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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02APR2026, which incorporates the amendments made in the After Final Response filed 09MAR2026, has been entered.
Status of Claims
The amendments and remarks filed on 09MAR2026 have been entered and considered.
Claims 1, 4-12, & 15-20 are currently pending.
Claims 1, 10-12, & 20 have been amended.
No new matter has been added.
Claims 1, 4-12, & 15-20 are under examination.
Response to Arguments
Applicant's arguments/amendments filed 09MAR2026 regarding the rejections under 35 U.S.C 101 have been fully considered and are found to obviate the rejections. Therefore, the 101 rejections has been withdrawn.
Applicant's arguments filed 09MAR2026 regarding the rejections under 35 U.S.C 102(a)(1) have been fully considered and are persuasive. Therefore, the rejections under 102(a)(1) have been withdrawn.
Applicant's arguments filed 09MAR2026 regarding the rejections under 35 U.S.C 103 have been fully considered but are not persuasive. Parts deemed not persuasive discussed below:
Applicant argues (Pages 12-13 of the Remarks):
Thakur discloses, at paragraph [0089], that "the first alert is confirmed if the variability exceeds a pre-specified threshold" or, at paragraph [0088], "the first alert is cancelled if the variability is substantially less than the impedance variability that drove the first alert."
Thakur does not disclose "determine whether the value is outside a first threshold range during occurrence of the activity" and "determine whether the value is outside a second threshold range during occurrence of the activity, wherein the first threshold range is within the second threshold range." Thakur also does not disclose "in response to determining that the value is outside the first threshold range and not outside the second threshold range: output a first alert warning that patient movement could dislodge the one or more trialing leads," much less and "modify a therapy stimulation program of the neurostimulator to compensate for movement of the one or more trialing leads," set forth in the claims.
The examiner maintains that Thakur teaches limitation “determine whether the value is outside a first threshold range during occurrence of the activity” in citation (Thakur ¶0076 “In embodiments, a user (e.g., a clinician) may order a lead integrity study or the device (or another, communicatively coupled device) may order the study. In embodiments, an IMD may be continuously (or continually) collecting information that may be used to assess lead integrity such as, for example, impedance data and another type of data (e.g., posture information, impedance measured on electrodes on another lead, and/or the like). Upon detection of a trigger event (e.g., a lead failure indication), the IMD (or another device) may be configured to analyze the lead's the impedance data in the context of the other data (e.g., the posture data). Depending on the results of the analysis, the alert may be discontinued or sustained (e.g., if the analysis meets specified criteria).”; ¶0089 “In some embodiments, if the second set of information includes posture information, analysis of the lead failure alert may mean comparing the variability in the impedance sensor at a fixed posture or sets of extreme postures (e.g., extreme displacement of arms and/or shoulders), and the first alert is confirmed if the variability exceeds a pre-specified threshold. This analysis may indicate that the lead failure alert was not triggered by a patient's posture and therefore the lead may be failing.”). The remaining limitation cited above relate to the cited reference Armstrong which is used in combination with Thakur to satisfy the claim limitations as detailed below. The applicant is reminded that references cited in combination should not be argued separately.
The Office Action cited Armstrong for features related to second threshold range of claim 1, such as col. 8, lines 50 and 51 of Armstrong. However, in col. 8, lines 50 and 51, Armstrong states: "The external unit 270 may also receive and upload various status conditions and other data from the IMD 200." Armstrong does not disclose processing circuitry configured to "determine whether the value is outside a first threshold range during occurrence of the activity" and "determine whether the value is outside a second threshold range during occurrence of the activity, wherein the first threshold range is within the second threshold range," as set forth in claim 1. Armstrong also does not disclose processing circuitry configured to "in response to determining that the value is outside the first threshold range and not outside the second threshold range, output a first alert warning that patient movement could dislodge the one or more trialing leads," as set forth in claim 1.
The examiner maintains that Thakur teaches limitation processing circuitry configured to "determine whether the value is outside a first threshold range during occurrence of the activity" in citation (Thakur ¶0076 “In embodiments, a user (e.g., a clinician) may order a lead integrity study or the device (or another, communicatively coupled device) may order the study. In embodiments, an IMD may be continuously (or continually) collecting information that may be used to assess lead integrity such as, for example, impedance data and another type of data (e.g., posture information, impedance measured on electrodes on another lead, and/or the like). Upon detection of a trigger event (e.g., a lead failure indication), the IMD (or another device) may be configured to analyze the lead's the impedance data in the context of the other data (e.g., the posture data). Depending on the results of the analysis, the alert may be discontinued or sustained (e.g., if the analysis meets specified criteria).”; ¶0089 “In some embodiments, if the second set of information includes posture information, analysis of the lead failure alert may mean comparing the variability in the impedance sensor at a fixed posture or sets of extreme postures (e.g., extreme displacement of arms and/or shoulders), and the first alert is confirmed if the variability exceeds a pre-specified threshold. This analysis may indicate that the lead failure alert was not triggered by a patient's posture and therefore the lead may be failing.”); The remaining limitation cited above relate to the cited reference Armstrong which is used in combination with Thakur to satisfy the claim limitations as detailed below. Armstrong is maintained to teach the limitation “determine whether the value is outside a second threshold range during occurrence of the activity, wherein the first threshold range is within the second threshold range” in (Armstrong Figure 7 & Figure 8 showing that the activity of a particular level will cause the lead impedance thresholds to also be exceeded.). Finally, limitation "in response to determining that the value is outside the first threshold range and not outside the second threshold range, output a first alert warning that patient movement could dislodge the one or more trialing leads," is taught by Armstrong in citation (Armstrong Column 8 Lines 50-51 “The external unit 270 may also receive and upload various status conditions and other data from the IMD 200. “; Column 16 Lines 28-41). The applicant is reminded that references cited in combination should not be argued separately.
Moreover, amended claim 1 recites that the processing circuitry is configured to "in response to determining that the value is outside the second threshold range: output a second alert warning of potentially dislodged trialing leads; and modify a therapy stimulation program of the neurostimulator to compensate for movement of the one or more trialing leads." Nothing in the cited portions of Thakur or Armstrong discloses such subject matter.
