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 .
Response to Arguments
Applicant’s arguments, filed 7/15/2026, with respect to claim interpretation under 35 U.S.C. 112(f) have been fully considered and are persuasive. The claim interpretation under 35 U.S.C. 112(f) has been withdrawn.
Applicant’s arguments, with respect to 35 U.S.C. 101 have been fully considered and are persuasive. The rejection under 35 U.S.C. 101 has been withdrawn.
Applicant’s arguments, with respect to the rejection(s) of claim(s) 1-10, 12-21 under 35 U.S.C 102 & 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 Therefore, the rejection has been withdrawn.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 Hareland. Hareland discloses the amended limitations of reprogramming the programmed parameters and performing therapy using the reprogrammed parameters. In addition, amended claim 19 is rejected under 35 U.S.C 112(b).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 19 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention; recites “one or more of.” It is unclear if that means one or more shocks in a shock event and an ATP event, one or more shock events and an ATP event, or at least one of a shock event or an ATP event. For the purpose of continued examination, examiner interprets “one or more of” as at least one of a shock event or an ATP event.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 1-5, 10, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hresko et al (US Pre Grant Publication US 2017/0300653), in view of Hareland et al (US Pre Grant Publication 2017/0312510 A1).
Regarding claim 1, Hresko teaches a method comprising:
detecting, using a medical device (at least one of: controller (10), processor (32), sensing electrode (14)) [0003-0007] including one or more of a pulse generator and a cardiac monitor ([0067]; therapy delivery interface 24 requires pulse generator; sensor interface 12 includes ECG electrodes), cardiac activity based on a comparison of physiological data collected by the medical device to one or more programmed parameters of the medical device ([0068], Fig. 4); controller (10) configured to determine events related to patient condition based on analysis of data; examiner notes that event determinations necessarily require comparisons of physiological data to baseline conditions or values.
performing, using the medical device, a therapy event during the detecting of the cardiac activity ([0063]; wearable defibrillator configured to continuously monitor vital signs for indication of treatment then delivers therapeutic shocks);
generating, using the medical device, metadata associated with one or both of the therapy event and the cardiac activity [0069-0074]; metadata includes cardiac physiological, non-cardiac physiological, non-cardiac, device-initiated, malfunction, misuse, and temporal event data.
creating, using a computing system (216), a timeline (410) of both the therapy event and the cardiac activity for display, the timeline including icons associated with the subevents and including at least some of the metadata ([0108], Fig. 7; icons identify when treatment provided on timeline),
but does not disclose,
detecting, using the medical device, subevents associated with the therapy event during the cardiac activity;
reprogramming the medical device in response to the timeline, wherein the reprogramming includes altering at least one of the one or more programmed parameters; and
performing, using the reprogrammed medical device, a second therapy event during the detecting of the cardiac activity.
as claimed.
However, Hareland teaches a system and a method for adjusting cardiac therapy based on sensed therapy signals. Hareland is analogous to the claimed invention because it is reasonably pertinent to the problem of reprogramming therapy parameters by monitoring a patient’s response to cardiac therapy.
Hareland further teaches,
detecting, using a medical device including one or more of a pulse generator and a cardiac monitor, cardiac activity based on a comparison of physiological data collected by the medical device to one or more programmed parameters of the medical device ([0048], [0091]; thresholds compared to baseline pacing mode parameters 90);
detecting, using the medical device, subevents associated with the therapy event during the cardiac activity ([0083]; detects amplitude above threshold);
reprogramming the medical device in response to the timeline, wherein the reprogramming includes altering at least one of the one or more programmed parameters ([0091]; updates baseline values); and
performing, using the reprogrammed medical device, a second therapy event during the detecting of the cardiac activity ([0091]; delivers pacing pulse with updated values).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method, as taught by Hresko, with detecting, subevents associated with the therapy event during the cardiac activity, reprogramming the medical device in response to the timeline, wherein the reprogramming includes altering at least one of the one or more programmed parameters, and performing, using the reprogrammed medical device, a second therapy event during the detecting of the cardiac activity, as taught by Hareland. One of ordinary skill in the art would have been motivated to make these modifications to improve anti-tachyarrhythmia shock therapy by suspending ATP to prevent inducing another arrhythmia (Hareland, [0040]).
