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 Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: a medical device in claims 1 & 19.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter of abstract ideas under the mental processes and mathematical concepts groupings, without significantly more.
The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) prong 1: Does the claim recite an abstract idea, law of
nature, or natural phenomenon and (2a) prong 2: Does the claim recite additional elements
that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception.
Under Step (1): Independent claims 1, 13, and 19 are directed to a system or a method, and thus, the claims all fall under one of the four patent eligible categories.
Under Step 2(a) prong 1:
Independent claim 1 recites limitations of “detecting, using a medical device, a cardiac event”, “detecting, using the medical device, subevents associated with the cardiac event”, “generating, using the medical device, metadata associated with the cardiac event”, and creating, using a computing system, a timeline of the cardiac event for display.” Under broadest reasonable interpretation, these limitations appear to be directed toward mental processes because detection and generation of cardiac events and subevents concern the identification, comparison, and/or evaluation of signals and/or data while creation concerns organizing data, all of which can be performed in the mind or with pen and paper.
For example, a person can identify cardiac events and subevents by comparing collected physiological data to programmed threshold values. Through further evaluation and mental judgments, that person can associate pertinent metadata with each corresponding event and construct a timeline that includes drawings or icons representative of these events. Accordingly, claim 1 is directed toward a judicial exception including one or more abstract ideas under mental processes.
Dependent claims 2-7 & 14-17 recite additional limitations of “at least one of the subevents includes sensing event”, “the sensing event includes onset of the cardiac event or an end of the cardiac event”, “at least one of the subevents includes a therapy event”, “the therapy event includes a shock event”, “the therapy event includes an anti-tachycardia pacing (ATP) event”, and “the ATP event includes a burst event or a scan event.” These additional limitations appear to be directed toward mental processes because they further specify one or more abstract determinations and because the device is detecting subevents and not requiring the device to provide a specific therapy.
Dependent claim 8 recites an additional limitation of “embedding a hyperlink into the icons.” This limitation appears to be directed towards mental processes because, under broadest reasonable interpretation, it concerns organizing data through selectable links which can be performed in the mind or with pen and paper.
Dependent claim 9 recites an additional limitation of “displaying a plot of the physiological data associated with the subevent associated with the one of the icons.” This limitation appears to be directed towards mental processes because it further specifies one or more abstract determinations.
Dependent claim 10 recites “initiating a therapy event based on a comparison of the physiological data to the one or more programmed parameters.” This limitation appears to be directed towards mental processes because it further specifies one or more abstract determinations and because the therapy is not necessarily something provided by the medical device and includes having the person take an oral medication.
Independent claim 13 recites additional limitations of “generate a timeline”, “embed hyperlinks to plots”, and “display, via the user interface, one of the plots.” Under broadest reasonable interpretation, these limitations appear to be directed toward mental processes because generate, embed, and display concern analyzing, organizing, and/or linking data which can be performed in the mind or with pen and paper.
Dependent claim 18 recites additional limitations of “detect a cardiac event based on a first set of programmed parameters and physiological signals sensed by the pacemaker” and “detect the subevents associated with the cardiac event.” These limitations appear to be directed toward mental processes because they further specify one or more abstract determinations.
Independent claim 19 recites additional limitations of “ sense physiological signals”, “detect a cardiac event”, “detect subevents associated with the cardiac event”, “generate a timeline of the cardiac event for display in the user interface”, and “embed hyperlinks to plots of the physiological signals associated with the subevents.” These limitations appear to be directed toward mental processes because sensing, detecting, generating, and embedding concern identification, observation, judgement, and linking of data which can be performed in the mind or with pen and paper.
Under Step 2(a) prong 2: This part of the eligibility analysis evaluates whether the claim
as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d).
Claims 1 & 19 recite additional elements of “medical device” and “computing system” but appears to link the abstract ideas to a particular technological environment and implements abstract ideas using a generic computer and/or components. In addition, “sense physiological signals” is directed to insignificant pre-solution activity.
Claim 10 recites “initiating a therapy event based on a comparison” and appears to output data in the form of therapy parameters and directed to extra-solution activity.
Claims 12 & 20 recite additional elements of a pacemaker or defibrillator but do not improve upon a technology or a technical field and are directed to insignificant pre-solution activity.
Claim 13 recites additional elements of “user interface”, “computing device including one or more processors”, and “a first computer-readable medium” but appears to implement abstract ideas using a generic computer and/or components. In addition, claim 13 recites “display” which appears to output data and is directed to post-solution activity.
