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 preliminary Amendments filed on 17 December 2024, the following has occurred: claims 21, 23-28 and 30-37 have been amended; claims 1-20, 22, 29 and 38-79 have been canceled.
Now claims 21, 23-28 and 30-37 are pending.
Information Disclosure Statement
. The Information Disclosure Statement(s) filed on 17 December 2024, has been 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 21, 23-28 and 30-37 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.
Claim 21 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites a system for collecting and organizing patient data to provide output for a healthcare provider to interact with in their care of the various patients (i.e., a human workflow). The limitations of:
[…] a user interface […] to enable user interaction [… obtain …] answer data comprising symptom data and/or medication data based on user input to the user interface to a set of [… output …] queries […] relating to one or more health parameters from at least one of a symptoms category and a medication category, and send the answer data […] to [… obtain …] the answer data […] for the multiple users, process the answer data relative to baseline data associated with each respective user to generate a graphical dashboard that is accessible or [… output …], and wherein: the graphical dashboard depicts a summary time-series chart for each user of their processed answer data relative to their baseline data on a category basis, each summary time-series chart depicting or representing deviations of the symptom data and/or medication data relative to their respective baseline data over a time period, and the generated graphical dashboard being […output …]; wherein the summary time-series chart for each user comprises a time-series graph that plots both symptom data deviation and medication data deviation and […] to process the answer data to extract or generate symptom data deviation and medication data deviation in a form of category deviation parameters for plotting that represent a total number of health parameters in each respective category for a user that have deviated from their respective baseline data for each time-interval associated with a time-axis of the time-series graph.
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 human interaction with various generic computer components. That is, by a human user interacting with multiple respiratory therapy devices that comprise a flow generator, humidifier and controller with a display, a display device and a data server, 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, by a human user interacting with multiple respiratory therapy devices that comprise a flow generator, humidifier and controller with a display, a display device and a data server, the claim encompasses collection of data from various human users, organization of the collected data relative to a baseline and providing output for a healthcare provider based on the results of the organization of data for the healthcare provider to interact with in their care of the patients. 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 display device and a data server, which implements the abstract idea. The display device and a data server are recited at a high-level of generality (i.e., a general-purpose computers/ computer component implementing generic computer functions; see at least Applicant’s specification: Figure 19) 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 multiple respiratory therapy devices that comprise a flow generator, humidifier and controller with a display, “data communication… receive” and “presented… rendered for display… displayed or rendered”. The multiple respiratory therapy devices that comprise a flow generator, humidifier and controller with a display is recited at a high-level of generality (i.e., an off-the respiration device to provide a generic therapy to a patient) and amounts to generally linking the abstract idea to a particular technological environment. The “data communication… 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 “presented… rendered for display… displayed or rendered” is recited at a high-level of generality (i.e., outputting 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 display device and a data server, 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 multiple respiratory therapy devices that comprise a flow generator, humidifier and controller with a display, “data communication… receive” and “presented… rendered for display… displayed or rendered” were considered post/extra-solution activity and/or generally linking to a particular technological environment. The multiple respiratory therapy devices that comprise a flow generator, humidifier and controller with a display 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 Liu (20220076822): Figs. 3-5, paragraphs [0023], [0048], [0055]; Levings (20170209657): Figs. 3-5, paragraph [0025], [0028]-[0032]; Mathews (20230238124): Figs. 3-5, paragraphs [0012]-[0013], [0186]; use of respiratory therapy devices with flow generator, humidifier and controller/display is well-understood, routine and conventional. The “data communication… 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 “presented… rendered for display… displayed or rendered” was considered generally linking to a particular technological environment. This 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 Page (20210065889): Figs. 3-21, paragraphs [0025], [0057]; Barrett (20190189258): Figs. 3-5, paragraphs [0067]-[0068]; Liu (20220076822): Figs. 6, 10, paragraphs [0203]-[0205]; displaying 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 23-28 and 30-37 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 23, 28, 31-33 and 36-37 further describes the display of data, however display of data was already considered above and is incorporated herein.
Claims 24-27 and 34-35 further describes the plotting of data, however does not recite any new additional elements not already considered above and therefore cannot provide a practical application and/or significantly more.
Claim 30 further describes the organization of the data in various categories for plotting of data, however does not recite any new additional elements not already considered above and therefore cannot provide a practical application and/or significantly more.
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) 21, 23-28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 20210065889 (hereafter “Page”), in view of U.S. Patent Pub. No. 20190189258 (hereafter “Barrett”), further in view of U.S. Patent Pub. No. 20220076822 (hereafter “Liu”).
