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 .
Status of Claims
The amendments and remarks filed on 10SEP2025 have been entered and considered.
Claims 1-15 & 19-23 are currently pending.
Claims 1, 4, 13 have been amended.
No Claims are withdrawn.
Claims 16-18 have been canceled by applicant.
Claims 21-23 have been added.
No new matter has been added.
Support for Limitation “determining that a first segment of the ECG indicates that the individual has ventricular fibrillation (VF) by analyzing a frequency of the first segment of the ECG, the first segment of the ECG being detected during a first time period” can be found in ¶0051 of the Specification;
Support for Limitation “in response to determining that the first segment of the ECG indicates that the individual has VF, classifying the VF as coarse VF by determining that an amplitude of the first segment is greater than a first threshold” can be found in ¶0053-¶0054 of the Specification;
Support for Limitation “increasing a second threshold in response to classifying the VF as coarse VF” can be found in ¶0043 of the Specification;
Support for Limitation “determining that a first segment of the ECG is indicative of VF; and in response to determining that the first segment of the ECG is indicative of VF, whether the first segment of the ECG is indicative of coarse VF by comparing an amplitude of the first segment of the ECG to a first threshold” can be found in ¶0054 of the Specification;
Support for Limitation “wherein determining the second threshold by analyzing the analysis factor comprises selecting a first level or a second level as the second threshold, the first level being higher than the second level” can be found in ¶0081 of the Specification;
Support for Limitation “wherein determining whether the VF comprises coarse VF comprises determining that the VF comprises coarse VF by determining that the amplitude of the first segment of the ECG is greater than the first threshold, and wherein determining the second threshold comprises selecting the first level as the second threshold” can be found in ¶0081 & ¶0118 of the Specification;
Support for Limitation “wherein determining whether the VF comprises coarse VF comprises determining that the VF comprises fine VF by determining that the amplitude of the first segment of the ECG is less than the first threshold, and wherein determining the second threshold comprises selecting the second level as the second threshold.” can be found in ¶0081 & ¶0118 of the Specification.
Claims 1-15 & 19-23 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10SEP2025 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant's amendments filed 10SEP2025 regarding the rejections under 35 USC 112(a) have been fully considered and have been found to obviate the rejections of claims 1-3. Therefore, the rejection has been withdrawn.
Applicant's arguments filed 10SEP2025 regarding the rejections under 35 USC 103 have been fully considered and have been found to be not persuasive. Parts deemed not persuasive discussed below:
Applicant states (see Pages 9-10 of the Remarks):
“The sensitivity thresholds of Bornzin are not used for classifying an identified instance of VF as coarse VF. Although the Office asserts that FIG. 7 of Bornzin shows a coarse VF signal (Office Action, p. 8), Applicant respectfully disagrees. FIG. 7 shows a "portion 410 [that] may be noise or an actual signal associated with ventricular fibrillation." 14:56-67. By reviewing a "second cycle," "a decision may be made that the portion 410 is noise and not associated with ventricular fibrillation." Id. at 15:4- 6. In other words, FIG. 7 does not show any type of VF. Therefore Bornzin does not teach or suggest "in response to determining that the first segment of the ECG indicates that the individual has VF, classifying the VF as coarse VF by determining that an amplitude of the first segment is greater than a first threshold," as recited in amended claim 1.”
The examiner is not persuaded because Bornzin further discloses that the methods are used in examples for the noise detection but also for detection of cardiac events, see Bornzin Column 12 Lines 34-39 “This "monitoring" process not only provides improved sensing (reduced false positive detections caused by noise), but also allows for improved detection of premature ventricular contractions (PVCs) and/or other arrhythmias, which may be more easily detected when the stimulation device is operating in a higher sensitivity state.”. Bornzin is shown to detect noise in a signal but also the cardiac events if they are present in the noise. This is seen in Bornzin by the disclosure of filtering processes which will remove detected noise. The citation of Figure 7 waveform 440 is maintained to show detection of coarse VF as described because the waveform shows an example of coarse VF regardless of if the disclosure references detecting noise as well. Bronzin Column 7 Lines 35-47 further detail how there are components of Bronzin specifically included to classify the detected ECG waveforms along with the noise removal. The examiner therefore maintains that the prior art teaches the limitation as discussed further below.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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, 3-5, 10-14, & 19-23 are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Liu et al. (US Publication Number 20170361120, Previously Cited), in view of Bornzin (US Patent No. 7756570; Previously Cited).
Regarding claim 1, Liu discloses an external defibrillator, comprising: a detection circuit configured to detect an electrocardiogram (ECG) of an individual receiving chest compressions (Liu Abstract “A defibrillator and method for using a defibrillator which adopts an ECG analysis algorithm that can detect a cardiac arrhythmia in the presence of noise artifact induced by cardio pulmonary resuscitation (CPR) compressions.”; ¶0020 “Also in accordance with the principles of the present invention, a method for controlling an electrotherapy output from a defibrillator during the application of CPR is described, comprising the steps of receiving an ECG signal data stream from two or more external electrodes in electrical contact with a patient, the ECG signal data comprising a cardiac signal characterized by corruption from a CPR compressions”; ¶0072) an output device configured to output a recommendation to administer an electrical shock to the individual (Liu ¶0066 “In the case of an AED, the prompt may also instruct “the user to press the shock button 892 to deliver a shock.”; ¶0078 “Processor 34 also provides control of the user interface (UI) output functions in the device. The user interface 18 is the primary means for guiding the user through the progress of the cardiac rescue protocol, and so includes at least one of an aural instruction output and a visual display.”; ¶0151); a discharge circuit configured to output the electrical shock to the individual (Liu ¶0077 “When the user presses the shock button 92 on the user interface 818, a defibrillation shock is delivered from HV energy storage source 70 through a shock delivery circuit 80. In a preferred embodiment, shock delivery circuit 80 is electrically connected via an output of the AED to the same electrodes 16 which receive the raw ECG signal.”; ¶0039; ¶0091 “The fully automatic AED may use methods such as electrode impedance monitoring or using the analysis algorithm to determine an absence of CPR-related signal noise artifact to determine when the operator is not touching the