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 .
Status of the Application
Claims 1-20 are currently pending in this case and have been examined and addressed below. This communication is a Final Rejection in response to the Amendments to the Claims and Remarks filed on 09/25/2025.
Claim 20 is currently amended.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/12/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 a judicial exception (i.e., an abstract idea) without significantly more.
Step 1: Claims 1-14 and 19-20 are drawn to a machine. Claims 15-18 is drawn to a process. As such, claims 1-20 are drawn to one of the statutory categories of invention (Step 1: YES).
Step 2A - Prong One: In prong one of step 2A, the claim(s) is/are analyzed to evaluate whether it/they recite(s) a judicial exception.
Independent Claim 1: A medical device for a patient, the medical device comprising:
a computing system configured to generate time series data for the patient;
a display device configured to display the time series data generated by the computing system;
an annotation module executable by the computing system and configured to receive an annotation input, wherein the annotation input includes an event time, wherein the annotation module is configured to time-associate the event time with the time series data and to display a time-based annotation at the event time along with the time series data, and wherein the annotation input is provided as at least one of a user input and an automated trigger;
and a memory system configured to store the time series data generated by the computing system and the time-based annotation for subsequent display on the display device.
Independent Claim 15: A method for providing annotations to time series data for a patient from a medical device, the method comprising:
configuring a computing system to generate the time series data for the patient;
configuring a display device to display the time series data generated by the computing system;
providing an annotation module executable by the computing system and configuring the annotation module to receive an annotation input, wherein the annotation input includes an event time, wherein the annotation module is configured to time-associate the event time with the time series data and to display a time-based annotation at the event time along with the time series data, and wherein the annotation input is provided as at least one of a user input and an automated trigger;
and configuring the time series data generated by the computing system and the time-based annotation to be stored in a memory system for subsequent display on the display device.
Independent Claim 20: A bedside monitor for a patient, the bedside monitor comprising:
a computing system configured to generate time series data for the patient;
a display device configured to display the time series data generated by the computing system, wherein the time series data includes a waveform of physiological data for the patient;
an annotation module executable by the computing system and configured to receive an annotation input, wherein the annotation input includes an event time, wherein the annotation module is configured to time-associate the event time with the time series data and to display a time-based annotation at the event time along with the time series data, and wherein the annotation input is provided as at least one of a user input and an automated trigger;
and a memory system configured to store the time series data generated by the computing system and the time-based annotation for subsequent display on the display device;
wherein the annotation input is provided as at least one of free text entry, a selection from a predefined list of interventions, and an automated trigger, wherein the automated trigger is provided when the annotation module identifies group alarm conditions within the time series data that satisfy trigger criteria saved in the memory module;
and wherein the time-based annotation is classified into a group selectable for display on the display device.
(Examiner notes: The above claim terms underlined are additional elements that fall under Step 2A - Prong Two analysis section detailed below)
These steps amount to methods of organizing human activity which includes functions relating to interpersonal and intrapersonal activities, such as managing relationships or transactions between people, social activities, and human behavior; satisfying or avoiding a legal obligation; advertising, marketing, and sales activities or behaviors; and managing human mental activity (MPEP § 2106.04(a)(2)(II)(C) citing the abstract idea grouping for methods of organizing human activity for managing personal behavior or relationships or interactions between people). Therefore, generate time series data, receive annotation input, and time-associate the event time with the time series data are directed to managing personal interactions or personal behavior.
The dependent claim 2 is directed to the time series data and time-based annotation are displayed as one or more waveforms.
The dependent claim 3 is directed to the annotation input selected from a predefined list of interventions.
The dependent claim 4 is directed to the predetermined list of interventions is limited based on at least on a user-selected procedure.
The dependent claim 5 is directed to the predefined list of interventions classified into groups and the predefined list of interventions based on a selection among the groups for display.
The dependent claim 6 is directed to the displayed time-based annotation is selectable to display additional information corresponding to the annotation input.
The dependent claim 7 is directed to output the time series data and the time-based annotation to a remote electronic medical record.
The dependent claim 8 is directed to the time-based annotation is among a plurality of time-based annotations and generate a list of the plurality of time-based annotations separate from the associated time series data.
The dependent claim 9 is directed to selecting one of the plurality of time-based annotations to display the one of the plurality of time-based annotations along with the associated time series data.
