DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed on August 3, 2026 has been entered. Claims 1-6, 8-13, and 15-22 remain pending in the application.
Response to Arguments
35 U.S.C. § 103
Applicant’s argument on pages 10-11 that Sullivan does not teach or suggest a differentiation between a potential ventricular fibrillation (VF) and an actual VF has been fully considered but is not found persuasive. As set forth in the previous Office action and also acknowledged by the Applicant, Sullivan does teach a system for detecting VF events (Col. 7, lines 24-27 and page 4 of the Office action dated 05/01/2026). In order to detect VF events, Sullivan teaches a method of analyzing ECG signals to distinguish any false positives and negatives (Col. 12, lines 56-64). All signals being analyzed are potential VF until they are processed and determined to be VF or not. Any false positive or negative after analysis can be considered a “potential VF”, while any signal that is determined to be VF after analysis can be considered an “actual VF” (Col. 14, lines 32-40 & pages 4-5 of the Office action dated 05/01/2026). In view of the response to arguments above, Sullivan does teach a differentiation between a potential VF and an actual VF through signal analysis.
Applicant’s arguments, see pages 12-13, filed August 3, 2026, with respect to the rejection of claims 1, 8 and 15 under Sullivan in view of Li have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Sullivan in view of Kim (US 20240041381 A1), as described below.
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 1, 8, 15, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan et. al (US 11154230 B2, published 10/26/2021, hereinafter known as Sullivan) in view of Kim (US 20240041381 A1, published 02/08/2024).
Regarding claims 1, 8, and 15, Sullivan discloses a wearable medical system (Col. 2, line 13), the system comprising:
a support structure configured to be worn by a patient (“wearable cardioverter defibrillator (WCD) including a support structure configured to be worn by an ambulatory patient” Col. 2, lines 13-15);
a plurality of electrocardiogram (ECG) electrodes, coupled to the support structure (“sensing electrodes can be attached to the inside of support structure” Col. 6, lines 12-13), operable to sense a plurality of ECG signals of the patient (“electrodes configured to render an electrocardiogram (ECG) signal of the patient while the patient is wearing the support structure” Col. 2, lines 18-20);
a discharge circuit operable to deliver one or more electrical pulses to the patient (“WCD system…is configured to defibrillate a patient who is wearing it, by delivering an electrical charge to the patient's body in the form of an electric shock delivered in one or more pulses” Col. 3, lines 1-4) and
a processor in communication with the plurality of ECG electrodes (“the processor is configured to receive the ECG signal” Col. 2, lines 22-23), the processor configured to:
receive the plurality of ECG signals from a plurality of channels associated with the plurality of ECG electrodes (“for a device that monitors multiple ECG channels, the thresholds may be different for different channels since QRS amplitudes may be different” Col. 10, lines 42-44);
detect a plurality of QRS complexes based on the plurality of ECG signals (“a QRS complex is detected, processor may look at the unfiltered ECG signal” Col. 10, lines 55-57);
determine a heart rate of the patient based on an R-R interval between two QRS complexes of each of the plurality of ECG signals (“processor determines the activity of heart at least from the ECG signal, which may include identifying QRS complexes within the ECG to compute the patient's heart rate…for a device that monitors multiple ECG channels”, it is commonly known in the art that calculating the heart rate of a patient based on a plurality of ECG signals is done using the R-R interval between two QRS complexes; this is an intuitive, well-known process, Col. 10, lines 14-17 & Col. 10, lines 42-44);
determine whether the heart rate exceeds a heart rate threshold (“the processor, through the detection module and the advice module, performs a rhythm analysis to decide when a patient should receive a shock…the rhythm analysis uses heart rate…to make a shock decision”, shown below in annotated Table 1 depicting the VF heart rate threshold as >200BPM, Col. 9, lines 61-67);
detect that the patient is experiencing potential ventricular fibrillation based on a determination that the heart rate exceeds the heart rate threshold and optionally a width of the plurality of QRS complexes; (“baseline physiological parameters of patient can be measured, such as the heart rate…the patient's sensed ECG from measurement circuit, which can be available as physiological inputs, data, or other signals, may be used by the VF detector to determine whether the patient is experiencing VF…”, shown in annotated Fig. 1 below, once the heart rate is determined to be above the threshold of 200BPM and the QRS width is determined to be above the threshold of 80ms, the system determines this to be ventricular fibrillation, Col. 9, lines 9-10 & Col. 7, lines 24-27);
calculate a plurality of measurements based on the plurality of QRS complexes (“the heart rate of the patient is calculated using the ten qualified RR intervals in operation”, heart rate and RR intervals are both measurements (a plurality of measurements) that can be calculated from QRS complexes, Col. 12, lines 43-45);
determine whether the potential ventricular fibrillation is actual ventricular fibrillation or noise based on the plurality of measurements (“processor is configured to receive the ECG signal, determine whether noise is present on the ECG signal…baseline physiological parameters of patient can be measured, such as the heart rate…the patient's sensed ECG from measurement circuit, which can be available as physiological inputs, data, or other signals, may be used by the VF detector to determine whether the patient is experiencing VF…” Col. 2, lines 22-24 & Col. 9, lines 9-10 & Col. 7, lines 24-27); and
control, based on a determination that the potential ventricular fibrillation is the actual ventricular fibrillation, the discharge circuit to deliver the one or more electrical pulses to the patient (“when the determination is to shock, an electrical charge is delivered to the patient…delivering the electrical charge is also known as discharging” Col. 7, lines 45-47).
