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 .
The current application has the priority date of 06/27/2023 according to the priority chain on the record.
Claim Objection
Claims 6 and 16 are objected to because of the following informalities: the limitation “…comprises using all previously determined the electrode impedance scores to determine at least one factor…” is grammatically awkward. 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)(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.
Claims 1-7, 10-17, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Astrom et al. US 2017/0333720 A1 (hereinafter “Astrom”, cited in applicants IDS).
Regarding claim 1, Astrom discloses a method for optimizing deep brain stimulation (DBS) for a patient having a stimulator device (Figs.1 and 3, and [0035 0059] deep brain stimulation system, i.e. DBS system 100)) comprising a plurality of electrodes in an electrode array (electrodes 28, array/arrangement as shown in Figs. 2a-2c and 4) on an electrode lead (lead arrangement 18) implanted in the patient’s brain (Fig. 1 and [0030-0031]), the method comprising:
providing test stimulation according to a plurality of combinations ([0026-0027] testing different electrode combinations, including impedance modeling of the electrodes), each combination comprising (i) a position within the electrode array and (ii) at least one stimulation parameter ([0024] “A set of stimulation parameters, as discussed herein, may define values for electrode combinations, current or voltage amplitudes, pulse frequencies, pulse widths, duty cycle, etc.” Also see [0027, 0045, 0078], Fig. 8 for selecting electrode combinations and Fig. 10 for test stimulation work flow), by:
(a) providing stimulation at a combination, and measuring an electrode impedance at at least one of the plurality of electrodes ([0027, 0078] “measuring the resulting excitation voltage, and deriving an impedance between the electrodes based on the test stimulation current and the resulting excitation voltage”; Fig. 10: 200, 202, 204, also see [0117] selecting an initial electrodes combination and apply a selected (test) stimulation program);
(b) determining at least one score for the combination ([0026-0027, 0078, 0107] and Table 1: for selected different electrodes combination(s): impedance values or impedance difference, power consumption value, and field similarity scores), wherein one of the at least one score comprises an electrode impedance score based on the measured impedance ([0023] “The impedance used in determining the power consumption may be the total impedance for the entire system (e.g., a collective impedance for a circuit that includes a specified electrode combination through which the electrical stimulation pulses are delivered)…” In here, measured impedance values are further analyzed to determine ‘power consumption value’, it is taken to encompass “electrode impedance score” in this and following claims);
(c) determining a next combination using at least all previously determined electrode impedance scores (selecting an alternative/next electrode combination based on impedance values; see [0026] “the alternative electrode combinations may have respective collective impedances (i.e., a total impedance for a stimulation signal delivered via the alternative electrode combination) that are lower than the collective impedance of the initial electrode combination.” Also see [0044-0045] “also generate information that allows each alternative electrode combination to be compared to the initial electrode combination”, this includes respective impedance or collective impedance calculated under a common stimulation parameters);
(d) repeating the steps prescribed in steps (a)-(c) for a next combination to determine and test further next combinations until a stopping criterium is met ([0078, 0103] testing alternative electrode combinations until all different combinations are measured or the calculated score is below a predetermined threshold; also see Fig. 10: 202, 204 looking for new or alternative combination of electrodes, and repeating the previous testing steps); and
using at least the impedance scores to determine an optimal therapeutic stimulation for the patient ([0046-0047] presenting the electrode combinations based on impedance values rankings; [0104, 0108] finding the electrode combinations that has the lowest power consumption- based on the impedance score).
Regarding claim 2, Astrom discloses the method of claim 1, wherein the at least one stimulation parameter comprises stimulation amplitude. ([0024] “A set of stimulation parameters, as discussed herein, may define values for electrode combinations, current or voltage amplitudes, pulse frequencies, pulse widths, duty cycle, etc.” [0078] also discusses test stimulation currents)
Regarding claim 3, Astrom discloses the method of claim 1, wherein the positions vary longitudinally on the lead. ([0024, 0078] electrode combinations and alternative combinations, also see Fig. 4: electrodes are varied longitudinally e.g. 66, 68, 70, 72)
Regarding claim 4, Astrom discloses the method of claim 1, wherein the positions vary rotationally around the lead. ([0024, 0078] electrode combinations and alternative combinations, also see Fig. 4: electrodes are varied rotationally or circumferentially, e.g. 66A, 66B, 66C)
Regarding claim 5, Astrom discloses the method of claim 1, wherein determining the optimal therapeutic stimulation comprises determining an optimal position and a value of the at least one stimulation parameter. ([0045, 0053-0054] selecting best/lowest power consumption based on different electrode combinations and different operating parameter, e.g. current pulse widths pulse frequencies etc.)