patient, and automatically deliver the shock accordingly.”); a processor (Liu ¶0070 “Most of the method steps can thus be accomplished in a single digital signal processor (DSP) that is arranged to receive the ECG signal stream, to process the stream, and then to output a continuous, time aligned and transformed ECG data stream.”; ¶0072; ¶0105); and memory storing instructions that (Liu ¶0079 “Software instructions for operating controller 30 are disposed in an onboard memory 40.”; ¶0137; ¶0170), when executed by the processor, cause the processor to perform operations comprising: determining that a first segment of the ECG indicates that the individual has ventricular fibrillation (VF), by analyzing a frequency of the first segment of the ECG the first segment of the ECG being detected during a first time period (Liu ¶0057 “Each original time-segmented ECG buffer can thus be designated as “shock advised”, i.e. corresponding to VF, or “undecided”, i.e. corresponding to “other than VF”. Once the ECG buffer is determined as shock advised or undecided, ART repeats the steps of capturing, obtaining, filtering, and analyzing for the next ECG buffer in the time sequence as shown in “select next ECG buffer” step 212.”; ¶0048; ¶0062; ¶0069); generating a shock index of a second segment of the ECG, the second segment of the ECG being detected during a second time period occurring after the first time period (Liu ¶0055 “The analyzing step 210 begins by comparing the filtered ECG buffer scores to a predetermined decision surface. The decision surface, which is constructed using databases of ECG signal data having CPR corruption noise, defines whether a given set of buffer scores indicates “VF” or “undecided”, i.e. other than VF. One example of a decision surface in the CLAS and FLATS dimensions is illustrated in FIG. 5. In that example, decision surface 510 is constructed of corresponding pairs of one of the CLAS scores and FLATS scores. Score pairs that fall within the decision surface 510 indicate a VF condition. Score pairs that fall outside the decision surface 510 indicate an undecided condition. Additional dimensions of decision surface may be added using threshold values for additional filtered ECG buffers as desired to create a more accurate VF decision. Although only two dimensions are shown here, three or more dimensions may be used for a decision surface that incorporates the other CLAS scores as well”; ¶0054); determining that the second segment indicates that the individual has VF by determining that the shock index is greater than the second threshold (Liu ¶0055 “The analyzing step 210 begins by comparing the filtered ECG buffer scores to a predetermined decision surface. The decision surface, which is constructed using databases of ECG signal data having CPR corruption noise, defines whether a given set of buffer scores indicates “VF” or “undecided”, i.e. other than VF. One example of a decision surface in the CLAS and FLATS dimensions is illustrated in FIG. 5. In that example, decision surface 510 is constructed of corresponding pairs of one of the CLAS scores and FLATS scores. Score pairs that fall within the decision surface 510 indicate a VF condition. Score pairs that fall outside the decision surface 510 indicate an undecided condition. Additional dimensions of decision surface may be added using threshold values for additional filtered ECG buffers as desired to create a more accurate VF decision. Although only two dimensions are shown here, three or more dimensions may be used for a decision surface that incorporates the other CLAS scores as well”; ¶0062; ¶0040); and in response to determining that the second segment indicates that the individual has VF: causing the output device to output the recommendation. (Liu ¶0066 “In the case of an AED, the prompt may also instruct “the user to press the shock button 892 to deliver a shock.”; ¶0078 “Processor 34 also provides control of the user interface (UI) output functions in the device. The user interface 18 is the primary means for guiding the user through the progress of the cardiac rescue protocol, and so includes at least one of an aural instruction output and a visual display.”; ¶0151), and causing the discharge circuit to output the electrical shock to the individual (Liu ¶0077 “When the user presses the shock button 92 on the user interface 818, a defibrillation shock is delivered from HV energy storage source 70 through a shock delivery circuit 80. In a preferred embodiment, shock delivery circuit 80 is electrically connected via an output of the AED to the same electrodes 16 which receive the raw ECG signal.”; ¶0039; ¶0091 “The fully automatic AED may use methods such as electrode impedance monitoring or using the analysis algorithm to determine an absence of CPR-related signal noise artifact to determine when the operator is not touching the patient, and automatically deliver the shock accordingly.”).
Liu does not disclose in response to determining that the first segment of the ECG indicates that the individual has VF, classifying the VF as coarse VF by determining that an amplitude of the first segment is greater than a first threshold and raising a second threshold in response to classifying the VF as coarse VF. Bornzin in a similar field of endeavor of assessing heart rate viability teaches in response to determining that the first segment of the ECG indicates that the individual has VF, classifying the VF as coarse VF by determining that an amplitude of the first segment is greater than a first threshold and raising a second threshold in response to classifying the VF as coarse VF (Bornzin Figure 6; Column 15 Lines 59-67 “FIG. 8 shows an exemplary scenario 802 with an associated exemplary method 804. The exemplary scenario 802 includes waveforms covering approximately three cycles. For the first cycle, logic associated with the low sensitivity threshold indicates that no amplitude exceeded the low sensitivity threshold while logic associated with the high sensitivity threshold indicates that one or more amplitudes exceeded the high sensitivity threshold. As a consequence, a determination is made that ventricular fibrillation may be present.”; Column 3 Lines 63-67-Column 4 Lines 1-18; Figure 7 Waveform 440 Showing that the detected VF is a coarse vf signal based on its morphology also described in terms of the thresholds in Column 14 Lines 56-67; Examiner is interpreting the low sensitivity threshold as the coarse VF threshold (the first threshold) as it is a higher threshold value than the high sensitivity threshold (see Fig. 7).). Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify system in Liu with the programming for in response to determining that the first segment of the ECG indicates that the individual has VF, the VF as coarse VF by determining that an amplitude of the first segment is greater than a first threshold and raising a second threshold in response to classifying the VF as coarse VF, as taught by Bornzin. The applicant defines coarse VF as a “high-amplitude” VF (see Abstract.) Applicant has not defined any particular amplitude value, and therefore under the broadest reasonable interpretation examiner is interpreting the low sensitivity threshold as the coarse VF threshold (the first threshold) as it is a higher threshold value than the high sensitivity threshold (see Fig. 7). By integrating the processing logic of Bornzin into Liu, the resulting device will reduce the false rate of false shockable rhythms by accounting for varying patient ECG waveforms and external noise.
