DETAILED ACTION
Status of Claims
This action is in reply to the amendment filed on 09/08/2025.
Claims 1, 12-13, 15-16, 19 and 21-22 have been amended.
Claims 1-7, 9-16 and 18-22 are currently pending and have been examined.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 1-7, 9-16 and 18-22 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1-7, 9-11 and 21-22 are directed to a method (i.e., a process), claim 12 is directed to non-transitory computer readable medium (i.e., a manufacture) and claims 14-16 and 18-20 are directed to a system (i.e., a machine) and. Accordingly, claims 1-7, 9-16 and 18-22 are all within at least one of the four statutory categories.
Step 2A - Prong One:
An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) mathematical concepts, b) certain methods of organizing human activity, and/or c) mental processes.
Representative independent claim 13 includes limitations that recite an abstract idea. Note that independent claim 13 is the system claim, while claim 1 covers a method claim and claim 12 covers the matching computer readable medium.
Specifically, independent claim 13 recites:
A system for clinical decision support in medical treatment, the system comprising:
a display for displaying a user interface;
a digital processor in communication with the display and a user input device; and
a non-transitory memory storing an electronic patient clinical decision support system (CDSS) file pertaining to a patient, the information comprising a clinical guideline for medical treatment of the patient, wherein the clinical guideline includes a directed graph of nodes and a set of care phases, and instructions that, when executed by the digital processor, cause the digital processor to:
generate a dialog window for display on the display of the computer, wherein the dialog window comprises a display region showing a graphical representation of the directed graph of nodes retrieved from the electronic patient CDSS file;
represent, in the display region of the user interface displayed on the display, the clinical guideline for medical treatment of the patient as the graph of connected nodes, wherein each node in the graph represents an action to be taken or a decision to be made during the medical treatment, wherein a direction of the graph indicates a time progression of the medical treatment;
visually grouping one or more contiguous nodes of the directed graph into the care phases on the display, respectively;
visually delineate start times and end times of visual graphics indicating time intervals of the care phases on the display, respectively, wherein each care phase includes the one or more contiguous nodes of the directed graph displayed in the graphics indicating of the time interval of the care phase on the display;
receive, via an input region of the user interface displayed on the display, user input for associating a patient data set including an acquisition date with a selected care phase of the clinical guideline; and
automatically update the graphics indicating the time interval of the selected care phase on the display by adjusting the start time and the end time of at least the time interval of the selected care phase based on the acquisition date, such that the time interval of the selected care phase includes the acquisition date of the patient data set, thereby improving readability of the display with regard to the patient data set.
The Examiner submits that the foregoing underlined limitations constitute: (a) “certain methods of organizing human activity” because presenting a clinical guideline for medical treatment for a patient and representing an action to be taken or decision to be made during the medical treatment is providing a medical service and a part of a medical workflow, which are managing human behavior/interactions between people. Furthermore, these limitations constitute (b) “a mental process” because presenting a updating a timeline of a patient’s medical treatment with a time interval delineating a start and end of the time interval are clinical observations/evaluations/analysis that can be performed in the human mind or with a pen and paper. The foregoing underlined limitations also relate to claim 13 (similarly to claims 1 and 12).
Accordingly, the claim describes at least one abstract idea.
In relation to claims 2-7, 9-11, 14-16 and 18-22, these claims merely recite determining steps such as: claim 2 - receiving the acquisition date of the patient data set in the input region, claim 3 - the input region is displayed in response to selection of a node of the directed graph, claim 4 - the displayed input region is formatted specifically for input of a type of patient data expected to be associated with the selected node, claim 5 - highlighting the selected node of the directed graph in the display region of the dialog window displayed on the display, claim 6 - displaying, if the selected node is associated with a plurality of care phases, a dialog box for selecting a care phase from the a plurality of care phases with which the patient data set is to be associated, claim 7 - associating the patient data set with one of the phases based, at least in part, on the acquisition date specified via the second input element, claim 8 - the plurality of variables includes a physician type, a physician status, and a length of stay associated with a record of a past encounter with a physician predetermined to be properly attributed, claim 9 – selecting… one of the plurality of paths as a selected path responsive to user input at a decision node of the directed graph, and updating the directed graph to follow the selected path of the clinical guideline, claim 10 - displaying a percent complete indicator for at least one of the nodes of the directed graph, claim 11 – automatically setting the at least one time interval intervals of the care phases into which nodes are grouped such that no time intervals of the at least one time interval intervals overlap at any point in time, claim 14 - receives the acquisition date of the patient data set to be associated with the node via the input region, claim 15 – highlighting the node on the display responsive to selection of the node and displaying a percent complete indicator for at least one of the nodes of the graph of connected nodes, claim 16 - stores a plurality of clinical guidelines including the first clinical guideline, claim 18 - to group nodes of the graph such that time intervals of no more than two care phases overlap at any given point in time, claim 19 - display a dialog for receiving the acquisition date of the patient data set, when the acquisition date is consistent with only a single care phase, assign the data set based on the acquisition date and when the acquisition date is consistent with a plurality of care phases, display a further dialog for receiving user input regarding the selected care phase on the user interface, claim 20 - automatically select one of the plurality of paths as a selected path responsive to user input via the user interface at a decision node of the graph; and update the graph to follow the selected path of the clinical guideline, claim 21 – visually delineating the start times and the end times of the visual representations of time intervals of the care phases comprises providing shading or coloration on the display between the start time and the end time of each of the visual representations and claim 22 - visually delineating the start times and the end times of the visual representations of time intervals of the care phases comprises providing vertical delineation lines on the display corresponding to the start time and the end time of each of the visual representations.
Step 2A - Prong Two:
Regarding Prong Two of Step 2A, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted, it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.”
