DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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.
Claim(s) 1, 15, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huelskamp et al. (US 20180117339), cited in IDS, in view of Ousdigian (US 20050154421).
Regarding claim 1, Huelskamp discloses a leadless cardiac pacemaker (LCP) 100 for implantation in a heart 300 of a patient (Figs. 1, 3, section 0041, leadless cardiac pacemaker (LCP) that may be implanted on the heart or within a chamber of the heart and may operate to sense physiological signals and parameters and deliver one or more types of electrical stimulation therapy to the heart of the patient), the LCP comprising: a housing 120 (Fig. 1); two or more electrodes 114, 114’ exposed to an exterior of the housing (Fig. 1); a three-axis accelerometer 108 disposed within the housing (Fig. 1, section 0054, Mechanical sensing module may include, or be electrically connected to, various sensors, such as accelerometers, including multi-axis accelerometers such as two- or three-axis accelerometers), the three-axis accelerometer providing an acceleration signal for each of the three axes of the three-axis accelerometer (section 0115, motion level signals from different axes, x-axis, y-axis, and z-axis, respectively, generated by a motion sensor, such as a three-axis accelerometer); a memory (section 0042, processing module 110 (e.g., a controller including memory); a controller 104, 110 disposed within the housing and operably coupled with the two or more electrodes (section 0055-0056, pulse generator module 104 and/or energy storage module may be considered a controller of the LCP. Processing module 110 may be configured to direct the operation of LCP 100 and may, in some embodiments, be termed a controller), the three-axis accelerometer and the memory, the controller configured to: identify a cardiac cycle of the heart, the cardiac cycle having a cardiac cycle duration that is dependent on a current heart rate of the heart (Section 0112, the measurements taken by the motion sensor of the mechanical sensing module for each of the N heart beats may be taken during the systole phase of the cardiac cycle); determine the heart is experiencing an arrhythmia (Section 0081, one or more of devices 100a/100b may receive such signals and, based on the received signals, determine an occurrence of an arrhythmia); receive the acceleration signal from each of the three axes of the three-axis accelerometer (section 0115, motion level signals from different axes, x-axis, y-axis, and z-axis, respectively, generated by a motion sensor, such as a three-axis accelerometer); combine the acceleration signals from each of the three axes of the three-axis accelerometer into a combined acceleration signal having a magnitude (Section 0115, Signal 962, shown in a dashed line in graphs 960a-960c, represents an average of accelerometer magnitude signals (e.g., a baseline motion level signal) for N pace initiated heart beats on the respective axis. Signal 964, represented in a solid line, represents an average of accelerometer magnitude signals (e.g., a baseline motion level signal) for N intrinsically initiated heart beats); identify a predetermined morphological feature 962 in the magnitude of the combined acceleration signal (Fig. 11A-C); identify a relative time of occurrence of the predetermined feature within the cardiac cycle duration (Fig. 11A-C, section 0116, a pre-determined time may be 200 ms, at line A-A, after a heart beat has been identified); determine whether the arrhythmia is an arrhythmia that should be treated by delivery of a therapy by the LCP based at least in part on the relative time of occurrence of the predetermined feature within the cardiac cycle duration (Section 0058, After determining an occurrence of an arrhythmia, processing module 110 may control pulse generator module 104 to generate electrical stimulation pulses in accordance with one or more electrical stimulation therapies to treat the determined arrhythmia); when the arrhythmia is determined to be an arrhythmia that should be treated by delivery of the therapy by the LCP, the controller configured to deliver the therapy to the heart via two or more electrodes of the LCP (Section 0043, Electrodes 114 may generally conduct electrical signals to and/or from LCP 100 and the surrounding tissue and/or blood. Such electrical signals may include communication signals, electrical stimulation pulses, and intrinsic cardiac electrical signals).
However, Huelskamp does not disclose determine whether an arrhythmia that should not be treated by the LCP based at least in part on the relative time of occurrence of the predetermined feature within the cardiac cycle duration and when the arrhythmia is determined to be an arrhythmia that should not be treated by the LCP, the controller is configured to not deliver the therapy to the heart via two or more electrodes of the LCP.