Regarding (Currently Amended) claim 21, Page teaches a system (Page: paragraph [0019], “systems and methods as disclosed herein operate to facilitate perioperative care for a plurality of patients, and supervision of a plurality of care providers attending to the plurality of patients. To facilitate the perioperative care and supervision described herein, the systems and methods as disclosed herein collect and process a wide variety of medical device data”) comprising:
multiple respiratory therapy devices that are configured to deliver a flow of gases to respective multiple users for respiratory therapy (Page: paragraph [0019], “facilitate perioperative care for a plurality of patients, and supervision of a plurality of care providers attending to the plurality of patients. To facilitate the perioperative care and supervision described herein, the systems and methods as disclosed herein collect and process a wide variety of medical device data”, paragraph [0031], “the hospital network 14 includes a plurality of medical devices 16. The medical devices 16 may include physiological monitoring devices 16a as well as patient therapy devices 16b. Physiological monitoring devices 16a may include, but are not limited to, heart rate monitors, blood pressure oxygenation monitors, respiration monitors, ECG monitors, EEG monitors, or EMG monitors… patient therapy device 16b, although it will be recognized by a person of ordinary skill in the art that other devices, including but not limited to patient respiratory assistance devices”, paragraph [0088], “machine parameter may be displayed… a second parameter, oxygen or medical gas flow rate to the patient”, paragraph [0119], “an oxygen/medical gas flow via the ventilator”. The Examiner notes one of ordinary skill in the art would find respiratory assistance devices delivering a flow of gasses prima facie obvious under the broadest reasonable interpretation), each respiratory therapy device comprising:
a flow generator for generating the flow of gases (Page: paragraph [0119], “oxygen/medical gas flow via the ventilator”), […],
a user interface comprising a display to enable user interaction […] (Page: Fig. 1, paragraph [0058]-[0059], “The graphical user interfaces that are generated via the supervisory application 44 may be displayed on one or more suitable display devices associated with a respective care provider device and/or medical facility administration device… When viewing graphical user interfaces generated via the supervisory application 44 via a display of a care provider device, a care provider may enter input (e.g., via the user input device, which may include a keyboard, mouse, microphone, touch screen, stylus, or other device) that may be processed by the care provider device and sent to edge device 20”);
a data server that is in data communication with the respiratory therapy devices (Page: Fig. 1, paragraph [0028], “medical device data processing system 12, the system 12 is implemented by one or more networked processors or computing devices. Processing system 12 may be implemented in a cloud computing platform and/or infrastructure. Memory and processors as referred to herein can be standalone or integrally constructed as part of various programmable devices, including for example, computers or servers”, paragraph [0033], “The medical devices 16 may be communicatively connected to one or more edge devices, such as edge device 20. Edge device 20 may exemplarily be an edge processing device, cloud processing device”); and
a display device that is in data communication with the data server (Page: Fig. 1, paragraph [0026], “a supervisory application that facilitates presentation of the medical device data in real-time or near real-time via one or more graphical user interfaces that may be displayed on a device of the supervising care provider, such as a mobile device (e.g., smart phone, tablet, wearable)”, paragraph [0056]-[0058], “The graphical user interfaces that are generated via the supervisory application 44 may be displayed on one or more suitable display devices associated with a respective care provider device and/or medical facility administration device. As shown in FIG. 1B, a plurality of care provider devices 120 may be included as part of hospital network 14, from a first care provider device 134, a second care provider device 136, and on up to an nth care provider device 138, and may be communicatively coupled to edge device 20 via hospital network 14”),
the […] respiratory therapy devices being configured to receive answer data comprising […]data based on user input to the user interface to a set of presented queries on the display relating to one or more health parameters from at least one of a […] category (Page: paragraphs [0124]-[0126], “a message banner 1004 to be displayed. The message banner 1004 may indicate the nature of the message that has been received… other types of messages may be received, such as SMS-based text messages from another care provider requesting a particular type of assistance, asking questions… a message input box 1008 where the user may enter text or voice input in order to send a message to the requesting care provider… Thus, FIGS. 2-10 show various views of a single-patient GUI that may be displayed… view and respond to alarms, insights, and/or messages specific to the patient”, paragraph [0155], “FIGS. 2-20 may be displayed on the user's device when prompted”, paragraph [0091], “patient monitoring parameters that are displayable via single-patient GUI 200 may be organized into categories… a circulation category 310, an oxygenation category 312, a ventilation category 314, and a neurology category 316, although other categories are possible without departing from the scope of this disclosure”, paragraph [0152], “a condition (heart rate being greater than 150 beats per minute)”. A response to a question is an answer for a symptom category under the broadest reasonable interpretation), and
send the answer data to the data server, the data server being configured to receive the answer data from the multiple respiratory therapy devices for the multiple users, process the answer data relative to baseline data associated with each respective user to generate a graphical dashboard that is accessible or rendered for display by the display device (Page: paragraph [0036], “The high speed ingestion module 22 takes the time series medical device data from the medical devices of one or more hospital networks and formats it for further processing by a data quality management module 24”, paragraphs [0044]-[0047], “group the clinical cases into groups, for example normal cases, edge cases, and outlier cases. These determinations may be made in view of a comparison between the time series data in the clinical case against normal distributions of the same type of time series machine data in other similar clinical cases… a normal case may be within a standard deviation of a median value in the normal distribution while edge cases are between one and two standard deviations and outlier cases are greater than two standard deviations from the median. The categorized cases, as explained in further detail herein, for example, identified edge cases may be further investigated to create or improve event detection algorithms, rules for clinical decision support, alert algorithms, and predictive algorithms… the detected events may be presented visually through graphical user interfaces and graphical displays… dashboards presented in a graphical user interface on a graphical display”. Also see paragraph [0052]. The Examiner notes that “to generate a graphical dashboard that is accessible or rendered for display by the display device” is an intended use of the processing of the answer data relative to baseline data that is not required to occur. This feature has been fully considered by the Examiner; however, the limitation does not provide patentable distinction over the cited prior art because it is an intended use or result of the processing of the answer data relative to baseline data), and wherein:
