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 .
Specification
The disclosure is objected to because of the following informalities: the first paragraph of the specification should be updated to indicate the present status of the priority application.
Appropriate correction is required.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 10/14/24 has/have been acknowledged and is/are being considered by the Examiner.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lybarger et al. (U.S. Pub. 2021/0052895 hereinafter “Lybarger”).
Regarding claims 1 and 12, Lybarger discloses an implantable medical device (e.g. 14), comprising: a signal receiver circuit (e.g. 86) configured to receive, for a first cardiac cycle, electrical information from a cardiac conduction system location at or near a ventricle of a heart of a patient (e.g. see Fig. 1), the cardiac conduction system location proximate a His bundle, left or right bundle branches, or between an AV node and Purkinje fibers of the heart of the patient (e.g. ¶¶26-27); and an assessment circuit (e.g. 80) configured to: detect or receive an atrial sense event in the first cardiac cycle using electrical information from an atrium of the heart of the patient for the first cardiac cycle (e.g. 152; ¶67; senses both intrinsic and paced signals; it is noted that the claim is silent as the type of atrial sensed event, just that the sensed event has to come from the atrial. ); and apply, in response to the detected or received atrial sense event in the first cardiac cycle, a ventricular blanking period (e.g. 160) for the first cardiac cycle to the electrical information from the cardiac conduction system location at or near the ventricle of the heart of the patient (e.g. see Figs. 1-5 regarding electrode placement); and detect a ventricular sense event in the first cardiac cycle using the received electrical information from the cardiac conduction system location at or near the ventricle of the heart of the patient following the applied ventricular blanking period (e.g. 168; wherein the sensed information is used to detect a ventricular sense).
Regarding claims 2-3 and 13-14, Lybarger further discloses wherein the assessment circuit is configured to: determine, in response to the detected atrial sense event in the first cardiac cycle (e.g. 152), the ventricular blanking period for the first cardiac cycle (e.g. 160); and apply the determined ventricular blanking period for the first cardiac cycle in response to the detected or received atrial sense event in the first cardiac cycle (e.g. see Fig. 6; blanking period in response to received atrial sense; it is noted that the claim is an open ended comprising claim and does not preclude other steps between the atrial sense and blanking period as long as the blanking period occurs in response to the atrial sense event).
Regarding claims 4 and 15, Lybarger further discloses wherein the signal receiver circuit is configured to receive the electrical information from the atrium of the heart of the patient for the first cardiac cycle, wherein the assessment circuit is configured to detect the atrial sense event in the first cardiac cycle using the received electrical information from the atrium of the heart of the patient for the first cardiac cycle (e.g. 152; ¶67; senses both intrinsic and paced signals; it is noted that the claim is silent as the type of atrial sensed event, just that the sensed event has to come from the atrial during the first cycle);
Regarding claims 5 and 16, Lybarger further discloses wherein the signal receiver circuit includes: a first channel configured to receive the electrical information from the atrium of the heart of the patient (e.g. see Figs. 1-5 regarding electrode placement); and a second channel configured to receive the electrical information from the cardiac conduction system location at or near the ventricle of the heart of the patient, wherein the assessment circuit is configured to apply the ventricular blanking period for the first cardiac cycle to the second channel (e.g. 168).
Regarding claims 6 and 17, Lybarger further discloses wherein the first channel comprises an atrial lead port (e.g. 16), wherein the second channel (e.g. 21) comprises a ventricular lead port (e.g. 18), wherein the assessment circuit is configured to determine the ventricular blanking period after a detected atrial sensed event while the implantable medical device is in a cardiac conduction system pacing mode to improve detection of ventricular events from the ventricular lead port (e.g. ¶¶27, 68), and wherein the assessment circuit is configured to apply the determined ventricular blanking period to the second channel for the first cardiac cycle after the detected atrial sense event to avoid sensing a P-wave from the cardiac conduction system location proximate the His bundle, the left or right bundle branches, or between the AV node and the Purkinje fibers of the heart (e.g. ¶68).
Regarding claims 7 and 20, Lybarger further discloses a therapy circuit (e.g. 84) configured to generate a cardiac conduction system pacing pulse for delivery at or near the His bundle, the left or right bundle branches, or between the AV node and the Purkinje fibers of the heart (e.g. 32, 34), wherein the assessment circuit is configured to control delivery of the cardiac conduction system pacing pulse, including to initiate delivery of the cardiac conduction system pacing pulse in the first cardiac cycle after the detected or received atrial sense event by a timing parameter (e.g. ¶¶ 21, 68 and 75).
Regarding claim 8, Lybarger further discloses wherein the assessment circuit is configured to initiate delivery of the His bundle pacing pulse using the second channel (e.g. ¶¶ 21, 68 and 75).
Regarding claim 9, Lybarger further discloses wherein the atrium comprises the right atrum and the ventricle comprise the right ventricle (e.g. see Fig. 1; ¶¶ 27, 51, 110).
Regarding claims 10 and 18, Lybarger further discloses wherein the ventricular blanking period is a selectable time period, between 45 and 105 ms, after a detected atrial sense event (e.g. ¶82).
Regarding claims 11 and 19, Lybarger further discloses wherein the cardiac conduction system location is proximate the left or right bundle branches or between an AV node and Purkinje fibers of the heart of the patient at or near the ventricle of the heart (e.g. see Figs. 1-2).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7, 10, 12-18 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 7-11 of U.S. Patent No. 12,186,567. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the current application are obvious variants of the ‘567 patent. Specifically claims 1 and 4-5 combined teach claim 1 of the ‘567 patent, including a first channel in the atrium, a second channel in the ventricle, detecting atrial sense in the first channel, determine a blanking period and detect a ventricular sense following the blanking period. Claims 2-3 of the current application teach the same limitations as claim 2 of the ‘567 patent. Claim 6 of the current application teaches the same limitations as claim 4 of the ‘567 patent. Claim 7 of the current application teaches an obvious variation of claim 3 of the ‘567 patent. Claim 10 of the current application teaches an obvious variation of claim 5 of the ‘567 patent. Claim 12 of the current application teaches claim 7 of the ‘567 patent. Specifically claim 12 is directed toward receiving data from the atrium and from near the ventricle, detect atrial sense event, determine ventricular blanking period and then detect a ventricular sense event following the blanking period. Claims 13-14 of the current application teach the same limitations as claims 7-8 of the ‘567 patent. Claim 15 of the current application teaches the same limitations as claim 7 of the ‘567 patent. Claims 16-17 of the current application teaches an obvious variation of claim 10 of the ‘567 patent. Claim 18 of the current application teaches an obvious variation of claim 11 of the ‘567 patent. Claim 20 of the current application teaches an obvious variation of claim 9 of the ‘567 patent.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Vandegriff (U.S. Pat. 4,967,746) – teaches determining ventricular blanking period after atrial sense (Col. 7, ll. 1-19).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached on (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REX R HOLMES/Primary Examiner, Art Unit 3796
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