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
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) 1-5, 7, 9-14, 16, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou (US 2022/0362558 A1).
Regarding claims 1, 10, and 18, Zhou 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 (eg. Fig. 2, electrodes coming out of 13, Para. 174-191), the list of electrodes including types of electrodes available to the AMD and position of the electrodes (Eg. Para. 148, 153-155, 171, 177, 184-199); sending a selection of one or more capture confirming criteria to confirm pacing capture to the AMD (eg. Para. 265, 291); performing, by the AMD, an automatic pacing threshold test for all potential pacing vectors that include the electrodes in the list of electrodes (Eg. Para. 239-240, 254, 262, 262-267, 276, 290, 319, 351, 366-368, 383); collecting data for each pace of the pacing threshold test confirmed to capture according to the selected one or more capture confirming criteria (Eg. Para. 240, 254, 262, 262-267, 276, 290, 319, 351, 366-368, 383); communicating the collected data to the programming device (Eg. Para. 158-160); 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 (Eg. Para. 166-167, 340).
While Zhou does not explicitly disclose a trend, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have shown a graph on histories of previously detected rhythmic episodes and conductions to provide the predictable result of visualizing the selected data over a period of time (Eg. Para. 226, 248, 251, 323, 373).
Regarding claims 2 and 19, Zhou 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. Para. 155, 163, 177, 182, 191, 196).
Regarding claims 3 and 12, Zhou 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 than when testing a pacing electrode not positioned at the interventricular septum (eg. Para. 268, 270, 301, 312, 357, 358, 361, 368, 377, 379, 383).
Regarding claims 4, 13, 20, Zhou 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 Para. 55, 163, 255, 290, 379).
Regarding claims 5 and 14, Zhou 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. Para. 290).
Regarding claims 7 and 16, Zhou 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. Para. 112, 149, 171, 211, 232, 240, 251, 261, 290-291, 301, 313).
Regarding claims 9, Zhou 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. Para. 155, 182, 185, 189-194).
Regarding claim 11, Zhou discloses the control circuit is configured to: perform the automatic pacing threshold test to determine optimized pacing stimulation energy to deliver to an electrode positioned in an interventricular septum; and communicate pacing capture data for the interventricular septum and capture confirming data for the selected one or more capture confirming criteria for the interventricular septum (eg. Para. 149, 160, 242-243, 373).
Claim(s) 6, 8, 15, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou (US 2022/0362558 A1) in view of Herrmann (US 2019/0201698 A1).
Regarding claims 6 and 15, Zhou discloses the invention of claim 5, but does not disclose 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.
Herrmann teaches a pacing system that outputs alarms (eg. Para. 60-61, 87) when thresholds are exceeded.
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 Zhou with the alerts with Herrmann to provide the predictable result of alerting when there is a loss of capture and there needs to be intervention (EG. Herrmann, Para. 87).
Regarding claims 8 and 17, the combined invention of Zhou and Herrmann 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. Herrmann, Para. 60-61, 87).
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL J LAU/ Examiner, Art Unit 3796