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 .
Response to Amendment
Applicant’s amendments to the claims, filed 12/16/2025, are accepted and appreciated by the
Examiner.
Response to Arguments
Applicant’s arguments, see Remarks, filed 12/16/2025, with respect to the rejection(s) of claim 146 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hoffman (US 20210339028 A1) as modified by Demmer (US 20180243568 A1) and Ciciarelli (US 20180021583 A1). Furthermore, Demmer does teach optimizing communication latency and power of the IMD. Even though Demmer does not use the word optimize it can be clearly seen in Para. [0094] of Demmer that it teaches mitigating latency which would optimize latency as the lower the latency the lower the response time of the device. Para. [0004] shows that power can be extended by improving the telemetry process by modulating beaconing rates where beaconing rates are viewed as an event parameter and extending power is viewed as optimizing the power. Demmer is not used to teach a data event parameter that is based on a care usage pattern only that changing a polling interval/ beaconing rate would have those effects on an IMD device.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 146, 147, 149, 150, 153, and 163 are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman (US 20210339028 A1) as modified by Demmer (US 20180243568 A1) and Ciciarelli (US 20180021583 A1).
With respect to claim 146,
Hoffman teaches,
A method comprising: identifying a care usage pattern of an implantable medical device (IMD) for a patient associated with the IMD, wherein the care usage pattern of the IMD is associated with care provided by the IMD to the patient; (Para. [0039] teaches “In the foregoing example, IMD 16 determines a power consumption of IMD 16 due to telemetry. However, in some examples, IMD 16 may determine a power consumption of IMD 16 due to other operations of IMD 16. For example, IMD 16 may determine a power consumption due to one or more parameters defining delivery of therapy by IMD 16 to a patient,”)
setting a data event parameter for the IMD based on the care usage pattern. (Para. [0006] teaches “furthermore, the techniques of the disclosure may enable an IMD to more accurately predict when a power source of the IMD may be depleted as a result of historical power usage by the IMD and/or adjust a rate of telemetry by the IMD so as to adjust the rate of power consumption.” Para. [0075] teaches “Processing circuitry 80 may determine the power capacity used by telemetry circuitry 88 during the current time interval to be a function of historical device usage, such as programmed settings, a wireless communication advertisement rate, etc.”)
setting a data event parameter for the IMD based on the care usage pattern to optimize power of the IMD (Para. [0006] teaches “furthermore, the techniques of the disclosure may enable an IMD to more accurately predict when a power source of the IMD may be depleted as a result of historical power usage by the IMD and/or adjust a rate of telemetry by the IMD so as to adjust the rate of power consumption.” Para. [0084] teaches “In either event, in response to determining that the predetermined threshold is exceeded, processing circuitry 80 may adjust one or more parameters of IMD 16 so as to conserve power usage and prolong the battery life of power source 90. For example, in response to determining that the remaining power capacity of power source 90 is less than the predetermined threshold, processing circuitry 80 may switch from telemetering at the first rate (e.g., the “high” rate) to telemetering at a second rate (e.g., a “low” rate)”)
wherein the data event parameter comprises a polling interval for data communication by the IMD; and transitioning the IMD to the polling interval for data communication. (Para. [0084] teaches “In either event, in response to determining that the predetermined threshold is exceeded, processing circuitry 80 may adjust one or more parameters of IMD 16 so as to conserve power usage and prolong the battery life of power source 90. For example, in response to determining that the remaining power capacity of power source 90 is less than the predetermined threshold, processing circuitry 80 may switch from telemetering at the first rate (e.g., the “high” rate) to telemetering at a second rate (e.g., a “low” rate)”)
Hoffman does not explicitly teach,
setting a data event parameter for the IMD to optimize communication latency and power of the IMD, identifying a plurality of time windows during which the polling interval is to be set to below a threshold interval value based on the care usage pattern; and setting the polling interval to below the threshold interval value for at least a subset of the plurality of time windows based on a target total polling time for data communication;
Demmer teaches,
setting a data event parameter for the IMD to optimize communication latency and power of the IMD, (Para. [0094] teaches “Moreover, telemetry latency associated with the telemetry circuit 602 can be mitigated and/or performance of the medical device 104 can be improved by employing a modulated beaconing rate for an advertising data packet via the classification component 202 and/or the communication component 204, as more fully disclosed herein.” Para. [0004] teaches “In particular, many medical devices operate from power sources that have a limited lifespan and/or are not readily replaceable. Numerous processes associated with a medical device directly impact life of a power source of the medical device. For example, a telemetry process between a medical device and another device is generally inefficient and can unnecessarily drain power from a power source of the medical device if not properly managed. Thus, extending life of a power source of a medical device by improving a telemetry process between the medical device and another device and/or by employing modulated beaconing rates for the medical device is highly desirable.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hoffman with setting a data event parameter for the IMD to optimize communication latency and power of the IMD such as that of Demmer.