The limitations of claims 1, 12 and 13, as drafted is a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components. That is, other than reciting a user interface, a clinical decision support system (CDSS), a display, a non-transitory storage medium, a non-transitory memory storing instructions, a computer, a system, a digital processor, and a digital processing device to perform the limitations, nothing in the claim elements precludes the steps from practically being performed in the mind. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation within a health care environment in the mind but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” and “Mental Process” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
The judicial exception is not integrated into a practical application. In particular, the user interface, clinical decision support system (CDSS), display, non-transitory storage medium, non-transitory memory storing instructions, computer, system, digital processor, and digital processing device are recited at high levels of generality (i.e., as generic computer components performing generic computer functions of receiving data/inputs, determining and providing data) such that it amounts no more than mere instructions to apply the exception using the generic computer components.
Regarding the additional limitations “a display region of a dialog window”, “a directed graph of nodes” and “visually delineate start times and end times of the visual representation of at least one the time interval”, the Examiner submits that this additional limitation amount to merely using a computer to perform the at least one abstract idea (see MPEP § 2106.05(f)). Regarding the additional limitation “receiving, via an input region of the dialog window …., user input for associating a patient data set”, the Examiner submits that this additional limitation merely adds insignificant pre-solution activity (data gathering; selecting data to be manipulated) to the at least one abstract idea (see MPEP § 2106.05(g)).
Thus, taken alone, the additional elements do not amount to significantly more than the above identified judicial exception (the abstract idea). Looking at the limitations as an ordered combination add nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvements in the functioning of a computer or an improvement to another technology or technical field, apply or us the above-noted implement/use to above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is not more than a drafting effort designed to monopolize the exception (See MPEP §2106.05). Their collective functions merely provide conventional computer implementation.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to the integration of the abstract idea into practical application, the additional elements amount to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using generic computer component provide an inventive concept. The claims are not patent eligible.
Step 2B:
Regarding Step 2B, in representative independent claim 13, regarding the additional limitations of the user interface, clinical decision support system (CDSS), display, non-transitory storage medium, non-transitory memory storing instructions, computer, system, digital processor, and digital processing device, the Examiner submits that these limitations amount to merely using a computer to perform the at least one abstract idea (see MPEP § 2106.05(f)).
Thus, representative independent claim 13 and analogous independent claims 1 and 12 do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
The dependent claims no not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reason discussed above with respect to determining that the dependent claims do not integrate the at least abstract idea into a practical application.
Therefore, claims 1-8, 9-16 and 18-22 are ineligible under 35 USC §101.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 1-4, 7, 12-14, 16 and 19-22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Linthicum (US 2010/0131482 A1) in view of Elshoz (US 2009/0222286 A1) further in view of Weidenhaupt (US 2008/0235057 A1).
Claim 1:
Linthicum discloses A method of implementing a user interface on a display of a digital processing device to implement a clinical decision support system (CDSS) (See Fig. 2, P0065 where the widgets provide clinical decision support. Also, see P0044 and [P0085] Composition Decision Logic ("CDL"), such as aggregation, elimination of redundant information, lightweight summarization of information, and fusion of results, to compose the information.), the method comprising:
representing, in the display region of the dialog window displayed on the display (Besides multimedia video, audio and cellphone for conversations in P0077, see ability to retrieve only relevant information from dialogs in P0101-P0102.), the clinical guideline as the directed graph of nodes, wherein each node in the directed graph represents an action to be taken or decision to be made during the medical treatment, wherein a direction of the graph indicates a time progression of the medical treatment (See P0149-P0150] displaying relationships between discrete but disparate data types. The graph 1300 provides a model of dynamic relationships between clinical items and their effects over time, for example. Nodes in the graph 1300 represent events and their connection through categories and dates, for example, and The graph 1400 can be provided by a real-time configurable graphing widget that displays any data type that benefits from a trending view. Showing labs, meds, vitals, inputs and outputs, and being able to compare these variables over time can lead to better, individualized treatment, for example.),
visually delineating start times and end times of visual graphics indicating time intervals of the care phases on the display, respectively, wherein each care phase includes the one or more contiguous nodes of the directed graph displayed in the graphics indicating the time interval of the care phase on the display (See P0150 and Fig. 14 where an exemplary span of “12 years” for clinical elements/sub elements such as labs, meds, vitals, inputs and outputs over time allows for delineating start and end times for care phases.).
Although Linthicum discloses a method implementing a clinical decision support system with visually delineating time interval representing a selected care phase on display, Linthicum does not explicitly teach updating the visual representation of the time interval of the selected care phase on the display by inputting a date, the start time and the end time of the time interval of the selected care phase. Elshoz teaches:
receiving, via an input region of the dialog window on the display, user input for associating a patient data set specific to the patient, wherein the patient data set includes an acquisition date with a selected care phase of the care phases (See P0062-P0063 incorporating patient events into the patient timeline according to date, Fig. 3-4 GUI depicting a window containing waveforms and hemodynamic information mentioned in P0030-P0011. Also, see Fig. 2 Event Summary as a selected care phase with Date of Procedure (P0150-P0153) and Customizing Timeline View mentioned in P0124-P0131.) and
automatically updating, based on the acquisition date, the graphics indicating the time interval of the selected care phase on the display by adjusting the start time and the end time of the time interval of the selected care phase, such that the time interval of the selected care phase includes the acquisition date of the patient data set thereby improving readability of the display with regard to the patient data set (The user is able to select start and end times with the GUI when viewing the patient’s timeline as mentioned in P0015, P0017 and P0059. Besides, the Customizing Timeline View (P0124-P0131), see [P0121-P0125] The "Last Updated" message will display the date and time when the patient timeline was last refreshed and in [P0029] – [P0030] 3.1.3 Function: The patient timeline is divided into easy-to-read time periods (month, year, etc.)….3.1.3.1 The patient timeline has an easy-to-read appearance, regardless of the number of patient events.).
