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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/26/2026 has been entered.
Response to Amendment
Applicant's amendments overcome the previous 35 U.S.C. 112(b) rejections. Claim 16 has been added. Claims 1-16 remain pending.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-13 and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US 20200038286 A1), hereafter Johnson, in view of Addison et al. (US 20170065484 A1), hereafter Addison, and further in view of Jensen et al. (US 20130310718 A1), hereafter Jensen.
Regarding claim 1, Johnson discloses a cardio pulmonary resuscitation (CPR) feedback system for assessing CPR carried out by a person on a subject and providing CPR feedback to the person (Fig. 2/2A), comprising: an electrocardiogram (ECG) system configured to measure ECG signals of the subject (Fig. 2, ECG leads); a biosignal system configured to measure biosignals of the subject (Fig. 2, oximeter probe and other sensors, par. 0039 ln 1-7); a CPR assessment system connected to the ECG system to receive ECG signals and connected to the biosignal system to receive biosignals (Fig. 2, AED 10); and a feedback unit connected to the CPR assessment system (Fig. 2A, display 18) and configured to receive CPR feedback signals and issue CPR feedback to the person (par. 0039 ln 7-20), wherein the CPR assessment system is configured to: (i) establish a reference ECG signal metric (AMSA value is determined from ECG, par. 0119) and two or more target biosignal metrics selected from a group consisting of: thoracic impedance, a thoracic impedance signal comprising time-varying impedance changes measured from thoracic electrodes, the thoracic impedance signal including sinusoidal or periodic waveforms associated with intrathoracic physiological activity over a predefined time window, end-tidal carbon dioxide signals, saturation of peripheral oxygen signals, and blood pressure signals (threshold values for physiological parameters, par. 0176 ln 4-6; one or more physiological parameters include end-tidal carbon dioxide information, arterial pressure information, par. 0162); (ii) produce a CPR feedback signal advising the person to start CPR (Fig. 3A, rescuer instructed to start CPR; par. 0081 ln 3-7); (iii) receive ECG signals measured during a plurality of chest compressions and use the ECG signals to establish a current ECG signal metric (Fig. 9A, box 700 ECG signal analyzed during chest compressions); (iv) receive biosignals measured during the plurality of chest compressions and use the biosignals to establish two or more current biosignal metrics (Fig. 13, box 932 physiological parameter measured during chest compressions); (v) compare the current ECG signal metric with the reference ECG signal metric (ECG metric is monitored based on a threshold and trends, par. 0119 ln 6-9) and compare the two or more current biosignal metrics with the two or more target biosignal metrics (Fig. 13, box 934 analyze physiological data trends in one or more physiological parameters).
Johnson discloses giving feedback regarding CPR based on target biosignal metrics (see Fig. 13-14), but does not disclose giving feedback regarding the CPR based on the target biosignal metric in combination with an ECG metric. Johnson uses ECG signal analysis to determine appropriate application of a defibrillation shock.
Addison teaches a CPR feedback system wherein an ECG metric is used to determine efficacy of CPR (par. 0044). Addison teaches an ECG metric can provide an indication of whether the CPR is improving the health of the heart in preparation for a successful defibrillator shock (par. 0047 ln 1-8). Addison also teaches that using multiple metrics can provide a better indication of CPR efficacy (par. 0053).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Johnson to give feedback on the CPR based on an ECG metric as taught by Addison for the purpose of providing a better indication of CPR efficacy.
