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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1-29 are rejected under 35 U.S.C. 101 because the claim invention is direct to a judicial exception without significantly more.
Determination as to whether a claim satisfies the criteria for subject matter eligibility is a stepwise process (MPEP 2016).
Step 1: Does the claim fall within a statutory category of invention?
Claims 1 and 13 recite a process(method) and claim 7 recites a machine(system), which are within the four statutory categories. Therefore, claims 1, 7, and 13 are directed to a statutory category of invention.
Step 2A: Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claims 1, 7, and 13 are directed to an abstract idea.
Claims 1 and 13 are directed to a method of treating a disorder comprising: monitoring a subject in order to detect whether a marker exceeds a predetermined threshold, determining a time period during which the subject is at a greater risk of an adverse event relating to the disorder based on the detected marker that exceeded the predetermined threshold, and administering a medical intervention to the subject for the calculated period of time during which the greater risk of the adverse event is present.
Claim 7 is directed to a system of monitoring and treating a disorder comprising: a device configured to: connect to a personal electronic device, detect a level of a marker for a disorder in a subject in real time, determine a time period that the level of the marker is detected, determine if the time period meets or exceeds a pre-determined threshold time period during which the subject is at risk for an adverse event associated with the disorder, and communicate the detected level of the marker and the determined time period to a server; and a server configured to receive the marker and time period data from the device and further configured to: responsive to the marker exceeding the pre-determined threshold, notify the patient to begin a treatment, and receive an acknowledgement from the patient.
The limitations of detecting a level of a marker for a disorder, determining a time period that the level of marker is detected, and determining a time period during which the subject is at a greater risk of an adverse event relating to the disorder based on the detected marker that exceeded the predetermined threshold, as drafted, under their broadest reasonable interpretations, are merely mental processes, because these steps are skin to having a doctor or other human actor performing these actions with pen and paper. For example, “determining a time period during which the subject is at a greater risk of an adverse event relating to the disorder based on the detected marker that exceeded the predetermined threshold” encompasses nothing more than a doctor mentally evaluating the detected marker data and performing calculations to reach a conclusion about a period of time when the patient is at risk for an adverse event.
The limitations of monitoring a subject in order to detect whether a marker exceeds a predetermined threshold encompasses nothing more than a human actor or doctor collecting these pieces of information by hand.
Therefore, claims 1, 7, and 13 recite an abstract idea.
Claims 2-6 depend on claim 1, claims 8-12 depend on claim 7, and claims 14-29 depend on claim 13. These dependent claims only recite addition features of analysis and intended usage of the methods and system described in claims 1, 7, and 13, which may also be performed by a human actor mentally and using a pen and paper. For example claim 3 recites “wherein the personal monitoring device intermittently and passively assesses the subject to detect the marker”, which encompasses nothing more than a human actor intermittently assessing the subject to detect the marker. Claim 23 recites “wherein the medical intervention is an anticoagulant providing rapid therapeutic onset to reduce the risk of the adverse event, and the anticoagulant is administered by way of at least one of swallowing, inhalation, absorption, and injection”, which encompasses nothing more than a human actor or doctor physically administering treatment based on the detected marker results.
Therefore, claims 1-29 recite an abstract idea.
Step 2A, Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
The judicial exception is not integrated into a practical application.
Claim 7 recites the additional limitations “a personal electronic device” and “a server”. These additional elements are recited at a high level of generality(i.e. most generic computers would be known to have these components). Further, these generic limitations are only discloses to be in communication/connection with “a device”. There are no elements of practical application specifically referred to incorporated as a part of the “device”. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Therefore claim 7 does not integrate the judicial exception into a practical application.
Claims 1, 7, and 13 recite the additional limitations ““detect a level of a marker”, which amounts to no more than mere pre-solution activity of data gathering. Therefore the generic claimed material does not integrate the judicial exception into a practical application.
As described above, dependent claims 2-6, 8-12, and 14-29 only recited limitations of the method and instructions recited in claims 1, 7, and 13, which may be done mentally by a human actor and/or with a pen and paper.
