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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 16, 2025 has been entered.
Response to Arguments
The Applicant filed Amendments to the Claims and Remarks on December 16, 2026 in response to the Examiner’s Final Office Action, mailed September 16, 2025 and Advisory Action, mailed November 20, 2025.
Amendments to the Claims
At this time, claims 1-7, 9-18, and 20-26 are pending. Claims 1, 14, 20, and 23-25 have been amended. (Remarks, pg. 9)
Claim Rejections
Applicant’s arguments, see Remarks, pg. 9-14, with respect to pending claims 1-7, 9-18,and 20-26 have been fully considered and are persuasive. The 35 U.S.C. 102(a)(2) and 35 U.S.C. 103 rejections of September 16, 2025 have been withdrawn.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 26 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Skelton et al. (US 8175720 B2, hereinafter referred to as Skelton).
Regarding independent claim 26, Skelton discloses a system comprising:
telemetry circuitry (telemetry circuity 88 in Fig. 4; [col. 11, li. 15-18]: “In either case, programmer 20 may then transmit the patient inputs to IMD 14, e.g., using telemetry circuitry as described with reference to FIG. 4.”) configured for communication between a medical device (IMD 14 in Fig. 4) and an external device (external programmer 20 in Figs. 1A-1C, 6, 7) associated with the medical device; and
processing circuitry (processor 80 in Fig. 4) configured to:
receive an indication of a plurality of user inputs ([col. 47, li. 63 – col. 48, li. 1]: “In addition to presenting patient inputs and correlated posture states, therapy programs, and input times, patient programmer 30 may present options for a user to make selections for adjusting subsequently applied therapy programs based on one or more of the correlations between patient input, patient input time, sensed posture state, and therapy program.”), each user input of the plurality of user inputs indicating a respective value of a plurality of values for a stimulation parameter ([col. 4, li. 23-31]: “To maintain therapeutic efficacy, it may be desirable to adjust therapy parameters based on different postures and/or activities engaged by the patient to maintain effective therapy. A medical device may adjust therapy by modifying values for one or more therapy parameters, e.g., by specifying adjustments to a specific therapy parameter or by selecting different therapy programs or groups of programs that define different sets of therapy parameter values.”) that at least partially defines therapy provided to a patient in a posture state of a plurality of posture states ([col. 1, li. 50-55]: “Various posture states may be defined and detected by a medical device, at least in part, by different sets of posture reference data. In some examples, a posture sensor module associated with the medical device compares posture data from one of multiple posture sensors to the posture reference data to detect the posture occupied by the patient.”);
determine a representative value for the stimulation parameter based on the plurality of values for the stimulation parameter that at least partially defines therapy provided to the patient in the posture state ([col. 4, li. 23-26]: “To maintain therapeutic efficacy, it may be desirable to adjust therapy parameters based on different postures and/or activities engaged by the patient to maintain effective therapy.”) and a heart rate of the patient ([col. 25, li. 50-55]: “In other embodiments, posture state module 86 may additionally or alternatively be configured to sense one or more physiological parameters of patient 12. For example, physiological parameters may include heart rate, electromyography (EMG), an electroencephalogram (EEG), an electrocardiogram (ECG), temperature, respiration rate, or pH.”); and
control the medical device to provide the therapy according to the representative value for the stimulation parameter when the patient is in the posture state ([col. 49, li. 24-27]: “Processor 80 delivers therapy to patient 12 according to instructions stored in memory 82 that are associated with the posture state of patient 12 sensed by the posture state module 86.”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5, 9, 11-17, 20-21, and 23-25 are rejected under 35 U.S.C. 103 as being anticipated by Skelton in view of King (US 2006/0253174).
Regarding amended, independent claim 1, Skelton discloses a posture-responsive therapy control based on patient input. Skelton further discloses system ([col. 2, li. 35-36]: “…an implantable medical system configured to deliver posture-responsive therapy to a patient…”) comprising:
telemetry circuitry (telemetry circuity 88 in Fig. 4; [col. 11, li. 15-18]: “In either case, programmer 20 may then transmit the patient inputs to IMD 14, e.g., using telemetry circuitry as described with reference to FIG. 4.”) configured for communication between a medical device (IMD 14 in Fig. 4) and an external device (external programmer 20 in Figs. 1A-1C, 6, 7) associated with the medical device; and
processing circuitry (processor 80 in Fig. 4) configured to:
receive an indication of a plurality of user inputs ([col. 47, li. 63 – col. 48, li. 1]: “In addition to presenting patient inputs and correlated posture states, therapy programs, and input times, patient programmer 30 may present options for a user to make selections for adjusting subsequently applied therapy programs based on one or more of the correlations between patient input, patient input time, sensed posture state, and therapy program.”), each user input of the plurality of user inputs indicating a respective value of a plurality of values for a stimulation parameter ([col. 4, li. 23-31]: “To maintain therapeutic efficacy, it may be desirable to adjust therapy parameters based on different postures and/or activities engaged by the patient to maintain effective therapy. A medical device may adjust therapy by modifying values for one or more therapy parameters, e.g., by specifying adjustments to a specific therapy parameter or by selecting different therapy programs or groups of programs that define different sets of therapy parameter values.”) that at least partially defines therapy provided to a patient in a posture state of a plurality of posture states ([col. 1, li. 50-55]: “Various posture states may be defined and detected by a medical device, at least in part, by different sets of posture reference data. In some examples, a posture sensor module associated with the medical device compares posture data from one of multiple posture sensors to the posture reference data to detect the posture occupied by the patient.”);
Skelton is silent to processing circuitry configured to:
determine a range of values for the stimulation parameter based on a sensed signal corresponding to the posture state (, the range of values comprising at least one of a minimum value for the stimulation parameter or a maximum value for the stimulation parameter;
determine a representative value for the stimulation parameter based on the plurality of values for the stimulation parameter that at least partially defines therapy provided to the patient in the posture state and based on the range of values for the stimulation parameter based on the sensed signal; and
control the medical device to provide the therapy according to the representative value for the stimulation parameter when the patient is in the posture state.