Claim 18 recites additional elements of “a pacemaker” and “apply a therapy” but does not improve upon a technology or technical field. Examiner notes that application of therapy based on a second set of programmed parameters and detecting cardiac events and subevents are functions of a generic pacemaker and the abstract ideas do not necessarily affect the therapy output.
Claim 18 also recites additional elements of “a second computer-readable medium” and “second processor” but appears to cover performance of abstract mental processes using generic computer elements.
Claim 19 recites an additional element of “user interface” but does not improve upon a technology or technical field and/or implements one or more abstract ideas on a generic computer or component.
Despite the fact that the abstract ideas claimed are performed on a generic computer, the courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind." Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016)
(holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer"). See MPEP 2106.04(a)(2)(III).
Furthermore, generic computer components that perform abstract ideas are still
abstract mental processes unless the claim limitation cannot be practically performed in the
mind. As such, “medical device”, “computing system”, “user interface”, “computing device including one or more processors”, “computer-readable medium”, and “embedding hyperlink” appears to amount to nothing more than a suggestion to “apply it” on a computer; Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984.
Under Step 2b: The claims also do not include additional elements that are sufficient to
amount to significantly more than the judicial exception. As discussed above with respect to
integration of the judicial exception into a practical application, the additional elements of “medical device”, “pacemaker”, “computing system”, “computer-readable medium”, and “embed hyperlinks” are well-understood, routine, and conventional activities previously known in the fields of electrostimulation and graphical user interface technology as indicated in the following references:
US 20070265668 A1: See [0018] AIMD for medical device.
US 20070112398 A1: See [0209] pacemaker for medical device.
US 20090024187 A1: See [0084] external interface platform for computing system.
US 20040138716 A1: See [0032] microcontroller (at least RAM/ROM or memory) for computer-readable medium.
US 20130053680 A1: See [0060] hyperlinks.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 10, & 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hresko et al (US Pre Grant Publication US 2017/0300653).
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], a cardiac event 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.
detecting, using the medical device, subevents associated with the cardiac event
([0068], [0134]); controller (10) configured to determine events related to events or device operation based on analysis of data;
generating, using the medical device, metadata associated with the cardiac event
[0069-0074]; and; 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 the cardiac event for
display, the timeline including icons associated with the subevents and including at least some of the metadata ([0108], [0134], Fig. 7).
Regarding claim 2, Hresko 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 teaches the method of claim 2, and further teaches a method wherein the sensing event includes an onset of the cardiac event [0134] or an end of the cardiac event [0135].
Regarding claim 4, Hresko 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 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 teaches the method of claim 1, and a method further
comprising:
initiating a 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 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) 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Butka et al (WO 2023/279003 A1).
Regarding claim 13, teaches a system comprising:
a user interface (108; Fig. 1) [0034];
a computing device (2000) including one or more processors (2002)
[00107]; and
a first computer-readable medium (2004/2006) having a first set of computer-
executable instructions embodied thereon, the first set of instructions configured to be executed to cause the computing device to [00109-00110]; data storage devices (2004) and/or memory devices capable of performing computer executable instructions.
generate a timeline of a cardiac event for display in the user interface, the
timeline including icons associated with subevents of the cardiac
event ([0033], [0059], Fig. 13); medical device platform (204) includes at least provider portal (306, Fig. 3), and monitoring interval visualizer (410, Fig. 4); monitoring interval visualizer generates timeline GUI with interactive indicators and/or icons for a particular monitoring interval or subevent.
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).
Claim Rejections - 35 USC § 103
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) 6 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 Sawchuk (US Pre Grant Publication US 2022/0039728 A1).
Regarding claim 6, Hresko 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 system of Hresko 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]).
Claim(s) 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 Sawchuk (US Pre Grant Publication US 2022/0039728 A1), and in further view of Hareland et al (US Pre Grant Publication 2017/0312510 A1).
Regarding claim 7, Hresko and Sawchuk teach the modified method of claim 6 but do
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 modify the method of Hresko and Sawchuk wherein the ATP event includes a burst event as taught by Hareland. 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 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 Butka et al (WO 2023/279003 A1).
Regarding claim 8, Hresko 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 system of Hresko with the 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 and Butka teach the modified method of claim 8 but do 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 modify the system of Hresko and Butka with the plots of physiological data in response to icon selection 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 (Butka, [0003]).