Step 2B: Does the claim include additional elements that are sufficient to amount to significantly more than the judicial exception?
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
As explained above with respect to the integration of the judicial exception into a practical application (Step 2A, Prong 2), the additional elements of using components in communication/connection with the device amounts to no more than mere instructions to apply the judicial exception using generic computer elements. The structural elements recited in claim 7, are “a personal electronic device” and “a server”. These additional elements are recited at a high level of generality. Paragraphs [0034] and [0073] of the specification describe the server and personal electronic device at a high level of generality , and only provides conventional, well-known computing functions that do not add meaningful limits to practicing the abstract idea.
Claims 1, 7 and 13, recited the additional limitations “detect a level of a marker” . As discussed with respect to integration of the abstract idea into a practical application (Step 2A, Prong 2), the additional elements of a detector to collect data(markers) amounts to no more than mere pre-solution data gathering. This pre-solution activity of data gathering using a detector is well-understood, routine, and conventional in the field of patient monitoring. The explanation of insignificant extra-solution activity is shown in case law in, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989).
Therefore, claims 1-29 are not patient-eligible under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-7, 12-22, and 25-29 are rejected under 35 U.S.C. 103 as being unpatentable over Li(US 20220152406 A1), and further in view of Sharma(US 20190329043 A1).
Regarding claim 1, Li discloses a method of treating a disorder comprising:
monitoring a subject in order to detect whether a marker exceeds a predetermined threshold(wear compliance onset event. As described herein, a wear compliance onset event, or simply an onset event, is a change in one or more monitored signals that indicates that the patient has transitioned from not wearing a wearable medical device to wearing the wearable medical device. For example, as noted herein, when a predetermined threshold based on ECG signal information is met, the patient is deemed to be wearing the wearable medical device[0102]), and
administering a medical intervention to the subject for the calculated period of time during which the greater risk of the adverse event is present(During the period of time in which they are worn by the patient, the wearable defibrillator can be configured to continuously or substantially continuously monitor the vital signs of the patient and, upon determination that treatment is required, can be configured to deliver one or more therapeutic electrical pulses to the patient[0189]). Li fails to disclose “determining a time period during which the subject is at a greater risk of an adverse event relating to the disorder based on the detected marker that exceeded the predetermined threshold”.
However , Sharma teaches “The evaluation period serves as an evaluation window that encompasses data, acquired from each patient, that are within the boundaries (i.e. start and end times). Exemplary calculations performed by processor 106a-c can be calculating risk of a heart failure event for each evaluation period[0029]. In addition to dynamically calculating new risk scores, alerts can be automatically generated when acquired data indicates that a threshold is crossed and/or that the threshold is repeatedly crossed over a pre-specified period of time[0127]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the wearable monitor of Li with the evaluation time of the medical system of Sharma. Doing so would specify a time when the risk events are likely to happen based on acquired data in order for the patient or physician to know when adverse events will happen.
Regarding claim 2, Li in view of Sharma teaches the method of claim 1, wherein the disorder is monitored by a personal monitoring device that is at least one of a wearable device, an external device, and an implantable device configured to connect to a personal mobile device(Patients who are at risk, have been hospitalized for, or otherwise are suffering from, adverse heart conditions can be prescribed a wearable cardiac monitoring and/or treatment device.[0003]. FIGS. 10E and 10F illustrate sample feedback that can be provided to the patient regarding the patient's wear compliance information. The feedback can be transmitted to a personal computing device such as the patient's smartphone for processing and display[0162]).
Regarding claim 3, Li in view of Sharma teaches the method of claim 2, wherein the personal monitoring device intermittently and passively assesses the subject to detect the marker(For example, the processor can monitor the physiological signals received from physiological sensors and combine the physiological signals with motion signals received from motion sensors to identify changes that may be indicative of an onset event. Once an onset event has been detected, the processor can continue to monitor the signals for changes that may indicate an offset event[0067]).