Therefore, it would have been obvious to one of ordinary skill in the art of displaying medical timelines before the effective filing date of the claimed invention to modify the method, system and software of Linthicum to include updating the visual representation of the time interval of the selected care phase on the display by inputting a date, the start time and the end time of the time interval of the selected care phase as taught by Elshoz to allow a physician to see at a glance every major hospital encounter a particular patient has had over the duration of the timeline mentioned in Elshoz’ P0002.
Although Linthicum and Elshoz teach the method of implementing a user interface on a display of a digital processing device to implement a clinical decision support system (CDSS) when updating the visual representation of the time interval of the selected care phase on the display is based on inputting a date, the start time, end time of the time interval of the selected care phase and delineating contiguous nodes of a directed graph displayed in the visual representation of the time interval of the care phase on the display as mentioned above. Linthicum and Elshoz do not explicitly teach when a stored medium, electronic patient CDSS file comprising a clinical guideline for medical treatment of the patient includes a directed graph of nodes and a set of care phases, generating and displaying a dialog window on the display of the digital processing device showing a graphical representation of the directed graph of nodes retrieved from the electronic patient CDSS file and grouping one or more contiguous nodes of the directed graph into the care phases on the display, respectively. Weidenhaupt teaches:
storing in an electronic patient CDSS file on a storage medium information pertaining to a patient, the information comprising a clinical guideline for medical treatment of the patient, wherein the clinical guideline includes a directed graph of nodes and a set of care phases (Besides Clinical Findings window 2 in Fig. 2, Fig. 4 that includes history, physical, medical, laboratory, images, ECGs, orders, or other suitable categories mentioned in P0028, see P0021 electronic patient records system for accessing clinical data. Also, see graphical representation as nodal clinical events 18, action 19 and decision 21 items that take place mentioned in P0035-P0040.);
generating and displaying a dialog window on the display of the digital processing device, wherein the dialog window comprises a display region showing a graphical representation of the directed graph of nodes retrieved from the electronic patient CDSS file (See Fig. 2, [P0035-P0040] where the Protocol & Time Map 4 includes the graphical representation as nodal clinical events 18, action 19 and decision 21 items that take place. Also, see [P0021] As illustrated in FIG. 1, it is assumed that the application (102) according to the embodiments of the present disclosure is interfaced with the healthcare IT infrastructure (100) and coupled to various other systems. The various other systems can comprise, for example, a workflow/guideline management system (104), a decision support module (106), and an electronic patient record system (108).):
visually grouping one or more contiguous nodes of the directed graph into the care phases on the display, respectively (See Fig. 2 the timeline/time bar 23 aligned respectively with clinical workflow (P0042) of the Protocol & Time Map 4.).
Therefore, it would have been obvious to one of ordinary skill in the art of clinical workflow and decision support before the effective filing date of the claimed invention to modify the method, system and software of Linthicum and Elshoz to include a stored medium, electronic patient CDSS file comprising a clinical guideline for medical treatment of the patient includes a directed graph of nodes and a set of care phases, generating and displaying a dialog window on the display of the digital processing device showing a graphical representation of the directed graph of nodes retrieved from the electronic patient CDSS file and grouping one or more contiguous nodes of the directed graph into the care phases on the display, respectively as taught by Weidenhaupt to help clinicians adhere to a standard practice of medicine and to prevent medical errors by providing suggestions to the clinicians mentioned in Weidenhaupt’s P0003.
Regarding claim 2, Linthicum discloses The method of claim 1 further comprising receiving the acquisition date of the patient data set in the input region (See list of doctor visit summaries with dates in Fig. 2, P0066. See [P0141] a range of clinical information including patient vitals, laboratory results, diagnoses, etc. A "projects" view 1020 delineates different encounters and/or dates during which the data of the services view 1010 was obtained (e.g., a patient clinic visit where a physical examination was conducted and blood was drawn for testing).).
Regarding claim 3, Linthicum discloses The method of claim 2, wherein the input region is displayed in response to selection of a node of the directed graph (See [P0149] a model of dynamic relationships between clinical items and their effects over time, for example. Nodes in the graph 1300 represent events and their connection through categories and dates, for example.)
Regarding claim 4, Linthicum discloses The method of claim 3, wherein the displayed input region is formatted specifically for input of a type of patient data expected to be associated with the selected node (See clinical items in P0149 as input.).
Regarding claim 7, although Linthicum, Elshoz and Weidenhaupt teach the method of claim 1 mentioned above by implementing a clinical decision support system with visually delineating time interval representing a selected care phase on display, Linthicum and Weidenhaupt do not explicitly teach receiving a data type of the patient data set and a second input element for specifying the acquisition date and associating the patient data set with the different care phases based, at least in part, on the acquisition date specified via the second input element. Elshoz teaches:
receiving, via another dialog window, a first input element for selecting a data type of the patient data set and a second input element for specifying the acquisition date of the patient data set; and associating the patient data set with one of the different care phases based, at least in part, on the acquisition date specified via the second input element (See [P0015] The bubble window typically contains a number of pertinent pieces of information relating to the selected procedure, including, but not limited to, the date and type of procedure, the performing physician, a brief conclusion, and recommendations. Fig. 4, P0011, P0167-P0180 depicting care phases as window containing waveforms, hemodynamic, Lab values and ECG information for selecting a data type of the patient data set and a second input element. The user is able to select start and end times with the GUI when viewing the patient’s timeline as mentioned in P0015, P0017 and P0059.).
Therefore, it would have been obvious to one of ordinary skill in the art of displaying medical timelines before the effective filing date of the claimed invention to modify the method, system and software of Linthicum and Weidenhaupt to include receiving a data type of the patient data set and a second input element for specifying the acquisition date and associating the patient data set with the different care phases based, at least in part, on the acquisition date specified via the second input element as taught by Elshoz to allow a physician to see at a glance every major hospital encounter a particular patient has had over the duration of the timeline mentioned in Elshoz’ P0002.