The dependent claim 10 is directed to identify group alarm conditions within the time series data, trigger criteria for determining whether the group alarm conditions are satisfied, and the annotation input is automatically provided as the automated trigger when the trigger criteria is satisfied.
The dependent claim 11 is directed to satisfying the trigger criteria requires at least two individual conditions to be satisfied.
The dependent claim 12 is directed to the trigger criteria is user-defined and at least one of the at least two individual conditions relates to physiological data.
The dependent claim 13 is directed to the annotation input is among a plurality of annotation inputs provided by user input and automated trigger, the user input indicates an intervention in response to the automated trigger, determine a delay between the event times of the user input and the automated trigger, and output the delay.
The dependent claim 14 is directed to the automated trigger is among a plurality of automated triggers corresponding to a plurality of time-based annotations, indicate a total of the plurality of automated triggers corresponding to each of the group alarm conditions.
The dependent claim 16 is directed to the time series data and the time-based annotation are displayed as a waveform and receive the annotation input as at least one of free text entry and a selection from a predefined list of interventions.
The dependent claim 17 is directed to the predefined list of interventions is classified into groups and the predefined list of interventions available for selection is limited based on a selection among the groups.
The dependent claim 18 is directed to identify group alarm conditions within the time series data, trigger criteria for determining whether the group alarm conditions are satisfied, and the annotation input is automatically provided as the automated trigger when the group alarm conditions are satisfied.
The dependent claim 19 is directed to the trigger criteria user-defined and at least one of the at least two individual conditions relates to physiological data for the patient.
Each of these steps of the preceding dependent claims 2-14 and 16-19 only serve to further limit or specify the features of independent claims 1, 15, and 20 accordingly, and hence are nonetheless directed towards fundamentally the same abstract idea as the independent claim and utilize the additional elements analyzed below in the expected manner.
As such, the Examiner concludes that the preceding claims recite an abstract idea (Step 2A – Prong One: YES).
Step 2A - Prong Two: In prong two of step 2A, an evaluation is made whether a claim recites any additional element, or combination of additional elements, that integrate the exception into a practical application of that exception. An “additional element” is an element that is recited in the claim in addition to (beyond) the judicial exception (i.e., an element/limitation that sets forth an abstract idea is not an additional element). The phrase “integration into a practical application” is defined as requiring an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
Claims 1, 3, 7, and 15 recite the use of a medical device, in this case to user-selected procedure determines the predetermined list of interventions, only recites the medical device as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2).
Claims 1, 7, 8, 9, 10, 13, 14, 15, 18, and 20 recite the use of a computing system, in this case to generate time series data, output the time series data and the time-based annotation to an electronic medical record, generate a list of the plurality of time-based annotations separate from the time series data, select one of the plurality of time-based annotations, identify group alarm conditions within the time series data, determined a delay between the event times of the user input and the automated trigger, output the delay, indicate a total of the plurality of automated triggers corresponding to each of the group alarm conditions, only recites the computing system as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2).
Claims 1, 2, 5, 9, 15, 16, and 20 recite the use of a display device configured to display the time series data generated by the computing system, in this case to display the time series data, time-based annotation, one of the plurality of time-based annotations along with the associated time series data, a time-based annotation at the event time along with the time series data, only recites the display device as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2).
Claims 1, 10, 15, 16, 18, and 20 recite the use of an annotation module, in this case to receive an annotation input, time-associate the event time with the time series data, uses trigger criteria for determining whether the group alarm conditions are satisfied, only recites the annotation module as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2).
Claims 1, 15, and 20 recite the use of a memory system configured to store the time series data generated by the computing system and the time-based annotation for subsequent display on the display device, only as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2).
Claim 4 recites the use of a model of the medical device, in this case to determine the predetermined list of interventions, only recites the model of the medical device as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2).
Claim 13 recites the use of an external device, in this case to receive the delay between the event times of the user input and the automated trigger, only recites the external device as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2).
The Examiner has therefore determined that the additional elements, or combination of additional elements, do not integrate the abstract idea into a practical application. Accordingly, the claim(s) is/are directed to an abstract idea (Step 2A – Prong two: NO).
Step 2B: In step 2B, the claims are analyzed to determine whether any additional element, or combination of additional elements, is/are sufficient to ensure that the claims amount to significantly more than the judicial exception.