the graphical dashboard depicts a summary time-series chart for each user of their processed answer data relative to their baseline data on a category basis, each summary time-series chart depicting or representing deviations of the […] data relative to their respective baseline data over a time period, and the generated graphical dashboard being displayed or rendered on the display device (Page: paragraphs [0021]-[0023], “The displayed medical device data for the plurality of patients may be displayed simultaneously in a multi-patient graphical user interface (GUI), which may allow the supervising care provider to easily monitor patient status for each patient, even if the care provider is located away from the patient(s)… The supervisory application may also generate a trends GUI that may be output on the supervising care provider's device. Via the trends GUI, the supervising care provider may assess, for a plurality of selected patient monitoring parameters, change in medical device data over time. The trend for each selected patient monitoring parameter may be displayed simultaneously in a time-aligned fashion… a relative change in each patient monitoring parameter over a specified time duration may be determined and displayed”, paragraphs [0044]-[0047], “group the clinical cases into groups, for example normal cases, edge cases, and outlier cases. These determinations may be made in view of a comparison between the time series data in the clinical case against normal distributions of the same type of time series machine data in other similar clinical cases… the detected events may be presented visually through graphical user interfaces and graphical displays… dashboards presented in a graphical user interface on a graphical display”, paragraph [0053], “The supervisory application 44 allows for users (e.g., clinicians such as anesthesiologists, nurses, and other care providers) to view ventilator, anesthesia, and vital parameters of a plurality of patients in different locations (e.g., in different operating rooms) on various smart phones, tablets, or other computing devices associated with the users”, paragraph [0077], “over a particular time period”, paragraph [0095], “Each trend line is plotted on its own y-axis, such that the values of each patient monitoring parameter may be plotted on different scales and with different units where applicable. Each trend line is plotted on a common x-axis, so that the trend lines are time-aligned. The trend lines may be stacked vertically. In this way, relationships or correspondence of changes among the displayed patient monitoring parameters may be easily identified by a viewer”);
wherein the summary time-series chart for each user comprises a time-series graph that plots both [… first category …] data deviation and [… second category …] data deviation and the data server is configured to process the answer data to extract or generate [… first category …] data deviation and [… second category …] data deviation in a form of category deviation parameters for plotting that represent a total number of health parameters in each respective category for a user that have deviated from their respective baseline data for each time-interval associated with a time-axis of the time-series graph (Page: paragraphs [0044]-[0047], “group the clinical cases into groups, for example normal cases, edge cases, and outlier cases. These determinations may be made in view of a comparison between the time series data in the clinical case against normal distributions of the same type of time series machine data in other similar clinical cases… the detected events may be presented visually through graphical user interfaces and graphical displays… dashboards presented in a graphical user interface on a graphical display”, paragraphs [0091]-[0093], “The patient monitoring categories shown in FIG. 2 include a circulation category 310, an oxygenation category 312, a ventilation category 314, and a neurology category 316, although other categories are possible without departing from the scope of this disclosure… when a category is expanded, a plurality of patient monitoring parameters may be displayed”, paragraph [0112], “display a timeline 612, similar to the timeline 432 described above, that bisects each trend line and that may be moved along the x-axis to a desired time. As explained above, the timeline 612 may include an instantaneous value for each patient monitoring parameter at the time coinciding with the position of the timeline 612.”, paragraph [0129], “a number may be displayed in the alarm tile 1112, indicating the number of alarms that have been triggered for that patient. Similar numbers may be displayed in the insights tile 1110 and message tile 1114 when insights or messages, respectively, are triggered or received for that patient”. The Examiner notes that “to extract or generate [… first category …] data deviation and [… second category …] data deviation in a form of category deviation parameters for plotting” is an intended use of the processing of data that is not required to occur. This feature has been fully considered by the Examiner; however, the limitation does not provide patentable distinction over the cited prior art because it is an intended use or result of the processing of data).
Page may not explicitly teach (underlined below for clarity):
the […] respiratory therapy devices being configured to receive answer data comprising symptom data and/or medication data based on user input to the user interface to a set of presented queries on the display relating to one or more health parameters from at least one of a symptoms category and a medication category, […], and wherein: the graphical dashboard depicts a summary time-series chart for each user of their processed answer data relative to their baseline data on a category basis, each summary time-series chart depicting or representing deviations of the symptom data and/or medication data relative to their respective baseline data over a time period, and the generated graphical dashboard being displayed or rendered on the display device; wherein the summary time-series chart for each user comprises a time-series graph that plots both symptom data deviation and medication data deviation and the data server is configured to process the answer data to extract or generate symptom data deviation and medication data deviation in a form of category deviation parameters for plotting that represent a total number of health parameters in each respective category for a user that have deviated from their respective baseline data for each time-interval associated with a time-axis of the time-series graph.
