DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Notice to Applicant
2. This communication is in response to the communication filed 5/20/2026. Claims 1-16, 29-52 and 56-58 are cancelled. Claims 18-20, 24, 26-27 and 54 are currently amended. Claims 17-28 and 53-55 are currently pending.
Election/Restrictions
3. Original claims 1-58 were restricted. Applicant has elected, without traverse, Invention II, claims 17-28 and 53-55.
Claim Rejections - 35 USC § 101
4. 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.
4.1. Claims 17-28 and 53-55 are rejected under 35 U.S.C. § 101 because while the claims (1) are to a statutory category (i.e., process, machine, manufacture or composition of matter, the claims (2A1) recite an abstract idea (i.e., a law of nature, a natural phenomenon); (2A2) do not recite additional elements that integrate the abstract idea into a practical application; and (2B) are not directed to significantly more than the abstract idea itself.
In regards to (1), the claims are to a statutory category (i.e., statutory categories including a process, machine, manufacture or composition of matter). In particular, independent claims 17 and 53, and their respective dependent claims are directed, in part, to methods and systems for assessing future cardiac risk for a patient.
In regards to (2A1), the claims, as a whole, recite and are directed to an abstract idea because the claims include one or more limitations that correspond to an abstract idea including mental processes and/or certain methods of organizing human activity which encompasses both certain activity of a single person, certain activity that involves multiple people, and certain activity between a person and a computer. For example, independent claims 17 and 53, as a whole, are directed to assessing future cardiac risk for a patient by, inter alia, obtaining ECG signals from a patient wearing a wearable cardiac sensing device, identifying ECG data points corresponding to premature ventricular contractions (PVCs) of the patient, determining a count and/or a burden associated with the PVC patterns, and outputting risk information concerning sudden cardiac arrest event, etc. which are human activities and/or interactions and therefore, certain methods of organizing human activity which encompasses both certain activity of a single person, certain activity that involves multiple people, and certain activity between a person and a computer. The dependent claims include all of the limitations of their respective independent claims and thus are directed to the same abstract idea identified for the independent claims but further describe the elements and/or recite field of use limitations.
Furthermore, the claims are also directed to an abstract idea because the claims, except for certain limitations (* identified below in bold), under the broadest reasonable interpretation, can be reasonably and practically performed in the human mind and/or with pen and paper using observation, evaluation, judgment and/or opinion. That is, other than reciting the certain additional elements, nothing in the claims precludes the limitations from being practically performed in the mind and/or with pen and paper. For example, nothing in the claims prevents a human from assessing future cardiac risk for a patient, identifying ECG data points corresponding to PVC, determining PVC patterns based on ECG data points corresponding to the PVC, determining count and/or burden associated with the PVC pattern, outputting risk information, etc. using observation, evaluation, judgment and/or opinion.
CLAIM 17
A cardiac event risk assessment system for assessing future cardiac risk for a patient, the system comprising:
a wearable cardiac sensing device configured to be removably, bodily-attached to the patient, the wearable cardiac sensing device configured to sense electrocardiogram (ECG) signals from a patient and provide digitized ECG signals; and
a processor in communication with the wearable cardiac sensing device, the processor configured for:
identifying ECG data points corresponding to premature ventricular contractions (PVCs) of the patient based on the digitized ECG signal;
determining one or more PVC patterns based on the identified ECG data points corresponding to the PVCs of the patient;
determining one or more of a count or a burden associated with the one or more PVC patterns; and
outputting risk information concerning sudden cardiac arrest event occurring within a predetermined future period of time by applying a trained machine learning algorithm to the determined one or more of the count or the burden associated with the patient, wherein the trained machine learning algorithm is trained at least in part on historical PVC pattern data derived from a plurality of patients.
CLAIM 18
The system of claim 17, wherein a PVC pattern comprises a PVC run, wherein a PVC run is indicative of a number of consecutive PVCs, and the PVC run is one of a singlet, couplet, triplet, quadruplet, or Non-sustained ventricular tachycardia (NSVT).
CLAIM 19
The system of claim 17, wherein a PVC pattern comprises a n-geminy, wherein an n-geminy is indicative of the-an interval between PVCs, and the n-geminy is one of a bigeminy, trigeminy, quadrageminy, or 5 geminy.
CLAIM 20
The system of claim 17, wherein a burden associated with the one or more PVC patterns comprises a count associated with the one or more PVC patterns over a total time of the digitized ECG signal.