Regarding claim 2, Hresko, in view of Hareland, teaches the method of claim 1, and further teaches a method wherein at least one of the subevents includes a sensing event [0067]; “The sensors are in electronic communication with a sensor interface 12, which is configured to receive and process signals therefrom.”
Regarding claim 3, Hresko, in view of Hareland, teaches the method of claim 2, and further teaches a method wherein the sensing event includes an onset of the cardiac activity [0134] or an end of the cardiac activity [0135].
Regarding claim 4, Hresko, in view of Hareland, teaches the method of claim 2, and further teaches a method wherein at least one of the subevents includes a therapy event ([0063], 0071]); “…the wearable defibrillator is configured to continuously or substantially continuously monitor the vital signs of the patient and, upon determination that treatment is indicated, is capable of delivering one or more therapeutic electrical pulses to the patient. For example, such therapeutic shocks can be pacing, defibrillation, or transcutaneous electrical nerve stimulation (TENS) pulses;” processor (32) can be configured to identify device-initiated events, such as when a defibrillator shock (e.g. a treatment event) is provided to the patient.
Regarding claim 5, Hresko, in view of Hareland, teaches the method of claim 4, and further teaches a method wherein the therapy event includes a shock event ([0063], [0071]).
Regarding claim 10, Hresko, in view of Hareland, teaches the method of claim 1, and further teaches wherein the therapy event based on a comparison of the physiological data to the one or more programmed parameters [0063]; “During the period of time in which they are worn by the patient, the wearable defibrillator is configured to continuously or substantially continuously monitor the vital signs of the patient and, upon determination that treatment is indicated, is capable of delivering one or more therapeutic electrical pulses to the patient;” examiner notes that determination of treatment necessarily requires comparison of physiological data to baseline values or parameters.
Regarding claim 12, Hresko, in view of Hareland, teaches the method of claim 1, and further teaches a method wherein the medical device is a pacemaker [0005] or defibrillator [0063]; “During the period of time in which they are worn by the patient, the wearable defibrillator is configured to continuously or substantially continuously monitor the vital signs of the patient and…”
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hresko et al (US Pre Grant Publication US 2017/0300653), in view of Hareland et al (US Pre Grant Publication 2017/0312510 A1), in further view of Sawchuk (US Pre Grant Publication US 2022/0039728 A1).
Regarding claim 6, Hresko, in view of Hareland, teaches the method of claim 4 but does not disclose a therapy event that includes an anti-tachycardia pacing (ATP) event.
However, Sawchuk teaches a method wherein the therapy event includes an anti-
tachycardia pacing (ATP) event [0089];
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method, as taught by Hresko and Hareland, with the ATP therapy event as taught by Sawchuk. One of ordinary skill in the art would have been
motivated to make these modifications to provide therapy for a wide range of abnormal cardiac rhythms including ventricular tachycardia (Sawchuk, [0049]).
Regarding claim 7, Hresko, in view of Hareland and Sawchuk, teaches the method of claim 6 but does not disclose an ATP burst event.
However, Hareland teaches a method wherein the ATP event includes a burst event [0067] or a scan event; “Each train of pulses during ATP may last for a duration of between approximately 0.5 seconds to approximately 15 seconds or be defined as a specific number of pulses. Each pulse, or burst of pulses, may include a ramp up in amplitude or in pulse rate.”
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the method of Hresko, Hareland, and Sawchuk with an ATP event that includes a burst event. One of ordinary skill in the art would have been motivated to make these modifications to improve ATP treatment efficacy by increasing burst amplitudes and/or pulse rates (Hareland, [0067]).
Claim(s) 8-9, 13, 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hresko et al (US Pre Grant Publication US 2017/0300653), in view of Hareland et al (US Pre Grant Publication 2017/0312510 A1), in further view of Butka et al (WO 2023/279003 A1).
