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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 64-73) in the reply filed on 06/15/2026 is acknowledged.
Claims 74-93 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II and Group III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/15/2026.
Claim Objections
Regarding claim 69, the claim recites, “wherein the one or more additional segments are from a second channel…”. However, in claim 68 (which claim 69 depends from), the claim recites, “and/or of one or more additional segments.” Based on the language of claim 69, the additional ECG segments are necessitated. But, in claim 68, the analysis of additional ECG segments is optional. It is clear that the claim includes additional ECG segments, but the language is slightly confusing given that the analysis of these segments is optional in claim 68. The Examiner recommends amending claim 68 to ”and of one or more ECG segments…” (line 3).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 64-66 and 73 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Weinstein et al. (US 20210121090 A1, “Weinstein”).
Regarding claims 64, Weinstein teaches a wearable cardiac monitoring and treatment system (Fig. 12; para. [0069]: "FIG. 12 illustrates an example medical device (e.g., external heart monitoring device) that is external, ambulatory, and wearable by a patient, according to some embodiments." Abstract) configured to remotely identify and/or verify treatable cardiac arrhythmias in an ambulatory patient (abstract: "cardiac diagnosis and/or arrhythmia monitoring, and more particularly, systems, devices and methods for arrhythmia monitoring with a trained classifier including at least one neural network… transmit the at least one determined ECG signal portion to a remote computer system."), comprising: a wearable cardiac monitoring and treatment device (Fig. 12; para. [0460]: "FIG. 12 illustrates an example heart monitoring device, e.g., medical device 1200 that is external, ambulatory, and wearable by a patient 1202") configured for long-term continuous cardiac monitoring of the ambulatory patient (para. [0460]: "Such a medical device 1200 can be, for example, an ambulatory medical device that is capable of and designed for moving with the patient as the patient goes about his or her daily routine...In one example scenario, such wearable defibrillators can be worn nearly continuously or substantially continuously for two to three months at a time."), the device comprising a plurality of ECG electrodes (Fig. 12; par. [0461]: "one or more sensing electrodes 1212 (e.g., ECG electrodes)…") configured to be in long-term continuous contact with skin of the ambulatory patient (para. [0640] discusses wearing the monitor continuously; para. [0463] discusses attachment to a patient's skin with adhesive, as shown in Fig. 12: "In some implementations, the sensing electrodes 1212 and at least one of the therapy electrodes 1214 can be included on a single integrated patch and adhesively applied to the patient's body.") and sense electrical signals indicative of cardiac activity in the ambulatory patient (para. [0464]: " The sensing electrodes 1212 can be configured to detect one or more cardiac signals. Examples of such signals include ECG signals and/or other sensed cardiac physiological signals from the patient."), a plurality of therapy electrodes (Fig. 12; 1214) configured to deliver one or more therapeutic electrical shocks to the ambulatory patient (para. [0460]: "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. For example, such therapeutic shocks can be pacing, defibrillation, or transcutaneous electrical nerve stimulation (TENS) pulses."; para. [0465]: "One or more of the therapy electrodes 1214 can be configured to deliver one or more therapeutic defibrillating shocks to the body of the patient 1202"), and a medical device controller (para. [0461]: "a medical device controller 1220") coupled to the plurality of ECG electrodes (para. [0462]: "The medical device controller 1220 can be operatively coupled to the sensing electrodes 1212…") and/or the plurality of therapy electrodes (para. [0462]: "The medical device controller 1220 can be operatively coupled to the therapy electrodes 1214."), and a remote server in electronic communication with the medical device controller of the wearable cardiac monitoring and treatment device (Fig. 13; para. [0473]: " the network interface 1306 can facilitate the communication of information between the medical device controller 1220 and one or more other devices or entities over a communications network. For example, where the medical device controller 1220 is included in an ambulatory medical device (such as medical device 1200), the network interface 1306 can be configured to communicate with a remote computing device such as a remote server or other similar computing device."); wherein the medical device controller comprises one or more processors (processor 1318; fig. 13) configured to generate an ECG signal based on the sensed electrical signals indicative of the cardiac activity in the ambulatory patient (para. [0464]: "The sensing electrodes 1212 can be configured