The modified Johnson discloses (vi) when the current ECG signal metric is less than the reference ECG signal metric and the two or more current biosignal metrics are less than the two or more target biosignal metrics, produce the CPR feedback signal advising the person to improve CPR performance (Johnson Fig. 13, box 936, 940; if the biosignal trends indicate deterioration in the patient status, feedback is given to adjust CPR performance, par. 0163; it is noted that Johnson provides the general teaching of using threshold values as an alternate to trends, par. 0176; Johnson additionally discloses using a lower threshold ECG signal metric to produce CPR improvement advice, see par. 0119; Addison discloses combining an ECG and biosignal metric to improve CPR performance); (vii) when the current ECG signal metric is less than the reference ECG signal metric and the two or more current biosignal metrics are equal to or greater than the two or more target biosignal metrics, produce the CPR feedback signal advising the person to improve CPR performance (Johnson discloses using a lower threshold ECG signal metric to produce CPR improvement advice, see par. 0119; Johnson also discloses to maintain current CPR performance when the biosignal metric is greater than the target, see discussion in limitation below, Figs. 13-14; Addison discloses combining an ECG and biosignal metric to improve CPR performance, see Fig. 7, and a highest weight is given to the ECG metric when determining CPR efficacy based on multiple metrics, see par. 0053); (viii) when the current ECG signal metric is equal to or greater than the reference ECG signal metric, produce the CPR feedback signal advising the person to maintain current CPR performance (when trend is indicative of patient improvement, rescuer is instructed to continue CPR at current depth, Johnson par. 0164).
The modified Johnson does not disclose in step (vii) increase the two or more target biosignal metrics and in step (viii) set the reference ECG signal metric equal to the current ECG signal metric.
Jensen teaches a CPR quality threshold which is not constant and can change over time (par. 0074). Jensen teaches that changing a threshold or target is known in the art.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further modify the system of Johnson to increase the two or more target biosignal metrics in step (vii) and set the reference ECG signal metric equal to the current ECG signal metric in step (viii) since Jensen teaches a CPR quality threshold which changes over time. This would provide the benefit of adapting the target/reference metric to the current condition of the patient, especially in the case of improvement in the patient’s condition.
The modified Johnson does not disclose increasing the two or more target biosignal metrics each by a respective percentage in a range of 1% to 50%, inclusive.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Johnson to increase the two or more target biosignal metrics each by a respective percentage in a range of 1% to 50% as Applicant appears to have placed no criticality on the claimed percentage range (par. 0019 of Applicant specification states metric “may” be increased by 1% to 50%) and determining the optimal range would only have required routine skill in the art.
Regarding claim 2, the modified Johnson discloses a CPR feedback system according to claim 1 (shown above) in which the biosignal system is configured to measure one or more type of biosignals of the subject (Johnson par. 0162).
Regarding claim 3, the modified Johnson discloses a CPR feedback system according to claim 2 (shown above), wherein the one or more type of biosignals comprise chest compression depth signals (Johnson par. 0172).
Regarding claim 4, the modified Johnson discloses a CPR feedback system according to claim 1 (shown above), wherein establishing the reference ECG signal metric comprises receiving ECG signals from the ECG system measured over a predefined period of time prior to commencement of CPR and using the ECG signals to establish the reference ECG signal metric (ECG analysis is initiated prior to commencement of CPR, Johnson par. 0008-0009).
Regarding claim 5, the modified Johnson discloses a CPR feedback system according to claim 4 (shown above) in which using the ECG signals to establish the reference ECG signal metric comprises establishing a score of an ECG signal derived from any of one or more time-domain features of the ECG signals, one or more frequency-domain features of the ECG signals, one or more time-domain features and one or more frequency-domain features (Johnson par. 0073).
Regarding claim 6, the modified Johnson discloses a CPR feedback system according to claim 1 (shown above), wherein establishing the two or more target biosignal metrics comprises receiving a pre-determined target biosignal metric comprising at least one target biosignal metric component for one or more types of biosignal comprising any of at least one target frequency biosignal metric component, at least one target amplitude biosignal metric component, at least one target frequency biosignal metric component and at least one target amplitude biosignal metric component (Johnson par. 0158 ln 1-7).
