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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-6 and 16-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 is unclear because it is unclear what is meant by the limitation “a first-ordered trough of a stimulation wave,” since it is not clear whether the term “first-ordered” refers to a first order in an ordinal sequence, which is not recited or defined in the claim, or to some other meaning of “first-ordered” related to systems, equations, waveforms, or the like. Additionally, the specification does not provide clarity on this term. For examination purposes, the limitation will be read as a trough of a stimulation response wave.
Similarly, also in claim 3, it is unclear what is meant by the limitation “a second-ordered positive peak of a stimulation wave,” since it is not clear whether the term “second-ordered” refers to a second order in an ordinal sequence, which is not recited or defined in the claim, or to some other meaning of “second-ordered” related to systems, equations, waveforms, or the like. Additionally, the specification does not provide clarity on this term. For examination purposes, the limitation will be read as a positive peak of a stimulation response wave.
In claims 4 and 16, the limitation “each peak” does not have sufficient antecedent basis in the claim, and the limitation “a relative amplitude of each peak” is therefore unclear in scope. For examination purposes, the limitation will be read as an amplitude of at least one of the sensed ERs. Dependent claims 5 and 17 are necessarily rejected as depending upon rejected base claims.
In claim 6, line 4, there appears to have been a misprint or language omitted from the claim, which renders the claim unclear because it is unclear if the phrase “the first stimulation threshold second stimulation threshold” refers to the first or second stimulation threshold, to both, or to some other combination. For examination purposes, this limitation will be read as the second stimulation threshold only.
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.
Claims 1, 4-6, 9-11, 13-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson et al. (US PGPub No. 2023/0069981), hereinafter Isaacson, in view of Parker et al. (WO 2024/243648, effectively filed 01 June 2023), hereinafter Parker.
Regarding claims 1 and 20, Isaacson teaches a system and method, comprising:
at least one lead including a plurality of electrodes (Fig. 2: leads 114A-B);
an electrostimulator configured to provide electrostimulation to a neural target of a patient (Fig. 2: stimulation generation circuitry 202);
a sensing circuit configured to sense an evoked response (ER) to the electrostimulation (Fig. 2: sensing circuitry 204; par. 0122: “sensing circuitry 204 may be configured to sense one or more biomarker signals, and processing circuitry 210 may receive the first instance of the biomarker signal from sensing circuitry 204. Examples of the biomarker signal include a local field potential (LFP) signal, an evoked compound action potential (ECAP) signal, and an electromyography (EMG) signal”);
and a controller circuit operably connected to the electrostimulator and the sensing circuit (Fig. 2: processing circuitry 210),
the controller circuit configured to: deliver the electrostimulation to the neural target of the patient in accordance with a stimulation setting via a at least one stimulating electrode selected from the plurality of electrodes on the at least one lead (par. 0092: “processing circuitry 210 of IMD 106 may deliver, via electrodes 116, 118 (and stimulation generation circuitry 202), electrical stimulation therapy to patient 112”);
collect sensed ERs to the electrostimulation using at least one sensing electrode on the at least one lead (par. 0092: “Processing circuitry 210 of IMD 106 may sense, via electrodes 116, 118 interposed along leads 114 (and sensing circuitry 204), one or more biomarker signals of brain 120 of patient 112”);
and determine characteristics for a stimulation parameter based on the sensed ERs (par. 0092: “Processing circuitry 210, via electrodes 116, 118, delivers to patient 112 adaptive DBS and may adjust one or more parameters defining the electrical stimulation based on corresponding parameters of the sensed one or more bioelectric signals of brain 120”).
Isaacson does not explicitly teach determining a first or second stimulation threshold for the stimulation parameter, wherein the first stimulation threshold indicates a minimum value or a maximum value for a first sensed threshold of the sensed ERs; and the second stimulation threshold indicates a maximum value for the sensed ERs; and delivering electrostimulation therapy to the neural target using a stimulation parameter set to cause a subsequent sensed ER value to be above the minimum value or below the maximum value and below the second stimulation threshold.
However, in an analogous art, Parker teaches a neurostimulation system and method comprising determining minimum and maximum stimulation thresholds based on sensed ERs in order to adapt to postural changes in the patient (Figs. 4a-4b: therapeutic range 412 within ECAP threshold 404 and discomfort threshold 408, posture-varying thresholds 508-512; par. 0055-0056: “as the patient’s posture changes, the ECAP threshold changes, as indicated by the ECAP thresholds 508, 510, and 512 for the respective activation plots 502, 504, and 506. Additionally, as the patient’s posture changes, the patient sensitivity also changes, as indicated by the varying slopes of activation plots 502, 504, and 506 […] To keep the applied stimulus intensity within the therapeutic range as patient posture varies, in some implementations an implantable neuromodulation device such as the stimulator 100 may adjust the applied stimulus intensity based on a feedback variable that is determined from one or more measured ECAP characteristics”), and delivering electrostimulation therapy using a stimulation parameter set to cause a subsequent sensed ER to be within the minimum and maximum thresholds for effective and comfortable neuromodulation (par. 0005: “For effective and comfortable neuromodulation, it is necessary to maintain stimulus intensity above a recruitment threshold. Stimuli below the recruitment threshold will fail to recruit sufficient neurons to generate action potentials with a therapeutic effect. In some neuromodulation applications, response from a single class of fibre is desired, but the stimulus waveforms employed can evoke action potentials in other classes of fibres which cause unwanted side effects. In pain relief, it is therefore desirable to apply stimuli with intensity below a discomfort threshold, above which uncomfortable or painful percepts arise […] It is therefore desirable to maintain stimulus intensity within a therapeutic range between the recruitment threshold and the discomfort threshold”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system and method of Isaacson by implementing the steps of determining minimum and maximum thresholds and delivering electrostimulation therapy to cause a subsequent sensed ER to be within the minimum and maximum thresholds, as taught by Parker, in order to adapt to postural changes and deliver effective and comfortable neuromodulation, as taught by Parker (see par. 0005 and 0055-0056).
