7Notice 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 .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims (1,4,5,10,11,12,13,14,15,17) are rejected under 35 U.S.C 103 as being unpatentable over Gallant ( US 4,316,249-hereinafter Gallant) in view of Wang (US 4,838,278-hereinafter Wang).
Regarding claim 1 :Gallant teaches a method comprising collecting ECG data from a patient (Fig. 4) and creating a normal template from successive sets of the ECG data, wherein the stored reference template is continuously updated as the tape is analyzed, with each new template value calculated as a weighted average of the incoming QRS complex and the prior template (col. 13 lines 1–8,) ;the template being formed and refreshed automatically from the patient's own incoming beats without an operator labeling each individual beat, and thus being learned in an unsupervised manner. Gallant further teaches detecting whether a specific arrhythmia is present in the ECG data by comparing each incoming beat against the stored template and continuously updating the R-R interval and area values following each comparison and executing a corresponding response through a coupled display/printer interface. (col. 19 lines 5–25, claim 2, Fig. 4).
Gallant does not explicitly teach wherein the ECG data collected includes a stimulation artifact from a cardiovascular device used by the patient, nor a knowledge-based beat classifier configured to classify beats using pace-pulse timing information.
Wang teaches a system for detecting and classifying paced ECG complexes (Abstract), wherein a pace pulse detector detects pacing pulses in the ECG signal, associates each pulse with a corresponding QRS complex, and applies a clustering analysis to classify the QRS complex, using stored template information, as a specific type of paced beat (Fig 3 col. 3, lines 1–65). Wang further explains that paced patients generate paced beats and that classification based only on a preceding pace pulse can produce false alarms (col. 1, lines 5–65).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ECG-template comparison system of Gallant, to incorporate the pace-pulse detection and clustering-based beat classification as taught by Wang, since such modification would still predictably result in, for example, a system capable of correctly classifying beats from paced patients and reducing the false alarms that Wang explains arise when a paced patient's rhythm is analyzed by a system not designed to recognize stimulation artifacts.
Gallant Fig 4:
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Wang Fig 3:
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Regarding Claim 4: Gallant teaches that an incoming beat’s R-R interval is compared against the patient’s own running average R-R interval, with the acceptable range being operator adjustable such as (80—120% of the average interval), such that a beat arriving significantly sooner than the normal interval; abnormally fast heart rate falls outside the accepted range and is treated as abnormal; that defines the tachycardia.
Therefore, it would have been obvious to one of ordinary skill in the art to distinguish that Gallant’s own R-R interval based abnormal beat detection already identifies tachycardia as one of the specific arrhythmias flagged by the combined Gallant and Wang system, since a rate based classifier of this kind necessarily flag as a sustained fast rate defining the characteristic of tachycardia; abnormal condition.
Regarding Claim 5: Gallant teaches that an incoming beat is accepted as matching the normal template, and used to update it, only if the beat's R-R interval falls within an operator-adjustable percentage of the running average interval for instance 80–120% and its area difference from the template falls below an operator-adjustable percentage as low as 40% , the unsupervised learning process continues, and the template keeps being refreshed, only until this threshold correlation is met for a given beat. Gallant further teaches that the reference-template computation itself functions as a discrete-time low-pass filter that continues tracking incoming QRS data until an update command is issued, at which point the roles of the old and new template memories are exchanged; describing the percentage-based R-R interval and area-difference acceptance criteria, and the low-pass-filter template update, respectively. Wang separately confirms that using a fixed clustering-interval threshold; in one embodiment, an interval difference of less than 40 ms to decide whether successive beat intervals are close enough to be grouped together was a known, predictable design choice in this field (Wang Fig 6a). Therefore, Gallant's own threshold-based acceptance criteria already teach this limitation, and it would been obvious to one of ordinary skill in the art to apply a numeric threshold-based similarity decision, of the kind confirmed by Wang, to Gallant's template-updating process, since such a combination would predictably result in a reliable, quantitative way of deciding when successive ECG data sets correlate closely enough with each other to be treated as representing the same underlying rhythm.
