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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/30/2026 has been entered.
Response to Arguments
Applicant's arguments filed on 03/30/2026 have been fully considered but they are not persuasive. Applicant argues that Karantonis fails to teach selecting an amplitude value based on a determined value of at least one stimulation artifact feature and adjusting an amplitude of neurostimulation to the selected amplitude value. Applicant further contends that the change in amplitudes disclosed by Karantonis are pre-selected for use, rather than selected on the basis of a value measured during the test. Examiner respectfully disagrees and maintains that an amplitude value is selected based on at least one stimulation artifact feature as disclosed in Figure 16. Even if the ratios of amplitudes are pre-selected during a testing phase, only one of those ratios is selected for ongoing stimulation based on an identified minima in artifact (Step 1650). Therefore, the ratio (containing an amplitude value) is adopted for ongoing stimulation based on the value of the stimulation artifact feature (identified minima).
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.
Claim(s) 46, 58, 60, and 62-65 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Karantonis et al (US 2019/0239768) hereinafter Karantonis.
Regarding claims 46 and 65, Karantonis discloses a method (Figure 16) for operating an implantable neurostimulator device (Fig. 1: neurostimulator 100) comprising a plurality of neurostimulator electrodes (Fig. 1: electrode array 150) configured to provide neurostimulation to a patient's neural tissue, the method comprising:
providing neurostimulation at an amplitude ([0093] step 1610) at at least two electrodes selected from the plurality of neurostimulator electrodes of the implantable neurostimulator device ([0071] stimulus from electrodes 2 and 4);
sensing a stimulation artifact ([0093] step 1620) over time at at least one sensing electrode selected from the plurality of neurostimulator electrodes and different from the at least two electrodes that provide the neurostimulation ([0071] signals sensed by the measurement electrodes 6 and 8),
wherein the stimulation artifact comprises a signal formed by an electric field induced in the neural tissue by the neurostimulation ([0093] At 1620, artefact resulting from the stimulus is measured and recorded),
wherein the stimulation artifact is different from a neural response to the stimulation ([0093] At 1610 a stimulus is applied, below a threshold for neural recruitment so as to ensure that neural responses are not evoked and do not contribute to measurements);
determining a value of at least one feature of the stimulation artifact ([0093] step 1650, where the minima in artefact is identified from all the recordings);
using at least the value of the at least one stimulation artifact feature to select an amplitude value ([0093] The ratio which gave rise to that minimum artefact is then adopted for ongoing stimulation; A similar approach may be used to identify optimal ratios of stimulation phase amplitudes); and
adjusting the amplitude of the neurostimulation to the selected amplitude value ([0093] The ratio which gave rise to that minimum artefact is then adopted for ongoing stimulation; Examiner notes this would require the amplitude of the stimulation to be adjusted to the selected ratio).
Karantonis further discloses a non-transitory computer readable medium for delivering a neural stimulus [0025].
Regarding claim 58, Karantonis discloses wherein the at least one stimulation artifact feature is indicative of an energy of the stimulation artifact ([0093] step 1650, where the minima in artefact is identified from all the recordings).
Regarding claim 60, Karantonis discloses wherein the value of the at least one stimulation artifact comprises an amplitude, and further comprising using the value of the at least one stimulation artifact to select the amplitude value ([0093] identify optimal ratios of stimulation phase amplitudes; step 1650, where the minima in artefact is identified from all the recordings. The ratio which gave rise to that minimum artefact is then adopted for ongoing stimulation at supra-threshold therapeutic levels).
Regarding claim 62, Karantonis discloses wherein the implantable neurostimulator device comprises a Spinal Cord Stimulator device ([0066] FIG. 1 schematically illustrates an implanted spinal cord stimulator 100).
Regarding claim 63, Karantonis discloses wherein the method is repeated to continually adjust the neurostimulation ([0031] Such adaptive embodiments provide a means by which to repeatedly or continually optimize the reduction of artefact observed in the recording).