Regarding claim 8, Hresko, in view of Hareland, teaches the method of claim 1 but does not disclose embedding a hyperlink into the icons.
However, Butka teaches a method further comprising:
embedding a hyperlink into the icons ([0046], [0052], [0078], Fig. 15); provider portal
(306) has API functionality which includes embedding web links and data visualization with monitoring interval visualizer (410) which includes generating timelines, shapes, and/or icons; EHR records include embedded weblinks of data comprising graphs of diagnostic results, physiological data, and responses.).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method, as taught by Hresko and Hareland, with icons embedded with a hyperlink as taught by Butka. One of ordinary skill in the art would have been motivated to make these modifications to improve patient care by reducing the complexity of managing and viewing patient data [0003].
Regarding claim 9, Hresko, in view of Hareland and Butka, teaches the method of claim 8 but does not disclose displaying a plot of physiological data in response to an icon selection.
However, Butka further teaches a method comprising:
in response to a selection of one of the icons embedded within the hyperlink, displaying a plot of the physiological data associated with the subevent associated with the one of the icons ([0046], [0059], [0078]); examiner notes “icons embedded within the hyperlink” was previously addressed and interpreted to mean icons embedded with the hyperlink for further examination; provider portal (306) has API functionality which includes embedding web links and data visualization with monitoring interval visualizer (410) which includes generating timelines with selectable shapes, indicators, and/or icons; monitoring interval tracker (222) can access network database (110, Fig. 4, [0034]) to generate plot details, in response to user selection of physiological data, which necessitates one or more hyperlinks or some equivalent network data linking process;
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the method, as taught by Hresko, Hareland, and Butka, with plots of physiological data in response to icon selection. One of ordinary skill in the art would have been motivated to make these modifications to improve patient care by reducing the complexity of managing and viewing patient data (Butka, [0003]).
Regarding claim 13, Hresko teaches a system comprising:
a user interface (222, Fig. 4);
a medical device including one or more of a pulse generator and a cardiac monitor ([0063]; wearable defibrillator configured to continuously monitor vital signs for indication of treatment then delivers therapeutic shocks);
a computing device including one or more processors (216, Fig. 4) ([0089]; computer); and
a first computer-readable medium (34, Fig. 3) having a first set of computer-executable instructions embodied thereon, the first set of instructions configured to be executed to cause the computing device ([0068]; executed instructions perform functions) to:
perform, using the medical device, a therapy event during the detecting of the cardiac activity ([0063]; wearable defibrillator configured to continuously monitor vital signs for indication of treatment then delivers therapeutic shocks);
generate, using the medical device, metadata associated with one or both of the therapy event and the cardiac activity ([0069-0074]; metadata includes cardiac physiological, non-cardiac physiological, non-cardiac, device-initiated, malfunction, misuse, and temporal event data);
generate a timeline (410) of both the therapy event and the cardiac activity for display in the user interface, the timeline including icons associated with subevents of the cardiac activity and including at least some of the metadata ([0108], Fig. 7; icons identify when treatment provided on timeline),
but does not disclose,
detect, using the medical device, cardiac activity based on a comparison of physiological data collected by the medical device to one or more programmed parameters of the medical device;
detect, using the medical device, subevents associated with the therapy event during the detecting of the cardiac activity;
embed hyperlinks to plots of physiological signals associated with the subevents, and display, via the user interface, one of the plots in response to a user selection of one of the icons;
reprogram the medical device in response to the timeline, wherein the reprogramming includes altering at least one of the one or more programmed parameters; and
perform, using the reprogrammed medical device, a second therapy event during the detecting of the cardiac activity,
as claimed.
However, Hareland teaches,
detect, using the medical device, cardiac activity based on a comparison of physiological data collected by the medical device to one or more programmed parameters of the medical device ([0091]; baseline pacing mode parameters 90);
detect, using the medical device, subevents associated with the therapy event during the detecting of the cardiac activity ([0083]; detects amplitude above threshold);
reprogram the medical device in response to the timeline, wherein the reprogramming includes altering at least one of the one or more programmed parameters ([0091]; updates baseline values); and
perform, using the reprogrammed medical device, a second therapy event during the detecting of the cardiac activity ([0091]; delivers pacing pulse with updated values),
but does not disclose,
embed hyperlinks to plots of physiological signals associated with the subevents, and display, via the user interface, one of the plots in response to a user selection of one of the icons.
