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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 15 Dec 2025 has been entered.
This Office Action is responsive to the amendment filed on 15 Dec 2025. As directed by the amendment: claims 1, 4, 14, and 17 have been amended, no claims have been canceled, and no claims have been added. Thus, claims 1-20 are presently pending in this application.
Response to Arguments
The Rejection of Claims Under § 102
Applicant's arguments filed 15 Dec 2025 have been fully considered but they are not persuasive.
Applicant argues that “Denison does not teach using frequency analysis or temporal trending of patient physiological information to detect the absence of tremor or the loss of the patient signal” because “The PLL circuit 76 merely locks onto the incoming patient signal for synchronization, but does not perform frequency analysis or temporal trending, nor does it compute a frequency drift. In other words, the reference is directed to phase-locked timing adjustment, rather than frequency drift detection” (Remarks, pages 7-8).
Examiner respectfully disagrees. Denison discloses detecting patient physiological information (paragraph [0042], "therapy system 10 is configured to sense bioelectrical signals of patient 12 (e.g., bioelectrical brain signals in the example of FIG. 1) ... the signals may be generated from an accelerometer or some other device ... the patient generates a patient signal indicative of a patient condition"; paragraph [0080], "the patient signal may be a sensed LFP signal"; paragraphs [0054], [0081]-[0083] describe the patient physiological information as accelerometer data; paragraph [0045] lists examples of bioelectrical brain signals).
Denison further discloses determining the frequency (in other words, performing a frequency analysis) of the patient physiological information (paragraph [0130] (emphasis added), "while the patient signal indicative of a patient condition may be based on patient movement as sensed by an accelerometer or gyroscope, the patient signal could alternatively or additionally be any physiological signal from which frequency information (frequency content and/or phase information) can be derived. This may include local field potential (LFP) signals or other physiological signals processed using filtering, Fourier transforms, or other processing techniques to extract that frequency information").
Denison further discloses that “a phase locked loop (PLL) circuit may track the phase of the input signal, and output a timing signal that is locked to the input signal (e.g., the frequency of the timing signal is approximately equal to or a set multiple of the input signal)” (paragraph [0006]) and that “Although there may be occasional changes, any perturbations (e.g., return of tremor) may nudge the PLL circuit to output the correct timing signal. In this manner, the delivery of therapy may be responsive to near-instantaneous, as well as long-term, changes in the frequency of the sensed patient signal” (paragraph [0064]). Denison further discloses that “PLL circuit 76 may receive a patient signal indicative of a patient condition (100), and may determine a timing signal having a frequency based on the patient signal (102) … the voltage level outputted to reference oscillator 86 causes reference oscillator 86 to output a timing signal having a frequency that is the same or a multiple of the frequency of the patient signal” (paragraph [0109]). In other words, Denison discloses determining frequency changes of the patient physiological information.
Paragraph [0005] of the specification of the instant application discloses that “The intrinsic oscillatory neural activity may be caused by patient underlying pathological conditions, such as essential tremor or neurodegenerative diseases such as Parkinson's disease”. Thus, under the broadest reasonable interpretation, “detecting a frequency drift of an intrinsic oscillatory neural activity in the patient” encompasses the detection of “changes in the frequency of the sensed patient signal” disclosed by Denison.
Therefore, the rejection of claim 1 under 35 U.S.C. 102 is maintained. The rejections of independent claims 14 and 17 are also maintained for reasons similar to those of claim 1.
The Rejection of Claims Under § 103
No specific arguments were made regarding dependent claims 2-13, 15-16, and 18-20 and the previously cited prior art. Therefore, claims 2-13, 15-16, and 18-20 are also rejected below.
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.
Claims 1-4, 14, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Denison et al. (US 20160287879 A1, previously cited), hereinafter Denison.