Regarding claim 3, Liu further discloses an input device configured to receive an input signal from a user, wherein the operations further comprise: causing the discharge circuit to discharge the electrical shock is further in response to the input device receiving the input signal. (Liu ¶0077 “When the user presses the shock button 92 on the user interface 818, a defibrillation shock is delivered from HV energy storage source 70 through a shock delivery circuit 80. In a preferred embodiment, shock delivery circuit 80 is electrically connected via an output of the AED to the same electrodes 16 which receive the raw ECG signal.”; ¶0039). Regarding claim 4, Liu discloses a medical device, comprising a detection circuit configured to detect an electrocardiogram (ECG) of an individual receiving chest compressions (Liu Abstract “A defibrillator and method for using a defibrillator which adopts an ECG analysis algorithm that can detect a cardiac arrhythmia in the presence of noise artifact induced by cardio pulmonary resuscitation (CPR) compressions.”; ¶0020 “Also in accordance with the principles of the present invention, a method for controlling an electrotherapy output from a defibrillator during the application of CPR is described, comprising the steps of receiving an ECG signal data stream from two or more external electrodes in electrical contact with a patient, the ECG signal data comprising a cardiac signal characterized by corruption from a CPR compressions”; ¶0072); an output device configured to output a recommendation to administer an electrical shock to the individual (Liu ¶0066 “In the case of an AED, the prompt may also instruct the user to press the shock button 892 to deliver a shock.”); a discharge circuit configured to output the electrical shock to the individual (Liu ¶0077 “When the user presses the shock button 92 on the user interface 818, a defibrillation shock is delivered from HV energy storage source 70 through a shock delivery circuit 80. In a preferred embodiment, shock delivery circuit 80 is electrically connected via an output of the AED to the same electrodes 16 which receive the raw ECG signal.”; ¶0039; ¶0091 “The fully automatic AED may use methods such as electrode impedance monitoring or using the analysis algorithm to determine an absence of CPR-related signal noise artifact to determine when the operator is not touching the patient, and automatically deliver the shock accordingly.”); a processor (Liu ¶0070 “Most of the method steps can thus be accomplished in a single digital signal processor (DSP) that is arranged to receive the ECG signal stream, to process the stream, and then to output a continuous, time aligned and transformed ECG data stream.”; ¶0072; ¶0105); and memory storing instructions that (Liu ¶0079 “Software instructions for operating controller 30 are disposed in an onboard memory 40.”; ¶0137; ¶0170), determining a second threshold by analyzing the analysis factor by determining whether a first segment of the ECG is indicative of VF (Liu ¶0062 “The repeated, second analyzing step 210 of an ECG buffer of a later, second predetermined time segment is provided to the deciding step 214. Deciding step 214 then additionally bases its final decision on the second analyzing step.”; ¶0054; Showing how the thresholds may adapt over the course of multiple analysis); generating a filtered segment of the ECG by removing, from a second segment of the ECG, an artifact associated with the chest compressions (Liu ¶0025 “FIG. 3 illustrates the frequency characteristics of a set of filters for removing CPR artifact and other signal noise from an ECG signal”; ¶0043 “The ART algorithm suppresses CPR artifact related noise”; ¶0046); generating a shock index by analyzing the filtered segment (Liu ¶0019 “The processor is operable to execute software instructions to adjust a shock decision criteria if the confidence level is less than a predetermined confidence threshold, decide that a shock is to be delivered by an electrotherapy delivery circuit based on the adjusted shock decision criteria, and arm an electrotherapy delivery circuit responsive to a shock delivery decision. The AED may adjust the shock decision criteria by, for example, increasing a minimum number of a shockable cardiac rhythm determinations from three to four required by the ECG analyzer prior to finalizing a shock delivery decision.”; ¶0208); determining whether the second segment of the ECG comprises a shockable rhythm by comparing the shock index to the second threshold (Liu ¶0053 “At step 208, data in each of the filtered ECG buffers is compared to a threshold value. The number of data points falling within the threshold value for that filtered ECG buffer, called a score, is then calculated for use by the analyzing step 210.”; ¶0055; ¶0062; ¶0040); in response to determining whether the second segment of the ECG comprises the shockable rhythm, causing the output device to output the recommendation. (Liu ¶0066 “In the case of an AED, the prompt may also instruct “the user to press the shock button 892 to deliver a shock.”; ¶0078 “Processor 34 also provides control of the user interface (UI) output functions in the device. The user interface 18 is the primary means for guiding the user through the progress of the cardiac rescue protocol, and so includes at least one of an aural instruction output and a visual display.”; ¶0151).
Liu does not disclose determining that a first segment of the ECG is indicative of VF; and in response to determining that the first segment of the ECG is indicative of VF, whether the first segment of the ECG is indicative of coarse VF by comparing an amplitude of the first segment of the ECG to a first threshold. Bornzin in a similar field of endeavor of assessing heart rate viability teaches determining that a first segment of the ECG is indicative of VF; and in response to determining that the first segment of the ECG is indicative of VF, whether the first segment of the ECG is indicative of coarse VF by comparing an amplitude of the first segment of the ECG to a first threshold; (Bornzin Figure 6; Column 15 Lines 59-67 “FIG. 8 shows an exemplary scenario 802 with an associated exemplary method 804. The exemplary scenario 802 includes waveforms covering approximately three cycles. For the first cycle, logic associated with the low sensitivity threshold indicates that no amplitude exceeded the low sensitivity threshold while logic associated with the high sensitivity threshold indicates that one or more amplitudes exceeded the high sensitivity threshold. As a consequence, a determination is made that ventricular fibrillation may be present.”; Column 3 Lines 63-67-Column 4 Lines 1-18; Figure 7 Waveform 440 Showing that the detected VF is a coarse vf signal based on its morphology also described in terms of the thresholds in Column 14 Lines 56-67).
Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify system in Liu with the programming for determining that a first segment of the ECG is indicative of VF; and in response to determining that the first segment of the ECG is indicative of VF, whether the first segment of the ECG is indicative of coarse VF by comparing an amplitude of the first segment of the ECG to a first threshold, as taught by Bornzin, by integrating the processing logic of Bornzin into Liu to reduce the false rate of false shockable rhythms by accounting for varying patient ECG waveforms and external noise.
Regarding claim 5, Liu further discloses the second segment of the ECG being detected during a first time period (Liu ¶0057 “Each original time-segmented ECG buffer can thus be designated as “shock advised”, i.e. corresponding to VF, or “undecided”, i.e. corresponding to “other than VF”. Once the ECG buffer is determined as shock advised or undecided, ART repeats the steps of capturing, obtaining, filtering, and analyzing for the next ECG buffer in the time sequence as shown in “select next ECG buffer” step 212.”; ¶0062; ¶0069), wherein determining the whether the ECG is indicative of VF comprises: identifying the first segment of the ECG detected during a second time period (Liu ¶0055 “The analyzing step 210 begins by comparing the filtered ECG buffer scores to a predetermined decision surface. The decision surface, which is constructed using databases of ECG signal data having CPR corruption noise, defines whether a given set of buffer scores indicates “VF” or “undecided”, i.e. other than VF. One example of a decision surface in the CLAS and FLATS dimensions is illustrated in FIG. 5. In that example, decision surface 510 is constructed of corresponding pairs of one of the CLAS scores and FLATS scores. Score pairs that fall within the decision surface 510 indicate a VF condition. Score pairs that fall outside the decision surface 510 indicate an undecided condition. Additional dimensions of decision surface may be added using threshold values for additional filtered ECG buffers as desired to create a more accurate VF decision. Although only two dimensions are shown here, three or more dimensions may be used for a decision surface that incorporates the other CLAS scores as well”; ¶0054), the second time period beginning a threshold time or less before the first time period (Liu ¶0051 “At buffering step 204, each stream of filtered ECG signal data is segmented into sequential time segments, i.e. buffers ECG1 ECG2 . . . ECGi. One preferred arrangement is non-overlapped adjoining buffers of 3.5 seconds length. One sampling rate is 250 samples per second, which equates to 875 samples of ECG per buffer. Time segment length and sampling rates are predetermined, and may differ within the scope of the invention.”; ¶0062).
