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 .
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.
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.
Claim(s) 1-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sheldon et al. (US 2019/0009095) in view of one having ordinary skill in the art, via KSR Int’l Co. v. Teleflex Inc, 550 U.S. 398, 417 (2007).
Sheldon et al. discloses;
1
A medical device including a motion sensor/control circuit
E.G. via the disclosed motion sensor 212 and control circuit 206 configured to detect cardiac motion signal and to process the motion signal for atrial event detection and pacing control; [0028]-[0032], [0052]-[0058], Fig 3.
Identify plurality of ventricular cycles
E.G. via the disclosed identifying ventricular electrical/pacing events on a beat-by-beat and multi-cycle basis, including ventricular interval tracking, median ventricular intervals, etc.; [0072]-[0074], [0108]-[0118], [0165]-[0174]
Determine ventricular cycles relative to ventricular diastolic event window timing
E.G. via the disclosed determining ventricular diastolic event metrics/timing intervals and comparing ventricular-cycle timing relationships over multiple cycles for adjusting sensing/refractory operations; [0108]-[0118], [0165]-[0174].
Sheldon et al. does not explicitly disclose requiring a threshold number of ventricular cycles longer than a ventricular diastolic event window ending time. However, it would have been obvious to one having ordinary skill in the art to implement such repeated cycle qualification logic to improve sensing reliability and reduce transient/noise-related false detections as predictable optimization of Sheldon’s disclosed multi-cycle ventricular timing analysis. See KSR.
Determine maximum motion-signal amplitude after ventricular diastolic timing relationship
E.G. via the disclosed determining motion-signal amplitudes associated with atrial mechanical event detection after ventricular timing intervals/events and adjusting sensing operations responsive thereto; [0073]-[0075], [0089]-[0093], [0108]-[0110], [0175]-[0178]
Determine sensing threshold amplitude from determined amplitude
E.G. via the disclosed determining/adjusting sensing threshold amplitude based on detected motion-signal amplitudes and atrial event metrics; [0075], [0089]-[0092], [0175]-[0178], Figs. 5-6.
Generate ventricular pacing pulse in response to sensed atrial event.
E.G. via the disclosed pacing pulses responsive to atrial event detection from the motion signal by control circuit 206; [0057]-[0058], [0079]-[0083], [0181]-[0187].
2.
Maximum amplitude does not meet adjustment threshold/decrement low sensing threshold
E.G. via the disclosed comparing detected motion-signal amplitudes to sensing thresholds/criteria and adjusting sensing thresholds accordingly; [0075], [0089]-[0092], [0175]-[0178].
Sheldon et al. teaches decreasing detection threshold amplitudes to improve atrial event detection reliability when signals are insufficient or missed, [0176]-[0178].
3.
Maximum amplitude meets adjustment threshold/increment low sensing threshold.
E.G. via the disclosed increasing sensing/detection threshold amplitudes in response to oversensing or excessive atrial event detections/noise [0169]-[0178].
4.
Motion signal fails to meet low threshold during ventricular cycles longer than ventricular diastolic window/decrease threshold
E.G. via the disclosed identifying ventricular cycles exceeding ventricular timing intervals/windows and adjusting atrial sensing thresholds based on missed or insufficient atrial detections occurring during such cycles; [0108]-[0118], [0165]-[0178].
The examiner notes adjusting the threshold downward in response to insufficient signal detections would have been obvious to improve atrial sensing reliability. See KSR.
5.
Determine undersensing atrial events/decrease threshold
E.G. via the disclosed identifying missed atrial events and decreasing sensing thresholds to improve atrial event tracking reliability; [0176]-[0178].
6.
Determine oversensing atrial events/increase threshold
E.G. via the disclosed identifying oversensing/noise-related atrial detections and increasing sensing threshold to reduce false detections, [0169]-[0178].
7.
Determining maximum amplitudes after ventricular diastolic window in threshold number of ventricular cycles/determine minimum maximum amplitude/threshold based thereon
Sheldon et al. discloses determining motion-signal amplitudes after ventricular timing intervals across multiple ventricular cycles and adjusting sensing thresholds based on measured amplitudes and cycle analysis; [0108]-[0118], [0175]-[0178]
It would have been obvious to one having ordinary skill in the art at the time the invention was made to select a minimum value from multiple detected amplitudes for conservative threshold determination since it would have been an obvious design choice for improving sensing stability and reducing false positives. See KSR.
8.
Count early atrial events before threshold interval/count normal atrial events after threshold interval/determine threshold based on counts and maximum amplitude
E.G. via the disclosed distinguishing early versus normal atrial events relative to timing windows/intervals and adjusting atrial sensing thresholds responsive to event timing and tracking performance; [0165]-[0178].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use counts/statistics of detected early and normal atrial events to optimize threshold settings since it would have been an obvious predictable refinement of Sheldon’s multi-cycle atrial event analysis. See KSR.
9.
Apply ventricular diastolic event window ending time/sense atrial event after threshold crossing.
E.G. via the disclosed applying atrial sensing windows/timing intervals and sensing atrial events from motion signals when the signal crosses a sensing threshold after the relevant ventricular timing interval/window; [0073]-[0083], [0175]-[0178].
10.
Determine regular atrial event sensing criteria are met/increase threshold
E.G. via the disclosed confirming regular atrial tracking conditions and increasing sensing thresholds in response to oversensing or repetitive atrial detections, [0165]-[0178].
11.
