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, see pages 9-15, filed 6/4/2026, with respect to the rejection(s) of claim(s) 1-20 under USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of over Demmer (US 8718770 B2) in view of Casavant (US 11707630 B2).
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Demmer (US 8718770 B2) in view of Casavant (US 11707630 B2).
Regarding claims 1, 10, and 18, Demmer discloses a method of operating a cardiac rhythm management (CRM) system (eg. Fig. 1-2), the method comprising: sending a list of electrodes to an ambulatory medical device (AMD) of the CRM system from a programming device for the AMD, the list of electrodes including types of electrodes available to the AMD and position of the electrodes (eg. Col. 6, Ln. 65 – Col. 7, Ln. 56); an automatic pacing threshold test for all potential pacing vectors that include the electrodes in the list of electrodes (eg. Col. 8 ,Ln. 15-30, Col. 17, Ln. 19-28, Col. 20, Ln. 15-21); collecting data for each pace of the pacing threshold test confirmed to capture according to the selected one or more capture confirming criteria (eg. Col. 14, Ln. 15-67; communicating the collected data to the programming device (eg. Col. 17, Ln. 28-55; but does not disclose sending a selection of one or more capture confirming criteria to confirm pacing capture to the AMD; performing, by the AMD, and presenting, by the programming device, the collected data as a trend relative to at least one selected capture confirming criterion and the pacing stimulation energy that resulted in capture.
Casavant teaches a pacemaker device with verifying capture using far-field QRS width and heart sounds information, endocardial acceleration information, cardiac impedance information, or cardiac pressure information (eg. Claim 5, Col. 20, Ln. 50-65) and the output unit may generate a trend of QRS width and displayed to a user (eg. Col. 20, Ln. 15-50).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Demmer with the capture criteria and trend displays as taught by Casavant to provide the predictable result of improving the accuracy of detecting captures/non-captures and displaying to help a user make programming changes to therapy (eg. Casavant Col. 20, Ln. 15-50).
Regarding claim 2, 11, and 19, the combined invention of Demmer and Casavant discloses the sending the list of electrodes includes sending a list of electrodes that includes an electrode positioned in the interventricular septum; wherein the collecting data includes collecting pacing capture data for a pacing vector that includes the electrode positioned in the interventricular septum; and wherein the presenting the trend includes presenting a trend of the pacing capture data for the electrode positioned in the interventricular septum and data related to the at least one selected capture confirming criterion (eg. Casavant, Col. 8, Ln. 39 – Col. 9, Ln. 2, Col. 12, Ln. 55 – Col. 13, Ln. 6).
Regarding claims 3 and 12, the combined invention of Demmer and Casavant discloses the performing the automatic pacing threshold test includes using a longer capture detection timing window when testing the electrode positioned at the interventricular septum at a His bundle or a left bundle branch position than when testing a pacing electrode not positioned at the interventricular septum. (eg. Casavant, Col. 17, Ln. 15-42).
Regarding claims 4, 13, and 20, the combined invention of Demmer and Casavant discloses the selectable capture confirming criteria include: a magnitude of one or more heart sounds from a pace confirmed to capture; a width of a far-field QRS complex associated with the pace confirmed to capture, the far-field QRS complex sensed using sensed using a combination of one or more transvenous electrodes and an electrode on the AMD; a time interval from the pace confirmed to capture to a peak amplitude of the far-field QRS complex; and a time interval from the pace confirmed to capture to a sensed electrocardiogram (EGM) of the pace sensed using an electrode combination that delivered the pace (eg. Casavant Col. 20, Ln. 50 – Col. 21, Ln. 26).
Regarding claim 5 and 14, the combined invention of Demmer and Casavant discloses sending a selection of one more pacing vectors to the AMD; sending an operating range for the selected one or more capture confirming criteria; recurrently performing automatic pacing threshold tests for the selected vectors according to a schedule and monitoring the selected one or more capture confirming criteria; and setting the one or both of the pacing energy amplitude and pacing energy pulse width for the pacing vectors according to the operating range for the selected one or more capture confirming criteria (eg. Casavant Col. 13, Ln. 5-25, Col. 17, Ln. 59 – Col. 19, Ln. 45).
Regarding claim 6, and 15, the combined invention of Demmer and Casavant discloses triggering an alert when an automatic pacing threshold test detects that the selected one or more capture confirming criteria remains outside the operating range for the automatic pacing threshold tests (eg. Casavant Col. 13, Ln. 5-25, Col. 17, Ln. 59 – Col. 19, Ln. 45, Col. 20, Ln. 15-50).
Regarding claims 7 and 16, the combined invention of Demmer and Casavant discloses sending a selection of one more pacing vectors to the AMD; sending an operating range for one or both of pacing energy amplitude and pacing energy pulse width for the pacing vectors; and delivering cardiac pacing therapy using the selected pacing vectors (eg. Col. 13, Ln. 5-25, Col. 18, Ln. 45 – Col. 19, Ln. 45, Col. 22, Ln. 48 – Col. 23, Ln. 3).
Regarding claims 8 and 17, the combined invention of Demmer and Casavant discloses recurrently performing automatic pacing threshold tests for the selected vectors according to a schedule; setting the one or both of the pacing energy amplitude and pacing energy pulse width for the pacing vectors according to the recurrent automatic pacing threshold tests; and triggering an alert when the one or both of the pacing energy amplitude and pacing energy pulse width remain outside the operating range for the automatic pacing threshold tests (eg. Casavant Col. 13, Ln. 5-25, Col. 17, Ln. 59 – Col. 19, Ln. 45, Col. 20, Ln. 15-50).
Regarding claim 9, the combined invention of Demmer and Casavant discloses the sending the list of electrodes includes sending a list including can electrodes of the AMD and ring electrodes and tip electrodes of all implantable leads connected to the AMD; and wherein the collecting data includes collecting automatic pacing threshold data for all potential pacing vectors that use any combination of the can electrode, ring electrodes, and tip electrodes (eg. Demmer, Col. 6, Ln. 45-60, Col. 8, Ln. 15-28).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J LAU whose telephone number is (571)272-2317. The examiner can normally be reached 8-5:30 PM.
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/MICHAEL J LAU/Examiner, Art Unit 3796
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