Patent Application 18976825 - ADVANCED PACING - Rejection

Patent Application 18976825 - ADVANCED PACING

Title: ADVANCED PACING

Application Information

• Invention Title: ADVANCED PACING
• Application Number: 18976825
• Submission Date: 2025-05-13T00:00:00.000Z
• Effective Filing Date: 2024-12-11T00:00:00.000Z
• Filing Date: 2024-12-11T00:00:00.000Z
• Examiner Employee Number: 82573
• Art Unit: 3796
• Tech Center: 3700

Rejection Summary

• 102 Rejections: 1
• 103 Rejections: 2

Cited Patents

The following patents were cited in the rejection:

• US 0039904🔗
• US 0032067🔗

Office Action Text

    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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 5/2/25; 4/18/25 has/have been acknowledged and is/are being considered by the Examiner.
Response to Arguments
Applicant's arguments filed 4/24/25 have been fully considered but they are not persuasive. The Applicant argues that Kornet fails to describe an algorithm to assess the susceptibility to an arrhythmia either the initiation or the maintenance of the arrhythmia. The Examiner respectfully disagrees.  The claims only state that the pacing minimizes the susceptibility to initiation of fibrillation.  In this case the algorithms as clearly disclosed in Kornet teach each and every limitation including pacing that minimizes the susceptibility to initiation of fibrillation (e.g. ¶93).  The Applicant further argues that the pacing technologies of Kornet are the same as the current application.  The Examiner is unable to find any limitations in the claims that clearly define the type of pacing other than the words pacing.  For this reason, the rejections stand as Kornet clearly discloses pacing.  The Applicant further argues that Kornet fails to suspend the first pacing energy if the third algorithm detects AF.  The Examiner respectfully disagrees.  As Kornet clearly discloses discontinuing the first energy if the third algorithm determines AF (e.g. ¶88).  The Applicant also argues that the 103 reference fails to cure the deficiencies of the Kornet reference and therefore the rejections are invalid.  As shown above, the Kornet reference clearly anticipates the claims and therefore the Applicant’s arguments are moot.  

