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 § 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.
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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vansickle et al. (WO 2014/145222) in view of Lee et al. (US 2015/0005842).
A system…a stimulator device comprising a plurality of electrodes each configured to be electrically coupled in contact with a patient’s tissue:
E.G. Vansickle et al. disclosed IPG 14 coupled to implanted leads 12 carrying electrodes 26 for delivering stimulation to spinal tissue ([00115]-[00116]; Figs, 2-3).
…a machine-implementable algorithm…control stimulation circuitry…generate a stimulation waveform pursuant to a stimulation program:
E.G. Vansickle et al. disclosed microcontroller 39 executing a program stored in memory 41 to control modulation output circuitry 49 and generate programmed pulsed waveforms ([00117]-[00118]).
…at a first configuration of the electrodes defining a center point of stimulation (CPS) in a patient’s tissue:
E.G. Vansickle et al. discloses programmed electrode polarities and fractionalized currents, including a virtual anodic monopole having a defined location ([00118], [00186]). The identified virtual-pole location is the proposed correspondence to CPS.
…determining an…ECAP…or at least one feature…at least one electrode:
E.G. Vansickle expressly senses stimulation-evoked ECAPs at one or more electrodes 26 [00148].
…based on the determined ECAP or…feature, adjust the stimulation program…at a second configuration…different from the first:
E.G. Vansickle discloses converting fractionalized electrode combinations, but does not expressly disclose the claimed ECAP-dependent conversion ([00143]).
E.G. Lee et al. teaches using ECAP-derived thresholds to compute threshold ratios and select effective electrode sets ([0020]-[0022], [0092]-[0093]). Lee additionally teaches distributing energy among selected electrode sets based on their threshold ratios [0026], using independently controlled electrode currents and fractionalized configurations ([0058]-[0059]).
…the second electrode configuration…[has] a CPC…that equals the CPS…defined by the first electrode configuration:
E.G. Vansickle teaches maintaining field locus during configuration conversion, including locating a converted cathodic pole at the preceding anodic-pole location ([00143], [00186], [00188], [00191]).
It would have been obvious to one of ordinary skill in the art before the effective filing data to use Lee’s ECAP-derived threshold information when selecting Vansickle’s converted electrode configuration, while retaining Vansickle’s prescribed stimulation location. The reason would have been to select a configuration suited to the patient’s measured neural response without relocating the established stimulation target. Under this proposed modification, eCAP-derived information would guide configuration selection, and Vansickle’s virtual-pole computation would constrain the selected configuration to the preserved location. A reasonable expectation of success would require establishing that Lee’s selection criteria can operate within that location constraint using the disclosed programmable electrode-current controls.
Claim 2.
…the algorithm is stored on a non-transitory machine-readable medium within the stimulator device…executed within the stimulator device:
E.G. Vansickle discloses implanted controller 39, memory 41, and implant-executed calibration ([00117], [00157]).
Claim 3.
…an external system configured to communicate with the stimulator device:
E.G. Vansickle disclosed external RC 16 and CP 18 communicating with IPG 14 ([00112]-[00113]).
Claim 4.
…a portion of the algorithm is stored on a non-transitory machine-readable medium within the external system:
E.G. Vansickle discloses CP memory 82 storing executable programming package 84 [00162]. In the proposed combination, the externally performed adjustment operations would form part of that stored programming package.
Claim 5.
…receive the determined ECAP or the at least one feature of the ECAP from the stimulator device:
E.G. Lee discloses ECAP monitoring and transmission through implant telemetry ([0056]-[0057]).
…determine the at least one feature from the ECAP if the at least one feature was not received from the stimulator device:
E.G. Lee discloses ECAP template comparison for threshold determination ([0092]-[0093]).
…based on the determined ECAP or the at least one feature, adjust the stimulation program to the stimulator device:
E.G. Lee discloses response-based electrode selection and transmission of adjusted programming parameters ([0020]-[0022], [0083], [0092]-[0097]).
Claim 6.