However, King teaches a system including an implantable medical device that adjusts a stimulation parameter based on measured impedance according to a predetermined patient-specific relationship between impedance and the parameter. King further teaches processing circuitry (processor 44 in Fig. 3) configured to:
determine a range of values for the stimulation parameter based on a sensed signal corresponding to the posture state (step 80 in Fig. 5, shown below; [0068]: “FIG. 5 is a flow diagram illustrating an example method for delivering stimulation according to a selected patient-specific relationship 50 between a stimulation parameter, such as amplitude, and impedance. The example method may be performed by IMD 14. IMD 14 may identify a posture, activity or activity level, and/or a current electrode combination (80). IMD 14 may identify the activity or posture based on the signals output by one or more sensors 54, or based on input received from patient 12 via programming device 21.”), the range of values comprising at least one of a minimum value for the stimulation parameter or a maximum value for the stimulation parameter ([0030]: “… IMD 14 adjusts a stimulation parameter, such as voltage or current amplitude, based on measured impedance. IMD 14 adjusts the stimulation parameter according to a predetermined patient-specific relationship between impedance and the parameter. In this manner, IMD 14 may adjust the stimulation such that the intensity of the stimulation as perceived by patient 12 remains substantially constant despite movement of electrodes used to deliver the stimulation relative to tissues of the patient.”. The Examiner notes that a minimum value for the stimulation parameter or a maximum value for the stimulation parameter are established by patient perception of the stimulation intensity, thus maximum and minimum values corresponding to a posture state would be limited to a range that feels constant to the patient.);
determine a representative value for the stimulation parameter based on the plurality of values for the stimulation parameter that at least partially defines therapy provided to the patient in the posture state and based on the range of values for the stimulation parameter based on the sensed signal (steps 82 and 84 in Fig. 5; [0069]: “IMD 14 selects an impedance/parameter value relationship 50 based on the posture, activity, electrode combination, or a combination thereof (82). IMD 14 measures an impedance associated with one or more of electrodes 40 (84).”); and
control the medical device to provide the therapy according to the representative value for the stimulation parameter when the patient is in the posture state (steps 86 and 88 in Fig. 5; [0069]: “IMD 14 adjusts the parameter value based on the measured impedance and the selected relationship 50 (86). For example, IMD 14 may adjust amplitude by a percentage based on a measured impedance according to a relationship 50 between amplitude and impedance. IMD 14 periodically measures impedances and adjusts the parameter value according to the selected relationship until a new posture, activity or electrode combination is detected (88).”).
King teaches a similar pursuit to that of Skelton and the instant application in teaching stimulation parameters controlled by body position or posture. Therefore, It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Skelton to include determining a range of values for the stimulation parameter based on the posture state, determine a representative value for the stimulation parameter, and controlling the stimulation parameters accordingly in order to provide adaptive and safe therapy to a patient regardless of their posture.
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Regarding claim 2, in view of the Skelton/King combination, Skelton discloses that the processing circuitry is configured to, for each respective user input of the plurality of user inputs:
determine posture information for the patient corresponding to a time that the respective user input was received (Step 226 in Fig. 11: “present patient inputs and correlated input times, posture states, and therapy programs as a function of time”);
determine, based on the posture information, the posture state ([col. 1, li. 52-55]: “In some examples, a posture sensor module associated with the medical device compares posture data from one of multiple posture sensors to the posture reference data to detect the posture occupied by the patient.”); and
determine, based on the determination that the posture information corresponds to the posture state, that the respective user input is to be associated with the plurality of user inputs for the posture state (The example of FIG. 13 shows six patient efficacy inputs 304-314 at six times T1-T6 respectively. These efficacy inputs are further correlated with input time, posture state (step function plot 300), and therapy programs (A-G) as a function of time.).