Ousdigian discloses a IMD (Fig. 1-2) that determines whether an arrhythmia that should not be treated by the pacemaker 10 based at least in part on the relative time of occurrence of the predetermined feature within the cardiac cycle duration and when the arrhythmia is determined to be an arrhythmia that should not be treated by the pacemaker (section 0053, microprocessor 60 additionally or alternatively analyzes the regularity of measured VCLs and/or morphological features the ventricular rhythm to determine whether the arrhythmia is suspected non-lethal. Microprocessor can, for example, calculate the variability of measured VCLs over the previous intervals, and the morphological analysis can include, for example, an analysis of the width of ventricular depolarizations and/or a wavelet analysis), the controller is configured to not deliver the therapy to the heart via electrodes of the pacemaker (Section 0062, microprocessor 60 can eliminate the shocks and instead deliver ATP alone for if the suspected non-lethal arrhythmia is a slow suspected non-lethal arrhythmias). This allows for the pacemaker to treat non-lethal arrythmias differently and not deliver inappropriate therapy a non-lethal arrythmia. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Huelskamp by adding determine whether an arrhythmia that should not be treated by the pacemaker based at least in part on the relative time of occurrence of the predetermined feature within the cardiac cycle duration and when the arrhythmia is determined to be an arrhythmia that should not be treated by the pacemaker, the controller is configured to not deliver the therapy to the heart via two or more electrodes of the pacemaker as taught by Ousdigian in order to facilitate the pacemaker to treat non-lethal arrythmias differently and not deliver inappropriate therapy a non-lethal arrythmia.
Regarding claim 3, Huelskamp in view of Ousdigian, specfically Huelskamp discloses receive an electrocardiogram signal via the two or more electrodes 114 that are exposed to the exterior of the housing 120 (Fig. 1); and identify the cardiac cycle of the heart based at least in part on the electrocardiogram signal (section 0043, Electrodes may generally conduct electrical signals to and/or from LCP and the surrounding tissue and/or blood. Such electrical signals may include communication signals, electrical stimulation pulses, and intrinsic cardiac electrical signals, to name a few. Intrinsic cardiac electrical signals may include electrical signals generated by the heart and may be represented by an electrocardiogram).
Regarding claim 4, Huelskamp in view of Ousdigian, specfically Huelskamp discloses the controller is configured to determine the heart is experiencing an arrhythmia based at least in part on the electrocardiogram signal (section 0048, Some example functions include delivering sensed data, using communicated data for determining occurrences of events such as arrhythmias, coordinating delivery of electrical stimulation therapy, and/or other functions. In some cases, LCP 100 may use communication signals to communicate raw information, processed information, messages and/or commands, and/or other data. Raw information may include information such as sensed electrical signals (e.g. a sensed ECG), signals gathered from coupled sensors).
Regarding claim 5, Huelskamp in view of Ousdigian, specfically Huelskamp discloses the controller is configured to determine the heart is experiencing an arrhythmia based at least in part on the acceleration signal of one or more of the three axes of the three-axis accelerometer (Fig. 6, section 0048, using communicated data for determining occurrences of events such as arrhythmias. Processed information may also include parameters and/or events that are determined by the LCP 100 and/or another device, such as a determined heart rate, timing of determined heartbeats, timing of other determined events, determinations of threshold crossings, expirations of monitored time periods, accelerometer signals, activity level parameters, blood-oxygen parameters, blood pressure parameters, heart sound parameters).
Regarding claim 6, Huelskamp in view of Ousdigian, specfically Ousdigian discloses the controller is configured to determine whether the arrhythmia is an arrhythmia that should be treated by delivery of the therapy by the LCP (Fig.6, section 0073, If microprocessor determines that the rhythm is not suspect, microprocessor controls delivery of therapy scheduled for the detected arrhythmia) or an arrhythmia that should not be treated by the LCP based at least in part on whether the relative time of occurrence of the predetermined feature falls within a defined time window of the cardiac cycle duration, wherein the defined time window has a duration that is less than the cardiac cycle duration (section 0062, 0073, microprocessor can eliminate the shocks and instead deliver ATP alone for if the suspected non-lethal arrhythmia is a slow suspected non-lethal arrhythmias. In some embodiments, the microprocessor can simply withhold delivery of any therapies based on the determination that the rhythm is a slow suspected non-lethal arrhythmia. If microprocessor determines that the rhythm is a suspected non-lethal arrhythmia, microprocessor changes the scheduled therapy as described above).This allows for the pacemaker to treat non-lethal arrythmias differently and not deliver inappropriate therapy for a detected non-lethal arrythmia.