As discussed above in “Step 2A – Prong 2”, the identified additional elements, such as the medical device, computing system, display device configured to display the time series data generated by the computing system, annotation module, memory system configured to store the time series data generated by the computing system and the time-based annotation for subsequent display on the display device, model of the medical device, external device, and bedside monitor in independent claims 1, 15, and 20 and dependent claims 2-14 and 16-19 are equivalent to adding the words “apply it” on a generic computer. Each of these elements is only recited as a tool for performing steps of the abstract idea, such as the use of the computer and data processing devices to apply the algorithm. These additional elements therefore only amount to mere instructions to perform the abstract idea using a computer and are not sufficient to amount to significantly more than the abstract idea (MPEP 2016.05(f) see for additional guidance on the “mere instructions to apply an exception”). Each additional element under Step 2A, Prong 2 is analyzed in light of the specification’s explanation of the additional element’s structure. The claimed invention’s additional elements are directed to generic computer component and functions being used to perform the abstract idea.
This conclusion is based on a factual determination. Applicant’s own disclosure in paragraphs [0033] and [0040] acknowledges that the “a patient monitoring device as the medical device (e.g., GE Healthcare's ®B1x5 M/P patient monitoring device)…and… a medical device 20, such as GE Healthcare's ®B1x5 M/P patient monitoring device…The medical device 20 includes a computing system CS100, which controls operation of the medical device 20…The medical device 20 shown here further includes a display device 22 that serves as a graphical user interface (for example, a touch-screen GUTI24)”. Paragraph [0041] discloses “the medical device 20 is part of a greater system 10, which includes a central computing system 30 operatively connected to the medical device 20”. Additionally, paragraph [0045] acknowledges that the “control system CS 100 may be a computing system that includes a processing system CS 110, memory system CS120, and input/output (I/0) system CS130 for communicating with other devices, such as input devices CS99 (e.g., sensors and other devices connected to the medical device 20) and output devices CS101 (e.g., the central computing system 30,remote computing system 32, an Electronic Medical Record (EMR 50, see FIG. 3), and/or other external devices (e.g., additional external devices 52 of FIG. 3, such as smart phones or tablets), which may also or alternatively be stored in a cloud CS102)”. The disclosure also acknowledges in paragraph [0047] that the “memory system CS120 may comprise any storage media readable by the processing system CS 110 and capable of storing the executable program CS 122 and/or data CS124. The memory system CS120 may be implemented as a single storage device, or be distributed across multiple storage devices or sub-systems that cooperate to store computer readable instructions, data structures, program modules, or other data. The memory system CS120 may include volatile and/or non-volatile systems, and may include removable and/or non- removable media implemented in any method or technology for storage of information. The storage media may include non-transitory and/or transitory storage media, including random access memory, read only memory, magnetic discs, optical discs, flash memory, virtual memory, and non-virtual memory, magnetic storage devices, or any other medium which can be used to store information and be accessed by an instruction execution system, for example”. Paragraph [0048] discloses the “annotation module 40 may be stored within the memory system CS120 of the medical device 20 and may be comprised of hardware and/or software executable by the processing system CS110." Furthermore, paragraph [0049] acknowledges the “medical device data element 42 accesses and/or stores the time-series data (TSD) from the medical device 20, the make and model of the medical device 20 providing the TSD, settings thereof (including a selected procedure for which the medical device 20 is being used, which may include neonatal monitoring, for example)".
The Examiner has therefore determined that no additional element, or combination of additional claims elements is/are sufficient to ensure the claim(s) amount to significantly more than the abstract idea identified above (Step 2B: NO).
Therefore, claims 1-20 are not eligible subject matter under 35 USC 101.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-9 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Stuebe et al. (US 20130245463 A1)[hereinafter Stuebe], in view of Kelly et al. (US 20200357493 A1)[hereinafter Kelly].