Regarding claim 3, in view of the Skelton/King combination, Skelton discloses an accelerometer configured to generate the posture information ([col. 9, li. 37-41]: “…the posture state module may receive input from one or more accelerometers each of which generates a signal with which IMD 14 determines when patient 12 occupies a posture state in which it is appropriate to change the stimulation therapy.”).
Regarding claim 4, in view of the Skelton/King combination, Skelton discloses that, to receive the indication of the plurality of user inputs, the processing circuitry is configured to:
receive a first user input (patient efficacy inputs 304-314 in Fig. 13) of the plurality of user inputs during a first time (patient efficacy input 304 at time T1 in Fig. 13); and
receive a second user input (patient efficacy inputs 304-314 in Fig. 13) of the plurality of user inputs during a second time that is different from the first time (The example of FIG. 13 shows six patient efficacy inputs 304-314 at six times T1-T6 respectively.).
Regarding claim 5, in view of the Skelton/King combination, Skelton discloses that, to determine the representative value for the stimulation parameter ([col. 10, li. 30-32]: “…a program may be characterized by an electrode combination, electrode polarities, voltage or current amplitude, pulse width, pulse rate, and/or duration.”), the processing circuitry is configured to average the plurality of values for the stimulation parameter ([col. 14, li. 31-34]: “In another example, IMD 14 may use various averaging or other statistical techniques to combine parameters from various therapy programs that received inputs with the same level of efficacy from patient 12.”). The specification of the instant application cites stimulation parameter values that includes one or more of an amplitude, a pulse width, or rate.
Regarding claim 9, in view of the Skelton/King combination, Skelton discloses that, to determine the representative value for the stimulation parameter, the processing circuitry is further configured to determine the representative value based on a heart rate of the patient ([col. 25, li. 50-55]: “In other embodiments, posture state module 86 may additionally or alternatively be configured to sense one or more physiological parameters of patient 12. For example, physiological parameters may include heart rate, electromyography (EMG), an electroencephalogram (EEG), an electrocardiogram (ECG), temperature, respiration rate, or pH.”).
Regarding claim 11, in view of the Skelton/King combination, Skelton discloses that, to determine the representative value for the stimulation parameter, the processing circuitry is configured to:
determine an average value based on the plurality of values for the stimulation parameter ([col. 14, li. 31-34]: “In another example, IMD 14 may use various averaging or other statistical techniques to combine parameters from various therapy programs that received inputs with the same level of efficacy from patient 12.”); and
determine the representative value to be less than the average value based on a determination that the posture information of the patient indicates a motion ([col. 49, li. 18-20]: “Posture state information may indicate the patient posture, activity level, or any other static position or motion of patient 12.”) that is less than a threshold motion value ([col. 26, li. 35-42]: “As another example, the activity parameter value may be defined describing direction of motion. This activity parameter value may be associated with a vector and an associated tolerance, which may be a distance from the vector. Another example of an activity parameter value relates to acceleration. The value quantifying a level of change of motion over time in a particular direction may be associated with this parameter referenced in the activity parameter value.”).
Regarding claim 12, in view of the Skelton/King combination, Skelton discloses that the processing circuitry is configured to, before the processing circuitry controls the medical device to provide the therapy using the representative value, control the medical device to provide the therapy using the respective value indicated by a user input of the plurality of user inputs ([col. 13, li. 61-col. 13, li. 1]: “In addition to adjusting one subsequent therapy program based on the therapy program associated with the highest level of patient efficacy input for a particular posture state, for all posture states, or for a particular patient input time, IMD 14 may adjust multiple therapy programs associated with one or more posture states based on a single correlation between patient input, patient input time, sensed posture state, and therapy program.”).
Regarding claim 13, in view of the Skelton/King combination, Skelton discloses that the medical device (IMD 14 in Fig. 4) comprises the processing circuitry (processor 80 in Fig. 4).
