DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Notice to Applicant
This communication is in response to the amendment filed 8/13/26. Claims 1, 6, and 10 have been amended. Claims 14-20 are withdrawn. Claims 1-20 are pending. Claims 1-13 are rejected.
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.
Claim(s) 1-3, 5, 7-9, 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Badawi (US 2014/0136225 A1) in view of Vanier et al. (US 2014/0297302 A1), in view of Perry (US 2017/0185930 A1), in view of Nikolova-Simons et al. (US 2013/0325515 A1), and further in view of Volosin et al. (US 2021/0035674 A1).
(A) Referring to claim 1, Badawi discloses A method executable by one or more processors of a patient downgrade recommendation system according to instructions stored in memory of the patient downgrade recommendation system, the method comprising: (Fig. 2, abstract and para. 33, 39 & 40 of Badawi; With reference to FIG. 6, a method 150 for assessing the readiness of a patient to be discharged from an intensive care unit (ICU) is provided. The processors 46 of the CDSS 16 suitably perform the method 150. The components of the IT infrastructure 10 suitably include processors 46 executing computer executable instructions embodying the foregoing functionality, where the computer executable instructions are stored on memories 48 associated with the processors 46):
selecting a respective set of downgrade criteria for each patient of a plurality of selected patients of an intensive care unit (ICU) (para. 39, 25, & 26 of Badawi; Using the patient data, the CDSS 16 evaluates the risks of discharging the patients from the ICU based both on risk of death (ROD) and risk of readmission (ROR). ROD for a patient is calculated by inputting patient data, including values for predictive variables, received for the patient to an ROD model that predicts the ROD for a patient using the predictive variables. In some embodiments, the ROD model is selected from a plurality of ROD models in an ROD database 38. Similar to ROD, ROR for a patient is calculated by inputting patient data, including values for predictive variables, received for the patient to an ROR model that predicts ROR for a patient using the predictive variables. In some embodiments, the ROR model is selected from an ROR database 40.);
from a respective first, larger set of patient data of each patient accessible from a plurality of sources communicably coupled to the patient downgrade recommendation system, automatically compiling a respective second, smaller set of patient data of each patient based on the respective set of downgrade criteria for that patient (Fig. 2 and para. 23-25 of Badawi; The clinical data producers 12 generate patient data for corresponding patients cared for in the ICU. The patient data suitably includes data indicative of one or more physiological parameters, such as heart rate, temperature, blood oxygen saturation, level of consciousness, concern, pain, urine output, and so on. The patient data can be generated continuously and/or upon the happening of an event, such as a timer event, a user input event, and so on. Further, the patient data can be generated automatically and/or manually. The CDSS 16 receives patient data from the IT infrastructure 10, such as from the clinical data producers 12 and/or the patient information system 14. It is also contemplated that the patient data can be received from user input devices 34, optionally with display devices 36 providing users a user interface within which to enter the patient data. Using the patient data, the CDSS 16 evaluates the risks of discharging the patients from the ICU based both on risk of death (ROD) and risk of readmission (ROR));
automatically arranging, with the patient downgrade recommendation system, a graphical downgrade recommendation for each patient of the plurality of selected patients in a single integrated view of a user interface (UI) of the patient downgrade recommendation system, each graphical downgrade recommendation summarizing a respective downgrade recommendation for a corresponding patient (Figures 3 & 4 and para. 29-32 of Badawi; With reference to FIG. 3, an example report is illustrated. The report includes a plurality of rows, each including patient data for a different patient. Each row includes a patient name, a ROD, a ROR, age, prognosis, and so on. The ROD and the ROR are presented as probabilities and textual severity indicators (i.e., "L", "M", and "H" for low, medium and high, respectively). With reference to FIG. 4, an example user interface for patient data is illustrated. Similar to the report, the user interface includes a plurality of rows, each including patient data for a different patient. Further, each row includes a ROD and a ROR represented as an icon with a probability overlaid thereon. Notably, the backgrounds of the icons are color coded based on severity, where severity increases with the darkness of background color.); and
