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 .
DETAILED ACTION
In the response filed on 29 December 2025, the following has occurred: claims 1, 10, 13, 15 and 20 have been amended; claims 12 and 19 have been canceled; claims 21 and 22 are newly added.
Now claims 1-11, 13-18 and 20-22 are pending.
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 1-11, 13-18 and 20-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1 and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite system and method for providing output of data to a human user for human user interaction. The limitations of:
Claim 1, which is representative of claim 15
[… provide …] requests […] to retrieve electrocardiogram (ECG) data associated with a patient study session, wherein the requests are generated according to a dynamic priority protocol, and wherein the ECG data is associated with metadata, which includes beat classifications; [… obtain …] the ECG data in response to the requests; [… output …], plots of the ECG data that have been received; analyze, […], the ECG data and the metadata; modify, […], the beat classifications; and generate a report based on the modified beat classifications, wherein the metadata with the beat classifications are [… obtained …] before the ECG data is [… obtained …], wherein the requests each include [… an address …] to respective strips of ECG data containing beat classifications indicating ectopic beats, and wherein the dynamic priority protocol prioritizes [… obtaining …] the respective strips of the ECG data associated with the beat classifications indicating ectopic beats based on the [… address …] to the respective strips of ECG data.
, as drafted, is a system, which under its broadest reasonable interpretation, covers a method of
organizing human activity (i.e., managing personal behavior including following rules or
instructions) via the use of generic computer components. That is, by a human user interacting with a user interface, one or more processors, a first computer-readable medium (CRM) and a server (claim 1), a computer and a user interface (claim 15), the claimed invention amounts to managing personal behavior or interaction between people, the Examiner notes as stated in 2106.04(a)(2), “certain activity between a person and a computer… may fall within the “certain methods of organizing human activity” grouping”. For example, but for a user interface, one or more processors, a first computer-readable medium (CRM) and a server (claim 1), a computer and a user interface (claim 15), the claim encompasses a user selecting what data to interact with to be provided an output of data. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “method of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of a user interface, one or more processors, a first computer-readable medium (CRM) and a server (claim 1), a computer and a user interface (claim 15) which implements the abstract idea. The a user interface, one or more processors, a first computer-readable medium (CRM) and a server (claim 1), a computer and a user interface (claim 15) are recited at a high-level of generality (i.e., a general-purpose computers/ computer components implementing generic computer functions; see Applicant’s Specification Figure 1, paragraphs [0088]-[0092]) such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, these additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim recites the additional elements of “send… to a server… receive…”, “display, on the user interface”, “downloading…” and “a pointer”. The “send… to a server… receive…” steps are recited at a high-level of generality (i.e., as a general means of receiving/transmitting data) and amounts to the mere transmission and/or receipt of data, which is a form of extra-solution activity. The “downloading…” is recited at a high-level of generality (i.e., as a general means of storing data) and amounts to the mere storage of data, which is a form of extra-solution activity. The “display, on the user interface” is recited at a high-level of generality (i.e., as a generic display interface for presentation of information to a user) and amounts to generally linking the abstract idea to a particular technological environment. The “a pointer” is recited at a high-level of generality (i.e., as an address to organize data) and amounts to generally linking the abstract idea to a particular technological environment. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
The claim does 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 abstract idea into a practical application, the additional elements of a user interface, one or more processors, a first computer-readable medium (CRM) and a server (claim 1), a computer and a user interface (claim 15) to perform the noted steps amounts to no more than mere instructions to apply the exception using generic hardware components. Mere instructions to apply an exception using a generic hardware component cannot provide an inventive concept (“significantly more”).
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of “send… to a server… receive…”, “downloading…”, “display, on the user interface” and “a pointer”. were considered generally linking the abstract idea to particular technological environment and/or extra-solution activity. The “send… to a server… receive…” steps have been re-evaluated under the “significantly more” analysis and determined to amount to be well- understood, routine, and conventional elements/functions. As described in MPEP 2106.05(d)(II)(i) “Receiving or transmitting data over a network” is well-understood, routine, and conventional. The “downloading…” has been re-evaluated under the “significantly more” analysis and determined to amount to be well-understood, routine, and conventional elements/functions. As described in MPEP 2106.05(d)(II)(iv) “Storing and retrieving information in memory” is well-understood, routine, and conventional. The “display, on the user interface” has been re-evaluated under the “significantly more” analysis and determined to amount to be well-understood, routine, and conventional elements/functions. As described in Goil (20240065637): see below but at least Fig. 6, paragraph [0114]; MacIver (20210401316): Figures 2, 4, paragraph [0001]; Finkelmeier (20210280283): Figures 1-2, paragraph [0004]; display of data on a user interface is well-understood, routine, and conventional. The “a pointer” has been re-evaluated under the “significantly more” analysis and determined to amount to be well-understood, routine, and conventional elements/functions. As described in Finkelmeier (20210280283): claim 21; Moore (20130271470): paragraph [0046]; use of an address to organize data is well-understood, routine, and conventional. Well-understood, routine, and conventional elements/functions cannot provide “significantly more.” As such the claim is not patent eligible.