Regarding claim 4, Li in view of Sharma teaches the method of claim 3, wherein the subject wears the monitoring device for an average time period of at least 14 to 24 hours a day, wherein the average time period includes active hours and/or resting hours(For example, the wearable medical device can be configured to be worn by a patient for as many as 24 hours a day. In some implementations, the patient can remove the wearable medical device for a short portion of the day (e.g., for half an hour to bathe)[0167]).
Regarding claim 5, Li in view of Sharma teaches the method of claim 3, wherein the subject wears the monitoring device for a near continuous amount of time(As the wearable device is generally prescribed for continuous or near-continuous use (e.g., only to be removed when bathing), the patient wears the device during all daily activities such as walking, sitting, climbing stairs, resting or sleeping, and other similar daily activities. Maintaining continuous use of the device as prescribed can be promote better confidence in the data collected from monitoring patient progress as well as ensuing better protection to the patient including providing treatment if needed[0003]).
Regarding claim 6, Li in view of Sharma teaches the method of claim 1, but Li fails to disclose wherein the medical intervention is intermittently administered, the method further comprising: responsive to determining whether the marker exceeds the predetermined threshold, administering the medical intervention to the subject for the calculated period of time during which the greater risk of the adverse event is present; responsive to completing the calculated period of time, ending the medical intervention; and responsive to determining the marker does not exceed the predetermined threshold, continue to monitor the subject without administering treatment.
However, Sharma teaches “In one embodiment, the risk score can be dynamically calculated on a real-time basis using the most currently acquired data. The most current data can comprise any designated time period for data obtained from implantable and/or non-implantable devices. Exemplary time periods can comprise the previous 30 days, the previous week, the previous day and/or data obtained on a real-time basis[0124]. In addition to dynamically calculating new risk scores, alerts can be automatically generated when acquired data indicates that a threshold is crossed and/or that the threshold is repeatedly crossed over a pre-specified period of time. In this scenario, the patient and/or healthcare provider would be alerted that the patient needs to go to a hospital to be evaluated by a physician for an implantable medical device and/or other therapy[0127]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the wearable monitor of Li with the evaluation time of the medical system of Sharma. Doing so would specify a time when the risk events are likely to happen based on acquired data in order for the patient or physician to know when adverse events will happen.
Regarding claim 7, Li discloses a system of monitoring and treating a disorder comprising:
a device configured to:
connect to a personal electronic device( As described herein, wear compliance information as generated by a wearable medical device can be transmitted to a remote server for additional processing and access by, for example, the patient's physician for review. Additionally, the wear compliance information can be presented to the patient on a user interface integrated into the wearable medical device (e.g., user interface 308 as shown in FIG. 3 and described herein) or via a personal computing device assigned to or otherwise accessed by the patient such as a smartphone[0153]),
detect a level of a marker for a disorder in a subject in real time(The processor can monitor 504 the received signals for an indication of a wear compliance onset event. As described herein, a wear compliance onset event, or simply an onset event, is a change in one or more monitored signals that indicates that the patient has transitioned from not wearing a wearable medical device to wearing the wearable medical device. For example, as noted herein, when a predetermined threshold based on ECG signal information is met, the patient is deemed to be wearing the wearable medical device[0102],
determine a time period that the level of the marker is detected(For example, for each onset event and offset event measured during a particular time period, the processor can record an associated occurrence time associated with the events. The processor can further calculate and record total wear compliance time by calculating the time between an onset event and a subsequent offset event[0109], and
communicate the detected level of the marker and the determined time period to a server; and
a server configured to receive the marker and time period data from the device and further configured to:
responsive to the marker exceeding the pre-determined threshold, notify the patient to begin a treatment(During the period of time in which they are worn by the patient, the wearable defibrillator can be configured to continuously or substantially continuously monitor the vital signs of the patient and, upon determination that treatment is required, can be configured to deliver one or more therapeutic electrical pulses to the patient[0189]), and
receive an acknowledgement from the patient(In some examples, the wearable medical device can include a user interface that provides the patient with the option to input various information.[0114]). Li fails to disclose “determine if the time period meets or exceeds a pre-determined threshold time period during which the subject is at risk for an adverse event associated with the disorder”.