Regarding claim 7, the modified Johnson discloses a CPR feedback system according to claim 1 (shown above), wherein establishing the two or more target biosignal metrics comprises (i) receiving one or more types of biosignals measured during a plurality of chest compressions by the person, and (ii) using at least one of the one or more types of biosignals to establish the two or more target biosignal metrics (Johnson par. 0167 ln 8-19, par. 0176).
Regarding claim 8, the modified Johnson discloses a CPR feedback system according to claim 7 (shown above), wherein the two or more target biosignal metrics comprises at least one target biosignal metric component for the or each or some of the types of biosignal comprising any of at least one target frequency biosignal metric component, at least one target amplitude biosignal metric component at least one target frequency biosignal metric component and at least one target amplitude biosignal metric component (Johnson par. 0158 ln 1-7).
Regarding claim 9, the modified Johnson discloses a CPR feedback system according to claim 1 (shown above), wherein using the ECG signals to establish the current ECG signal metric comprises establishing a score of the ECG signals derived from any of one or more time-domain feature of the ECG signals, one or more frequency-domain features of the ECG signals, one or more time-domain features and one or more frequency-domain features (Johnson par. 0073).
Regarding claim 10, the modified Johnson discloses a CPR feedback system according to claim 1 (shown above), wherein using the biosignals measured during the plurality of chest compressions to establish the two or more current biosignal metrics comprises establishing at least one current biosignal metric component for at least one type of biosignals comprising any of at least one current frequency biosignal metric component, at least one current amplitude biosignal metric component, at least one current frequency biosignal metric component and at least one current amplitude biosignal metric component (Johnson par. 0158 ln 1-7).
Regarding claim 11, the modified Johnson discloses a CPR feedback system according to claim 10 (shown above), wherein comparing the two or more current biosignal metrics with the two or more target biosignal metrics comprises comparing at least one current biosignal metric component for the at least one type of biosignals with at least one equivalent target biosignal metric component for the at least one type of biosignals (Johnson par. 0176).
Regarding claim 12, the modified Johnson discloses a CPR feedback system according to claim 1 (shown above), wherein the CPR assessment system is configured to repeat steps (iii) to (viii) (Johnson par. 0039, CPR analysis is performed periodically) over a predetermined period of time and when the predetermined period of time has been reached, produce the CPR feedback signal advising the person to stop CPR (Johnson par. 0081, CPR is paused after interval).
Regarding claim 13, the modified Johnson discloses a CPR feedback system according to claim 1 (shown above), wherein the CPR assessment system is configured to repeat steps (i) to (viii) (trends in ECG metric and biosignal metric are periodically monitored during CPR to display feedback indicative of CPR effectiveness, Johnson par. 0039).
Regarding claim 15, the modified Johnson discloses a CPR feedback system according to claim 1 (shown above) wherein the CPR feedback system is part of a defibrillator (Fig 2, AED).
Regarding claim 16, Johnson discloses a method for assessing cardiopulmonary resuscitation (CPR) carried out by a person on a subject and providing CPR feedback to the person (Fig. 2/2A), the method comprising: (a) measuring, by an electrocardiogram (ECG) system, ECG signals of the subject (Fig. 2, ECG leads); (b) measuring, by a biosignal system, biosignals of the subject (Fig. 2, oximeter probe and other sensors, par. 0039 ln 1-7); (c) by a CPR assessment system connected to the ECG system to receive ECG signals and connected to the biosignal system to receive biosignals (Fig. 2, AED 10), performing steps comprising: (i) establishing a reference ECG signal metric (AMSA value is determined from ECG, par. 0119) and two or more target biosignal metrics selected from a group consisting of: thoracic impedance, a thoracic impedance signal comprising time-varying impedance changes measured from thoracic electrodes, the thoracic impedance signal including sinusoidal or periodic waveforms associated with intrathoracic physiological activity over a predefined time window, end-tidal carbon dioxide signals, saturation of peripheral oxygen signals, and blood pressure signals (threshold values for physiological parameters, par. 0176 ln 4-6; one or more physiological parameters include end-tidal carbon dioxide information, arterial pressure information, par. 0162); (ii) producing a CPR feedback signal advising the person to start CPR (Fig. 3A, rescuer instructed to start CPR; par. 0081 ln 3-7); (iii) receiving ECG signals measured during a plurality of chest compressions and using the ECG signals to establish a current ECG signal metric (Fig. 9A, box 700 ECG signal analyzed during chest compressions); (iv) receiving biosignals measured during the plurality of chest compressions and using the biosignals to establish two or more current biosignal metrics (Fig. 13, box 932 physiological parameter measured during chest compressions); (v) comparing the current ECG signal metric with the reference ECG signal metric (ECG metric is monitored based on a threshold and trends, par. 0119 ln 6-9) and comparing the two or more current biosignal metrics with the two or more target biosignal metrics (Fig. 13, box 934 analyze physiological data trends in one or more physiological parameters).