Claims 2-11, 13-14, 16-18 and 20-22 are similarly rejected because either further define the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible.
Claims 2 and 16 further describe the labels of the classifications, however does not recite any additional elements are therefore cannot provide a practical application and/or significantly more.
Claims 3 and 18 further describe the prioritization based on a label, however does not recite any additional elements are therefore cannot provide a practical application and/or significantly more.
Claims 4, 6 and 17 describe the additional element of display of various windows and indicators on a user interface, however this feature was already considered above and is incorporated herein.
Claims 5, 7-9 and 20-21 describe modification of data via human activity (i.e., the abstract idea), however does not recite any additional elements are therefore cannot provide a practical application and/or significantly more.
Claims 10 and 11 further describe the communication of data between the generic hardware components, however communication of data was already considered above and is incorporated herein.
Claims 13 and 22 further describe the strips of data, however does not recite any additional elements are therefore cannot provide a practical application and/or significantly more.
Claim 14 further describes the server already considered above and incorporated herein, and additionally recites communication that was also already considered above and incorporated herein.
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.
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) 1-4, 6-11, 13-18 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 20240065637 (hereafter “Goil”) in view of U.S. Patent Pub. No. 20210401316 (hereafter “MacIver”), in view of U.S. Patent Pub. No. 20160080685 (hereafter “De Saint Salvy”), further in view of U.S. Patent Pub. No. 20210280283 (hereafter “Finkelmeier”).
Regarding (Currently Amended) claim 1, Goil teaches a system (Goil: Figures 1-2, 8-9, paragraph [0003], “systems and methods for processing data obtained from an implantable medical device (IMD) by utilizing machine-learning models to manage presentation of electrogram (EGM) segments corresponding to detected arrhythmic episodes”) comprising:
a remote computing system comprising: a user interface, one or more processors, and a first computer-readable medium having a first set of computer-executable instructions (Goil: Figures 1-2, 6, 8-9, paragraph [0004], “remote monitoring of cardiac arrhythmias, and more generally remote patient care”, paragraph [0018], “the server system may include one or more server processors, a database, a server memory, and a network interface… server system may be cloud-based… select for display (on, for example, a clinician's display device”, paragraph [0020], “the system is more specifically configured to: (a) receive, from a remote device… a display device in communication with the system”, paragraph [0029], “a clinician's user interface to a system”, paragraphs [0112]-[0115], “an example user interface 600 to or of a system… A front-end application presents at user interface 600 a query (generated, e.g., by the back-end server system) to a clinician user”, paragraphs [0124]-[0125], “Any of the processor-based components in FIG. 8 (e.g., workstation 810, cell phone 814, local monitoring device 816, server 802, and programmer 806) may perform one or more processes or steps discussed herein… the server system also includes one or more server processors 802c configured to execute the first, second and third sets of instructions”, paragraphs [0134]-[0137], “user workstation 810 may process and/or display EGM datasets… display a user interface presenting input queries”. Also see, paragraphs [0067], [0138], [0152]) configured to be executed to cause the remote computing system to:
send requests to a server to retrieve [… electrogram (EGM) …] data associated with a patient study session, wherein the requests are generated according to a dynamic priority protocol (Goil: Figures 1-2, 6, 8-9, paragraph [0005], “the cardiac activity signals (e.g., electrocardiograms (ECG) or EGM signals)”, paragraph [0011], “a plurality of classified electrogram (EGM) datasets corresponding to a plurality of arrhythmic episodes detected by the IMD during a period of time, where each classified EGM dataset includes (1) EGM segment data corresponding to an arrhythmic episode, and (2) an IMD classification for the arrhythmic episode”, paragraph [0019], “the server system is a cloud-based system, and the communication link is a wireless communication link… transmit an alert signifying a request to initiate transmission of the plurality of signals”, paragraph [0022], “a set of patient-specific longitudinal data relating to the set of arrhythmic episodes… a set of alert conditions relating to the set of arrhythmic episodes and the patient-specific longitudinal data… conditionally reset the set of alert conditions based upon the at least one assessment”, paragraph [0128], “transmit an alert signifying a request to initiate transmission of the plurality of signals to the external device”. The Examiner notes the alert conditions, read on a dynamic priority protocol under the broadest reasonable interpretation, and are used to transmit a request to initiate communication (i.e., retrieve ECG data) associated with patient specific longitudinal data (i.e., a patient study session). Also see, paragraphs [0085], [0133]-[0134]), and
wherein the [… EGM …] data is associated with metadata, which includes beat classifications (Goil: Figures 1-2, 6, 8-9, paragraphs [0009]-[0011], “a server system that receives transmissions of classified EGM datasets, where each classified EGM dataset corresponds to an arrhythmic episode detected… receiving… a plurality of classified electrogram (EGM) datasets corresponding to a plurality of arrhythmic episodes detected by the IMD during a period of time, where each classified EGM dataset includes (1) EGM segment data corresponding to an arrhythmic episode, and (2) an IMD classification for the arrhythmic episode”, paragraph [0056], “The respective EGM segment data is indicative of an EGM segment corresponding to the arrhythmic episode; respective classification data specifies a type of the arrhythmic episode, such as, but not limited to, bradycardia, tachycardia, cardiac pause, and AF… a classified EGM dataset includes EGM segment data (which may also include marker data, examples of which were discussed above), associated classification data, and other types of metadata (e.g., a date/time stamp; IMD/patient identifying information; etc.)”, paragraph [0123], “a distinct classified EGM dataset in the plurality of classified EGM datasets is described in connection with a series of beats-thus a distinct classified EGM dataset includes distinct EGM segment data representing EGM signals for two or more beats”. Also see, paragraph [0086]);