displaying the UI on a display device of the patient downgrade recommendation system, wherein each respective graphical downgrade recommendation and associated one or more downgrade elements are arranged into rows of the UI that are ordered by each respective downgrade recommendation (para. 23-26 & 30-32 and Figures 3 & 4 of Badawi; note the display devices providing users a user interface. When displaying patient data and/or generating a report, the report and/or display suitably includes at least patient name, ROD and ROR for at least one patient. Where the received patient data includes patient data for a plurality of patients, the received patient data is suitably formatted in a table structure with a plurality of rows corresponding to the patients. In some embodiments, the rows are sorted and/or can be sorted by severity of ROD and/or ROR.);
in response to a user selecting a selected graphical downgrade recommendation of the UI corresponding to a first downgrade recommendation of a first patient of the plurality of selected patients, displaying a first display panel with information of the first downgrade recommendation and controls associated with the selected graphical downgrade recommendation (Figures 3 & 4 and para. 29-32, 39, & 40 of Badawi; The report includes a plurality of rows, each including patient data for a different patient. Each row includes a patient name, a ROD, a ROR, age, prognosis, and so on. The ROD and the ROR are presented as probabilities and textual severity indicators (i.e., "L", "M", and "H" for low, medium and high, respectively). With reference to FIG. 4, an example user interface for patient data is illustrated. Similar to the report, the user interface includes a plurality of rows, each including patient data for a different patient. Further, each row includes a ROD and a ROR represented as an icon with a probability overlaid thereon. Notably, the backgrounds of the icons are color coded based on severity, where severity increases with the darkness of background color. Based on the calculations, a risk of discharge is determined 162 for a selected one of the plurality of patients. The risk of discharge can be selected with a user input device, such as the user input devices 42. The risk of discharge for the selected patient is presented 164 to a clinician via a report or a user interface. For example, a clinician is presented an ROD for a patient on the display devices 44.).
Badawi does not expressly disclose structuring, with the patient downgrade recommendation system, a limited list of machine-implementable exclusionary disqualification rules and storing the limited list of machine-implementable exclusionary disqualification rules in a database of the patient downgrade recommendation system; serially applying a respective set of rules associated with the respective set of downgrade criteria to each second, smaller set of patient data to generate a respective downgrade recommendation for each patient on whether that patient may be downgraded from a first status to a second, lower status, the first status and the second status based on one or more medical conditions of that patient, each respective set of rules associated with a respective patient and selected from the limited list of machine-implementable exclusionary disqualification rules based on the associated respective set of downgrade criteria for that patient and applied such that once a downgrade from the first status to the second status is excluded for that patient due to the respective second, smaller set of patient data for that patient not meeting conditions imposed by one rule of the respective set of rules, no further data collection and rule analysis is immediately performed for that patient with the respective second, smaller set of patient data for that patient or data collection and rule analysis for that patient is performed in background processing, to thereby improve computational efficiency; arranging one or more downgrade elements associated with each downgrade recommendation in a single integrated view of a user interface (UI), and each of the one or more downgrade elements indicating a respective criterion that was not satisfied when generating the associated downgrade recommendation; wherein the selected graphical downgrade recommendation summarizes the first downgrade recommendation; in response to the user selecting a selected downgrade element of the UI, displaying a second display panel with information and controls associated with the selected downgrade element; wherein the selected downgrade element is associated with the first downgrade recommendation such that the selected downgrade element indicates a first criterion that was not satisfied when generating the first downgrade recommendation.
