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 .
Information Disclosure Statement
The Information Disclosure Statement (IDS) dated 10/07/2024 has been considered by the Examiner.
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.
Claims 1-16 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1 and 10 are directed to the abstract idea/mental process of determining a first cardiac event parameter indicative of a probability of a future cardiac event based on a first and/or second set of parameters based on sensor data, which can generally be considered to be concepts performable in the human mind including observation, evaluation, and judgement.
Step 1
Claim 1 recites a machine and claim 10 recites a method.
Step 2A, Prong 1
Claims 1 and 10 recite the limitations of determining a first set of first parameters based on sensor data,
determining a second set of second parameters based on sensor data,
determining if one or more transmission criteria are satisfied, and
determining first cardiac event parameter indicative of a probability of a future cardiac event, wherein the first cardiac event parameter is based on one or more of the first or second set of parameters based on sensor data.
These steps, under their broadest reasonable interpretation, can be practically performed in the human mind and are thereby considered to be directed to an abstract idea/mental process. A human could determine a first and second set of parameters based on measured sensor data, determine a parameter (threshold) indicative of a probability of a future cardiac event, based on the first or second set of parameters based on sensor data, and determine if the cardiac event parameter met a threshold (transmission criteria).
Step 2A, Prong 2
Claims 1 and 10 not include any additional elements that integrate the abstract idea into a practical application.
Claims 1 and 10 include the additional elements of a first lead for cardiac stimulation;
one or more sensors;
a processing device comprising a processor, a communication interface, and a lead interface; and an accessory device.
The first lead for cardiac stimulation merely links the use of the judicial exception to a particular technological environment.
The one or more sensors amount to insignificant extra-solution activity of mere data gathering, in the form of performing clinical tests, in this case the measurement of parameters based on sensor data including heart rate, to obtain input for an equation, wherein the equation is the determination of a first cardiac event parameter indicative of the probability of a future cardiac event. See MPEP 2106.05(g), In re Grams, 888 F.2d 835.
The processing device comprising a processor, a communication interface, and a lead interface merely amounts to the computer implementation of the abstract idea.
The accessory device amounts to post-solution activity of necessary data outputting required for the use of the recited judicial exception.
None of the additional elements alone or in combination integrate the abstract idea into practical application.
Step 2B
Claims 1 and 10 do not include any additional elements that amount to significantly more than the abstract idea.
See the analysis of the additional elements of a first lead for cardiac stimulation;
one or more sensors;
a processing device comprising a processor, a communication interface, and a lead interface; and an accessory device above in Step 2A, Prong 2.
Additionally, the additional elements of the claimed apparatus (implantable cardiac lead, one or more sensors, processing device, and accessory device) can be held to be well-understood, routine, and conventional in the art, and they are recited with a high level of generality which does not amount to significantly more than the abstract idea itself.
Claims 2, 4, 6, 7, 11, 13, 15, and 16 further limit the abstract idea.
Claims 3, 5, 8, 9, 12, and 14 further limit the extra-solution activity of data gathering.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 1-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sweeney et al (US 20020016550 A1).