One of ordinary skill would have been motivated to modify Hoffman, because improving latency will improve any delays in care and optimizing power usage will ensure that the IMD has enough power when it is needed. Also, according to Para. [0004] of Demmer “Thus, extending life of a power source of a medical device by improving a telemetry process between the medical device and another device and/or by employing modulated beaconing rates for the medical device is highly desirable.”)
Ciciarelli teaches,
identifying a plurality of time windows during which the polling interval is to be set to below a threshold interval value based on the care usage pattern; (Para. [0102] teaches “For example, it may be desirable to manage transmit windows such that conducted communications are transmitted during a refractory period experienced by a local region of the patient. There may be various reasons for managing transmission of conducted communications only during a refractory period. For example, it may be desirable to transmit conducted communication pulses between IMDs only during the refractory period of the particular chamber(s) where the IMDs are implanted.” (i.e. the threshold interval value is the interval where polling occurs during the refractory period. A period of time where the pacemaker is inactive. Therefore, it is based on the care usage pattern of the pacemaker.) Claim [0019] teaches “When a paced or sensed event is detected at the first LIMD, the first LIMD transmits event related information in a next successive transmit window, through conducted communication.” (i.e. paced event represents care.)
and setting the polling interval to below the threshold interval value for at least a subset of the plurality of time windows based on a target total polling time for data communication; (Para. [0105] teaches “limiting conducted communication to the refractory period of the transmitting chamber,”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Hoffman and Demmer with identifying a plurality of time windows during which the polling interval is to be set to below a threshold interval value based on the care usage pattern such as that of Ciciarelli.
One of ordinary skill would have been motivated to modify the combination of Hoffman and Demmer, because as seen in Para. [0102] of Ciciarelli limiting the communication to a refractory window would avoid unintentional effects on the body due to communication signals.
With respect to claim 147,
The combination of Hoffman, Demmer, and Ciciarelli teaches the method of claim 146.
Hoffman further teaches,
wherein the care usage pattern comprises a care cycle comprising a therapy treatment time and an amount of therapy provided by the IMD, (Para. [0023] teaches “For example, the IMD may incorporate various operations performed by the IMD into the estimate of the remaining power source longevity, such as a rate or frequency of occurrence of wireless communications or advertisements, use conditions of therapy provided to the patient (e.g., a percentage of time where cardiac pacing is delivered, etc.), a rate of sensing operations performed by the IMD, and/or therapy parameter settings that define therapy delivered by the IMD.”)
and setting a time window for data processing by the IMD. (Para. [0080] teaches “In some examples, processing circuitry 80 counts a number of such telemetric operations performed over the time interval, multiplies the number of such telemetric operations by the power consumption value stored for each telemetric operation, and subtracts the result from the timer of timer circuitry 96 to update the value stored by the timer.”)
Hoffman does not explicitly teach,
and setting the data event parameter comprises setting a polling interval for data communication with external circuitry by the IMD for a time window;
Demmer further teaches,
and setting the data event parameter comprises setting a polling interval for data communication with external circuitry by the IMD for a time window; (Para. [0041] teaches “medical device 104 can employ a fixed polling interval for broadcasting an advertising data packet and/or can adjust the fixed polling interval to allow for increased polling based on detection of a defined event associated with the medical device 104. For instance, the fixed polling interval can be related to a start time and a stop time for repeatedly broadcasting the advertising data packet”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hoffman and setting the data event parameter comprises setting a polling interval for data communication with external circuitry by the IMD for a time window such as that of Demmer.
One of ordinary skill would have been motivated to modify Hoffman, because setting a time interval for polling would ensure the device is not continuously polling therefore saving the battery. Also, according to Para. [0004] of Demmer “Thus, extending life of a power source of a medical device by improving a telemetry process between the medical device and another device and/or by employing modulated beaconing rates for the medical device is highly desirable.”)
With respect to claim 149,
The combination of Hoffman, Demmer, and Ciciarelli teaches the method of claim 146.
Hoffman further teaches,
wherein the care usage pattern comprises: expected care cycles of the IMD; (Para. [0021] teaches “The clinician may program the RRT threshold to occur earlier than the actual onset of RRT in the power source of the IMD so as to provide sufficient time for the patient to undergo surgery to replace the IMD. This large margin of error accommodates IMDs that consume more power than expected.” Para. [0022] teaches “Considering the specific use conditions of the IMD allows more accurate prediction of a remaining life of a power source of an IMD. Exchanging telemetry by the IMD may comprise a majority of the power consumption of the power source of the IMD. Using the techniques described herein, an IMD may adjust a timer indicating a remaining lifetime of the power source when the IMD is operating between the pre-RRT power source service event and the RRT and/or EOS power source service events.”
observed care cycles of the IMD; (Para. [0006] teaches “Furthermore, the techniques of the disclosure may enable an IMD to more accurately predict when a power source of the IMD may be depleted as a result of historical power usage by the IMD”)
and a current care cycle of the IMD (Para. [0039] teaches “For example, IMD 16 may determine a power consumption due to one or more parameters defining delivery of therapy by IMD 16 to a patient, a rate or frequency of occurrence of delivery of such therapy, etc.”)