Claim(s) 11 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 Snell et al (US Pre Grant Publication US 2011/0112597 A1).
Regarding claim 11, Hresko teaches the method of claim 1 but does not disclose reprogramming the medical device in response to the timeline.
However, Snell teaches a method further comprising:
reprogramming the medical device in response to the timeline, wherein the reprogramming
includes altering at least one of the one or more programmed parameters [0012-0013]; event detection system of device selectively reprograms device sensitivity in response to false detection event; timeline is generated from device signal data; event detection system reprograms medical device in response to analysis of signal data; therefore, medical device is reprogrammed in response to event data or timeline.
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 of Hresko with the reprogramming of the medical device in response to the timeline as taught by Snell. One of ordinary skill in the art would have been motivated to make these modifications to optimize event detection by adjusting sensitivity parameters (Snell, [0013]).
Claim(s) 14-15, 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Butka et al (WO 2023/279003 A1), in view of Sawchuk (US Pre Grant Publication US 2022/0039728 A1).
Regarding claim 14, 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 and another one of the subevents is a therapy event [0031]; “…variety of cardiac devices configured for sensing cardiac events and determining a cardiac event 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 of Butka with the sensing and therapy subevents 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, Butka & Sawchuk teach the modified system of claim 14 but do 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 event 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 of Butka and Sawchuk with the ATP event as further 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 17, Butka & Sawchuk teach the modified system of claim 16 but do not
disclose a sensing event that includes an onset or end of the cardiac event.
However, Sawchuk further teaches a system wherein the sensing event includes an onset of the cardiac event or an end of the cardiac event [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 modify the system of Butka and Sawchuk with a sensing event that includes an onset of the cardiac event as further taught by Sawchuk. 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, Butka teaches the system of claim 13 but does not disclose a
pacemaker that includes computer-readable medium with executable instructions that cause the device to detect cardiac events, detect subevents, and apply therapy.
However, Sawchuk teaches a system comprising:
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 event sensing and determination of sensed cardiac event 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 event based on a first set of programmed parameters and physiological signals sensed by the pacemaker [0066], (2) detect the subevents associated with the cardiac event [0069], and (3) apply a 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 of Butka with a pacemaker comprising a computer-readable medium with executable instructions that cause the device to detect cardiac events, subevents, and apply therapy as taught by Sawchuk. One of ordinary skill in the art would have been motivated to make these modifications to cooperatively implement the aforementioned functionalities into one device by integrating sensing, determination, and therapy within a pacemaker (Sawchuk, [0074]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Butka et al (WO 2023/279003 A1), in view of Sawchuk (US Pre Grant Publication US 2022/0039728 A1), and in further view of Hareland et al (US Pre Grant Publication 2017/0312510 A1).
Regarding claim 16, Butka & Sawchuk teach the modified system of claim 15 but do
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 modify the system of Butka and Sawchuk wherein the ATP event includes a burst event as taught by Sawchuk. 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) 19 & 20 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 Butka et al (WO 2023/279003 A1).
Regarding claim 19, Hresko teaches a system comprising:
a medical device programmed to (Hresko, [0063]; wearable cardioverter defibrillator):
(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 event 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 event ([0069]; medical device controller 10: at least processor (32), Fig. 3), and (4) apply a therapy based on a second set of programmed parameters ([0077]; medical device controller (10): at least processor (32), therapy delivery interface (24), and one of therapy electrode (26)); and
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 the cardiac event for display in the user interface, the timeline including icons associated with the subevents ([0108], [0134], Fig. 7).
Hresko does not disclose subevents with embedded hyperlinks to plots of physiological signals.
However, Butka teaches a computing system (2000, Fig. 20) that includes a user
interface (108, Fig. 1) and programmed to [0034]: (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 of Hresko with embedded with embedded hyperlinks to physiological plots 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 (Butka, [0003]).
Regarding claim 20, Hresko and Butka teach the modified system of claim 19, and Hresko further teaches a system wherein the medical device is a pacemaker or defibrillator ([0063], Fig. 3); LifeVest defibrillator.
However, Hresko further teaches a system wherein the medical device is a
pacemaker or defibrillator (LifeVest) [0063].
Conclusion
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.
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, Ben Klein can be reached at (571) 270-5213. 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.
/DWANE COLLARD/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796