CLAIM 21
The system of claim 17, wherein the historical PVC pattern data derived from a plurality of patients comprises a first set of PVC pattern data associated with a group of patients who experienced a sudden cardiac arrest event and a second set of PVC pattern data associated with a group of patients who did not experience a sudden cardiac arrest event.
CLAIM 22
The system of claim 17 wherein the risk information comprises one or more of a binary classification of high risk or low risk, a plurality of classes comprising a high-risk, medium-risk, or low risk, a risk score comprising a percentage between 0 and 100, or a risk score comprising a probabilistic measure between 0 and 1.
CLAIM 23
The system of claim 17, wherein the risk information comprises a survival function including a probability that a patient will remain free of having a sudden cardiac arrest event after the predetermined future period of time, or the risk information comprises a hazard function indicative of a frequency or a rate that a sudden cardiac arrest event will occur after the predetermined future period of time has elapsed without the patient having a sudden cardiac arrest event.
CLAIM 24
The system of claim 17, wherein the risk of the future sudden cardiac arrest event is determined for a predetermined future period of time, comprising one of one month, 14-days, 10-days, 5-days, 3-days, 1-day, 20 hours, 16 hours, 10 hours, 5 hours, 3 hours, or 1 hour, and is based on a time span derived from training data comprising the PVC pattern data and known sudden cardiac arrest events.
CLAIM 25
The system of claim 17, wherein outputting the risk information comprises at least one of displaying the risk information on a display screen, generating a medical report comprising the risk information, initiating an alarm responsive to the risk information, or initiating a therapeutic protocol responsive to the risk information.
CLAIM 26
The system of claim 17, wherein the wearable cardiac sensing device further comprises:
a garment configured to be worn around the a patient's torso for an extended period of time; and
one or more sensors configured to sense physiological signals, wherein the physiological signals comprises electrocardiogram (ECG) signals, wherein at least a portion of the one or more sensors are configured to be removably mounted onto or permanently integrated into the garment.
CLAIM 27
The system of claim 26, wherein the wearable cardiac sensing device further comprises a removable adhesive patch configured to be adhere to skin of the patient, and at least a portion of the plurality-one or more of-sensors are configured to be removably mounted onto the removable adhesive patch.
CLAIM 28
The system of claim 27, wherein the wearable cardiac sensing device further comprises a cardiac sensing unit incorporating the portion of the one or more sensors, the cardiac sensing unit configured to be removably mounted onto the removable adhesive patch.
CLAIM 53
A non-transitory computer-readable medium for assessing future cardiac risk for a patient, the computer-readable medium comprising program instructions that, when executed by at least one processor, cause the at least one processor to:
identify ECG data points corresponding to premature ventricular contractions (PVCs) of the patient based on a digitized ECG signal, wherein the digitized ECG signal is provided by a wearable cardiac sensing device configured to sense electrocardiogram (ECG) signals from the patient and is configured to be removably, bodily-attached to the patient;
determine one or more PVC patterns based on the identified ECG data points corresponding to the PVCs of the patient;
determine one or more of a count or a burden associated with the one or more PVC patterns; and
output risk information concerning sudden cardiac arrest event occurring within a predetermined future period of time by applying a trained machine learning algorithm to the determined one or more of the count or the burden associated with the patient, wherein the trained machine learning algorithm is trained at least in part on historical PVC pattern data derived from a plurality of patients.
CLAIM 54
The non-transitory computer-readable medium of claim 53, wherein the one or more PVC patterns comprises a PVC run or an n-geminy, and a burden associated with the one or more PVC patterns comprises a count associated with the one or more PVC patterns over the a total time of the digitized ECG signal, wherein the PVC run is indicative of the-a_number of consecutive PVCs, and the PVC run is one of a singlet, couplet, triplet, quadruplet, or Non- sustained ventricular tachycardia (NSVT), and the PVC pattern comprises a n-geminy, wherein an n-geminy is indicative of the-an interval between PVCs, and the n-geminy is one of a bigeminy, trigeminy, quadrageminy, or 5-geminy.
CLAIM 55
The non-transitory computer-readable medium of claim 53, wherein the program instructions further cause the at least one processor to at least one of: display the risk information on a display screen, generate a medical report comprising the risk information, initiate an alarm responsive to the risk information, or initiate a therapeutic protocol responsive to the risk information.
* The limitations that are in bold are considered “additional elements” that are further analyzed below in subsequent steps of the 101 analysis. The limitations that are not in bold are abstract and/or can be reasonably and practically performed in the human mind and/or with pen paper.