As per Claim 1, Stuebe discloses a medical device for a patient in paragraph [0008] (a patient monitoring system (synonymous to a medical device for a patient)), the medical device comprising: a computing system configured to generate time series data for the patient in paragraphs [0020-0021] and [0024] and [0029] (a computing system to generate physiological signals (synonymous to time series data) of a patient, wherein the signals are physiological measurements measured as a function of time); a display device configured to display the time series data generated by the computing system in paragraphs [0020-0021] (a user interface (synonymous to a display device), wherein the user interface includes a user display, to display physiological signals generated by the system); and wherein the annotation input is provided as at least one of a user input and an automated trigger in paragraphs [0020] and [0033-0034] (the annotation input is provided by user input and an alarm (synonymous to an automated trigger)); and a memory system configured to store the time series data generated by the computing system and the time-based annotation for subsequent display on the display device in paragraphs [0023] and [0027-0028] and [0032-0033] (a memory or database to store physiological signals generated by the computing system and the time-based annotation for display on the user display).
Stuebe discloses receiving an annotation input, but does not disclose an annotation module. However, Kelly discloses an annotation module executable by the computing system and configured to receive an annotation input in paragraphs [0023-0024] and [0027] and [0043] (a physiological waveform module (synonymous to an annotation module) executable by the computing system and to receive an annotation input), wherein the annotation input includes an event time in paragraphs [0035] and [0043] and Figure 6 (the annotation input includes an event time), wherein the annotation module is configured to time-associate the event time with the time series data and to display a time-based annotation at the event time along with the time series data in paragraphs [0027-0029] and [0039] and [0043] (the physiological waveform module associates the event time, wherein the event time is the duration of the event, with the waveforms or data (synonymous to the time series data) through the event time line component, wherein the waveforms are signals corresponding to measurements associated with a patient, and to display the time-based annotation at the start and end times of the waveform displays (synonymous to display a time-based annotation at the event time along with the time series data) (Examiner notes that the event time line component is a component in the physiological waveform module that associates the duration with the waveforms)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a medical device including a computing system, display device, and a memory system to annotate time series data, as disclosed by Stuebe, to be combined with an annotation module to receive an input including an event time, time-associate the event time with the time series data, and display a time-based annotation at the event time along with the time series data, as disclosed by Kelly, for the purpose of efficiently reviewing physiological waveform data [0002].
As per Claim 2, Stuebe and Kelly disclose the medical device according to claim 1, Stuebe also discloses wherein the time series data is displayed on the display device as one or more waveforms in paragraphs [0020] (the physiological signals are displayed on the user display as waveforms), and wherein the time-based annotation is displayed on the display device as an overlay to the one or more waveforms in paragraphs [0020] and [0030] and [0032-0033] and Figure 2 (the time-based annotation is displayed on the user display as an overlay to the waveform).
As per Claim 3, Stuebe and Kelly disclose the medical device according to claim 1.
Stuebe does not disclose the following limitations. However, Kelly discloses wherein the annotation input is selected from a predefined list of interventions in paragraphs [0045-0046] (the annotation input is selected from a predefined list of types of events (synonymous to a predefined list of interventions) (Examiner notes that the predefined list of types of events includes events that intervenes with signals of a normal cardiac rhythm)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a medical device including a computing system, display device, and a memory system to annotate time series data, as disclosed by Stuebe, to be combined with the annotation input is selected from a predefined list of interventions, as disclosed by Kelly, for the purpose of efficiently reviewing physiological waveform data [0002].
As per Claim 4, Stuebe and Kelly disclose the medical device according to claim 3.
Stuebe does not disclose the following limitations. However, Kelly discloses wherein the predetermined list of interventions is limited based on at least one of a model of the medical device and on a user-selected procedure for using the medical device in paragraphs [0045-0046] (the predefined list of types of events is limited based on the type of device used to measure the physiological data (synonymous to a model of the medical device) (Examiner notes that the model of the medical device meets the limitation of "at least one of")).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a medical device including a computing system, display device, and a memory system to annotate time series data, as disclosed by Stuebe, to be combined with the predetermined list interventions is limited based on at least one of a model of the medical device and on a user-selected procedure for using the medical device, as disclosed by Kelly, for the purpose of efficiently reviewing physiological waveform data [0002].
As per Claim 5, Stuebe and Kelly disclose the medical device according to claim 4.