The examiner maintains that Thakur teaches limitation “output a second alert warning of potentially dislodged trialing leads” in citation (Thakur ¶0088 “This analysis may indicate that the lead failure alert was triggered by a patient's posture causing the lead to measure impedance below a predetermined threshold.”; ¶0014 “the at least one processing device is configured to confirm the first lead failure alert by generating a second lead failure alert, the second lead failure alert comprising an instruction configured to cause a display device to present an indication of failure of the lead.”; ¶0039; ¶0029). The remaining limitation cited above relates to the cited reference Armstrong which is used in combination with Thakur to satisfy the claim limitations as detailed below. Armstrong is maintained to teach the limitation “modify a therapy stimulation program of the neurostimulator to compensate for movement of the one or more trialing leads” in citation .(Armstrong Column 12 Lines 19-23 “For example, even if the impedance experienced across the leads changes, the op amp 320, in conjunction with the amplifier control circuitry 310, adjusts to deliver a controlled or constant current despite the change in the impedance experienced across the leads.”; Column 13 Lines 16-21). The applicant is reminded that references cited in combination should not be argued separately.
Claim Objections
Claims 1, 12 are objected to because of the following informalities: In claims 1, 12, and 20, the limitation “movement of the one or more trialing leads” in the last line of the claims should be amended to refer back to the “dislodging of the one or more trialing leads” in the determination step. Specification provides support for the exchangeable terms “move” and “dislodge” in [0057]. Appropriate correction is required.
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.
Claims 1, 4, 10, 12, & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Thakur et al. (US Publication No. 20170296810; Previously Cited), in view of Armstrong (US Patent No. 8868203; Previously Cited)
Regarding claim 1, Thakur discloses a medical system comprising: a neurostimulator external to a patient (Thakur ¶0061 “External device 190 may include an external therapy and/or sensing device such as, for example, a wearable defibrillator, an external cardiac monitor, and/or the like.”); one or more trialing leads configured to be implanted within the patient and coupled to the neurostimulator, (Thakur Abstract “A system for lead integrity monitoring includes an implantable medical device (IMD)”; ¶0006 “a system, comprising: an implantable medical device (IMD) configured to be implanted within a patient's body, the IMD comprising: a housing enclosing a control circuit; and a lead, having a first sensor, wherein the lead is coupled to the housing and electrically coupled to the control circuit); wherein the neurostimulator is configured to deliver stimulation or sense signals via the one or more trialing leads to the patient during a trialing period prior to implantation of an implantable medical device in the patient (Thakur ¶0006 “wherein the lead is coupled to the housing and electrically coupled to the control circuit; and at least one processing device configured to: identify a first lead failure alert, the first lead failure alert comprising an indication of a potential lead failure based on a first set of information satisfying an alert criterion; obtain a second set of information generated by a second sensor; perform an evaluation of the first set of information in the context of the second set of information; and confirm or cancel the first lead failure alert based on the evaluation”; ¶0076);one or more sensors configured to determine a value for a sensed parameter indicative of an activity level of an activity of the patient during occurrence of the activity and during the trialing period (Thakur ¶0006 “wherein the lead is coupled to the housing and electrically coupled to the control circuit; and at least one processing device configured to: identify a first lead failure alert, the first lead failure alert comprising an indication of a potential lead failure based on a first set of information satisfying an alert criterion; obtain a second set of information generated by a second sensor; perform an evaluation of the first set of information in the context of the second set of information; and confirm or cancel the first lead failure alert based on the evaluation”; ¶0076); and processing circuitry configured to: receive the value from the one or more sensors during occurrence of the activity (Thakur ¶0006 “wherein the lead is coupled to the housing and electrically coupled to the control circuit; and at least one processing device configured to: identify a first lead failure alert, the first lead failure alert comprising an indication of a potential lead failure based on a first set of information satisfying an alert criterion; obtain a second set of information generated by a second sensor; perform an evaluation of the first set of information in the context of the second set of information; and confirm or cancel the first lead failure alert based on the evaluation”); determine whether the value is outside a first threshold range during occurrence of the activity (Thakur ¶0076 “In embodiments, a user (e.g., a clinician) may order a lead integrity study or the device (or another, communicatively coupled device) may order the study. In embodiments, an IMD may be continuously (or continually) collecting information that may be used to assess lead integrity such as, for example, impedance data and another type of data (e.g., posture information, impedance measured on electrodes on another lead, and/or the like). Upon detection of a trigger event (e.g., a lead failure indication), the IMD (or another device) may be configured to analyze the lead's the impedance data in the context of the other data (e.g., the posture data). Depending on the results of the analysis, the alert may be discontinued or sustained (e.g., if the analysis meets specified criteria).”; ¶0089 “In some embodiments, if the second set of information includes posture information, analysis of the lead failure alert may mean comparing the variability in the impedance sensor at a fixed posture or sets of extreme postures (e.g., extreme displacement of arms and/or shoulders), and the first alert is confirmed if the variability exceeds a pre-specified threshold. This analysis may indicate that the lead failure alert was not triggered by a patient's posture and therefore the lead may be failing.”); in response to determining that the value is outside the second threshold range, output a second alert warning of potentially dislodged trialing leads. (Thakur ¶0088 “This analysis may indicate that the lead failure alert was triggered by a patient's posture causing the lead to measure impedance below a predetermined threshold.”; ¶0014 “the at least one processing device is configured to confirm the first lead failure alert by generating a second lead failure alert, the second lead failure alert comprising an instruction configured to cause a display device to present an indication of failure of the lead.”; ¶0039; ¶0029).
Thakur does not disclose to determine whether the value for a sensed parameter indicative of an activity level of an activity of the patient during occurrence of the activity and during the trialing period is outside a second threshold range during occurrence of the activity, wherein the first threshold range is within the second threshold range, in response to determining that the value is outside the first threshold range and not outside the second threshold range, output a first alert warning that patient movement could dislodge the one or more trialing leads and modify a therapy stimulation program of the neurostimulator to compensate for movement of the one or more trialing leads. Armstrong in a similar field of endeavor of Dynamic Lead Condition Detection teaches to determine whether the value for a sensed parameter indicative of an activity level of an activity of the patient during occurrence of the activity and during the trialing period is outside a second threshold range during occurrence of the activity, wherein the first threshold range is within the second threshold range (Armstrong Figure 7 & Figure 8 showing that the activity of a particular level will cause the lead impedance thresholds to also be exceeded. Where Figure 8 Step 810 shows the impedance threshold which needs to be crossed prior to correlating it to a patient activity such that an outlying patient activity level (step 845 showing activity of a certain degree can be linked to exceeded impedance ranges) the relationship between impedance and patient activity can be connected) in response to determining that the value is outside the first threshold range and not outside the second threshold range, output a first alert warning that patient movement could dislodge the one or more trialing leads, (Armstrong Column 8 Lines 50-51 “The external unit 270 may also receive and upload various status conditions and other data from the IMD 200. “; Column 16 Lines 28-41) and modify a therapy stimulation program of the neurostimulator to compensate for movement of the one or more trialing leads (Armstrong Column 12 Lines 19-23 “For example, even if the impedance experienced across the leads changes, the op amp 320, in conjunction with the amplifier control circuitry 310, adjusts to deliver a controlled or constant current despite the change in the impedance experienced across the leads.”; Column 13 Lines 16-21).