to detect one or more cardiac signals. Examples of such signals include ECG signals and/or other sensed cardiac physiological signals from the patient."), determine one or more ECG segments corresponding to a suspected arrhythmia occurring in the ambulatory patient based on the ECG signal (para. [0483]: " In some embodiments, an ECG analysis system (e.g., arrhythmia monitoring system, heart failure status monitoring, and/or the like) may include ECG being acquired with a sensor on the body (e.g., external heart monitoring device, which may include ECG electrodes and/or ECG processing circuitry, as described herein). Additionally or alternatively, a neural net may process the ECG signal(s) to identify and flag reportable intervals (e.g., ECG signal portions associated with at least one predetermined rhythm change, as descried herein)."), transmit the determined one or more ECG segments corresponding to the suspected arrhythmia occurring in the ambulatory patient to the remote server (para. [0484]: " In some embodiments, a reportable event may include an ECG snippet (e.g., ECG signal portion), which may include a rhythm change from one rhythm type to another. Additionally or alternatively, the network (e.g., neural network) may identify the rhythm change without having to classify the specific rhythm type. For example, the network (e.g., neural network) may detect rhythm type change from normal sinus rhythm (NSR) to Atrial Fibrillation (AFIB), from AFIB to NSR, from AFIB to Atrial Flutter (AFL), etc. Additionally or alternatively, every time a rhythm change is identified, the ECG strip (e.g., ECG signal portion) containing the change may be marked and/or sent to a server (e.g., remote computer system, as described herein)."), receive, from the remote server, a remote indication based on the one or more ECG segments as to whether the ambulatory patient is experiencing a treatable arrhythmia (para. [0494]: "In some embodiments, in addition to the (first) neural network, the server may include a second neural network. For example, the second neural network may be larger, more accurate, and/or the like compared to the (first) neural network. Additionally or alternatively, the second neural network may also be capable of classifying the specific arrhythmia type."; para. [0495]: "In some embodiments, data transmission and processing may be significantly reduced by sending only the flagged intervals (e.g., ECG signal portions associated with at least one predetermined rhythm change) to the server analysis layers (e.g., remote computer system). Additionally or alternatively, only flagged intervals may be processed at the server for arrhythmia type classification and/or presented to technician for annotation."), independently analyze, at the medical device controller, the one or more ECG segments to generate a local indication as to whether the ambulatory patient is experiencing a treatable arrhythmia (para. [0492] mentions implementing the neural network in the heart monitoring device, which performs analysis locally.), and determine whether to deliver, via the plurality of therapy electrodes, a therapeutic shock to the ambulatory patient based on the received remote indication and the local indication as to whether the ambulatory patient is experiencing a treatable arrhythmia. (para. [0465]: "One or more of the therapy electrodes 1214 can be configured to deliver one or more therapeutic defibrillating shocks to the body of the patient 1202 when the medical device 1200 determines that such treatment is warranted based on the signals detected by the sensing electrodes 1212 and processed by the medical device controller 1220. Example therapy electrodes 1214 can include conductive metal electrodes such as stainless steel electrodes that include, in certain implementations, one or more conductive gel deployment devices configured to deliver conductive gel to the metal electrode prior to delivery of a therapeutic shock."; para. [0386]: " For example, remote computer system 104 may detect, with the arrhythmia type classifier, a type of arrhythmia in the ECG signal(s) and time data associated with the detected type of arrhythmia, as described herein. For example, the time data may include at least one of a start time, a time interval, any combination thereof, and/or the like, as described herein. In some embodiments, remote computer system 104 may determine, based on the time data, at least one ECG signal portion associated with the detected type of arrhythmia in the ECG signal(s), as described herein.").
Regarding claim 65, Weinstein teaches the wearable cardiac monitoring and treatment system of claim 64 (see above), wherein the one or more processors are further configured to query the remote server for the remote indication upon generating a local indication that the ambulatory patient is experiencing a treatable arrhythmia. (para. [0484]; This discloses that a snippet of an ECG signal is sent by the processors to the remote server based on suspected signals, which is a form of a query, and is based on an initial analysis by the local indicator/determination from ECG analysis (i.e., only the suspected snippets are sent).