With respect to claim 150,
The combination of Hoffman, Demmer, and Ciciarelli teaches the method of claim 146.
Hoffman does not explicitly teach,
wherein the polling interval is set based on a time of day and wherein optimizing the communication latency and power of the IMD comprises balancing communication latency including a speed at which the IMD responds to a request for data communication from external circuitry with at least one of energy consumption and power performance of the IMD.
Demmer further teaches,
wherein the polling interval is set based on a time of day. (Col. 6 Ln(s). [29-32] teach “one example, the fixed polling interval and/or a beaconing rate of an advertising data packet can be adjusted based on timestamp associated with an advertising data packet (e.g., based on a time of day associated with transmission of an advertising data packet) to facilitate synchronization of polling with respect to the medical device 104 and the external device 116.” Where the predetermined time is understood as a time of day.)
and wherein optimizing the communication latency and power of the IMD comprises balancing communication latency including a speed at which the IMD responds to a request for data communication from external circuitry with at least one of energy consumption and power performance of the IMD. (Para. [0042] teaches “physician associated with the external device 116 can adjust the fixed polling interval and/or a beaconing rate of an advertising data packet based on longevity tradeoff). In certain embodiments, the medical device 104 and/or the external device 116 can provide a patient (e.g., a patient associated with the body 102) with information related to timing for an expected connection between the medical device 104 and the external device 116 based on other information related to a last successful connection between the medical device 104 and the external device 116.” Para. [0094] teaches “Therefore, by providing a modulated beaconing rate for an advertising data packet as more fully disclosed herein, the classification component 202 and/or the communication component 204 can facilitate balancing current drain of the battery 604 to maximize utility and life of the battery 604 and/or the medical device 104. For example, the classification component 202 and/or the communication component 204 can be employed to calculate a beaconing rate for an advertising data packet that minimally impacts the battery 604 while also broadcasting the advertising data packet and/or delivering data associated with the medical device 104 to the external device 116. Longevity of the battery 604 and/or the medical device 104 can also be improved by employing a modulated beaconing rate for an advertising data packet via the classification component 202 and/or the communication component 204, as more fully disclosed herein. Moreover, telemetry latency associated with the telemetry circuit 602 can be mitigated and/or performance of the medical device 104 can be improved by employing a modulated beaconing rate for an advertising data packet via the classification component 202 and/or the communication component 204, as more fully disclosed herein.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hoffman wherein the polling interval is set based on a time of day and wherein optimizing the communication latency and power of the IMD comprises balancing communication latency including a speed at which the IMD responds to a request for data communication from external circuitry with at least one of energy consumption and power performance of the IMD such as that of Demmer.
One of ordinary skill would have been motivated to modify Hoffman, because balancing latency with energy consumption would ensure good communication quality with battery life for the device. Also, according to Para. [0094] of Demmer “For example, the classification component 202 and/or the communication component 204 can be employed to calculate a beaconing rate for an advertising data packet that minimally impacts the battery 604 while also broadcasting the advertising data packet and/or delivering data associated with the medical device 104 to the external device.”)
With respect to claim 153,
The combination of Hoffman, Demmer, and Ciciarelli does not explicitly teach the method of claim 146.
Hoffman does not explicitly teach,
further comprising identifying a plurality of time windows during which the polling interval is to be set to below a threshold interval value based on the care usage pattern.
Ciciarelli further teaches,
wherein the IMD is transitioned to the polling interval for data communication during the at least subset of plurality of time windows. (Para. [0092] teaches “The third defined beaconing rate related to the time interval C can be less frequent than the first defined beaconing rate related to the time interval A and the second defined beaconing rate related to the time interval B. In an embodiment, the first polling process 502 can be associated with a first urgency level, the second polling process 504 can be associated with a second urgency level, and the third polling process 506 can be associated with a third urgency level.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Hoffman and Demmer wherein the IMD is transitioned to the polling interval for data communication during the at least subset of plurality of time windows such as that of Ciciarelli.
One of ordinary skill would have been motivated to modify the combination of Hoffman and Demmer, because as seen in Para. [0102] of Ciciarelli limiting the communication to a refractory window would avoid unintentional effects on the body due to communication signals.
With respect to claim 163,
The combination of Hoffman, Demmer, and Ciciarelli teaches the method of claim 146.
Hoffman further teaches,
and sensing at least a portion of the physiological data via at least one implantable sensor in communication with the IMD, the physiological data comprising at least body movement and posture of the patient, wherein the at least one implantable sensor includes an acceleration sensor. (Para. [0057] teaches “In some examples, IMD 16 may include one or more additional sensors, such as accelerometers 84. In some examples, accelerometers 84 may comprise one or more three-axis accelerometers. Signals generated by accelerometers 84 may be indicative of, for example, gross body movement of patient 14, such as a patient posture or activity level.”)