However , Sharma teaches “The evaluation period serves as an evaluation window that encompasses data, acquired from each patient, that are within the boundaries (i.e. start and end times). Exemplary calculations performed by processor 106a-c can be calculating risk of a heart failure event for each evaluation period[0029]. In addition to dynamically calculating new risk scores, alerts can be automatically generated when acquired data indicates that a threshold is crossed and/or that the threshold is repeatedly crossed over a pre-specified period of time[0127]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the wearable monitor of Li with the evaluation time of the medical system of Sharma. Doing so would specify a time when the risk events are likely to happen based on acquired data in order for the patient or physician to know when adverse events will happen.
Regarding claim 12, Li in view of Sharma teaches the system of claim 7, wherein the server is further configured to: notify a physician to review the marker and the time period data, notify a subject to review the marker and the time period data and prepare to receive instructions from a physician, and communicate a treatment plan from the physician to the subject(Once an offset event has been detected, the processor can process or otherwise generate information related to the patient's wear compliance for presentation to, for example, the patient's physician or healthcare provider (HCP), the patient, or another person associated with providing care for the patient.[0067]. In response to such an alert, the physician can take actions to correct the non-compliance before any potential adverse events happen to the patient that could have otherwise been avoided if the patient followed the wear compliance information associated with the wearable medical device[0069]).
Regarding claim 13, Li discloses a method of monitoring and treating a disorder comprising:
monitoring a subject in order to detect a marker that exceeds a predetermined threshold(wear compliance onset event. As described herein, a wear compliance onset event, or simply an onset event, is a change in one or more monitored signals that indicates that the patient has transitioned from not wearing a wearable medical device to wearing the wearable medical device. For example, as noted herein, when a predetermined threshold based on ECG signal information is met, the patient is deemed to be wearing the wearable medical device[0102]);
administering a medical intervention to the subject for the calculated period of time during which the greater risk of the adverse event is present(During the period of time in which they are worn by the patient, the wearable defibrillator can be configured to continuously or substantially continuously monitor the vital signs of the patient and, upon determination that treatment is required, can be configured to deliver one or more therapeutic electrical pulses to the patient[0189]). Li fails to disclose “determining a time period during which the subject is at a greater risk of an adverse event relating to the disorder based on the detected marker”.
However , Sharma teaches “The evaluation period serves as an evaluation window that encompasses data, acquired from each patient, that are within the boundaries (i.e. start and end times). Exemplary calculations performed by processor 106a-c can be calculating risk of a heart failure event for each evaluation period[0029]. In addition to dynamically calculating new risk scores, alerts can be automatically generated when acquired data indicates that a threshold is crossed and/or that the threshold is repeatedly crossed over a pre-specified period of time[0127]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the wearable monitor of Li with the evaluation time of the medical system of Sharma. Doing so would specify a time when the risk events are likely to happen based on acquired data in order for the patient or physician to know when adverse events will happen.
Regarding claim 14, Li in view of Sharma teaches the method of claim 13, wherein the server is further configured to: notify a physician if the marker exceeds the pre-determined threshold and provide the time period calculation; prompt the physician to review the marker and the time period detected to determine the medical intervention; notify the subject; and communicate a treatment plan from the physician to the subject(Once an offset event has been detected, the processor can process or otherwise generate information related to the patient's wear compliance for presentation to, for example, the patient's physician or healthcare provider (HCP), the patient, or another person associated with providing care for the patient.[0067]. In response to such an alert, the physician can take actions to correct the non-compliance before any potential adverse events happen to the patient that could have otherwise been avoided if the patient followed the wear compliance information associated with the wearable medical device[0069]).