Regarding claim 1, Denison discloses a system for providing electrostimulation to a patient (Fig. 1, paragraph [0027], therapy system 10), comprising:
an implantable stimulator (Fig. 1, paragraph [0029], IMD 16) configured to provide burst stimulation (paragraph [0053], "IMD 16 may deliver a burst of therapy, e.g., a burst of stimulation pulses") to a neural target of the patient (paragraph [0033], "Leads 20 may be positioned to deliver electrical stimulation to one or more target tissue sites within brain 28"; paragraphs [0028]-[0034] list target tissue sites; paragraph [0067]), the burst stimulation comprising a pulse train followed by a pulse-free period (paragraph [0055], "a burst of therapy (e.g., a burst of stimulation pulses for a finite time ... By delivering a burst of therapy (e.g., a burst of stimulation pulses for a finite time between a peak and trough, or a trough and a peak) at peak or troughs of the patient signal, IMD 16 may be able to deliver therapy when the tremor symptoms are at their worst"; Fig. 6A illustrates gaps between bursts of therapy 112A-112D; paragraphs [0114]-[0115], [0117], bursts last between certain phases of the patient signal); and
a controller circuit (Fig. 2, paragraph [0071], processor 60 and PLL circuit 76) configured to:
detect a frequency drift of an intrinsic oscillatory neural activity in the patient based on frequency analysis or temporal trending of patient physiological information (paragraph [0042], "therapy system 10 is configured to sense bioelectrical signals of patient 12 (e.g., bioelectrical brain signals in the example of FIG. 1) ... the signals may be generated from an accelerometer or some other device ... the patient generates a patient signal indicative of a patient condition"; paragraph [0080], "the patient signal may be a sensed LFP signal"; paragraphs [0054], [0081]-[0083] describe the patient physiological information as accelerometer data; paragraph [0064], "the delivery of therapy may be responsive to near-instantaneous, as well as long-term, changes in the frequency of the sensed patient signal"; paragraph [0109], "PLL circuit 76 may receive a patient signal indicative of a patient condition (100), and may determine a timing signal having a frequency based on the patient signal (102)"; paragraph [0130], "while the patient signal indicative of a patient condition may be based on patient movement as sensed by an accelerometer or gyroscope, the patient signal could alternatively or additionally be any physiological signal from which frequency information (frequency content and/or phase information) can be derived. This may include local field potential (LFP) signals or other physiological signals processed using filtering, Fourier transforms, or other processing techniques to extract that frequency information");
determine or adjust a burst stimulation parameter in response to the detected indication of frequency drift (paragraph [0020], "The PLL circuit may adjust the frequency of the timing signal until the difference between the patient signal and the timing signal is small (e.g., approximately zero). In this manner, the frequency and the phase of the timing signal are approximately equal to the frequency and phase of the patient signal"; paragraph [0024], "the medical device would use the patient signal to determine when to deliver therapy, and deliver therapy accordingly"; paragraph [0026], "the PLL circuit may receive a patient signal. The PLL circuit may then adjust the voltage level of the reference oscillator to output an updated timing signal that better tracks the patient signal, and the timing of the electrical stimulation therapy delivery can be based on the updated timing signal"; paragraph [0099], "PLL circuit 76 may receive this new patient signal, and determine an updated timing signal that is locked to the patient signal"); and
generate a control signal to the implantable stimulator to provide burst stimulation in accordance with the determined or adjusted burst stimulation parameter (paragraph [0099], "IMD 16 may then deliver therapy based on the updated timing signal").
Regarding claim 2, Denison discloses the system of claim 1, as explained above. Denison further discloses that the burst stimulation parameter includes a timing to initiate the burst stimulation at a particular phase of an oscillation cycle of the intrinsic oscillatory neural activity (paragraphs [0055]-[0056], [0084], [0094]-[0095]).
Regarding claim 3, Denison discloses the system of claim 1, as explained above. Denison further discloses that the implantable stimulator includes an implantable deep-brain stimulator configured to provide burst stimulation to a brain target of the patient (paragraphs [0029], [0032]-[0035], [0040], [0041], [0067]).
Regarding claim 4, Denison discloses the system of claim 1, as explained above. Denison further discloses that the controller circuit is configured to detect the frequency drift of the intrinsic oscillatory neural activity based on a temporal trend of a signal metric derived from the patient physiological information (paragraph [0064], "the delivery of therapy may be responsive to near-instantaneous, as well as long-term, changes in the frequency of the sensed patient signal").