Stuebe does not disclose the following limitations. However, Kelly discloses wherein the predefined list of interventions is classified into groups, and wherein the predefined list of interventions is based on a selection among the groups for display in paragraphs [0045-0046] (the predefined list of types of events is classified into cardiac rhythm event types or other event types, wherein the predefined list of event types is based on the selection of cardiac rhythm event types or other event types for display (Examiner notes that the cardiac rhythm event types and other event types are considered as groups of event types)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a medical device including a computing system, display device, and a memory system to annotate time series data, as disclosed by Stuebe, to be combined with the predefined list of interventions is classified into groups, as disclosed by Kelly, for the purpose of efficiently reviewing physiological waveform data [0002].
As per Claim 6, Stuebe and Kelly disclose the medical device according to claim 1.
Stuebe does not disclose the following limitations. However, Kelly discloses wherein the time-based annotation displayed on the display device is selectable to display additional information corresponding to the annotation input in paragraph [0047] and Figure 13 (the time-based annotation displayed on a display device is optional to display a comment (synonymous to additional information) corresponding to the annotation input).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a medical device including a computing system, display device, and a memory system to annotate time series data, as disclosed by Stuebe, to be combined with the time-based annotation displayed, as disclosed by Kelly, for the purpose of efficiently reviewing physiological waveform data [0002].
As per Claim 7, Stuebe and Kelly disclose the medical device according to claim 1.
Stuebe does not disclose the following limitations. However, Kelly discloses wherein the computing system is further configured to output the time series data and the time-based annotation to an electronic medical record remote from the medical device in paragraphs [0055-0056] (save the waveform and the time-based annotation to an electronic medical record remote from the medical device (Examiner notes that saving the waveform and time-based annotation to an electronic medical record is synonymous to outputting the time series data and time-based annotation to an electronic medical record)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a medical device including a computing system, display device, and a memory system to annotate time series data, as disclosed by Stuebe, to be combined with outputting the time series data and the time-based annotation to an electronic medical record, as disclosed by Kelly, for the purpose of efficiently reviewing physiological waveform data [0002].
As per Claim 8, Stuebe and Kelly disclose the medical device according to claim 1.
Stuebe does not disclose the following limitations. However, Kelly discloses wherein the time-based annotation is among a plurality of time-based annotations, and wherein the computing system is further configured to generate a list of the plurality of time-based annotations separate from the time series data in paragraphs [0050-0051] and Figure 17 (the time-based annotation is among of plurality of time-based annotations, wherein the computing system generates a list of the plurality of time-based annotations separate from the waveforms).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a medical device including a computing system, display device, and a memory system to annotate time series data, as disclosed by Stuebe, to be combined with the time-based annotation being amongst a plurality of time-based annotations and generate a list of the plurality of time-based annotations separate from the time series data, as disclosed by Kelly, for the purpose of efficiently reviewing physiological waveform data [0002].
As per Claim 9, Stuebe and Kelly disclose the medical device according to claim 8.
Stuebe does not disclose the following limitations. However, Kelly discloses wherein the computing system is further configured such that selecting one of the plurality of time-based annotations causes the display device to display the one of the plurality of time-based annotations along with the time series data associated therewith in paragraphs [0050-0051] and Figure 17 (select one of the plurality of time-based annotations will display the time-based annotation along with the associated waveforms).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a medical device including a computing system, display device, and a memory system to annotate time series data, as disclosed by Stuebe, to be combined with selecting a time-base annotation to be displayed along with the time series data, as disclosed by Kelly, for the purpose of efficiently reviewing physiological waveform data [0002].
As per Claim 15, Stuebe discloses a method for providing annotations to time series data for a patient from a medical device in paragraphs [0029] and [0039] (a method of providing annotations to physiological signals (synonymous to time series data) for a patient from an electronic fetal monitoring machine (synonymous to a medical device), wherein the signals are physiological measurements measured as a function of time), the method comprising: configuring a computing system to generate the time series data for the patient in paragraphs [0020-0021] and [0024] (a computing system to generate physiological signals (synonymous to time series data) of a patient); configuring a display device to display the time series data generated by the computing system in paragraphs [0020-0021] (a user interface (synonymous to a display device), wherein the user interface includes a user display, to display physiological signals generated by the system); and wherein the annotation input is provided as at least one of a user input and an automated trigger in paragraphs [0020] and [0033-0034] (the annotation input is provided by user input and an alarm (synonymous to an automated trigger)); and configuring the time series data generated by the computing system and the time- based annotation to be stored in a memory system for subsequent display on the display device in paragraphs [0023] and [0027-0028] and [0032-0033] (the physiological signals generated by the computing system and the time-based annotation stored in a memory or database for display on the user display).