Claim 12:
Linthicum discloses A non-transitory storage medium storing instructions for providing a user interface on a display of a computer, that when executed by the computer (CDSS) (See P0011, P0112 machine readable medium, Fig. 2, P0065 where the widgets provide clinical decision support. Also, see P0044 and [P0085] Composition Decision Logic ("CDL"), such as aggregation, elimination of redundant information, lightweight summarization of information, and fusion of results, to compose the information.), cause the computer to:
represent, in the display region of the dialog window displayed on the display (Besides multimedia video, audio and cellphone for conversations in P0077, see ability to retrieve only relevant information from dialogs in P0101-P0102.), the clinical guideline as the directed graph of nodes, wherein each node in the directed graph represents an action to be taken or decision to be made during the medical treatment, wherein a direction of the graph indicates a time progression of the medical treatment (See P0149-P0150] displaying relationships between discrete but disparate data types. The graph 1300 provides a model of dynamic relationships between clinical items and their effects over time, for example. Nodes in the graph 1300 represent events and their connection through categories and dates, for example, and The graph 1400 can be provided by a real-time configurable graphing widget that displays any data type that benefits from a trending view. Showing labs, meds, vitals, inputs and outputs, and being able to compare these variables over time can lead to better, individualized treatment, for example.),
visually delineate start times and end times of graphics indicating time intervals of the care phases are delineated on the display, respectively, wherein each care phase includes the one or more contiguous nodes of the directed graph displayed in graphics indicating the time interval of the care phase on the display (See P0150 and Fig. 14 where an exemplary span of “12 years” for clinical elements/sub elements such as labs, meds, vitals, inputs and outputs over time allows for delineating start and end times for care phases.).
Although Linthicum discloses a method implementing a clinical decision support system with visually delineating time interval representing a selected care phase on display, Linthicum does not explicitly teach updating the visual representation of the time interval of the selected care phase on the display by inputting a date, the start time and the end time of the time interval of the selected care phase. Elshoz teaches:
receive, via an input region of the dialog window on the display, user input for associating a patient data set including an acquisition date with a selected care phase of the care phases (See P0062-P0063 incorporating patient events into the patient timeline according to date, Fig. 3-4 GUI depicting a window containing waveforms and hemodynamic information mentioned in P0030-P0011. Also, see Fig. 2 Event Summary as a selected care phase with Date of Procedure (P0150-P0153) and Customizing Timeline View mentioned in P0124-P0131.) and
automatically update, based on the acquisition date, the graphics indicating the time interval of the selected care phases phase on the display by adjusting the start time and the end time of at least the time interval of the selected care phase, such that the time interval of the selected care phase includes the acquisition date of the patient data, thereby improving readability of the display with regard to the patient data set (The user is able to select start and end times with the GUI when viewing the patient’s timeline as mentioned in P0015, P0017 and P0059. Besides, the Customizing Timeline View (P0124-P0131), see [P0121-P0125] The "Last Updated" message will display the date and time when the patient timeline was last refreshed and in [P0029] – [P0030] 3.1.3 Function: The patient timeline is divided into easy-to-read time periods (month, year, etc.)….3.1.3.1 The patient timeline has an easy-to-read appearance, regardless of the number of patient events.).
Therefore, it would have been obvious to one of ordinary skill in the art of displaying medical timelines before the effective filing date of the claimed invention to modify the method, system and software of Linthicum to include updating the visual representation of the time interval of the selected care phase on the display by inputting a date, the start time and the end time of the time interval of the selected care phase as taught by Elshoz to allow a physician to see at a glance every major hospital encounter a particular patient has had over the duration of the timeline mentioned in Elshoz’ P0002.
Although Linthicum and Elshoz teach the method of implementing a user interface on a display of a digital processing device to implement a clinical decision support system (CDSS) when updating the visual representation of the time interval of the selected care phase on the display is based on inputting a date, the start time, end time of the time interval of the selected care phase and delineating contiguous nodes of a directed graph displayed in the visual representation of the time interval of the care phase on the display as mentioned above. Linthicum and Elshoz do not explicitly teach when a stored medium, electronic patient CDSS file comprising a clinical guideline for medical treatment of the patient includes a directed graph of nodes and a set of care phases, generating and displaying a dialog window on the display of the digital processing device showing a graphical representation of the directed graph of nodes retrieved from the electronic patient CDSS file and grouping one or more contiguous nodes of the directed graph into the care phases on the display, respectively. Weidenhaupt teaches:
an electronic patient clinical decision support system (CDSS) file pertaining to a patient, the information comprising a clinical guideline for medical treatment of the patient, wherein the clinical guideline includes a directed graph of nodes and a set of care phases (Besides Clinical Findings window 2 in Fig. 2, Fig. 4 that includes history, physical, medical, laboratory, images, ECGs, orders, or other suitable categories mentioned in P0028, see P0021 electronic patient records system for accessing clinical data. Also, see graphical representation as nodal clinical events 18, action 19 and decision 21 items that take place mentioned in P0035-P0040.);
generate a dialog window for display on the display of the computer, wherein the dialog window comprises a display region showing a graphical representation of the directed graph of nodes retrieved from the electronic patient CDSS file (See Fig. 2, [P0035-P0040] where the Protocol & Time Map 4 includes the graphical representation as nodal clinical events 18, action 19 and decision 21 items that take place. Also, see [P0021] As illustrated in FIG. 1, it is assumed that the application (102) according to the embodiments of the present disclosure is interfaced with the healthcare IT infrastructure (100) and coupled to various other systems. The various other systems can comprise, for example, a workflow/guideline management system (104), a decision support module (106), and an electronic patient record system (108).):
visually grouping one or more contiguous nodes of the directed graph into the care phases on the display, respectively (See Fig. 2 the timeline/time bar 23 aligned respectively with clinical workflow (P0042) of the Protocol & Time Map 4.).