Regarding claim 14, Denison discloses a system for providing electrostimulation to a patient (Fig. 1, paragraph [0027], therapy system 10), comprising:
an implantable stimulator (Fig. 1, paragraph [0029], IMD 16) configured to provide burst stimulation (paragraph [0053], "IMD 16 may deliver a burst of therapy, e.g., a burst of stimulation pulses") to a neural target of the patient (paragraph [0033], "Leads 20 may be positioned to deliver electrical stimulation to one or more target tissue sites within brain 28"; paragraphs [0028]-[0034] list target tissue sites; paragraph [0067]), the burst stimulation comprising a pulse train followed by a pulse-free period (paragraph [0055], "a burst of therapy (e.g., a burst of stimulation pulses for a finite time ... By delivering a burst of therapy (e.g., a burst of stimulation pulses for a finite time between a peak and trough, or a trough and a peak) at peak or troughs of the patient signal, IMD 16 may be able to deliver therapy when the tremor symptoms are at their worst"; Fig. 6A illustrates gaps between bursts of therapy 112A-112D; paragraphs [0114]-[0115], [0117], bursts last between certain phases of the patient signal); and
a controller circuit (Fig. 2, paragraph [0071], processor 60 and PLL circuit 76) configured to:
evaluate patient responses to burst stimulation delivered to the neural target in accordance with a stimulation parameter (paragraphs [0050], [0053], [0055], [0060], [0064]); and
detect a frequency drift of an intrinsic oscillatory neural activity in the patient based on frequency analysis or temporal trending of patient physiological information (paragraph [0042], "therapy system 10 is configured to sense bioelectrical signals of patient 12 (e.g., bioelectrical brain signals in the example of FIG. 1) ... the signals may be generated from an accelerometer or some other device ... the patient generates a patient signal indicative of a patient condition"; paragraph [0080], "the patient signal may be a sensed LFP signal"; paragraphs [0054], [0081]-[0083] describe the patient physiological information as accelerometer data; paragraph [0064], "the delivery of therapy may be responsive to near-instantaneous, as well as long-term, changes in the frequency of the sensed patient signal"; paragraph [0109], "PLL circuit 76 may receive a patient signal indicative of a patient condition (100), and may determine a timing signal having a frequency based on the patient signal (102)"; paragraph [0130], "while the patient signal indicative of a patient condition may be based on patient movement as sensed by an accelerometer or gyroscope, the patient signal could alternatively or additionally be any physiological signal from which frequency information (frequency content and/or phase information) can be derived. This may include local field potential (LFP) signals or other physiological signals processed using filtering, Fourier transforms, or other processing techniques to extract that frequency information");
generate a control signal to the implantable stimulator to adjust the burst stimulation based on the detected frequency drift of the intrinsic oscillatory neural activity (paragraph [0020], "The PLL circuit may adjust the frequency of the timing signal until the difference between the patient signal and the timing signal is small (e.g., approximately zero). In this manner, the frequency and the phase of the timing signal are approximately equal to the frequency and phase of the patient signal"; paragraph [0024], "the medical device would use the patient signal to determine when to deliver therapy, and deliver therapy accordingly"; paragraph [0026], "the PLL circuit may receive a patient signal. The PLL circuit may then adjust the voltage level of the reference oscillator to output an updated timing signal that better tracks the patient signal, and the timing of the electrical stimulation therapy delivery can be based on the updated timing signal"; paragraph [0099], "PLL circuit 76 may receive this new patient signal, and determine an updated timing signal that is locked to the patient signal").
Regarding claim 17, Denison discloses a method for providing electrostimulation to a patient (paragraph [0018]), comprising:
detecting, via a controller circuit (Fig. 2, paragraph [0071], processor 60 and PLL circuit 76), a frequency drift of an intrinsic oscillatory neural activity in the patient based on frequency analysis or temporal trending of patient physiological information (paragraph [0042], "therapy system 10 is configured to sense bioelectrical signals of patient 12 (e.g., bioelectrical brain signals in the example of FIG. 1) ... the signals may be generated from an accelerometer or some other device ... the patient generates a patient signal indicative of a patient condition"; paragraph [0080], "the patient signal may be a sensed LFP signal"; paragraphs [0054], [0081]-[0083] describe the patient physiological information as accelerometer data; paragraph [0064], "the delivery of therapy may be responsive to near-instantaneous, as well as long-term, changes in the frequency of the sensed patient signal"; paragraph [0109], "PLL circuit 76 may receive a patient signal indicative of a patient condition (100), and may determine a timing signal having a frequency based on the patient signal (102)"; paragraph [0130], "while the patient signal indicative of a patient condition may be based on patient movement as sensed by an accelerometer or gyroscope, the patient signal could alternatively or additionally be any physiological signal from which frequency information (frequency content and/or phase information) can be derived. This may include local field potential (LFP) signals or other physiological signals processed using filtering, Fourier transforms, or other processing techniques to extract that frequency information");