Regarding claim 1, Sweeney teaches a cardiovascular implantable electronic device (105) comprising:
a first lead (110A-C) for cardiac stimulation one or more sensors for provision of sensor data (310 and/or 320); and
a processing device (105) comprising
a processor (325),
a communication interface (305), and
a lead interface (see Fig. 3, [0041]; sensing module 310 senses intrinsic heart activity signals from one or more electrodes, therapy is provided at the electrodes via therapy module 315),
wherein the processor is configured to:
obtain sensor data from the one or more sensors (see Fig. 3, [0041-0042]; sensing module 310 senses intrinsic heart activity signals from one or more electrodes, sensor module 320 includes one or more sensors and may receive control signals from the processor)
determine a first set of first parameters based on the sensor data (see [0044]; trigger/marker module 345 detects one or more triggers/markers based at least in part on signals received from sensing modules 310 and 320);
wherein the first parameter(s) is/are indicative of heart rate (see [0035]; markers, which may be obtained from one or more electrophysiologic signals, or from one or more signals from one or more other sensors, include heart rate, increased or decreased heart rate, abnormal heart rate variability, etc.),
determine a second set of second parameters based on the sensor data (see [0052-0054]; detection processing module 405 uses the beat-to-beat intervals and morphological data extracted from the signals by beat classification module 400 and also extracts any additional morphological measure required for trigger/marker detection);
determine a first cardiac event parameter indicative of a probability of a future cardiac event (see Fig. 6, arrhythmia prediction module 350) and indicative of a probability of a first cardiac event occurring within a first time period of 15 minutes to 1 week (see [0061-0065]; predictions of future arrhythmias are made at approximately regular time intervals such as the BTP, basic time period, wherein the BTP may correspond to times ranging from 2 minutes to 1 week or longer),
wherein the first cardiac event parameter is based on one or more first parameters of the first set and one or more second parameters of the second set (see [0067-0070]; arrhythmia prediction module 350 includes a set of one or more arrhythmia probability assertions or statements which identifies which trigger, marker, or combination thereof contributed to the magnitude of the probability);
determine if one or more transmission criteria are satisfied (see [0007]; predicting the occurrence of an arrhythmia within a specified prediction time period if the estimated arrhythmia probability exceeds a specified threshold value); and
in accordance with a first transmission criterion being satisfied, transmit a first warning signal to an accessory device, the first warning signal being indicative of the first cardiac event parameter (see [0101]; preventative therapy control module 355 automatically decides whether to invoke preventative therapy based on arrhythmia probability statements from prediction module 350, wherein preventative therapy may include diagnostic warnings for the physician such as by transmitting diagnostic information from device 105 to external programmer 125 using a telemetry or other communication link).
Regarding claim 2, Sweeney teaches the cardiovascular implantable electronic device according to claim 1, wherein the first transmission criterion is based on the first cardiac event parameter (see [0101]; preventative therapy control module 355 automatically decides whether to invoke preventative therapy based on arrhythmia probability statements from arrhythmia prediction module 350, [0007]; predicting the occurrence of an arrhythmia within a specified prediction time period if the estimated arrhythmia probability exceeds a specified threshold value).
Regarding claim 3, Sweeney teaches the cardiovascular implantable electronic device according to claim 1,
wherein the processor is configured to determine a third set of third parameters based on the sensor data and determine a fourth set of fourth parameters based on the sensor data (see Fig. 4A, [0054-0056]; triggers/markers list wherein a type of triggers/markers may be a "value type" which are based on morphology intrinsic heart activity signals including QRS duration, ST magnitude, QT interval, and R-wave amplitude),
wherein the first cardiac event parameter is based on one or more third parameters of the third set and/or one or more fourth parameters of the fourth set (see [0067-0070]; arrhythmia prediction module 350 includes a set of one or more arrhythmia probability assertions or statements which identifies which trigger, marker, or combination thereof contributed to the magnitude of the probability).
Regarding claim 4, Sweeney teaches the cardiovascular implantable electronic device according to claim 1, wherein the first cardiac event is selected from electrical storm, atrial fibrillation, and ventricular fibrillation/ventricular tachycardia (see [0007]; prediction of an arrhythmia event, [0002]; arrhythmias can cause the heart to beat too slowly, bradycardia, or too quickly, tachycardia).
Regarding claim 5, Sweeney teaches the cardiovascular implantable electronic device according to claim 1, wherein the processor is configured to determine a fifth set of fifth parameters based on the sensor data (see Fig. 4A, [0054-0056]; triggers/markers list wherein a type of triggers/markers may be a "value type" which are based on morphology intrinsic heart activity signals including QRS duration, ST magnitude, QT interval, and R-wave amplitude), and
wherein the first cardiac event parameter is based on one or more fifth parameters of the fifth set (see [0067-0070]; arrhythmia prediction module 350 includes a set of one or more arrhythmia probability assertions or statements which identifies which trigger, marker, or combination thereof contributed to the magnitude of the probability).