Therefore, it would have been obvious to one of ordinary skill in the art of clinical workflow and decision support before the effective filing date of the claimed invention to modify the method, system and software of Linthicum and Elshoz to include a stored medium, electronic patient CDSS file comprising a clinical guideline for medical treatment of the patient includes a directed graph of nodes and a set of care phases, generating and displaying a dialog window on the display of the digital processing device showing a graphical representation of the directed graph of nodes retrieved from the electronic patient CDSS file and grouping one or more contiguous nodes of the directed graph into the care phases on the display, respectively as taught by Weidenhaupt to help clinicians adhere to a standard practice of medicine and to prevent medical errors by providing suggestions to the clinicians mentioned in Weidenhaupt’s P0003.
Claim 13:
Linthicum discloses A system for clinical decision support in medical treatment (Fig. 2, P0065 where the widgets provide clinical decision support. Also, see P0044 and [P0085] Composition Decision Logic ("CDL"), such as aggregation, elimination of redundant information, lightweight summarization of information, and fusion of results, to compose the information.), cause the computer to:
a display for displaying a user interface (See Abstract and Fig.8.);
a digital processor in communication with the display and a user input device (See processor 812 in Fig.8.); and
a non-transitory memory storing instructions that, when executed by the digital processor (See P0011, P0112, P0128 machine readable medium.), cause the digital processor to:
represent, in the display region of the user interface displayed on the display, (Besides multimedia video, audio and cellphone for conversations in P0077, see ability to retrieve only relevant information from dialogs in P0101-P0102.), the first clinical guideline for medical treatment of the patient as the graph of connected nodes, wherein each node in the graph represents an action to be taken or a decision to be made during the medical treatment, wherein a direction of the graph indicates a time progression of the medical treatment (See P0149-P0150] displaying relationships between discrete but disparate data types. The graph 1300 provides a model of dynamic relationships between clinical items and their effects over time, for example. Nodes in the graph 1300 represent events and their connection through categories and dates, for example, and The graph 1400 can be provided by a real-time configurable graphing widget that displays any data type that benefits from a trending view. Showing labs, meds, vitals, inputs and outputs, and being able to compare these variables over time can lead to better, individualized treatment, for example.),
visually delineate start times and end times of visual graphics indicating time intervals of the care phases are delineated on the display, respectively, wherein each care phase includes the one or more contiguous nodes of the directed graph displayed in the graphics indicating the time interval of the care phase on the display (See P0150 and Fig. 14 where an exemplary span of “12 years” for clinical elements/sub elements such as labs, meds, vitals, inputs and outputs over time allows for delineating start and end times for care phases.).
Although Linthicum discloses a method implementing a clinical decision support system with visually delineating time interval representing a selected care phase on display, Linthicum does not explicitly teach updating the visual representation of the time interval of the selected care phase on the display by inputting a date, the start time and the end time of the time interval of the selected care phase. Elshoz teaches:
receive, via an input region of the user interface displayed on the display, user input for associating a patient data set including an acquisition date with a selected care phase of the clinical guideline (See P0062-P0063 incorporating patient events into the patient timeline according to date, Fig. 3-4 GUI depicting a window containing waveforms and hemodynamic information mentioned in P0030-P0011. Also, see Fig. 2 Event Summary as a selected care phase with Date of Procedure (P0150-P0153) and Customizing Timeline View mentioned in P0124-P0131.) and
automatically update the graphics indicating the time interval of the selected care phase on the display by adjusting the start time and the end time of at least the time interval of the selected care phase based on the acquisition date, such that the time interval of the selected care phase includes the acquisition date of the patient data set, thereby improving readability of the display with regard to the patient data set (The user is able to select start and end times with the GUI when viewing the patient’s timeline as mentioned in P0015, P0017 and P0059. Besides, the Customizing Timeline View (P0124-P0131), see [P0121-P0125] The "Last Updated" message will display the date and time when the patient timeline was last refreshed and in [P0029] – [P0030] 3.1.3 Function: The patient timeline is divided into easy-to-read time periods (month, year, etc.)….3.1.3.1 The patient timeline has an easy-to-read appearance, regardless of the number of patient events.).
Therefore, it would have been obvious to one of ordinary skill in the art of displaying medical timelines before the effective filing date of the claimed invention to modify the method, system and software of Linthicum to include updating the visual representation of the time interval of the selected care phase on the display by inputting a date, the start time and the end time of the time interval of the selected care phase as taught by Elshoz to allow a physician to see at a glance every major hospital encounter a particular patient has had over the duration of the timeline mentioned in Elshoz’ P0002.
Although Linthicum and Elshoz teach the method of implementing a user interface on a display of a digital processing device to implement a clinical decision support system (CDSS) when updating the visual representation of the time interval of the selected care phase on the display is based on inputting a date, the start time, end time of the time interval of the selected care phase and delineating contiguous nodes of a directed graph displayed in the visual representation of the time interval of the care phase on the display as mentioned above. Linthicum and Elshoz do not explicitly teach when a stored medium, electronic patient CDSS file comprising a clinical guideline for medical treatment of the patient includes a directed graph of nodes and a set of care phases, generating and displaying a dialog window on the display of the digital processing device showing a graphical representation of the directed graph of nodes retrieved from the electronic patient CDSS file and grouping one or more contiguous nodes of the directed graph into the care phases on the display, respectively. Weidenhaupt teaches:
an electronic patient clinical decision support system (CDSS) file pertaining to a patient, the information comprising a clinical guideline for medical treatment of the patient, wherein the clinical guideline includes a directed graph of nodes and a set of care phases (Besides Clinical Findings window 2 in Fig. 2, Fig. 4 that includes history, physical, medical, laboratory, images, ECGs, orders, or other suitable categories mentioned in P0028, see P0021 electronic patient records system for accessing clinical data. Also, see graphical representation as nodal clinical events 18, action 19 and decision 21 items that take place mentioned in P0035-P0040.);
generate a dialog window for display on the display of the computer, wherein the dialog window comprises a display region showing a graphical representation of the directed graph of nodes retrieved from the electronic patient CDSS file (See Fig. 2, [P0035-P0040] where the Protocol & Time Map 4 includes the graphical representation as nodal clinical events 18, action 19 and decision 21 items that take place. Also, see [P0021] As illustrated in FIG. 1, it is assumed that the application (102) according to the embodiments of the present disclosure is interfaced with the healthcare IT infrastructure (100) and coupled to various other systems. The various other systems can comprise, for example, a workflow/guideline management system (104), a decision support module (106), and an electronic patient record system (108).); and
visually grouping one or more contiguous nodes of the directed graph into the care phases on the display, respectively (See Fig. 2 the timeline/time bar 23 aligned respectively with clinical workflow (P0042) of the Protocol & Time Map 4.).