Vanier discloses structuring, with the patient downgrade recommendation system, a limited list of machine-implementable exclusionary disqualification rules and storing the limited list of machine-implementable exclusionary disqualification rules in a database of the patient downgrade recommendation system (para. 37, 38, & 67-74 of Vanier; In a typical hospital setting, data is stored in four databases, namely Utilization Management/Clinical Criteria (UM/CC), Bed Board (BB), Dashboard and Analytics (DA) and Assessments (AS). Currently, all four of these systems, namely UM/CC, BB, DA and AS, are provided independently. This has the drawback that data from one module is not used to inform decisions related to another module, which leads to sub-optimal resource allocation and increased costs. The present disclosure overcomes these drawbacks by providing a fully integrated database including each of UM/CC, BB, DA and AS. The UM/CC data comprises clinical criteria sets. Clinical criteria sets lay a common framework for multi-disciplinary dialogue on clinical status, providing confidence and consistency in patient assessment. The criteria are researched from international best practices and based on a) intensity of service requirements of the patient; and b) severity of illness of the patient. The two part assessment identifies firstly the appropriateness of the patient for their current level of care (setting) and secondly their readiness for a safe discharge/transition to another level of care. In at least some embodiments, built-in criteria sets designed for specific types of patients are provided. For example, these built-in criteria sets may include, but are not limited to, criteria sets for pre-admittance patients, medical-surgical patients, ICU, mental health patients, pediatrics, newborns, post partum, complex continuing care, and rehabilitation. In at least one embodiment, the BB module is integrated with the UM/CC module and publishes, in dialogs such as that shown in FIG. 4, a "Criteria Status", whereas the Criteria Status indicates that an appropriate level of care is being provided (i.e., "MET"), that a delay or barrier has been identified, (i.e., "NOT MET"), and that the patient is ready for discharge (i.e., "RFD") or not ready for discharge (i.e. "NRFD").); serially applying a respective set of rules associated with the respective set of downgrade criteria to each second, smaller set of patient data to generate a respective downgrade recommendation for each patient on whether that patient may be downgraded from a first status to a second, lower status, the first status and the second status based on one or more medical conditions of that patient (para. 67-74 of Vanier; criteria set further includes a readiness for discharge (RFD) test. Thus, when none of the criteria of the first subset are met, and none of the criteria of the second subset are not met, this suggests that a patient is ready for discharge. The RFD test may include questions about the patient's condition and symptoms. If at least one of the criteria of the second subset are not met then the patient is considered not ready for discharge (NRFD).), each respective set of rules associated with a respective patient and selected from the limited list of machine-implementable exclusionary disqualification rules based on the associated respective set of downgrade criteria for that patient (para. 62, 63, & 67-74 of Vanier; a clinical criteria set further includes a readiness for discharge (RFD) test. Thus, when none of the criteria of the first subset are met, and none of the criteria of the second subset are not met, this suggests that a patient is ready for discharge. The RFD test may include questions about the patient's condition and symptoms. If at least one of the criteria of the second subset are not met then the patient is considered not ready for discharge (NRFD).).
Perry discloses rules applied such that once a downgrade from the first status to the second status is excluded for that patient due to the respective second, smaller set of patient data for that patient not meeting conditions imposed by one rule of the respective set of rules, no further data collection and rule analysis is immediately performed for that patient with the respective second, smaller set of patient data for that patient or data collection and rule analysis for that patient is performed in background processing, to thereby improve computational efficiency (para. 75 and Fig. 7 of Perry; In step 704, network server 160 may continually monitor the received data to determine whether a triggering event occurs, such as the change of a status of the patients and/or beds. For example, network server 160 may determine whether the expected discharge of any of the patients has occurred, and/or whether an employee has indicated the status of a bed has changed. For instance, user 125 may indicate that a discharge has occurred via one or more of user device 120 and/or computer terminal 140. In some embodiments, network server 160 may determine the change in status of a bed by determining the location and/or status of the patient assigned to the bed. For example, using collected data from one or more location or occupancy sensors, network server 160 may determine that an RFID badge has been removed from a patient and/or the patient has been in a lobby of a hospital (e.g., facility system 102) for a predetermined time period. Network server 160 may determine that, based on the location/occupancy data satisfying one or more conditions or exceeding one or more rules, the patient is being discharged from the hospital, and the bed to which the patient was assigned is now unoccupied and ready for cleaning. Further triggering events may include receipt of an order for treatment (such as infusion therapy, a procedure, or a test) or an inventory status change such as an inventory crossing a threshold, for instance a Par level variance in a clean utility room. If network server 160 determines that a trigger event has not occurred (“NO”; step 704), network server 160 may continually retrieve and processing data according to step 702. However, if network server 160 determines that a trigger event has occurred (“YES”; step 704), network server 160 may proceed to step 706.).