Wang Fig 6A:
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Regarding claim 10: Wang teaches determining a pacing mode by classifying QRS complexes according to the timing of the pace pulse relative to the QRS complex, across atrially-paced, ventricularly-paced, and dual-chamber-paced categories. Therefore, for the reasons discussed with respect to claim 1, it would have been obvious to one of ordinary skill in the art to apply Wang's pace-timing classification to the combined system of Gallant and Wang to determine the specific pacing mode of the cardiovascular device; including
atrial pacing/ventricular sensing
atrial sensing/ventricular pacing
atrial pacing/ventricular pacing
fused-beat conditions
since Wang's classifier already measures the timing relationships needed to distinguish these conditions. (Wang Col 5 and Col 6 lines 1-18)
Regarding Claim 11: Wang teaches determining pace-pulse-to-QRS intervals and storing this interval information together with the QRS complex. Using this stored, device-specific timing information to infer information about the structure, programing, or origin of the cardiovascular device would have been an obvious use of data that Wang's system already collects and stores, for the reasons discussed above with respect to claim 1. (Wang Col 1 line 60 -Col 2 line 12).
Regarding claims (12,13 and 17): Gallant teaches that a new reference template is computed as a weighted average of the incoming QRS complex and the old reference template, and that this new template is stored in one of two memories, the roles of which are exchanged upon an update command. Gallant further recites comparing successive QRS areas against a reference area and continuously updating the R-R interval and area following each comparison. This teaches converting newly collected, analyzed ECG test data into training data used to update the stored normal template, as recited in claim 12, and the functions (collect/compare/update) sequence recited in system claim 13 and computer-readable-medium claim 17. For the reasons discussed above with respect to claim 1, it would have been obvious to combine this teaching of Gallant with Wang's pace-pulse collection and classification to read on at the systems of claims 13 and 17.
Regarding claims 14,15: Gallant teaches an ECG input coupled to a beat detector and arrhythmia processor (Fig. 4, elements 216, 200), which corresponds to an ECG monitoring sensor communicatively coupled to the ECG port. Wang teaches detecting pace pulses generated by a cardiovascular device used by the patient such as a pacemaker or ICD (col. 1, lines 5–65). Therefore, it would have been obvious to combine the ECG-sensing hardware of Gallant, the pacemaker/ICD-generated stimulation artifacts of Wang, to arrive at the systems of claims 14 and 15.
Regarding claims 2,3,16: are rejected under 35 U.S.C. 103 as being unpatentable over Gallant in view of Wang, further in view of Sitzman (US 9,572,538-hereinafter Sitzman).
The combination of Gallant and Wang teaches storing a normal template and a beat classifier, but does not explicitly teach wherein a data structure links a specific arrhythmia to a corresponding response.
Sitzman teaches a system that evaluates a detected arrhythmia (a non-perfusion event identified from ECG heart-rate and blood-pressure/pulse-rate data), classifies the severity of that event, and displays the event together with its severity classification on a clinician terminal, with the underlying patient and event data stored in a population data table (Fig.1, Fig. 2, Fig.4,). Therefore, it would have been obvious to one of ordinary skill in the art modify the template/classifier system of Gallant and Wang, to incorporate the severity-linked response data structure as taught by Sitzman, since such modification would still predictably result in a system that not only classifies a beat but automatically links that classification to the clinically appropriate response, reducing the burden on clinical staff to manually assess the severity of each alarm.
Regarding claim 3, the combination of Gallant and Wang teaches storing a normal template but does not explicitly teach wherein intrinsic normal templates are stored separately from normal templates with stimulation artifacts.
Wang teaches a single template storage buffer that nonetheless holds two functionally distinct categories of information for each stored QRS shape group: ordinary shape-grouping data written by the QRS complex grouper and a separate paced-template classification (dual-chamber/atrial/ventricular-paced or not-paced) written by the paced template classification means (elements 10, 12, 24 of Fig. 3). This shows that Wang's own system already distinguishes, and separately tags, paced-beat information from ordinary beat-shape information before it is used to classify or update a given group's template.
Therefore, it would have been obvious to one of ordinary skill in the art to modify the single, undifferentiated template store of the combined Gallant and Wang system, to instead maintain two separate normal templates ;one for intrinsic (non-paced) beats and one for beats containing a stimulation artifact as a straightforward reorganization of the two categories of beat information that Wang's own system already distinguishes and tags, since such modification would predictably result in more accurate templates for each beat type and would reduce inappropriate template contamination between paced and non-paced beats.