Barrett teaches the […] respiratory therapy devices being configured to receive answer data comprising symptom data and/or medication data based on user input to the user interface to a set of presented queries on the display relating to one or more health parameters from at least one of a symptoms category and a medication category, […], and wherein: the graphical dashboard depicts a summary time-series chart for each user of their processed answer data relative to their baseline data on a category basis, each summary time-series chart depicting or representing deviations of the symptom data and/or medication data relative to their respective baseline data over a time period, and the generated graphical dashboard being displayed or rendered on the display device; wherein the summary time-series chart for each user comprises a time-series graph that plots both symptom data deviation and medication data deviation and the data server is configured to process the answer data to extract or generate symptom data deviation and medication data deviation in a form of category deviation parameters for plotting that represent a total number of health parameters in each respective category for a user that have deviated from their respective baseline data for each time-interval associated with a time-axis of the time-series graph (Barrett: Figs .4-5, paragraph [0002], “manage respiratory symptoms such as constricted airflow”, paragraph [0005], “require patients to accurately recall and report the frequency of symptoms, inhaler usage, and activity level and restriction over some period of time (usually two to four weeks)”, paragraph [0033], “The medication event information is sent to the application server 130 for use in analysis, presentation of a dashboard to the healthcare provider, generation of notifications, and other purposes”, paragraph [0078], “The report of controller inhaler usage 402c, also referred to as an adherence measurement, may be represented as a graphical indicator that visually indicates the patient's adherence over the same or a different monitoring period”, paragraph [0095], “present information 406a regarding any triggering conditions or symptoms experienced by the patient. Triggering conditions may be environmental (e.g., air quality index, humidity, temperature, wind speed, etc.) or habitual (e.g., missed controller medication doses). In addition to the triggering conditions and symptoms, the patient daily rescue display may comprise a geographical map 406b detailing the locations of the rescue medication usage events”, paragraph [0105], “A trend card includes statistical information presented using a graph or a chart designed for clear comprehension by the recipient. FIG. 5C illustrates two different example trend cards, plotting asthma rescue events 510c and asthma controller medication adherence 510d, both over various time periods… Card 510aa displays a time of day trend, card 510bb displays a symptom trend, card 510cc displays a day of week trend, and card 510dd displays a trigger trend”. The Examiner notes trends for categories of symptoms and medication adherence read on what is required of the claimed categories under the broadest reasonable interpretation).
One of ordinary skill in the art before the effective filing date would have found it obvious use symptom and medication categories as taught by Barrett within the capture and display of respiratory data deviation to a baseline as taught by Page with the motivation of “improve disease management” (Barrett: paragraph [0022]).
Page and Barrett may not explicitly teach (underlined below for clarity):
[…] respiratory therapy device comprising: a flow generator for generating the flow of gases, a humidifier for heating and humidifying the flow of gases, a controller that is operable to control the flow generator and humidifier, a user interface comprising a display to enable user interaction with the controller; […]; the controllers of the respiratory therapy devices being configured to […];
Liu teaches […] respiratory therapy device comprising: a flow generator for generating the flow of gases, a humidifier for heating and humidifying the flow of gases, a controller that is operable to control the flow generator and humidifier, a user interface comprising a display to enable user interaction with the controller; […]; the controllers of the respiratory therapy devices being configured to […] (Liu: Figs. 4-5, paragraphs [0055]-[0058], “The use of a humidifier with an RPT device and the patient interface produces humidified gas that minimizes drying of the nasal mucosa and increases patient airway comfort… A range of artificial humidification devices and systems are known”, paragraphs [0185]-[0186], “therapy device controller 4240 is a therapy control module 4330 that forms part of the algorithms 4300 executed by the central controller 4230…. therapy device controller 4240 is a dedicated motor control integrated circuit”, paragraph [0289]-[0290], “a humidifier 5000 (e.g. as shown in FIG. 5A) to change the absolute humidity of air or gas for delivery to a patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity and increase the temperature of the flow of air (relative to ambient air) before delivery to the patient's airways”);
One of ordinary skill in the art before the effective filing date would have found it obvious to use a humidifier and controller as taught by Liu within the respiratory devices taught by Page and Barrett with the motivation of “minimize[…] drying of the nasal mucosa and increases patient airway comfort” (Liu: paragraph [0055]).