Regarding claim 6, Astrom discloses the method of claim 1, wherein determining the next combination in step (c) comprises using all previously determined the electrode impedance scores (i.e. power consumption value) to determine at least one factor for each possible next combination. ([0027] “…This modeling of the electrode combinations may include resistance or impedance modeling of the electrodes (e.g., an R-matrix or Z-matrix, respectively) and/or electrical field modeling and/or electrical potential distribution modeling, one, two, or all of which may be used to determine the electrical field, electrical potential distribution, volume of neuron activation (VNA), or volume of tissue activation (VTA)…” In here, impedance modeling to calculate power consumption and field similarity score, are individually interpreted as “factor” in this claim. Also see [0028, 0045])
Regarding claim 7, Astrom discloses the method of claim 6, wherein the at least one factor is computed using a distance between each possible next combination and each of the previously tested combinations. (see rejection to claim 6 above, stimulation field similarity score is based on relative distance between electrodes, according to [0108])
Regarding claim 10, Astrom discloses the method of claim 1, wherein a second score is additionally determined for each tested combination in step (b). (See [0026-0027, 0078, 0107] and Table 1: for selected different electrodes combination(s): impedance values or impedance difference, power consumption value, and field similarity scores are calculated based on impedance measurements. In here, ‘field similarity score’ is interpreted as “second score” in this claim.)
Regarding claim 11, Astrom discloses the method of claim 10, wherein the second score is indicative of a patient symptom, a patient response, or a side effect in response to the test stimulation. (With regard to the field similarity score, as discussed to claim 10 above, it represents “volume of anatomy in which neural brain activity (in the example of deep brain stimulation) is modulated by the distribution of the stimulation pulses delivered from one or more electrodes of a stimulation lead” according to [0028]. Accordingly, the field similarity score is taken to also encompass “patient response” to the test stimulation, in this claim. Alternatively, see [0037: last 2 sentences] feedback on efficacy including patients’ subjective feedback/response, and objective physiological parameter, e.g. muscle activity or muscle tone)
Regarding claim 12, Astrom discloses the method of claim 10, wherein in step (c) the next combination is determined using all previously determined electrode impedance scores and all previously determined second scores. ([0047-0048] ranking electrode combinations based on power consumption value- interpreted to encompass “electrode impedance score”, and also field similarity stored- interpreted to encompass “second score.”)
Regarding claim 13, Astrom discloses the method of claim 10, wherein the optimal combination is determined using the electrode impedance scores and the second scores. ([0047-0048] ranking electrode combinations based on power consumption value- interpreted to encompass “electrode impedance score”, and also field similarity stored- interpreted to encompass “second score”)
Regarding claim 14, Astrom discloses a system ([0030] and Fig. 1: neurostimulation system 10), comprising:
an external device (Fig. 6 and [0035] external programmer 20) for optimizing deep brain stimulation (DBS) for a patient having a stimulator device (Fig.3: [0059]deep brain stimulation system, i.e. DBS system 100) comprising a plurality of electrodes in an electrode array (electrodes 28, array/arrangement as shown in Figs. 2a-2c and 4) on an electrode lead (lead arrangement 18) implanted in the patient’s brain (Fig. 1 and [0030-0031]), wherein the external device (20) is configured to:
provide test stimulation according to a plurality of combinations ([0026-0027] testing different electrode combinations, including impedance modeling of the electrodes), each combination comprising (i) a position within the electrode array and (ii) at least one stimulation parameter ([0024] “A set of stimulation parameters, as discussed herein, may define values for electrode combinations, current or voltage amplitudes, pulse frequencies, pulse widths, duty cycle, etc.” Also see [0027, 0045, 0078], Fig. 8 for selecting electrode combinations and Fig. 10 for test stimulation work flow), by:
(a) providing stimulation at a combination, and measuring an electrode impedance at at least one of the plurality of electrodes ([0027, 0078] “measuring the resulting excitation voltage, and deriving an impedance between the electrodes based on the test stimulation current and the resulting excitation voltage”; Fig. 10: 200, 202, 204, also see [0117] selecting an initial electrodes combination and apply a selected (test) stimulation program);
(b) determining at least one score for the combination ([0026-0027, 0078, 0107] and Table 1: for selected different electrodes combination(s): impedance values or impedance difference, power consumption value, and field similarity scores), wherein one of the at least one score comprises an electrode impedance score based on the measured impedance ([0023] “The impedance used in determining the power consumption may be the total impedance for the entire system (e.g., a collective impedance for a circuit that includes a specified electrode combination through which the electrical stimulation pulses are delivered)…” In here, measured impedance values are further analyzed to determine ‘power consumption value’, it is taken to encompass “electrode impedance score” in this and following claims);
(c) determining a next combination using at least all previously determined electrode impedance scores (selecting an alternative/next electrode combination based on impedance values; see [0026] “the alternative electrode combinations may have respective collective impedances (i.e., a total impedance for a stimulation signal delivered via the alternative electrode combination) that are lower than the collective impedance of the initial electrode combination.” Also see [0044-0045] “also generate information that allows each alternative electrode combination to be compared to the initial electrode combination”, this includes respective impedance or collective impedance calculated under a common stimulation parameters);
(d) repeating the steps prescribed in steps (a)-(c) for a next combination to determine and test further next combinations until a stopping criterium is met ([0078, 0103] testing alternative electrode combinations until all different combinations are measured or the calculated score is below a predetermined threshold; also see Fig. 10: 202, 204 looking for new or alternative combination of electrodes, and repeating the previous testing steps); and
use at least the impedance scores to determine an optimal therapeutic stimulation for the patient ([0046-0047] presenting the electrode combinations based on impedance values rankings; [0104, 0108] finding the electrode combinations that has the lowest power consumption- based on the impedance score).