Hoffman does not explicitly teach,
identifying the care usage pattern by applying a data model to input comprising physiological data and care usage data over a period of time, wherein the care usage data comprises at least one of a type, an amount, a period of time, a time of day, and a day of the week associated with providing care by the IMD;
Demmer teaches,
identifying the care usage pattern by applying a data model to input comprising physiological data and care usage data over a period of time, wherein the care usage data comprises at least one of a type, an amount, a period of time, a time of day, and a day of the week associated with providing care by the IMD; (Para. [0128] teaches “Other directed and undirected model classification approaches include, e.g., naive Bayes, Bayesian networks, decision trees, neural networks, fuzzy logic models, and probabilistic classification models providing different patterns of independence can be employed. Classification as used herein also is inclusive of statistical regression that is utilized to develop models of priority.” Para. [0068] teaches “For instance, the communication component 204 can modify the defined beaconing rate and/or transmit the advertising data packet at a defined time of day (e.g., increase a beaconing rate of the advertising data packet and/or begin transmitting the advertising at a defined beaconing rate at 5 pm, etc.). In one example, based on a determination that a time of day of the broadcast satisfies a defined criterion, the communication component 204 can decrease the defined beaconing rate.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hoffman with identifying the care usage pattern by applying a data model to input comprising physiological data and care usage data over a period of time, wherein the care usage data comprises at least one of a type, an amount, a period of time, a time of day, and a day of the week associated with providing care by the IMD such as that of Demmer.
One of ordinary skill would have been motivated to modify Hoffman, because the patient could require different levels of care or monitoring depending on the time of day.
Claims 151, 152, 157-161, 164, and 165 are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman (US 20210339028 A1) as modified by Demmer (US 20180243568 A1) and Ciciarelli (US 20180021583 A1) as applied to claim 146 above, and further in view of Corndorf (US 8145320 B2).
With respect to claim 151,
The combination of Hoffman, Demmer, and Ciciarelli does not explicitly teach,
the method of claim 146, wherein the polling interval is set based on at least one patient state wherein the at least one patient state comprises a body position.
Corndorf further teaches,
wherein the polling interval is set based on at least one patient state wherein the at least one patient state comprises a body position. (Col. 5 Ln(s). [11-17] teach “For example, when sensor 22 senses parameters indicating an increase in activity in the patient, such as when the patient is waking up or when the patient is performing physical exercise, the polling interval (T.sub.P) can be reduced as there may be a higher likelihood that IMD 10 will need to send or receive data from external device 28.” Where the state is the activity of the patient which indicates a change in body position. Col. 6 ln(s). [23-25] “In one or more embodiments, the polling interval (T.sub.P) of telemetry module 20 is configured at least partially based upon the at least one parameter sensed by sensor 22”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hoffman wherein the polling interval is set based on at least one patient state wherein the at least one patient state comprises a body position such as that of Corndorf.
One of ordinary skill would have been motivated to modify Hoffman, because there may be only certain positions that need to be monitored by the IMD and only polling when the patient is in those positions would help the battery of the IMD last longer. Furthermore, Corndorf Col. 6 ln(s). [32-36] teach “In one or more embodiments, the polling interval (T.sub.P) of telemetry module 20 is configured at least partially based upon the at least one parameter sensed by sensor 22”
With respect to claim 152,
The combination of Hoffman, Demmer, and Ciciarelli does not explicitly teach,
the method of claim 151, further comprising determining a transition between different patient states among a plurality of patient states, including the at least one patient state, wherein the different patient states include at least one of: different body positions; and different sleep-wake statuses.
Corndorf further teaches,
further comprising determining a transition between different patient states among a plurality of patient states, including the at least one patient state, wherein the different patient states include at least one of: different body positions; and different sleep-wake statuses. (Col. 5 Ln(s) [11-17] teach “For example, when sensor 22 senses parameters indicating an increase in activity in the patient, such as when the patient is waking up or when the patient is performing physical exercise, the polling interval (T.sub.P) can be reduced as there may be a higher likelihood that IMD 10 will need to send or receive data from external device 28.” Where the state is the activity of the patient. Col 2 Ln(s) 18-19 teach “In one embodiment, the sensor is a position sensor. In one embodiment, the sensor is a patient activity sensor.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Hoffman, Demmer, and Ciciarelli further comprising determining a transition between different patient states among a plurality of patient states, including the at least one patient state, wherein the different patient states include at least one of: different body positions; and different sleep-wake statuses such as that of Corndorf.
One of ordinary skill would have been motivated to modify the combination of Hoffman, Demmer, and Ciciarelli because there may be only certain positions that need to be monitored by the IMD and only polling when the patient is in those positions would help the battery of the IMD last longer. Furthermore, Corndorf Col. 6 ln(s). [32-36] teaches “In one or more embodiments, the polling interval (T.sub.P) of telemetry module 20 is configured at least partially based upon the at least one parameter sensed by sensor 22.”
