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
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6, 8-18 & 20-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Min et al. (US 2020/0215337) in view of Sheldon et al. (US 9,687,654) and one of ordinary skill in the art as evidenced by, KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007)
Min et al. teaches a method for use with a dual chamber leadless pacemaker system including an atrial leadless pacemaker (aLP) implanted in the RA chamber and a ventricular leadless pacemaker (vLP) implanted in the RV chamber [0034].
Min et al. further teaches:
Dual chamber leadless pacemaker system including an atrial leadless pacemaker (aLP) and a ventricular leadless pacemaker (vLP)
E.G. via the disclosed dual-chamber leadless pacemaker system first leadless pacemaker implanted in the RA chamber, aLP, and a second leadless pacemaker implanted in the RV chamber, vLP; [0014], [0034].
aLp operating in an AAI mode, including atrial sensing, atrial pacing and inhibition based on sensed atrial activity
E.G. via the disclosed RA leadless pacemaker operating in an AAI pacing mode, wherein atrial activity is sensed and atrial pacing is delivered or inhibited based upon detection of intrinsic atrial events [0033]-[0034].
vLP operating in a VVI mode, including ventricular sensing, ventricular pacing and inhibition based on sensed ventricular activity
E.G. via the disclosed RV leadless pacemaker [0007]-[0008]. The examiner also notes that VVI pacing is a well-known pacing mode in which ventricular pacing occurs in the absence of a sensed ventricular event, ventricular activity is sensed and ventricular pacing is inhibited upon sensing ventricular activity.
Concurrent and independent operations of the aLP and vLP.
E.G. via the disclosed operation of the aLP and vLP within the same dual chamber pacing system, wherein the the aLP and vLP communicate through implant-to-implant messaging and coordinate pacing functions [0049], [0089]-[0091].
Sheldon et al. teaches separate atrial and ventricular pacemakers concurrently operating using separate AA and VV pacing intervals, independently determining pacing rates based upon sensed physiologic conditions and operating at different asynchronous pacing rates; (col 11, lines 23-49), (col 16, line 29)-(col 17, lines 1-41).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the dual chamber leadless pacemaker system of Min et al. to permit concurrent and independently controlled chamber pacing was a known technique for accommodating differing chamber-specific pacing requirements and improving pacing flexibility. Applying the known pacing control techniques of Sheldon et al. to the dual chamber leadless pacemaker system of Min et al. would have predictably maintained appropriate pacing therapy under varying physiologic conditions. See KSR.
2.
i2i communication hardware and communication suppression during independent AAI/VVI operation.
E.G. via each leadless pacemakers including communication capability, transmitters, receivers, etc. used to exchange implant to implant messages; Min, [0049]-[0050]. Min et al. further teaches independent operation of the atrial LP and ventricular LP, while Sheldon et al. teaches independent AAI and VVI pacing operation without coordinated dual-chamber pacing signals; (col 15, lines 55)-(col 17, line 8). Therefore, during independent chamber operation, the LPs inherently abstain from transmitting coordination messages intended to synchronize chamber operation.
3.
atrial pacing rate greater than ventricular pacing rate, i.e. AA interval shorter than VV interval.
E.G. via the disclosed asynchronous operation in which the atrial pacemaker and ventricular pacemaker may operate at different pacing rates and different pacing intervals; Sheldon (col 17, lines 1-8 & 65-67)-(col 18, lines 1-7). A shorter atrial pacing interval than ventricular pacing interval would have been an obvious implementation of Sheldon’s disclosed independent pacing-rate selection.
4.
activity-responsive atrial rate adjustment while ventricular rate remains unchanged.
E.G. via the disclosed RA pacemaker determining a sensor indicated rate (SIR) based upon patient activity and adjusting atrial pacing rate accordingly, while the RV pacemaker may independently maintain its selected ventricular pacing rate; Sheldon (col. 10, lines 35-40), (col 15, lines 55-67)-(col 16., lines 1-10) & (col 17, lines 1-8).
5.
sensing intrinsic atrial/ventricular activity and crosstalk protection.
E.G. via the disclosed atrial and ventricular LPs sensing intrinsic atrial and ventricular events, respectively, using sensing circuitry and electrogram signals; Min [0033], [0035], [0049]. Min et al. further discloses blanking sense inputs and preventing inappropriate crosstalk sensing in response to pacing events transmitted by the other LP, [0049], corresponding to the claimed crosstalk monitoring and protection duration.
6.
vLP determines criterion, suppresses i2i messaging, then transmits mode-switch message causing coordinated dual-chamber operation
E.G. via the disclosed transmission of implant-to-implant messages between LPs and operation in coordinated dual-chamber pacing modes; Min, [0034], [0049], [0091], [0094]. Min et al. further teaches reverting between pacing modes depending on communication status and operating conditions, [0094]. Sheldon et al. teaches monitoring pacing conditions and switching operational modes based upon detected pacing needs and AV block conditions, (col. 11-12), (col. 15-18).
It would have been obvious to initiate coordinated dual-chamber operation only after a predetermined ventricular pacing condition was satisfied and to communicate such transition using the existing i2i messaging architecture of Min et al. because doing so represents a predictable use of known communication protocols to transition between known pacing modes.
8.
criterion based on threshold amount of ventricular pacing during a specified duration.