receive the [… EGM …] data in response to the requests (Goil: Figures 1-2, 6, 8-9, paragraphs [0009]-[0011], “a server system that receives transmissions of classified EGM datasets, where each classified EGM dataset corresponds to an arrhythmic episode detected… receiving… a plurality of classified electrogram (EGM) datasets corresponding to a plurality of arrhythmic episodes detected by the IMD during a period of time, where each classified EGM dataset includes (1) EGM segment data corresponding to an arrhythmic episode, and (2) an IMD classification for the arrhythmic episode”);
display, on the user interface, plots of the [.. EGM …] data that have been received (Goil: Figures 1-2, 6, 8-9, paragraph [0011], “providing for display on a display device in communication with the data processing system, the at least one patient database record identified for display”, paragraph [0020], “provide for display (on a display device in communication with the system) the set of diagnostic information and the subset of machine-adjudicated EGM datasets, comprising EGM segment data to be displayed”, paragraph [0041], “Managing the presentation of EGM segments”, paragraph [0053], “Markers may be superimposed upon EGM signals or presented proximate to, and temporally aligned with, EGM signals or segments”);
analyze, using the user interface, the [… EGM …] data and the metadata; modify, using the user interface, the beat classifications (Goil: Figs. 3, 6, paragraphs [0004]-[0007], “manually review in the form of recorded electrogram (EGM) segments… manually reviewing or otherwise analyzing the AE datasets”, paragraph [00015], “determining an alternative classification for one or more said classified EGM dataset stored in the plurality of patient database records for which the respective confidence indicator associated with the classified EGM dataset is indicative of a false positive designation… replacing the IMD classification with the alternative classification and by updating the respective confidence indicator to an alternative confidence indicator, thereby associating a different type of arrhythmic episode with the EGM segment data of the classified EGM dataset stored in the patient database record”, paragraph [0099], “the ML model may include a detection threshold that may be changed/tuned by clinicians based on the clinician's needs and/or one or more various other factors”, paragraph [0109], “include a detection threshold that may be changed/tuned by a clinician based on the clinician's needs and/or one or more various other factors”, paragraph [0137], “display a user interface presenting input queries that enable a physician/clinical to: (a) set/reset patient device settings; (b) set/reset ML model settings and parameters; (c) select diagnostic information for analysis and/or display (including a time period for the analysis); (d) set/reset display criteria or key episodes); and (e) set/reset alert conditions for a patient”); and
generate a [… summary …] based on the modified beat classifications (Goil: Figs. 6-7, 9, paragraph [0007], “where AE datasets including EGM segment data and respective IMD classification data obtained by an ICM may be used to generate summary diagnostic information, inclusion of false positives can introduce important inaccuracies in diagnostic histograms and reported trends over time for a given patient”, paragraph [0078], “provide comprehensive diagnostic information including a summary of heart rate data, in order to assist physicians in diagnosis and treatment of patient conditions”), […], and
wherein the dynamic priority protocol prioritizes downloading the respective strips of the [… EGM …] data associated with the beat classifications indicating ectopic beats based on the […] respective strips of [… EGM …] data (Goil: Figures 1-2, 6, 8-9, paragraph [0019], “the server system is a cloud-based system, and the communication link is a wireless communication link… transmit an alert signifying a request to initiate transmission of the plurality of signals”, paragraph [0022], “a set of alert conditions relating to the set of arrhythmic episodes and the patient-specific longitudinal data, (b) generate at least one assessment of an alert condition of the set of alert conditions based upon the set of diagnostic information, and (c) conditionally reset the set of alert conditions based upon the at least one assessment”, paragraph [0035], “Rhythms that do not follow the sequence of events described above are known as arrhythmias… Tachyarrhythmias (aka tachycardias) are further classified as supraventricular tachycardias (SVTs) and ventricular tachycardias (VTs)”, paragraphs [0038]-[0039], “Overall, SVTs are not typically immediately life threatening when compared to ventricular arrhythmias… Ventricular arrhythmias, which originate in the ventricles, include ventricular tachycardia (VT) and ventricular fibrillation (VF). Ventricular arrhythmias are often associated with rapid and/or chaotic ventricular rhythms”, paragraph [0041], “reduce clinical review burden by managing presentation of EGM segments that correspond to detected arrhythmic episodes”, paragraph [0048], “generate classified EGM datasets for… download to a remote server system (such as a secured, cloud-based system) for additional processing and clinical evaluation”, paragraph [0053], “Non-limiting examples of markers may include R-wave markers, noise markers, activity markers, interval markers, refractory markers, P-wave markers, T-wave markers, PVC markers, sinus rhythm markers, AF markers and other arrhythmia markers”, paragraph [0085], “The alert transmissions are automatically initiated when the IMD detects that a configurable alert condition has been met”. The Examiner notes an alert condition provides a request that all classifications corresponding to ventricular and supraventricular (i.e., ectopic beats) that are detected be retrieved, which teaches what is required of the dynamic priority protocol under the broadest reasonable interpretation).