Therefore, it would have been obvious to one of ordinary skill in the art of clinical workflow and decision support before the effective filing date of the claimed invention to modify the method, system and software of Linthicum and Elshoz to include a stored medium, electronic patient CDSS file comprising a clinical guideline for medical treatment of the patient includes a directed graph of nodes and a set of care phases, generating and displaying a dialog window on the display of the digital processing device showing a graphical representation of the directed graph of nodes retrieved from the electronic patient CDSS file and grouping one or more contiguous nodes of the directed graph into the care phases on the display, respectively as taught by Weidenhaupt to help clinicians adhere to a standard practice of medicine and to prevent medical errors by providing suggestions to the clinicians mentioned in Weidenhaupt’s P0003.
Regarding claim 14, Linthicum discloses The system of claim 13, wherein the digital processor receives the acquisition date of the patient data set to be associated with the node via the input region of the user interface displayed on the display (See P0149-P0150] displaying relationships between discrete but disparate data types. The graph 1300 provides a model of dynamic relationships between clinical items and their effects over time, for example. Nodes in the graph 1300 represent events and their connection through categories and dates, for example, and The graph 1400 can be provided by a real-time configurable graphing widget that displays any data type that benefits from a trending view. Showing labs, meds, vitals, inputs and outputs, and being able to compare these variables over time can lead to better, individualized treatment, for example.).
Regarding claim 16, Linthicum discloses The system of claim 13 further comprising a data storage device that stores a plurality of clinical guidelines including the first clinical guideline (Besides procedures and guidelines in P0048, and Fig. 7, see treatment protocols in P0148, Fig. 12.).
Regarding claim 19, Linthicum discloses The system of claim 18, wherein the instructions further cause the digital processing device to display a dialog for receiving the acquisition date of the patient data set on the user interface (See P0066, Fig. 2 list of dates 233 and ability to retrieve only relevant information from dialogs in P0101-P0102.) and
when the acquisition date is consistent with only a single care phase, assign the data set based on the acquisition date (See P0051, P0057 and P0138 summarizing a signal document and a single repository for patient data.); and
when the acquisition date is consistent with a plurality of care phases, display a further dialog for receiving user input regarding the selected care phase on the user interface (See Fig. 4, P0083 progression notes.).
Regarding claim 20, Linthicum discloses The system of claim 13, wherein the clinical guideline comprises a plurality of paths, and the instructions further cause the digital processing device to automatically select one of the plurality of paths as a selected path responsive to user input via the user interface at a decision node of the graph; and update the graph to follow the selected path of the clinical guideline (See [P0143] This type of view provides improved insight into causal function(s) of underlying pathologies, for example. Rather than focusing only on event or encounter based organization, the record 1000 facilitates navigation of a patient record by clinical element and/or by patient encounter.).
Regarding claims 21, although
although Linthicum, Elshoz and Weidenhaupt teach the method of claim 1 mentioned above by implementing a clinical decision support system with visually delineating time interval representing a selected care phase on display, Linthicum and Weidenhaupt do not explicitly teach shading or coloration on the display between the start time and the end time of each of the visual representations. Elshoz teaches wherein visually delineating the start times and the end times of the graphic indicating time intervals of the care phases comprises providing shading or coloration on the display between the start time and the end time of each of the graphics (See [P0034-P0055] Procedures and other events are preferably displayed using color-coded event markers.).
Therefore, it would have been obvious to one of ordinary skill in the art of displaying medical timelines before the effective filing date of the claimed invention to modify the method, system and software of Linthicum and Weidenhaupt to include shading or coloration on the display between the start time and the end time of each of the visual representations as taught by Elshoz to allow a physician to see at a glance every major hospital encounter a particular patient has had over the duration of the timeline mentioned in Elshoz’ P0002.
Regarding claim 22, Linthicum discloses The method of claim 1, wherein visually delineating the start times and the end times of the graphic indicating time intervals of the care phases comprises providing vertical delineation lines on the display corresponding to the start time and the end time of each of the graphics (See P0150 and Fig. 14 where an exemplary span of “12 years” for clinical elements/sub elements such as labs, meds, vitals, inputs and outputs over time allows for delineating start and end times for care phases.).
Claims 5-6 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Linthicum (US 2010/0131482 A1) in view of Elshoz (US 2009/0222286 A1) further in view of Weidenhaupt (US 2008/0235057 A1) and Donati (WO 02/33577 A1).
Regarding claim 5, although Linthicum, Elshoz and Weidenhaupt teach the method of claim 3 mentioned above, Linthicum, Elshoz and Weidenhaupt do not explicitly teach highlighting the selected node of the directed graph in the display region of the dialog window. Donati teaches further comprising highlighting the selected node of the directed graph in the display region of the dialog window displayed on the display (With the databases viewed through nodes (Abstract), see Fig. 3C-J, page 12, lines 3-18 where exemplary selected Cardiac structures are highlighted in free-text comment sections (Fig. 3J,7A, 7B, 9B and 9C.) and time entry nodes mentioned in page 5, lines 5-8, page 10, lines 14-35.) Also, see Fig. 13.).
