DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 5/12/16 have been fully considered but they are not persuasive. The Applicant argues that Tan fails to read on the claims as frequency peaks are not the equivalent to Amplitude Peaks of an ECG signals. The Examiner respectfully disagrees. The claims do not require frequency or time domain analysis. The claims only require that the data that is processed is ECG values based on the ECG signal and that the peak amplitudes of that data is processed for analysis. Therefore, the Applicant’s arguments are moot. Since the system of Tan analyzes the decrease in peak amplitudes of ECG data (e.g. ¶19), it reads on the claims. Therefore, the rejections stand.
The Applicant argues that the dependent claims are allowable as they depend from the allowable independent claims. As discussed above, the independent claim stands rejected, therefore the dependent claims stand rejected.
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.
Claim(s) 1-5 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tan et al. (U.S. Pub. 2005/0256415 hereinafter “Tan”) in view of Volpe et al. (U.S. Pub. 2013/0085538 hereinafter “Volpe”).
Regarding claim 1, Tan discloses a wearable medical system ("WMS") for a patient (e.g. see Fig. 2; “electrodes attached to the body”), the WMS including at least: sensing electrodes configured to sense electrical activity of the heart of the patient and output an Electrocardiogram (ECG) signal (e.g. ¶¶118-119; “ECG electrodes”); an energy storage module (e.g. 24; “defibrillator pulse generator”); a therapy electrode coupled to the energy storage module (e.g. ¶¶117-119; “defibrillator pads”); a memory (e.g. ¶81; “memory”); and one or more processors (e.g. 22; “processor”) configured to: store, in the memory, ECG values based on the ECG signal (e.g. ¶81), generate a patient input based on the ECG values (e.g. ¶¶40-47, 81), determine, from the patient input, whether a heart rate of the patient exceeds a high threshold heart rate (e.g. ¶¶3, 67; “High VF rate”), responsive to a determination that the heart rate exceeds the high threshold heart rate (e.g. ¶¶3, 67; “High VF rate”), determine: from the present ECG peak amplitude and from the previous ECG peak amplitude, whether a peak amplitude decrease criterion is met (e.g. ¶19), cause, responsive at least in part to a determination that the peak amplitude decrease criterion is met, electrical charge to be discharged from the energy storage module via the therapy electrode through the patient so as to deliver a shock to the patient (e.g. ¶¶18-19; “peak amplitude decrease by a percentage then deliver defibrillation”); and store in the memory a record that indicates the shock was delivered (e.g. ¶81; “store peak number when defibrillation was given and successful”). Tan discloses the claimed invention except for the wearable system having a support structure configured to be worn by the patient that includes a memory on board that stores the shock record. However, Volpe teaches that it is known to use a support structure with all of the elements attached as set forth in Paragraph 31-33 and 37 to provide structure to support the device during ambulatory movement and provide records to the physician for analysis. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Tan, with the support structure that holds and positions all of the necessary elements on the user as taught by Volpe, since such a modification would provide the predictable results of provide structure to support the device during ambulatory movement and provide records to the physician for analysis.
Regarding claim 2, meeting the limitations of claim 1 above, Tan further discloses that the high threshold heart rate is about 170 beats per minute (e.g. ¶67; “150 bm is about 170bpm”).
Regarding claim 3, meeting the limitations of claim 1 above, Tan further discloses that the peak amplitude decrease criterion comprises the present ECG peak amplitude being less than the previous ECG peak amplitude by at least a threshold fraction (e.g. ¶19).
Regarding claim 4, meeting the limitations of claim 1 above, Tan further discloses that the threshold fraction is about 15% (e.g. ¶19; “15%”).
Regarding claim 5, meeting the limitations of claim 1 above, Tan further discloses in which the processor is further configured to: detect, from the patient input, whether a sudden onset event occurred before a determination that the heart rate exceeded the high threshold heart rate (e.g. ¶19), and in which, responsive to a detection of the sudden onset event, the previous ECG peak amplitude is determined from the ECG values stored in the memory fewer than 30 minutes prior to the determination that the heart rate exceeds the high threshold heart rate (e.g. ¶19).
Regarding claim 8, meeting the limitations of claim 1 above, Tan further discloses in which the processor is further configured to: detect, from the patient input, whether a sudden onset event occurred before a determination that the heart rate exceeded the high threshold heart rate, and responsive to the sudden onset event not being detected, the previous ECG peak amplitude is determined from the ECG values stored in the memory at least 30 minutes prior to the determination that the heart rate exceeds the high threshold heart rate (e.g. ¶19; “adjacent peaks”).
Claim(s) 6-7 and 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tan in view of Volpe as applied to claims 1-5 and 8 above, and further in view of Kim et al. (U.S. Pat. 7,702,384 hereinafter “Kim”).
Regarding claims 6-7 and 9-11, Tan in view of Volpe discloses the claimed invention except for the use of a heart rate jump threshold to determine tachyarrhythmias. However, Kim teaches that it is known to use a heart rate jump threshold as set forth in Paragraph Column 4, line 48 to Column 5, line 15 to provide a known percentage increase in heart rate that is about 20 percent that equates to a ventricular tachyarrhythmia. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Tan in view of Volpe, with a heart rate jump sensor that is about 20 percent as taught by Kim, since such a modification would provide the predictable results of using a known method of determining a sudden onset of tachyarrhythmia.
Claim(s) 12-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tan in view of Volpe as applied to claims 1-5 and 8 above, and further in view of Chen et al. (U.S. Pub. 2013/0338519 hereinafter “Chen”).
Regarding claims 12-17, Tan in view of Volpe discloses the claimed invention except for the use of morphology stability criterion to determine signal averaged QRS complexes from a plurality of peaks and determine statistics to determine ECG morphology to determine conditions. However, Chen teaches that it is known to use signal averaged QRS complexes to determine morphology stability criterion as set forth in Paragraph 27 to provide that the system is using the QRS complexes of the highest quality for the most accuracy. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Tan in view of Volpe, with signal averaged QRS complexes to determine morphology stability criterion as taught by Chen, since such a modification would provide the predictable results of using the QRS complexes of the highest quality for the most accuracy.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached Monday-Thursday 7:00AM-5:30PM.
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/REX R HOLMES/Primary Examiner, Art Unit 3796
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