Johnson discloses giving feedback regarding CPR based on target biosignal metrics (see Fig. 13-14), but does not disclose giving feedback regarding the CPR based on the target biosignal metric in combination with an ECG metric. Johnson uses ECG signal analysis to determine appropriate application of a defibrillation shock.
Addison teaches a CPR feedback system wherein an ECG metric is used to determine efficacy of CPR (par. 0044). Addison teaches an ECG metric can provide an indication of whether the CPR is improving the health of the heart in preparation for a successful defibrillator shock (par. 0047 ln 1-8). Addison also teaches that using multiple metrics can provide a better indication of CPR efficacy (par. 0053).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Johnson to give feedback on the CPR based on an ECG metric as taught by Addison for the purpose of providing a better indication of CPR efficacy.
The modified Johnson discloses (vi) when the current ECG signal metric is less than the reference ECG signal metric and the two or more current biosignal metrics are less than the two or more target biosignal metrics, producing the CPR feedback signal advising the person to improve CPR performance (Johnson Fig. 13, box 936, 940; if the biosignal trends indicate deterioration in the patient status, feedback is given to adjust CPR performance, par. 0163; it is noted that Johnson provides the general teaching of using threshold values as an alternate to trends, par. 0176; Johnson additionally discloses using a lower threshold ECG signal metric to produce CPR improvement advice, see par. 0119; Addison discloses combining an ECG and biosignal metric to improve CPR performance); (vii) when the current ECG signal metric is less than the reference ECG signal metric and the two or more current biosignal metrics are equal to or greater than the two or more target biosignal metrics, producing the CPR feedback signal advising the person to improve CPR performance (Johnson discloses using a lower threshold ECG signal metric to produce CPR improvement advice, see par. 0119; Johnson also discloses to maintain current CPR performance when the biosignal metric is greater than the target, see discussion in limitation below, Figs. 13-14; Addison discloses combining an ECG and biosignal metric to improve CPR performance, see Fig. 7, and a highest weight is given to the ECG metric when determining CPR efficacy based on multiple metrics, see par. 0053); and (viii) when the current ECG signal metric is equal to or greater than the reference ECG signal metric, producing the CPR feedback signal advising the person to maintain current CPR performance (when trend is indicative of patient improvement, rescuer is instructed to continue CPR at current depth, Johnson par. 0164); and (d) receiving, by a feedback unit (Johnson Fig. 2A, display 18), the CPR feedback signal and issuing CPR feedback to the person responsive to the CPR feedback signal (Johnson par. 0039 ln 7-20).
The modified Johnson does not disclose in step (vii) increasing the two or more target biosignal metrics and in step (viii) setting the reference ECG signal metric equal to the current ECG signal metric.
Jensen teaches a CPR quality threshold which is not constant and can change over time (par. 0074). Jensen teaches that changing a threshold or target is known in the art.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further modify the method of Johnson to increase the two or more target biosignal metrics in step (vii) and set the reference ECG signal metric equal to the current ECG signal metric in step (viii) since Jensen teaches a CPR quality threshold which changes over time. This would provide the benefit of adapting the target/reference metric to the current condition of the patient, especially in the case of improvement in the patient’s condition.