Nikolova-Simons discloses arranging one or more downgrade elements associated with each downgrade recommendation in a single integrated view of a user interface (UI), and each of the one or more downgrade elements indicating a respective criterion that was not satisfied when generating the associated downgrade recommendation (para. 23, 29-31, and 37 of Nikolova-Simons; The processor 102 is capable of running an evaluation manager program 114 for evaluating the patient record 110 and determining whether the discharge criteria 120 are satisfied, a predictions manager program 116 for predicting future results for the patient record 110 based on the population database 112 and a decisions manager program 118 for generating recommendations regarding 1) whether the patient is ready for discharge and/or 2) a treatment for the patient should be changed. The user inputs instructions selecting a desired program and/or task associated with the evaluations manager 114, predictions manager 116 or the decisions manager 118 via the user interface 104. The discharge criteria score may indicate whether each of the discharge criteria is considered satisfied, somewhat satisfied or unsatisfied. Similarly to the evaluation flags described above in regard to the method 200, the satisfied discharge criteria may be represented by a green color (or a full pie-chart), the somewhat satisfied criteria may be represented by a yellow color (or a partially-filled pie chart) and the unsatisfied criteria may be represented by a red color (or an empty pie-chart). It will be understood by those of skill in the art that the discharge criteria may be displayed using other scoring methods besides the green, yellow and red color codes. For example, the scores may be represented using any predetermined color code, graphical representation, using descriptive terms such as "satisfied", "somewhat satisfied" and "not satisfied," numerical values, which may fall within defined ranges indicating a level of satisfaction, or any combination thereof. Where the current discharge score is determined to be satisfied, the method 500 proceeds to a step 540, in which the decisions manager 118 recommends that the patient be discharged. The recommendation may, for example, be displayed on the display 106 as "Ready to Discharge Now." As will be understood by those of skill in the art, however, the readiness for discharge may be indicated to the user in any of a variety of ways so long as it clear to the user that the decisions manager 118 recommends that the patient be discharged, i.e., the patient has been stabilized under the current treatment. Where the current discharge score is not satisfactory in the step 530, the method 500 proceeds to a step 550, in which the decisions manager 118 evaluates whether modifications in the current treatment could potentially increase the patient's readiness for discharge.); wherein the selected graphical downgrade recommendation summarizes the first downgrade recommendation, and wherein the selected downgrade element is associated with first downgrade recommendation such that the selected downgrade element indicates a first criterion that was not satisfied when generating the first downgrade recommendation (para. 23, 29-32, and 37 of Nikolova-Simons; The discharge criteria score may indicate whether each of the discharge criteria is considered satisfied, somewhat satisfied or unsatisfied. Similarly to the evaluation flags described above in regard to the method 200, the satisfied discharge criteria may be represented by a green color (or a full pie-chart), the somewhat satisfied criteria may be represented by a yellow color (or a partially-filled pie chart) and the unsatisfied criteria may be represented by a red color (or an empty pie-chart). It will be understood by those of skill in the art that the discharge criteria may be displayed using other scoring methods besides the green, yellow and red color codes. For example, the scores may be represented using any predetermined color code, graphical representation, using descriptive terms such as "satisfied", "somewhat satisfied" and "not satisfied," numerical values, which may fall within defined ranges indicating a level of satisfaction, or any combination thereof. In a step 330, the individual discharge criteria scores are used to generate a discharge score indicating whether the patient is ready to be discharged. The discharge score indicates a patient response to treatment and a level of readiness to be discharged. The recommendation may, for example, be displayed on the display 106 as "Ready to Discharge Now." As will be understood by those of skill in the art, however, the readiness for discharge may be indicated to the user in any of a variety of ways so long as it clear to the user that the decisions manager 118 recommends that the patient be discharged, i.e., the patient has been stabilized under the current treatment. Where the current discharge score is not satisfactory in the step 530, the method 500 proceeds to a step 550, in which the decisions manager 118 evaluates whether modifications in the current treatment could potentially increase the patient's readiness for discharge.).