In regards to (2A2), the claims do not recite additional elements that integrate the abstract idea into a practical application. The additional elements in the claims (i.e., * identified above in bold) do not integrate the abstract idea into a practical application because the additional elements merely add insignificant extra-solution activity to the abstract idea; merely link the use of the judicial exception to a particular technological environment or field of use; and/or simply append technologies and functions, specified at a high level of generality, to the abstract idea (i.e., the additional elements do not amount to more than a recitation of the words “apply it” (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer).
Here, the additional elements (e.g., wearable cardiac sensing device, processor, machine learning, display, etc.) are recited at a high-level of generality such that it amounts to no more than mere instructions to apply the abstract idea using generic computer technologies. Moreover, the claims recite “processor configured for”, “cause the ate least one processor”, etc. devoid of any meaningful technological improvement details and thus, further evidence the additional elements are merely being used to leverage generic technologies to automate what otherwise could be done manually. Accordingly, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Furthermore, the additional elements do not recite improvements to the functioning of a computer, or to any other technology or technical field—the additional elements merely recite general purpose computer technology; the additional elements do not recite applying or using a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition—there is no actual administration of a particular treatment; the additional elements do not recite applying the judicial exception with, or by use of, a particular machine—the additional elements merely recite general purpose computer technology; the additional elements do not recite limitations effecting a transformation or reduction of a particular article to a different state or thing—the additional elements do not recite transformation such as a rubber mold process; the additional elements do not recite applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment—the additional elements merely leverage general purpose computer technology to link the abstract idea to a technological environment.
In regards to (2B), the claims, individually, as a whole and in combination with one another, do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of (A) a generic computer structure(s) that serves to perform computer functions that serve to merely link the abstract idea to a particular technological environment (i.e., computers); and/or (B) functions that are well-understood, routine, and conventional activities previously known to the pertinent industry.
Here, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply the exception using generic computer technologies. Mere instructions to apply an exception using generic computer technologies cannot provide an inventive concept.
Moreover, paragraphs [0083]-[0085] of applicant's specification (US 2025/0057463) recites that the system/method may be implemented using desktop computers, laptop computers, and/or portable personal digital assistants (e.g., smartphones, tablet computers, etc.) which are well-known general purpose or generic-type computers and/or technologies. The use of generic computer components recited at a high level of generality to process information through an unspecified processor/computer does not impose any meaningful limit on the computer implementation of the abstract idea. Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception (the abstract idea). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Furthermore, the additional elements are merely well-known general purpose computers, components and/or technologies that receive, transmit, store, display, generate and otherwise process information which are akin to functions that courts consider well-understood, routine, and conventional activities previously known to the pertinent industry, such as, performing repetitive calculations; receiving or transmitting data over a network; electronic recordkeeping; retrieving and storing information in memory; and sorting information (See, for example, MPEP § 2106).
Therefore, the claims are not patent-eligible under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 103
5. 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.
5.1. Claims 17-20, 24-28 and 53-55 are rejected under 35 U.S.C. 103 as being unpatentable over Freeman et al. (US 2018/0272147), in view of Burnes et al. (US 2021/0128005).