With respect to claim 157,
The combination of Hoffman, Demmer, and Ciciarelli teaches the method of claim 146.
Hoffman does not explicitly teach, wherein setting the data event parameter comprises adjusting the polling interval to different values with respect to different times of the day based on the care usage pattern to optimize communication latency and power performance of the IMD.
Demmer teaches,
wherein setting the data event parameter comprises adjusting the polling interval to different values with respect to different times of the day based on the care usage pattern to optimize communication latency and power performance of the IMD. (Para. [0042] teaches “In one example, the fixed polling interval and/or a beaconing rate of an advertising data packet can be adjusted based on timestamp associated with an advertising data packet (e.g., based on a time of day associated with transmission of an advertising data packet)” Para. [0094] teaches “Moreover, telemetry latency associated with the telemetry circuit 602 can be mitigated and/or performance of the medical device 104 can be improved by employing a modulated beaconing rate for an advertising data packet via the classification component 202 and/or the communication component 204, as more fully disclosed herein.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hoffman wherein setting the data event parameter comprises adjusting a polling interval to different values with respect to different times of the day based on the care usage pattern to optimize communication latency and power performance of the IMD such as that of Demmer.
One of ordinary skill would have been motivated to modify Hoffman, because optimizing the latency would improve device performance as taught in Para. [0094] of Demmer “Moreover, telemetry latency associated with the telemetry circuit 602 can be mitigated and/or performance of the medical device 104 can be improved.”
The combination of Hoffman, Demmer, and Ciciarelli does not explicitly teach,
wherein the different values of the polling interval comprises: a first polling interval for a first time window that follows a time of day of the therapy treatment; and a second polling interval that is greater than the first polling interval for a second time window, wherein the first polling interval is additionally set for a third time window associated with a time of day prior to sleep onset of an awake state from a sleep state for the patient.
Corndorf further teaches,
wherein the different values of the polling interval comprises: a first polling interval for a first time window that follows a time of day of the therapy treatment; and a second polling interval that is greater than the first polling interval for a second time window, wherein the first polling interval is additionally set for a third time window associated with a time of day prior to sleep onset of an awake state from a sleep state for the patient. (Para. [0023] teaches “Under certain conditions, the polling interval (T.sub.P) of telemetry module 20 can either be shortened or reduced in order to perform sniff operations more frequently, as shown by the shortened polling interval (T.sub.P) of FIG. 3B as compared to the polling interval (T.sub.P) shown in FIG. 5A. In one or more embodiments, the polling interval (T.sub.P) is reduced in situations where IMD 10 is more likely to require telemetry communications. In certain circumstances, the polling interval (T.sub.P) can be reduced to zero such that telemetry module 20 is immediately activated to perform sniff operations or other telemetry communications. For example, when sensor 22 senses parameters indicating an increase in activity in the patient, such as when the patient is waking up or when the patient is performing physical exercise, the polling interval (T.sub.P) can be reduced as there may be a higher likelihood that IMD 10 will need to send or receive data from external device 28.” Further see figures 3A-3C.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Hoffman, Demmer, and Ciciarelli wherein the different values of the polling interval comprises: a first polling interval for a first time window that follows a time of day of the therapy treatment; and a second polling interval that is greater than the first polling interval for a second time window, wherein the first polling interval is additionally set for a third time window associated with a time of day prior to sleep onset of an awake state from a sleep state for the patient such as that of Corndorf.
One of ordinary skill would have been motivated to modify the combination of Hoffman, Demmer, and Ciciarelli, because according to Para. [0024] of Corndorf “In order to conserve power, telemetry module is only powered on to perform these sniff operations during the period of time (TA) and maintained in low power or power off inactive "sleep" state at other times, unless actually powered up to perform wireless data telemetry between IMD 10 and external device 28.”
With respect to claim 158,
The combination of Hoffman, Demmer, and Ciciarelli does not explicitly teach,
the method of claim 146, wherein setting the data event parameter further comprises setting at least one time window for performing data processing by the IMD, and configuring the IMD to include the care usage pattern comprises programming the IMD to set the at least one time window based on the care usage pattern.
Corndorf further teaches,
wherein setting the data event parameter further comprises setting at least one time window for performing data processing by the IMD, and configuring the IMD to include the care usage pattern comprises programming the IMD to set the at least one time window based on the care usage pattern. (Claim 19 teaches “a length of the polling interval of the telemetry module being configurable at least partially based upon the at least one parameter sensed by the sensor, wherein the controller is configured with a first integration time for processing the sensed parameter to determine whether to reduce a length of the polling interval and a second integration time that is longer than the first integration time for processing the sensed parameter to determine whether to increase the length of the polling interval.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Hoffman, Demmer, and Ciciarelli wherein setting the data event parameter further comprises setting at least one time window for performing data processing by the IMD, and configuring the IMD to include the care usage pattern comprises programming the IMD to set the at least one time window based on the care usage pattern such as that of Corndorf.