Regarding claim 15, Li in view of Sharma teaches the method of claim 13, wherein the disorder is atrial fibrillation(Example cardiac conditions that can be monitored include atrial fibrillation (AF), bradycardia, tachycardia, atrio-ventricular block, Lown-Ganong-Levine syndrome, atrial flutter, sino-atrial node dysfunction, cerebral ischemia, pause(s), and/or heart palpitations[0203]).
Regarding claim 16, Li in view of Sharma teaches the method of claim 15, wherein atrial fibrillation is monitored by an atrial fibrillation detecting device worn during a time of activity and a time of rest and configured to: detect the marker of atrial fibrillation(Patients who are at risk, have been hospitalized for, or otherwise are suffering from, adverse heart conditions can be prescribed a wearable cardiac monitoring and/or treatment device. In addition to the wearable device, the patient can also be given a battery charger and a set of rechargeable batteries. As the wearable device is generally prescribed for continuous or near-continuous use (e.g., only to be removed when bathing), the patient wears the device during all daily activities such as walking, sitting, climbing stairs, resting or sleeping, and other similar daily activities. Maintaining continuous use of the device as prescribed can be promote better confidence in the data collected from monitoring patient progress as well as ensuing better protection to the patient including providing treatment if needed[0003]).
Regarding claim 17, Li in view of Sharma teaches method of claim 15, but Li fails to explicitly state wherein atrial fibrillation is monitored by an implantable atrial fibrillation detecting device configured to: detect the marker of atrial fibrillation.
However, Sharma teaches “Metric detection module 92 may include additional sub-modules or sub-routines that detect and monitor other patient metrics used to monitor patient 14 and/or generate the HF risk level. In other examples, metric detection module 92 may additionally receive data from one or more implanted or external devices used to detect each metric which IMD 16 may store as metric data[0078]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the wearable monitor of Li with the atrial fibrillation markers of the medical system of Sharma. Doing so would specify the atrial fibrillation marker is detected via an implantable element for accurate measurements.
Regarding claim 18, Li in view of Sharma teaches the method of claim 15, wherein atrial fibrillation is monitored by an external device configured to: responsive to patient activation, detect the marker of atrial fibrillation(The teachings of the present disclosure can be generally applied to external medical monitoring and/or treatment devices that include one or more sensors as described herein. Such external medical devices can include, for example, ambulatory medical devices as described herein that are capable of and designed for moving with the patient as the patient goes about his or her daily routine. An example ambulatory medical device can be a wearable medical device such as a WCD, a wearable cardiac monitoring device, an in-hospital device such as an in-hospital wearable defibrillator (HWD), a short-term wearable cardiac monitoring and/or therapeutic device, mobile cardiac event monitoring devices, and other similar wearable medical devices[0166]).
Regarding claim 19, Li in view of Sharma teaches the method of claim 16, wherein a notification of a qualifying event is configured to: track a patient written note; and send the patient written note to the physician and the patient health record database(FIGS. 10A-10C describe one or more interfaces for delivering wear compliance information to a physician including, for example, a summary screen (or portion of a screen) with presentation of key compliance data for a quick glance, and a more detailed screen (or portion of a screen) with very detailed information underlying the key compliance data presented on the summary screen.[0154]). The screen of FIGS. 10A-10C can include patient input(i.e. notes from the patient).
Regarding claim 20, Li in view of Sharma teaches the method of claim 16, wherein a notification of a qualifying event is configured to: store qualifying events and patient compliance with recommended therapy in the patient health record database(A medical device controller as described herein can include one or more database tables configured to store wear compliance information[0208]. In some examples, the data storage 304 can be configured to store information such as ECG data as received from, for example, the sensing electrode interface[0177]).