Regarding claim 16: Sitzman teaches one or more patient monitors, configured to provide ECG and pulsatile-cardiovascular-signal information, coupled through an electronic communication network to a server, a clinician terminal, and a database. Therefore, it would have been obvious to one of ordinary skill in the art combine the ECG-sensing hardware of Gallant, the pacemaker/ICD-generated stimulation artifacts of Wang, and the communication network of Sitzman into a single physiological monitoring system, since each of these elements was well known individually, and combining them would still predictably result in a system capable of collecting, classifying, and reporting arrhythmia information to remote clinical staff.
(Sitzman Fig. 1)
( server 110, network 120, clinician terminal 130, database 150, patient monitors 160).
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Claims 6 and 9 rejected under 35 U.S.C. 103 as being unpatentable over Gallant in view of Wang, further in view of Foshee (US 11,364,388- hereinafter Foshee).
The combination of Gallant and Wang teaches detecting a tachycardia as discussed above, but does not explicitly teach withholding an emergency alarm when the tachycardia self-corrects within a predetermined time, or escalating to an emergency alarm when it persists uncorrected.
Foshee teaches a wearable cardioverter defibrillator system that, upon detecting a cardiac arrhythmia, withholds any human-perceptible alarm for a confirmation period so as to give the arrhythmia a chance to resolve on its own; if the arrhythmia self-terminates before the confirmation period ends, no alarm is output, but if the arrhythmia is instead confirmed such as persists through the confirmation period, the system proceeds to output an alarm and deliver therapy within a second, shorter time period.
Therefore, it would have been obvious to one of ordinary skill in the art to modify the tachycardia-detection system of Gallant and Wang, to incorporate the confirmation-period logic of Foshee, since such modification would predictably result in withholding an emergency alarm for a tachycardia that the cardiovascular device corrects within the confirmation period , while still escalating to an emergency alarm requesting immediate clinician intervention for a tachycardia that persists uncorrected through that period , consistent with the Foshee own stated purpose of avoiding unnecessary alarms for self-limiting events while still promptly flagging events that do not resolve.
Regarding Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Gallant in view of Wang, further in view of Sitzman, and further in view of Harthorne. (Harthorne, "Pacemaker-Mediated Tachycardias: An Unresolved Problem," PACE, Vol. 7, 1984)
The combination of Gallant, Wang, and Sitzman teaches the elements discussed above, but does not explicitly name pacemaker-mediated endless-loop tachycardia as the specific arrhythmia detected.
Harthorne describes a pacemaker-mediated endless-loop tachycardia describing endless-loop tachycardia and its recognized clinical urgency; in a way Harthorne NPL refers to a well-known specific type of pacing-related tachycardia caused by retrograde conduction through the pacemaker's own sensing/pacing loop
It would have been obvious to one of ordinary skill in the art to apply Wang's pace-pulse-based beat classification, in combination with Sitzman's severity-graded alarm response, to this well-known specific arrhythmia, since doing so would predictably result in an urgent alert appropriate to the known, moderate-to-serious clinical risk that endless-loop tachycardia presents.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Gallant in view of Wang, further in view of Lekholm (US 4763646, hereinafter Lekhlom), and further in view of Sitzman.
The combination of Gallant and Wang teaches the elements discussed above, but does not explicitly teach detecting a pacemaker-mediated exit-block tachycardia.
Lekholm teaches a heart pacemaker having detector/control circuitry wherein exit blocks, tachycardias, and fibrillations can each be detected using the same detector signal, and wherein that detector signal is further used to automatically adjust the stimulation pulses so that exit block can be avoided, (Col 2 lines 35-46) Sitzman teaches escalating a detected arrhythmia to the highest available alarm severity when the arrhythmia reflects a dangerous, actionable condition (Fig. 4; col. 1, lines 5–65).
Therefore, it would have been obvious to one of ordinary skill in the art to modify the combined ECG-monitoring system of Gallant and Wang, to incorporate the exit-block/tachycardia detection circuitry as taught by Foshee, and to further apply Sitzman's highest-severity alarm handling to the resulting condition, since such modification would still predictably result in, for example, prompt identification of a dangerous pacing failure and immediate presentation of that condition to clinical staff.
Conclusion
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/MOHAMAD HASSAN KANAAN/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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