Regarding (Currently Amended) claim 23, Page, Barrett and Liu teach the limitations of claim 21, and further teach wherein the plots of symptom data deviation and medication data deviation are visually distinguishable from each other or visually represented as separate data sets within the same time-series graph (Page: paragraphs [0092]-[0095], “In the first view 400, the user has selected two categories to expand (the circulation category 310 and the oxygenation category 312) and two categories remain collapsed (the ventilation category 314 and the neurology category 316)… Each trend line is plotted on its own y-axis, such that the values of each patient monitoring parameter may be plotted on different scales and with different units where applicable. Each trend line is plotted on a common x-axis, so that the trend lines are time-aligned. The trend lines may be stacked vertically. In this way, relationships or correspondence of changes among the displayed patient monitoring parameters may be easily identified by a viewer”, paragraph [0114], “one or more of the patient monitoring parameter trends may be displayed in a different format, such as a series of bar graphs”, paragraph [0129], “the tile may change in color, become highlighted, or otherwise change in visual appearance to signify the presence of an insight, alarm, or message”, paragraph [0164], “selection of the format button 2301 may cause the snapshot view to be displayed in a different format”, paragraph [0172], “a tile is resized, different information may be displayed in a smaller tile versus a larger tile. As an example, if a user chooses to view a patient monitoring parameter as a trend rather than or in addition to a value, that patient monitoring parameter tile may be increased in size and more information may be displayed… the tile changing color or transparency”; Barrett: paragraph [0085], “the separate indicators may be color coded… uses graphically differentiated indicators”, paragraph [0105] “plotting asthma rescue events 510c and asthma controller medication adherence 510d, both over various time periods… card 510bb displays a symptom trend, card 510cc displays a day of week trend, and card 510dd displays a trigger trend”).
The motivation to combine is the same as in claim 21, incorporated herein.
Regarding (Currently Amended) claim 24, Page, Barrett and Liu teach the limitations of claim 23, and further teach wherein the plots of symptom data deviation and medication data deviation are represented by the same or different types of plots (Page: paragraph [0114], “The displayed trends may be customized by the user, for example by selecting the edit button 608… While each of the trends shown in FIG. 6 are formatted as trend lines, in some embodiments one or more of the patient monitoring parameter trends may be displayed in a different format, such as a series of bar graphs”, paragraph [0193], “a trend graph (which may be a line graph, a series of bar graphs, or another suitable representation of data values over time)”; Barrett: paragraph [0090], “the histories are displayed as histograms, however in alternate implementations any similar data plotting mechanism may be used, such as line plots.”).
The motivation to combine is the same as in claim 21, incorporated herein.
Regarding (Currently Amended) claim 25, Page, Barrett and Liu teach the limitations of claim 23, and further teach wherein the plots of symptom data deviation and medication data deviation are represented by independent plots within the same time-series graph or as combined plots within the same time-series graph (Page: paragraphs [0092]-[0095], “Each trend line is plotted on its own y-axis, such that the values of each patient monitoring parameter may be plotted on different scales and with different units where applicable. Each trend line is plotted on a common x-axis, so that the trend lines are time-aligned. The trend lines may be stacked vertically. In this way, relationships or correspondence of changes among the displayed patient monitoring parameters may be easily identified by a viewer”; Barrett: paragraph [0077], “The report of rescue inhaler usage 402b may be represented graphically on a per day basis with separate indicators for each day over a defined period of time, also referred to as a monitoring period. The monitoring period may be the same or different from the period of time used to determine the asthma control score 402a”).
The motivation to combine is the same as in claim 21, incorporated herein.
Regarding (Currently Amended) claim 26, Page, Barrett and Liu teach the limitations of claim 21, and further teach wherein the plots representing the symptom data deviation and medication data deviation are selected from any one or more of the following types of plots: dot plot, line chart or line graph, bar chart, lollipop chart, stacked bar chart, and grouped bar chart (Page: paragraph [0095], “Each trend line is plotted on its own y-axis, such that the values of each patient monitoring parameter may be plotted on different scales and with different units where applicable. Each trend line is plotted on a common x-axis, so that the trend lines are time-aligned. The trend lines may be stacked vertically”, paragraph [0114], “While each of the trends shown in FIG. 6 are formatted as trend lines, in some embodiments one or more of the patient monitoring parameter trends may be displayed in a different format, such as a series of bar graphs”, paragraph [0119], “a visual notification of the addition insights may be displayed, such as the two dots”, paragraph [0193], “a trend graph (which may be a line graph, a series of bar graphs, or another suitable representation of data values over time)”; Barrett: paragraph [0090], “the histories are displayed as histograms, however in alternate implementations any similar data plotting mechanism may be used, such as line plots”).
The motivation to combine is the same as in claim 21, incorporated herein.
Regarding (Currently Amended) claim 27, Page, Barrett and Liu teach the limitations of claim 21, and further teach wherein the summary time-series graph for each user comprises the symptom data deviation being plotted as a time-series bar chart and the medication data deviation being plotted as a time-series line chart, or vice versa, within the same time-series graph (Page: paragraph [0114], “While each of the trends shown in FIG. 6 are formatted as trend lines, in some embodiments one or more of the patient monitoring parameter trends may be displayed in a different format, such as a series of bar graphs”, paragraph [0193], “a trend graph (which may be a line graph, a series of bar graphs, or another suitable representation of data values over time)”; Barrett: paragraph [0090], “the histories are displayed as histograms, however in alternate implementations any similar data plotting mechanism may be used, such as line plots”).
The motivation to combine is the same as in claim 21, incorporated herein.