Regarding claim 7, Huelskamp in view of Ousdigian, specfically Ousdigian discloses the controller is configured to determine that the arrhythmia is an arrhythmia that should be treated by delivery of the therapy by the LCP when the relative time of occurrence of the predetermined feature falls within the defined time window of the cardiac cycle duration of the cardiac cycle (Fig.6, section 0073, If microprocessor determines that the rhythm is not suspect, microprocessor controls delivery of therapy scheduled for the detected arrhythmia). This allows for the pacemaker to treat non-lethal arrythmias differently and not deliver inappropriate therapy for a detected non-lethal arrythmia.
Regarding claim 8, Huelskamp in view of Ousdigian, specfically Ousdigian discloses the defined time window has a duration that corresponds to a first predetermined percent of the cardiac cycle duration and a start time that corresponds to a second predetermined percent of the cardiac cycle duration (section 0032, IMD detects a ventricular arrhythmia if a sufficient number of VCLs measured during a time period that precedes and includes the current ventricular interval fall within the VCL zone associated with that arrhythmia. The NID can be expressed, for example, as a number of intervals within the zone within a period of time, i.e., a "time to detect," a number of consecutive intervals within the zone, or as a fraction, e.g., "A" of the last "B" intervals within the zone.) This allows for the pacemaker to treat non-lethal arrythmias differently and not deliver inappropriate therapy for a detected non-lethal arrythmia.
Regarding claim 9, Huelskamp in view of Ousdigian, specfically Ousdigian discloses once the controller determines whether the arrhythmia is an arrhythmia that should be treated by delivery of a therapy by the LCP or an arrhythmia that should not be treated by the LCP, the controller is configured to communicate that determination to one or more other devices (section 0062, 0073, Fig.6, If microprocessor determines that the rhythm is not suspect, microprocessor controls delivery of therapy scheduled for the detected arrhythmia microprocessor can eliminate the shocks and instead deliver ATP alone for if the suspected non-lethal arrhythmia is a slow suspected non-lethal arrhythmias. In some embodiments, the microprocessor can simply withhold delivery of any therapies based on the determination that the rhythm is a slow suspected non-lethal arrhythmia. If microprocessor determines that the rhythm is a suspected non-lethal arrhythmia, microprocessor changes the scheduled therapy as described above). This allows for the pacemaker to treat non-lethal arrythmias differently and not deliver inappropriate therapy for a detected non-lethal arrythmia.
Regarding claim 11, Huelskamp in view of Ousdigian, specfically Huelskamp discloses the predetermined morphological feature comprises one or more of: a minimum in the magnitude of the combined acceleration signal; a maximum in the magnitude of the combined acceleration signal; a maximum change versus time of the magnitude of the combined acceleration signal; and a maximum change in the change versus time of the magnitude of the combined acceleration signal (Figs. 11A-C, section 0116, an offset may be selected by determining a difference between signal and at a predetermined time in each graph and using the greatest difference at the predetermined time as the offset. The processing module or other module may select the difference of the x-axis as the offset because it is the greatest difference between signals and at 200 ms out from when a heartbeat was initiated).
Regarding claim 12, Huelskamp in view of Ousdigian, specfically Huelskamp discloses the controller identifies the predetermined morphological feature by comparing the magnitude of the combined acceleration signal with a plurality of morphological feature templates, and identifies the predetermined morphological feature as that which corresponds to a matching one of the plurality of morphological feature templates (Fig. 11A-C, section 0116, a pre-determined time may be 200 ms, at line A-A, after a heart beat has been identified).