Regarding amended, independent claim 14, Skelton discloses a method ([col. 1, li. 55-62]: “Some examples according to this disclosure include methods and systems in which patient efficacy inputs (e.g., patient provided efficacy ratings) are received over a period of time during which the patient occupies a variety of posture states and correlated with the times at which the inputs were received, sensed posture states of the patient, and therapy programs defining therapy delivery.”) comprising:
receiving, by one or more processors (processor 80 in Fig. 4), an indication of a plurality of user inputs ([col. 47, li. 63 – col. 48, li. 1]: “In addition to presenting patient inputs and correlated posture states, therapy programs, and input times, patient programmer 30 may present options for a user to make selections for adjusting subsequently applied therapy programs based on one or more of the correlations between patient input, patient input time, sensed posture state, and therapy program.”), each user input of the plurality of user inputs indicating a respective value of a plurality of values for a stimulation parameter ([col. 4, li. 23-31]: “To maintain therapeutic efficacy, it may be desirable to adjust therapy parameters based on different postures and/or activities engaged by the patient to maintain effective therapy. A medical device may adjust therapy by modifying values for one or more therapy parameters, e.g., by specifying adjustments to a specific therapy parameter or by selecting different therapy programs or groups of programs that define different sets of therapy parameter values.”) that at least partially defines therapy provided to a patient in a posture state of a plurality of posture states ([col. 1, li. 50-55]: “Various posture states may be defined and detected by a medical device, at least in part, by different sets of posture reference data. In some examples, a posture sensor module associated with the medical device compares posture data from one of multiple posture sensors to the posture reference data to detect the posture occupied by the patient.”);
Skelton is silent to determining, by the one or more processors, a range of values for the stimulation parameter based on a sensed signal corresponding to the posture state, the range of values comprising at least one of a minimum value for the stimulation parameter or a maximum value for the stimulation parameter;
determining, by the one or more processors, a representative value for the stimulation parameter based on the plurality of values for the stimulation parameter that at least partially defines therapy provided to the patient in the posture state and based on the range of values for the stimulation parameter based on the sensed signal; and
controlling, by the one or more processors, the medical device to provide the therapy according to the representative value for the stimulation parameter when the patient is in the posture state.
However, King teaches determining, by the one or more processors (processor 44 in Fig. 3), a range of values for the stimulation parameter based on a sensed signal corresponding to the posture state (step 80 in Fig. 5; [0068]: “FIG. 5 is a flow diagram illustrating an example method for delivering stimulation according to a selected patient-specific relationship 50 between a stimulation parameter, such as amplitude, and impedance. The example method may be performed by IMD 14. IMD 14 may identify a posture, activity or activity level, and/or a current electrode combination (80). IMD 14 may identify the activity or posture based on the signals output by one or more sensors 54, or based on input received from patient 12 via programming device 21.”), the range of values comprising at least one of a minimum value for the stimulation parameter or a maximum value for the stimulation parameter ([0030]: “… IMD 14 adjusts a stimulation parameter, such as voltage or current amplitude, based on measured impedance. IMD 14 adjusts the stimulation parameter according to a predetermined patient-specific relationship between impedance and the parameter. In this manner, IMD 14 may adjust the stimulation such that the intensity of the stimulation as perceived by patient 12 remains substantially constant despite movement of electrodes used to deliver the stimulation relative to tissues of the patient.”. The Examiner notes that a minimum value for the stimulation parameter or a maximum value for the stimulation parameter are established by patient perception of the stimulation intensity, thus maximum and minimum values corresponding to a posture state would be limited to a range that feels constant to the patient.);
determining, by the one or more processors (processor 44 in Fig. 3), a representative value for the stimulation parameter based on the plurality of values for the stimulation parameter that at least partially defines therapy provided to the patient in the posture state and based on the range of values for the stimulation parameter based on the sensed signal (steps 82 and 84 in Fig. 5; [0069]: “IMD 14 selects an impedance/parameter value relationship 50 based on the posture, activity, electrode combination, or a combination thereof (82). IMD 14 measures an impedance associated with one or more of electrodes 40 (84).”); and
controlling, by the one or more processors (processor 44 in Fig. 3), the medical device to provide the therapy according to the representative value for the stimulation parameter when the patient is in the posture state (steps 86 and 88 in Fig. 5; [0069]: “IMD 14 adjusts the parameter value based on the measured impedance and the selected relationship 50 (86). For example, IMD 14 may adjust amplitude by a percentage based on a measured impedance according to a relationship 50 between amplitude and impedance. IMD 14 periodically measures impedances and adjusts the parameter value according to the selected relationship until a new posture, activity or electrode combination is detected (88).”).
King teaches a similar pursuit to that of Skelton and the instant application in teaching stimulation parameters controlled by body position or posture. Therefore, It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Skelton to include determining a range of values for the stimulation parameter based on the posture state, determine a representative value for the stimulation parameter, and controlling the stimulation parameters accordingly in order to provide adaptive and safe therapy to a patient regardless of their posture.
Regarding claim 15, in view of the Skelton/King combination, Skelton discloses, for each respective user input of the plurality of user inputs:
determining, by the one or more processors, posture information for the patient corresponding to a time that the respective user input was received (Step 226 in Fig. 11: “present patient inputs and correlated input times, posture states, and therapy programs as a function of time”);
determining, by the one or more processors, based on the posture information, the posture state ([col. 1, li. 52-55]: “In some examples, a posture sensor module associated with the medical device compares posture data from one of multiple posture sensors to the posture reference data to detect the posture occupied by the patient.”); and
determining, by the one or more processors, based on the determination that the posture information corresponds to the posture state, that the respective user input is to be associated with the plurality of user inputs for the posture state (The example of FIG. 13 shows six patient efficacy inputs 304-314 at six times T1-T6 respectively. These efficacy inputs are further correlated with input time, posture state (step function plot 300), and therapy programs (A-G) as a function of time.).