Stuebe discloses receiving an annotation input, but does not disclose an annotation module. However, Kelly discloses providing an annotation module executable by the computing system and configuring the annotation module to receive an annotation input in paragraphs [0023-0024] and [0027] and [0043] (a physiological waveform module (synonymous to an annotation module) executable by the computing system and to receive an annotation input), wherein the annotation input includes an event time in paragraphs [0035] and [0043] and Figure 6 (the annotation input includes an event time), wherein the annotation module is configured to time-associate the event time with the time series data and to display a time-based annotation at the event time along with the time series data in paragraphs [0027-0029] and [0039] and [0043] (the physiological waveform module associates the event time, wherein the event time is the duration of the event, with the waveforms or data (synonymous to the time series data) through the event time line component, wherein the waveforms are signals corresponding to measurements associated with a patient, and to display the time-based annotation at the start and end times of the waveform displays (synonymous to display a time-based annotation at the event time along with the time series data) (Examiner notes that the event time line component is a component in the physiological waveform module that associates the duration with the waveforms)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a method providing annotations to time series data for a patient from a medical device, as disclosed by Stuebe, to be combined with an annotation module to receive an input including an event time, time-associate the event time with the time series data, and display a time-based annotation at the event time along with the time series data, as disclosed by Kelly, for the purpose of efficiently reviewing physiological waveform data [0002].
As per Claim 16, Stuebe and Kelly disclose the method according to claim 15, Stuebe also discloses wherein the time series data is displayed on the display device as a waveform in paragraphs [0020] (the physiological signals are displayed on the user display as waveforms), wherein the time-based annotation is displayed on the display device as an overlay to the waveform in paragraphs [0020] and [0030] and [0032-0033] and Figure 2 (the time-based annotation is displayed on the user display as an overlay to the waveform).
Stuebe does not disclose the following limitations. However, Kelly discloses and wherein the annotation module is configured to receive the annotation input as at least one of free text entry and a selection from a predefined list of interventions in paragraphs [0043] and [0045-0046] Figure 13 (the physiological waveform module receive the annotation input as a dialog box (synonymous to a free text entry) and the predefined list of types of events (synonymous to a predefined list of interventions) (Examiner notes that the predefined list of types of events includes events that intervenes with signals of a normal cardiac rhythm)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a method providing annotations to time series data for a patient from a medical device, as disclosed by Stuebe, to be combined with the annotation input as at least one of free text entry and a selection from a predefined list of interventions, as disclosed by Kelly, for the purpose of efficiently reviewing physiological waveform data [0002].
As per Claim 17, Stuebe and Kelly disclose the method according to claim 16.
Stuebe does not disclose the following limitation. However, Kelly discloses wherein the predefined list of interventions is classified into groups, and wherein the predefined list of interventions available for selection is limited based on a selection among the groups in paragraphs [0045-0046] (the predefined list of types of events is classified into cardiac rhythm event types or other event types, wherein the predefined list of event types is based on the selection of cardiac rhythm event types or other event types for display (Examiner notes that the cardiac rhythm event types and other event types are considered as groups of event types)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a method providing annotations to time series data for a patient from a medical device, as disclosed by Stuebe, to be combined with the predefined list of interventions is classified into groups, as disclosed by Kelly, for the purpose of efficiently reviewing physiological waveform data [0002].
Claims 10, 14, 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Stuebe et al. (US 20130245463 A1)[hereinafter Stuebe], in view of Kelly et al. (US 20200357493 A1)[hereinafter Kelly], in view of Rusin et al. (US 9830801 B2)[hereinafter Rusin].
As per Claim 10, Stuebe and Kelly disclose the medical device according to claim 1.