Regarding claim 21, Li in view of Sharma teaches the method of claim 19, wherein the atrial fibrillation detecting device is further comprising: an activity tracker configured to: collect a plurality of activity data, and store the plurality of activity data, and a heart rate tracker configured to: collect a plurality of heart rate data, and store the plurality of heart rate data; wherein the atrial fibrillation detecting device is further configured to: and responsive to determining the subject is not adherent, notify a health center(As shown in FIG. 6C, the processor can receive 642 signals from, for example, one or more motion sensors and associated circuitry such as accelerometers as described herein that are configured to output one or more electrical signals indicative of physical activity or motion of the patient. The processor can identify 644 one or more features in the motion signals that are indicative of a particular movement of the patient. [0122]. Heart rate for use with compliance monitoring can be determined using one or more detections methods or processes. For example, heart rate detection implementations can include, but are not limited to, one or more of the following: [0260] Analysis of ECG time signal: Heart rate is assessed by measuring the duration between two ECG complexes. [0261] The processor can derive 624 one or more physiological metrics from the received physiological signals. For example, the physiological metrics can include ECG metrics including, for example, heart rate (such as average, median, mode, or other statistical measure of the heart rate, and/or maximum, minimum, resting, pre-exercise, and post-exercise heart rate values and/or ranges), heart rate variability metrics, premature ventricular contraction (PVC) burden or counts, atrial fibrillation burden metrics, pauses, heart rate turbulence, QRS height, QRS width, changes in a size or shape of morphology of the ECG information, cosine R-T, artificial pacing, QT interval, QT variability, T wave width, T wave alternans, T-wave variability, and ST segment changes. ECG metrics are described herein by way of example only and additional physiological metrics such as those described, for example, the detailed discussion of FIG. 3 below can be processed by the process as well.[0115]). Li fails to disclose “determine the subject's adherence to wearing the atrial fibrillation sensing smart watch based on the plurality of activity data and the plurality of heart rate data”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the wearable monitor of Li with the smartwatch of the medical system of Sharma. Doing so would specify the wearable system as being a smartwatch to be worn on the wrist of the patient to ensure continuous skin contact.
Regarding claim 22, Li in view of Sharma teaches the method of claim 21, wherein the atrial fibrillation detecting device is further configured to perform an ECG(Wearable medical devices, such as cardiac event monitoring and/or treatment devices, are used in clinical or outpatient settings to monitor and/or record various ECG and other physiological signals of a patient. These ECG and other physiological signals can be used to monitor for arrhythmias, and, in example devices described herein, provide treatment such as defibrillation or pacing shocks in the event of life-threatening arrhythmias[0063]).
Regarding claim 25, Li in view of Sharma teaches the method of claim 13, wherein the adverse event is an atrial fibrillation related stroke(In examples of the wearable defibrillator, to record the wear offset event can include to detect a change in the at least one electrical signal indicating an invalid ECG signal and record the wear offset event based upon the invalid ECG signal[0014]. For example, the physiological metrics can include ECG metrics including, for example, heart rate (such as average, median, mode, or other statistical measure of the heart rate, and/or maximum, minimum, resting, pre-exercise, and post-exercise heart rate values and/or ranges), heart rate variability metrics, premature ventricular contraction (PVC) burden or counts, atrial fibrillation burden metrics, pauses, heart rate turbulence, QRS height, QRS width, changes in a size or shape of morphology of the ECG information, cosine R-T, artificial pacing, QT interval, QT variability, T wave width, T wave alternans, T-wave variability, and ST segment changes. ECG metrics are described herein by way of example only and additional physiological metrics such as those described, for example, the detailed discussion of FIG. 3 below can be processed by the process as well[0115]). ECG signals can detect heart irregularities, and be used to predict conditions for a stroke, as is common in current medical practice.