Regarding claim 10, Liu further discloses wherein determining the analysis factor comprises determining that at least a portion of the chest compressions were administered to the individual during a cardiopulmonary resuscitation (CPR) period, and wherein the second threshold is dependent on determining that at least the portion of the chest compressions were administered to the individual during the CPR period. (Liu ¶0019 “Alternatively, the AED may adjust the shock decision criteria by first prompting a user to stop CPR via the AED user interface and then to confirm that a shock is to be delivered based on a second (PAS) ECG analyzer. The prompting may occur either during the ongoing CPR period or immediately at its conclusion.”; ¶0020; ¶0069; ¶00151).
Regarding claim 11, Liu further discloses the second segment of the ECG being detected during a first time period (Liu ¶0057 “Each original time-segmented ECG buffer can thus be designated as “shock advised”, i.e. corresponding to VF, or “undecided”, i.e. corresponding to “other than VF”. Once the ECG buffer is determined as shock advised or undecided, ART repeats the steps of capturing, obtaining, filtering, and analyzing for the next ECG buffer in the time sequence as shown in “select next ECG buffer” step 212.”; ¶0062; ¶0069), wherein determining the analysis factor comprises: determining a first slope of a third segment of the ECG detected during a second time period, the second time period ending before a beginning time of the first time period; determining a second slope of the second segment of the ECG; determining a change between the first slope and the second slope (Liu ¶0055 “The analyzing step 210 begins by comparing the filtered ECG buffer scores to a predetermined decision surface. The decision surface, which is constructed using databases of ECG signal data having CPR corruption noise, defines whether a given set of buffer scores indicates “VF” or “undecided”, i.e. other than VF. One example of a decision surface in the CLAS and FLATS dimensions is illustrated in FIG. 5. In that example, decision surface 510 is constructed of corresponding pairs of one of the CLAS scores and FLATS scores. Score pairs that fall within the decision surface 510 indicate a VF condition. Score pairs that fall outside the decision surface 510 indicate an undecided condition. Additional dimensions of decision surface may be added using threshold values for additional filtered ECG buffers as desired to create a more accurate VF decision. Although only two dimensions are shown here, three or more dimensions may be used for a decision surface that incorporates the other CLAS scores as well”; ¶0054; Figure 3 as described in ¶0048 showing the ECG signals being smoothed by filtering for easy distinct value determinations, such as slope), and wherein the second threshold is dependent on the change between the first slope and the second slope. (Liu ¶0062 “The repeated, second analyzing step 210 of an ECG buffer of a later, second predetermined time segment is provided to the deciding step 214. Deciding step 214 then additionally bases its final decision on the second analyzing step.”; ¶0054; Showing how the thresholds may adapt over the course of multiple analysis).
Regarding claim 12, Liu further discloses the second segment of the ECG being detected during a first time period, (Liu ¶0057 “Each original time-segmented ECG buffer can thus be designated as “shock advised”, i.e. corresponding to VF, or “undecided”, i.e. corresponding to “other than VF”. Once the ECG buffer is determined as shock advised or undecided, ART repeats the steps of capturing, obtaining, filtering, and analyzing for the next ECG buffer in the time sequence as shown in “select next ECG buffer” step 212.”; ¶0062; ¶0069) wherein determining the analysis factor comprises: determining a shock index of a third segment of the ECG detected during a second time period (Liu ¶0055; ¶0054); the second time period ending before the first time period begins, and wherein the second threshold is dependent on the shock index of the third segment of the ECG detected during the second time period. (Liu ¶0055; Figure 3 as described in ¶0048 showing the ECG signals being smoothed by filtering for easy distinct value determinations, such as slope; ¶0062 “The repeated, second analyzing step 210 of an ECG buffer of a later, second predetermined time segment is provided to the deciding step 214. Deciding step 214 then additionally bases its final decision on the second analyzing step.”; ¶0054; Showing how the thresholds may adapt over the course of multiple analysis). Regarding claim 13, Liu discloses a method performed by a medical device, the method comprising detecting an electrocardiogram (ECG) of an individual receiving chest compressions (Liu ¶0051 “buffering step 204, each stream of filtered ECG signal data is segmented into sequential time segments, i.e. buffers ECG1 ECG2 . . . ECGi.; ¶0057; ¶0072); generating a filtered segment of the ECG by removing, from a second segment of the ECG, an artifact associated with the chest compressions (Liu ¶0025 “FIG. 3 illustrates the frequency characteristics of a set of filters for removing CPR artifact and other signal noise from an ECG signal”; ¶0043 “The ART algorithm suppresses CPR artifact related noise”; ¶0046); generating a shock index based on the filtered segment (Liu ¶0019 “The processor is operable to execute software instructions to adjust a shock decision criteria if the confidence level is less than a predetermined confidence threshold, decide that a shock is to be delivered by an electrotherapy delivery circuit based on the adjusted shock decision criteria, and arm an electrotherapy delivery circuit responsive to a shock delivery decision. The AED may adjust the shock decision criteria by, for example, increasing a minimum number of a shockable cardiac rhythm determinations from three to four required by the ECG analyzer prior to finalizing a shock delivery decision.”; ¶0208); determining a second threshold dependent on whether the first segment of the ECG is indicative of VF (Liu ¶0062 “The repeated, second analyzing step 210 of an ECG buffer of a later, second predetermined time segment is provided to the deciding step 214. Deciding step 214 then additionally bases its final decision on the second analyzing step.”; ¶0054; Showing how the thresholds may adapt over the course of multiple analysis); determining whether the second segment of the ECG comprises a shockable rhythm by comparing the shock index to the second threshold (Liu ¶0053 “At step 208, data in each of the filtered ECG buffers is compared to a threshold value. The number of data points falling within the threshold value for that filtered ECG buffer, called a score, is then calculated for use by the analyzing step 210.”; ¶0055; ¶0062; ¶0040); and in response to determining whether the second segment of the ECG comprises the shockable rhythm, outputting a recommendation indicating whether a electrical shock is advised. (Liu ¶0066 “In the case of an AED, the prompt may also instruct “the user to press the shock button 892 to deliver a shock.”; ¶0078 “Processor 34 also provides control of the user interface (UI) output functions in the device. The user interface 18 is the primary means for guiding the user through the progress of the cardiac rescue protocol, and so includes at least one of an aural instruction output and a visual display.”; ¶0151), and outputting the electrical shock (Liu ¶0077 “When the user presses the shock button 92 on the user interface 818, a defibrillation shock is delivered from HV energy storage source 70 through a shock delivery circuit 80. In a preferred embodiment, shock delivery circuit 80 is electrically connected via an output of the AED to the same electrodes 16 which receive the raw ECG signal.”; ¶0039; ¶0091 “The fully automatic AED may use methods such as electrode impedance monitoring or using the analysis algorithm to determine an absence of CPR-related signal noise artifact to determine when the operator is not touching the patient, and automatically deliver the shock accordingly.”).