Stuebe and Kelly do not disclose the following limitations. However, Rusin discloses wherein the computing system is configured to identify group alarm conditions within the time series data in column 2 lines 36-46 and column 6 lines 5-21 and column 10 lines 32-60 and column 13 lines 42-67 (matches the conditions of the alarm (synonymous to the group alarm conditions) with an alarm rule based on the physiological data (synonymous to time series data) (Examiner notes that matching the conditions of the alarm indicates that the alarm conditions were identified)), wherein the annotation module includes trigger criteria for determining whether the group alarm conditions are satisfied in column 11 lines 13-35 and column 12 lines 40-62 and column 13 lines 42-67 and Figure 6 (alarm criticality discernment tool of rules, wherein the tool includes alarm rules (synonymous to trigger criteria) determine whether alarm thresholds are satisfied, wherein the thresholds are the conditions of the alarm), and wherein the annotation input is automatically provided as the automated trigger when the trigger criteria is satisfied in column 3 lines 3-14 and column 4 lines 5-6 and column 10 lines 46-60 and column 11 lines 13-35 and column 12 lines 40-62 and column 13 lines 42-67 (a timestamp (synonymous to an annotation input) is automatically provided as the alarm (synonymous to the automated trigger) when the alarm rules are matched (synonymous to the trigger criteria is satisfied)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a medical device including a computing system, display device, a memory system, and an annotation module to annotate time series data, as disclosed by Stuebe and Kelly, to be combined with identifying alarm conditions, determining whether the alarm conditions are satisfied using trigger criteria, and automatically providing the annotation input as the automated trigger when the trigger criteria is satisfied, as disclosed by Rusin, for the purpose of improving alarm management in an hospital setting [column 1 lines 5-33].
As per Claim 14, Stuebe and Kelly disclose the medical device according to claim 10.
Stuebe and Kelly do not disclose the following limitations. However, Rusin discloses wherein the automated trigger is among a plurality of automated triggers corresponding to a plurality of time-based annotations in column 3 lines 3-14 and column 4 lines 5-6 and column 11 line 61-column 12 line 7 and column 14 lines 6-14 (an alarm is among alarm floods (synonymous to a plurality of automated triggers), wherein alarm floods include multiple alarms corresponding to a plurality of timestamps (synonymous to time-based annotations)), and wherein the computing system is further configured to indicate a total of the plurality of automated triggers corresponding to each of the group alarm conditions in column 11 line 61-column 12 line 7 and column 13 line 42-column 14 line 14 and column 15 line 20-column 16 line 37 (indicate a total amount of alarms in the alarm flood corresponding to the conditions of the alarm (Examiner notes that identifying an alarm flood indicates a total of the plurality of alarms due to the total number of multiple alarms having to exceed a predefined threshold in order to be considered an alarm flood)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a medical device including a computing system, display device, a memory system, and an annotation module to annotate time series data, as disclosed by Stuebe and Kelly, to be combined with the automated trigger being among a plurality of automated triggers corresponding to a plurality of time-based annotations and indicate a total of the plurality of automated triggers corresponding to the alarm conditions, as disclosed by Rusin, for the purpose of improving alarm management in an hospital setting [column 1 lines 5-33].
As per Claim 18, Stuebe and Kelly disclose the method according to claim 16.
Stuebe and Kelly do not disclose the following limitations. However, Rusin discloses further comprising configuring the computing system to identify group alarm conditions within the time series data in column 2 lines 36-46 and column 6 lines 5-21 and column 10 lines 32-60 and column 13 lines 42-67 (matches the conditions of the alarm (synonymous to the group alarm conditions) with an alarm rule based on the physiological data (synonymous to time series data) (Examiner notes that matching the conditions of the alarm indicates that the alarm conditions were identified)), wherein the annotation module includes trigger criteria for determining whether the group alarm conditions are satisfied in column 11 lines 13-35 and column 12 lines 40-62 and column 13 lines 42-67 and Figure 6 (alarm criticality discernment tool of rules, wherein the tool includes alarm rules (synonymous to trigger criteria) determine whether alarm thresholds are satisfied, wherein the thresholds are the conditions of the alarm), and wherein the annotation input is automatically provided as the automated trigger when the group alarm conditions are satisfied in column 3 lines 3-14 and column 4 lines 5-6 and column 10 lines 46-60 and column 11 lines 13-35 and column 12 lines 40-62 and column 13 lines 42-67 (a timestamp (synonymous to an annotation input) is automatically provided as the alarm (synonymous to the automated trigger) when the alarm rules are matched (synonymous to the trigger criteria is satisfied)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a method providing annotations to time series data for a patient from a medical device, as disclosed by Stuebe and Kelly, to be combined with identifying alarm conditions, determining whether the alarm conditions are satisfied using trigger criteria, and automatically providing the annotation input as the automated trigger when the trigger criteria is satisfied, as disclosed by Rusin, for the purpose of improving alarm management in an hospital setting [column 1 lines 5-33].