Regarding (Currently Amended) claim 28, Page, Barrett and Liu teach the limitations of claim 27, and further teach wherein the bar and line charts representing the symptom data deviation and medication data deviation are visually distinguished from each other by colour, pattern, or shade (Page: paragraph [0129], “the tile may change in color, become highlighted, or otherwise change in visual appearance to signify the presence of an insight, alarm, or message”, paragraph [0172], “the tile changing color or transparency”; Barrett: paragraph [0085], “the separate indicators may be color coded… uses graphically differentiated indicators”).
The motivation to combine is the same as in claim 21, incorporated herein.
Regarding (Currently Amended) claim 30, Page, Barrett and Liu teach the limitations of claim 21, and further teach wherein the data server is configured to generate: a symptom category deviation parameter representing or being a function of the total number of health parameters that deviate from their baseline for each time-interval, and a medication category deviation parameter representing or being a function of the total number of health parameters that deviate from their baseline for each time-interval, each deviation parameter being plotted in the time-series graph; or a worsening deviation parameter for each category representing or being a function of the total number of health parameters in the category that have a worsening deviation from their baseline for each time-interval, and an improvement deviation parameter for each category representing or being a function of the total number of health parameters in the category that have an improving deviation from their baseline for each time-interval, each deviation parameter being plotted in the time-series graph (Page: paragraphs [0044]-[0047], “group the clinical cases into groups, for example normal cases, edge cases, and outlier cases. These determinations may be made in view of a comparison between the time series data in the clinical case against normal distributions of the same type of time series machine data in other similar clinical cases… a normal case may be within a standard deviation of a median value in the normal distribution while edge cases are between one and two standard deviations and outlier cases are greater than two standard deviations from the median. The categorized cases, as explained in further detail herein, for example, identified edge cases may be further investigated to create or improve event detection algorithms, rules for clinical decision support, alert algorithms, and predictive algorithms… the detected events may be presented visually through graphical user interfaces and graphical displays… dashboards presented in a graphical user interface on a graphical display”, paragraph [0129], “when an alarm has been triggered for that patient, a number may be displayed in the alarm tile 1112, indicating the number of alarms that have been triggered for that patient. Similar numbers may be displayed in the insights tile 1110 and message tile 1114 when insights or messages, respectively, are triggered or received for that patient”; Barrett: paragraph [0077], “a graphic illustrating each day within the period with a count of the total number of rescue events experienced during that day. In addition, the report 402b may include a cumulative account of the number of rescue events experienced during the period”, paragraph [0090], “the histories are displayed as histograms, however in alternate implementations any similar data plotting mechanism may be used, such as line plots”, paragraph [0105], “A trend card includes statistical information presented using a graph or a chart designed for clear comprehension by the recipient. FIG. 5C illustrates two different example trend cards, plotting asthma rescue events 510c and asthma controller medication adherence 510d, both over various time periods… Card 510aa displays a time of day trend, card 510bb displays a symptom trend, card 510cc displays a day of week trend, and card 510dd displays a trigger trend”).
The motivation to combine is the same as in claim 21, incorporated herein.
Claim(s) 31-35 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 20210065889 (hereafter “Page”), U.S. Patent Pub. No. 20190189258 (hereafter “Barrett”) and U.S. Patent Pub. No. 20220076822 (hereafter “Liu”) as applied to claim 21 above, and further in view of U.S. Patent 10395770 (hereafter “Leppala”).
Regarding (Currently Amended) claim 31, Page, Barrett and Liu teach the limitations of claim 30, and further teach wherein the data server is configured to generate a symptom category deviation parameter(s) and medication category deviation parameter(s) for each time-interval based on a data set representing a related colour-coded time-series plot of the answer data for the user for the one or more health parameters over a time period, wherein each plotted answer of the answer data is selectively colour-coded for display […] (Page: paragraph [0129], “the tile may change in color, become highlighted, or otherwise change in visual appearance to signify the presence of an insight, alarm, or message”, paragraph [0164], “selection of the format button 2301 may cause the snapshot view to be displayed in a different format”, paragraph [0172], “a tile is resized, different information may be displayed in a smaller tile versus a larger tile. As an example, if a user chooses to view a patient monitoring parameter as a trend rather than or in addition to a value, that patient monitoring parameter tile may be increased in size and more information may be displayed… the tile changing color or transparency”; Barrett: paragraph [0085], “the separate indicators may be color coded… uses graphically differentiated indicators”, paragraph [0105] “plotting asthma rescue events 510c and asthma controller medication adherence 510d, both over various time periods… card 510bb displays a symptom trend, card 510cc displays a day of week trend, and card 510dd displays a trigger trend.”).
Page, Barrett and Liu may not explicitly teach (underlined below for clarity below):
wherein the data server is configured to generate a symptom category deviation parameter(s) and medication category deviation parameter(s) for each time-interval based on a data set representing a related colour-coded time-series plot of the answer data for the user for the one or more health parameters over a time period, wherein each plotted answer of the answer data is selectively colour-coded for display according to a baseline colour spectrum or one or more deviation colour spectrums, the colour spectrum selected for each answer being a function of or based on any deviation of the answer data relative to the baseline data.