Regarding claim 13, Huelskamp in view of Ousdigian, specfically Ousdigian discloses the controller is configured to: identify the relative time of occurrence of the predetermined feature within the cardiac cycle duration for each of a plurality of cardiac cycles of the heart (Fig. 6, section 0072 , Microprocessor 60 measures VCLs within a ventricular rhythm, and determines whether a NID for an arrhythmia is met. When the NID for a ventricular arrhythmia is met, microprocessor 60 further determines whether the rhythm is a suspected non-lethal arrhythmia using any of the techniques described above); determine a variability in the relative time of occurrence of the predetermined feature within the cardiac cycle duration among the plurality of cardiac cycles of the heart; determine whether the arrhythmia is an arrhythmia that should be treated by delivery of a therapy by the LCP (Fig.6, section 0073, If microprocessor determines that the rhythm is not suspect, microprocessor controls delivery of therapy scheduled for the detected arrhythmia) or an arrhythmia that should not be treated by the LCP based at least in part on: the relative time of occurrence of the predetermined feature within the cardiac cycle duration; and the variability in the relative time of occurrence of the predetermined feature within the cardiac cycle duration for each of the plurality of cardiac cycles of the heart (section 0062, 0073, microprocessor can eliminate the shocks and instead deliver ATP alone for if the suspected non-lethal arrhythmia is a slow suspected non-lethal arrhythmias. In some embodiments, the microprocessor can simply withhold delivery of any therapies based on the determination that the rhythm is a slow suspected non-lethal arrhythmia. If microprocessor determines that the rhythm is a suspected non-lethal arrhythmia, microprocessor changes the scheduled therapy as described above). This allows for the pacemaker to treat non-lethal arrythmias differently and not deliver inappropriate therapy for a detected non-lethal arrythmia
Regarding claim 14, Huelskamp in view of Ousdigian, specfically Huelskamp discloses the controller is further configured to: determine a posture of the patient based at least in part on the acceleration signal of one or more of the three axes of the three-axis accelerometer (section 0119, , the LCP 100 may detect when the patient is in a particular position or posture and may automatically initiate a calibration window); determine whether the arrhythmia is an arrhythmia that should be treated by delivery of a therapy by the LCP (Fig.6, section 0073, If microprocessor determines that the rhythm is not suspect, microprocessor controls delivery of therapy scheduled for the detected arrhythmia) or an arrhythmia that should not be treated by the LCP based at least in part on: the relative time of occurrence of the predetermined feature within the cardiac cycle duration (section 0062, 0073, microprocessor can eliminate the shocks and instead deliver ATP alone for if the suspected non-lethal arrhythmia is a slow suspected non-lethal arrhythmias. In some embodiments, the microprocessor can simply withhold delivery of any therapies based on the determination that the rhythm is a slow suspected non-lethal arrhythmia. If microprocessor determines that the rhythm is a suspected non-lethal arrhythmia, microprocessor changes the scheduled therapy as described above); and the posture of the patient (Section 0121, processing module 110 or other processing module may identify a baseline pace motion level for the identified patient posture or position).
Regarding claim 15, Huelskamp discloses a method for operating an implantable medical device (IMD) for implantation in a heart of a patient (Figs. 1, 3, section 0041, leadless cardiac pacemaker (LCP) that may be implanted on the heart or within a chamber of the heart and may operate to sense physiological signals and parameters and deliver one or more types of electrical stimulation therapy to the heart of the patient), the IMD having a three-axis accelerometer that provides an acceleration signal for each of the three axes of the three-axis accelerometer (section 0115, motion level signals from different axes, x-axis, y-axis, and z-axis, respectively, generated by a motion sensor, such as a three-axis accelerometer), the method comprising: identifying a cardiac cycle of the heart, the cardiac cycle having a cardiac cycle duration that is dependent on a current heart rate of the heart (Section 0112, the measurements taken by the motion sensor of the mechanical sensing module for each of the N heart beats may be taken during the systole phase of the cardiac cycle); combining the acceleration signals from each of the three axes of the three-axis accelerometer into a combined acceleration signal having a magnitude (Section 0115, Signal 962, shown in a dashed line in graphs 960a-960c, represents an average of accelerometer magnitude signals (e.g., a baseline motion level signal) for N pace initiated heart beats on the respective axis. Signal 964, represented in a solid line, represents an average of accelerometer magnitude signals (e.g., a baseline motion level signal) for N intrinsically initiated heart beats); identifying a predetermined morphological feature 962 in the magnitude of the combined acceleration signal (Fig. 11A-C); identifying a relative time of occurrence of the predetermined feature within the cardiac cycle duration (Section 0058, After determining an occurrence of an arrhythmia, processing module 110 may control pulse generator module 104 to generate electrical stimulation pulses in accordance with one or more electrical stimulation therapies to treat the determined arrhythmia)
However, Huelskamp does not specifically disclose discriminating between two or more different arrhythmia types based at least in part on the relative time of occurrence of the predetermined feature within the cardiac cycle duration; and the IMD causing delivery of a therapy to the heart when an arrhythmia of a first arrhythmia type is identified and the IMD not causing delivery of the therapy to the heart when an arrhythmia of a second arrhythmia type is identified.