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) 37-47, 50-52 and 54-55 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kornet et al. (U.S. Pub. 2022/0032067 hereinafter “Kornet”).
Regarding claim 37, Kornet discloses a method of treating a patient, comprising: (a) selecting the patient for treatment (e.g. ¶4; “HFpEF”); (b) implanting an implantable device in the patient (e.g. 16), wherein the implantable device comprises: an array of multiple electrodes (e.g. 40, 42, 44, 45, 46, 47, 48, 50, 58, 62, 64, 66); a controller (e.g. 80) operatively connected to the multiple electrodes (e.g. see Fig. 3B); and a memory storage (e.g. 82) component coupled to the controller (e.g. see Fig. 3B), wherein the memory storage component stores instructions for the controller to perform one or more algorithms (e.g. ¶¶25-27 and 93), wherein during the implanting the multiple electrodes are positioned on an epicardial surface of a heart of the patient proximate a left atrium (e.g. see Fig. 3B; ¶27); (c) using a first set of the multiple electrodes to sense electrical activity of the heart (e.g. ¶22); and (d) delivering a first configuration of pacing energy to the heart using a second set of the multiple electrodes based on an assessment of the patient's susceptibility to an arrythmia performed by a first algorithm of the one or more algorithms (e.g. ¶¶ 4, 31 and 49), wherein the assessment is performed by analyzing the sensed electrical activity (e.g. ¶87); wherein a second algorithm of the one or more algorithms is configured to determine one or more parameters of the first configuration of pacing energy to be delivered (e.g. ¶93); wherein the first configuration of pacing energy delivery is configured to minimize susceptibility to initiation of atrial fibrillation in the patient (e.g. ¶93); wherein a third algorithm of the one or more algorithms is configured to monitor for atrial fibrillation by analyzing the sensed electrical activity (e.g. ¶88), and wherein the delivery of the first configuration of pacing energy is discontinued if atrial fibrillation is detected via the third algorithm (e.g. ¶88).
Regarding claim 38, Kornet further discloses (e) delivering a second configuration of pacing energy to the heart using a third set of the multiple electrodes based on a detection of atrial fibrillation of the patient as determined by a fourth algorithm of the one or more algorithms, wherein the assessment is performed by analyzing the sensed electrical activity (e.g. ¶¶25-26); wherein a fifth algorithm of the one or more algorithms is configured to determine one or more parameters of the second configuration of pacing energy to be delivered (e.g. ¶¶25-26); and wherein the second configuration of pacing energy delivery is configured to terminate the atrial fibrillation in the patient (e.g. ¶26).
Regarding claim 39, Kornet further discloses wherein the second set of electrodes and the third set of electrodes comprises the same electrodes of the multiple electrodes (e.g. ¶26; “Both therapies can use same electrodes”).
Regarding claim 40, Kornet further discloses wherein step (e) is performed prior to step (d) (e.g. see Fig. 4; “algorithms can be run in any order or parallel”).
Regarding claim 41, Kornet further discloses wherein the second configuration of pacing energy is based on a complexity assessment of the atrial fibrillation detected (e.g. ¶¶25-27).
Regarding claim 42, Kornet further discloses wherein the second configuration of pacing energy is configured to control a fibrillating substrate by deterministically pacing into a narrowed excitable gap present during atrial fibrillation (e.g. ¶94).
Regarding claim 43, Kornet further discloses wherein a sixth algorithm of the one or more algorithms is configured to identify a restoration of normal rhythm and to terminate the delivery of the second configuration of pacing energy (e.g. ¶95).
Regarding claim 44, Kornet further discloses wherein the first configuration of pacing energy and/or the second configuration of pacing energy is configured to advance and/or block one or more cardiac activation wavefronts (e.g. ¶¶87-94).
Regarding claim 45, Kornet further discloses wherein the first configuration of pacing energy and/or the second configuration of pacing energy is delivered ahead of an approaching cardiac activation wavefront (e.g. ¶94).
Regarding claim 46, Kornet further discloses wherein the first configuration of pacing energy and/or the second configuration of pacing energy is configured to synchronize atrial activation (e.g. ¶¶87-94).
Regarding claim 47, Kornet further discloses wherein the first configuration of pacing energy comprises a variable rate pacing arrangement (e.g. ¶¶21, 28; “adjustable rate; rate responsive”).
Regarding claim 50, Kornet further discloses wherein the first configuration of pacing energy comprises different durations of earliness corresponding to a heartbeat, and wherein the first configuration of pacing energy is further configured to impose a desired variability in the heart rate over time (e.g. ¶¶37, 46).
Regarding claim 51, Kornet further discloses wherein the delivering of the first configuration of pacing energy is occasionally inhibited such that the intrinsically-longest cycle length is achieved.
Regarding claim 52, Kornet further discloses wherein the delivering of the first configuration of pacing energy is periodically inhibited, and wherein the mean and standard deviation of heart rate is assessed during the inhibition period (e.g. ¶37).
Regarding claim 54, Kornet further discloses wherein the delivering of the pacing energy is imperceptible to the patient (e.g. ¶¶91-92; “sub-threshold”).
Regarding claim 55, Kornet further discloses wherein the patient has atrial fibrillation and HFpEF (e.g. ¶18).
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) 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kornet.
Regarding claim 48, Kornet further discloses wherein the first configuration of pacing energy comprises pacing that is faster than normal sinus rhythm (e.g. ¶90). Kornet disclose the claimed invention except for explicitly stating the percentage of overdrive pacing.  It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the pacing as taught by Kornet to have a percentage faster than normal sinus rhythm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.  In re Aller, 105 USPQ 233.
Claim(s) 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kornet as applied to claims 37-47, 50-52 and 54-55 above, and further in view of Bulkes et al. (U.S. Pub. 2008/0039904 hereinafter “Bulkes”).
Regarding claim 53, Kornet further discloses a system that includes a wireless transmission means, but fails to explicitly state that the system transmits an alert condition to a clinician device.  Bulkes teaches that it is known to use the wireless transmission means to alert a clinician as set forth in paragraphs 270-271 to provide a means to alert the clinician for events that require a quick follow up such as atrial fibrillation.  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 Kornet, with alerting a clinician as taught by Bulkes, since such a modification would provide the predictable results of providing a means to alert the clinician for events that require a quick follow up such as atrial fibrillation.
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 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