Before the effective filing date, it would have been obvious to a person of skill in the art to modify the system of Thakur by integrating wherein determine whether the value for a sensed parameter indicative of an activity level of an activity of the patient during occurrence of the activity and during the trialing period is outside a second threshold range during occurrence of the activity, wherein the first threshold range is within the second threshold range in response to determining that the value is outside the first threshold range and not outside the second threshold range, output a first alert warning that patient movement could dislodge the one or more trialing leads and modify a therapy stimulation program of the neurostimulator to compensate for movement of the one or more trialing leads, as taught by Armstrong, into the processing circuitry of Thakur for the purposes of adjusting the lead or modify the patient's routines, etc., to avoid intermittent lead problems (Armstrong Column 16 Lines 20-22).
Regarding claim 4, claim 1 is obvious over Thakur and Armstrong as indicated hereinabove. Thakur additionally discloses wherein the sensors comprises one or more accelerometers (Thakur ¶0032 “wherein the second sensor comprises at least one of an accelerometer”).
Regarding claim 10, claim 1 is obvious over Thakur and Armstrong as indicated hereinabove. Thakur additionally discloses wherein the neurostimulator includes the one or more sensors (Thakur ¶0059 “The sensing circuit may also include sensors such as posture sensors, activity sensors, heart sound sensors, and/or the like.”) and the processing circuitry (Thakur ¶0006 “at least one processing device”).
Regarding claim 12, Thakur discloses method (Thakur ¶0016) comprising: one or more sensors (Thakur ¶0059 “The sensing circuit may also include sensors such as posture sensors, activity sensors, heart sound sensors, and/or the like.”); and processing circuitry (Thakur ¶0006 “wherein the lead is coupled to the housing and electrically coupled to the control circuit; and at least one processing device configured to: identify a first lead failure alert, the first lead failure alert comprising an indication of a potential lead failure based on a first set of information satisfying an alert criterion; obtain a second set of information generated by a second sensor; perform an evaluation of the first set of information in the context of the second set of information; and confirm or cancel the first lead failure alert based on the evaluation”), receiving from one or more sensors, by processing circuitry, a first value for a first sensed parameter indicative of a first activity level of a first activity of a patient during occurrence of the first activity and during a trialing period (Thakur ¶0006 “wherein the lead is coupled to the housing and electrically coupled to the control circuit; and at least one processing device configured to: identify a first lead failure alert, the first lead failure alert comprising an indication of a potential lead failure based on a first set of information satisfying an alert criterion; obtain a second set of information generated by a second sensor; perform an evaluation of the first set of information in the context of the second set of information; and confirm or cancel the first lead failure alert based on the evaluation”; ¶0076); in which a neurostimulator, external to the patient (Thakur ¶0061 “External device 190 may include an external therapy and/or sensing device such as, for example, a wearable defibrillator, an external cardiac monitor, and/or the like.”), is configured to deliver stimulation or sense signals via one or more trialing leads configured to be implanted within the patient prior to implantation of an implantable medical device in the patient (Thakur Abstract “A system for lead integrity monitoring includes an implantable medical device (IMD)”; ¶0006 “a system, comprising: an implantable medical device (IMD) configured to be implanted within a patient's body, the IMD comprising: a housing enclosing a control circuit; and a lead, having a first sensor, wherein the lead is coupled to the housing and electrically coupled to the control circuit and at least one processing device configured to: identify a first lead failure alert, the first lead failure alert comprising an indication of a potential lead failure based on a first set of information satisfying an alert criterion; obtain a second set of information generated by a second sensor; perform an evaluation of the first set of information in the context of the second set of information; and confirm or cancel the first lead failure alert based on the evaluation”; ¶0076); receiving from the one or more sensors, by the processing circuitry, a second value for a second sensed parameter indicative of a second activity level of a second activity of the patient during occurrence of the second activity and during the trialing period determining, by the processing circuitry, that the second value is outside the second threshold range during occurrence of the second activity (Thakur ¶0006 “wherein the lead is coupled to the housing and electrically coupled to the control circuit; and at least one processing device configured to: identify a first lead failure alert, the first lead failure alert comprising an indication of a potential lead failure based on a first set of information satisfying an alert criterion; obtain a second set of information generated by a second sensor; perform an evaluation of the first set of information in the context of the second set of information; and confirm or cancel the first lead failure alert based on the evaluation”; ¶0076); and in response to determining that the value is outside the second threshold range, outputting a second alert warning of potentially dislodged trialing leads (Thakur ¶0088 “This analysis may indicate that the lead failure alert was triggered by a patient's posture causing the lead to measure impedance below a predetermined threshold.”; ¶0014 “the at least one processing device is configured to confirm the first lead failure alert by generating a second lead failure alert, the second lead failure alert comprising an instruction configured to cause a display device to present an indication of failure of the lead.”; ¶0039; ¶0029).