Regarding claim 64, Karantonis discloses an implantable neurostimulator device (Fig. 1: stimulator 100), comprising:
a plurality of neurostimulator electrodes configured to provide neurostimulation to a patient's neural tissue ([0066] electrode assembly 150);
stimulation circuitry (pulse generator 124) configured to provide neurostimulation at an amplitude at at least two of the electrodes selected from the plurality of neurostimulator electrodes ([0068] a pulse generator 124 to generate stimuli in the form of current pulses; Electrode selection module 126 switches the generated pulses to the appropriate electrode(s) of electrode array 150);
a sense amplifier (amplifier and ADC 128) configured to sense a stimulation artifact over time at at least one sensing electrode selected from the plurality of neurostimulator electrodes and different from the at least two electrodes that provide the neurostimulation ([0068] Measurement circuitry 128 is configured to capture measurements of neural responses sensed at sense electrode(s)),
wherein the stimulation artifact comprises a signal formed by an electric field induced in the neural tissue by the neurostimulation ([0093] At 1620, artefact resulting from the stimulus is measured and recorded),
wherein the stimulation artifact is different from a neural response to the stimulation ([0093] At 1610 a stimulus is applied, below a threshold for neural recruitment so as to ensure that neural responses are not evoked and do not contribute to measurements); and
control circuitry (controller 116; [0093] process 1600 may be executed by controller 116) configured to:
determine a value of at least one feature of the stimulation artifact ([0093] step 1650, where the minima in artefact is identified from all the recordings);
use at least the value of the determined at least one stimulation artifact feature to select an amplitude value of the ([0093] The ratio which gave rise to that minimum artefact is then adopted for ongoing stimulation; A similar approach may be used to identify optimal ratios of stimulation phase amplitudes); and
adjust the amplitude of the neurostimulation to the selected amplitude value ([0093] The ratio which gave rise to that minimum artefact is then adopted for ongoing stimulation; Examiner notes this would require the amplitude of the stimulation to be adjusted to the selected ratio).
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) 47-49 and 59 are rejected under 35 U.S.C. 103 as being unpatentable over Karantonis (US 2019/0239768) in view of Esteller et al (US 2019/0099602) hereinafter Esteller.
Regarding claim 47, Karantonis discloses the method of claim 46 as discussed above, but fails to disclose wherein the electric field is further configured to recruit neural fibers in the neural tissue causing a neural response. However, Esteller discloses wherein the electric field is further configured to recruit neural fibers in the neural tissue causing a neural response ([0029] Such stimulation produces an electromagnetic (EM) field in a volume 95 of the patient's tissue around the selected electrodes. Some of the neural fibers within the EM field volume 95 will be recruited and fire). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Karantonis with the electric field is further configured to recruit neural fibers in the neural tissue causing a neural response as taught by Esteller. Such a modification would provide the predictable results of masking signals indicative of pain in an SCS application, thus providing a desired therapy (Esteller, [0029]).
Regarding claim 48, the modified Karantonis discloses the method of claim 46 as discussed above, but fails to disclose: sensing the neural response at the at least one sensing electrode; determining a value of at least one feature of the neural response; and using the value of the at least one neural response feature to further adjust the neurostimulation.
However, Esteller discloses sensing the neural response at the at least one sensing electrode ([0045] The ECAP algorithm 124a could choose more than one electrode to act as a sense electrode);
determining a value of at least one feature of the neural response ([0077] Next the ECAP algorithm 124a assesses the one or more features of the ECAP to determine whether they are acceptable (150)); and
using the value of the at least one neural response feature to further adjust the neurostimulation ([0081] If the ECAP feature(s) are not acceptable (150), the ECAP algorithm 124a can adjust the electrode configuration).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Karantonis with sensing the neural response at the at least one sensing electrode; determining a value of at least one feature of the neural response; and using the value of the at least one neural response feature to further adjust the neurostimulation as taught by Esteller. Such a modification would provide the predictable results of adjusting a stimulation program while keeping a location of a central point of stimulation constant (Esteller, [0081]).
Regarding claim 49, Karantonis discloses wherein the sensed stimulation artifact excludes the neural response ([0093] At 1610 a stimulus is applied, below a threshold for neural recruitment so as to ensure that neural responses are not evoked and do not contribute to measurements).
Regarding claim 59, Karantonis discloses the method of claim 46 as discussed above, but fails to disclose the at least two electrodes are spaced at a distance from the at least one sensing electrode, and further comprising using the distance to adjust the stimulation.