Regarding claim 6, Sweeney teaches the cardiovascular implantable electronic device according to claim 1, wherein the processor is configured to:
determine a second cardiac event parameter indicative of a probability of a future cardiac event, wherein the second cardiac event parameter is based on one or more first parameters of the first set and one or more second parameters of the second set (see [0063-0065]; device 105 does not necessarily make the same set of predictions each time predictions are made, the device may make one set of predictions for each basic time period, BTP, that cover times on the order of the BTP, then at BTP multiples that correspond to longer internals, e.g. 20 minutes, 1 hour, 1 day, 1 week, 1 month, a corresponding set of additional predictions are made which cover the correspondingly longer time intervals); and
in accordance with a second transmission criterion being satisfied (see [0007]; predicting the occurrence of an arrhythmia within a specified prediction time period if the estimated arrhythmia probability exceeds a specified threshold value), transmit a second warning signal to an accessory device (125), the second warning signal being indicative of the second cardiac event parameter (see [0101]; preventative therapy control module 355 automatically decides whether to invoke preventative therapy based on arrhythmia probability statements from prediction module 350, wherein preventative therapy may include diagnostic warnings for the physician such as by transmitting diagnostic information from device 104 to external programmer 125 using a telemetry or other communication link).
Regarding claim 7, Sweeney teaches the cardiovascular implantable electronic device according to claim 6, wherein the second cardiac event parameter is indicative of a probability of a second cardiac event occurring within a second time period (see [0063-0065]; device 105 does not necessarily make the same set of predictions each time predictions are made, the device may make one set of predictions for each basic time period, BTP, that cover times on the order of the BTP, then at BTP multiples that correspond to longer internals, e.g. 20 minutes, 1 hour, 1 day, 1 week, 1 month, a corresponding set of additional predictions are made which cover the correspondingly longer time intervals).
Regarding claim 8, Sweeney teaches the cardiovascular implantable electronic device according to claim 1, wherein the second parameter is indicative of average heart rate (see [0055]; trigger/marker may be based on an average of morphology values over some number of previous normal beats).
Regarding claim 9, Sweeney teaches the cardiovascular implantable electronic device according to claim 1, wherein the third parameter is indicative of activity (see [0055]; value triggers/markers may include the present activity level of the patient).
Regarding claim 10, Sweeney teaches a method, performed in a cardiovascular implantable electronic device (105), for cardiovascular event prediction, the method comprising:
obtaining sensor data from one or more sensors (310 and/or 320) of the cardiovascular implantable electronic device (see Fig. 3, [0041-0042]; sensing module 310 senses intrinsic heart activity signals from one or more electrodes, sensor module 320 includes one or more sensors and may receive control signals from the processor),
determining a first set of first parameters based on the sensor data, wherein the first parameter(s) is/are indicative of heart rate (see [0035]; markers, which may be obtained from one or more electrophysiologic signals, or from one or more signals from one or more other sensors, include heart rate, increased or decreased heart rate, abnormal heart rate variability, etc.),
determining a second set of second parameters based on the sensor data (see [0052-0054]; detection processing module 405 uses the beat-to-beat intervals and morphological data extracted from the signals by beat classification module 400 and also extracts any additional morphological measure required for trigger/marker detection);
determining a first cardiac event parameter indicative of a probability of a future cardiac event (see Fig. 6, arrythmia prediction module 350) and indicative of a probability of a first cardiac event occurring within a first time period of 15 minutes to 1 week (see [0061-0065]; predictions of future arrhythmias are made at approximately regular time intervals such as the BTP, basic time period, wherein the BTP may correspond to times ranging from 2 minutes to 1 week or longer),
wherein the first cardiac event parameter is based on one or more first parameters of the first set and one or more second parameters of the second set (see [0067-0070]; arrhythmia prediction module 350 includes a set of one or more arrhythmia probability assertions or statements which identifies which trigger, marker, or combination thereof contributed to the magnitude of the probability) determining if one or more transmission criteria are satisfied (see [0007]; predicting the occurrence of an arrhythmia within a specified prediction time period if the estimated arrhythmia probability exceeds a specified threshold value); and
in accordance with a first transmission criterion being satisfied, transmitting a first warning signal to an accessory device (125), the first waring signal being indicative of the first cardiac event parameter (see [0101]; preventative therapy control module 355 automatically decides whether to invoke preventative therapy based on arrhythmia probability statements from prediction module 350, wherein preventative therapy may include diagnostic warnings for the physician such as by transmitting diagnostic information from device 105 to external programmer 125 using a telemetry or other communication link).