Liu does not disclose classifying the VF as coarse VF by determining that a first segment of the ECG is indicative of VF: and in response to determining that the first segment of the ECG is indicative of VF, determining whether the first segment of the ECG is indicative of coarse VF by comparing an amplitude of the first segment of the ECG to a first threshold. Bornzin in a similar field of endeavor of assessing heart rate viability teaches classifying the VF as coarse VF by determining that a first segment of the ECG is indicative of VF: and in response to determining that the first segment of the ECG is indicative of VF, determining whether the first segment of the ECG is indicative of coarse VF by comparing an amplitude of the first segment of the ECG to a first threshold; (Bornzin Figure 6; Column 15 Lines 59-67 “FIG. 8 shows an exemplary scenario 802 with an associated exemplary method 804. The exemplary scenario 802 includes waveforms covering approximately three cycles. For the first cycle, logic associated with the low sensitivity threshold indicates that no amplitude exceeded the low sensitivity threshold while logic associated with the high sensitivity threshold indicates that one or more amplitudes exceeded the high sensitivity threshold. As a consequence, a determination is made that ventricular fibrillation may be present.”; Column 3 Lines 63-67-Column 4 Lines 1-18; Figure 7 Waveform 440 Showing that the detected VF is a coarse vf signal based on its morphology also described in terms of the thresholds in Column 14 Lines 56-67).
Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify system in Liu with the programming for classifying the VF as coarse VF by determining that a first segment of the ECG is indicative of VF: and in response to determining that the first segment of the ECG is indicative of VF, determining whether the first segment of the ECG is indicative of coarse VF by comparing an amplitude of the first segment of the ECG to a first threshold, as taught by Bornzin, by integrating the processing logic of Bornzin into Liu to reduce the false rate of false shockable rhythms by accounting for varying patient ECG waveforms and external noise.
Regarding claim 14, Liu further discloses the second segment of the ECG being detected during a first time period (Liu ¶0057 “Each original time-segmented ECG buffer can thus be designated as “shock advised”, i.e. corresponding to VF, or “undecided”, i.e. corresponding to “other than VF”. Once the ECG buffer is determined as shock advised or undecided, ART repeats the steps of capturing, obtaining, filtering, and analyzing for the next ECG buffer in the time sequence as shown in “select next ECG buffer” step 212.”; ¶0062; ¶0069), wherein determining whether the first segment of the ECG is indicative of VF comprises: identifying the first segment of the ECG detected during a second time period (Liu ¶0055 “The analyzing step 210 begins by comparing the filtered ECG buffer scores to a predetermined decision surface. The decision surface, which is constructed using databases of ECG signal data having CPR corruption noise, defines whether a given set of buffer scores indicates “VF” or “undecided”, i.e. other than VF. One example of a decision surface in the CLAS and FLATS dimensions is illustrated in FIG. 5. In that example, decision surface 510 is constructed of corresponding pairs of one of the CLAS scores and FLATS scores. Score pairs that fall within the decision surface 510 indicate a VF condition. Score pairs that fall outside the decision surface 510 indicate an undecided condition. Additional dimensions of decision surface may be added using threshold values for additional filtered ECG buffers as desired to create a more accurate VF decision. Although only two dimensions are shown here, three or more dimensions may be used for a decision surface that incorporates the other CLAS scores as well”; ¶0054), the second time period beginning a threshold time or less before the first time period (Liu ¶0051 “At buffering step 204, each stream of filtered ECG signal data is segmented into sequential time segments, i.e. buffers ECG1 ECG2 . . . ECGi. One preferred arrangement is non-overlapped adjoining buffers of 3.5 seconds length. One sampling rate is 250 samples per second, which equates to 875 samples of ECG per buffer. Time segment length and sampling rates are predetermined, and may differ within the scope of the invention.”; ¶0062).