Ousdigian discloses discriminating between two or more different arrhythmia types (lethal and non-lethal) based at least in part on the relative time of occurrence of the predetermined feature within the cardiac cycle duration (Fig. 6, section 0072 , Microprocessor 60 measures VCLs within a ventricular rhythm (130), and determines whether a NID for an arrhythmia is met (132). When the NID for a ventricular arrhythmia is met, microprocessor 60 further determines whether the rhythm is a suspected non-lethal arrhythmia using any of the techniques described above); and the IMD causing delivery of a therapy 146 to the heart when an arrhythmia of a first arrhythmia type is identified (Fig.6, section 0073, If microprocessor determines that the rhythm is not suspect, microprocessor controls delivery of therapy scheduled for the detected arrhythmia) and the IMD not causing delivery of the therapy 136 to the heart when an arrhythmia of a second arrhythmia type is identified (section 0062, 0073, microprocessor can eliminate the shocks and instead deliver ATP alone for if the suspected non-lethal arrhythmia is a slow suspected non-lethal arrhythmias. In some embodiments, the microprocessor can simply withhold delivery of any therapies based on the determination that the rhythm is a slow suspected non-lethal arrhythmia. If microprocessor determines that the rhythm is a suspected non-lethal arrhythmia, microprocessor changes the scheduled therapy as described above).This allows for the pacemaker to treat non-lethal arrythmias differently and not deliver inappropriate therapy for a detected non-lethal arrythmia. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Huelskamp by adding discriminating between two or more different arrhythmia types based at least in part on the relative time of occurrence of the predetermined feature within the cardiac cycle duration; and the IMD causing delivery of a therapy to the heart when an arrhythmia of a first arrhythmia type is identified and the IMD not causing delivery of the therapy to the heart when an arrhythmia of a second arrhythmia type is identified as taught by Ousdigian in order to facilitate the pacemaker to treat non-lethal arrythmias differently and not deliver inappropriate therapy for a detected non-lethal arrythmia.
Regarding claim 16, Huelskamp in view of Ousdigian, specfically Ousdigian discloses discriminating between two or more different arrhythmia types is based at least in part on whether the relative time of occurrence of the predetermined feature falls within a defined time window of the cardiac cycle duration, wherein the defined time window has a duration that is less than the cardiac cycle duration (Fig. 7, section 0075, IMD 10 determines the median VCL and ACL for a number of previous intervals, e.g., the ten intervals, that preceded the interval in which a NID for an arrhythmia is met. If the median VCL is greater than or equal to a minimum VCL threshold for suspected non-lethal arrhythmias, and the difference between the median VCL and median ACL is greater than or equal to a suspect threshold, microprocessor 60 determines that the rhythm in question is a suspected non-lethal arrhythmia. If either of the thresholds is not met, microprocessor determines that the rhythm is non-suspect, and proceeds to deliver a ventricular therapy scheduled for the detected arrhythmia). This allows for the pacemaker to treat non-lethal arrythmias differently and not deliver inappropriate therapy for a detected non-lethal arrythmia.
Regarding claim 17, Huelskamp in view of Ousdigian, specfically Ousdigian discloses the arrhythmia is identified as the first arrhythmia type when the relative time of occurrence of the predetermined feature falls within the defined time window of the cardiac cycle duration of the cardiac cycle (Fig. 7, section 0075, IMD 10 determines the median VCL and ACL for a number of previous intervals, e.g., the ten intervals, that preceded the interval in which a NID for an arrhythmia is met. If the median VCL is greater than or equal to a minimum VCL threshold for suspected non-lethal arrhythmias, and the difference between the median VCL and median ACL is greater than or equal to a suspect threshold, microprocessor 60 determines that the rhythm in question is a suspected non-lethal arrhythmia). This allows for the pacemaker to treat non-lethal arrythmias differently and not deliver inappropriate therapy for a detected non-lethal arrythmia.