Regarding claim 11, Sweeney teaches the method according to claim 10, wherein the first transmission criterion is based on the first cardiac event parameter (see [0101]; preventative therapy control module 355 automatically decides whether to invoke preventative therapy based on arrhythmia probability statements from arrhythmia prediction module 350, [0007]; predicting the occurrence of an arrhythmia within a specified prediction time period if the estimated arrhythmia probability exceeds a specified threshold value).
Regarding claim 12, Sweeney teaches the method according to claim 10, the method comprising:
determining a third set of third parameters based on the sensor data; and determining a fourth set of parameters based on the sensor data (see Fig. 4A, [0054-0056]; triggers/markers list wherein a type of triggers/markers may be a "value type" which are based on morphology intrinsic heart activity signals including QRS duration, ST magnitude, QT interval, and R-wave amplitude),
wherein the first cardiac event parameter is based on one or more third parameters of the third set, and/or one or more fourth parameters of the fourth set (see [0067-0070]; arrhythmia prediction module 350 includes a set of one or more arrhythmia probability assertions or statements which identifies which trigger, marker, or combination thereof contributed to the magnitude of the probability).
Regarding claim 13, Sweeney teaches the method according to claim 10, wherein the first cardiac event is selected from electrical storm, atrial fibrillation, and ventricular fibrillation/ventricular tachycardia (see [0007]; prediction of an arrhythmia event, [0002]; arrhythmias can cause the heart to beat too slowly, bradycardia, or too quickly, tachycardia).
Regarding claim 14, Sweeney teaches the method according to claim 10, the method comprising determining a fifth set of fifth parameters based on the sensor data (see Fig. 4A, [0054-0056]; triggers/markers list wherein a type of triggers/markers may be a "value type" which are based on morphology intrinsic heart activity signals including QRS duration, ST magnitude, QT interval, and R-wave amplitude), and
wherein the first cardiac event parameter is based on one or more fifth parameters of the fifth set (see [0067-0070]; arrhythmia prediction module 350 includes a set of one or more arrhythmia probability assertions or statements which identifies which trigger, marker, or combination thereof contributed to the magnitude of the probability).
Regarding claim 15, Sweeney teaches the Method according to claim 10, the method comprising:
determining a second cardiac event parameter indicative of a probability of a future cardiac event, wherein the second cardiac event parameter is based on one or more first parameters of the first set and one or more second parameters of the second set (see [0063-0065]; device 105 does not necessarily make the same set of predictions each time predictions are made, the device may make one set of predictions for each basic time period, BTP, that cover times on the order of the BTP, then at BTP multiples that correspond to longer internals, e.g. 20 minutes, 1 hour, 1 day, 1 week, 1 month, a corresponding set of additional predictions are made which cover the correspondingly longer time intervals); and
in accordance with a second transmission criterion being satisfied, transmitting a second warning signal to an accessory device, the second warning signal being indicative of the second cardiac event parameter (see [0101]; preventative therapy control module 355 automatically decides whether to invoke preventative therapy based on arrhythmia probability statements from prediction module 350, wherein preventative therapy may include diagnostic warnings for the physician such as by transmitting diagnostic information from device 104 to external programmer 125 using a telemetry or other communication link).