Regarding claim 16, in view of the Skelton/King combination, Skelton discloses that receiving the indication of the plurality of user inputs, comprises:
receiving a first user input (patient efficacy inputs 304-314 in Fig. 13) of the plurality of user inputs during a first time (patient efficacy input 304 at time T1 in Fig. 13); and
receiving a second user input (patient efficacy inputs 304-314 in Fig. 13) of the plurality of user inputs during a second time that is different from the first time (The example of FIG. 13 shows six patient efficacy inputs 304-314 at six times T1-T6 respectively.).
Regarding claim 17, in view of the Skelton/King combination, Skelton discloses that determining the representative value for the stimulation parameter ([col. 10, li. 30-32]: “…a program may be characterized by an electrode combination, electrode polarities, voltage or current amplitude, pulse width, pulse rate, and/or duration.”) comprises averaging the plurality of values for the stimulation parameter ([col. 14, li. 31-34]: “In another example, IMD 14 may use various averaging or other statistical techniques to combine parameters from various therapy programs that received inputs with the same level of efficacy from patient 12.”).
Regarding amended, independent claim 20, Skelton discloses a non-transitory computer-readable storage medium having stored thereon instructions ([col. 2, li. 18-20]: “…computer-readable medium is disclosed that includes instructions for causing a programmable processor to carry out a method.”) that, when executed, cause processing circuitry (processor 80 in Fig. 4) to:
receive an indication of a plurality of user inputs ([col. 47, li. 63 – col. 48, li. 1]: “In addition to presenting patient inputs and correlated posture states, therapy programs, and input times, patient programmer 30 may present options for a user to make selections for adjusting subsequently applied therapy programs based on one or more of the correlations between patient input, patient input time, sensed posture state, and therapy program.”), each user input of the plurality of user inputs indicating a respective value of a plurality of values for a stimulation parameter ([col. 4, li. 23-31]: “To maintain therapeutic efficacy, it may be desirable to adjust therapy parameters based on different postures and/or activities engaged by the patient to maintain effective therapy. A medical device may adjust therapy by modifying values for one or more therapy parameters, e.g., by specifying adjustments to a specific therapy parameter or by selecting different therapy programs or groups of programs that define different sets of therapy parameter values.”) that at least partially defines therapy provided to the patient in a posture state of a plurality of posture states ([col. 1, li. 50-55]: “Various posture states may be defined and detected by a medical device, at least in part, by different sets of posture reference data. In some examples, a posture sensor module associated with the medical device compares posture data from one of multiple posture sensors to the posture reference data to detect the posture occupied by the patient.”);
Skelton is silent to causing processing circuitry to:
determine a range of values for the stimulation parameter based on a sensed signal corresponding to the posture state, the range of values comprising at least one of a minimum value for the stimulation parameter or a maximum value for the stimulation parameter;
determine a representative value for the stimulation parameter based on the plurality of values for the stimulation parameter that at least partially defines therapy provided to the patient in the posture state and based on the range of values for the stimulation parameter based on the sensed signal; and
control the medical device to provide the therapy according to the representative value for the stimulation parameter when the patient is in the posture state
However, King teaches causing processing circuitry to:
determine a range of values for the stimulation parameter based on a sensed signal corresponding to the posture state (step 80 in Fig. 5; [0068]: “FIG. 5 is a flow diagram illustrating an example method for delivering stimulation according to a selected patient-specific relationship 50 between a stimulation parameter, such as amplitude, and impedance. The example method may be performed by IMD 14. IMD 14 may identify a posture, activity or activity level, and/or a current electrode combination (80). IMD 14 may identify the activity or posture based on the signals output by one or more sensors 54, or based on input received from patient 12 via programming device 21.”), the range of values comprising at least one of a minimum value for the stimulation parameter or a maximum value for the stimulation parameter ([0030]: “… IMD 14 adjusts a stimulation parameter, such as voltage or current amplitude, based on measured impedance. IMD 14 adjusts the stimulation parameter according to a predetermined patient-specific relationship between impedance and the parameter. In this manner, IMD 14 may adjust the stimulation such that the intensity of the stimulation as perceived by patient 12 remains substantially constant despite movement of electrodes used to deliver the stimulation relative to tissues of the patient.”. The Examiner notes that a minimum value for the stimulation parameter or a maximum value for the stimulation parameter are established by patient perception of the stimulation intensity, thus maximum and minimum values corresponding to a posture state would be limited to a range that feels constant to the patient.);
determine a representative value for the stimulation parameter based on the plurality of values for the stimulation parameter that at least partially defines therapy provided to the patient in the posture state and based on the range of values for the stimulation parameter based on the sensed signal (steps 82 and 84 in Fig. 5; [0069]: “IMD 14 selects an impedance/parameter value relationship 50 based on the posture, activity, electrode combination, or a combination thereof (82). IMD 14 measures an impedance associated with one or more of electrodes 40 (84).”); and
control the medical device to provide the therapy according to the representative value for the stimulation parameter when the patient is in the posture state (steps 86 and 88 in Fig. 5; [0069]: “IMD 14 adjusts the parameter value based on the measured impedance and the selected relationship 50 (86). For example, IMD 14 may adjust amplitude by a percentage based on a measured impedance according to a relationship 50 between amplitude and impedance. IMD 14 periodically measures impedances and adjusts the parameter value according to the selected relationship until a new posture, activity or electrode combination is detected (88).”).