Regarding claim 18, Huelskamp in view of Ousdigian, specfically Ousdigian discloses identifying the relative time of occurrence of the predetermined feature within the cardiac cycle duration for each of a plurality of cardiac cycles of the heart (Fig. 6, section 0072 , Microprocessor 60 measures VCLs within a ventricular rhythm, and determines whether a NID for an arrhythmia is met. When the NID for a ventricular arrhythmia is met, microprocessor 60 further determines whether the rhythm is a suspected non-lethal arrhythmia using any of the techniques described above); determining a variability in the relative time of occurrence of the predetermined feature within the cardiac cycle duration among the plurality of cardiac cycles of the heart (Fig.6, section 0073, If microprocessor determines that the rhythm is not suspect, microprocessor controls delivery of therapy scheduled for the detected arrhythmia); discriminating between two or more different arrhythmia types based at least in part on: the relative time of occurrence of the predetermined feature within the cardiac cycle duration; and the variability in the relative time of occurrence of the predetermined feature within the cardiac cycle duration for each of the plurality of cardiac cycles of the heart (section 0062, 0073, microprocessor can eliminate the shocks and instead deliver ATP alone for if the suspected non-lethal arrhythmia is a slow suspected non-lethal arrhythmias. In some embodiments, the microprocessor can simply withhold delivery of any therapies based on the determination that the rhythm is a slow suspected non-lethal arrhythmia. If microprocessor determines that the rhythm is a suspected non-lethal arrhythmia, microprocessor changes the scheduled therapy as described above). This allows for the pacemaker to treat non-lethal arrythmias differently and not deliver inappropriate therapy for a detected non-lethal arrythmia.
Regarding claim 19, Huelskamp discloses a non-transitory computer readable medium storing instructions that when executed by one or more processors (section 0064, Processing module, may include a memory circuit and processing module may store information on and read information from the memory circuit) cause the one or more processors to: identify a cardiac cycle of a heart, the cardiac cycle having a cardiac cycle duration that is dependent on a current heart rate of the heart (Section 0112, the measurements taken by the motion sensor of the mechanical sensing module for each of the N heart beats may be taken during the systole phase of the cardiac cycle); combine acceleration signals from each of three axes of a three-axis accelerometer into a combined acceleration signal having a magnitude (Section 0115, Signal 962, shown in a dashed line in graphs 960a-960c, represents an average of accelerometer magnitude signals (e.g., a baseline motion level signal) for N pace initiated heart beats on the respective axis. Signal 964, represented in a solid line, represents an average of accelerometer magnitude signals (e.g., a baseline motion level signal) for N intrinsically initiated heart beats); identify a predetermined morphological feature 962 in the magnitude of the combined acceleration signal (Fig. 11A-C); identify a relative time of occurrence of the predetermined feature within the cardiac cycle duration (Section 0058, After determining an occurrence of an arrhythmia, processing module 110 may control pulse generator module 104 to generate electrical stimulation pulses in accordance with one or more electrical stimulation therapies to treat the determined arrhythmia).
However, Huelskamp does not specfically disclose discriminate between two or more different arrhythmia types based at least in part on the relative time of occurrence of the predetermined feature within the cardiac cycle duration; and cause delivery of a therapy to the heart when an arrhythmia of a first arrhythmia type is identified and not causing delivery of the therapy to the heart when an arrhythmia of a second arrhythmia type is identified.