Goil may not explicitly teach (Underlined below for clarity):
send requests to a server to retrieve electrocardiogram (ECG) data associated with a patient study session, wherein the requests are generated according to a dynamic priority protocol, and wherein the ECG data is associated with metadata, which includes beat classifications; receive the ECG data in response to the requests; display, on the user interface, plots of the ECG data that have been received; analyze, using the user interface, the ECG data and the metadata; modify, using the user interface, the beat classifications; and generate a report based on the modified beat classifications, […], wherein the dynamic priority protocol prioritizes downloading the respective strips of the ECG data associated with the beat classifications indicating ectopic beats based on the […] respective strips of ECG data.
MacIver teaches send requests to a server to retrieve electrocardiogram (ECG) data associated with a patient study session, wherein the requests are generated according to a dynamic priority protocol, and wherein the ECG data is associated with metadata, which includes beat classifications; receive the ECG data in response to the requests; display, on the user interface, plots of the ECG data that have been received; analyze, using the user interface, the ECG data and the metadata; modify, using the user interface, the beat classifications; and generate a report based on the modified beat classifications, […], wherein the dynamic priority protocol prioritizes downloading the respective strips of the ECG data associated with the beat classifications indicating ectopic beats based on the […] respective strips of ECG data (MacIver: Figures 3-4, 10, paragraphs [0006]-[0008], “provide the technician with interactive interfaces that enable the technician to determine usability of ECG recordings, prioritize analyses and correlate analytical results with patient-recorded symptomatic events… a process for prioritizing ECG analyses is performed, the plurality of executable programmatic instructions comprising: programmatic instructions, stored in the computer readable non-transitory medium, for receiving an ECG recording of a patient for a first duration… automatically performing a first analysis of the ECG recording for the first duration to detect events indicative of at least one of a plurality of arrhythmias within the first duration… generating a GUI, wherein the GUI is configured to display ECG waveforms corresponding to the first duration along with the automatically detected events indicative of at least one of the plurality of arrhythmias and wherein one of a plurality of areas within the GUI is designated for each of the plurality of arrhythmias”, paragraph [0016], “the computer readable non-transitory medium further comprises programmatic instructions for displaying, in the GUI, the generated textual information and programmatic instructions for integrating the textual information into a report upon selection of an option within the GUI”, paragraph [0037], “an ECG analysis report”, paragraph [0089], ‘”The group of electrodes 105 is configured to sense and acquire ECG (electrocardiogram) recording corresponding to electrical activity of the patient's heart”).
One of ordinary skill in the art before the effective filing date would have found it obvious to include using ECG data to generate a report as taught by MacIver within the use of EGM data for dynamic data prioritization and providing summaries as taught by Goil with the motivation of “reduce wasted effort for clinicians and help accelerate diagnosis in cases where specific arrhythmias or conditions are suspect” (MacIver: paragraph [0098]).
Goil and MacIver may not explicitly teach (Underlined below for clarity):
wherein the metadata with the beat classifications are downloaded to the remote computer before the ECG data is downloaded to the remote computer,
De Saint Salvy teaches wherein the metadata with the beat classifications are downloaded to the remote computer before the ECG data is downloaded to the remote computer (Se Saint Salvy: paragraph [0041], “the media player device 100 first downloads the metadata 302, then progressively downloads… starting at the beginning of the content, and proceeding to the end in sequential order. This enables the media player device 100 to begin playing the content once a defined amount of data has been downloaded”).
One of ordinary skill in the art before the effective filing date would have found it obvious to include downloading metadata first as taught by De Saint Salvy within the downloading of data for presentation of ECG data as taught by Goil and MacIver with the motivation of “begin playing the content once a defined amount of data has been downloaded” (De Saint Salvy: paragraph [0041]).
Goil, MacIver and De Saint Salvy may not explicitly teach (Underlined below for clarity):
wherein the requests each include a pointer to respective strips of ECG data containing beat classifications indicating ectopic beats, and wherein the dynamic priority protocol prioritizes downloading the respective strips of the ECG data associated with the beat classifications indicating ectopic beats based on the pointer to the respective strips of ECG data.
Finkelmeier teaches wherein the requests each include a pointer to respective strips of ECG data containing beat classifications indicating ectopic beats, and wherein the dynamic priority protocol prioritizes downloading the respective strips of the ECG data associated with the beat classifications indicating ectopic beats based on the pointer to the respective strips of ECG data (Finkelmeier: claim 21, “an address index comprising: a strip pointer comprising the strip address and, adjacent thereto, a signifier of an ECG strip; and an AF summary pointer comprising the AF summary address and, adjacent thereto, a signifier of atrial fibrillation”).
