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 .
Priority
This application is a national stage entry under 35 USC 371 of PCT/EP2022/064221 filed 25 May 2022 which is entitled to the benefit of foreign priority from European Application no. 21178516.7 filed 9 June 2021.
Response to Amendment
The preliminary amendment filed 1 November 2023 has been acknowledged. Claims 1-15 are pending.
Claim Rejections - 35 USC § 103
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 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) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Demmer (US Publication no. 2016/0206892 – disclosed by Applicant).
In regard to claim 1, Demmer disclose a method for controlling the operation of at least two implantable medical devices (IMDs 12, 14, 16, 18, and 30) for stimulating a human or animal heart (para 22 and para 27), the method comprising the following steps:
receiving, with a control device (para 34, external programmer 50 is configured for two functions: sending data to the IMDs and retrieving data from one of IMDs, wherein an example of retrieved data may include currently programmed control parameters and considered to suggest that programmer 50 receives operation data from a first IMD), a first operational parameter of a first device of the at least two implantable medical devices (e.g., any of IMDs 12, 14, 16, 18, or 30);
receiving, with the control device (para 34, external programmer 50), a second operational parameter of a second device of the at least two implantable medical devices (e.g., any of IMDs 12, 14, 16, 18, or 30);
automatically checking whether there exists a conflict between the first operational parameter and the second operational parameter precluding a safe operation of the first device and the second device (para 130, programming commands may be automatically generated by programmer 50 to enable or disable other features to promote patient safety, minimize or eliminate functional redundancy, avoid conflicting or unnecessary simultaneous therapy delivery from more than one device); and
visualizing the first operational parameter, the second operational parameter, and programming data on a display of the control device (para 132, step 410 figure 8, programmer 50 may optionally generate IMD-specific programming summary report(s) for display to a user. The programming summary report may list the pending programmable feature values as converted by the programmer 50, wherein the “pending programmable feature values “ of programming summary reports are considered to comprise the first operational parameter and second operational parameter).
Demmer is considered to substantially describe the invention as claimed, however does not teach the step for if a conflict has been identified, visualizing the first operational parameter, the second operational parameter, and data on the conflict on a display of the control device. There it not express teaching for visualizing conflict data together with the conflicting operational parameters on a display after the conflict has been identified. It is considered that the programmer 50 is capable of displaying the conflict information as part of the “programming summary report” and would provide the benefit to the user to quickly identify and resolve programming settings that may be unnecessary or unsafe in order to improve patient safety and comfort, as well as reducing excessive power depletion. Modification of Demmer to enable visualization of a parameter conflict on the display of programmer is considered to have been obvious to one of ordinary skill in the art in order to improve user understanding, reduce programming errors, improve patient safety, and mitigate unnecessary power consumption.
In regard to claim 2, in Demmer the control device 50 receives the first operational parameter and/or the second operational parameter from an input of a user of the control device (para 35, the user may select a device-specific programmable parameter setting that is transmitted to the target IMD by programmer 50, also see para 40-42, 95, 104, and 125-126).
In regard to claim 3, in Demmer the control device 50 receives the first operational parameter from a memory of the first device and/or the second operational parameter from a memory of the second device (para 67 and 88).
In regard to claim 4, in Demmer the control device 50 prevents an application of the first parameter by the first device and/or an application of the second parameter by the second device if a conflict has been identified (para 35 and 130).
In regard to claim 5, in Demmer the first operational parameter is chosen from the group that wherein consisting of a stimulation frequency (para 89, programmable therapy control parameters includes type of therapy, pulse amplitude, and number of pulses which is considered to comprise stimulation frequency), frequency boundaries that need to be exceeded for delivering an antitachycardic pacing, and a condition to be fulfilled for delivery of an antitachycardic pacing (para 24, 49, 89 the IMDS apply anti-tachycardia therapy). The elements are considered to comprise obvious variations.
In regard to claim 6, in Demmer the second operational parameter is chosen from the group characterized that wherein consisting of a lower frequency boundary for defibrillation, an upper frequency boundary for defibrillation, a frequency zone for defibrillation between a lower and an upper frequency boundary, and an activation of a shock function of the second implantable medical device (para 83, selecting programmable control parameters used for detecting shockable rhythms and delivering therapy). The elements are considered to comprise obvious variations.
In regard to claim 7, in Demmer the first device is a leadless pacemaker (para 27).
In regard to claim 8, in Demmer the leadless pacemaker comprises a function for an antitachycardic stimulation of a human or animal heart (para 49).
In regard to claim 9, in Demmer the second device is an implantable in wherein that cardioverter/defibrillator (para 24, 28-29).
In regard to claim 10, in Demmer the second device is a non-transvenously implantable cardioverter/defibrillator (i.e., IMD 30, figure 1).
In regard to claim 11, in Demmer the first device comprises a first patient identifier and the second device comprises a second patient identifier, wherein the control device queries the first patient identifier and the second patient identifier and performs the checking whether there exists a conflict between the first operational parameter and the second operational parameter only if the first patient identifier and the second patient identifier are assigned to the same patient (para 86-87, the IMD identifiers taught here are considered functionally the same as the patient identifiers as claimed).