However, Butka teaches,
embed hyperlinks to plots of physiological signals associated with the subevents (([0046],[0052], [0078], Fig. 15); provider portal (306) has API functionality which includes embedding web links and data visualization with monitoring interval visualizer (410) which includes generating timelines, shapes, and/or icons; monitoring interval tracker (222) can access network database (110, Fig. 4, [0034]) to generate plot details, in response to user selection of physiological data, which necessitates one or more hyperlinks or some equivalent network data linking process; EHR records include embedded weblinks of data comprising graphs of diagnostic results, physiological data, and responses.), and display, via the user interface, one of the plots in response to a user selection of one of the icons ([0078], Fig. 15).
), and display, via the user interface, one of the plots in response to a user selection of one of the icons ([0078], Fig. 15).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system, as taught by Hresko, with detect, using the medical device, cardiac activity based on a comparison of physiological data collected by the medical device to one or more programmed parameters of the medical device, detect, using the medical device, subevents associated with the therapy event during the detecting of the cardiac activity, reprogram the medical device in response to the timeline, wherein the reprogramming includes altering at least one of the one or more programmed parameters, and
perform, using the reprogrammed medical device, a second therapy event during the detecting of the cardiac activity, as taught by Hareland, and with embed hyperlinks to plots of physiological signals associated with the subevents, and display, via the user interface, one of the plots in response to a user selection of one of the icons, as taught by Hresko. One of ordinary skill in the art would have been motivated to make these modifications to improve anti-tachyarrhythmia shock therapy by suspending ATP to prevent inducing another arrhythmia (Hareland, [0040]) and to improve patient care by facilitating access to medical data from external systems through embedded web links (Butka, [0046]).
Regarding claim 19, Hresko teaches a system comprising:
a medical device, including one or more of a pulse generator and a cardiac monitor ([0067]; therapy delivery interface 24 requires pulse generator; sensor interface 12 includes ECG electrodes), programmed to:
(1) sense physiological signals ([0067]; medical device controller (10): at least sensor interface (12) and one of sensing electrode (14), Fig. 3),
(2) detect a cardiac activity based on a first set of programmed parameters and the physiological signals ([0068]; medical device controller 10: at least processor (32), Fig. 3),
(3) detect subevents associated with the cardiac activity ([0069]; medical device controller 10: at least processor (32), Fig. 3), and
(6) generate metadata associated with one or both of the therapy event and the cardiac activity ([0069-0074]; metadata includes cardiac physiological, non-cardiac physiological, non-cardiac, device-initiated, malfunction, misuse, and temporal event data);
a computing system (216, Fig. 4) including a user interface (400, Fig. 7) and programmed
to (Hresko, [0105-0106]):
(1) generate a timeline (410, Fig. 7) of both the therapy event and the cardiac activity for display in the user interface, the timeline including icons associated with the subevents ([0108], Fig. 7; icons identify when treatment provided on timeline),
but does not disclose,
(4) apply a therapy, during the detecting of the cardiac activity based on a second set of programmed parameters,
(5) detect subevents associated with the therapy event during the detecting of the cardiac activity, and
(2) embed hyperlinks to plots of the physiological signals associated with the subevents, and
(3) reprogram the medical device in response to the timeline, wherein the reprogramming includes altering at least one of the one or more the first set and the second set of programmed parameters,
wherein the medical device further programmed to perform, using the reprogrammed medical device, a second therapy event during the detecting of the cardiac activity.