determining or adjusting, via the controller circuit, a burst stimulation parameter in response to the detected indication of frequency drift (paragraph [0020], "The PLL circuit may adjust the frequency of the timing signal until the difference between the patient signal and the timing signal is small (e.g., approximately zero). In this manner, the frequency and the phase of the timing signal are approximately equal to the frequency and phase of the patient signal"; paragraph [0024], "the medical device would use the patient signal to determine when to deliver therapy, and deliver therapy accordingly"; paragraph [0026], "the PLL circuit may receive a patient signal. The PLL circuit may then adjust the voltage level of the reference oscillator to output an updated timing signal that better tracks the patient signal, and the timing of the electrical stimulation therapy delivery can be based on the updated timing signal"; paragraph [0099], "PLL circuit 76 may receive this new patient signal, and determine an updated timing signal that is locked to the patient signal"); and
generating, via the controller circuit, burst stimulation in accordance with the determined or adjusted burst stimulation parameter (paragraph [0099], "IMD 16 may then deliver therapy based on the updated timing signal"), the burst stimulation comprising a pulse train followed by a pulse-free period (paragraph [0055], "a burst of therapy (e.g., a burst of stimulation pulses for a finite time ... By delivering a burst of therapy (e.g., a burst of stimulation pulses for a finite time between a peak and trough, or a trough and a peak) at peak or troughs of the patient signal, IMD 16 may be able to deliver therapy when the tremor symptoms are at their worst"; Fig. 6A illustrates gaps between bursts of therapy 112A-112D; paragraphs [0114]-[0115], [0117], bursts last between certain phases of the patient signal);
delivering, via an implantable stimulator (Fig. 1, paragraph [0029], IMD 16), the burst stimulation to a neural target of the patient (paragraph [0099], "IMD 16 may then deliver therapy based on the updated timing signal").
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.
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.
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.
Claims 5-10, 13, 16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Denison et al. (US 20160287879 A1, previously cited), hereinafter Denison, in view of Gliner et al. (US 20040158298 A1, previously cited), hereinafter Gliner.
Regarding claim 5, Denison discloses the system of claim 1, as explained above. Although Denison discloses that the implantable stimulator is initially programmed by a clinician by testing several different therapy programs and evaluating the patient's response to those programs (paragraph [0050]), Denison does not explicitly disclose that to determine or adjust the burst stimulation parameter, the controller circuit is configured to: evaluate respective patient responses to each of a plurality of test stimulation bursts delivered in accordance with respective values of the burst stimulation parameter; determine a direction of adjustment based on the respective patient responses; and adjust the burst stimulation parameter in accordance with the determined direction.
However, Gliner teaches methods and devices for automatically optimizing the stimulus parameters to provide neural stimulation to a patient (Abstract) wherein to determine or adjust the stimulation parameter, the controller circuit (Fig. 1, paragraph [0024], "The controller 130, for example, can be a computer and the programmable computer medium can be software loaded into the memory of the computer and/or hardware that performs the processes described below") is configured to:
evaluate respective patient responses to each of a plurality of test stimulation bursts delivered in accordance with respective values of the burst stimulation parameter (Fig. 5, paragraph [0053], step 570);
determine a direction of adjustment based on the respective patient responses (Fig. 5, paragraph [0052], step 540; paragraph [0055], "Each of the parameters are believed to be independent from one another, thus one of the parameters can be optimized by applying a number of different stimuli using different values for the parameter to determine whether increasing or decreasing the parameter enhances the efficacy of the stimulus."); and
adjust the burst stimulation parameter in accordance with the determined direction (Fig. 5, paragraph [0052], step 540; paragraph [0055], "Once it is determined whether increasing or decreasing the parameter provides a better result, then the parameter can be further increased or decreased (whichever is more desirable) until the effectiveness of the stimulation degrades.").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Denison with the teachings of Gliner so that the controller circuit is configured to: evaluate respective patient responses to each of a plurality of test stimulation bursts delivered in accordance with respective values of the burst stimulation parameter; determine a direction of adjustment based on the respective patient responses; and adjust the burst stimulation parameter in accordance with the determined direction, because doing so using an automatic process is more cost effective and less time consuming than performing the calibration manually (Gliner, paragraph [0012]).