Regarding claim 26, Li in view of Sharma teaches the method of claim 13, wherein the adverse event is an atrial fibrillation related systemic embolization(In examples of the wearable defibrillator, to record the wear offset event can include to detect a change in the at least one electrical signal indicating an invalid ECG signal and record the wear offset event based upon the invalid ECG signal[0014]. For example, the physiological metrics can include ECG metrics including, for example, heart rate (such as average, median, mode, or other statistical measure of the heart rate, and/or maximum, minimum, resting, pre-exercise, and post-exercise heart rate values and/or ranges), heart rate variability metrics, premature ventricular contraction (PVC) burden or counts, atrial fibrillation burden metrics, pauses, heart rate turbulence, QRS height, QRS width, changes in a size or shape of morphology of the ECG information, cosine R-T, artificial pacing, QT interval, QT variability, T wave width, T wave alternans, T-wave variability, and ST segment changes. ECG metrics are described herein by way of example only and additional physiological metrics such as those described, for example, the detailed discussion of FIG. 3 below can be processed by the process as well[0115]). ECG signals can detect heart irregularities, and be used to identify system embolization.
Regarding claim 27, Li in view of Sharma teaches the method of claim 13, wherein the adverse event is an atrial fibrillation related mortality(In examples of the wearable defibrillator, to record the wear offset event can include to detect a change in the at least one electrical signal indicating an invalid ECG signal and record the wear offset event based upon the invalid ECG signal[0014]. Because the victim has no perceptible warning of the impending fibrillation, death often occurs before the necessary medical assistance can arrive[0002].
Regarding claim 28, Li in view of Sharma teaches the method of claim 13, wherein the medical intervention is intermittently administered to prevent a second adverse event(During the period of time in which they are worn by the patient, the wearable defibrillator can be configured to continuously or substantially continuously monitor the vital signs of the patient and, upon determination that treatment is required, can be configured to deliver one or more therapeutic electrical pulses to the patient[0189]).
Regarding claim 29, Li in view of Sharma teaches the method of claim 13, but Li fails to disclose wherein the calculated time period of risk is based on the detection of a marker, the method further comprising, monitoring the patient during the administration of the medical intervention in order to detect the marker; determining if the marker exceeds the predetermined threshold; responsive to the determining the marker exceeds the predetermined threshold during the medical intervention, restarting the calculated time period of risk for the medical intervention to be administered for(In one embodiment, the risk score can be dynamically calculated on a real-time basis using the most currently acquired data. The most current data can comprise any designated time period for data obtained from implantable and/or non-implantable devices. Exemplary time periods can comprise the previous 30 days, the previous week, the previous day and/or data obtained on a real-time basis[0124]. In addition to dynamically calculating new risk scores, alerts can be automatically generated when acquired data indicates that a threshold is crossed and/or that the threshold is repeatedly crossed over a pre-specified period of time. In this scenario, the patient and/or healthcare provider would be alerted that the patient needs to go to a hospital to be evaluated by a physician for an implantable medical device and/or other therapy[0127]. Intervals defined by the timing and control module within processor 80 may include atrial and ventricular pacing escape intervals, refractory periods during which sensed P-waves and R-waves are ineffective to restart timing of the escape intervals, and the pulse widths of the pacing pulses. As another example, the timing and control module may withhold sensing from one or more channels of sensing module 86 for a time interval during and after delivery of electrical stimulation to heart 12. The durations of these intervals may be determined by processor 80 in response to stored data in memory 82[0060]).
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the wearable monitor of Li with the evaluation time of the medical system of Sharma. Doing so would specify a time when the risk events are likely to happen based on acquired data in order for the patient or physician to know when adverse events will happen.
Claim(s) 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Sharma, and further in view of Fretwell(US 9838854 B2).
Regarding claim 8, Li in view of Sharma discloses the system of claim 7, but fails to explicitly state wherein the server is configured to notify the subject with a plurality of push notifications, including sending an SMS text message to the subject after a push notification is repeated once without acknowledgment from the subject.
However, Fretwell teaches “FIG. 5 is a flow chart of an example process on the example server for pushing notifications to the user devices;(Brief description of drawings, paragraph 6) the computer system sending periodic ping messages to said user mobile device over a communication network; in response to the user the user device receiving the ping messages, the user device providing a response interface on the user device configured to accept an input from the user acknowledging receipt of the ping messages;(Summary, paragraph 1)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the wearable monitor of Li with the text alerts of the remote health monitoring system of Fretwell. Doing so would specify push notifications being sent to the user to make sure the user has acknowledged the monitoring system.