In regard to claim 12, in Demmer the method is carried out by at least one of a programming in characterized that device application, a server application, an application for remote monitoring the at least two implantable medical devices, an application for remote programming the at least two implantable medical devices, and a mobile app (para 48
In regard to claim 13, Demmer discloses a cardiac rhythm management system, comprising a first implantable medical device (IMDs 12, 14, 16, 18, and 30) for stimulating a human or animal heart, (para 22 and para 27), a second implantable medical device (IMDs 12, 14, 16, 18, and 30)) for stimulating the same heart-(para 22 and para 27), and a control device (para 37, external programmer 50) operatively coupled to the first implantable medical device and the second implantable medical device , wherein the control device 50 comprises a memory 53 and a processor 52 (para 37, figure 1), wherein the memory comprises computer-readable code that causes the processor to perform the following steps when executed on the processor:
receiving, with a control device (para 34, external programmer 50 is configured for two functions: sending data to the IMDs and retrieving data from one of IMDs, wherein an example of retrieved data may include currently programmed control parameters and considered to suggest that programmer 50 receives operation data from a first IMD), a first operational parameter of a first device of the at least two implantable medical devices (e.g., any of IMDs 12, 14, 16, 18, or 30);
receiving, with the control device (para 34, external programmer 50), a second operational parameter of a second device of the at least two implantable medical devices (e.g., any of IMDs 12, 14, 16, 18, or 30);
automatically checking whether there exists a conflict between the first operational parameter and the second operational parameter precluding a safe operation of the first device and the second device (para 130, programming commands may be automatically generated by programmer 50 to enable or disable other features to promote patient safety, minimize or eliminate functional redundancy, avoid conflicting or unnecessary simultaneous therapy delivery from more than one device); and
visualizing the first operational parameter, the second operational parameter, and programming data on a display of the control device (para 132, step 410 figure 8, programmer 50 may optionally generate IMD-specific programming summary report(s) for display to a user. The programming summary report may list the pending programmable feature values as converted by the programmer 50, wherein the “pending programmable feature values “ of programming summary reports are considered to comprise the first operational parameter and second operational parameter).
Demmer is considered to substantially describe the invention as claimed, however does not teach the step for if a conflict has been identified, visualizing the first operational parameter, the second operational parameter, and data on the conflict on a display of the control device. There it not express teaching for visualizing conflict data together with the conflicting operational parameters on a display after the conflict has been identified. It is considered that the programmer 50 is capable of displaying the conflict information as part of the “programming summary report” and would provide the benefit to the user to quickly identify and resolve programming settings that may be unnecessary or unsafe in order to improve patient safety and comfort, as well as reducing excessive power depletion. Modification of Demmer to enable visualization of a parameter conflict on the display of programmer is considered to have been obvious to one of ordinary skill in the art in order to improve user understanding, reduce programming errors, improve patient safety, and mitigate unnecessary power consumption.
In regard to claim 14, in Demmer the control device (external programmer 50) is operatively coupled to the first implantable medical device (any of IMDs 12, 14, 16, 18, or 30) and the second implantable medical device (any of IMDs 12, 14, 16, 18, or 30) in a wireless manner (para 32-33).
In regard to claim 15, Demmer disclose a computer program product comprising computer-readable code that causes a processor 52 of programmer 50 to perform the following steps when executed on the processor (para 37 and 88):
receiving, with a control device (para 34, external programmer 50 is configured for two functions: sending data to the IMDs and retrieving data from one of IMDs, wherein an example of retrieved data may include currently programmed control parameters and considered to suggest that programmer 50 receives operation data from a first IMD), a first operational parameter of a first device of the at least two implantable medical devices (e.g., any of IMDs 12, 14, 16, 18, or 30);
receiving, with the control device (para 34, external programmer 50), a second operational parameter of a second device of the at least two implantable medical devices (e.g., any of IMDs 12, 14, 16, 18, or 30);
automatically checking whether there exists a conflict between the first operational parameter and the second operational parameter precluding a safe operation of the first device and the second device (para 130, programming commands may be automatically generated by programmer 50 to enable or disable other features to promote patient safety, minimize or eliminate functional redundancy, avoid conflicting or unnecessary simultaneous therapy delivery from more than one device); and
visualizing the first operational parameter, the second operational parameter, and programming data on a display of the control device (para 132, step 410 figure 8, programmer 50 may optionally generate IMD-specific programming summary report(s) for display to a user. The programming summary report may list the pending programmable feature values as converted by the programmer 50, wherein the “pending programmable feature values “ of programming summary reports are considered to comprise the first operational parameter and second operational parameter).
Demmer is considered to substantially describe the invention as claimed, however does not teach the step for if a conflict has been identified, visualizing the first operational parameter, the second operational parameter, and data on the conflict on a display of the control device. There it not express teaching for visualizing conflict data together with the conflicting operational parameters on a display after the conflict has been identified. It is considered that the programmer 50 is capable of displaying the conflict information as part of the “programming summary report” and would provide the benefit to the user to quickly identify and resolve programming settings that may be unnecessary or unsafe in order to improve patient safety and comfort, as well as reducing excessive power depletion. Modification of Demmer to enable visualization of a parameter conflict on the display of programmer is considered to have been obvious to one of ordinary skill in the art in order to improve user understanding, reduce programming errors, improve patient safety, and mitigate unnecessary power consumption.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 4 February 2026