…allow for the input of the CPS via a user interface:
E.G. Vansickle discloses user-directed graphical positioning of a virtual pole [00182]. Under broadest reasonable interpretation “input” may encompass graphical positioning.
Claim 7.
…compute the stimulation program and the adjusted stimulation program using the input CPS:
E.G. Vansickle discloses virtual-pole based computation and conversion retaining the pole location ([00182], [00186], [00188]).
Claim 8.
…define which…electrode should be active [and] whether each active electrode comprises an anode electrode or a cathode electrode:
E.G. Lee discloses active, anodic, cathodic, and off-state electrode programming ([0058]-[0059], [0082]).
…a percentage of a total anodic current for each active anode electrode, and a percentage of a total cathodic current for each active cathode electrode:
E.G. Lee discloses fractional allocation of current among selected electrodes ([0058]-[0059], [0082]).
Claim 9.
…the total anodic and total cathodic current of the second electrode configuration equals the total anodic and total cathodic current of the first electrode configuration:
E.G. Lee discloses independently controlled electrode currents and fractionalized current allocation ([0058]-[0059], [0082]).
Although equal respective totals across the two configurations are not expressly established, it would have been obvious to maintain the total anodic and cathodic currents while changing their distribution among electrodes to assess the configuration’s effect on the ECAP without introducing a change in total current as an additional variable. The proposed modification would retain the respective current totals while permitting different fractional allocations.
Claim 10.
…the at least one feature is indicative of the shape and/or size of the ECAP…
E.G. Lee discloses comparing sensed ECAPs with stored ECAP characteristics to determine stimulation thresholds ([0092]-[0093]).
It would have been obvious to implement that comparison using a known ECAP-amplitude metric indicative of response and provide an objective basis for electrode selection. Using response size satisfies the recited “shape and/or size” alternative.
Claim 11.
…the at least one feature comprises a time defining a duration of any portion of the ECAP, or a time delay from stimulation to issuance of the ECAP:
E.G. Lee discloses ECAP analysis and comparison with stored response characteristics ([0092]-[0093].
It would have been obvious to implement that analysis using a known ECAP-duration or latency metric to distinguish neural responses and provide an additional objective basis for selecting an electrode configuration.
Claim 12.
…the algorithm is configured to determine in the stimulator device the neural response…at least one non-active electrode:
E.G. Lee discloses implanted monitoring circuitry for sensing ECAPs and selectable electrode activation states ([0055]-[0056], [0059]).
It would have been obvious to configure an electrode not delivering the stimulation waveform to record the resulting ECAP, thereby separating stimulation and recording functions to facilitate neural-response measurement within the stimulator device.
Claim 13.
…the adjusted stimulation program comprises the same pulse width, frequency, duty cycle and waveform shape as the stimulation program:
E.G. Vansickle discloses programmable waveform parameters and electrode configuration, and Lee discloses adjustment of fractionalized electrode combinations (Vansickle, [00118]; Lee [0059], [0082]-[0083]).
It would have been obvious to retain pulse width, frequency, duty cycle, and waveform shape while varying electrode configuration to assess the configuration’s effect on the ECAP without confounding that assessment with simultaneous waveform changes. The proposed modification would vary the spatial current distribution while retaining the specified waveform parameters.
Claim 14.
…the stimulation program and the adjusted stimulation program comprise the same energy:
E.G. Vansickle discloses programmable stimulation parameters, and Lee discloses electrode selection based on measured neural responses (Vansickle, [00118]; Lee [0020]-[0022], [0092]-[0097]).
It would have been obvious to compare different electrode configurations at equal delivered energy to assess their relative neural-recruitment efficiency without introducing unequal energy delivery as an additional variable.
Claim 15.
A method for controlling a stimulator device comprising a plurality of electrodes…in contact with a patient’s tissue:
E.G. Vansickle disclosed IPG 14 controlling tissue-contacting electrode 26 carried by leads 12 ([00115]-[00118]).