Regarding claim 15, the limitations of this claim are also rejected for the same reasons set forth previously in the rejection of independent claims 1 and 20, since Isaacson teaches a non-transitory computer-readable medium storing instructions executable by a processor (Fig. 2: memory 211), and the combination teaches the method steps recited thereafter.
Regarding claims 4 and 16, the combination teaches the method of claim 1 and the medium of claim 15 as described previously. Isaacson further teaches wherein the electrostimulation therapy is delivered based on additional sensed parameters; and the additional sensed parameters comprise a frequency of at least one of the sensed ERs, an N1-P2 peak amplitude, an N1-P2 peak delay, a size of an evoked potential envelope, or an amplitude of at least one of the sensed ERs (par. 0028: “Examples of differences between the first instance and the second instance of the biomarker signals include differences in amplitude, differences in ratio of spectral powers in different frequency bands, differences in spectral powers in the same frequency band, etc”).
Regarding claims 5 and 17, the combination teaches the method of claim 4 and the medium of claim 16 as described previously. Isaacson further teaches further comprising using the processing system to use at least one of the additional sensed parameters to determine a state of the patient (par. 0061: “IMD 106 may utilize the biomarker signals as a way to determine a change of patient state”), wherein the state of the patient comprises one of a sleep state, an awake state, a state of receiving medication, or a state of diminishing medication release, sufficient therapy, insufficient therapy, or an experience of at least one side effect (par. 0032: “a first patient state may be when the patient is awake and standing, and a second patient state may be when the patient is asleep and lying down”).
Regarding claims 6 and 18, the combination teaches the method of claim 1 and the medium of claim 15 as described previously. Isaacson further teaches further comprising using the processing system to update the first or second stimulation threshold based on a change of state of the patient (par. 0139: “processing circuitry 210 may be configured to cause stimulation generation circuitry 202 to transition between delivering electrical stimulation having a first parameter set based on patient 112 being in the first patient state and delivering electrical stimulation having a second parameter set based on patient 112 being in the second patient state”).
Regarding claim 9, the combination teaches the method of claim 1 as described previously. Isaacson further teaches comprising using the processing system to determine a state of the patient and adjusting the delivered electrostimulation to a predetermined stimulation value associated with the determined state (par. 0062: “when patient 112 is in a first patient state (e.g., not moving), IMD 106 may be configured to deliver electrical stimulation having a first parameter set. When patient 112 is in a second patient state (e.g., moving), IMD 106 may be configured to deliver electrical stimulation having a second parameter set”).
Regarding claim 10, the combination teaches the method of claim 1 as described previously. Isaacson further teaches wherein the sensing electrodes include two or more electrodes immediately adjacent to the stimulating electrode on the at least one lead (Fig. 2 and par. 0036: “some of electrodes 116, 118 may be configured to sense neurological brain signals and others of electrodes 116, 118 may be configured to deliver adaptive electrical stimulation to brain 120”).
Regarding claim 11, the combination teaches the method of claim 1 as described previously. Isaacson further teaches wherein the at least one lead includes a deep brain stimulation (DBS) lead (Fig. 1: deep brain stimulation leads 114A-B), and wherein the electrostimulator is configured to provide DBS to a brain target of the patient (par. 0033: “an implantable medical device (IMD) 106 configured to deliver adaptive deep brain stimulation (DBS) to a patient 112”).
Regarding claims 13-14, the combination teaches the method of claim 1 as described previously. Isaacson further teaches further comprising using the processing system to determine the first stimulation threshold or the second stimulation threshold based on a particular activity being performed by the patient, and to provide stimulation values for the stimulation parameter set based on at least one of a time of day that the electrostimulation is performed and a particular activity being performed by the patient (par. 0062: “when patient 112 is in a first patient state (e.g., not moving), IMD 106 may be configured to deliver electrical stimulation having a first parameter set. When patient 112 is in a second patient state (e.g., moving), IMD 106 may be configured to deliver electrical stimulation having a second parameter set”).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson in view of Parker and further in view of Sinclair et al. (WO 2019/210371), hereinafter Sinclair.