However, Esteller discloses the at least two electrodes are spaced at a distance from the at least one sensing electrode ([0041] a sense electrode S be sensibly chosen with respect to the active electrodes), and
further comprising using the distance to adjust the stimulation ([0081] If the ECAP feature(s) are not acceptable, the ECAP algorithm 124a can adjust the electrode configuration).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Karantonis, with the at least two electrodes are spaced at a distance from the at least one sensing electrode, and further comprising using the distance to adjust the stimulation as taught by Esteller, since such a modification would provide the predictable results of adjusting the electrode configuration in order to minimize the artifact caused by the EM fields around the electrodes.
Claim(s) 50 is rejected under 35 U.S.C. 103 as being unpatentable over Karantonis (US 2019/0239768) in view of Esteller (US 2019/0099602) and further in view of Single (US 2017/00493435).
Regarding claim 50, the modified Karantonis discloses the method of claim 47 as discussed above, but fails to disclose the sensed stimulation artifact occurs before arrival of the neural response at the at least one sensing electrode. However, Single teaches the sensed stimulation artifact occurs before arrival of the neural response at the at least one sensing electrode ([0005] The artifact is often restricted to a time of 1-2 ms after the stimulus and so, provided the neural response is detected after this time window, data can be obtained; [0013] Measuring a neural response signal present at sense electrodes).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Karantonis, with the sensed stimulation artifact occurring before arrival of the neural response at the at least one sensing electrode as taught by Single. Such a modification would provide the predictable results of increased efficiency regarding neural response monitoring since the sensed signal would not be influenced by the artifact.
Claim(s) 51-53 are rejected under 35 U.S.C. 103 as being unpatentable over Karantonis (US 2019/0239768) in view of Donofrio et al (US 2010/0114198) hereinafter Donofrio.
Regarding claim 51, Karantonis discloses the method of claim 46 as discussed above, but fails to disclose using the value of the at least one stimulation artifact feature to determine a posture or activity of the patient. However, Donofrio discloses a relationship between the stimulation artifact sensed by an implanted device and patient posture ([0311] The amount of neurostimulation artifact that ICD 16 senses may change as a function of the position of leads 28, 29 within patient 12), and measuring the stimulation artifact at different postures ([0312] Processor 130 of programmer 24 may evaluate the neurostimulation artifact while patient 12 is in different postures and/or activity levels). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Karantonis, with using the relationship between the measured stimulation artifact and the posture of the patient as taught by Donofrio, to determine the posture of the patient based on the measured stimulation artifact. Such a modification would provide the predictable results of aiding the clinicians in evaluating the spectrum of crosstalk that may be present (Donofrio, [0312]).
Regarding claim 52, the modified Karantonis discloses the method of claim 51 as discussed above, but fails to disclose wherein the implantable neurostimulator device is programmed with a database associating values or ranges of values of the at least one stimulation artifact with different postures or activities. However, Donofrio discloses an implantable stimulator device is programmed with a database associating values or ranges of values of the at least one stimulation artifact with different postures or activities ([0312] processor 130 may evaluate the neurostimulation artifact while patient 12 is in different postures and/or activity levels; record baseline electrical signals in different postures).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Karantonis with an implantable stimulator device being programmed with a database associating values or ranges of values of the at least one stimulation artifact with different of the postures or activities as taught by Donofrio since such a modification would provide the predictable results of better evaluating the neurostimulation artifact present in a signal (Donofrio, [0312]).
Regarding claim 53, the modified Karantonis discloses the method of claim 52 as discussed above, but fails to disclose wherein using the value of the at least one stimulation artifact feature to determine a posture or activity of the patient comprises using the determined value to select from the database one of the postures or activities that is associated with a value or range of values that matches the determined value.
However, Donofrio discloses using the determined value to select from the database one of the postures or activities that is associated with a value or range of values that matches the determined value ([0306] Step 296; [0312] processor 130 of programmer 24 may evaluate the neurostimulation artifact while patient 12 is in different postures and/or activity levels).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Karantonis, with using the relationship between the measured stimulation artifact feature value and the posture of the patient as taught by Donofrio, to select from the database of postures or activities that is associated with a value that matches the determined stimulation artifact feature value. Such a modification would provide the predictable results of better evaluating the neurostimulation artifact present in a signal (Donofrio, [0312]).