Therefore, it would have been obvious to one of ordinary skill in the art of medical reporting management before the effective filing date of the claimed invention to modify the method, system and software of Linthicum, Elshoz and Weidenhaupt to have highlighting the selected node of the directed graph in the display region of the dialog window as taught by Donati to have an easy to use and flexible interface for the entry of medical information into a database, and generation of customized reports from that information mentioned in Donati‘s page 4, lines 1-16.
Regarding claim 6, although Linthicum, Elshoz and Weidenhaupt teach the method of claim 4 mentioned above, Linthicum, Elshoz and Weidenhaupt do not explicitly teach selecting a care phase from care phases with which the patient data set is to be associated if the selected node is associated with a plurality of care phases. Donati teaches further comprising displaying, if the selected node is associated with a plurality of care phases, a dialog box for selecting a care phase from the a plurality of care phases with which the patient data set is to be associated (See page 12, line 26 to page 13, line 4, page 14, lines 18-25 care phases from different providers and procedures. With the databases viewed through nodes (Abstract), see Fig. 3C-J, page 12, lines 3-18 where exemplary selected Cardiac structures are highlighted in free-text comment sections (Fig. 3J,7A, 7B, 9B and 9C.) and time entry nodes mentioned in page 5, lines 5-8, page 10, lines 14-35.) Also, see Fig. 13.).
Therefore, it would have been obvious to one of ordinary skill in the art of medical reporting management before the effective filing date of the claimed invention to modify the method, system and software of Linthicum, Elshoz and Weidenhaupt to have selecting a care phase from care phases with which the patient data set is to be associated if the selected node is associated with a plurality of care phases as taught by Donati to have an easy to use and flexible interface for the entry of medical information into a database, and generation of customized reports from that information mentioned in Donati‘s page 4, lines 1-16.
Claim 9 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Linthicum (US 2010/0131482 A1) in view of Elshoz (US 2009/0222286 A1) further in view of Weidenhaupt (US 2008/0235057 A1) and Ram (US 2005/0108049 A1).
Regarding claim 9, although Linthicum, Elshoz and Weidenhaupt teach the method of claim 1 mentioned above, Linthicum, Elshoz and Weidenhaupt do not explicitly teach highlighting a clinical guideline comprising paths as a selected path responsive to user input at a decision node of the directed graph, and updating the directed graph to follow the selected path of the clinical guideline. Ram teaches wherein the clinical guideline comprises a plurality of paths, and wherein the method further comprises selecting, by the digital processing device, one of the plurality of paths as a selected path responsive to user input at a decision node of the directed graph, and updating the directed graph to follow the selected path of the clinical guideline (See [0057] A decision node in an activity graph can represent clinical decision logic by listing alternatives (typically subsequent action nodes), and specifying the criteria that need to be met to reach those nodes. During execution of an activity graph, the execution engine 100 may process all alternatives for which criteria are met, thereby allowing concurrent execution of multiple paths. Also, see P0072 and P0088.).
Therefore, it would have been obvious to one of ordinary skill in the art of clinical practice guidelines before the effective filing date of the claimed invention to modify the method, system and software of Linthicum, Elshoz and Weidenhaupt to have highlighting a clinical guideline comprising paths as a selected path responsive to user input at a decision node of the directed graph, and updating the directed graph to follow the selected path of the clinical guideline as taught by Ram to improve the delivery of clinical guidelines beyond the passive distribution of written materials to end-users as mentioned in Ram‘s P0008.
Claims 10 and 15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Linthicum (US 2010/0131482 A1) in view of Elshoz (US 2009/0222286 A1) further in view of Weidenhaupt (US 2008/0235057 A1) and Stojadinovic (US 2011/0295782 A1).
Regarding claim 10, although Linthicum, Elshoz and Weidenhaupt teach the method of claim 1 mentioned above, Linthicum, Elshoz and Weidenhaupt do not explicitly teach displaying a percent complete indicator for the nodes of the directed graph. Stojadinovic teaches further comprising displaying a percent complete indicator for at least one of the nodes of the directed graph (See Fig. 4, 7A-7E, 8, 10A and 12A-B exemplary pathology percentages 600 mentioned in P0093, P0107 and see [P0068] Each node in the directed acyclic graph represents a clinical parameter and includes two or more bins. Each bin represents a value range for the clinical parameter (e.g., bin 1: gene expression level less than or equal to 1.0; bin 2: gene expression level greater than 1.0). As described below, a node can be created such that each bin in the node includes an equal number of data points. For example, the value ranges of bins 1-3 can be created such that 33% of the training population is in each bin.).
Therefore, it would have been obvious to one of ordinary skill in the art of clinical decision models before the effective filing date of the claimed invention to modify the method, system and software of Linthicum, Elshoz and Weidenhaupt to have displaying a percent complete indicator for the nodes of the directed graph as taught by Stojadinovic for determining a patient-specific probability of malignancy, transplant glomerulopathy, healing rate of an acute traumatic wound, and/or breast cancer risk as mentioned in Stojadinovic ‘s P0001.
Regarding claim 15, although Linthicum, Elshoz and Weidenhaupt teach the system of claim 14 mentioned above, Linthicum, Elshoz and Weidenhaupt do not explicitly teach a interface highlighting a node and of the directed graph and displaying a percent complete indicator for the nodes of the graph of connected nodes. Stojadinovic teaches wherein the user interface further comprises at least one of: highlighting the node on the display responsive to selection of the node; or displaying a percent complete indicator for at least one of the nodes of the graph of connected nodes (See Fig. 4, 7A-7E, 8, 10A and 12A-B exemplary pathology percentages 600 mentioned in P0093, P0107 and see [P0068] Each node in the directed acyclic graph represents a clinical parameter and includes two or more bins. Each bin represents a value range for the clinical parameter (e.g., bin 1: gene expression level less than or equal to 1.0; bin 2: gene expression level greater than 1.0). As described below, a node can be created such that each bin in the node includes an equal number of data points. For example, the value ranges of bins 1-3 can be created such that 33% of the training population is in each bin.).