Regarding claim 6, the system of claim 5 is obvious over Denison and Gliner, as explained above. Denison further discloses that the controller circuit is configured to determine a target burst stimulation parameter value based on the respective patient responses (paragraph [0084], "PLL circuit 76 may increase or decrease the voltage level of that reference oscillator that generates the timing signal such that the phase of the timing signal is approximately the same as the phase of the patient signal, so that the timing signal and the patient signal are phase and frequency locked").
Regarding claim 7, the system of claim 5 is obvious over Denison and Gliner, as explained above. Denison further discloses a wearable device configured to detect patient responses (paragraphs [0050], [0054], motion sensor/accelerometer).
Gliner also further teaches a wearable device configured to detect the respective patient responses to each of the plurality of test stimulation bursts (paragraph [0033], "The sensing procedure 230 is generally performed after each iteration of the stimulation procedure 220. The sensing procedure 230 involves monitoring a location in the patient for a response to the stimulus applied in the stimulation procedure 220. ... The types of measurements for monitoring peripheral physiologic outcomes include: (a) EMG (surface, percutaneous, or implanted); (b) external potentiometer or other forms of physiologic input; and (c) motion detectors (e.g., accelerometers)").
Regarding claim 8, the system of claim 5 is obvious over Denison and Gliner, as explained above. Denison further discloses a user interface device configured to receive user inputs about respective patient responses to each of a plurality of test stimulation bursts (paragraphs [0047], [0050], programmer 14). Gliner also further teaches receiving user inputs about respective patient responses to each of the plurality of test stimulation bursts (paragraph [0027], "The system 100 can automatically test the efficacy of various electrode configurations and stimulus parameters either with or without subjective input from the patient").
Regarding claim 9, the system of claim 5 is obvious over Denison and Gliner, as explained above. Denison further discloses increasing or decreasing the voltage level of the reference oscillator that determines when the burst stimulation is delivered (paragraph [0084]), but does not explicitly disclose that to evaluate the respective patient responses, the controller circuit is configured to ramp up or ramp down values of the burst stimulation parameter, and to control the implantable stimulator to deliver the plurality of test stimulation bursts according to the ramped up or ramped down burst stimulation parameter values.
However, Gliner further teaches that to evaluate the respective patient responses, the controller circuit is configured to ramp up or ramp down values of the burst stimulation parameter, and to control the implantable stimulator to deliver the plurality of test stimulation bursts according to the ramped up or ramped down burst stimulation parameter values (paragraph [0055], "one of the parameters can be optimized by applying a number of different stimuli using different values for the parameter to determine whether increasing or decreasing the parameter enhances the efficacy of the stimulus. Once it is determined whether increasing or decreasing the parameter provides a better result, then the parameter can be further increased or decreased (whichever is more desirable) until the effectiveness of the stimulation degrades").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Denison with the teachings of Gliner so that to evaluate the respective patient responses, the controller circuit is configured to ramp up or ramp down values of the burst stimulation parameter, and to control the implantable stimulator to deliver the plurality of test stimulation bursts according to the ramped up or ramped down burst stimulation parameter values, because doing so using an automatic process is more cost effective and less time consuming than performing the calibration manually (Gliner, paragraph [0012]).
Regarding claim 10, the system of claim 5 is obvious over Denison and Gliner, as explained above. Denison does not explicitly disclose that the respective patient responses include respective levels of symptom relief in response to each of the plurality of test stimulation bursts, or that the controller circuit is configured to determine a target burst stimulation parameter value as one that has a greater level of symptom relief than other one or more burst stimulation parameter values.
However, Gliner further teaches that the respective patient responses include respective levels of symptom relief in response to each of the plurality of test stimulation bursts, and wherein the controller circuit is configured to determine a target burst stimulation parameter value as one that has a greater level of symptom relief than other one or more burst stimulation parameter values (paragraph [0055], "one of the parameters can be optimized by applying a number of different stimuli using different values for the parameter to determine whether increasing or decreasing the parameter enhances the efficacy of the stimulus. Once it is determined whether increasing or decreasing the parameter provides a better result, then the parameter can be further increased or decreased (whichever is more desirable) until the effectiveness of the stimulation degrades"; paragraph [0037]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Denison with the teachings of Gliner so that the respective patient responses include respective levels of symptom relief in response to each of the plurality of test stimulation bursts, or that the controller circuit is configured to determine a target burst stimulation parameter value as one that has a greater level of symptom relief than other one or more burst stimulation parameter values, because doing so using an automatic process is more cost effective and less time consuming than performing the calibration manually (Gliner, paragraph [0012]).