King teaches a similar pursuit to that of Skelton and the instant application in teaching stimulation parameters controlled by body position or posture. Therefore, It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Skelton to include determining a range of values for the stimulation parameter based on the posture state, determine a representative value for the stimulation parameter, and controlling the stimulation parameters accordingly in order to provide adaptive and safe therapy to a patient regardless of their posture.
Regarding claim 21, in view of the Skelton/King combination, Skelton discloses that the sensed signal comprises an evoked signal ([col. 35, li. 25-30]: “…an implantable monitoring device may be implanted in conjunction with an implantable stimulation device, and be configured to evaluate sensing integrity of leads or electrodes associated with the implantable monitoring device based on sensed signals evoked by delivery of stimulation by the implantable stimulation device.”).
Regarding amended claim 23, in view of the Skelton/King combination, Skelton is silent to that to determine the representative value for the stimulation parameter based on the range of values for the stimulation parameter based on the sensed signal, the processing circuitry is configured to determine that the representative value is within the range of values for the stimulation parameter.
However, King teaches that to determine the representative value for the stimulation parameter based on the range of values for the stimulation parameter based on the sensed signal, the processing circuitry is configured to determine that the representative value is within the range of values for the stimulation parameter ([0050]: “… memory 48 also stores one or more relationships 50 between impedance and a stimulation parameter, such as pulse amplitude, pulse width, pulse rate, or electrode combination. Relationships 50 may be linear or non-linear, and may take the form of look-up tables, equations, or the like. Processor 44 periodically controls impedance measurement circuitry 52 to measure one or more impedances associated with one or more of electrodes 40, and adjusts one or more stimulation parameters based on the impedances and one or more currently selected relationships 50.”).
The Examiner notes that the impedance mentioned in para. [0050] above is measured following a change in posture detection (see steps 62 and 64 in Fig. 4). It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Skelton to include determining that the representative value is within the range of values for the stimulation parameter in order to provide adaptive and safe therapy to a patient regardless of their posture.
Regarding amended claim 24, in view of the Skelton/King combination, Skelton is silent to that to determine the representative value for the stimulation parameter based on the range of values for the stimulation parameter based on the sensed signal, the processing circuitry is configured to:
determine a subset of values from the plurality of values based on the range of values for the stimulation parameter, the subset of values being within the range of values for the stimulation parameter, and some of the plurality of values being outside the range of values for the stimulation parameter; and
determine the representative value based on the subset of values.
However, King teaches that to determine the representative value for the stimulation parameter based on the range of values for the stimulation parameter based on the sensed signal (steps 82 and 84 in Fig. 5; [0069]), the processing circuitry (processor 44 in Fig. 3) is configured to:
determine a subset of values from the plurality of values based on the range of values for the stimulation parameter (impedance/parameter value relationship 50 in Fig. 3), the subset of values being within the range of values for the stimulation parameter ([0064]), and some of the plurality of values being outside the range of values for the stimulation parameter ([0013]: “…at impedance values where the patient experiences high stimulation intensity during a trial, a relationship between amplitude and impedance may call for a delivery of stimulation at a lower amplitude.”); and
determine the representative value based on the subset of values ([0050]: “… memory 48 also stores one or more relationships 50 between impedance and a stimulation parameter, such as pulse amplitude, pulse width, pulse rate, or electrode combination. Relationships 50 may be linear or non-linear, and may take the form of look-up tables, equations, or the like. Processor 44 periodically controls impedance measurement circuitry 52 to measure one or more impedances associated with one or more of electrodes 40, and adjusts one or more stimulation parameters based on the impedances and one or more currently selected relationships 50.”).
The Examiner notes that the impedance mentioned in para. [0050] above is measured following a change in posture detection (see steps 62 and 64 in Fig. 4). It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Skelton to include determining that the representative value is within the range of values for the stimulation parameter in order to provide adaptive and safe therapy to a patient regardless of their posture.
Regarding amended claim 25, in view of the Skelton/King combination, Skelton is silent to that determining the representative value for the stimulation parameter based on the range of values for the stimulation parameter based on the sensed signal comprises:
determining, by the one or more processors, a subset of values from the plurality of values based on the range of values for the stimulation parameter, the subset of values being within the range of values for the stimulation parameter ([0064]), and some of the plurality of values being outside the range of values for the stimulation parameter ([0013]: “…at impedance values where the patient experiences high stimulation intensity during a trial, a relationship between amplitude and impedance may call for a delivery of stimulation at a lower amplitude.”); and
determining, by the one or more processors, the representative value based on the subset of values.