Ousdigian discloses discriminating between two or more different arrhythmia types (lethal and non-lethal) based at least in part on the relative time of occurrence of the predetermined feature within the cardiac cycle duration (Fig. 6, section 0072 , Microprocessor 60 measures VCLs within a ventricular rhythm (130), and determines whether a NID for an arrhythmia is met (132). When the NID for a ventricular arrhythmia is met, microprocessor 60 further determines whether the rhythm is a suspected non-lethal arrhythmia using any of the techniques described above); and the IMD causing delivery of a therapy 146 to the heart when an arrhythmia of a first arrhythmia type is identified (Fig.6, section 0073, If microprocessor determines that the rhythm is not suspect, microprocessor controls delivery of therapy scheduled for the detected arrhythmia) and the IMD not causing delivery of the therapy 136 to the heart when an arrhythmia of a second arrhythmia type is identified (section 0062, 0073, microprocessor can eliminate the shocks and instead deliver ATP alone for if the suspected non-lethal arrhythmia is a slow suspected non-lethal arrhythmias. In some embodiments, the microprocessor can simply withhold delivery of any therapies based on the determination that the rhythm is a slow suspected non-lethal arrhythmia. If microprocessor determines that the rhythm is a suspected non-lethal arrhythmia, microprocessor changes the scheduled therapy as described above). Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Huelskamp by adding discriminating between two or more different arrhythmia types based at least in part on the relative time of occurrence of the predetermined feature within the cardiac cycle duration; and the IMD causing delivery of a therapy to the heart when an arrhythmia of a first arrhythmia type is identified and the IMD not causing delivery of the therapy to the heart when an arrhythmia of a second arrhythmia type is identified as taught by Ousdigian in order to facilitate the pacemaker to treat non-lethal arrythmias differently and not deliver inappropriate therapy for a detected non-lethal arrythmia.
Regarding claim 18, Huelskamp in view of Ousdigian, specfically Ousdigian discloses discriminate between two or more different arrhythmia types based at least in part on whether the relative time of occurrence of the predetermined feature falls within a defined time window of the cardiac cycle duration, wherein the defined time window has a duration that is less than the cardiac cycle duration (section 0062, 0073, microprocessor can eliminate the shocks and instead deliver ATP alone for if the suspected non-lethal arrhythmia is a slow suspected non-lethal arrhythmias. In some embodiments, the microprocessor can simply withhold delivery of any therapies based on the determination that the rhythm is a slow suspected non-lethal arrhythmia. If microprocessor determines that the rhythm is a suspected non-lethal arrhythmia, microprocessor changes the scheduled therapy as described above). This allows for the pacemaker to treat non-lethal arrythmias differently and not deliver inappropriate therapy for a detected non-lethal arrythmia.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huelskamp et al. (US 20180117339) in view of Ousdigian (US 20050154421) as applied to claim 1 above, and further in view of Kane et al. (US 20170056671).
Regarding claim 2, Huelskamp in view of Ousdigian disclose the invention substantially as claimed however does not show the controller is configured to combine the acceleration signals into the combined acceleration signal by: calculating a sum of the acceleration signals from each of the three axes of the three-axis accelerometer; calculating a root mean square of the acceleration signals from each of the three axes of the three-axis accelerometer; or calculating a root sum square of the acceleration signals from each of the three axes of the three-axis accelerometer into the combined acceleration signal. Kane discloses an LCP 100 (fig. 1, 3) with a controller is configured to combine the acceleration signals into the combined acceleration signal 510 by: calculating a sum of the acceleration signals from each of the three axes of the three-axis accelerometer; calculating a root mean square of the acceleration signals from each of the three axes of the three-axis accelerometer; or calculating a root sum square of the acceleration signals from each of the three axes of the three-axis accelerometer into the combined acceleration signal (section 0091, Signal may represent an accelerometer magnitude signal, which may be determined by summing signals or summing the absolute values of signals. In other embodiments, signal may represent a different signal generated by other combinations of signals, such as a root-mean-square or root-sum-square of signals, or any other derivation of signals). This allows for a relatively constant signal to be used for device for proper signals to have identifiable morphological features to be used for therapy to be delivered. Therefore it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Huelskamp in view of Ousdigian by adding the controller is configured to combine the acceleration signals into the combined acceleration signal by: calculating a sum of the acceleration signals from each of the three axes of the three-axis accelerometer; calculating a root mean square of the acceleration signals from each of the three axes of the three-axis accelerometer; or calculating a root sum square of the acceleration signals from each of the three axes of the three-axis accelerometer into the combined acceleration signal as taught by Kane in order to facilitate This allows for a relatively constant signal to be used for device for proper signals to have identifiable morphological features to be used for therapy to be delivered.
Allowable Subject Matter
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. There is no prior art found that discloses express a relationship between the cardiac cycle duration and the magnitude of the combined acceleration signal using a polar notation, where the cardiac cycle duration is normalized to 2π radians or 360 degrees, and the relative time of occurrence of the predetermined feature within the cardiac cycle duration is determined by an angular direction that the predetermined feature is observed in the polar notation.
Conclusion
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796