E.G. via the disclosed monitoring ventricular pacing activity, AV block conditions, and pacing rates over time to determine when pacing mode changes are appropriate; Sheldon, (col. 11-12) (col 18).
9.
mode switch back from coordinated dual-chamber operation to independent AAI/VVI operation upon satisfaction of a second criterion.
E.G. via the disclosed bidirectional mode transitions between coordinated and independent pacing modes based on changing pacing conditions and pacing burden thresholds; Min [0076]-[0084], [0088]-[0091].
Sheldon et al. teaches implant-to-implant messaging used to coordinate mode changes between devices; (col. 15)-(col. 18)
Therefore, it would have been obvious for the vLP to transmit a subsequent mode-switch message causing the system to return for coordinated operation to independent operation when a second criterion is satisfied.
10.
Second criterion comprises ventricular pacing below a threshold amount during a specified duration.
E.G. via the disclosed evaluating pacing burden over time and transition pacing modes when ventricular pacing requirements fall below predetermined thresholds; Min [0079]-[0084].
11.
Coordinated dual chamber operation comprises DDD operation.
E.G. via the disclosed coordinated dual-chamber pacing including DDD pacing modes; Min, [0052]-[0055], [0071]-[0075].
12.
Coordinated dual chamber operation comprises VDD, DDI, VDI or DOO operation.
E.G. via the disclosed multiple dual-chamber pacing modes, including DDD and other coordinated atrial/ventricular pacing modes selectable according to patient condition; Min [0052]-[0055], [0071]-[0075].
Selection among known dual-chamber pacing modes such as VDD, DDI, VDI or DOO would have been an obvious design choice to one of ordinary skill in the art depending on the desired pacing therapy, see KSR.
13.
Dual leadless pacemaker system including atrial LP and ventricular LP.
E.G. via the disclosed atrial LP implanted in an atrial chamber and a ventricular LP implanted in a ventricular chamber of the heart; Min [0008], [0034].
Independent AAI operation by aLP and VVI operating by vLP
E.G. via the disclosed operation of an atrial pacemaker in AAI mode and a ventricular pacemaker in VVI mode independently of one another; Sheldon (col. 15)-(col 17, 1-8)
AAI pacing behavior, i.e. pace, sense and inhibit.
E.G. Sheldon et al. teaches conventional AAI pacing in which atrial pacing occurs upon expiration of an AA interval, intrinsic atrial activity is sensed, and pacing is inhibited upon sensing intrinsic atrial activity (col. 16)-(col. 17).
VVI pacing behavior, i.e. pace, sense and inhibit.
E.G. Sheldon et al. teaches conventional VVI pacing in which atrial pacing occurs upon expiration of an AA interval, intrinsic atrial activity is sensed, and pacing is inhibited upon sensing intrinsic atrial activity (col. 16)-(col. 18).
14.
Substantially identical to Claim 2.
Min et al. teaches LP transmitters, receivers, etc. and implant-to-implant communication, Min [0049]-[0050].
Sheldon et al. teaches independent AAI/VVI operation.
Therefore, the LPs would abstain from transmitting coordination messages while operating independently (col 15, lines 55)-(col 17, line 8).
15.
Substantially identical to Claim 3
Sheldon et al. teaches independently selectable pacing rates and intervals for atrial and ventricular pacing, (col. 17)-(col 18).
16.
Substantially identical to claim 4
Sheldon et al. teaches sensor-indicated atrial rate adjustment based on patient activity; (col 10, lines 35-40).
Sheldon et al. further teaches independently operation ventricular pacing that need not adjust with atrial rate changes, (col. 15)-(col. 18).
17.
Substantially identical to claim 5.
Min et al. teaches atrial and ventricular sensing circuity, controllers, electrogram sensing and crosstalk prevention through blanking and protection intervals; [0033], [0035], [0049], [0091].
18.
Substantially identical to claim 6.
Min et al. teaches i2i messaging, mode changes, coordinated dual-chamber pacing and communication acknowledgements, [0049], [0091], [0094]
Sheldon et al. teaches monitoring pacing conditions and switching pacing modes based on pacing requirements; (col. 11)-(col. 12) & (col. 15)-(col. 18).
It would have been obvious to utilize Min’s implant-to-implant communication architecture to initiate coordinated dual-chamber pacing upon satisfaction of pacing conditions taught by Sheldon et al. because doing so represents the predictable use of known communication techniques to transition between known pacing modes and improve pacing therapy.
Claim(s) 7 & 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Min et al. (US 2020/0215337) in view of Sheldon et al. (US 9,687,654), as applied to claims 1-6, 8-18 & 20-27 above, further in view of Min et al. (US 2021/0370078)
Min (‘337) et al. discloses the claimed limitations of claim 1
Sheldon et al. teaches communication between leadless pacemakers using mode-switch messages and acknowledgment messaging.
Min (‘078) et al. teaches the dual leadless pacemaker system including aLP/vLP communication and selective enabling/disabling of receiver functionality to conserve battery power while receiving i2i communications when needed, [0140].
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate Sheldon’s communication and acknowledgment techniques into the dual leadless pacemaker system of Min (078) because both references are directed to implant-to-implant communication between leadless pacemakers, and doing so would improve reliability of inter-device communication while maintaining Min’s power-conservation objectives.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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, David Hamaoui can be reached at 571-270-5625. 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.
/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796
Prosecution Insights