One of ordinary skill would have been motivated to modify the combination of Hoffman, Demmer, and Ciciarelli, because it would allow the device to determine the length of the poling interval that would be best for the state that the patient and the IMD are in as seen in claim 9 of Corndorf.
With respect to claim 159,
The combination of Hoffman, Demmer, Ciciarelli, and Corndorf teaches the method of claim 158.
Hoffman does not explicitly teach,
wherein batched data is processed by the IMD during the at least one time window when a battery parameter of the IMD is within a threshold level based on the care usage pattern, and the data processing comprising time-insensitive data processing operations that impact an ability of the IMD to provide to the patient below a threshold.
Demmer teaches,
wherein batched data is processed by the IMD during the at least one time window when a battery parameter of the IMD is within a threshold level based on the care usage pattern, and the data processing comprising time-insensitive data processing operations that impact an ability of the IMD to provide to the patient below a threshold. (Para. [0070] teaches “the communication component 204 can modify the defined beaconing rate based on longevity data indicative of a lifespan period for a battery of the medical device 104.” Wherein the beaconing rate affects when the data is processed.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Hoffman, Demmer, Ciciarelli, and Corndorf wherein batched data is processed by the IMD during the at least one time window when a battery parameter of the IMD is within a threshold level based on the care usage pattern, and the data processing comprising time-insensitive data processing operations that impact an ability of the IMD to provide to the patient below a threshold such as that of Demmer.
One of ordinary skill would have been motivated to modify the combination of Hoffman, Demmer, Ciciarelli, and Corndorf, because according to Para. [0094] “Therefore, by providing a modulated beaconing rate for an advertising data packet as more fully disclosed herein, the classification component 202 and/or the communication component 204 can facilitate balancing current drain of the battery 604 to maximize utility and life of the battery 604 and/or the medical device 104.”
With respect to claim 160,
The combination of Hoffman, Demmer, and Corndorf teaches the method of claim 159.
Hoffman does not explicitly teach,
further comprising performing time-sensitive data processing operations during and outside the at least one time window, wherein the time-sensitive data processing operations are associated with providing care by the IMD.
Demmer teaches,
further comprising performing time-sensitive data processing operations during and outside the at least one time window, wherein the time-sensitive data processing operations are associated with providing care by the IMD. (Para. [0047] teaches “The medical device 104 can alternatively broadcast an advertising data packet at a third defined beaconing rate (e.g., continuously) based on a determination that the medical device is associated with an immediate urgency condition associated with a particular urgency level or an immediate urgency event associated with a particular urgency level such as, for example, a ventricular tachycardia episode, a ventricular fibrillation episode, critically low blood sugar, a myocardial infarction, or another type of medical condition critical to well being of the body 102.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Hoffman, Demmer, Ciciarelli, and Corndorf further comprising performing time-sensitive data processing operations during and outside the at least one time window, wherein the time-sensitive data processing operations are associated with providing care by the IMD such as that of Demmer.
One of ordinary skill would have been motivated to modify the combination of Hoffman, Demmer, Ciciarelli, and Corndorf, because if a condition is deemed to be urgent it should be transmitted immediately regardless of the defined windows for the health and safety of the patient.
With respect to claim 161,
The combination of Hoffman, Demmer, Ciciarelli, and Corndorf teaches the method of claim 158.
Hoffman further teaches,
identifying a battery parameter of the IMD is within a threshold level during the at least one-time window based on the care usage pattern; and in response to the identification, setting the at least one time window for performing the data processing. (Para. [0084] teaches “In either event, in response to determining that the predetermined threshold is exceeded, processing circuitry 80 may adjust one or more parameters of IMD 16 so as to conserve power usage and prolong the battery life of power source 90. For example, in response to determining that the remaining power capacity of power source 90 is less than the predetermined threshold, processing circuitry 80 may switch from telemetering at the first rate (e.g., the “high” rate) to telemetering at a second rate (e.g., a “low” rate). In other examples, processing circuitry 80 may adjust one or more parameters that define delivery of therapy to the patient or one or more parameters that define patient parametric data sensing performed by IMD 16.”)
With respect to claim 164,
The combination of Hoffman, Demmer, and Ciciarelli the method of claim 146.
