5).
Claims 15, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor (US PGPUB 2024/0307690), in view of Moffitt (US PGPUB 2012/0303087).
Regarding claim 15, Dinsmoor discloses the method of claim 1. Dinsmoor does not disclose wherein a second score is additionally determined for each tested combination in step (b). However, Moffitt, in the same field of endeavor of deep brain stimulation, “The method may further comprise assigning a score to each of the determined electrode combinations based on the respective clinical effect, and selecting one of the determined electrode combinations based on the assigned scores.” (Par. 57). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to include a second score for each electrode combination, as taught and suggested by Moffitt, in order to “takes into account both the therapeutic effect or the side-effect” of the stimulation (Par. 145).
Regarding claim 17, Dinsmoor in view of Moffitt discloses the method of claim 15. Dinsmoor does not disclose wherein in step (c) the next combination is determined using all previously determined neural response scores and all previously determined second scores. However, Moffit, in the same field of endeavor of deep brain stimulation, discloses “The user may enter the position of the neurostimulation lead or leads into the CP 18 (e.g., based on atlas, stereotactic coordinates, user estimate, etc.), and the clinical effects data collected during programming, and the CP 18 may output the optimal electrode configuration” (Par. 176). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to use the clinical effects data (i.e. the “second score”) to determine the electrode combination, as taught and suggested by Moffitt, for the purpose of “providing the ‘best guess’ optimal electrode configuration” (Par. 176).
Regarding claim 18, Dinsmoor in view of Moffitt discloses the method of claim 15. Dinsmoor does not disclose wherein in step (e) the optimal combination is determined using the neural response scores and the second scores. However, Moffit, in the same field of endeavor of deep brain stimulation, discloses “The user may enter the position of the neurostimulation lead or leads into the CP 18 (e.g., based on atlas, stereotactic coordinates, user estimate, etc.), and the clinical effects data collected during programming, and the CP 18 may output the optimal electrode configuration” (Par. 176). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to determine the optimal combination using neural response scores and second scores, as taught and suggested by Moffitt, for the purpose of “estimate[ing] the best electrode configuration that provides the best therapeutic stimulation” (Par. 176).
Response to Arguments
Applicant's arguments filed 10/24/2025 have been fully considered but they are not persuasive. Examiner still finds that Dinsmoor does disclose a plurality of different combination of a position on the lead and determining a next combination using at least all previously determined neural response scores. Applicant argues that “Dinsmoor is not involved in selecting or testing different combination of electrodes to provide stimulation”, Examiner disagrees as the whole flow chart of Dinsmoor in Fig. 10 leads to step 1014 which is the deliver stimulation using the determined electrode configuration from the previous steps which is also described in section 0143-0144 of Dinsmoor.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JON ERIC C MORALES whose telephone number is (571)272-3107. The examiner can normally be reached Monday-Friday 830AM-530PM CST.
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/Primary Examiner, Art Unit 3796
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