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 .
Response to Arguments
Applicants’ arguments, see Remarks, filed 7/30/26, with respect to the 112 rejections have been fully considered and are persuasive. The 112 rejections of claims 1-12 and 15-26 have been withdrawn.
Applicants’ arguments, see Remarks and amendments, filed 7/30/26, with respect to the rejection(s) of claim(s) 1-2, 4, 7, 13, 15-16, 18 and 21 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Sheldon et al. (U.S. Pub. 2019/0009095).
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) 1-4, 7, 12-13, 15-18, 21 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mogul et al. (U.S. Pub. 2016/0183793 hereinafter “Mogul”) in view of Sheldon et al. (U.S. Pub. 2019/0009095 hereinafter “Sheldon”).
Regarding claim 1, Mogul discloses a medical system, comprising a catheter device configured to be inserted into a cardiac chamber of a living subject (e.g. see Fig. 1), and including: a plurality of electrodes (e.g. 20), at least one of the electrodes being configured to sense intracardiac electrograms (IEGMs) (e.g. ¶¶15-16); first wireless communication circuitry configured to wirelessly receive pacing data based on at least one pacing parameter (e.g. 36; “Bluetooth transceiver”); and a first signal generator connected to the plurality of electrodes (e.g. 20), the first wireless communication circuitry (e.g. see Fig. 3A), configured to receive the IEGMs (e.g. ¶¶15-16; see Fig. 5) and generate a pacing signal responsively to the received pacing data and apply the pacing signal to one of the electrodes (e.g. 36; “Stimulator/Pulse Generator”). Mogul discloses the claimed invention except for explicitly stating that the system converts the IEGMs to digital signals and then synchronizes the sensed signals with the pacing pulses. However, Sheldon teaches a similar stimulation system that utilizes IEGMs to sense and provide data for pacing. Sheldon further teaches that it is known to digitize the IEGMs and then use wireless signals to transmit data to provide synchronized pacing through the electrodes as set forth in Paragraphs 31, 40-42 and 61 to provide pacing that is synchronized with the cardiac rhythm to enhance the cardiac output of the patient and reduce or avoid undesired cardiac muscle stimulation during sensitive rhythm periods. 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 Mogul, with wireless signals to transmit data to provide synchronized pacing through the electrodes as taught by Sheldon, since such a modification would provide the predictable results of providing provide pacing that is synchronized with the cardiac rhythm to enhance the cardiac output of the patient and reduce or avoid undesired cardiac muscle stimulation during sensitive rhythm periods.
Regarding claim 2, meeting the limitations of claim 1 above, Mogul further discloses wherein the at least one pacing parameter includes any one or more of the following: a pacing signal frequency; a pacing signal duty cycle; a pacing signal amplitude; a pacing signal pulse shape; a pacing signal pulse length; and a given electrode of the catheter device to which to apply pacing (e.g. ¶44).
Regarding claim 3, meeting the limitations of claim 1 above, Sheldon further discloses wherein the pacing signal is a pulsed signal comprising a plurality of pulses (e.g. ¶63).
Regarding claim 4, meeting the limitations of claim 1 above, Mogul further discloses wherein the first wireless communication circuitry of the catheter device is configured to wirelessly receive the at least one pacing parameter (e.g. ¶44); and the first signal generator of the catheter device is configured to generate the pacing signal responsively to the at least one pacing parameter (e.g. ¶45).
Regarding claim 7, meeting the limitations of claim 1 above, Mogul further discloses wherein the first wireless communication circuitry of the catheter device is configured to wirelessly receive a digitized version of the pacing signal (e.g. ¶444); and the first signal generator of the catheter device is configured to generate the pacing signal responsively to the digitized version of the pacing signal (e.g. ¶45).
Regarding claim 12, meeting the limitations of claim 1 above, Mogul further discloses wherein the first signal generator is configured to synchronize the pacing signal based on the diastolic phase in the IEGMs received from the at least one of the electrodes (e.g. ¶¶70-71).