One of ordinary skill in the art before the effective filing date would have found it obvious to include using pointers as taught by Finkelmeier within the prioritization of ECG strips as taught by Goil, MacIver and De Saint Salvy with the motivation of “avoids or reduces the need for the relevant strips to actually be presented on the first page 100” (Finkelmeier: paragraph [0038]).
Regarding (Original) claim 2, Goil, MacIver, De Saint Savy and Finkelmeier teach the limitations of claim 1, and further teach wherein the beat classifications indicating ectopic beats are ventricular beats and supraventricular beats (Goil: Figures 1-2, 6, 8-9, paragraph [0035], “Rhythms that do not follow the sequence of events described above are known as arrhythmias… Tachyarrhythmias (aka tachycardias) are further classified as supraventricular tachycardias (SVTs) and ventricular tachycardias (VTs)”, paragraphs [0038]-[0039], “Overall, SVTs are not typically immediately life threatening when compared to ventricular arrhythmias… Ventricular arrhythmias, which originate in the ventricles, include ventricular tachycardia (VT) and ventricular fibrillation (VF). Ventricular arrhythmias are often associated with rapid and/or chaotic ventricular rhythms”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Original) claim 3, Goil, MacIver, De Saint Savy and Finkelmeier teach the limitations of claim 2 and further teach wherein the strips of ECG data containing at least one ventricular beat are prioritized first, wherein the strips of ECG data containing at least one supraventricular beat are prioritized second (Goil: Figures 1-2, 6, 8-9, paragraphs [0038]-[0039], “Overall, SVTs are not typically immediately life threatening when compared to ventricular arrhythmias”, paragraph [0049], “may be implemented to monitor ventricular activity alone, or both ventricular and atrial activity”, paragraph [0093], “assign a ranking score (RS) (aka prioritize) to each of the classified EGM datasets (block 304b) and, based on those ranking scores (RSs), identify (or select) one or more patient database records for which corresponding EGM segment data and/or related information are to be provided”. The Examiner notes the ventricular beats being prioritized first is prima facie obvious under the broadest reasonable interpretation).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Original) claim 4, Goil, MacIver, De Saint Savy and Finkelmeier teach the limitations of claim 1, and further teach wherein the display of the plots of the ECG data includes: display the plots of the ECG data associated with ventricular beats in a first window in the user interface and displaying the plots of the ECG data associated with supraventricular beats in a second window in the user interface (MacIver: Fig. 4, paragraph [0120], “the ECG processing module 140 (FIG. 1) generates a GUI screen 400 … the GUI screen 400 is a composite interface having one sub-screen, window, area or section for each of the various categories of cardiac arrhythmia. In accordance with one embodiment, the screen 400, for example, illustrates a first sub-screen 405 for atrial fibrillation (AF) as a first category of arrhythmias, a second sub-screen 407 for pauses and long R-R intervals as a second category of arrhythmias, a third sub-screen 409 for ventricular tachycardia (VT) and ventricular run (V-run) as a third category of arrhythmias, a fourth sub-screen 411 for supraventricular tachycardia (SVT) and supraventricular run (SV-run) as a fourth category of arrhythmias, a fifth sub-screen 440 for bradycardia as a fifth category of arrhythmias, a sixth sub-screen 442 for V-pattern (including bigeminies and trigeminies) as a sixth category of arrhythmias, a seventh sub-screen 444 for displaying one or more patient-recorded events and an eighth sub-screen 446 for displaying one or more user events As shown, each sub-screen further displays a count of the events detected for the category of arrhythmias associated with the sub-screen and are also populated with ECG waveform segments of the events detected in the category”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Original) claim 6, Goil, MacIver, De Saint Savy and Finkelmeier teach the limitations of claim 1, and further teach display on the user interface a first indicator representing an amount of the ECG data associated with a first beat classification that has been downloaded to the remote computer; and display on the user interface a second indicator representing an amount of the ECG data associated with a second beat classification that has been downloaded to the remote computer (Goil: paragraph [0053], “Markers may be presented as symbols, dashed lines, numeric values, thickened portions of a waveform, and the like. Markers may represent events, intervals, refractory periods, ICM activity, and other algorithm related activity”, paragraph [0078], “including a summary of heart rate data, in order to assist physicians in diagnosis and treatment of patient conditions. By way of example, diagnostic information may include episode diagnostics for auto-trigger/alert events, episode duration, episode count, episode date/time stamp and heart rate histogram data”, paragraph [0090], “EGM segment data and/or related information (such as the aforementioned diagnostic information) are provided for display on a clinician's display device 307 for clinical evaluation. In some embodiments, block 306 may provide diagnostic information 315, including diagnostic information 315 may include episode diagnostics for auto-trigger/alert events, episode duration, episode count, episode date/time stamp and heart rate histogram data”, paragraph [0152], “a display that may be configured to present the various types of the EGM signals/datasets, DD markers, statistics (e.g., % valid, % invalid), diagnostics, recommendations for adjustments”; MacIver: Figure 4, paragraphs [0015]-[0016], “the GUI is adapted to display a count of a total number of automatically detected events… a count of events detected for each of a plurality of arrhythmias, or one or more statistics related to the events detected for each of the plurality of arrhythmias”, paragraphs [0118]-[0120], “As shown, each sub-screen further displays a count of the events detected for the category of arrhythmias associated with the sub-screen and are also populated with ECG waveform segments of the events detected in the category”, paragraph [0123], “The view events icon or button 418 enables the user to review all events detected in a category in situations where there are a large number of detected events (greater than ‘n’) in the category”. Also see, paragraph [0084]).