Regarding claim 13, the system of claim 10 is obvious over Denison and Gliner, as explained above. Denison further discloses that the burst stimulation parameter includes a burst frequency (paragraph [0055]), and that the controller circuit is configured to determine a target burst frequency of burst stimulation (paragraph [0055]).
Denison does not explicitly disclose that the controller circuit is configured to evaluate respective levels of symptom relief responsive to the plurality of test stimulation bursts having respective burst frequencies; and determine a target burst frequency of burst stimulation that induces a greater symptom relief than burst stimulation having other one or more burst frequencies.
However, Gliner further teaches that the controller circuit is configured to:
evaluate respective levels of symptom relief responsive to the plurality of test stimulation bursts having respective burst frequencies (paragraph [0011], frequency of the stimulus pulse, burst repetition rate; paragraph [0054], frequency of the pulses, stimulus burst frequency); and
determine a target burst frequency of burst stimulation that induces a greater symptom relief than burst stimulation having other one or more burst frequencies (paragraph [0037], "optimizing the frequency of the electrical stimulus").
Regarding claim 16, Denison discloses the system of claim 14, as explained above. Denison does not explicitly disclose that to evaluate the patient responses to the burst stimulation, the controller circuit is configured to determine respective levels of symptom relief in response to each of a plurality of test stimulation bursts delivered in accordance with respective values of the burst stimulation parameter.
However, Gliner teaches methods and devices for automatically optimizing the stimulus parameters to provide neural stimulation to a patient (Abstract) wherein to determine or adjust the stimulation parameter, the controller circuit (Fig. 1, paragraph [0024], "The controller 130, for example, can be a computer and the programmable computer medium can be software loaded into the memory of the computer and/or hardware that performs the processes described below") is configured to determine respective levels of symptom relief in response to each of a plurality of test stimulation bursts delivered in accordance with respective values of the burst stimulation parameter (paragraph [0055], "one of the parameters can be optimized by applying a number of different stimuli using different values for the parameter to determine whether increasing or decreasing the parameter enhances the efficacy of the stimulus. Once it is determined whether increasing or decreasing the parameter provides a better result, then the parameter can be further increased or decreased (whichever is more desirable) until the effectiveness of the stimulation degrades"; paragraph [0037]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Denison with the teachings of Gliner so that to evaluate the patient responses to the burst stimulation, the controller circuit is configured to determine respective levels of symptom relief in response to each of a plurality of test stimulation bursts delivered in accordance with respective values of the burst stimulation parameter, because doing so using an automatic process is more cost effective and less time consuming than performing the calibration manually (Gliner, paragraph [0012]).
Regarding claim 18, Denison discloses the system of claim 17, as explained above. Although Denison discloses that the implantable stimulator is initially programmed by a clinician by testing several different therapy programs and evaluating the patient's response to those programs (paragraph [0050]), Denison does not explicitly disclose that to determining or adjusting the burst stimulation parameter includes: evaluating respective patient responses to each of a plurality of test stimulation bursts delivered in accordance with respective values of the burst stimulation parameter; determining a direction of adjustment based on the respective patient responses; and adjusting the burst stimulation parameter in accordance with the determined direction.
However, Gliner teaches methods and devices for automatically optimizing the stimulus parameters to provide neural stimulation to a patient (Abstract) wherein determining or adjusting the burst stimulation parameter includes:
evaluating respective patient responses to each of a plurality of test stimulation bursts delivered in accordance with respective values of the burst stimulation parameter (Fig. 5, paragraph [0053], step 570);
determining a direction of adjustment based on the respective patient responses (Fig. 5, paragraph [0052], step 540; paragraph [0055], "Each of the parameters are believed to be independent from one another, thus one of the parameters can be optimized by applying a number of different stimuli using different values for the parameter to determine whether increasing or decreasing the parameter enhances the efficacy of the stimulus."); and
adjusting the burst stimulation parameter in accordance with the determined direction (Fig. 5, paragraph [0052], step 540; paragraph [0055], " Once it is determined whether increasing or decreasing the parameter provides a better result, then the parameter can be further increased or decreased (whichever is more desirable) until the effectiveness of the stimulation degrades.").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Denison with the teachings of Gliner so that the controller circuit is configured to: evaluate respective patient responses to each of a plurality of test stimulation bursts delivered in accordance with respective values of the burst stimulation parameter; determine a direction of adjustment based on the respective patient responses; and adjust the burst stimulation parameter in accordance with the determined direction, because doing so using an automatic process is more cost effective and less time consuming than performing the calibration manually (Gliner, paragraph [0012]).