Regarding claim 13, meeting the limitations of claim 1 above, Mogul discloses a patient interface unit (PIU) including wireless communication circuitry to wirelessly share data with a catheter device (e.g. Fig. 6; “WBS”); and a catheter device (e.g. 10; “WCM”) comprising: a catheter including an electrode (e.g. ¶¶15-16) and configured to be inserted into a cardiac chamber of a living subject (e.g. ¶¶15-16); wireless communication circuitry configured to wirelessly share the data with the PIU (e.g. 36; “Bluetooth transmitter”). Mogul discloses the claimed invention except for explicitly stating that the system converts the IEGMs to digital signals and then synchronizes the sensed signals with the pacing pulses. However, Sheldon teaches a similar stimulation system that utilizes IEGMs to sense and provide data for pacing. Sheldon further teaches that it is known to digitize the IEGMs and then use wireless signals to transmit data to provide synchronized pacing through the electrodes as set forth in Paragraphs 31, 40-42 and 61 to provide pacing that is synchronized with the cardiac rhythm to enhance the cardiac output of the patient and reduce or avoid undesired cardiac muscle stimulation during sensitive rhythm periods. 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 Mogul, with wireless signals to transmit data to provide synchronized pacing through the electrodes as taught by Sheldon, since such a modification would provide the predictable results of providing provide pacing that is synchronized with the cardiac rhythm to enhance the cardiac output of the patient and reduce or avoid undesired cardiac muscle stimulation during sensitive rhythm periods.
Regarding claim 15, Mogul discloses a method, comprising sensing intracardiac electrograms (IEGMs) by at least one electrode of a catheter device inserted into a cardiac chamber of a living subject (e.g. ¶¶15-16); wirelessly receiving pacing data based on at least one pacing parameter (e.g. 36, “Bluetooth transmitter”); generating a pacing signal responsively to the wirelessly received pacing data (36, “Stimulator/ Pulse Generator”); and applying the pacing signal to one of the electrodes of the catheter device (e.g. ¶¶44-45). Mogul discloses the claimed invention except for explicitly stating that the system converts the IEGMs to digital signals and then synchronizes the sensed signals with the pacing pulses. However, Sheldon teaches a similar stimulation system that utilizes IEGMs to sense and provide data for pacing. Sheldon further teaches that it is known to digitize the IEGMs and then use wireless signals to transmit data to provide synchronized pacing through the electrodes as set forth in Paragraphs 31, 40-42 and 61 to provide pacing that is synchronized with the cardiac rhythm to enhance the cardiac output of the patient and reduce or avoid undesired cardiac muscle stimulation during sensitive rhythm periods. 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 Mogul, with wireless signals to transmit data to provide synchronized pacing through the electrodes as taught by Sheldon, since such a modification would provide the predictable results of providing provide pacing that is synchronized with the cardiac rhythm to enhance the cardiac output of the patient and reduce or avoid undesired cardiac muscle stimulation during sensitive rhythm periods.
Regarding claim 16, meeting the limitations of claim 15 above, Mogul further discloses wherein the at least one pacing parameter includes any one or more of the following: a pacing signal frequency; a pacing signal duty cycle; a pacing signal amplitude; a pacing signal pulse shape; a pacing signal pulse length; and a given electrode of the catheter device to which to apply pacing (e.g. ¶44).
Regarding claim 17, meeting the limitations of claim 15 above, Sheldon further discloses wherein the pacing signal is a pulsed signal comprising a plurality of pulses (e.g. ¶63).
Regarding claim 18, meeting the limitations of claim 15 above, Mogul further discloses the wirelessly receiving includes wirelessly receiving the at least one pacing parameter (e.g. ¶44); and the generating includes generating the pacing signal responsively to the at least one pacing parameter (e.g. ¶45).
Regarding claim 21, meeting the limitations of claim 15 above, Mogul further discloses wherein the wirelessly receiving includes wirelessly receiving a digitized version of the pacing signal (e.g. ¶44) and the generating includes generating the pacing signal responsively to the digitized version of the pacing signal (e.g. ¶45).
Regarding claim 26, meeting the limitations of claim 15 above, Mogul further discloses wherein the first signal generator is configured to synchronize the pacing signal based on the diastolic phase in the IEGMs received from the at least one of the electrodes (e.g. ¶¶70-71).
Claim(s) 5-6, 8-11, 19-20 and 22-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mogul as applied to claims 1-4, 7, 12-13, 15-18, 21 and 26 above, and further in view of Eyster et al. (U.S. Pub. 2021/0393327 hereinafter “Eyster”).
Regarding claims 5-6, 8-11, 19-20 and 22-25, Mogul in view of Sheldon discloses the claimed invention including receiving stimulation parameters from a patient interface but fails to explicitly state that the interface has an interface that allows a user to choose when to shock or alter the parameters. However, Eyster teaches that it is known to provide a user interface on a patient interface to digitally send instructions the catheter device as set forth in Paragraphs 321, 369, 372, 381 and 476 to provide a means for a user to select and modify the treatment in order to provide the most effective treatment to the patient. 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 Mogul in view of Sheldon, with a user interface on the patient interface as taught by Eyster, since such a modification would provide the predictable results of providing a means for a user to select and modify the treatment in order to provide the most effective treatment to the patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Mokelke (U.S. Pub. 2009/0318984) – teaches providing IEGM data for defibrillation.
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
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