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However, Sullivan does not disclose determining a minimum heart rate of the patient based on the plurality of QRS complexes corresponding to the plurality of channels, wherein the minimum heart rate corresponds to a heart rate of a channel having lowest heart rate among the determined heart rate for each of the plurality of channels; and calculating a plurality of measurements based on the minimum heart rate.
Kim teaches a wearable medical system that detects cardiac arrythmia condition of a patient (Abstract). Multiple channels are considered for the heart rate calculation and each channel of the multiple channels is coupled to a dedicated QRS detector module…a channel, of the remaining channels, with lowest heart rate represents a noise free or lowest noise channel [0058].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the wearable medical system, method, and non-transitory computer-readable medium of Sullivan with the determination of the lowest heart rate of Kim because the channel with the lowest heart rate is the channel with the lowest amount of noise, which aids in ventricular tachycardia detection (Kim, [0058]).
Regarding claim 22, Sullivan discloses the wearable medical system, method, and non-transitory computer-readable medium for detecting ventricular fibrillation recited in claim 1, wherein the processor is further configured to:
detect noise in the plurality of ECG signals (“noise may also be determined in additional ways on the ECG signal” Col. 11, lines 65-66);
determine whether the detected noise exceeds a noise threshold (“noise thresholds can be set by a clinician when the WCD is first prescribed…processor is configured to determine noise is present on the ECG signal when a detected QRS complex is greater than a threshold” Col. 10, lines 40-41 & Col. 17, lines 60-62); and
responsive to a determination that the noise exceeds the noise threshold, provide an alert to instruct the patient or medical personnel to adjust at least one of the support structure or the plurality of ECG electrodes (“embodiments of the disclosure trigger a patient alert for noise that interferes with rhythm analysis… if the noise is present for an extended period of time, the patient should be alerted make adjustments to a garment or activity to clear up the noise”, Col. 9, lines 57-59 & Col. 15, lines 11-14).
Claims 2, 9, 16, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan in view of Kim as applied to claims 1, 8, and 15 above, and further in view of Sullivan (US 2016/0067514 A1, published 03/10/2016, hereinafter known as Sullivan 2).
Regarding claims 2, 9, and 16, Sullivan and Kim disclose the wearable medical system, method, and non-transitory computer-readable medium for detecting ventricular fibrillation recited in claims 1, 8 and 15 as set forth above.
However, Sullivan and Kim do not disclose the plurality of measurements comprises one or more of a predicted heart rate, a predicted organization, a predicted baseline shift, and a minimum median absolute deviation.
Sullivan 2 teaches a WCD system that includes one or more transducers that may sense patient parameters from different parts of the patient's body, and thus render physiological inputs from those parameters (Abstract). The detected first aspects may include respective values for a measure of QRS organization [0103].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the wearable medical system, method, and non-transitory computer-readable medium of Sullivan and Kim with the recording of QRS organization of Sullivan 2 because it acts as a reliable insight into ventricular activity and can help pinpoint abnormalities.
Regarding claim 21, Sullivan and Kim disclose the wearable medical system, method, and non-transitory computer-readable medium for detecting ventricular fibrillation recited in claim 1 as set forth above.
However, Sullivan and Kim do not disclose wherein the processor is further configured to calculate one or more of a predicted heart rate, a predicted organization, and a predicted baseline shift for the channel having the lowest heart rate among the determined heart rate for each of the plurality of channels.
Sullivan 2 teaches the detected first aspects may include respective values for a measure of QRS organization [0103]. The detected aspects may include at least two values for a heart rate, and the aggregated corresponding aspect can be generated by choosing a minimum value of the at least two values for the heart rate [0111].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the wearable medical system, method, and non-transitory computer-readable medium of Sullivan and Kim with the recording of QRS organization of Sullivan 2 because it acts as a reliable insight into ventricular activity and can help pinpoint abnormalities.
Claims 3, 4, 10, 11, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan in view of Kim and Sullivan 2 as applied to claims 2, 9, and 16 above, and further in view of Sullivan et. al, (US 2021/0205618 A1, published 08/07/2021, hereinafter known as Sullivan 3).
Regarding claims 3, 10 and 17, Sullivan, Kim, and Sullivan 2 disclose the wearable medical system, method, and non-transitory computer-readable medium for detecting ventricular fibrillation recited in claims 2, 9 and 16 as set forth above.