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Original) claim 7, Goil, MacIver, De Saint Savy and Finkelmeier teach the limitations of claim 6, and further teach wherein the ECG data associated with the first beat classification is prioritized for downloading in response to a user selecting the first indicator (MacIver: Figure 4, paragraphs [0015]-[0016], “the GUI is adapted to display a count of a total number of automatically detected events… a count of events detected for each of a plurality of arrhythmias, or one or more statistics related to the events detected for each of the plurality of arrhythmias”, paragraphs [0118]-[0120], “As shown, each sub-screen further displays a count of the events detected for the category of arrhythmias associated with the sub-screen and are also populated with ECG waveform segments of the events detected in the category”, paragraph [0123], “The view events icon or button 418 enables the user to review all events detected in a category in situations where there are a large number of detected events (greater than ‘n’) in the category”. Also see, paragraph [0084]. The Examiner notes by interacting with the button the events are shown, which teaches what is required under the broadest reasonable interpretation).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Original) claim 8, Goil, MacIver, De Saint Savy and Finkelmeier teach the limitations of claim 1, and further teach wherein the dynamic priority protocol includes a set of default rules (Goil: Figures 1-2, 6, 8-9, paragraph [0022], “obtain a set of alert conditions relating to the set of arrhythmic episodes and the patient-specific longitudinal data”, paragraph [0053], “As further nonlimiting examples, basic event markers may include”, paragraph [0076], “a default setting”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Original) claim 9, Goil, MacIver, De Saint Savy and Finkelmeier teach the limitations of claim 8, and further teach wherein the default rules are modified by a user's activity on the user interface (Goil: Figures 1-2, 6, 8-9, paragraph [0016], “facilitating a reprogramming of a set of instructions stored”, paragraphs [0115]-[0116], “A front-end application presents at user interface 600 a query (generated, e.g., by the back-end server system) to a clinician user (block 604), so as to obtain a set of patient-specific parameter settings… obtain a set of alert conditions relating to one or more arrhythmic episodes for the patient-specific longitudinal data (block 604d)”, paragraph [0137], “a user interface presenting input queries that enable a physician/clinical to: (a) set/reset patient device settings; (b) set/reset ML model settings and parameters; (c) select diagnostic information for analysis and/or display (including a time period for the analysis); (d) set/reset display criteria or key episodes); and (e) set/reset alert conditions for a patient”. The user may manually modify the alert conditions, which teaches what is required under the broadest reasonable interpretation).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Currently Amended) claim 10, Goil, MacIver, De Saint Savy and Finkelmeier teach the limitations of claim 1, and further teach wherein the first set of instructions are part of a package of data received from the server (Goil: Figures 1-2, 6, 8-9, paragraph [0016], “facilitating a reprogramming of a set of instructions stored”, paragraph [0022], “obtain… a set of patient-specific parameter settings… the set of patient-specific parameters settings includes a configurable time period used to generate the set of diagnostic information”, paragraph [0166]-[0169], “receiving, sending, or storing instructions and/or data implemented in accordance with the foregoing description”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Original) claim 11, Goil, MacIver, De Saint Savy and Finkelmeier teach the limitations of claim 10, and further teach wherein the first set of instructions are executed by a web browser at the remote computing system (Goil: Figures 1-2, 6, 8-9, paragraph [0166]-[0168], “utilizing a web server, the web server can run any of a variety of server or mid-tier applications… The server(s) also may be capable of executing programs or scripts in response to requests from user devices, such as by executing one or more web applications”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Currently Amended) claim 13, Goil, MacIver and Finkelmeier teach the limitations of claim 1, and further teach wherein the strips of ECG data are 5- to 10-minute-long strips (Goil: Figures 1-2, 6, 8-9, paragraph [0074], “EGM segment data (e.g., pre-event storage of 1-15 minutes and post-event storage of 1-15 minutes)”; MacIver: paragraphs [0047]-[0049], “the predetermined time window ranges between 1 to 20 minutes before and/or between 1 to 10 minutes after the at least one patient-recorded event… the predetermined time window is at least 3 minutes before and at least 3 minutes after the at least one patient-recorded event”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Original) claim 14, Goil, MacIver, De Saint Savy and Finkelmeier teach the limitations of claim 1, and further teach wherein: the server comprises: a database and a second computer-readable medium having a second set of computer-executable instructions configured to be executed (Goil: Figures 1-2, 6, 8-9, paragraph [0018], “the server system may include one or more server processors, a database, a server memory, and a network interface… server system may be cloud-based”, paragraph [0020], “the system is more specifically configured to: (a) receive, from a remote device… a display device in communication with the system”, paragraph [0029], “a clinician's user interface to a system”, paragraphs [0112]-[0115], “an example user interface 600 to or of a system… A front-end application presents at user interface 600 a query (generated, e.g., by the back-end server system) to a clinician user”, paragraphs [0124]-[0125], “Any of the processor-based components in FIG. 8 (e.g., workstation 810, cell phone 814, local monitoring device 816, server 802, and programmer 806) may perform one or more processes or steps discussed herein… the server system also includes one or more server processors 802c configured to execute the first, second and third sets of instructions”. Also see, paragraphs [0067], [0138], [0152]) to cause the server to:
in response to the requests, retrieve the ECG data from the database and transmit the strips of the ECG data to the remote computing system (Goil: Figures 1-2, 6, 8-9, paragraph [0055], “accessing memory of… external device or remote server where the EGM data, signals, information, etc. are stored, ii) receiving the data, signals, information, etc. over a wireless communication link between the ICM or other type of IMD and a local external device, iii) receiving the data, signals, information, etc. at a remote server over a network connection”).