Regarding claim 19, the method of claim 18 is obvious over Denison and Gliner, as explained above. Denison does not explicitly disclose that to evaluate the patient responses to the burst stimulation, the controller circuit is configured to determine respective levels of symptom relief in response to each of a plurality of test stimulation bursts delivered in accordance with respective values of the burst stimulation parameter.
However, Gliner further teaches that the respective patient responses include respective levels of symptom relief in response to each of the plurality of test stimulation bursts, and wherein the controller circuit is configured to determine a target burst stimulation parameter value as one that has a greater level of symptom relief than other one or more burst stimulation parameter values (paragraph [0055], "one of the parameters can be optimized by applying a number of different stimuli using different values for the parameter to determine whether increasing or decreasing the parameter enhances the efficacy of the stimulus. Once it is determined whether increasing or decreasing the parameter provides a better result, then the parameter can be further increased or decreased (whichever is more desirable) until the effectiveness of the stimulation degrades"; paragraph [0037]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Denison with the teachings of Gliner so that the respective patient responses include respective levels of symptom relief in response to each of the plurality of test stimulation bursts, or that the controller circuit is configured to determine a target burst stimulation parameter value as one that has a greater level of symptom relief than other one or more burst stimulation parameter values, because doing so using an automatic process is more cost effective and less time consuming than performing the calibration manually (Gliner, paragraph [0012]).
Claims 11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Denison et al. (US 20160287879 A1, previously cited), hereinafter Denison, in view of Gliner et al. (US 20040158298 A1, previously cited), hereinafter Gliner, and further in view of Giuffrida et al. (US 20140005743 A1, previously cited), hereinafter Giuffrida.
Regarding claim 11, the system of claim 10 is obvious over Denison and Gliner, as explained above. Neither Denison nor Gliner explicitly discloses that the controller circuit is configured to: generate a parameter prediction model representing a relationship between the burst stimulation parameter values and the respective levels of symptom relief; and predict the target burst stimulation parameter value using the parameter prediction model.
However, Giuffrida teaches methods for tuning treatment parameters in movement disorder therapy systems (Abstract) wherein the respective patient responses include respective levels of symptom relief in response to each of the plurality of test stimulation bursts (paragraph [0124], quantified movement score; paragraph [0132], symptom severity data, stimulation induced dyskinesias), and wherein the controller circuit is configured to determine a target burst stimulation parameter value as one that has a greater level of symptom relief than other one or more burst stimulation parameter values (paragraphs [0125], [0134], [0136]).
Giuffrida further teaches generating a parameter prediction model representing a relationship between the burst stimulation parameter values and the respective levels of symptom relief (paragraphs [0132], [0136], [0140], tuning algorithm); and
predicting the target burst stimulation parameter value using the parameter prediction model (paragraphs [0125], [0132], suggested stimulation parameter settings).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Denison and Gliner with the teachings of Giuffrida so that the controller circuit is configured to: generate a parameter prediction model representing a relationship between the burst stimulation parameter values and the respective levels of symptom relief; and predict the target burst stimulation parameter value using the parameter prediction model, because doing so reduces the amount of time required to tune the stimulation to alleviate the patient's symptoms (Giuffrida, paragraph [0135]), and minimize the required expertise of the clinician (Giuffrida, paragraph [0020]).
Regarding claim 20, the method of claim 19 is obvious over Denison, Gliner, and Giuffrida, as explained above. Neither Denison nor Gliner explicitly discloses generating a parameter prediction model representing a relationship between the burst stimulation parameter values and the respective levels of symptom relief; wherein determining the target burst stimulation parameter value includes predicting the target burst stimulation parameter value using the parameter prediction model.
However, Giuffrida teaches methods for tuning treatment parameters in movement disorder therapy systems (Abstract) wherein the respective patient responses include respective levels of symptom relief in response to each of the plurality of test stimulation bursts (paragraph [0124], quantified movement score; paragraph [0132], symptom severity data, stimulation induced dyskinesias), and wherein the controller circuit is configured to determine a target burst stimulation parameter value as one that has a greater level of symptom relief than other one or more burst stimulation parameter values (paragraphs [0125], [0134], [0136]).