As per Claim 19, Stuebe and Kelly disclose the medical device according to claim 10.
Stuebe and Kelly do not disclose the following limitations. However, Rusin discloses wherein the trigger criteria is user-defined and wherein at least one of the at least two individual conditions relates to physiological data for the patient in column 10 lines 46-60 and column 11 lines 13-35 and column 12 lines 40-62 and column 13 lines 9-19 (alarm rules are user-defined and the alarm thresholds (synonymous to one of the at least two individual conditions) relates to physiological data for the patient).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a medical device including a computing system, display device, a memory system, and an annotation module to annotate time series data, as disclosed by Stuebe and Kelly, to be combined with the trigger criteria is user-defined and at least of one of the two individual conditions relates to physiological data, as disclosed by Rusin, for the purpose of improving alarm management in an hospital setting [column 1 lines 5-33].
As per Claim 20, Stuebe discloses a bedside monitor for a patient in paragraph [0008] (a patient monitoring system (synonymous to a bedside monitor for a patient) includes a fetal monitoring machine (Examiner notes that according to Philips a fetal monitoring machine referred to as an electronic fetal monitor is a monitoring machine placed near the mother's bedside)), the bedside monitor comprising: a computing system configured to generate time series data for the patient in paragraphs [0020-0021] and [0024] and [0029] (a computing system to generate physiological signals (synonymous to time series data) of a patient, wherein the signals are physiological measurements measured as a function of time); a display device configured to display the time series data generated by the computing system, wherein the time series data includes a waveform of physiological data for the patient in paragraphs [0020-0021] (a user interface (synonymous to a display device), wherein the user interface includes a user display, to display physiological signals generated by the system, wherein the physiological signals includes a waveform of physiological measurements of an individual); and wherein the annotation input is provided as at least one of a user input and an automated trigger in paragraphs [0020] and [0033-0034] (the annotation input is provided by user input and an alarm (synonymous to an automated trigger)); and a memory system configured to store the time series data generated by the computing system and the time-based annotation for subsequent display on the display device in paragraphs [0023] and [0027-0028] and [0032-0033] (a memory or database to store physiological signals generated by the computing system and the time-based annotation for display on the user display); wherein the annotation input is provided as at least one of free text entry, a selection from a predefined list of interventions, and an automated trigger in paragraphs [0020] and [0033-0034] (the annotation input is provided an alarm (synonymous to an automated trigger) (Examiner notes that an annotation input being an automated trigger meets the limitation of "an annotation input is provided as at least one of")).
While Stuebe discloses receiving an annotation input, Kelly discloses an annotation module executable by the computing system and configured to receive an annotation input in paragraphs [0023-0024] and [0027] and [0043] (a physiological waveform module (synonymous to an annotation module) executable by the computing system and to receive an annotation input), wherein the annotation input includes an event time in paragraphs [0035] and [0043] and Figure 6 (the annotation input includes an event time), wherein the annotation module is configured to time-associate the event time with the time series data and to display a time-based annotation at the event time along with the time series data in paragraphs [0027-0029] and [0039] and [0043] (the physiological waveform module associates the event time, wherein the event time is the duration of the event, with the waveforms or data (synonymous to the time series data) through the event time line component, wherein the waveforms are signals corresponding to measurements associated with a patient, and to display the time-based annotation at the start and end times of the waveform displays (synonymous to display a time-based annotation at the event time along with the time series data) (Examiner notes that the event time line component is a component in the physiological waveform module that associates the duration with the waveforms)); and wherein the time-based annotation is classified into a group selectable for display on the display device in paragraphs [0045-0046] (the time-based annotation is classified into a cardiac rhythm event types or other event types (synonymous to a group selectable) for display on the display device (Examiner notes that the cardiac rhythm event types and other event types are considered as selectable groups of event types)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a bedside monitor and a computing system to annotate the time series data, as disclosed by Stuebe, to be combined with an annotation module to receive an input including an event time, time-associate the event time with the time series data, and display a time-based annotation at the event time along with the time series data, as disclose