Rejected for substantially the same reasons as claim 1, wherein Sheldon et al. discloses sensing a motion signal, determining ventricular cycle timing conditions, adjusting sensing threshold amplitudes based on motion-signal amplitudes, sensing atrial events from the motion signal and generating ventricular pacing pulses responsive thereto; [0057]-[0058], [0072]-[0083, [0108]-[0118], [0165]-[0187].
12.
Rejected for substantially the same reasons as claim 2, wherein Sheldon et al. discloses decreasing sensing threshold amplitudes responsive to insufficient or missed atrial detections; [0176]-[0178].
13.
Rejected for substantially the same reasons as claim 3, wherein Sheldon et al. discloses increasing sensing threshold amplitudes responsive to oversensing or excessive atrial detections/noise; [0169]-[0178].
14.
Rejected for substantially the same reasons as claim 4, wherein Sheldon et al. discloses decreasing sensing thresholds responsive to insufficient atrial detections during ventricular cycles exceeding timing intervals/windows; [0108]-[0118], [0165]-[0178], KSR
15.
Rejected for substantially the same reasons as claim 5, wherein Sheldon et al. discloses determining undersensed atrial events and decreasing sensing thresholds responsive thereto; [0176]-[0178].
16.
Rejected for substantially the same reasons as claim 6, wherein Sheldon et al. discloses determining oversensed atrial events and increasing thresholds responsive thereto.
17.
Rejected for substantially the same reasons as claim 7, wherein Sheldon et al. discloses determining motion-signal amplitudes across ventricular cycles and adjusting sensing threshold based thereon; [0108]-[0118], [0175]-[0178]
It would have been obvious to one having ordinary skill in the art at the time the invention was made to select a minimum amplitude value for threshold determination since it would have been an obvious design optimization. See KSR.
18.
Rejected for substantially the same reasons as claim 8, wherein Sheldon et al. discloses distinguishing early versus normal atrial events relative to timing intervals/windows and adjusting sensing thresholds responsive thereto; [0165]-[0178].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use event counts/statistics for threshold optimization since it would have obvious optimization. See KSR.
19.
Rejected for substantially the same reasons as claim 9, wherein Sheldon et al. discloses applying ventricular timing/windows to the motion signal and sensing atrial events based on the motion signal crossing a sensing threshold after the ventricular timing interval/window; [0072]-[0083], [0175]-[0178].
20.
Rejected for substantially the same reasons as claim 10, wherein Sheldon et al. discloses determining regular atrial sensing/tracking conditions and increasing sensing thresholds responsive thereto to reduce oversensing/noise detections; [0165]-[0178]).
21.
Rejected for substantially the same reasons as claim 11, wherein Sheldon et al. discloses a non-transitory computer readable medium including instructions executable to perform motion sensing, ventricular-cycle identification, sensing-threshold adjustment based on motion-signal amplitudes, atrial-event sensing and ventricular pacing operations; [0057]-[0058], [0072]-[0083], [0108]-[0118], [0165]-[0187].
22.
Rejected for substantially the same reasons as claim 1, wherein Sheldon et al. discloses storing ventricular timing/window parameters, determining motion-signal amplitudes after ventricular timing intervals/windows across ventricular cycles, and sensing atrial events from the motion signal based on sensing threshold after the ventricular timing interval/window; [0072]-[0083], [0108]-[0118], [0175]-[0178].
Response to Arguments
Applicant's arguments filed April 1, 2026 have been fully considered but they are not persuasive. The applicant argues the following points in which the examiner provides a reason(s) as to why the arguments are not persuasive:
The applicant argues that the primary reference, Sheldon et al., fails to disclose the following limitations: (i) determining motion-signal amplitudes after a ventricular diastolic event window ending time, (ii) adjusting sensing threshold amplitudes based on such amplitudes, and (iii) sensing atrial events relative to the claimed ventricular timing windows. The applicant further argues Sheldon et al. does not teach the claimed undersensing/oversensing threshold adjustment features.
The applicant’s arguments are not persuasive. Sheldon et al. teaches ventricular timing intervals/windows associated with ventricular cycles, detection of atrial events occurring after such interval/windows and adaptive adjustment of sensing threshold amplitudes based on atrial-event detections and motion signal analysis, [0072]-[0083], [0108]-[0118], [0165]-[0178]. Sheldon et al. further teaches increasing and decreasing sensing thresholds responsive to oversensing, undersensing, missed detections and excessive detections.
The applicant’s arguments improperly focus on the absence of identical terminology in Sheldon et al. rather than the functional teachings of the reference as a whole. The claims do not require the exact nomenclature used by the applicant. Accordingly, the rejections(a) are maintained.
Applicant’s arguments, filed April 1, 2026, with respect to the 35 U.S.C § 112 and 101 have been fully considered and are persuasive:
The amended claim recite specific cardiac sensing and pacing operations in which ventricular cycle timing determinations and motion-signal analysis are used to control generation of a ventricular pacing pulse.
When considered as a whole, the claims integrate any alleged judicial exception into a practical application involving a particular technological implementation for cardiac pacing and sensing operations, rather than merely reciting data analysis in the abstract. Accordingly, the § 101 rejection is withdrawn.
The applicant’s arguments regarding the definiteness and written description have been considered. The examiner agrees the amended claim terminology is reasonably clear and supported by the specification when read by one of ordinary skill in the art.
Therefore, the above rejections have been withdrawn.
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 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 NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796
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