However, King teaches that that determining the representative value for the stimulation parameter based on the range of values for the stimulation parameter based on the sensed signal (steps 82 and 84 in Fig. 5; [0069]) comprises:
determining, by the one or more processors (processor 44 in Fig. 3), a subset of values from the plurality of values based on the range of values for the stimulation parameter (impedance/parameter value relationship 50 in Fig. 3), the subset of values being within the range of values for the stimulation parameter, and some of the plurality of values being outside the range of values for the stimulation parameter; and
determining, by the one or more processors (processor 44 in Fig. 3), the representative value based on the subset of values ([0050]: “… memory 48 also stores one or more relationships 50 between impedance and a stimulation parameter, such as pulse amplitude, pulse width, pulse rate, or electrode combination. Relationships 50 may be linear or non-linear, and may take the form of look-up tables, equations, or the like. Processor 44 periodically controls impedance measurement circuitry 52 to measure one or more impedances associated with one or more of electrodes 40, and adjusts one or more stimulation parameters based on the impedances and one or more currently selected relationships 50.”).
The Examiner notes that the impedance mentioned in para. [0050] above is measured following a change in posture detection (see steps 62 and 64 in Fig. 4). It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Skelton to include determining that the representative value is within the range of values for the stimulation parameter in order to provide adaptive and safe therapy to a patient regardless of their posture.
Claims 6-7, 10, 18, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over the Skelton/King combination in view of Huertas Fernandez et al. (US 2020/0009367 A1, hereinafter referred to as Huertas Fernandez).
Regarding claim 6, in view of the Skelton/King combination, Skelton discloses that the plurality of user inputs comprises a plurality of first user inputs (patient efficacy inputs 304-314 in Fig. 13) and the plurality of values comprises a plurality of first values (step function plot 302 in Fig. 13), and wherein the processing circuitry is further configured to:
receive a second user input (patient efficacy inputs 304-314 in Fig. 13) indicating a second value for the stimulation parameter that at least partially defines therapy provided to the patient in the posture state (The example of FIG. 13 shows six patient efficacy inputs 304-314 at six times T1-T6 respectively. These efficacy inputs are further correlated with input time, posture state (step function plot 300), and therapy programs (A-G) as a function of time.); and
determine that an indication of a patient reported outcome indicates that the second value is an outlier value ([col. 42, li. 1-13]: “As an alternative, posture state module 86 may rely on cosine values or a range of cosine values to define the posture donut or toroid with respect to axis 153A… If the cosine value is in a second range, the posture is lying. If the cosine value is outside of the first and second ranges, the posture may be indeterminate.”).
The Skelton/King combination does not disclose to determine to omit the second value from the plurality of values based on the determination that a patient reported outcome indicated that the second value is the outlier value.
However, the instant application recites in Specification para. [0044] using an evoked compound action potential (ECAP), stating that with this “processing circuitry 210 may ignore adjustments outside of the range of threshold values and/or ensure that the representative value is within the range of threshold values.” (Specification, [0044]) . Huertas Fernandez teaches determining optimal sub-perception stimulation parameters for a Spinal Cord Stimulation patient. Huertas Fernandez further teaches an evoked compound action potential ([0197]: “Signals sensed at the electrodes may comprise those resulting from stimulation, such as Evoked Compound Action Potentials (ECAPs). Review of various features of detected ECAPs can be used to determine patient posture or activity...”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the processing circuit of the Skelton/King combination to include utilizing an ECAP taught by Huertas Fernandez to appropriately omit the second value from the plurality of values based on the determination that a patient reported outcome indicated that the second value is the outlier value.
Regarding claim 7, in view of the Skelton/King/Huertas Fernandez combination, Skelton discloses that the processing circuitry is configured to:
determine that the second value is a potential outlier value based on the plurality of first values and the second value ([col. 42, li. 1-13]: “As an alternative, posture state module 86 may rely on cosine values or a range of cosine values to define the posture donut or toroid with respect to axis 153A… If the cosine value is in a second range, the posture is lying. If the cosine value is outside of the first and second ranges, the posture may be indeterminate.”); and
subsequent to outputting the indication prompting whether the second value is associated with the outlier value, receive the indication of the patient reported outcome ([col. 4, li. 52-61]: “…a posture-responsive medical device receives patient efficacy inputs over a period of time during which the patient occupies a variety of posture states and presents the patient inputs correlated with the times at which the inputs were received, sensed posture states of the patient (e.g., the posture state determined at the time at each of the times the patient inputs were received), and therapy programs defining therapy delivery (e.g., the therapy programs defining the therapy delivered by the medical device at each of the times the patient inputs were received) as a function of time to a user.”).