The motivation to combine is the same as in claim 1, incorporated herein.
REGARDING CLAIM(S) 15-18
Claim(s) 15-18 is/are analogous to Claim(s) 1-4, thus Claim(s) 15-18 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 1-4.
Regarding (Currently Amended) claim 20, Goil, MacIver, De Saint Savy and Finkelmeier teach the limitations of claim 15, and further teach wherein the dynamic priority protocol includes a set of default rules (Goil: Figures 1-2, 6, 8-9, paragraph [0022], “obtain a set of alert conditions relating to the set of arrhythmic episodes and the patient-specific longitudinal data”, paragraph [0053], “As further nonlimiting examples, basic event markers may include”, paragraph [0076], “a default setting”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (New) claim 21, Goil, MacIver, De Saint Savy and Finkelmeier teach the limitations of claim 20 and further teaches wherein the default rules are modified by a user's activity on the user interface (Goil: Figures 1-2, 6, 8-9, paragraph [0016], “facilitating a reprogramming of a set of instructions stored”, paragraphs [0115]-[0116], “A front-end application presents at user interface 600 a query (generated, e.g., by the back-end server system) to a clinician user (block 604), so as to obtain a set of patient-specific parameter settings… obtain a set of alert conditions relating to one or more arrhythmic episodes for the patient-specific longitudinal data (block 604d)”, paragraph [0137], “a user interface presenting input queries that enable a physician/clinical to: (a) set/reset patient device settings; (b) set/reset ML model settings and parameters; (c) select diagnostic information for analysis and/or display (including a time period for the analysis); (d) set/reset display criteria or key episodes); and (e) set/reset alert conditions for a patient”. The user may manually modify the alert conditions, which teaches what is required under the broadest reasonable interpretation).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (New) claim 22, Goil, MacIver, De Saint Savy and Finkelmeier teach the limitations of claim 15 and further teaches wherein the strips of ECG data are 5- to 10-minute-long strips (Goil: Figures 1-2, 6, 8-9, paragraph [0074], “EGM segment data (e.g., pre-event storage of 1-15 minutes and post-event storage of 1-15 minutes)”; MacIver: paragraphs [0047]-[0049], “the predetermined time window ranges between 1 to 20 minutes before and/or between 1 to 10 minutes after the at least one patient-recorded event… the predetermined time window is at least 3 minutes before and at least 3 minutes after the at least one patient-recorded event”).
The motivation to combine is the same as in claim 1, incorporated herein.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 20240065637 (hereafter “Goil”), U.S. Patent Pub. No. 20210401316 (hereafter “MacIver”), U.S. Patent Pub. No. 20160080685 (hereafter “De Saint Salvy”) and .S. Patent Pub. No. 20210280283 (hereafter “Finkelmeier”) as applied to claim 1 above, and further in view of U.S. Patent Pub. No. 20160292373 (hereafter “Spors”).
Regarding (Original) claim 5, Goil, MacIver, De Saint Savy and Finkelmeier teach the limitations of claim 1, but may not explicitly teach wherein the dynamic priority protocol is modified in response to detecting that a user is scrolling through sections of the user interface associated with ECG data that has not been downloaded.
Spors teaches wherein the dynamic priority protocol is modified in response to detecting that a user is scrolling through sections of the user interface associated with ECG data that has not been downloaded (Spors: paragraph [0050], “the care provider can use an ECG graph 608 in window 606 to determine whether the patient has an irregular heart rhythm. In some embodiments, graph 608 may include a selector bar that permits the care provider to scroll the graph 608 to see different time periods rather than the one shown when GUI 600 is first displayed. For example, the time period for graph 608 may be the previous two minutes of heart activity for the patient. To confirm that the heart activity is irregular, the care provider may increase the time range of the graph 608, assuming the data was already sent to the workflow server from the sensor devices. If not, the event manager may transmit a request to the sensor devices to send the additional heart activity”).
