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 16 July 2026 have been fully considered but they are not persuasive.
Applicant argues that Zhang fails to teach determining that PNS episode criteria have been satisfied in response to detection of PNS over the plurality of heart beats and detecting a PNS episode in response to the PNS episode criteria being satisfied as set forth in the independent claims. Examiner disagrees. Zhang expressly discloses evaluating and confirming PNS across a plurality of cardiac cycles, and declaring PNS presence based on that multi-beat analysis (e.g. ¶ 99, 105 – 108).
Zhang states that the number of cardiac cycles may be nine (e.g. ¶ 99) and that signal analyzer analyzes an EGM-gated heart sound signal ensemble averaged over N beats (e.g. ¶ 107). The heart sound analysis used to identify the PNS artifact, therefore, is performed across a plurality of cardiac cycles.
Furthermore, “PNS episode criteria” is broad. The claims do not define “PNS episode criteria” beyond determining that such criteria have been satisfied in response to PNS detected over the plurality of beats and then detecting a PNS episode. The multi-beat confirmation that PNS is present as taught by Zhang reads on this limitation. Specifically, Zhang teaches that features are taken from an ensemble average over N beats (e.g. 5 to 10) (e.g. ¶ 107). Zhang then determines whether PNS is present from those multi-beat features (PNS amplitude relative to S1 compared to predetermined threshold) (e.g. ¶ 108).
The rejection of claims 1 – 20 under 35 U.S.C. § 102(a)(1) as being anticipated by Zhang et al. is maintained.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 – 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al. (US PGPUB 2012/0296388 – in IDS).
Regarding claims 1, 11, and 20, Zhang discloses a method for use in a cardiac medical device, a cardiac medical device, and a non-transitory computer readable medium, comprising a sensor to detect PNS (e.g. 82 in Fig. 3; ¶ 7); and a processor (e.g. 70) operably coupled to the sensor (e.g. Fig. 3) and configured to: detect phrenic nerve stimulation (PNS) using the sensor over a plurality of heart beats of a patient (e.g. Fig. 7; step 126 monitors heart sound and egm signals. This would necessarily be over a plurality of heart beats); determine that PNS episode criteria have been satisfied in response to the detection of PNS over the plurality of heart beats (e.g. 130); and detect a PNS episode in response to the PNS episode criteria being satisfied (e.g. ¶ 92 – 93).
Regarding claims 2, 3, 12, and 13, Zhang discloses determining that PNS episode criteria have been satisfied in response to the detection of PNS over the plurality of heart beats comprises: determining that PNS episode criteria have been satisfied in response to the PNS being detected over a predetermined number of consecutive heart beats (e.g. Fig. 7 and ¶ 92 – 93; when PNS is determined, pacing is decreased and PNS is monitored for the subsequent/consecutive beats; ¶ 56; processor 70 may initiate phrenic nerve stimulation detection during a predetermined time range).
Regarding claims 4 and 14, Zhang discloses the processor is further configured to: modify, in response to the PNS episode being detected, one or more pacing parameters to avoid PNS, wherein the one or more pacing parameters comprises one or more of pacing vector, pacing pulse strength, and lead placement (e.g. ¶ 40, and Fig. 7 – 132, 140).
Regarding claims 5 and 15¸Zhang discloses the processor is further configured to suspend delivery of a pacing therapy in response to the PNS episode being detected (e.g. ¶ 40; determine whether therapy should continue to be delivered).
Regarding claims 6 and 16, Zhang discloses the processor is further configured to: detecting noise using the sensor over the plurality of heart beats; and restrict the detection of PNS for a heart beat in response to the detection of noise (e.g. ¶ 57).
Regarding claims 7 and 17, Zhang discloses detecting noise over the plurality of heart beats comprises detecting noise during a noise window beginning after a PNS detection window of time immediately following one or more of a ventricular pace (Vp) beat, an atrial sense (As) beat, and an atrial pace (Ap) beat (e.g. ¶ 29-30).
Regarding claims 8 and 18, Zhang discloses the sensor is an acoustic sensor, wherein detecting PNS over the plurality of heart beats comprises: monitoring an acoustic signal using the acoustic sensor over the plurality of heart beats; determining a contraction of a diaphragm of the patient based on the acoustic signal; and detecting PNS in response to determining contraction of the diaphragm (e.g. ¶ 44, 57).
Regarding claims 9 and 19, Zhang discloses the sensor is an accelerometer, wherein detecting PNS over the plurality of heart beats comprises: monitoring an accelerometer signal using the accelerometer over the plurality over heart beats; determining a contraction of a diaphragm of the patient based on the accelerometer signal; and detecting PNS in response to determining contraction of the diaphragm (e.g. ¶ 25 and 36).
Regarding claim 10¸ Zhang discloses detecting PNS over the plurality of heart beats comprises detecting PNS using a cardiac signal in a PNS detection window immediately following one or more of a ventricular pace (Vp) beat, an atrial sense (As) beat, and an atrial pace (Ap) beat (e.g. ¶ 8; defined by a window after an applied stimulation).
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 JOSEPH M DIETRICH whose telephone number is (571)270-1895. The examiner can normally be reached Mon - Fri 8:00-5:00.
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/JOSEPH M DIETRICH/Primary Examiner, Art Unit 3796
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