Isaacson in view of Parker teaches the method of claim 1 as described previously. The combination does not explicitly teach further comprising using the processing system to detect a saturation point associated with the stimulation parameter; wherein the saturation point is detected based on a comparison of a difference in consecutive electrostimulation recordings; and wherein the difference in consecutive electrostimulation recordings comprises a comparison of a trough of a stimulation wave to a positive peak of the stimulation wave. However, in a related neurostimulation art, Sinclair teaches determining saturation based on a comparison of a difference in consecutive electrostimulation recordings (par. 0253: “ERNA amplitude initially increased with DBS amplitude and then plateaued at levels above 1.5 mA (Fig. 25B). While these effects may be related to the therapeutic effects of DBS, they may alternatively or additionally be due to saturation of neural firing in the STN”) and that the difference comprises a comparison of a trough to a positive peak of the stimulation wave (par. 0251: “We also calculated the amplitude difference between the first peak and the first trough as a representative measure of ERNA amplitude”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of the combined reference with the known technique of detecting saturation in a measured signal, as taught by Sinclair, because one of ordinary skill in the art would have recognized that applying the known technique to the method of the combined reference would have yielded predictable results and resulted in an improved method, namely, a method capable of detecting when a measured signal has lost signal information due to saturation.
Claims 7-8, 12, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson in view of Parker and further in view of Carcieri (US PGPub No. 2014/0243926).
Regarding claim 7, Isaacson in view of Parker teaches the method of claim 1 as described previously. The combination does not explicitly teach further using the processing system to: recalibrate the first stimulation threshold and the second stimulation threshold; and adjust the stimulation parameter to cause the subsequent sensed ER value to be above a minimum value or a maximum value each associated with the recalibrated first stimulation threshold or below the recalibrated second stimulation threshold. However, in a related neurostimulation art, Carcieri teaches recalibrating stimulation thresholds in order to optimize power consumption (par. 0081: “the system 10 may automatically decrease the amplitude, pulse width or pulse rate to find more energy efficient stimulation setting. The system 10 may also stimulate on electrodes with lower impedance, or electrodes that are nearer to the location where evoked action potentials are detected in order to determine if the same potentials can be evoked with more energy efficient settings;” par. 0083: “If the characteristics of the newly recorded evoked action potential match with the template, the desired therapeutic effect by the stimulation is verified. In such case, in step 1600, the threshold stimulation parameter set is replaced by the stimulation parameter set with the lower amplitude”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of the combined reference by recalibrating the first and second stimulation thresholds, as taught by Carcieri, in order to optimize power consumption, as taught by Carcieri.
Regarding claims 8 and 19, Isaacson in view of Parker teaches the method of claim 1 and the medium of claim 15 as described previously. The combination does not explicitly teach further comprising using the processing system to change the stimulation parameter associated with the delivered electrostimulation in response to the stimulation parameter causing the sensed ERs to be below the first threshold or above the second threshold. However, Carcieri further teaches changing a stimulation parameter in response to the stimulation parameter causing the sensed ERs to be below the first threshold or above the second threshold in order to avoid under-stimulation or over-stimulation (par. 0070-0071: “the system 10 identifies either under-stimulation or over-stimulation of the target tissue. In step 920, when no evoked action potential is measured from the recording electrodes 26 or the characteristics of the evoked action potential indicate under-stimulation, the system 10 adjusts the stimulation parameters in a way that the stimulation pulse generated by the IPG 14 is increased […] When the characteristics of evoked action potential measured from the recording electrodes 26 indicate over-stimulation in step 910, the system 10 adjusts the stimulation parameters in a way that the stimulation pulse generated by the IPG 14 is decreased in step 920”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method and medium of the combined reference by adjusting the stimulation parameter in response to the stimulation parameter causing the sensed ERs to be below the first threshold or above the second threshold, as taught by Carcieri, in order to avoid under-stimulation or over-stimulation, as taught by Carcieri.
Regarding claim 12, Isaacson in view of Parker teaches the method of claim 1 as described previously. The combination does not explicitly teach further comprising using the processing system to determine the first stimulation threshold or the second stimulation threshold based on a particular time period that the electrostimulation is delivered. However, Carcieri further teaches adjusting stimulation based on a particular time period that the electrostimulation is delivered so that the system can distinguish between temporary and permanent mismatches in recordings (par. 0069: “Constantly adjusting stimulation parameters to obtain perfectly matching evoked action potential in such cases may render the system 10 rather inefficient. Accordingly, in some embodiments, the system 10 may be provided with a specific tolerance rate for each characteristic of the evoked action potential so that the stimulation parameters are adjusted when the deviation goes beyond the tolerance rate. Similarly, the system 10 may be configured to adjust the stimulation parameter if the system 10 records mismatching evoked action potentials for more than a predetermined time period. Various other types of verification mechanisms may be employed by the system 10 to determine whether the recording of the mismatching evoked action potential is temporary or permanent”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of the combined reference by adjusting the stimulation thresholds based on a particular time period that the electrostimulation is delivered, as taught by Carcieri, so that the system can distinguish between temporary and permanent mismatches in recordings, as taught by Carcieri.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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/D.E.L./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