Regarding claim 16, Sweeney teaches the Method according to claim 15, wherein the second cardiac event parameter is indicative of a probability of a second cardiac event occurring within a second time period (see [0063-0065]; device 105 does not necessarily make the same set of predictions each time predictions are made, the device may make one set of predictions for each basic time period, BTP, that cover times on the order of the BTP, then at BTP multiples that correspond to longer internals, e.g. 20 minutes, 1 hour, 1 day, 1 week, 1 month, a corresponding set of additional predictions are made which cover the correspondingly longer time intervals).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-16 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 12-18 of U.S. Patent No. 12,133,737. Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to a cardiac implantable device (or method performed thereby) with cardiac event detection capabilities wherein sensor data is obtained from one or more sensors to determine a first set of first parameters and a second set of second parameters, and a first cardiac event parameter indicative of a probability of a future cardiac event is determined, wherein the first cardiac event parameter is based on one or more first parameters of the first set and one or more second parameters of the second set.
A brief, but non-exhaustive matching of the pending claims and the issued claims is provided below:
Pending Application
18/907,603
Issued Patent
No. 12,133,737
1. A cardiovascular implantable electronic device comprising: a first lead for cardiac stimulation one or more sensors for provision of sensor data; and a processing device comprising a processor, a communication interface and a lead interface, wherein the processor is configured to: obtain sensor data from the one or more sensors; determine a first set of first parameters based on the sensor data, wherein the first parameter(s) is/are indicative of heart rate; determine a second set of second parameters based on the sensor data determine a first cardiac event parameter indicative of a probability of a future cardiac event and indicative of a probability of a first cardiac event occurring within a first time period of 15 minutes to 1week, wherein the first cardiac event parameter is based on one or more first parameters of the first set and one or more second parameters of the second set; determine if one or more transmission criteria are satisfied: and in accordance with a first transmission criterion being satisfied, transmit a first warning signal to an accessory device, the first warning signal being indicative of the first cardiac event parameter.
1. A cardiovascular implantable electronic device comprising: a first lead for cardiac stimulation; one or more sensors for provision of sensor data; and a processing device comprising a processor, a communication interface and a lead interface, wherein the processor is configured to: obtain sensor data from the one or more sensors; determine a first set of first parameters based on the sensor data, the first set including a first primary parameter based on current sensor data and a first secondary parameter based on sensor data earlier than the current sensor data; determine a second set of second parameters based on the sensor data, the second parameters being different from the first parameters, the second set including a second primary parameter based on current sensor data and a second secondary parameter based on sensor data earlier than the current sensor data; determine, based on a model, a first cardiac event parameter indicative of a probability of a future cardiac event and indicative of a probability of a first cardiac event occurring within a first time period of 15 minutes to 1 week from determining the first cardiac event parameter, wherein the first cardiac event parameter is based on one or more first parameters of the first set and one or more second parameters of the second set; determine if one or more transmission criteria are satisfied; and in accordance with a first transmission criterion being satisfied, transmit a first warning signal to an accessory device, the first warning signal being indicative of the first cardiac event parameter.
9. Cardiovascular implantable electronic device according to claim 1, wherein the first parameter is indicative of heart rate.
2. Cardiovascular implantable electronic device according to claim 1, wherein the first transmission criterion is based on the first cardiac event parameter.
2. Cardiovascular implantable electronic device according to claim 1, wherein the first transmission criterion is based on the first cardiac event parameter.
3. Cardiovascular implantable electronic device according to claim 1, wherein the processor is configured to determine a third set of third parameters based on the sensor data and determine a fourth set of fourth parameters based on the sensor data, wherein the first cardiac event parameter is based on one or more third parameters of the third set and/or one or more fourth parameters of the fourth set.