Regarding claim 66, Weinstein teaches the wearable cardiac monitoring and treatment system of claim 64 (see above), wherein the one or more processors are configured to determine whether to deliver the therapeutic shock to the ambulatory patient by determining whether the remote indication and the local indication indicate that the ambulatory patient is experiencing a treatable arrhythmia. (See para. [0492]-[0495], which mentions splitting the processing across ECG (local) and the server (remote server). It is shown that the processing and analysis is performed in both local and remote processors to classify a heart rhythm determination).
Regarding claim 73, Weinstein teaches the wearable cardiac monitoring and treatment system of claim 64 (see 102 rejection above), wherein the wearable cardiac monitoring and treatment device further comprises a garment configured to be worn about a torso of the ambulatory patient, wherein the plurality of ECG electrodes and the plurality of therapy electrodes are configured to be disposed on the garment. (Fig. 12; para. [0461]: "The medical device 1200 can include one or more of the following: a garment 1210, one or more sensing electrodes 1212 (e.g., ECG electrodes), one or more therapy electrodes 1214a and 1214b (collectively referred to herein as therapy electrodes 1214), a medical device controller 1220, a connection pod 1230, a patient interface pod 1240, a belt 1250, or any combination of these. In some examples, at least some of the components of the medical device 1200 can be configured to be affixed to the garment 1210 (or in some examples, permanently integrated into the garment 1210), which can be worn about the patient's torso.").
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 67-72 are rejected under 35 U.S.C. 103 as being unpatentable over Weinstein et al. (US 20210121090 A1, “Weinstein”) in view of Volpe et al. (US 20210252292 A1, "Volpe").
Regarding claim 67, Weinstein teaches the wearable cardiac monitoring and treatment system of claim 66 (see 102 rejection above). However, Weinstein does not expressly disclose where the processor is configured to delay shock.
Volpe, in the same field of endeavor of cardiac monitoring and delivering therapeutic stimulation, discloses an ambulatory device for verifying an arrythmia. Volpe discloses wherein the one or more processors (processor 218) are further configured to delay the therapeutic shock to the ambulatory patient upon determining that the local indication indicates that the ambulatory patient is experiencing a treatable arrhythmia but that the remote indication does not indicate that the ambulatory patient is experiencing a treatable arrhythmia. (Fig 11; para. [0156]-[0161]; para. [0161] teaches a delay when the treatment controller fails to verify the declared arrythmia from the cardiac monitoring process in 604. ).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to include a processor that delays shock when the arrythmia is not verified by the remote server, as disclosed by Volpe, in the system of Weinstein. One of ordinary skill in the art would recognize the advantage of including this modification in that it reduces administration of therapeutic delivery based on false positives (see para. [0056] of Volpe). One of ordinary skill would recognize that including this false positive detection system would have been an obvious modification to make to the device of Weinstein. Thus, it would have been obvious to combine the system and device of Volpe with that of Weinstein.
Regarding claim 68, Weinstein, in combination with Volpe, teaches the wearable cardiac monitoring and treatment system of claim 67 (see 103 rejection above). Weinstein further discloses wherein the one or more processors are further configured to perform a second analysis of the one or more ECG segments and/or of one or more additional ECG segments corresponding to the suspected arrhythmia to generate a second local indication as to whether the ambulatory patient is experiencing a treatable arrhythmia. (para. [0028]: "[0028] In some embodiments, the processor may be further configured to determine with the rhythm change classifier a confidence score associated with the predetermined rhythm change based on the at least one ECG signal."; "rhythm change" implies a first ECG segment compared to a second ECG segment; Further, para. [0379] discloses a second set of ECG signals, which implies a second analysis. Additionally, para. [0496] describes a second analysis process.).
Regarding claim 69, Weinstein, in combination with Volpe, teaches the wearable cardiac monitoring and treatment system of claim 67 (see 103 rejection above). Weinstein further discloses wherein the one or more ECG segments are from a first channel of the plurality of ECG electrodes, and wherein the one or more additional ECG segments are from a second channel of the plurality of ECG electrodes. (para. [0394]-[0397] disclose a first and second ECG channel with a first and second ECG signal. Para. [0111] discloses a first ECG signal with a first channel and a second ECG signal with a second channel, and each channel corresponds to a respective electrode: ". Additionally or alternatively, the ECG signal(s) may include at least one respective ECG signal associated with each respective ECG channel. In some embodiments, the plurality of ECG channels may include a first ECG channel and a second ECG channel Additionally or alternatively, the ECG signal(s) may include a first respective ECG signal associated with the first ECG channel and a second respective ECG signal associated with the second ECG channel. In some embodiments, the first respective ECG signal may be substantially orthogonal to the second respective ECG signal. For example, the first ECG channel may be associated with a first electrode positioned proximate a front of the patient and a second electrode positioned proximate a back of the patient (e.g., a front-to-back (FB) channel).").