Regarding claim 19, Liu further discloses the second segment of the ECG being detected during a first time period (Liu ¶0057 “Each original time-segmented ECG buffer can thus be designated as “shock advised”, i.e. corresponding to VF, or “undecided”, i.e. corresponding to “other than VF”. Once the ECG buffer is determined as shock advised or undecided, ART repeats the steps of capturing, obtaining, filtering, and analyzing for the next ECG buffer in the time sequence as shown in “select next ECG buffer” step 212.”; ¶0062; ¶0069), wherein determining the analysis factor comprises: determining a first slope of a third segment of the ECG detected during the first time period, the second time period ending before the first time period begins; determining a second slope of the second segment of the ECG detected during the first time period; determining a change between the first slope and the second slope (Liu ¶0055 “The analyzing step 210 begins by comparing the filtered ECG buffer scores to a predetermined decision surface. The decision surface, which is constructed using databases of ECG signal data having CPR corruption noise, defines whether a given set of buffer scores indicates “VF” or “undecided”, i.e. other than VF. One example of a decision surface in the CLAS and FLATS dimensions is illustrated in FIG. 5. In that example, decision surface 510 is constructed of corresponding pairs of one of the CLAS scores and FLATS scores. Score pairs that fall within the decision surface 510 indicate a VF condition. Score pairs that fall outside the decision surface 510 indicate an undecided condition. Additional dimensions of decision surface may be added using threshold values for additional filtered ECG buffers as desired to create a more accurate VF decision. Although only two dimensions are shown here, three or more dimensions may be used for a decision surface that incorporates the other CLAS scores as well”; ¶0054; Figure 3 as described in ¶0048 showing the ECG signals being smoothed by filtering for easy distinct value determinations, such as slope), and wherein the second threshold is dependent on the change between the first slope and the second slope. (Liu ¶0062 “The repeated, second analyzing step 210 of an ECG buffer of a later, second predetermined time segment is provided to the deciding step 214. Deciding step 214 then additionally bases its final decision on the second analyzing step.”; ¶0054; Showing how the thresholds may adapt over the course of multiple analysis). Regarding claim 20, Liu further discloses the segment of the ECG being detected during a first time period, (Liu ¶0057 “Each original time-segmented ECG buffer can thus be designated as “shock advised”, i.e. corresponding to VF, or “undecided”, i.e. corresponding to “other than VF”. Once the ECG buffer is determined as shock advised or undecided, ART repeats the steps of capturing, obtaining, filtering, and analyzing for the next ECG buffer in the time sequence as shown in “select next ECG buffer” step 212.”; ¶0062; ¶0069) wherein determining the analysis factor comprises: determining a shock index of a third segment of the ECG detected during a second time period (Liu ¶0055; ¶0054); the second time period ending before the first time period begins, and wherein the second threshold is dependent on the shock index of the third segment of the ECG detected during the second time period. (Liu ¶0055; Figure 3 as described in ¶0048 showing the ECG signals being smoothed by filtering for easy distinct value determinations, such as slope; ¶0062 “The repeated, second analyzing step 210 of an ECG buffer of a later, second predetermined time segment is provided to the deciding step 214. Deciding step 214 then additionally bases its final decision on the second analyzing step.”; ¶0054; Showing how the thresholds may adapt over the course of multiple analysis).
Regarding claim 21, claim 4 is obvious over Liu in combination with Bornzin. Liu further discloses wherein determining the second threshold by analyzing the analysis factor comprises selecting a first level or a second level as the second threshold, the first level being higher than the second level. (Liu ¶0062 “The repeated, second analyzing step 210 of an ECG buffer of a later, second predetermined time segment is provided to the deciding step 214. Deciding step 214 then additionally bases its final decision on the second analyzing step.”; ¶0179 “One exemplary AED having a truncation feature may use two different ECG analysis algorithms which have different sensitivities to a shockable cardiac rhythm. A press of the truncation button may automatically shift from a first ECG analysis algorithm to a second ECG analysis algorithm having a higher sensitivity.” Showing the threshold values will shorten to increase sensitivity).
Regarding claim 22, Claims 4 and 21 are obvious over Liu in combination with Bornzin. Liu does not disclose wherein determining whether the VF comprises coarse VF comprises determining that the VF comprises coarse VF by determining that the amplitude of the first segment of the ECG is greater than the first threshold and wherein determining the second threshold comprises selecting the first level as the second threshold. Bornzin further teaches wherein determining whether the VF comprises coarse VF comprises determining that the VF comprises coarse VF by determining that the amplitude of the first segment of the ECG is greater than the first threshold (Bornzin Figure 6; Column 15 Lines 59-67; Column 3 Lines 63-67-Column 4 Lines 1-18; Figure 7 Waveform 440 Showing that the detected VF is a coarse vf signal based on its morphology also described in terms of the thresholds in Column 14 Lines 56-67; Examiner is interpreting the low sensitivity threshold as the coarse VF threshold (the first threshold) as it is a higher threshold value than the high sensitivity threshold (see Fig. 7).)., and wherein determining the second threshold comprises selecting the first level as the second threshold. (Bornzin Column 12 Lines 40-45 “The actual level of the higher and lower threshold values (or sensitivity levels) may be dynamically determined or predefined (by the physician or during manufacture). For example, in certain implementations, the threshold levels are determined based on the amplitude(s) of one or more detected R waves.”).
Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify system in Liu with the programming for wherein determining whether the VF comprises coarse VF comprises determining that the VF comprises coarse VF by determining that the amplitude of the first segment of the ECG is greater than the first threshold and wherein determining the second threshold comprises selecting the first level as the second threshold, as taught by Bornzin, by integrating the processing logic of Bornzin into Liu to reduce the false rate of false shockable rhythms by accounting for varying patient ECG waveforms and external noise.
Regarding claim 23, claims 4 & 21-22 are obvious over Liu in combination with Bornzin. Liu does not disclose wherein determining whether the VF comprises coarse VF comprises determining that the VF comprises fine VF by determining that the amplitude of the first segment of the ECG is less than the first threshold and wherein determining the second threshold comprises selecting the second level as the second threshold. Bornzin further teaches determining whether the VF comprises coarse VF comprises determining that the VF comprises fine VF by determining that the amplitude of the first segment of the ECG is less than the first threshold (Bornzin Figure 6; Column 15 Lines 59-67; Column 3 Lines 63-67-Column 4 Lines 1-18; Figure 7 Waveform 440 Showing that the detected VF is a coarse vf signal based on its morphology also described in terms of the thresholds in Column 14 Lines 56-67; Examiner is interpreting the low sensitivity threshold as the coarse VF threshold (the first threshold) as it is a higher threshold value than the high sensitivity threshold (see Fig. 7).)., and wherein determining the second threshold comprises selecting the second level as the second threshold (Bornzin Column 12 Lines 40-45 “The actual level of the higher and lower threshold values (or sensitivity levels) may be dynamically determined or predefined (by the physician or during manufacture). For example, in certain implementations, the threshold levels are determined based on the amplitude(s) of one or more detected R waves.”).
Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify system in Liu with the programming for wherein determining whether the VF comprises coarse VF comprises determining that the VF comprises fine VF by determining that the amplitude of the first segment of the ECG is less than the first threshold and wherein determining the second threshold comprises selecting the second level as the second threshold, as taught by Bornzin, by integrating the processing logic of Bornzin into Liu to reduce the false rate of false shockable rhythms by accounting for varying patient ECG waveforms and external noise.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US Publication Number 20170361120, Previously Cited) in view of Bornzin (US Patent No. 7756570; Previously Cited) and Freeman et al. (US Publication Number 20140243915, Previously Cited).
Regarding claim 7, the combination of Liu and Bornzin discloses the information of claim 4 as detailed above, but does not disclose wherein determining the analysis factor comprises determining that the individual is a child, and wherein the second threshold is further dependent on determining that the individual is a child. Freeman in a similar field of defibrillation teaches wherein determining the analysis factor comprises determining that the individual is a child, and wherein the second threshold is further dependent on determining that the individual is a child. (Freeman ¶0025 “The invention may feature a system that will alter the AED arrhythmia processing for adults or children based the automatic sensing or manual assignment of the patient type.”; ¶0033 “Some implementations may provide an automated means for determining the age of the victim with greater specificity. Victim weight is a commonly used clinical measure for determining defibrillation energies for children.”).
Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify system in Liu/Bornzin with items in Freeman by adding the determination circuitry programed to detect a child patient and adjusting the analysis factor thresholds accordingly. The motivation to integrate the teaching of Freeman into the technology of Liu/Bornzin would to be to create a device that can manage arrythmia tracking while accounting for external noise factors created by CPR and have a threshold for treatment and analysis as to optimize patient treatments. By creating a device that can determine the patients age, the device is able to adjust treatments accordingly as a child and adult cannot receive the same medical interventions for resuscitation. This prevents accidental injury and optimizes the device to better treat patients.
Claims 8-9, are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US Publication Number 20170361120, Previously Cited) in view of Bornzin (US Patent No. 7756570; Previously Cited) and Nilsson et al. (US Patent No. 10117804, Previously Cited).
Regarding claim 8, the combination of Liu and Bornzin discloses the information of claim 4 as detailed above, but does not disclose wherein determining the analysis factor comprises identifying a non-ECG physiological parameter of the individual, and wherein determining the second threshold is further dependent on the non-ECG physiological parameter. Nilsson in a similar field of resuscitation devices teaches wherein determining the analysis factor comprises identifying a non-ECG physiological parameter of the individual, and wherein determining the second threshold is further dependent on the non-ECG physiological parameter. (Nilsson Column 6 Lines 39-46 “In some embodiments, one or more physiological parameters of patient 182 are sensed, for example measured end tidal CO2, ROSC detection, pulse oximetry, etc. Upon a physiological parameter being sensed, a value of it can be transmitted to controller 110, as is suggested via arrow 119. Transmission can be wired or wireless. The transmitted values may further affect how controller 110 controls driver system 141.”; Column 15 Lines 58-63).
Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify system in Liu/Bornzin with items in Nilsson by adding the determination circuitry programed to detect a physiological signal of the patient and adjusting the analysis factor thresholds accordingly. The motivation to integrate the teaching of Nilsson into the technology of Liu/Bornzin would to be to create a device that can manage arrythmia tracking while accounting for external noise factors created by CPR and have a threshold for treatment and analysis as to optimize patient treatments based on these external factors such as a pulse. By creating a device that can account for physiological parameters, the device is able to adjust treatments accordingly as a patient receiving CPR will require different procedures and analysis to ensure non corrupted data is being recorded. This prevents accidental injury and optimizes the device to better treat patients as it can account for how a patient is reacting to treatments in real time of the therapeutic application.
Regarding claim 9, the combination of Liu and Bornzin discloses the information of claim 4 as detailed above, but does not disclose wherein determining the analysis factor further comprises determining, based on the non-ECG physiological parameter, whether the individual has exhibited a pulse within a time period; and wherein determining the second threshold is dependent on whether the individual has exhibited the pulse within the time period. Nilsson further teaches wherein determining the analysis factor further comprises determining, based on the non-ECG physiological parameter, whether the individual has exhibited a pulse within a time period (Nilsson Column 15 Lines 64-67 through Column 16 Lines 1-2 “In embodiments, the compressions are performed automatically in one or more series, and perhaps with pauses between them, as controlled by controller 1810. Driver system 1841 can be configured to drive compression mechanism 1848 automatically according to a motion-time profile, similarly for what was written for the system of FIG. 1”) and wherein determining the second threshold is dependent on whether the individual has exhibited the pulse within the time period. (Nilsson Column 19 Lines 42-55 “The CPR compressions and the releases are paused during time duration T42, where the compression is at a depth D1. A variety of values may be tried for D1, to study the blood flow of the patient as it settles. User interfaces may be designed to enable operation such as the above, or be automatic. For example, operating actuator 2102 may automatically cause the compressions to change pace, or pause. In addition, the transient blood flow may be further studied by further controlling the compression mechanism, as seen in the last four diagrams. Observations such as the transient blood flow may suggest a further change in the protocol, for example in the depth of the CPR compressions, their rate, their duty cycle, etc”).
Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify system in Liu/Bornzin with items in Nilsson by adding the determination circuitry programed to detect a physiological signal of the patient and adjusting the analysis factor thresholds accordingly. The motivation to integrate the teaching of Nilsson into the technology of Liu/Bornzin would to be to create a device that can manage arrythmia tracking while accounting for external noise factors created by CPR and have a threshold for treatment and analysis as to optimize patient treatments based on these external factors such as a pulse. By creating a device that can account for physiological parameters, the device is able to adjust treatments accordingly as a patient receiving CPR will require different procedures and analysis to ensure non corrupted data is being recorded. This prevents accidental injury and optimizes the device to better treat patients as it can account for how a patient is reacting to treatments in real time of the therapeutic application.
Claims 2, 6, & 15 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US Publication Number 20170361120, Previously Cited) in view of Bornzin (US Patent No. 7756570; Previously Cited), Freeman et al. (US Publication Number 20140243915, Previously Cited) and Nilsson et al. (US Patent No. 10117804, Previously Cited).
Regarding claim 2, the combination of Liu and Bornzin discloses the information of claim 1 as detailed above, but does not disclose wherein the operations further comprise: determining whether a mechanical chest compression device is administering the chest compressions to the individual. Freeman in a similar field of defibrillation teaches wherein the operations further comprise: determining whether a mechanical chest compression device is administering the chest compressions to the individual. (Freeman ¶0066 “While in this CPR state, the chest compression signal is received by `Detect & Increment Chest Compressions Counter` function that detects chest compressions and counts them.”; ¶0068; ¶0070; ¶0077); and determining whether the individual is a child (Freeman ¶0025 “The invention may feature a system th-=at will alter the AED arrhythmia processing for adults or children based the automatic sensing or manual assignment of the patient type.”; ¶0033 “Some implementations may provide an automated means for determining the age of the victim with greater specificity. Victim weight is a commonly used clinical measure for determining defibrillation energies for children.”).
Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify system in Liu/Bornzin with items in Freeman by adding the determination circuitry programed to detect a patient is receiving CPR and adjusting the analysis factor thresholds accordingly. The motivation to integrate the teaching of Freeman into the technology of Liu/Bornzin would to be to create a device that can manage arrythmia tracking while accounting for external noise factors created by CPR and have a threshold for treatment and analysis as to optimize patient treatments based on these external factors. By creating a device that can determine the use of a CPR machine, the device is able to adjust treatments accordingly as a patient receiving CPR from a person versus a machine will require different procedures to ensure the safety of the patient and the aide. This prevents accidental injury and optimizes the device to better treat patients.