3. Cardiovascular implantable electronic device according to claim 1, wherein the processor is configured to determine a third set of third parameters based on the sensor data and determine a fourth set of fourth parameters based on the sensor data, wherein the first cardiac event parameter is based on one or more third parameters of the third set and/or one or more fourth parameters of the fourth set.
4.Cardiovascular implantable electronic device according to claim 1, wherein the first cardiac event is selected from electrical storm, atrial fibrillation, and ventricular fibrillation/ventricular tachycardia.
6. Cardiovascular implantable electronic device according to claim 1, wherein the first cardiac event is selected from electrical storm, atrial fibrillation, and ventricular fibrillation/ventricular tachycardia.
5. Cardiovascular implantable electronic device according to claim 1, wherein the processor is configured to determine a fifth set of fifth parameters based on the sensor data, and wherein the first cardiac event parameter is based on one or more fifth parameters of the fifth set.
4. Cardiovascular implantable electronic device according to claim 3, wherein the processor is configured to determine a fifth set of fifth parameters based on the sensor data, and wherein the first cardiac event parameter is based on one or more fifth parameters of the fifth set.
6. Cardiovascular implantable electronic device according to claim1, wherein the processor is configured to: determine a second cardiac event parameter indicative of a probability of a future cardiac event, wherein the second cardiac event parameter is based on one or more first parameters of the first set and one or more second parameters of the second set; and in accordance with a second transmission criterion being satisfied, transmit a second warning signal to an accessory device, the second warning signal being indicative of the second cardiac event parameter.
7. Cardiovascular implantable electronic device according to claim 1, wherein the processor is configured to: determine a second cardiac event parameter indicative of a probability of a future cardiac event, wherein the second cardiac event parameter is based on one or more first parameters of the first set and one or more second parameters of the second set; and in accordance with a second transmission criterion being satisfied, transmit a second warning signal to an accessory device, the second warning signal being indicative of the second cardiac event parameter.
7. Cardiovascular implantable electronic device according to claim 6, wherein the second cardiac event parameter is indicative of a probability of a second cardiac event occurring within a second time period.
8. Cardiovascular implantable electronic device according to claim 7, wherein the second cardiac event parameter is indicative of a probability of a second cardiac event occurring within a second time period.
8. Cardiovascular implantable electronic device according to claim 1, wherein the second parameter is indicative of average heart rate.
10. Cardiovascular implantable electronic device according to claim 1, wherein the second parameter is indicative of average heart rate.
9. Cardiovascular implantable electronic device according to claim 1, wherein the third parameter is indicative of activity.
5. Cardiovascular implantable electronic device according to claim 3, wherein the third parameter is indicative of activity.
10. (New)Method, performed in a cardiovascular implantable electronic device, for cardiovascular event prediction, the method comprising: obtaining sensor data from one or more sensors of the cardiovascular implantable electronic device; determining a first set of first parameters based on the sensor data, wherein the first parameter(s) is/are indicative of heart rate; determining a second set of second parameters based on the sensor data; determining a first cardiac event parameter indicative of a probability of a future cardiac event and indicative of a probability of a first cardiac event occurring within a first time period of 15 minutes to 1 week. wherein the first cardiac event parameter is based on one or more first parameters of the first set and one or more second parameters of the second set determining if one or more transmission criteria are satisfied; and in accordance with a first transmission criterion being satisfied, transmitting a first warning signal to an accessory device, the first waring signal being indicative of the first cardiac event parameter.