Leppala teaches wherein the data server is configured to generate a symptom category deviation parameter(s) and medication category deviation parameter(s) for each time-interval based on a data set representing a related colour-coded time-series plot of the answer data for the user for the one or more health parameters over a time period, wherein each plotted answer of the answer data is selectively colour-coded for display according to a baseline colour spectrum or one or more deviation colour spectrums, the colour spectrum selected for each answer being a function of or based on any deviation of the answer data relative to the baseline data (Leppala: Col. 17, lines 5-end, “the reference color (or the base color of the reference color) is selected from the potential reference colors based on whether the patient parameter is above an upper limit or below a lower limit. The reference color above the upper limit and the reference color below the lower limit may have respective wavelengths that are separated by a designated amount along the visible spectrum… the reference color (or the base color of the reference color) associated with a patient parameter that is above the upper limit and the reference color associated with a patient parameter that is below the lower limit may be selected from separate color spectrums. In such embodiments, the reference colors may change within the designated color spectrum based on the patient parameter”).
One of ordinary skill in the art before the effective filing date would have found it obvious to use color spectrums to map data as taught by Leppala with the display of plotted answer data in a color as taught by Page, Barrett and Liu with the motivation of improving accessibility to information (Leppala: Col. 1, 30-end).
Regarding (Currently Amended) claim 32, Page, Barrett, Liu and Leppala teach the limitations of claim 31, and further teach wherein the category deviation parameters for each time-interval are based on or are a function of the number of answers in each respective category that are colour coded into a respective one of the deviation colour spectrums (Page: paragraphs [0091]-[0093], “The patient monitoring categories shown in FIG. 2 include a circulation category 310, an oxygenation category 312, a ventilation category 314, and a neurology category 316, although other categories are possible without departing from the scope of this disclosure… when a category is expanded, a plurality of patient monitoring parameters may be displayed”, paragraph [0129], “a number may be displayed in the alarm tile 1112, indicating the number of alarms that have been triggered for that patient. Similar numbers may be displayed in the insights tile 1110 and message tile 1114 when insights or messages, respectively, are triggered or received for that patient”; Barrett: Figs .4-5, paragraph [0002], “manage respiratory symptoms such as constricted airflow”, paragraph [0005], “require patients to accurately recall and report the frequency of symptoms, inhaler usage, and activity level and restriction over some period of time (usually two to four weeks)”, paragraph [0105], “A trend card includes statistical information presented using a graph or a chart designed for clear comprehension by the recipient. FIG. 5C illustrates two different example trend cards, plotting asthma rescue events 510c and asthma controller medication adherence 510d, both over various time periods… Card 510aa displays a time of day trend, card 510bb displays a symptom trend, card 510cc displays a day of week trend, and card 510dd displays a trigger trend”).
The motivation to combine is the same as in claim 31, incorporated herein.
Regarding (Currently Amended) claim 33, Page, Barrett and Liu teach the limitations of claim 21, and further teach wherein the summary time-series chart for each user comprises a colour-coded time-series plot of the answer data for the user for the one or more health parameters over a time period, and wherein each plotted answer of the answer data is selectively colour-coded for display […] (Page: paragraph [0129], “the tile may change in color, become highlighted, or otherwise change in visual appearance to signify the presence of an insight, alarm, or message”, paragraph [0172], “the tile changing color or transparency”; Barrett: paragraph [0085], “the separate indicators may be color coded… uses graphically differentiated indicators”).
Page, Barrett and Liu may not explicitly teach (underlined below for clarity below):
wherein the summary time-series chart for each user comprises a colour-coded time-series plot of the answer data for the user for the one or more health parameters over a time period, and wherein each plotted answer of the answer data is selectively colour-coded for display according to a baseline colour spectrum or one or more deviation colour spectrums, the colour spectrum selected for each answer being a function of or based on any deviation of the answer data relative to the baseline data.
Leppala teaches wherein the summary time-series chart for each user comprises a colour-coded time-series plot of the answer data for the user for the one or more health parameters over a time period, and wherein each plotted answer of the answer data is selectively colour-coded for display according to a baseline colour spectrum or one or more deviation colour spectrums, the colour spectrum selected for each answer being a function of or based on any deviation of the answer data relative to the baseline data (Leppala: Col. 17, lines 5-end, “the reference color (or the base color of the reference color) is selected from the potential reference colors based on whether the patient parameter is above an upper limit or below a lower limit. The reference color above the upper limit and the reference color below the lower limit may have respective wavelengths that are separated by a designated amount along the visible spectrum… the reference color (or the base color of the reference color) associated with a patient parameter that is above the upper limit and the reference color associated with a patient parameter that is below the lower limit may be selected from separate color spectrums. In such embodiments, the reference colors may change within the designated color spectrum based on the patient parameter”).
The motivation to combine is the same as in claim 31, incorporated herein.