Giuffrida further teaches generating a parameter prediction model representing a relationship between the burst stimulation parameter values and the respective levels of symptom relief (paragraphs [0132], [0136], [0140], tuning algorithm); and
predicting the target burst stimulation parameter value using the parameter prediction model (paragraphs [0125], [0132], suggested stimulation parameter settings).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Denison and Gliner with the teachings of Giuffrida to generate a parameter prediction model representing a relationship between the burst stimulation parameter values and the respective levels of symptom relief; wherein determining the target burst stimulation parameter value includes predicting the target burst stimulation parameter value using the parameter prediction model, because doing so reduces the amount of time required to tune the stimulation to alleviate the patient's symptoms (Giuffrida, paragraph [0135]), and minimize the required expertise of the clinician (Giuffrida, paragraph [0020]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Denison et al. (US 20160287879 A1, previously cited), hereinafter Denison, in view of Gliner et al. (US 20040158298 A1, previously cited), hereinafter Gliner, and further in view of Gupta et al. (US 20120071947 A1, previously cited), hereinafter Gupta.
Regarding claim 12, the system of claim 10 is obvious over Denison and Gliner, as explained above. Denison further discloses that the burst stimulation parameter includes a timing to initiate the burst stimulation at a particular phase of an oscillation cycle of the intrinsic oscillatory neural activity (paragraphs [0094]-[0095]), and that the controller circuit is configured to determine a target phase of the oscillation cycle to initiate burst stimulation (paragraphs [0094]-[0095]).
Neither Denison, nor Gliner, nor Giuffrida explicitly discloses that the controller circuit is configured to: evaluate respective levels of symptom relief responsive to the plurality of test stimulation bursts initiated at respective phases of the oscillation cycle; and determine a target phase of the oscillation cycle to initiate burst stimulation that induces a greater symptom relief than burst stimulation initiated at other one or more phases of the oscillation cycle.
However, Gupta teaches methods and apparatuses for potentiating a favorable brain state that is associated with relief in symptoms of a brain condition (Abstract) wherein the controller circuit is configured to:
evaluate respective levels of symptom relief responsive to the plurality of test stimulation bursts initiated at respective phases of the oscillation cycle (paragraphs [0060], [0063]); and
determine a target phase of the oscillation cycle to initiate burst stimulation that induces a greater symptom relief than burst stimulation initiated at other one or more phases of the oscillation cycle (paragraph [0063]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Denison, Gliner, and Giuffrida with the teachings of Gupta so that the controller circuit is configured to: evaluate respective levels of symptom relief responsive to the plurality of test stimulation bursts initiated at respective phases of the oscillation cycle; and determine a target phase of the oscillation cycle to initiate burst stimulation that induces a greater symptom relief than burst stimulation initiated at other one or more phases of the oscillation cycle, because doing so can reduce the amount of time that the stimulation has to be applied and reduce the required stimulation intensity to achieve the desired effect (Gupta, paragraph [0027]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Denison et al. (US 20160287879 A1, previously cited), hereinafter Denison, in view of Su et al. (US 20190269924 A1), hereinafter Su.
Regarding claim 15, Denison discloses the system of claim 14, as explained above. Denison does not explicitly disclose that the controller circuit is configured to evaluate the patient responses and to determine the frequency drift periodically or at scheduled intervals.
However, Su teaches devices, systems, and methods for autotitrating stimulation parameters (Abstract) wherein the controller circuit is configured to evaluate the patient responses and to determine the frequency drift periodically or at scheduled intervals (paragraphs [0043]-[0044], [0092]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Denison with the teachings of Su so that the controller circuit is configured to evaluate the patient responses and to determine the frequency drift periodically or at scheduled intervals, because doing so may be much quicker, convenient, and more accurate than manual trial and error configurations, and may be more accurate than relying on patient feedback (Su, paragraph [0044]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Zhu et al. (US 20210299452 A1) discloses a method of electrical stimulation parameter adjustment according to symptom changes in response to applying an electrical stimulation (Fig. 7, paragraphs [0077]-[0078])
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/CHRISTINE SISON/Examiner, Art Unit 3796
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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