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 § 102
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 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.
Claims 1, 3, 4, 7-11, 13, 14 and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bornzin et al (U.S. Patent Application Publication Number: US 2015/0335894 A1, hereinafter “Bornzin”- APPLICANT CITED).
Regarding claims 1, 11 and 20, Bornzin teaches a medical device system (e.g. 12 Fig.1), a method and a non-transitory computer-readable medium storing instructions, comprising:
an atrial pacemaker (e.g. 14 Fig.1, [0035]) comprising:
an atrial sensing circuit configured to sense atrial P-waves (e.g. [0036]: the cardiac event sensing channel, for an atrial pacing device, may be tuned and function to sense P-waves or paced events delivered in the atrium);
an atrial pulse generator configured to:
deliver atrial pacing pulses having a first pulse amplitude and a first pulse width for capturing an atrial chamber (e.g. [0035]-[0036]: LIMD 14 in the atrium provides sensing and pacing); and
deliver a first broadcast atrial event signal in response to the atrial sensing circuit sensing an atrial P-wave (e.g. 306 Fig.3, [0037]: pulse sensing circuitry is configured to detect trigger pulses that occur in a far field (FF) associated with a remote chamber so the atrial LIMD 14 sends a broadcast signal, [0049]: trigger signal sent by LIMD 14); and
a ventricular event detector circuit for detecting ventricular events (e.g. [0036]: ventricular pacing device may be tuned and function to sense R-waves or paced events delivered in the ventricle over the cardiac event sensing channel.); and
control circuitry configured to:
based on at least one ventricular event (e.g. [0056]) detected by the ventricular event detector circuit and one of a sensed atrial P-wave or a delivered atrial pacing pulse (e.g. [0049]: trigger signal sensed by LIMD 16), determine an event interval (e.g. [0059]);
determine that the event interval is not an expected event interval; and in response to determining that the event interval is not an expected event interval, adjust at least one control parameter of a plurality of control parameters of the medical device system (e.g. Fig. 3, [0057]-[0061]: LIMD 16 in the ventricle senses at least one R event and trigger pulse from LIMD14 from the atrium and determines an event interval and that is unexpected event interval and changes parameters).
Regarding claims 3 and 13, Bornzin teaches the control circuit is further configured to deliver the first broadcast atrial event signal having at least one of: a broadcast atrial event signal pulse amplitude that is at least the first pulse amplitude; or a broadcast atrial event signal pulse amplitude that is at least the first pulse width (e.g. [0043]: The trigger pulses may have various predetermined shapes, amplitudes, pulse widths, pulse patterns and the like).
Regarding claims 4 and 14, Bornzin teaches the atrial pulse generator is further configured to deliver the first broadcast atrial event signal (e.g. 428 Fig. 4) during an atrial physiological refractory period.
Regarding claims 7, 8 and 17, Bornzin teaches that the atrial pacemaker is further configured to deliver a second broadcast atrial event signal in response to delivering an atrial pacing pulse, the second broadcast atrial event signal being different than the first broadcast atrial event signal and wherein the atrial pacemaker is further configured to deliver at least one of the first broadcast atrial event signal or the second broadcast atrial event signal comprising at least two pulses delivered by the atrial pulse generator (e.g. [0043], [0044]: trigger pulses may have various predetermined shapes, amplitudes, pulse widths, pulse patterns . Different pulse formulations may be assigned different meanings to instruct receiving atrial or ventricular device to take difference actions).
Regarding claims 9, 10, 18 and 19, Bornzin further teaches a ventricular pacemaker (e.g. LIMD 16 Fig.1, [0034]-[0036]) configured to receive the first broadcast atrial event signal; and
wherein the ventricular pacemaker comprises a ventricular pulse generator configured to deliver a ventricular pacing pulse in response to receiving the first broadcast atrial event signal (e.g. [0037], [0061]) and
wherein the ventricular event detector circuit of the atrial pacemaker is configured to detect ventricular events at least by detecting pulses delivered by the ventricular pacemaker (e.g. [0037], [0040]).
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 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11 and 20 of U.S. Patent Numbers: US 10328270, US 11138461, US 12138461. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to systems and methods for sensing atrial P-waves; delivering atrial pacing pulses having a first pulse amplitude and a first pulse width for capturing an atrial chamber; delivering a first broadcast atrial event signal in response to sensing an atrial P-wave; detecting ventricular events; based on at least one detected ventricular event and one of a sensed atrial P-wave or a delivered atrial pacing pulse, determining an event interval; determining that the event interval is not an expected event interval; and in response to determining that the event interval is not an expected event interval adjusting at least one control parameter of a plurality of control parameters of a medical device system configured to deliver atrial synchronized ventricular pacing.
While no prior art is applied for claims 2, 12, 5, 6, 15 and 16 they cannot be indicated as allowable due to the double patenting rejections discussed above.
No prior art was found teaching individually, or suggesting in combination, all of the features of the applicants' invention, specifically "adjusting the control parameter by increasing at least one of a first broadcast atrial event signal pulse amplitude or a first broadcast atrial event signal pulse width” as claimed in claims 2 and 12 in combination with the recited limitations of the claimed invention.
No prior art was found teaching individually, or suggesting in combination, all of the features of the applicants' invention, specifically " determining that the event interval is not an expected event interval by comparing the determined event interval to an expected event interval matching range” and “determining that the event interval is not an expected event interval by comparing the determined event interval to an expected atrioventricular interval threshold” as claimed in claims 5,15, 6 and 16 in combination with the recited limitations of the claimed invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sheldon et al (U.S. Patent Application Publication Number: US 2016/0114162 A1, hereinafter “Sheldon”) teaches a dual chamber medical device system (e.g. Fig.1) and associated method for sensing cardiac events by an intracardiac pacemaker configured to deliver atrial-synchronized ventricular pacing.
Fishler et al (U.S. Patent Number: US 9522280 A1, hereinafter “Fishler”) teaches a dual chamber medical device system (e.g. Fig.1) for providing communications between first and second implantable medical devices (IMDs). The system comprises a first implantable medical device (IMD) configured to transmit a first event message during or preceding a first cardiac cycle, and a second IMD configured to receive the first event message, wherein receipt of the first event message configures the second IMD to generate pacing pulses based on the received message..
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
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