Regarding claim 70, Weinstein, in combination with Volpe, teaches the wearable cardiac monitoring and treatment system of claim 68 (see 103 rejection above). Weinstein further discloses wherein the one or more ECG segments are from a first period of time, and wherein the one or more additional ECG segments are from a second period of time later than the first period of time. (para. [0072]: " The processor(s) may also use the rhythm change classifier to detect time data corresponding to a rhythm change (e.g., predetermined rhythm change and/or the like) in the ECG signal(s). For example, the time data may include a start time, a time interval, any combination thereof, and/or the like. The processor(s) may also determine, based on the detected time data, at least one ECG signal portion associated with the detected time data corresponding to the predetermined rhythm change in the ECG signal(s). The processor(s) may also transmit the determined ECG signal portion(s) to a remote computer system (e.g., a remote server, a cardiac monitoring facility, and/or the like)."; A change in time implies a first signal taken at a first time and a second signal taken at a second time period different (later) than the first.).
Regarding claim 71, Weinstein teaches the wearable cardiac monitoring and treatment system of claim 64 (see above). However, Weinstein does not expressly teach wherein the one or more processors are configured to independently analyze, at the medical device controller, the one or more ECG segments to generate a local indication as to whether the ambulatory patient is experiencing a treatable arrhythmia using a second process. The Examiner notes that Weinstein does disclose a processor for determining the one or more ECG segments corresponding to the suspected arrhythmia occurring in the ambulatory patient based on the ECG signal using a first process (para. [0460]: "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. For example, such therapeutic shocks can be pacing, defibrillation, or transcutaneous electrical nerve stimulation (TENS) pulses."; para. [0465]: "One or more of the therapy electrodes 1214 can be configured to deliver one or more therapeutic defibrillating shocks to the body of the patient 1202"; para. [0483]: “In some embodiments, an ECG analysis system (e.g., arrhythmia monitoring system, heart failure status monitoring, and/or the like) may include ECG being acquired with a sensor on the body (e.g., external heart monitoring device, which may include ECG electrodes and/or ECG processing circuitry, as described herein). Additionally or alternatively, a neural net may process the ECG signal(s) to identify and flag reportable intervals (e.g., ECG signal portions associated with at least one predetermined rhythm change, as descried herein).”).
Volpe discloses wherein the one or more processors are configured to determine the one or more ECG segments corresponding to the suspected arrhythmia occurring in the ambulatory patient based on the ECG signal using a first process; and wherein the one or more processors are configured to independently analyze, at the medical device controller, the one or more ECG segments to generate a local indication as to whether the ambulatory patient is experiencing a treatable arrhythmia using a second process. (Fig. 11, para. [0156]-[0161]; Volpe teaches an abnormality detection process (first process) followed by medical controller's attempt to verify the declared arrythmia (second process).).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to include a second process for arrythmia verification in addition to the initial detection process, as disclosed by Volpe, in the system of Weinstein. One of ordinary skill in the art would recognize the advantage of including this modification in that it reduces administration of therapeutic delivery based on false positives (see para. [0056] of Volpe). One of ordinary skill would recognize that including this false positive detection system would have been an obvious modification to make to the device of Weinstein. Thus, it would have been obvious to combine the system and device of Volpe with that of Weinstein.
Regarding claim 72, Weinstein, in combination with Volpe, discloses the wearable cardiac monitoring and treatment system of claim 71 (see above). Volpe further discloses wherein the first process comprises a lower power process than the second process. (para. [0197] discloses where two different processes might have a different number of subprocesses; different power consumption is required for each number of subprocesses, and therefore, each process has a different power consumption level. The process with the lower power is considered the first process.).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sullivan et al. (US 20180116537 A1, “Sullivan”) discloses an ambulatory cardiac monitor that detects abnormal heart rhythm using a plurality of ECG and therapy electrodes. Sullivan is directed to distinguishing noise from a signal, and is pertinent to claims 64-72.
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/O.L.M./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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