Thakur does not disclose determining, by processing circuitry, that the first value for a sensed parameter indicative of an activity level of an activity of the patient during occurrence of the activity and during the trialing period is outside a first threshold range and not outside a second threshold range during occurrence of the first activity, wherein the first threshold range is within the second threshold range; and responsive to determining that the first value is outside the first threshold range, and not outside the second threshold range, outputting a first alert warning that patient movement could dislodge the one or more trialing leads and modify a therapy stimulation program of the neurostimulator to compensate for movement of the one or more trialing leads. Armstrong in a similar field of endeavor of Dynamic Lead Condition Detection teaches determining, by processing circuitry, that the first value for a sensed parameter indicative of an activity level of an activity of the patient during occurrence of the activity and during the trialing period is outside a first threshold range and not outside a second threshold range during occurrence of the first activity, wherein the first threshold range is within the second threshold range (Armstrong Figure 7 & Figure 8 showing that the activity of a particular level will cause the lead impedance thresholds to also be exceeded. Where Figure 8 Step 810 shows the impedance threshold which needs to be crossed prior to correlating it to a patient activity such that an outlying patient activity level (step 845 showing activity of a certain degree can be linked to exceeded impedance ranges) the relationship between impedance and patient activity can be connected); and responsive to determining that the first value is outside the first threshold range, and not outside the second threshold range, outputting a first alert warning that patient movement could dislodge the one or more trialing leads (Armstrong Column 8 Lines 50-51 “The external unit 270 may also receive and upload various status conditions and other data from the IMD 200. “; Column 16 Lines 28-41) and modify a therapy stimulation program of the neurostimulator to compensate for movement of the one or more trialing leads.(Armstrong Column 12 Lines 19-23 “For example, even if the impedance experienced across the leads changes, the op amp 320, in conjunction with the amplifier control circuitry 310, adjusts to deliver a controlled or constant current despite the change in the impedance experienced across the leads.”; Column 13 Lines 16-21).
Before the effective filing date, it would have been obvious to a person of skill in the art to modify the system of Thakur by integrating wherein determining, by processing circuitry, that the first value for a sensed parameter indicative of an activity level of an activity of the patient during occurrence of the activity and during the trialing period is outside a first threshold range and not outside a second threshold range during occurrence of the first activity, wherein the first threshold range is within the second threshold range; and responsive to determining that the first value is outside the first threshold range, and not outside the second threshold range, outputting a first alert warning that patient movement could dislodge the one or more trialing leads and modify a therapy stimulation program of the neurostimulator to compensate for movement of the one or more trialing leads, as taught by Armstrong, into the processing circuitry of Thakur for the purposes of adjusting the lead or modify the patient's routines, etc., to avoid intermittent lead problems (Armstrong Column 16 Lines 20-22).
Regarding claim 20, Thakur discloses a non-transitory computer-readable storage medium storing instructions thereon (Thakur ¶0066 “Lead integrity component 130 further may include computer-readable memory 136 for storing data received from an IMD, such as the continuous or episodic cardiac signals from IMD 105.”; ¶0067 “For example, lead integrity component 130 may include a set of computer-executable instructions stored in a memory that, when executed by a processor, causes the processor to perform aspects of embodiments of the functionality of the lead integrity component 130 described herein.”; ¶0068 “The memory may include non-transitory computer-readable media.”) that when executed cause one or more processors to receive from the one or more sensors, a first value for a first sensed parameter indicative of a first activity level of a first activity of a patient during occurrence of the first activity and during a trialing period (Thakur ¶0006 “wherein the lead is coupled to the housing and electrically coupled to the control circuit; and at least one processing device configured to: identify a first lead failure alert, the first lead failure alert comprising an indication of a potential lead failure based on a first set of information satisfying an alert criterion; obtain a second set of information generated by a second sensor; perform an evaluation of the first set of information in the context of the second set of information; and confirm or cancel the first lead failure alert based on the evaluation”; ¶0076); in which a neurostimulator, external to the patient, is configured to deliver stimulation or sense signals via one or more trialing leads configured to be implanted within the patient prior to implantation of an implantable medical device in the patient (Thakur Abstract “A system for lead integrity monitoring includes an implantable medical device (IMD)”; ¶0006 “a system, comprising: an implantable medical device (IMD) configured to be implanted within a patient's body, the IMD comprising: a housing enclosing a control circuit; and a lead, having a first sensor, wherein the lead is coupled to the housing and electrically coupled to the control circuit and at least one processing device configured to: identify a first lead failure alert, the first lead failure alert comprising an indication of a potential lead failure based on a first set of information satisfying an alert criterion; obtain a second set of information generated by a second sensor; perform an evaluation of the first set of information in the context of the second set of information; and confirm or cancel the first lead failure alert based on the evaluation”; ¶0076); receive from the one or more sensors a second value for a second sensed parameter indicative of a second activity level of a second activity of the patient during occurrence of the second activity and during the trialing period; determine that the second value is outside the second threshold range during occurrence of the second activity (Thakur ¶0006 “wherein the lead is coupled to the housing and electrically coupled to the control circuit; and at least one processing device configured to: identify a first lead failure alert, the first lead failure alert comprising an indication of a potential lead failure based on a first set of information satisfying an alert criterion; obtain a second set of information generated by a second sensor; perform an evaluation of the first set of information in the context of the second set of information; and confirm or cancel the first lead failure alert based on the evaluation”; ¶0076); and in response to determining that the value is outside the second threshold range, output a second alert warning of potentially dislodged trialing leads (Thakur ¶0088 “This analysis may indicate that the lead failure alert was triggered by a patient's posture causing the lead to measure impedance below a predetermined threshold.”; ¶0014 “the at least one processing device is configured to confirm the first lead failure alert by generating a second lead failure alert, the second lead failure alert comprising an instruction configured to cause a display device to present an indication of failure of the lead.”; ¶0039; ¶0029).
Thakur does not disclose to determine that the first value for a sensed parameter indicative of an activity level of an activity of the patient during occurrence of the activity and during the trialing period is outside a first threshold range and not outside a second threshold range during occurrence of the first activity, wherein the first threshold range is within the second threshold range; responsive to determining that the first value is outside the first threshold range and not outside the second threshold range, outputting a first alert warning that patient movement could dislodge the one or more trialing lead and modify a therapy stimulation program of the neurostimulator to compensate for movement of the one or more trialing leads. Armstrong in a similar field of endeavor of Dynamic Lead Condition Detection teaches to determine that the first value for a sensed parameter indicative of an activity level of an activity of the patient during occurrence of the activity and during the trialing period is outside a first threshold range and not outside a second threshold range during occurrence of the first activity, wherein the first threshold range is within the second threshold range(Armstrong Figure 7 & Figure 8 showing that the activity of a particular level will cause the lead impedance thresholds to also be exceeded. Where Figure 8 Step 810 shows the impedance threshold which needs to be crossed prior to correlating it to a patient activity such that an outlying patient activity level (step 845 showing activity of a certain degree can be linked to exceeded impedance ranges) the relationship between impedance and patient activity can be connected); responsive to determining that the first value is outside the first threshold range and not outside the second threshold range, outputting a first alert warning that patient movement could dislodge the one or more trialing leads (Armstrong Column 8 Lines 50-51 “The external unit 270 may also receive and upload various status conditions and other data from the IMD 200. “; Column 16 Lines 28-41) and modify a therapy stimulation program of the neurostimulator to compensate for movement of the one or more trialing leads.(Armstrong Column 12 Lines 19-23 “For example, even if the impedance experienced across the leads changes, the op amp 320, in conjunction with the amplifier control circuitry 310, adjusts to deliver a controlled or constant current despite the change in the impedance experienced across the leads.”; Column 13 Lines 16-21).