Regarding claim 15, this claim is rejected by Astrom under the same rationale as discussed to claim 2 above.
Regarding claims 16 and 17, these two claim are rejected by Astrom under the same rationale as discussed to claims 6 and 7 above.
Regarding claim 19, this claim is rejected by Astrom under the same rationale as discussed to claim 10 above.
Regarding claim 20, this claim is rejected by Astrom under the same rationale as discussed to claim 11 above.
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.
Claims 8-9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Astrom as applied to claims 1 and 14 above, and further in view of Esteller et al. US 2022/0296892 A1 (hereinafter “Esteller”, cited in Applicant’s IDS).
With regard to claims 8 and 9, Astrom discloses a plurality of factors is determined for each possible next combination (see rejection to claim 6, and Astrom: [0027-0028, 0045] using impedance modeling of different electrode combinations for calculating factors including power consumption value, and field similarity score; also see [0037] “programmer 20 may determine and present alternative electrode configurations that may consume less power during therapy and/or receive user input selecting one of the alternative electrode configurations… patient 1 may provide feedback to the clinician as to the efficacy of the specific program being evaluated or the clinician may evaluate the efficacy based on one or more physiological parameters of patient 1 (e.g., muscle activity or muscle tone)” ). Astrom does not disclose wherein the factors are weighted to determine a weighted factor at each possible next combination and wherein the next combination is determined using the weighted factors.
Esteller, another prior art reference in the analogous field of neurostimulation method and systems (abstract and Fig.1A-1B) discloses providing a stimulation device (Fig.1A-1B) comprising a plurality of leads, each having a plurality of electrodes thereon (Figs. 1B). Esteller further discloses optimizing therapy efficacy by measuring impedances of electrode contacts and measure the evoked potentials evoked using the present stimulation settings ([0127-0129]). Esteller further teaches using all previously determined the electrode impedance scores to determine at least one factor for each possible next combination ([0127] using evoked potential features, impedance measurements, etc., to diagnose potential declines in efficacy; also see [0129] “The indicators may be based on the behavior of the evoked potential features and the impedance measurements over time, as well as other factors, such as the time course of the decline in efficacy.” In here, ‘indicators’ with regard to efficacy are interpreted to encompass “factors” in this claim), wherein a plurality of factors is determined for each possible next combination ([0125] “ an indicator bar 1712 indicative of a value of one or more of the extracted evoked potential features (e.g., height of a selected peak, area under the curve, etc.)” [0129] (1) lead migration, (2) scar tissue formation, and (3) disease progression ), and wherein the factors are weighted to determine a weighted factor at each possible next combination, and wherein the next combination is determined using the weighted factors ([0129] “The algorithm may assign weights to each of these indicators to derive probabilities for the factors responsible for the decline in efficacy. ”). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Astrom in view of Esteller to further include assigning weights to each of various indicators (e.g. evoked potential features, efficacy, lead migration, scar tissue formation, and disease progression); the motivation for doing so is for optimizing stimulation efficacy based on the patient’s specific physiological condition/evoked response.
Claim 18 is rejected by Astrom in view of Esteller under the same rationale as discussed to claims 8 and 9 immediately above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: WO 2008/027885 discloses a method for testing stimulation by testing and selecting different pair of electrodes by calculating impedance values; as shown in Fig. 5.
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/SHIRLEY X JIAN/ Primary Examiner, Art Unit 3792
April 3, 2026
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