CLAIM 17
Freeman teaches a cardiac event risk assessment system for assessing future cardiac risk for a patient (Freeman: abstract), the system comprising:
a wearable cardiac sensing device configured to be removably, bodily-attached to the patient, the wearable cardiac sensing device configured to sense electrocardiogram (ECG) signals from a patient and provide digitized ECG signals (Freeman: abstract; ¶¶ [0026]-[0027] “wearable system 100 is configured to be worn by a patient and to provide cardiac monitoring, cardiac therapy, and/or remote ischemic conditioning (RIC) therapy” and “wearable system includes a garment 110, one or more sensing electrodes 112”, [0030] “sensing electrodes 112 are configured to monitor and detect electrocardiogram (ECG) signals of the patient”; FIGS. 1-12); and
a processor in communication with the wearable cardiac sensing device, the processor configured for (Freeman: abstract; ¶¶ [0044]-[0045] “The system controller 120 includes a processor 418, a memory 420, a sensor interface 412, a therapy delivery circuit 402, a communications network interface 406, a battery 410, and a cuff controller interface 404. In general, the system controller 120 is configured to monitor the patient's medical condition, to perform medical data logging, storage, and communication, and to provide medical treatment to the patient in response to a detected and/or predicted medical event or conditions”; FIGS. 1-4):
identifying ECG data points corresponding to premature ventricular contractions (PVCs) of the patient based on the digitized ECG signal (Freeman: abstract; ¶¶ [0134] “the processor 418 (or the one or more external computing devices 190) gather and clean input data from ECG and non-ECG data sources to provide a set of weighted metrics for each patient. For example, the metrics extracted from the ECG signal may include one or more of heart rate, measurement of premature ventricular contractions, heart rate variability, PVC burden or counts”; FIGS. 1-12);
determining one or more PVC based on the identified ECG data points corresponding to the PVCs of the patient (Freeman: abstract; ¶¶ [0134] “the processor 418 (or the one or more external computing devices 190) gather and clean input data from ECG and non-ECG data sources to provide a set of weighted metrics for each patient. For example, the metrics extracted from the ECG signal may include one or more of heart rate, measurement of premature ventricular contractions, heart rate variability, PVC burden or counts”; FIGS. 1-12);
determining one or more of a count or a burden associated with the one or more PVC (Freeman: abstract; ¶¶ [0134] “the processor 418 (or the one or more external computing devices 190) gather and clean input data from ECG and non-ECG data sources to provide a set of weighted metrics for each patient. For example, the metrics extracted from the ECG signal may include one or more of heart rate, measurement of premature ventricular contractions, heart rate variability, PVC burden or counts”; FIGS. 1-12); and
outputting risk information concerning sudden cardiac arrest event occurring within a predetermined future period of time by applying a trained machine learning algorithm to the determined one or more of the count or the burden associated with the patient, wherein the trained machine learning algorithm is trained at least in part on historical PVC pattern data derived from a plurality of patients (Freeman: abstract; ¶¶ [0135]-[0137] “processor 418 may calculate the cardiac event risk scores using various algorithms (e.g., various scoring models, mathematical models, statistical analysis, classifier models, and combinations thereof). In an implementation, the one or more external computing devices 190 may supplement the calculations performed by the processor 418. For example, the external computing devices may handle machine learning” and “risk scores for individual patients can be obtained by applying machine learning algorithms”; FIGS. 1-12).
Freeman may not explicitly teach the following:
patterns.
Burnes, however, teaches the following:
patterns (Burnes: abstract; ¶¶ [0007] “detect and identify patterns of PVCs”, [0081] “a beat pattern in a cardiac EGM signal comprising a normal beat, a PVC, a normal beat, a PVC”; FIGS. 1-10).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include the system and method for triggering storage of ECG detected PVCS using patterns, as taught by Burnes, with the wearable defibrillator integrated with remote ischemic conditioning protocol, as taught by Freeman, with the motivation of facilitating PVC detection (Burnes: ¶¶ [0002]-[0007]).
CLAIM 18
Freeman does not appear to explicitly teach the system of claim 17, wherein a PVC pattern comprises a PVC run, wherein a PVC run is indicative of a number of consecutive PVCs, and the PVC run is one of a singlet, couplet, triplet, quadruplet, or Non-sustained ventricular tachycardia (NSVT).
Burnes, however, teaches wherein a PVC pattern comprises a PVC run, wherein a PVC run is indicative of a number of consecutive PVCs, and the PVC run is one of a singlet, couplet, triplet, quadruplet, or Non-sustained ventricular tachycardia (NSVT) (Burnes: abstract; ¶¶ [0081]-[0083] “a bigeminy, a trigeminy, a quadrigeminy, a couplet, or a triplet event is detected”; FIGS. 1-10).
The motivation to include the teachings of Burnes with the teachings of Freeman is the same as that of claim 17 above and is incorporated herein.
CLAIM 19
Freeman does not appear to explicitly teach the system of claim 17, wherein a PVC pattern comprises a n-geminy, wherein an n-geminy is indicative of the-an interval between PVCs, and the n-geminy is one of a bigeminy, trigeminy, quadrageminy, or 5-geminy.
Burnes, however, teaches wherein a PVC pattern comprises a n-geminy, wherein an n-geminy is indicative of the-an interval between PVCs, and the n-geminy is one of a bigeminy, trigeminy, quadrageminy, or 5 geminy (Burnes: abstract; ¶¶ [0081]-[0083] “a bigeminy, a trigeminy, a quadrigeminy, a couplet, or a triplet event is detected”; FIGS. 1-10).
The motivation to include the teachings of Burnes with the teachings of Freeman is the same as that of claim 17 above and is incorporated herein.