However, Sullivan, Kim, and Sullivan 2 do not disclose the plurality of ECG electrodes comprises a first set of ECG electrodes corresponding to a first channel for QRS detection, a second set of ECG electrodes corresponding to a second channel for QRS detection, a third set of ECG electrodes corresponding to a third channel for QRS detection, and a fourth set of ECG electrodes corresponding to a fourth channel for QRS detection, and the plurality of channels includes the first channel, the second channel, the third channel, and the fourth channel.
Sullivan 3 teaches a wearable medical device containing a processor that monitors ECG signals (Abstract). Sullivan 3 teaches that the signals from four ECG electrodes can be combined to form up to six different vectors, and in some embodiments, wearable cardioverter defibrillator (WCD) uses four vectors for QRS complex analysis and/or heart rate analysis to determine if a shock should be applied ([0044]). The ECG analysis algorithm includes provisions for excluding vectors that have noise or when a leads-off condition or situation is detected ([0043]). Monitoring four vectors rather than monitoring two vectors is believed to contribute to enhanced ECG signal analysis and processing of the shock application algorithm to reduce the number of false shock events ([0043]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to use four electrodes corresponding to QRS detection channels as taught by Sullivan 3 with the sensing electrodes of Sullivan, Kim, and Sullivan 2 for enhanced ECG signal analysis and processing.
Regarding claims 4, 11 and 18, in the modified device of Sullivan, Sullivan discloses the processor is further configured to select one or more channels of the plurality of channels having a channel organization within a threshold, and wherein the threshold is configured to remove one or more noisy channels of the plurality of channels (Col. 11, lines 36-38 & Col. 11, lines 46-50).
Claims 5, 6, 12, 13, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan in view of Kim, Sullivan 2, and Sullivan 3 as applied to claims 4, 11, and 18 above, and further in view of Rindskopf et. al (International Encyclopedia of Education, 3rd Edition, 2010, p. 267-273), hereinafter referred to as Rindskopf).
Regarding claims 5, 12 and 19, Sullivan, Kim, Sullivan 2, and Sullivan 3 disclose the wearable medical system, method, and non-transitory computer-readable medium for detecting ventricular fibrillation recited in claims 4, 11 and 18 as set forth above.
In the modified device of Sullivan, Sullivan discloses the processor is configured to:
select the one or more channels having the channel organization within the threshold for a plurality of segments (Col. 7, lines 21-24), wherein each segment is about every 3 seconds to about every 5 seconds (Col. 12, lines 2-7);
calculate the R-R intervals of each selected channel for each segment (Col. 12, lines 39-43);
select an optimal channel of the plurality of channels having a lowest estimated heart rate error for each segment (Col. 10, lines 15-18 & Col. 12, lines 9-13);
calculate the predicted heart rate (Col. 10, lines 15-18), the predicted organization (Col. 12, lines 39-43), and the predicted baseline shift of the optimal channel for each segment (Col. 10, lines 45-52); and
analyze the minimum heart rate, the median absolute deviation, the predicted heart rate, the predicted organization, and the predicted baseline shift (Col. 9, lines 65-67) to determine whether the detected potential ventricular fibrillation is the actual ventricular fibrillation or noise for each segment (Col. 10, lines 20-34)
wherein the patient has ventricular fibrillation when the actual ventricular fibrillation is determined for at least four of five consecutive segments (Col. 15, lines 27-30).
The modified device of Sullivan discloses all of the elements recited in claims 5, 12, and 19 as stated above except for the median absolute deviation of the R-R intervals.
Rindskopf teaches an alternative way to summarize variance of data by using the statistic known as the median absolute deviation (MAD) (Rindskopf et. al, International Encyclopedia of Education, 3rd Edition, 2010, p. 267-273). Rindskopf teaches that MAD is a resistant measure of variability as it relies on the median as the estimate of the center of the distribution, and on the absolute difference rather than the squared difference, and that the clear advantage of MAD is the avoidance of influence by outliers (Rindskopf et. al, International Encyclopedia of Education, 3rd Edition, 2010, p. 267-273).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to use outlier determination using minimum MAD as taught by Rindskopf in the wearable medical system, method, and non-transitory computer-readable medium of Sullivan, Kim, Sullivan 2, and Sullivan 3 because in order to account for possible noise in ECG measurements, which would result in more accurate heart rate determination and avoid disturbances to the heart rate.
Regarding claims 6, 13, and 20, Sullivan discloses a plurality of segments from the plurality of QRS complexes within a segment agreement threshold, wherein each segment is about every 3 seconds to about every 5 seconds (“processor is configured to determine noise on the ECG signal in segments, each segment including a time period of ECG signal, which may be any desired time period, such as 4.8 seconds “, Col. 12, lines 2-7), and wherein the segment agreement threshold removes one or more noisy segments (Col. 10, lines 29-31).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FIONA M KOWALKOWSKI whose telephone number is (571)272-2790. The examiner can normally be reached Monday-Friday 7:30am-5:00pm.
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/F.M.K./Patent Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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