Before the effective filing date, it would have been obvious to a person of skill in the art to modify the system of Thakur by integrating wherein processing circuitry is configured to determine that the first value for a sensed parameter indicative of an activity level of an activity of the patient during occurrence of the activity and during the trialing period is outside a first threshold range and not outside a second threshold range during occurrence of the first activity, wherein the first threshold range is within the second threshold range; responsive to determining that the first value is outside the first threshold range and not outside the second threshold range, outputting a first alert warning that patient movement could dislodge the one or more trialing lead and modify a therapy stimulation program of the neurostimulator to compensate for movement of the one or more trialing leads, as taught by Armstrong, into the processing circuitry of Thakur for the purposes of adjusting the lead or modify the patient's routines, etc., to avoid intermittent lead problems (Armstrong Column 16 Lines 20-22).
Claims 5-9, 11, & 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Thakur et al. (US Publication No. 20170296810; Previously Cited), in view of Armstrong (US Patent No. 8868203; Previously Cited) as applied to claims 1 and 12 above, and further in view of Bocek et al. (US Publication No. 20120158089; Previously Cited).
Regarding claim 5, claim 1 is obvious over Thakur and Armstrong as indicated hereinabove. Neither Thakur nor Armstrong disclose wherein processing circuitry is configured to generate information indicating that there is low confidence in an accuracy of a signal sensed by the one or more trialing leads in response to one of determining that the value is outside the first threshold range and not outside the second threshold range or determining that the value is outside the second threshold range. Bocek in a similar field of endeavor teaches wherein processing circuitry is configured to generate information indicating that there is low confidence in an accuracy of a signal sensed by the one or more trialing leads in response to one of determining that the value is outside the first threshold range and not outside the second threshold range or determining that the value is outside the second threshold range (Bocek ¶0049 “In an example, a slope or difference between successive measurements can be used at least in part as a lead status criterion, such as to detect a change from the relatively stable initial duration of the lead impedance 402, to an increasing impedance 402.”; ¶0047-¶0048).
Before the effective filing date, it would have been obvious to a person of skill in the art to modify the system of Thakur and Armstrong by integrating wherein processing circuitry is configured to generate information indicating that there is low confidence in an accuracy of a signal sensed by the one or more trialing leads in response to one of determining that the value is outside the first threshold range and not outside the second threshold range or determining that the value is outside the second threshold range, as taught by Bocek, into the processing circuitry of Thakur for the purposes identifying situations in which lead failure or other issues tend to occur (Thakur ¶0092).
Regarding claim 6, claim 1 is obvious over Thakur and Armstrong as indicated hereinabove. Thakur additionally discloses a memory (Thakur ¶0066 “Lead integrity component 130 further may include computer-readable memory 136 for storing data”), and wherein to determine whether the value is outside the first threshold range or determine whether the value is outside the second threshold range, processing circuitry is further configured to: identify an activity type (Thakur ¶0092 “if analysis determines that lead failure alerts are repeatedly being initiated and canceled, criteria for initiating alerts may be modified. For example, impedance thresholds may be increased such that fewer false alerts are initiated. According to embodiments, the analysis may be used to identify situations in which lead failure or other issues tend to occur. That information may be used to adjust monitoring, encourage changes in patient behavior, and/or the like. For example, the analysis may be used to determine that potential lead failure, repositioning, or other issues may be more likely to occur when the subject is in a particular position, when the subject is changing postures, when the subject is engaging in activity at a certain level,”).
Thakur nor Armstrong disclose to retrieve one or more motion threshold ranges from the memory, wherein the motion threshold ranges retrieved are associated with the activity type; and determine whether the value is outside one or more of the motion threshold ranges associated with the activity type. Bocek further teaches to retrieve one or more motion threshold ranges from the memory, wherein the motion threshold ranges retrieved are associated with the activity type; and determine whether the value is outside one or more of the motion threshold ranges associated with the activity type (Bocek ¶0039 “Such logging can be triggered, for example, by a violation of one or more criteria including one or more fixed or dynamic thresholds or ranges, such as derived from a short- or long-term trend (e.g., a dynamic range or one or more dynamic limits determined using information about one or more previous impedance measurements or central tendencies). Such logging can include using information obtained from one or more sensors can be included as a portion of the such as an accelerometer, a posture sensor a multi-axis accelerometer), a respiration sensor e.g., an acoustic or impedance-based respiration sensor), a pressure sensor, a cardiac electrogram sensing channel, such as configured to provide stored or real-time electrograms, or information about an amplitude of intrinsic cardiac events.”).
Before the effective filing date, it would have been obvious to a person of skill in the art to modify the system of Thakur and Armstrong by integrating the instructions retrieve one or more motion threshold ranges from the memory, wherein the motion threshold ranges retrieved are associated with the activity type; and determine whether the value is outside one or more of the motion threshold ranges associated with the activity type, as taught by Bocek, into the processing circuitry of Thakur for the purposes identifying situations in which lead failure or other issues tend to occur (Thakur ¶0092).