Liu in view of Bornzin and Freeman further does not teach wherein the second threshold is further dependent on whether the mechanical chest compression device is administering the chest compressions to the individual and whether the individual is a child. Nilsson in the similar field of CPR devices teaches wherein the second threshold is further dependent on whether the mechanical chest compression device is administering the chest compressions to the individual and whether the individual is a child (Nilsson Column 10 Lines 2-10 “The CPR machine or other controller module would read the patient type from the smart sticker, for example by analyzing image 407, or from wireless communications, etc. This information would then be used to properly position the CPR machine for that type of patient, set thresholds for determining whether migration has occurred, and may even be used to set parameters for the compressions and decompressions (including active decompressions).”).
Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify system of Liu, Bornzin, and Freeman with the system of Nilsson by adding the determination circuitry programed to detect a child patient and adjusting the analysis factor thresholds accordingly. The motivation to integrate the teaching of Nilsson into the technology of Liu, Bornzin, and Freeman would to be to create a device that can manage arrythmia tracking while accounting for external noise factors created by CPR and have a threshold for treatment and analysis as to optimize patient treatments. By creating a device that can determine the patients age, the device is able to adjust treatments accordingly as a child and adult cannot receive the same medical interventions for resuscitation. This prevents accidental injury and optimizes the device to better treat patients.
Regarding claim 6, the combination of Liu and Bornzin discloses the information of claim 4 as detailed above, but does not disclose wherein determining the analysis factor comprises determining that the chest compressions are administered by a mechanical chest compression device. Freeman teaches determining the analysis factor comprises determining that the chest compressions are administered by a mechanical chest compression device (Freeman ¶0066 “While in this CPR state, the chest compression signal is received by `Detect & Increment Chest Compressions Counter` function that detects chest compressions and counts them.”; ¶0068; ¶0070; ¶0077).
Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify system in Liu and Bornzin with items in Freeman by adding the determination circuitry programed to detect a patient is receiving CPR and adjusting the analysis factor thresholds accordingly. The motivation to integrate the teaching of Freeman into the technology of Liu/Bornzin would to be to create a device that can manage arrythmia tracking while accounting for external noise factors created by CPR and have a threshold for treatment and analysis as to optimize patient treatments based on these external factors. By creating a device that can determine the use of a CPR machine, the device is able to adjust treatments accordingly as a patient receiving CPR from a person versus a machine will require different procedures to ensure the safety of the patient and the aide. This prevents accidental injury and optimizes the device to better treat patients.
Liu in view of Bornzin and Freeman further does not teach wherein determining the second threshold is further dependent on determining that the chest compressions are administered by the mechanical chest compression device. Nilsson in the similar field of CPR devices teaches wherein determining the second threshold is further dependent on determining that the chest compressions are administered by the mechanical chest compression device. (Nilsson Column 10 Lines 2-10 “The CPR machine or other controller module would read the patient type from the smart sticker, for example by analyzing image 407, or from wireless communications, etc. This information would then be used to properly position the CPR machine for that type of patient, set thresholds for determining whether migration has occurred, and may even be used to set parameters for the compressions and decompressions (including active decompressions).”).
Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify system in Liu, Bornzin, and Freeman with items in Nilsson by adding the determination circuitry programed to detect a patient is receiving CPR and adjusting the analysis factor thresholds accordingly. The motivation to integrate the teaching of Nilsson into the technology of Liu, Bornzin, and Freeman would to be to create a device that can manage arrythmia tracking while accounting for external noise factors created by CPR and have a threshold for treatment and analysis as to optimize patient treatments based on these external factors. By creating a device that can determine the use of a CPR machine, the device is able to adjust treatments accordingly as a patient receiving CPR from a person versus a machine will require different procedures to ensure the safety of the patient and the aide. This prevents accidental injury and optimizes the device to better treat patients.
Regarding claim 15, the combination of Liu and Bornzin discloses the information of claim 13 as detailed above, but does not disclose wherein determining the analysis factor comprises determining that the chest compressions are administered by a mechanical chest compression device. Freeman teaches determining the analysis factor comprises determining that the chest compressions are administered by a mechanical chest compression device (Freeman ¶0066 “While in this CPR state, the chest compression signal is received by `Detect & Increment Chest Compressions Counter` function that detects chest compressions and counts them.”; ¶0068; ¶0070; ¶0077).
Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify system in Liu and Bornzin with items in Freeman by adding the determination circuitry programed to detect a patient is receiving CPR and adjusting the analysis factor thresholds accordingly. The motivation to integrate the teaching of Freeman into the technology of Liu/Bornzin would to be to create a device that can manage arrythmia tracking while accounting for external noise factors created by CPR and have a threshold for treatment and analysis as to optimize patient treatments based on these external factors. By creating a device that can determine the use of a CPR machine, the device is able to adjust treatments accordingly as a patient receiving CPR from a person versus a machine will require different procedures to ensure the safety of the patient and the aide. This prevents accidental injury and optimizes the device to better treat patients.
Liu in view of Bornzin and Freeman further do not teach wherein determining the second threshold is further dependent on determining that the chest compressions are administered by the mechanical chest compression device. Nilsson in the similar field of CPR devices teaches wherein determining the second threshold is further dependent on determining that the chest compressions are administered by the mechanical chest compression device. (Nilsson Column 10 Lines 2-10 “The CPR machine or other controller module would read the patient type from the smart sticker, for example by analyzing image 407, or from wireless communications, etc. This information would then be used to properly position the CPR machine for that type of patient, set thresholds for determining whether migration has occurred, and may even be used to set parameters for the compressions and decompressions (including active decompressions).”).
Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify system in Liu, Bornzin, and Freeman with items in Nilsson by adding the determination circuitry programed to detect a patient is receiving CPR and adjusting the analysis factor thresholds accordingly. The motivation to integrate the teaching of Nilsson into the technology of Liu, Bornzin, and Freeman would to be to create a device that can manage arrythmia tracking while accounting for external noise factors created by CPR and have a threshold for treatment and analysis as to optimize patient treatments based on these external factors. By creating a device that can determine the use of a CPR machine, the device is able to adjust treatments accordingly as a patient receiving CPR from a person versus a machine will require different procedures to ensure the safety of the patient and the aide. This prevents accidental injury and optimizes the device to better treat patients.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN FEDORKY whose telephone number is (571)272-2117. The examiner can normally be reached M-F 9:30-4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached on M-F 9:30-4:30. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MEGAN T FEDORKY/
Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796