Regarding (Currently Amended) claim 34, Page, Barrett, Liu and Leppala teach the limitations of claim 33, and further teach wherein the plotted answers are grouped in rows or otherwise aligned with their associated health parameter when plotted against a time-axis of the colour-coded time-series plot (Page: paragraphs [0092]-[0095], “Each trend line is plotted on its own y-axis, such that the values of each patient monitoring parameter may be plotted on different scales and with different units where applicable. Each trend line is plotted on a common x-axis, so that the trend lines are time-aligned. The trend lines may be stacked vertically. In this way, relationships or correspondence of changes among the displayed patient monitoring parameters may be easily identified by a viewer”).
The motivation to combine is the same as in claim 31, incorporated herein.
Regarding (Currently Amended) claim 35, Page, Barrett, Liu and Leppala teach the limitations of claim 33, and further teach wherein the plotted answers are presented in defined category groups based on the category associated with the health parameter to which the plotted answer relates. (Page: paragraphs [0124]-[0126], “view and respond to alarms, insights, and/or messages specific to the patient”, paragraph [0091], “patient monitoring parameters that are displayable… may be organized into categories… a circulation category 310, an oxygenation category 312, a ventilation category 314, and a neurology category 316, although other categories are possible without departing from the scope of this disclosure”; Barrett: Figs .4-5, [0105], “A trend card includes statistical information presented using a graph or a chart designed for clear comprehension by the recipient. FIG. 5C illustrates two different example trend cards, plotting asthma rescue events 510c and asthma controller medication adherence 510d, both over various time periods… Card 510aa displays a time of day trend, card 510bb displays a symptom trend, card 510cc displays a day of week trend, and card 510dd displays a trigger trend”. The Examiner notes trends for categories of symptoms and medication adherence read on what is required of the claimed categories under the broadest reasonable interpretation).
The motivation to combine is the same as in claim 31, incorporated herein.
Claim(s) 36 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 20210065889 (hereafter “Page”), U.S. Patent Pub. No. 20190189258 (hereafter “Barrett”) and U.S. Patent Pub. No. 20220076822 (hereafter “Liu”) as applied to claim 21 above, and further in view of U.S. Patent Pub. No. 20210059616 (hereafter “Abrol”).
Regarding (Currently Amended) claim 36, Page, Barrett and Liu teach the limitations of claim 21, but may not explicitly teach wherein the data server is further configured to process the answer data for the multiple users to determine a priority status between the users, and wherein the graphical dashboard generated is configured to display or present the summary time-series charts of the multiple users based at least partly on the determined priority status of the users.
Abrol teaches wherein the data server is further configured to process the answer data for the multiple users to determine a priority status between the users, and wherein the graphical dashboard generated is configured to display or present the summary time-series charts of the multiple users based at least partly on the determined priority status of the users (Abrol: paragraph [0164], “presenting the normalized risk scores to the user, the user may make an informed decision regarding which patient(s) to prioritize”, paragraph [0170], “the highest ranking (e.g., highest four) patient monitoring parameters may be included in the set of trends”, paragraphs [0224]-[0225], “input signals may be ranked in decreasing order of importance… a plurality of trend lines may be ordered based on the rank”, paragraph [0230], “predicted risk/severity scores may be used to prioritize patient condition in multiple ORs in a hospital to allow the anesthesiologist focus their attention where it is needed most. Again, in the event where multiple patients are going through these events, the severity scores from each of these events from different patients may be normalized and compared to prioritize the risk for the care provider”).
One of ordinary skill in the art before the effective filing date would have found it obvious to include using prioritization as taught by Abrol with the dashboard presenting processed answers as taught by Page, Barrett and Liu with the motivation of “patient care may be improved” (Abrol: paragraph [0029]).
Regarding (Currently Amended) claim 37, Page, Barrett, Liu and Abrol teach the limitations of claim 36, and further teach wherein the priority status of each user represents their general health status relative to other users based on the answer data, and wherein the graphical dashboard is configured such that the summary time-series charts are presented in an order or arrangement that prioritises the users having a worse health status according to their priority status (Abrol: paragraph [0164], “presenting the normalized risk scores to the user, the user may make an informed decision regarding which patient(s) to prioritize”, paragraph [0170], “the highest ranking (e.g., highest four) patient monitoring parameters may be included in the set of trends”, paragraphs [0224]-[0225], “input signals may be ranked in decreasing order of importance… a plurality of trend lines may be ordered based on the rank”, paragraph [0230], “predicted risk/severity scores may be used to prioritize patient condition in multiple ORs in a hospital to allow the anesthesiologist focus their attention where it is needed most. Again, in the event where multiple patients are going through these events, the severity scores from each of these events from different patients may be normalized and compared to prioritize the risk for the care provider”).
The motivation to combine is the same as in claim 36, incorporated herein.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Pub. No. 20090054743 (hereafter “Stewart”) teaches providing to a healthcare provider a trend of their patients over time on a display.
U.S. Patent Pub. No. 20150154380 (hereafter “Duckworth”) teaches monitoring patient adherence to respiration therapy to determine adherence profiles.
U.S. Patent Pub. No. 20170209657 (hereafter “Levings”) teaches a respiratory therapy device to collect and monitor patient symptoms over time for a healthcare provider.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew E Lee whose telephone number is (571)272-8323. The examiner can normally be reached M-Th 9-5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached on 571-270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.E.L./Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684
Prosecution Insights