Regarding claim 7, claims 1 & 6 are obvious over Thakur, Armstrong, and Bocek as indicated hereinabove. Neither Thakur nor Armstrong disclose wherein the processing circuitry is configured to: save the value, activity type, and first alert or second alert to a database in the memory with a time stamp; and output information from the database in memory, for a physician, warning of potentially dislodged trialing leads. Bocek additionally teaches wherein the processing circuitry is configured to: save the value, activity type, and first alert or second alert to a database in the memory with a time stamp (Bocek ¶0038 “In an example, other physiologic or IMD 200 information can be stored, such as corresponding to environmental or patient conditions at the time of one of one or more impedance determinations. For example, a change in lead 224-223 characteristics can be provoked by movement, such as by patient movement including exercise or deep breathing, or by changes in the mechanical position and size of the heart during pumping. Patient movement can move the lead at or near a housing of the IMD 200, such as including pectoral muscle movement. Similarly, a posture can alter the lead position. Pumping motion of the heart can move a region of the lead 224-223 that is distally-located with respect to a housing of the IMD 200.”); and output information from the database in memory, for a physician, warning of potentially dislodged trialing leads (Bocek ¶0023 “Such impedance or other information can be transferred to a local external assembly 112, such as a physician programmer, a bed-side monitor, a hand-held or personal communication device (e.g., a wireless assembly or cellular device), outside of a patient body 103, such as using a telemetry circuit 137.”).
Before the effective filing date, it would have been obvious to a person of skill in the art to modify the system of Thakur and Armstrong by integrating wherein the processing circuitry is configured to: save the value, activity type, and first alert or second alert to a database in the memory with a time stamp; and output information from the database in memory, for a physician, warning of potentially dislodged trialing leads, as taught by Bocek, into the processing circuitry of Thakur for the purposes identifying situations in which lead failure or other issues tend to occur (Thakur ¶0092).
Regarding claim 8, claim 1 is obvious over Thakur and Armstrong as indicated hereinabove. Neither Thakur nor Armstrong disclose wherein the processing circuitry is further configured to: determine an impedance signal in the neurostimulator; and output the first alert or the second alert further based on the impedance signal being outside an impedance threshold range. Bocek additionally teaches wherein the processing circuitry is further configured to: determine an impedance signal in the neurostimulator (Bocek ¶0031 “In an example, the processor circuit 206 can be configured to determine an impedance corresponding to the excited terminal combination, such as excited by the excitation circuit 214 and measured by the detection circuit 210.”; ¶0024 “one or more of the lead impedance measurement or the intrinsic amplitude measurement, such as to determine a status of one or more of the leads 122-124. In an example, such as in response to one or more lead impedance measurements or intrinsic amplitude measurements, one or more of the 1MD 110, the local external assembly 112, or the remote external assembly 115 can be used to trigger an increased measurement frequency or to trigger measurement of additional combinations of leads or electrodes); and output the first alert or the second alert further based on the impedance signal being outside an impedance threshold range (Bocek ¶0033 “if a particular impedance measurement (e.g., a particular impedance determination made using information obtained from the detector circuit 210) indicates a lead impedance in violation of one or more rules outside of a specified range, above a specified threshold, or in violation of one or more criteria related to a short- or long-term trend), a frequency of one or more parameter determinations can be increased.”; ¶0024; ¶0037 “In response to one Or more of a fault or an alert, the processor circuit 206 can log other pertinent information about the patient or device (e.g., physiologic information), such as using the memory circuit 208, as discussed above. In an example, the IMD 200 can communicate with one or more of a local external assembly or a remote external assembly, such as using a telemetry circuit 237, such as to transmit information about one or more faults, alerts, or other information, or to provide one or more impedance determinations for similar analysis external to the patient.”).
Before the effective filing date, it would have been obvious to a person of skill in the art to modify the system of Thakur and Armstrong by integrating wherein the processing circuitry is further configured to: determine an impedance signal in the neurostimulator; and output the first alert or the second alert further based on the impedance signal being outside an impedance threshold range, as taught by Bocek, into the processing circuitry of Thakur for the purposes identifying situations in which lead failure or other issues tend to occur (Thakur ¶0092).
Regarding claim 9, claims 1 & 8 are obvious over Thakur, Armstrong, and Bocek as indicated hereinabove. Neither Thakur nor Armstrong disclose, a plurality of stimulation electrodes on the one or more trialing leads, and wherein the processing circuitry is further configured to: determine the impedance on each of the plurality of stimulation electrodes; and determine whether the impedance signal is outside the impedance threshold range for each of the plurality of stimulation electrodes; and responsive to determining that the impedance signal is outside the impedance threshold range for a predetermined number of the plurality of stimulation electrodes, output the first alert or the second alert. Bocek additionally teaches a plurality of stimulation electrodes on the one or more trialing leads (Bocek ¶0019 “For example, the first lead 122 can include one or more electrodes… For example, the second lead 123 can include one or more electrodes… The third lead 124 can include one or more electrodes”), and wherein the processing circuitry is further configured to: determine the impedance on each of the plurality of stimulation electrodes (Bocek ¶0031 “In an example, the processor circuit 206 can be configured to determine an impedance corresponding to the excited terminal combination, such as excited by the excitation circuit 214 and measured by the detection circuit 210.”; ¶0024 “one or more of the lead impedance measurement or the intrinsic amplitude measurement, such as to determine a status of one or more of the leads 122-124. In an example, such as in response to one or more lead impedance measurements or intrinsic amplitude measurements, one or more of the 1MD 110, the local external assembly 112, or the remote external assembly 115 can be used to trigger an increased measurement frequency or to trigger measurement of additional combinations of leads or electrodes”; ¶0022); and determine whether the impedance signal is outside the impedance threshold range for each of the plurality of stimulation electrodes (Bocek ¶0033 “if a particular impedance measurement (e.g., a particular impedance determination made using information obtained from the detector circuit 210) indicates a lead impedance in violation of one or more rules outside of a specified range, above a specified threshold, or in violation of one or more criteria related to a short- or long-term trend), a frequency of one or more parameter determinations can be increased.”; ¶0024); and responsive to determining that the impedance signal is outside the impedance threshold range for a predetermined number of the plurality of stimulation electrodes, output the first alert or the second alert (Bocek ¶0037 “In response to one Or more of a fault or an alert, the processor circuit 206 can log other pertinent information about the patient or device (e.g., physiologic information), such as using the memory circuit 208, as discussed above. In an example, the IMD 200 can communicate with one or more of a local external assembly or a remote external assembly, such as using a telemetry circuit 237, such as to transmit information about one or more faults, alerts, or other information, or to provide one or more impedance determinations for similar analysis external to the patient.”).