Hoffman further teaches,
transitioning from the polling interval or the at least one-time window to at least one revised polling interval or revised time window based on observed care cycles of the IMD for the patient, the observed care cycles being identified based on second data. (Para. [0040] teaches “and/or adjust a rate of telemetry by the IMD so as to adjust the rate of power consumption.” Para. [0084] teaches “In either event, in response to determining that the predetermined threshold is exceeded, processing circuitry 80 may adjust one or more parameters of IMD 16 so as to conserve power usage and prolong the battery life of power source 90. For example, in response to determining that the remaining power capacity of power source 90 is less than the predetermined threshold, processing circuitry 80 may switch from telemetering at the first rate (e.g., the “high” rate) to telemetering at a second rate (e.g., a “low” rate)”)
Hoffman does not explicitly teach,
wherein the care usage pattern comprises expected care cycles of the IMD for the patient which are identified based on first data and setting the data event parameter comprises setting the polling interval and at least one time window for performing data processing by the IMD, the method further comprising:
Corndorf teaches,
wherein the care usage pattern comprises expected care cycles of the IMD for the patient which are identified based on first data and setting the data event parameter comprises setting the polling interval and at least one time window for performing data processing by the IMD, the method further comprising: (Col. 5 Ln(s). [11-20] teach “For example, when sensor 22 senses parameters indicating an increase in activity in the patient, such as when the patient is waking up or when the patient is performing physical exercise, the polling interval (T.sub.P) can be reduced as there may be a higher likelihood that IMD 10 will need to send or receive data from external device 28. Similarly, when the patient performs a patient-activating motion (e.g., tapping the sensor 22), the polling interval (T.sub.P) can be reduced as the patient may be signaling that some action or communication by IMD 10 is desired by the patient.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Hoffman, Demmer, and Ciciarelli with transitioning from the polling interval or the at least one time window to at least one revised polling interval or revised time window based on observed care cycles of the IMD for the patient, the observed care cycles being identified based on second data such as that of Corndorf.
One of ordinary skill would have been motivated to modify the combination of Hoffman, Demmer, and Ciciarelli, because it would allow the device to determine the length of the poling interval that would be best for the state that the patient and the IMD are in as seen in claim 9 of Corndorf.
With respect to claim 165,
The combination of Hoffman, Demmer, Ciciarelli, and Corndorf teaches the method of claim 164.
Hoffman further teaches,
wherein: the first data comprises at least one of: literature data; input from a medical caregiver; demographic data associated with a plurality of representative patients; and input from the patient; (Para. [0034] teaches “A user, such as a physician, technician, or other clinician, may interact with external device 24 to communicate with IMD 16. For example, the user may interact with external device 24 to retrieve physiological or diagnostic information from IMD 16. A user may also interact with external device 24 to program IMD 16, e.g., to select values for operational parameters of the IMD.”)
and the second data comprises physiological data and care usage data sensed over a period of time via at least one implantable sensor in communication with the IMD. (Para. [0029] teaches “IMD 16 may sense patient data, such as electrical activity of heart 12. IMD 16 may store such sensed patient data and upload, on a periodic basis, the sensed patient data to an external device, such as external device 24 or another remote patient monitoring system.”
Claims 154 - 156 are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman (US 20210339028 A1) as modified by Demmer (US 20180243568 A1) and Ciciarelli (US 20180021583 A1) as applied to claim 146 above, and further in view of Janssen (US 9238144 B2)
With respect to claim 154,
Hoffman does not explicitly teach,
wherein the target total polling time for data communication comprises a maximum target polling time for a day.
Janssen teaches,
wherein the target total polling time for data communication comprises a maximum target polling time for a day. (Para. [0093] teaches “In some embodiments, the first threshold duration may be a pre-determined maximum desired telemetry monitoring duration set by the lead clinician or lead care provider of the facility (e.g., 24 hours) for patients that have not had a triggering event occur (as determined at 404) and are within the telemetry monitoring criteria (as determined at 416).”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Hoffman, Demmer, and Ciciarelli wherein the target total polling time for data communication comprises a maximum target polling time for a day such as that of Janssen.
One of ordinary skill would have been motivated to modify the combination of Hoffman, Demmer, and Ciciarelli, because as seen in Hoffman Para. [0084] the power capacity of the IMD is impacted by the telemetry rate. Therefore, a maximum polling time must be enforced as there is only a certain number of times that polling can happen in a day before the device runs out of power.
With respect to claim 155,
Hoffman does not explicitly teach,
wherein setting the polling interval below the threshold interval value for the at least subset of the plurality of time windows comprises: time limiting a total amount of time in the day that the IMD is set to the polling interval below the threshold interval value based on the target total polling time.
Janssen teaches,
wherein setting the polling interval below the threshold interval value for the at least subset of the plurality of time windows comprises: time limiting a total amount of time in the day that the IMD is set to the polling interval below the threshold interval value based on the target total polling time. (Para. [0100] teaches “The telemetry monitoring duration is compared to the second threshold duration (e.g., by the telemetry management system) in order to determine whether the telemetry monitoring duration is greater than the second threshold duration. In some embodiments, the second threshold duration may be a pre-determined maximum desired telemetry monitoring duration set by the lead clinician or lead care provider of the facility (e.g., 12 hours) for patients that have not had a triggering event occur (as determined at 404) and are not within the telemetry monitoring criteria (as determined at 416.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Hoffman, Demmer, and Ciciarelli wherein setting the polling interval below the threshold interval value for the at least subset of the plurality of time windows comprises: time limiting a total amount of time in the day that the IMD is set to the polling interval below the threshold interval value based on the target total polling time such as that of Janssen.