One of ordinary skill in the art before the effective filing date would have found it obvious to include using a dynamic protocol for downloading missing data as taught by Spors with the ECG data prioritization as taught by Goil, MacIver, De Saint Savy and Finkelmeier with the motivation of “improve patient care” (Spors: paragraph [0017]).
Response to Arguments
Applicant's arguments filed 29 December 2025 have been fully considered but they are not fully persuasive. Applicants’ arguments will be addressed herein below in the order in which they appear in the response filed on 29 December 2025.
Rejections under 35 U.S.C. § 112
In view of the amendments to claim 10, the antecedent basis rejection has been removed.
Rejections under 35 U.S.C. § 101
Regarding the rejection of claims 1-20, the Examiner has considered the Applicant’s arguments but does not find them persuasive. Any arguments inadvertently not addressed are unpersuasive for at least the following reasons:
Applicant argues:
Without conceding the propriety of this rejection, Applicant has amended the claims in view of the Examiner's comments. Applicant respectfully submits that claims now even more fully satisfy the requirements of 35 U.S.C. § 101.
The Examiner respectfully disagrees.
It is respectfully submitted, Applicant has not argued any portions of their specification for recitations of technical problems rooted in computer hardware technology, as currently drafted the claims amount to collection, organization and output of data in the form of a report for a human user to interact with which as stated in 2106.04(a)(2), “certain activity between a person and a computer… may fall within the “certain methods of organizing human activity” grouping”. The claims are directed toward organizing data between a human user using various generic computer components and is directed toward the certain method of organizing human activity grouping of abstract ideas.
Rejections under 35 U.S.C. § 103
23. Regarding the rejections of claims 1-20, the Examiner has considered the applicant’s arguments; however, the arguments are not persuasive as addressed herein. The Examiner has attempted to address all of the arguments presented by the Applicant; however, any arguments inadvertently not addressed are not persuasive for at least the following reasons:
Applicant argues:
However, Applicant respectfully submits that Goil, Maciver, Finkelmeier, and De Saint Salvy, whether taken individually or in combination, fail to disclose or render obvious at least "wherein the metadata with the beat classifications are downloaded to the remote computer before the ECG data is downloaded to the remote computer, wherein the requests each include a pointer to respective strips of ECG data containing beat classifications indicating ectopic beats, and wherein the dynamic priority protocol prioritizes downloading the respective strips of the ECG data associated with the beat classifications indicating ectopic beats based on the pointer to the respective strips of ECG data," as recited in claim 1. The other art of record fails to cure these deficiencies.
The Examiner respectfully disagrees.
It is respectfully submitted, the amended and argued limitation is taught by the combination of De Saint Savy and Finkelmeier within the teachings of Goil and MacIver, respectively. In particular, Goil explicitly analysis of EGM and metadata to modify classifications via user entry into a user interface (see above but at least paragraphs [0004]-[0007], [0015] and [0137]) and further formats this information into a summary for a human user (see above but at least [0078]), although not explicitly recited as using ECG data and outputting a report, MacIver explicitly teaches use of EGC data for classification into a report (see above but at least paragraphs [0006]-[0008], [0016]), and further De Saint Salvy teaches downloading of metadata first (see above but at least paragraph [0041]) and Finkelmeier teaches use of a pointer (see above but at least claim 21) therefore it is the combination that teaches the amended limitations and would be prima facie obvious to include with the motivation of "avoids or reduces the need for the relevant strips to actually be presented on the first page" (Finkelmeier: paragraph [0038]) and "begin playing the content once a defined amount of data has been downloaded" (De Saint Salvy: paragraph [0041]).
In addition, the Examiner respectfully notes that the cited reference was never applied as a reference under 35 U.S.C. 102 against the pending claims. As such, the Examiner respectfully submits that the issue at hand is not whether the applied prior art specifically teaches the claimed features, per se, but rather, whether or not the prior art, when taken in combination with the knowledge of average skill in the art, would put the artisan in possession of these features. Regarding this issue, it is well established that references are evaluated by what they suggest to one versed in the art, rather than by their specific disclosures, In re Bozek, 163 USPQ 545 (CCPA 1969). The issue of obviousness is not determined by what the references expressly state but by what they would reasonably suggest to one of ordinary skill in the art, as supported by decisions in In re DeLisle 406 Fed 1326, 160 USPQ 806; In re Kell, Terry and Davies 208 USPQ 871; and In re Fine, 837 F.2d 1071, 1074, 5 USPQ 2d 1596, 1598 (Fed. Cir. 1988) (citing In re Lalu, 747 F.2d 703, 705, 223 USPQ 1257, 1258 (Fed. Cir. 1988)). Further, it was determined in In re Lamberti et al, 192 USPQ 278 (CCPA) that:
(i) obviousness does not require absolute predictability;
(ii) non-preferred embodiments of prior art must also be considered; and
(iii) the question is not express teaching of references, but what they would suggest.
According to In re Jacoby, 135 USPQ 317 (CCPA 1962), the skilled artisan is presumed to know something more about the art than only what is disclosed in the applied references. In In re Bode, 193 USPQ 12 (CCPA 1977), every reference relies to some extent on knowledge of persons skilled in the art to complement that which is disclosed therein.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/A.E.L./Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684
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