Before the effective filing date, it would have been obvious to a person of skill in the art to modify the system of Thakur and Armstrong by integrating a plurality of stimulation electrodes on the one or more trialing leads, and wherein the processing circuitry is further configured to: determine the impedance on each of the plurality of stimulation electrodes; and determine whether the impedance signal is outside the impedance threshold range for each of the plurality of stimulation electrodes; and responsive to determining that the impedance signal is outside the impedance threshold range for a predetermined number of the plurality of stimulation electrodes, output the first alert or the second alert, as taught by Bocek, into the processing circuitry of Thakur for the purposes identifying situations in which lead failure or other issues tend to occur (Thakur ¶0092).
Regarding claim 11, claim 1 is obvious over Thakur and Armstrong as indicated hereinabove. Neither Thakur nor Armstrong disclose a wearable device and a medical device coupled to the one or more trialing leads, wherein the medical device includes both the one or more sensors and the processing circuitry. Bocek additionally teaches a wearable device (Bocek ¶0023 “Such impedance or other information can be transferred to a local external assembly 112, such as a physician programmer, a bed-side monitor, a hand-held or personal communication device (e.g., a wireless assembly or cellular device), outside of a patient body 103, such as using a telemetry circuit 137.” Where the personal wireless communication device encompasses smart watches which are a wearable user interface) wherein the neurostimulator includes both the one or more sensors and the processing circuitry (Bocek Figure 2 showing the configuration of implantable medical device (IMD) 200 which shows that the processing circuitry 206 and the sensors within the IMD).
Before the effective filing date, it would have been obvious to a person of skill in the art to modify the system of Thakur and Armstrong by integrating a wearable device wherein the neurostimulator includes both the one or more sensors and the processing circuitry., as taught by Bocek, into the processing circuitry of Thakur for the purposes identifying situations in which lead failure or other issues tend to occur (Thakur ¶0092).
Regarding claim 15, claim 12 is obvious over Thakur and Armstrong as indicated hereinabove. Neither Thakur nor Armstrong disclose generating information indicating that there is a low confidence in an accuracy of a signal sensed by the one or more trialing leads in response to one of determining that the value is outside the first threshold range and not outside the second threshold range or determining that the value is outside the second threshold range. Bocek in a similar field of endeavor teaches generating information indicating that there is a low confidence in an accuracy of a signal sensed by the one or more trialing leads in response to one of determining that the value is outside the first threshold range and not outside the second threshold range or determining that the value is outside the second threshold range (Bocek ¶0049 “In an example, a slope or difference between successive measurements can be used at least in part as a lead status criterion, such as to detect a change from the relatively stable initial duration of the lead impedance 402, to an increasing impedance 402.”; ¶0047-¶0048).
Before the effective filing date, it would have been obvious to a person of skill in the art to modify the system of Thakur and Armstrong by integrating the instructions for generating information indicating that there is a low confidence in an accuracy of a signal sensed by the one or more trialing leads in response to one of determining that the value is outside the first threshold range and not outside the second threshold range or determining that the value is outside the second threshold range, as taught by Bocek, into the processing circuitry of Thakur for the purposes identifying situations in which lead failure or other issues tend to occur (Thakur ¶0092).
Regarding claim 16, claim 12 is obvious over Thakur and Armstrong as indicated hereinabove. Neither Thakur nor Armstrong disclose wherein determining that the value is outside the first threshold range or determining that the value is outside the second threshold range comprises: identifying, by processing circuitry, an activity type; retrieving, by processing circuitry, from a memory, one or more motion threshold ranges wherein the motion threshold ranges retrieved are associated with the activity type; and determining, by processing circuitry, that the value is outside one or more of the motion threshold ranges associated with the activity type. Bocek additionally teaches wherein determining that the value is outside the first threshold range or determining that the value is outside the second threshold range comprises: identifying, by processing circuitry, an activity type (Bocek ¶0039 “Such movements (e,g., patient body, heart, or other motion) have the potential to expose lead 224-223 integrity issues. Thus, logging of such information (e.g., a respiration state, a posture, a patient activity level, cardiac electrograms, mechanical heart information such as pressure, etc.) during or near the time of a lead impedance measurement can aid in diagnosing a transient or incipient lead-related fault.”; ¶0038); retrieving, by processing circuitry, from a memory (Bocek ¶0080 “comprising an implantable medical device including a processor and a memory circuit,”), one or more motion threshold ranges wherein the motion threshold ranges retrieved are associated with the activity type; and determining, by processing circuitry, that the value is outside one or more of the motion threshold ranges associated with the activity type. (Bocek ¶0039 “Such logging can be triggered, for example, by a violation of one or more criteria including one or more fixed or dynamic thresholds or ranges, such as derived from a short- or long-term trend (e.g., a dynamic range or one or more dynamic limits determined using information about one or more previous impedance measurements or central tendencies). Such logging can include using information obtained from one or more sensors can be included as a portion of the such as an accelerometer, a posture sensor a multi-axis accelerometer), a respiration sensor e.g., an acoustic or impedance-based respiration sensor), a pressure sensor, a cardiac electrogram sensing channel, such as configured to provide stored or real-time electrograms, or information about an amplitude of intrinsic cardiac events.”).
Before the effective filing date, it would have been obvious to a person of skill in the art to modify the system of Thakur and Armstrong by integrating the instructions wherein determining that the value is outside the first threshold range or determining that the value is outside the second threshold range comprises: identifying, by processing circuitry, an activity type; retrieving, by processing circuitry, from a memory, one or more motion threshold ranges wherein the motion threshold ranges retrieved are associated with the activity type; and determining, by processing circuitry, that the value is outside one or more of the motion threshold ranges associated with the activity type, as taught by Bocek, into the processing circuitry of Thakur for the purposes identifying situations in which lead failure or other issues tend to occur (Thakur ¶0092).
Regarding claim 17, claims 12 & 16 are obvious over Thakur, Armstrong, and Bocek as indicated hereinabove. Neither Thakur nor Armstrong disclose saving, by processing circuitry, the value, activity type, and a first alert or second alert to a database in the memory with a time stamp and outputting information from the database in memory, by processing circuitry, for a physician, warning of potentially dislodged trialing leads. Bocek additionally teaches saving, by processing circuitry, the value, activity type, and a first alert or second alert to a database in the memory with a time stamp (Bocek ¶0038 “In an example, other physiologic or IMD 200 information can be stored, such as corresponding to environmental or patient conditions at the time of one of one or more impedance determinations. For example, a change in lead 224-223 characteristics can be provoked by movement, such as by patient movement including exercise or deep breathing, or by changes in the mechanical position and size of the heart during pumping. Patient movement can move the lead at or near a housing of the IMD 200, such as including pectoral muscle movement. Similarly, a posture can alter the lead position. Pumping motion of the heart can move a region of the lead 224-223 that is distally-located with respect to a housing of the IMD 200.”); and outputting information from the database in memory, by processing circuitry, for a physician, warning of potentially dislodged trialing leads. (Bocek ¶0023 “Such impedance or other information can be transferred to a local external assembly 112, such as a physician programmer, a bed-side monitor, a hand-held or personal communication device (e.g., a wireless assembly or cellular device), outside of a patient body 103, such as using a telemetry circuit 137.”).