Claim(s) 54-55 are rejected under 35 U.S.C. 103 as being unpatentable over Karantonis (US 2019/0239768) in view of Donofrio (US 2010/0114198), and further in view of Bourget et al (US 2007/0129774), hereinafter Bourget.
Regarding claim 54, Karantonis discloses the method of claim 46 as discussed above, but fails to disclose associating the values or ranges of values of the at least one stimulation artifact with different stimulation programs. However, Donofrio discloses a database associating values or ranges of the at least one stimulation artifact with patient postures ([0312] processor 130 of programmer 24 may evaluate the neurostimulation artifact while patient 12 is in different postures and/or activity levels). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Karantonis with the database associating values or ranges of values of the at least one stimulation artifact with patient postures as taught by Donofrio, since such a modification would provide the predictable results of allowing the stimulation device to provide real-time detection of lead migration (based on posture/activity) and switch sensing modules at a useful time before inappropriately delivering a shock to the patient (Donofrio, [0312-0313]).
Bourget discloses a database associating different stimulation programs with different patient postures (Figure 7). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Karantonis with associating stimulation programs with different postures as taught by Bourget since such a modification would provide the predictable results of increased efficacy regarding stimulation therapy by creating effective, patient specific stimulation programs.
Regarding claim 55 , the modified Karantonis discloses the method of claim 54 as discussed above, but fails to disclose wherein using the value of the at least one stimulation artifact feature to select the amplitude value comprises using the determined value to select from the database one of the stimulation programs that is associated with a value or range of values that matches the determined value.
However, Donofrio discloses a database associating a value or range of values that match the determined value of the at least one stimulation artifact feature with different postures and/or activity levels ([0312] processor 130 of programmer 24 may evaluate the neurostimulation artifact (measure magnitude) while patient 12 is in different postures and/or activity levels).
Bourget discloses a database of stimulation programs that is associated with different patient postures (Figure 7).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Karantonis with a database associating a value or range of values that match the determined value of the at least one stimulation artifact feature with different postures and/or activity levels as taught by Donofrio and associating stimulation programs with different postures, as taught by Bourget. Such a modification would provide the predictable results of allowing the stimulation device to provide real-time detection of lead migration (based on posture/activity) and switch sensing modules at a useful time before inappropriately delivering a shock to the patient (Donofrio, [0312-0313]) while also increasing efficacy regarding stimulation therapy by creating effective, patient specific stimulation programs.
Claim(s) 56-57 are rejected under 35 U.S.C. 103 as being unpatentable over Karantonis (US 2019/0239768) in view of Single (US 2017/00493435).
Regarding claim 56, Karantonis discloses the method of claim 56 as discussed above, but fails to disclose wherein the stimulation artifact is sensed at a sense amplifier in the implantable neurostimulation device in a single-ended manner using a fixed reference potential as a reference. However, Single discloses sensing, at a sense amplifier in a stimulation device in a single-ended manner using a fixed reference potential as a reference ([0017] a measurement amplifier for amplifying a neural response signal sensed at the one or more sense electrodes; [0021] a single ended measurement utilizing a single sense electrode and a distal reference electrode). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Karantonis, with sensing, at a sense amplifier in the stimulation device in a single-ended manner using a fixed reference potential as a reference as taught by Single since such a modification would provide the predictable results of increased cost efficiency since single ended sensing requires fewer wires.
Regarding claim 57, Karantonis discloses the method of claim 46 as discussed above, but fails to disclose wherein the stimulation artifact is sensed at a sense amplifier differentially in the implantable neurostimulation device using one electrode of the at least one sensing electrode as a reference. However, Single discloses sensing, at a sense amplifier differentially in the stimulation device using one electrode of the at least one sensing electrode as a reference ([0017] a measurement amplifier for amplifying a neural response signal sensed at the one or more sense electrodes; [0021] a differential measurement of the neural response by using two sense electrodes). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Karantonis, with sensing, at a sense amplifier differentially in the stimulation device using one electrode of the at least one sensing electrode as a reference as taught by Single. Such a modification would provide the predictable results of reduced noise and increased signal integrity due to minimizing EM interference.
Conclusion
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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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