The Skelton/King combination does not explicitly disclose output an indication prompting whether the second value is associated with an outlier value based on the determination that second value is a potential outlier value. However, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to prompt the user to indicate a reason for this outlying data point, as the patient already receives indications to complete prompts (on user interface 240 that may be presented by programmer 20, as seen in Skelton Figs. 15 and 16).
Regarding amended claim 10, in view of the Skelton/King/Huertas Fernandez combination, Skelton discloses that to determine the representative value for the stimulation parameter, the processing circuitry is configured to:
determine an average value based on the based on the plurality of values for the stimulation parameter ([col. 14, li. 31-34]: “In another example, IMD 14 may use various averaging or other statistical techniques to combine parameters from various therapy programs that received inputs with the same level of efficacy from patient 12.”).
The Skelton/King combination does not disclose that the processing circuit is configured to:
determine that the patient is associated with a sleeping state based on that the heart rate of the patient being less than a threshold heart rate value; and
determine the representative value to be less than the average value in response to the determination that the patient is associated with the sleeping state.
However, Huertas Fernandez teaches determining that the patient is associated with a sleeping state ([0180]: “For example, a sleep mode 502 provides stimulation optimized for sleep (e.g., when the patient is lying down and is not moving significantly)…”) based on the heart rate of the patient being less than a threshold heart rate value ([0199]: “In the example of FIG. 30 for example, the algorithm 610 may determine using the accelerometer 630, sensors 620, and the clock 640 that a person during evening hours is still, supine, or prone, and/or that his heart rate is slow, and thus determine that the person is presently sleeping.”); and
determine the representative value to be less than the average value in response to the determination that the patient is associated with the sleeping state ([0199]: “…heart rate is slow, and thus determine that the person is presently sleeping.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the processing circuit of the Skelton/King combination to include determining a sleep state based on heart rate in order to appropriately adjust the therapy stimulation parameters for the patient.
Regarding claim 18, in view of the Skelton/King/Huertas Fernandez combination, Skelton discloses that the plurality of user inputs comprises a plurality of first user inputs (patient efficacy inputs 304-314 in Fig. 13) and the plurality of values comprises a plurality of first values (step function plot 302 in Fig. 13), the method further comprising:
receiving, by the one or more processors, a second user input (patient efficacy inputs 304-314 in Fig. 13) indicating a second value for the stimulation parameter that at least partially defines therapy provided to the patient in the posture state (The example of FIG. 13 shows six patient efficacy inputs 304-314 at six times T1-T6 respectively. These efficacy inputs are further correlated with input time, posture state (step function plot 300), and therapy programs (A-G) as a function of time.); and
determining, by the one or more processors, that an indication of a patient reported outcome indicates that the second value is an outlier value([col. 42, li. 1-13]: “As an alternative, posture state module 86 may rely on cosine values or a range of cosine values to define the posture donut or toroid with respect to axis 153A… If the cosine value is in a second range, the posture is lying. If the cosine value is outside of the first and second ranges, the posture may be indeterminate.”).
The Skelton/King combination does not disclose determining, by the one or more processors, to omit the second value from the plurality of values based on the determination that a patient reported outcome indicated that the second value is the outlier value.
However, per [0044] of the instant application’s specification recites using an evoked compound action potential (ECAP), stating that with this “processing circuitry 210 may ignore adjustments outside of the range of threshold values and/or ensure that the representative value is within the range of threshold values.”. Huertas Fernandez teaches determining optimal sub-perception stimulation parameters for a Spinal Cord Stimulation patient. Huertas Fernandez further teaches an evoked compound action potential ([0197]: “Signals sensed at the electrodes may comprise those resulting from stimulation, such as Evoked Compound Action Potentials (ECAPs). Review of various features of detected ECAPs can be used to determine patient posture or activity...”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the processing circuit of the Skelton/King combination to include utilizing an ECAP taught by Huertas Fernandez to appropriately omit the second value from the plurality of values based on the determination that a patient reported outcome indicated that the second value is the outlier value.
Regarding new claim 22, in view of the Skelton/King/Huertas Fernandez combination, the Skelton/King combination is silent to the sensed signal comprising an evoked compound action potential.
However, Huertas Fernandez teaches that the sensed signal comprises an evoked compound action potential ([0197]: “Signals sensed at the electrodes may comprise those resulting from stimulation, such as Evoked Compound Action Potentials (ECAPs).”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the processing circuit of the Skelton/King combination to include utilizing an ECAP taught by Huertas Fernandez to observe the effects of the stimulation signal on the patient, such as to determine that the distance between electrodes and nerves has increased or decreased, or that the stimulation is eliciting a different level of nerve activity if the patient has not moved, in response to determining that the measured ECAP characteristic value has increased or decreased (instant Specification [0043]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY G SCHLUETER whose telephone number is (703)756-4601. The examiner can normally be reached M-F 9:00am-5:30pm EST.
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/M.G.S./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796