Regarding claim 9, Li in view of Sharma and Fretwell discloses the system of claim 8, but Li fails to disclose wherein the server is further configured to contact a health center if the plurality of push notifications are not acknowledged by the subject.
However, Fretwell teaches “This is done through operation of an application installed on the smart device which is regularly “pinged” by a central server, requiring a response from the individual to ensure that the individual is not impaired. Should no such response be forthcoming, the system will detect the lack of response and notify an appropriate person or organization or responder to attempt to contact the monitored individual and/or send aid.(abstract)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the wearable monitor of Li with the text alerts of the remote health monitoring system of Fretwell. Doing so would specify push notifications being sent to the user to make sure the user has acknowledged the monitoring system.
Regarding claim 10, Li in view of Sharm and Fretwell teach the system of claim 9, but Li fails to disclose wherein the device further comprises a heart rhythm detector configured to determine a time period during which the subject is at greater risk of having an adverse cardiovascular event based on the detection of an irregular heart rhythm that exceeds a pre-determined threshold.
However, Sharma teaches “Server 130 then executes computer instructions to determine whether the data crosses a pre-established threshold that may be indicative of decreasing cardiovascular health, as previously described. Additionally, server 130 can be configured to track the time period in which the threshold continued to be crossed.[0129]. Electrical sensing module 86 monitors signals from at least one of electrodes 40, 42, 44, 46, 48, 50, 58, 62, 64 or 66 in order to monitor electrical activity of heart 12, impedance, or other electrical phenomenon. Sensing may be done to determine heart rates or heart rate variability, or to detect arrhythmias or other electrical signals[0058]”
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the wearable monitor of Li with the evaluation time of the medical system of Sharma. Doing so would specify a time when the risk events are likely to happen based on acquired data in order for the patient or physician to know when adverse events will happen.
Regarding claim 11, Li in view of Sharma and Fretwell teaches system of claim 10, wherein the health center is further configured to: responsive to detecting non-adherence of wearing the device: contact the patient; and contact the physician(In some examples, the systems and methods as described herein provide the improved wear compliance information to the patient. For example, the patient can access their wear compliance information or receive alerts regarding certain conditions that may or may not be met based on the improved wear compliance information[0070]).
Claim(s) 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Sharma and further in view of Yan(US 20230165874 A1).
Regarding claim 23, Li in view of Sharma teaches the method of claim 13, but fails to disclose wherein the medical intervention is an anticoagulant providing rapid therapeutic onset to reduce the risk of the adverse event, and the anticoagulant is administered by way of at least one of swallowing, inhalation, absorption, and injection.
However, Yan teaches “The present disclosure relates to anticoagulants and derivatives thereof and their use in therapeutic applications, and in particular with devices and uses in pulmonary applications[0002]. The method of clause 1 or 2, wherein delivering the therapeutically effective dose of the therapeutic composition comprises any one or more of inhalation, ventilation, instillation, ultrasound, vibration, and injection.[0194]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the wearable monitor of Li with the anticoagulant therapy of the method of Yan. Doing so would specify anticoagulant dosage being administered to the patient for cardiac therapy to treat heart disorders.
Regarding claim 24, Li in view of Sharma and Yan teaches the method of claim 23, but Li fails to disclose wherein the anticoagulant providing rapid therapeutic onset comprises at least one of apixaban, betrixaban, edoxaban, otamixaban, razaxaban, rivaroxaban. However, Yan teaches “In specific examples, the direct factor Xa inhibitor may be selected from the group consisting of apixaban, betrixaban, edoxaban, otamixaban, razaxaban, rivaroxaban[0022]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the wearable monitor of Li with the anticoagulant therapy of the method of Yan. Doing so would specify anticoagulant dosage being administered to the patient for cardiac therapy to treat heart disorders.
Conclusion
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/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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