Therefore, it would have been obvious to one of ordinary skill in the art of clinical decision models before the effective filing date of the claimed invention to modify the method, system and software of Linthicum, Elshoz and Weidenhaupt to have a interface highlighting a node and of the directed graph and displaying a percent complete indicator for the nodes of the graph of connected nodes as taught by Stojadinovic for determining a patient-specific probability of malignancy, transplant glomerulopathy, healing rate of an acute traumatic wound, and/or breast cancer risk as mentioned in Stojadinovic ‘s P0001.
Claims 11 and 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Linthicum (US 2010/0131482 A1) in view of Elshoz (US 2009/0222286 A1) further in view of Weidenhaupt (US 2008/0235057 A1) and Ober (US 2007/0185739 A1).
Regarding claim 11, although Linthicum, Elshoz and Weidenhaupt teach the method of claim 1 mentioned above, Linthicum, Elshoz and Weidenhaupt do not explicitly teach setting the time intervals of the care phases into nodes that are grouped such that no time intervals of the time intervals overlap at any point in time. Ober teaches further comprising automatically setting the time intervals of the care phases into which nodes are grouped such that no time intervals of the time intervals overlap at any point in time (See Fig. 5, P0070 exemplary standard treatment steps 2 and 3 not overlapping. Also, see P0068.).
Therefore, it would have been obvious to one of ordinary skill in the art of providing clinical care before the effective filing date of the claimed invention to modify the method, system and software of Linthicum, Elshoz and Weidenhaupt to have setting the time intervals of the care phases into nodes that are grouped such that no time intervals of the time intervals overlap at any point in time as taught by Ober for optimizing the utilization of resources for managing capacity and improve financial performance as mentioned in Ober‘s P0015.
Regarding claim 18, although Linthicum, Elshoz and Weidenhaupt teach The system of claim 13 mentioned above, Linthicum, Elshoz and Weidenhaupt do not explicitly teach grouping nodes of the graph such that time intervals of no more than two care phases overlap at any given point in time. Ober teaches wherein the instructions further cause the digital processing device to group nodes of the graph such that time intervals of no more than two care phases overlap at any given point in time (See Fig. 5, P0070 exemplary standard treatment steps 2 and 3 not overlapping. Also, see P0068.).
Therefore, it would have been obvious to one of ordinary skill in the art of providing clinical care before the effective filing date of the claimed invention to modify the method, system and software of Linthicum, Elshoz and Weidenhaupt to have grouping nodes of the graph such that time intervals of no more than two care phases overlap at any given point in time as taught by Ober for optimizing the utilization of resources for managing capacity and improve financial performance as mentioned in Ober‘s P0015.
Response to Arguments
Applicant alleges that that claim 1, for example, does not fall into any of the specific categories to which the “certain methods of organizing human activity”, the claims do not recite at least one abstract idea based on organizing human activities. See pgs. 11-12 of Remarks – Examiner disagrees.
The claimed invention is directed to an abstract idea without significantly more. The claims recite “represent, in the display region of the user interface displayed on the display, the clinical guideline for medical treatment of the patient as the graph of connected nodes, wherein each node in the graph represents an action to be taken or a decision to be made during the medical treatment, wherein a direction of the graph indicates a time progression of the medical treatment”, “grouping one or more contiguous nodes of the directed graph”, “delineate start times and end times of visual graphics indicating time intervals of the care phases… wherein each care phase includes the one or more contiguous nodes of the directed graph displayed in the graphics indicating of the time interval of the care phase” and, “associating a patient data set including an acquisition date with a selected care phase of the clinical guideline”, which is an abstract idea. The claimed limitations fall within the “certain method of organizing human activity” and “mental process” grouping of abstract ideas because, in this case, the claims involve presenting clinical guidelines is a form of providing medical services to a patient and presenting clinical updates according to a timeline of a patient’s medical treatment with a time interval delineating a start and end of the time interval. As described in Applicant’s Specification at Pg. 1, line 22 to Pg. 2, line 10, making a clinical decision based on test results and tracked therapies are human-based task and thus the claimed invention represents an organization of a human-based task, i.e., an abstract idea.
Applicant argues that claim 1, for example, integrates any potential abstract idea into at least the practical application, liken to example 37. See pgs. 13-14 of Remarks – Examiner disagrees.
The claim recites “automatically updating, based on the acquisition date, the graphic indicating the time interval of the selected care phase on the display by adjusting the start time and the end time of the time interval of the selected care phase, such that the time interval of the selected care phase includes the acquisition date of the patient data set, thereby improving readability of the display with regard to the patient data set”, conveys care phase updates based on selection and user inputs, where automatically updating is part of the abstract idea and the abstract cannot integrate itself into a practical application. Also, the display is not improved. Unlike example 37, neither icons on a screen are dynamically relocating nor is the computer performing properties conveying technological improvement.
Furthermore, no technological improvements have been placed within making clinical decisions and dialogue screen, clinical analysis, artificial intelligence algorithms and the functionality of a computing device itself, specifically for implementing the abstract idea. For example, the analysis used for outputting the graphical representation of clinical guideline and decisions are have no evidence showing improvement to the structural or functional properties of the computer itself, outside of improving the computer specifically for implementing the abstract idea.
Applicant’s arguments have been fully considered, but are now moot in view of the new grounds of rejection. The Examiner has entered a new rejection under 35 USC § 103(a) and applied new art and art already of record.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/T.S.W./Examiner, Art Unit 3687
12/18/2025
/MAMON OBEID/Supervisory Patent Examiner, Art Unit 3687
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