However, Hareland teaches,
(2) detect a cardiac activity based on a first set of programmed parameters and the physiological signals ([0048], [0091]; programmed thresholds necessitate comparisons to baseline pacing mode parameters 90),
(4) apply a therapy, during the detecting of the cardiac activity based on a second set of programmed parameters ([0048]; programmed parameters control baseline pacing),
(5) detect subevents associated with the therapy event during the detecting of the cardiac activity ([0083]; detects amplitude above threshold), and
(3) reprogram the medical device in response to the timeline, wherein the reprogramming includes altering at least one of the one or more the first set and the second set of programmed parameters ([0091]; updates baseline values),
wherein the medical device further programmed to perform, using the reprogrammed medical device, a second therapy event during the detecting of the cardiac activity ([0091]; processing circuitry 80 controls therapy delivery circuitry to deliver pacing pulse with updated baseline value),
but does not disclose,
(2) embed hyperlinks to plots of the physiological signals associated with the subevents.
However, Butka teaches,
(2) embed hyperlinks to plots of the physiological signals associated with the subevents (Butka, [0046],[0052], [0078], Fig. 15; provider portal (306) has API functionality which includes embedding web links and data visualization with monitoring interval visualizer (410) which includes generating timelines, shapes, and/or icons; monitoring interval tracker (222) can access network database (110, Fig. 4, [0034]) to generate plot details, in response to user selection of physiological data, which necessitates one or more hyperlinks or some equivalent network data linking process; EHR records include embedded weblinks of data comprising graphs of diagnostic results, physiological data, and responses)
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system, as taught by Hresko, with a medical device programmed to apply a therapy, during the detecting of the cardiac activity based on a second set of programmed parameters, detect subevents associated with the therapy event during the detecting of the cardiac activity, and reprogram the medical device in response to the timeline, wherein the reprogramming includes altering at least one of the one or more the first set and the second set of programmed parameters, as taught by Hareland, and to embed hyperlinks to plots of physiological signals associated with the subevents, as taught by Butka. One of ordinary skill in the art would have been motivated to make these modifications to improve anti-tachyarrhythmia shock therapy by suspending ATP to prevent inducing another arrhythmia (Hareland, [0040]) and to improve patient care by reducing the complexity of managing and viewing patient data (Butka, [0003]).
Regarding claim 20, Hresko, in view of Hareland and Butka, teaches the system of claim 19, and Hresko further teaches wherein the medical device is a pacemaker or defibrillator ([0005]; implantable or external pacemakers).
Regarding claim 21, Hresko, in view of Hareland and Butka, teaches the system of claim 19, and Hresko further teaches wherein the therapy event includes one or more of a shock event ([0071]; processor 32 identifies defibrillator shocks e.g. treatment events) and an anti-tachycardia pacing (ATP) event.
Claim(s) 14-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hresko et al (US Pre Grant Publication US 2017/0300653), in view of Hareland et al (US Pre Grant Publication 2017/0312510 A1), and in further view of Butka et al (WO 2023/279003 A1) and Sawchuk (US Pre Grant Publication US 2022/0039728 A1).
Regarding claim 14, Hresko, in view of Hareland and Butka, teaches the system of claim 13 but does not disclose a subevent comprised of a sensing event or therapy event.
However, Sawchuk teaches a system wherein at least one of the subevents
includes a sensing event [0031]; “…variety of cardiac devices configured for sensing cardiac activitys and determining a cardiac activity interval or rate for detecting a cardiac rhythm and, in some cases, controlling a cardiac electrical stimulation therapy.”
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system, as taught by Hresko, Hareland, and Butka, with at least one of the subevents includes a sensing event, as taught by Sawchuk. One of ordinary skill in the art would have been motivated to make these modifications to detect and control abnormal cardiac rhythms by determining treatment parameters through event analysis (Sawchuk, [0030]).
Regarding claim 15, Hresko, in view of Hareland and Butka, teaches the system of claim 13, but does not disclose a therapy event that includes an ATP event.
However, Sawchuk further teaches a system wherein the therapy event includes an anti-tachycardia pacing (ATP) event [0070]; “In some examples, pacemaker 214 may detect a tachyarrhythmia based on sensed cardiac activity intervals and deliver ATP therapy in response to detecting the tachyarrhythmia.”