One of ordinary skill would have been motivated to modify the combination of Hoffman, Demmer, and Ciciarelli, because as seen in Hoffman Para. [0084] the power capacity of the IMD is impacted by the telemetry rate. Therefore, limiting the polling time would ensure that the device does not run out of power during the monitoring period.
With respect to claim 156,
Hoffman further teaches,
wherein the care usage pattern includes observed communication patterns of the IMD. (Para. [0023] teaches “For example, the IMD may adjust a value stored by the timer based on delivery of therapy by the IMD (e.g., a percentage of time over a time interval where the IMD delivers cardiac pacing), a rate of sensing operations by the IMD, a total amount of telemetry performed by the IMD, a frequency of wireless communications or advertisements transmitted or received by the IMD, etc.)”)
Hoffman does not explicitly teach,
wherein setting the polling interval below the threshold interval value for the at least subset of the plurality of time windows based on the target total polling time comprises: limiting a total daily polling time of the IMD based on the target total polling time and allocating the total daily polling time based on the care usage pattern.
Janssen teaches,
wherein setting the polling interval below the threshold interval value for the at least subset of the plurality of time windows based on the target total polling time comprises: limiting a total daily polling time of the IMD based on the target total polling time and allocating the total daily polling time based on the care usage pattern. (Para. [0100] teaches “The telemetry monitoring duration is compared to the second threshold duration (e.g., by the telemetry management system) in order to determine whether the telemetry monitoring duration is greater than the second threshold duration. In some embodiments, the second threshold duration may be a pre-determined maximum desired telemetry monitoring duration set by the lead clinician or lead care provider of the facility (e.g., 12 hours) for patients that have not had a triggering event occur (as determined at 404) and are not within the telemetry monitoring criteria (as determined at 416.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Hoffman, Demmer, and Ciciarelli wherein setting the polling interval below the threshold interval value for the at least subset of the plurality of time windows based on the target total polling time comprises: limiting a total daily polling time of the IMD based on the target total polling time and allocating the total daily polling time based on the care usage pattern such as that of Janssen.
One of ordinary skill would have been motivated to modify the combination of Hoffman, Demmer, and Ciciarelli, because as seen in Hoffman Para. [0023] the power capacity of the IMD is impacted by the telemetry rate and the care provided by the IMD. Therefore, limiting the polling time would ensure that the device does not run out of power during the monitoring period.
Claim 162 is rejected under 35 U.S.C. 103 as being unpatentable over Hoffman (US 20210339028 A1) as modified by Demmer (US 20180243568 A1) and Ciciarelli (US 20180021583 A1) as applied to claim 146 above, and further in view of Greene (US 9238144 B2)
With respect to claim 162,
The combination of Hoffman, Demmer, and Ciciarelli teaches the method of claim 146.
Hoffman further teaches,
wherein the care usage pattern comprises a care cycle and a data communication cycle, (Para. [0021] teaches “For example, the more frequently that the IMD performs high-energy operations, such as wireless telemetry or delivering therapy, the shorter the lifetime of the power source.”)
the care cycle being associated with a therapy treatment time and an amount of therapy provided to the patient by the IMD, the therapy treatment comprising simulation therapy delivered to the patient and (Para. [0002] teaches “In some cases, an implantable medical device may sense intrinsic depolarizations of the heart, and control the delivery of therapeutic stimulation to the heart based on the sensing.” Para. [0023] teaches “use conditions of therapy provided to the patient (e.g., a percentage of time where cardiac pacing is delivered, etc.), a rate of sensing operations performed by the IMD, and/or therapy parameter settings that define therapy delivered by the IMD”)
the data communication cycle being associated with a time and amount of data communicated between the IMD and external circuitry.
Greene teaches,
and the data communication cycle being associated with a time and amount of data communicated between the IMD and external circuitry. (Col. 18 Ln(s). [55-62] teaches “The data retrieval apparatus may incorporate programmable constraints that limit total data retrieval to avoid implantable medical device battery depletion. For example, data retrieval could be adaptable as described herein, but could be limited to occur no more frequently than every N days or some other interval that is acceptable relative to impact on battery longevity. Alternatively, the amount of data per unit time could be used as a constraint.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Hoffman, Demmer, and Ciciarelli with the data communication cycle being associated with a time and amount of data communicated between the IMD and external circuitry such as that of Greene.
One of ordinary skill would have been motivated to modify the combination of Hoffman, Demmer, and Ciciarelli because according to Col. 18 Ln(s). [55-57] of Greene “The data retrieval apparatus may incorporate programmable constraints that limit total data retrieval to avoid implantable medical device battery depletion.”
Conclusion
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/JOSHUA L FORRISTALL/Examiner, Art Unit 2857
/ANDREW SCHECHTER/Supervisory Patent Examiner, Art Unit 2857