12. Method, performed in a cardiovascular implantable electronic device, for cardiovascular event prediction, the method comprising: obtaining sensor data from one or more sensors of the cardiovascular implantable electronic device; determining a first set of first parameters based on the sensor data, the first set including a first primary parameter based on current sensor data and a first secondary parameter based on sensor data earlier than the current sensor data; determining a second set of second parameters based on the sensor data, the second parameters being different from the first parameters, the second set including a second primary parameter based on current sensor data and a second secondary parameter based on sensor data earlier than the current sensor data; determining, based on a model, a first cardiac event parameter indicative of a probability of a future cardiac event and indicative of a probability of a first cardiac event occurring within a first time period of 15 minutes to 1 week from determining the first cardiac event parameter, wherein the first cardiac event parameter is based on one or more first parameters of the first set and one or more second parameters of the second set; determining if one or more transmission criteria are satisfied; and in accordance with a first transmission criterion being satisfied, transmitting a first warning signal to an accessory device, the first warning signal being indicative of the first cardiac event parameter.
11. Method according to claim 10, wherein the first transmission criterion is based on the first cardiac event parameter.
13. Method according to claim 12, wherein the first transmission criterion is based on the first cardiac event parameter.
12. Method according to claim 10. the method comprising: determining a third set of third parameters based on the sensor data; and determining a fourth set of parameters based on the sensor data, wherein the first cardiac event parameter is based on one or more third parameters of the third set, and/or one or more fourth parameters of the fourth set.
14. Method according to claim 12, the method comprising: determining a third set of third parameters based on the sensor data; and determining a fourth set of fourth parameters based on the sensor data, wherein the first cardiac event parameter is based on one or more third parameters of the third set, and/or one or more fourth parameters of the fourth set.
13. Method according to claim 10, wherein the first cardiac event is selected from electrical storm, atrial fibrillation, and ventricular fibrillation/ventricular tachycardia.
16. Method according to claim 12, wherein the first cardiac event is selected from electrical storm, atrial fibrillation, and ventricular fibrillation/ventricular tachycardia.
14.(New)Method according to claim 10, the method comprising determining a fifth set of fifth parameters based on the sensor data, and wherein the first cardiac event parameter is based on one or more fifth parameters of the fifth set.
15. Method according to claim 14, the method comprising determining a fifth set of fifth parameters based on the sensor data, and wherein the first cardiac event parameter is based on one or more fifth parameters of the fifth set.
15. Method according to claim 10, the method comprising: determining a second cardiac event parameter indicative of a probability of a future cardiac event, wherein the second cardiac event parameter is based on one or more first parameters of the first set and one or more second parameters of the second set; and
in accordance with a second transmission criterion being satisfied, transmitting a second warning signal to an accessory device, the second warning signal being indicative of the second cardiac event parameter.
17. Method according to claim 12, the method comprising: determining a second cardiac event parameter indicative of a probability of a future cardiac event, wherein the second cardiac event parameter is based on one or more first parameters of the first set and one or more second parameters of the second set; and in accordance with a second transmission criterion being satisfied, transmitting a second warning signal to an accessory device, the second warning signal being indicative of the second cardiac event parameter.
16. Method according to claim 15, wherein the second cardiac event parameter is indicative of a probability of a second cardiac event occurring within a second time period.
18. Method according to claim 17, wherein the second cardiac event parameter is indicative of a probability of a second cardiac event occurring within a second time period.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Fischell et al (US 20090082682 A1) which teaches a method and apparatus for detecting cardiac events based on heart rate sensitive parameters.
Shaquer et al (US 20090270939 A1) which teaches a device and method for detecting a plurality of ventricular events and obtaining a series of probabilities of an atrial fibrillation event.
Astrom et al (US 20050256413 A1) which teaches an apparatus for analyzing cardiac events using feature extraction.
Ghanem et al (US 20110301479 A1) which teaches a system and method for assessing a likelihood of a patient to experience a future cardiac arrhythmia using dynamic changes in a biological parameter.
Sharma et al (US 20160038093 A1) which teaches a method of operation of a medical device system for determining the prospective risk of heart failure hospitalization.
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/A.J.S./Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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