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system, as taught by Hresko, Butka, and Sawchuk, with a therapy event that includes an ATP event, as taught by Sawchuk. One of ordinary skill in the art would have been motivated to make these modifications to treat ventricular tachycardia or ventricular fibrillation by delivering ATP therapy (Sawchuk, [0049]).
Regarding claim 16, Hresko, in view of Hareland, Butka, and Sawchuk, teaches the system of claim 15, but does not disclose an ATP event that includes a burst or scan event.
However, Hareland teaches a method wherein the ATP event includes a burst event [0067] or a scan event; “Each train of pulses during ATP may last for a duration of between approximately 0.5 seconds to approximately 15 seconds or be defined as a specific number of pulses. Each pulse, or burst of pulses, may include a ramp up in amplitude or in pulse rate.”
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the system, as taught by Hresko, Hareland, Butka, and Sawchuk with an ATP event includes a burst event. One of ordinary skill in the art would have been motivated to make these modifications to improve ATP treatment efficacy by increasing burst amplitudes and/or pulse rates (Hareland, [0067]).
Regarding claim 17, Hresko, in view of Hareland, Butka, and Sawchuk, teaches the system of claim 16, but does not disclose the sensing event includes an onset of the cardiac activity or end of the cardiac activity.
However, Sawchuk further teaches a system wherein the sensing event includes an onset of the cardiac activity or an end of the cardiac activity [0087]; “Tachyarrhythmia detector 92 may be configured to perform other signal analysis for determining if other detection criteria are satisfied before detecting VT or VF, such as R-wave morphology criteria and onset criteria.”
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the system, as taught by Hresko, Hareland, Butka, and Sawchuk, with a sensing event that includes an onset of the cardiac activity or end of the cardiac activity. One of ordinary skill in the art would have been motivated to make these modifications to perform additional signal analysis by detecting other signal criteria such as onset criteria (Sawchuk, [0087]).
Regarding claim 18, Hresko, in view of Hareland and Butka, teaches the system of claim 13, but does not disclose wherein the medical device is a pacemaker including a second computer-readable medium having a second set of computer-executable instructions embodied thereon, the second set of instructions configured to be executed by the second processor to cause the second processor to: (1) detect a cardiac activity based on a first set of programmed parameters and physiological signals sensed by the pacemaker, (2) detect the subevents associated with the cardiac activity, and (3) apply the therapy based on a second set of programmed parameters.
However, Sawchuk teaches wherein the medical device is a pacemaker (241, Fig. 4) including a second computer-readable medium having a second set of computer-executable instructions embodied thereon, the second set of instructions configured to be executed by the second processor (81, Fig. 5) to cause the second processor to (([0074], Fig. 5); “For example, cardiac activity sensing and determination of sensed cardiac activity features and sensed event intervals may be performed cooperatively by sensing circuit 86 and control circuit 80 and may include operations implemented in a processor or other signal processing circuitry included in control circuit 80 executing instructions stored in memory 82;” control circuitry may be implemented within ICD (14)): (1) detect a cardiac activity based on a first set of programmed parameters and physiological signals sensed by the pacemaker [0066], (2) detect the subevents associated with the cardiac activity [0069], and (3) apply the therapy based on a second set of programmed parameters [0070].
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system, as taught by Hresko, Hareland, and Butka, with a pacemaker including a second computer-readable medium having a second set of computer-executable instructions embodied thereon, the second set of instructions configured to be executed by the second processor to cause the second processor to detect a cardiac activity based on a first set of programmed parameters and physiological signals sensed by the pacemaker, detect the subevents associated with the cardiac activity, and apply the therapy based on a second set of programmed parameters, as taught by Sawchuk. One of ordinary skill in the art would have been motivated to make these modifications to improve cardiac therapy by improving cardiac event detection (Sawchuk, [0030]).
Conclusion
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 DWANE COLLARD whose telephone number is (571)272-6553. The examiner can normally be reached M-F 9 am-6 pm.
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/DWANE COLLARD/Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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