Volosin discloses in response to the user selecting a selected downgrade element of the UI, displaying a second display panel with information and controls associated with the selected downgrade element (para. 110, 129, and 130 of Volosin; As illustrated in FIG. 7C, the user interface screen 715 includes user interface controls 716, 718, 720, and 722. In some examples, the user interface control 716 provides access to patient specific information such as the cardiac patient's name and an identifier associated with the cardiac patient. The user interface control 718 can include a button or other selectable control. In some examples, the processor responds to input selecting the user interface control by automatically generating a recommended cardiac rehabilitation plan for the patient. This recommended rehabilitation plan can be based on a plan template (e.g., a plan template selected from the one or more plan templates 316 of FIG. 3). For instance, the processor can be configured to recommend a rehabilitation plan from the one or more plan templates that correspond with the ACC/AHA classification of the patient. FIG. 7E illustrates a sample user interface screen 735 that the processor can provide to a physician in response to, for example, receiving a selection of the plan control 718 of FIG. 7C by the physician to generate a recommended plan based upon starting information and goal information provided by a patient's physician.).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify Badawi’s discharge readiness assessment system to include the aforementioned features of Vanier, Perry, Nikolova-Simons, and Volosin. The motivation for doing so would have been to provide a comprehensive real-time understanding of appropriateness of the care setting according to the patient's care intensity needs (para. 22 of Vanier), to use collected data to determine a change of a status of the patients (para. 75 of Perry), to facilitate patient discharge planning (para. 23 of Nikolova-Simons), and to provide access to patient specific information (para. 110 of Volosin).
(B) Referring to claim 2, Badawi discloses wherein the respective first larger set of patient data of each patient of the plurality of selected patients is distributed across one or more systems and databases communicatively coupled to a computer system of the ICU via a network, including one or more Electronic Health Record (EHR) systems (para. 22-24 of Badawi).
(C) Referring to claim 3, Badawi discloses wherein generating the first downgrade recommendation for the first patient of the plurality of selected patients further comprises: in a first condition, in response to a second, smaller set of patient data of the first patient meeting each condition imposed by the respective set of rules for the first patient, generating the first downgrade recommendation indicating that the first patient be downgraded; and in a second condition, in response to the second, smaller set of patient data of the first patient not meeting one or more of the conditions imposed by the respective set of rules for the first patient, generating the first downgrade recommendation indicating that the first patient not be eligible for a downgrade. (para. 25, 31, 32, & 35-39 of Badawi).
(D) Referring to claim 5, Badawi and Vanier do not expressly disclose wherein once the downgrade from the first status to the second status is excluded for that patient due to the respective second, smaller set of patient data for that patient not meeting conditions imposed by one rule of the respective set of rules, no further data collection and rule analysis is immediately performed for that patient with the respective second, smaller set of patient data for that patient.
Perry discloses wherein once the downgrade from the first status to the second status is excluded for that patient due to the respective second, smaller set of patient data for that patient not meeting conditions imposed by one rule of the respective set of rules, no further data collection and rule analysis is immediately performed for that patient with the respective second, smaller set of patient data for that patient (para. 75 of Perry).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned features of Perry within Badawi and Vanier. The motivation for doing so would have been to use collected data to determine a change of a status of the patients (para. 75 of Perry).
(E) Referring to claim 7, Badawi discloses wherein each rule of each respective set of rules includes a condition corresponding to no more than 3 downgrade criteria to be satisfied by patient data of the second, smaller set of patient data for each patient (para. 30-33, 35, 36, and 39 of Badawi).
(F) Referring to claim 8, Badawi does not expressly disclose wherein each disqualification rule of the limited list of machine-implementable exclusionary disqualification rules is stored as a separate record in the database, and serially applying the respective set of rules includes: retrieving one or more rules of the limited list of machine- implementable exclusionary disqualification rules corresponding to each set of downgrade criteria from the database to form each respective set of rules; applying one or more rules of each respective set of rules in series to corresponding data of each second, smaller set of patient data; and generating each respective downgrade recommendation based on whether that patient was disqualified by one or more of the one or more rules of each respective set of rules.