CLAIM 20
Freeman teaches the system of claim 17, wherein a burden associated with the one or more PVC patterns comprises a count associated with the one or more PVC patterns over a total time of the digitized ECG signal (abstract; ¶¶ [0043] “sensing electrodes 112 and/or the additional sensors may provide the system controller 120 with physiological signals at periodic or aperiodic time intervals and times. These time intervals and/or times may be pre-determined and/or user input or other events may trigger monitoring”, [0134] “PVC burden or counts”; FIGS. 1-12).
CLAIM 24
Freeman teaches the system of claim 17, wherein the risk of the future sudden cardiac arrest event is determined for a predetermined future period of time, comprising one of one month, 14-days, 10-days, 5-days, 3-days, 1-day, 20 hours, 16 hours, 10 hours, 5 hours, 3 hours, or 1 hour, and is based on a time span derived from training data comprising the PVC pattern data and known sudden cardiac arrest events (Freeman: abstract; ¶¶ [0090] “cardiac event risk score corresponds to a time interval (e.g., a time-until-event) and a particular cardiac event. The time-until-event (TuE) (e.g., seconds, minutes, hours, days, weeks, etc.)”, [0092], [0137]; Table 1; FIGS. 1-12).
CLAIM 25
Freeman teaches the system of claim 17, wherein outputting the risk information comprises at least one of displaying the risk information on a display screen, generating a medical report comprising the risk information, initiating an alarm responsive to the risk information, or initiating a therapeutic protocol responsive to the risk information ((Freeman: abstract; ¶¶ [0006] “The controller may be configured to transmit the cardiac information of the patient to one or more external computing devices via the communications network interface and to receive a cardiac event risk score via the communications network interface”, [0050] “therapy delivery circuit 402 is coupled to the one or more therapy electrodes 114. For example, the therapy delivery circuit 402 can include, or be operably connected to, circuitry components that are configured to generate and provide pacing and/or defibrillation pulses”, [0089]-[0090] “wearable system 100 may implement RIC therapy to treat the patient at the earliest stages of the cardiac event”, [0113] “method 800 includes controlling delivery of a defibrillation shock based on the cardiac information for the patient”; FIGS. 1-12).
CLAIM 26
Freeman teaches the system of claim 17, wherein the wearable cardiac sensing device further comprises: a garment configured to be worn around the a patient's torso for an extended period of time; and one or more sensors configured to sense physiological signals, wherein the physiological signals comprises electrocardiogram (ECG) signals, wherein at least a portion of the one or more sensors are configured to be removably mounted onto or permanently integrated into the garment (Freeman: abstract; ¶¶ [0028]-[0029] “garment 110 may be a vest, as shown for example in FIG. 1, a shirt, a jacket, or other garment configured to be worn on the torso of the patient”, [0030] “physiological sensors”; FIGS. 1-12).
CLAIM 27
Freeman teaches the system of claim 26, wherein the wearable cardiac sensing device further comprises a removable adhesive patch configured to be adhere to skin of the patient, and at least a portion of the plurality-one or more of-sensors are configured to be removably mounted onto the removable adhesive patch (Freeman: abstract; ¶¶ [0030] “adhesive layer”, [0036] “adhesive surface”; FIGS. 1-12).
CLAIM 28
Freeman teaches the system of claim 27, wherein the wearable cardiac sensing device further comprises a cardiac sensing unit incorporating the portion of the one or more sensors, the cardiac sensing unit configured to be removably mounted onto the removable adhesive patch (Freeman: abstract; ¶¶ [0030] “sensing electrodes 112 may include an adhesive layer configured to stick to the skin of the patient”, [0036] “adhesive surface”; FIGS. 1-12).
CLAIMS 53-55
Claims 53-55 repeat substantially the same limitations as those in claims 17-20 and 25. As such, claims 53-55 are rejected for substantially the same reasons given for claims 17-20 and are incorporated herein.
5.2. Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Freeman et al. (US 2018/0272147), in view of Burnes et al. (US 2021/0128005), and further in view of Sullivan et al. (US 2016/0135706).
CLAIM 21
Freeman and Burnes do not appear to explicitly teach the system of claim 17, wherein the historical PVC pattern data derived from a plurality of patients comprises a first set of PVC pattern data associated with a group of patients who experienced a sudden cardiac arrest event and a second set of PVC pattern data associated with a group of patients who did not experience a sudden cardiac arrest event.