The modified Johnson does not disclose increasing the two or more target biosignal metrics each by a respective percentage in a range of 1% to 50%, inclusive.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Johnson to increase the two or more target biosignal metrics each by a respective percentage in a range of 1% to 50% as Applicant appears to have placed no criticality on the claimed percentage range (par. 0019 of Applicant specification states metric “may” be increased by 1% to 50%) and determining the optimal range would only have required routine skill in the art.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Addison in view of Jensen as applied to claim 1 above, and further in view of Geheb et al. (US 20040267324 A1), hereafter Geheb.
Regarding claim 14, the modified Johnson discloses a CPR feedback system according to claim 1 (shown above), wherein the CPR assessment system is configured to: produce the CPR feedback signal advising the person to perform CPR chest compressions (Johnson Fig. 8C, indication to perform CPR 632), receive ECG signals measured during the CPR chest compressions and use the ECG signals to establish a current ECG signal metric (Johnson Fig. 9A, box 700), compare the current ECG signal metric with the reference ECG signal metric (Johnson par. 0119 ln 6-9), when the current ECG signal metric is less than the reference ECG signal metric, adjust the rate (Johnson Fig. 13, box 936, 940; abstract ln 7-17), produce the CPR feedback signal advising the person to adjust the rate of performance of the CPR chest compressions (Johnson abstract ln 7-17, provide feedback about adjusted rate of CPR) and go back to step (ii) to produce the CPR feedback signal advising the person to start CPR (Johnson par. 0039, CPR analysis is performed periodically; Johnson par. 0081, CPR is paused after interval; Johnson par. 0143, indication to resume CPR after pause), and when the current ECG signal metric is equal to or greater than the reference ECG signal metric, produce the CPR feedback signal advising the person to maintain the rate of performance of the CPR chest compressions (when trend is indicative of patient improvement, rescuer is instructed to maintain CPR, Johnson par. 0164; CPR parameter can also include compression rate Johnson claim 3). The modified Johnson further discloses audio feedback to indicate a quality of the chest compression (Johnson par. 0173).
The modified Johnson does not disclose a signal advising the person to perform CPR chest compressions at a rate equal to a rate of an audible metronome signal emitted by a metronome of the CPR assessment system and adjusting the rate of the audible metronome signal and advising the person to adjust the rate of chest compressions to equal an adjusted rate of the audible metronome signal.
Geheb teaches an apparatus for assisting CPR (abstract ln 1-2) comprising a signal advising the person to perform CPR chest compressions at a rate equal to a rate of an audible metronome signal emitted by a metronome (par. 0015) and adjusting the rate of the audible metronome signal (par. 0020) to convey a desired rate of compression to the rescuer (claim 10) for the purpose of improving the CPR quality (par. 0006).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further modify the system of Johnson to comprise a metronome as taught by Geheb for the purpose of improving the CPR quality.
Response to Arguments
Applicant's arguments filed 1/26/2026 have been fully considered but they are not persuasive.
Regarding claim 1 step (vii), Applicant argues that Jensen’s adjustable CPR quality threshold is materially different from target biosignal metrics. However, Jensen is relied upon for what the adjustable CPR quality threshold would have suggested to one of ordinary skill in the art. Jensen teaches that a threshold value relating to CPR quality can be changed over time (par. 0074). In view of this, one of ordinary skill in the art would have recognized that similarly, a target biosignal metric could also be changed over time. The conditional control rule referred to in Applicant’s arguments is taught by Johnson in view of Addison, as shown in the rejection above, and in view of Jensen, it would have been obvious to one of ordinary skill in the art to increase a target biosignal metric as needed, especially in the case of an improvement in the patient’s condition.
Conclusion
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/K.R./Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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