…generating a stimulation waveform…at a first configuration…defining a center point of stimulation (CPS):
E.G. Vansickle discloses programmed stimulation using electrode configurations computed to emulate a virtual pole at a selected tissue location ([00118], [00182]).
…determining an [ECAP]…or at least one feature of the ECAP:
E.G. Lee discloses sensing stimulation-evoked ECAPs and analyzing those responses to determine stimulation thresholds ([0056], [0092]-[0093]).
…based on the determined ECAP…adjusting the stimulation program…[to] a second configuration…different from the first…[having an equal] CPS:
E.G. Lee teaches ECAP-based threshold determination used in electrode selection ([0020]-[0022], [0092]-[0097]).
E.G. Vansickle teaches computing a different electrode configuration while retaining the virtual-pole location and resulting field locus ([0186], [0188], [0191]).
It would have been obvious to incorporate Lee’s ECAP-based electrode selection into Vansickle’s configuration-conversion process to assess electrode effectiveness objectively while retaining the previously selected stimulation location.
Claim 16.
The method…is configured to be executed within the stimulator device:
E.G. Vansickle discloses implanted microcontroller 39 and memory 41 and expressly permits calibration within IPG 14 without external communication when user input is unnecessary ([00117], [00157]).
E.G. Lee disclosed implanted ECAP-monitoring circuitry ([0055]-[0056]).
It would have been obvious to implement the combined response analysis and configuration-adjustment operations within the implanted controller to permit autonomous adjustment without requiring an external communication link.
Claim 17.
…Step (c) is executed in an external system in communication with the stimulator device:
E.G. Vansickle discloses CP 18 computing converted electrode configurations and communicating programming parameters to IPG 14 ([00158], [00162], [00186]-[00191].
Applying Lee’s ECAP-based electrode-selection processing in that external programmer would permit the programmer to perform the combined adjustment operation and transmit the resulting program to the implant, using the existing external programming architecture.
Claim 18.
.…Step (b) is executed in the external system in communication with the stimulator device:
E.G. Lee discloses transmission of sensed ECAPs responses with stored characteristics ([0057], [0092]-[0093]).
It would have been obvious to perform that response determination in the external programmer receiving the ECAP data, thereby making the determined response available to the adjustment processing recited in claim 17. Under BRI, external determination does not necessarily require external physical acquisition of the signal; implanted electrodes may acquire the waveform for external analysis.
Claim 19.
…The first and second electrode configuration define which…electrodes should be active [and] whether each active electrode comprise an anode electrode or a cathode electrode:
E.G. Lee discloses selectable active electrodes and anodic, cathodic, or off states ([0058]-[0059], [0082]).
…a percentage of a total anodic current for each active anode electrode, and a percentage of a total cathodic current for each active cathode electrode:
E.G. Lee discloses independently controlled electrode currents and fractionalized current allocations ([0058]-[0059], [0082]), providing the respective current percentages for the first and second configurations.
Claim 20.
…The CPS is input by a user via a user interface:
E.G. Vansickle discloses graphical controls through which the user positions a virtual pole and the processor computes corresponds electrode current ([00182]).
Under BRI, input of a location encompasses graphical positioning and need not require numerical coordinate entry. Accordingly, this disclosure supports user input of the CPS if the virtual-pole location is established to correspond to the specification’s CPS definition.
Response to Arguments
Applicant’s arguments concerning the rejection under 35 U.S.C §103 over Jaax have been considered and are persuasive in that the previously cited disclosures do not adequately establish adjustment, based on an ECAP or a feature thereof, from a first electrode configuration to a different second electrode configuration while maintaining the same center point of stimulation. Accordingly, the rejection based on Jaax is withdrawn.
The present rejection relies on Vansickle in view of Lee et al. Vansickle discloses conversion between electrode configurations while preserving the stimulation-field locus ([00186], [00188], [00191]), and Lee discloses ECAP-based threshold determination used in electrode selection ([0020]-[0022], [0092]-[0097]). The accompanying rejection sets forth the mapping of these disclosures to the pending claims and the rationale for their combination.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796