Sullivan, however, teaches wherein the historical PVC pattern data derived from a plurality of patients comprises a first set of PVC pattern data associated with a group of patients who experienced a sudden cardiac arrest event and a second set of PVC pattern data associated with a group of patients who did not experience a sudden cardiac arrest event (Sullivan: abstract; ¶¶ [0429] “training database may comprise substantially equal numbers of subjects who have experienced degradation of a medical condition—in the case of a cardiac event, a cardiac arrest—and subjects that have not experienced degradation of a medical condition”; FIGS. 1-17).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include the system and method for medical premonitory event estimation, as taught by Sullivan, with the system and method for triggering storage of ECG detected PVCS using patterns, as taught by Burnes, with the wearable defibrillator integrated with remote ischemic conditioning protocol, as taught by Freeman, with the motivation of facilitating cardiac event estimation (Sullivan: ¶¶ [0003]-[0007]).
5.3. Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Freeman et al. (US 2018/0272147), in view of Burnes et al. (US 2021/0128005), and further in view of Whiting et al. (US 2018/0235537).
CLAIM 22
Freeman and Burnes do not appear to explicitly teach the system of claim 17 wherein the risk information comprises one or more of a binary classification of high risk or low risk, a plurality of classes comprising a high-risk, medium-risk, or low risk, a risk score comprising a percentage between 0 and 100, or a risk score comprising a probabilistic measure between 0 and 1.
Whiting, however, teaches wherein the risk information comprises one or more of a binary classification of high risk or low risk, a plurality of classes comprising a high-risk, medium-risk, or low risk, a risk score comprising a percentage between 0 and 100, or a risk score comprising a probabilistic measure between 0 and 1 (Whiting: abstract; ¶¶ [0009] “severity level for each of the plurality of zone rankings comprises at least one of low risk, medium risk, high risk”, [0091]; FIGS. 1-13).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include the system and method for assigning zone-based rankings and actions to patients with cardiac health ailments, as taught by Whiting, with the system and method for triggering storage of ECG detected PVCS using patterns, as taught by Burnes, with the wearable defibrillator integrated with remote ischemic conditioning protocol, as taught by Freeman, with the motivation of facilitating monitoring and treatment of patients (Whiting: ¶¶ [0001]-[0006]).
5.4. Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Freeman et al. (US 2018/0272147), in view of Burnes et al. (US 2021/0128005), and further in view of Nemani et al. (US 11869668).
CLAIM 23
Freeman and Burnes do not appear to explicitly teach the system of claim 17, wherein the risk information comprises a survival function including a probability that a patient will remain free of having a sudden cardiac arrest event after the predetermined future period of time, or the risk information comprises a hazard function indicative of a frequency or a rate that a sudden cardiac arrest event will occur after the predetermined future period of time has elapsed without the patient having a sudden cardiac arrest event.
Nemani, however, teaches wherein the risk information comprises a survival function including a probability that a patient will remain free of having a sudden cardiac arrest event after the predetermined future period of time, or the risk information comprises a hazard function indicative of a frequency or a rate that a sudden cardiac arrest event will occur after the predetermined future period of time has elapsed without the patient having a sudden cardiac arrest event (Nemani: abstract; col. 26, lns. 24-43 “incidence-free survival analysis”; col. 28, lns. 33-62 “incidence-free survival curves” Examiner notes that an ”incidence-free curve” is a graph that shows the percentage of people who remain free of a specific medical event (e.g., PVC) over a period of time.; FIGS. 1-31).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include the artificial intelligence based cardiac event predictor system and method, as taught by Nemani, with the system and method for triggering storage of ECG detected PVCS using patterns, as taught by Burnes, with the wearable defibrillator integrated with remote ischemic conditioning protocol, as taught by Freeman, with the motivation of better predicting cardiac event risks (Nemani: col. 1, ln. 34-col. 3, ln. 40).
Relevant Non-Cited Prior Art
6. The following discovered prior art was not cited in this rejection but may be relevant:
Hanuliak (US 2018/0168471) – System and Method for ECG Signal Processing
Kaib et al. (US 10729910) – Garments for Wearable Medical Devices
Messier et al. (US 2011/0082378) – Cardiac Risk Stratification
Zimmerman (US 2022/0378379) – Artificial Intelligence Based Cardiac Event Predictor Systems and Methods
Conclusion
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Tomaszewski whose telephone number is (313)446-4863. The examiner can normally be reached M-F 5:30 am - 2:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter H Choi can be reached at (469) 295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL TOMASZEWSKI/Primary Examiner, Art Unit 3681
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