Before the effective filing date, it would have been obvious to a person of skill in the art to modify the system of Thakur and Armstrong by integrating the instructions for saving, by processing circuitry, the value, activity type, and a first alert or second alert to a database in the memory with a time stamp and outputting information from the database in memory, by processing circuitry, for a physician, warning of potentially dislodged trialing leads, as taught by Bocek, into the processing circuitry of Thakur for the purposes identifying situations in which lead failure or other issues tend to occur (Thakur ¶0092).
Regarding claim 18, claim 12 is obvious over Thakur and Armstrong as indicated hereinabove. Neither Thakur nor Armstrong disclose determining, by processing circuitry, an impedance signal in a neurostimulator and outputting the first alert or the second alert further based on the impedance signal being outside an impedance threshold range. Bocek additionally teaches determining, by processing circuitry, an impedance signal (Bocek ¶0031 “In an example, the processor circuit 206 can be configured to determine an impedance corresponding to the excited terminal combination, such as excited by the excitation circuit 214 and measured by the detection circuit 210.”; ¶0024 “one or more of the lead impedance measurement or the intrinsic amplitude measurement, such as to determine a status of one or more of the leads 122-124. In an example, such as in response to one or more lead impedance measurements or intrinsic amplitude measurements, one or more of the 1MD 110, the local external assembly 112, or the remote external assembly 115 can be used to trigger an increased measurement frequency or to trigger measurement of additional combinations of leads or electrodes) in a neurostimulator (Bocek ¶0006; ¶0025 “In an example, such terminals can include a first therapy delivery terminal 227 that can be coupled to a first lead. 224, such as including a first electrode 225, or one or more other electrodes, such as disposed in or near a first tissue site to be electrostimulated a heart 202 or a neural target”; ¶0042); and outputting the first alert or the second alert further based on the impedance signal being outside an impedance threshold range (Bocek ¶0037 “In response to one Or more of a fault or an alert, the processor circuit 206 can log other pertinent information about the patient or device (e.g., physiologic information), such as using the memory circuit 208, as discussed above. In an example, the IMD 200 can communicate with one or more of a local external assembly or a remote external assembly, such as using a telemetry circuit 237, such as to transmit information about one or more faults, alerts, or other information, or to provide one or more impedance determinations for similar analysis external to the patient.”).
Before the effective filing date, it would have been obvious to a person of skill in the art to modify the system of Thakur and Armstrong by integrating the instructions for determining, by processing circuitry, an impedance signal in a neurostimulator and outputting the first alert or the second alert further based on the impedance signal being outside an impedance threshold range, as taught by Bocek, into the processing circuitry of Thakur for the purposes identifying situations in which lead failure or other issues tend to occur (Thakur ¶0092).
Regarding claim 19, claims 12 & 18 are obvious over Thakur, Armstrong, and Bocek as indicated hereinabove. Neither Thakur nor Armstrong disclose determining, by processing circuitry, the impedance on each of a plurality of stimulation electrodes; and determining, by processing circuitry, that the impedance signal is outside the impedance threshold range for a predetermined number of the plurality of stimulation electrodes and responsive to determining that the impedance signal is outside the impedance threshold range for the predetermined number of the plurality of stimulation electrodes, outputting a first alert or the second alert. Bocek additionally teaches determining, by processing circuitry, the impedance on each of a plurality of stimulation electrodes (Bocek ¶0031 “In an example, the processor circuit 206 can be configured to determine an impedance corresponding to the excited terminal combination, such as excited by the excitation circuit 214 and measured by the detection circuit 210.”; ¶0024 “one or more of the lead impedance measurement or the intrinsic amplitude measurement, such as to determine a status of one or more of the leads 122-124. In an example, such as in response to one or more lead impedance measurements or intrinsic amplitude measurements, one or more of the 1MD 110, the local external assembly 112, or the remote external assembly 115 can be used to trigger an increased measurement frequency or to trigger measurement of additional combinations of leads or electrodes”; ¶0022); and determining, by processing circuitry, that the impedance signal is outside the impedance threshold range for a predetermined number of the plurality of stimulation electrodes (Bocek ¶0033 “if a particular impedance measurement (e.g., a particular impedance determination made using information obtained from the detector circuit 210) indicates a lead impedance in violation of one or more rules outside of a specified range, above a specified threshold, or in violation of one or more criteria related to a short- or long-term trend), a frequency of one or more parameter determinations can be increased.”; ¶0024); and responsive to determining that the impedance signal is outside the impedance threshold range for the predetermined number of the plurality of stimulation electrodes, outputting a first alert or the second alert. (Bocek ¶0037 “In response to one Or more of a fault or an alert, the processor circuit 206 can log other pertinent information about the patient or device (e.g., physiologic information), such as using the memory circuit 208, as discussed above. In an example, the IMD 200 can communicate with one or more of a local external assembly or a remote external assembly, such as using a telemetry circuit 237, such as to transmit information about one or more faults, alerts, or other information, or to provide one or more impedance determinations for similar analysis external to the patient.”).
Before the effective filing date, it would have been obvious to a person of skill in the art to modify the system of Thakur and Armstrong by integrating the instructions for determining, by processing circuitry, the impedance on each of a plurality of stimulation electrodes; and determining, by processing circuitry, that the impedance signal is outside the impedance threshold range for a predetermined number of the plurality of stimulation electrodes and responsive to determining that the impedance signal is outside the impedance threshold range for the predetermined number of the plurality of stimulation electrodes, outputting a first alert or the second alert., as taught by Bocek, into the processing circuitry of Thakur for the purposes identifying situations in which lead failure or other issues tend to occur (Thakur ¶0092). Conclusion
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/MEGAN T FEDORKY/Examiner, Art Unit 3796
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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