Vanier discloses wherein each disqualification rule of the limited list of machine-implementable exclusionary disqualification rules is stored as a separate record in the database, and serially applying the respective set of rules includes: retrieving one or more rules of the limited list of machine- implementable exclusionary disqualification rules corresponding to each set of downgrade criteria from the database to form each respective set of rules; applying one or more rules of each respective set of rules in series to corresponding data of each second, smaller set of patient data; and generating each respective downgrade recommendation based on whether that patient was disqualified by one or more of the one or more rules of each respective set of rules (para. 37-40 & 67-74 of Vanier).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify Badawi’s discharge readiness assessment system to include the aforementioned features of Vanier. The motivation for doing so would have been to provide a comprehensive real-time understanding of appropriateness of the care setting according to the patient's care intensity needs (para. 22 of Vanier).
(G) Referring to claim 9, Badawi discloses wherein each second, smaller set of patient data is updated asynchronously, and the patient downgrade recommendation system periodically reapplies the respective set of rules to each second, smaller set of patient data to generate real-time updates to downgrade recommendations (para. 26, 27, 29, 39 of Badawi).
(H) Referring to claim 11, Badawi discloses further comprising: in response to the user of the patient downgrade recommendation system confirming the first downgrade recommendation via a control of the first display panel: initiating a transfer of the first patient from the ICU to a receiving care unit (abstract, para. 4, 36, and 39 of Badawi); displaying one or more discharge milestones and alerts for the first patient in the UI (para. 31 & 32 of Badawi); displaying one or more downgrade readiness icons in the UI, indicating a readiness of the first patient to be transferred (para. 39 of Badawi); periodically retrieving updated information of the one or more discharge milestones and alerts from the one or more systems and databases communicatively coupled to the patient downgrade recommendation system via the network (Fig. 1, para. 27, 29, & 39 of Badawi); and automatically updating the one or more discharge milestones and alerts in the UI with the updated information (para. 27-32 and 39 of Badawi).
(I) Referring to claim 12, Badawi discloses wherein the selected graphical downgrade recommendation for the first patient of the plurality of patients is selected from a group of possible graphical downgrade recommendations, the group comprising: an indication that the first patient is ready for a transfer; an indication that the first patient is ready to downgrade to an intermediate/step- down unit; an indication that the first patient may possibly be ready to be downgraded; an indication that the first patient has met sub-specialty criteria and is ready to laterally transfer to another ICU; and an indication that the first patient is not eligible for a downgrade (abstract, para. 36, 39, and 30-32 of Badawi).
(J) Referring to claim 13, Badawi discloses wherein automatically compiling each second, smaller set of patient data based on the respective set of downgrade criteria further includes, for a selected second, smaller set of patient data for a selected patient, retrieving a plurality of clinical markers of the selected patient, each clinical marker of the plurality of clinical markers recorded at a different time, and including in the selected second, smaller set of patient data one of: a most recent clinical marker of the plurality of clinical markers; and a result of analyzing a trend in the plurality of clinical markers (para. 23, 24, 26, and 27 of Badawi).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Badawi (US 2014/0136225 A1) in view of Vanier et al. (US 2014/0297302 A1), in view of Perry (US 2017/0185930 A1), in view of Nikolova-Simons et al. (US 2013/0325515 A1), in view of Volosin et al. (US 2021/0035674 A1), and further in view of Vasudevan et al. (US 2021/0375437 A1).
(A) Referring to claim 4, Badawi, Vanier, Perry, Nikolova-Simons, and Volosin do not expressly disclose further comprising: in response to clinical information of the second, smaller set of patient data of the first patient being unavailable, the clinical information relied on for applying a rule to the patient data: displaying a textual indication in the UI that the first downgrade recommendation of the first patient is pending an availability of the clinical information that is unavailable; periodically attempting to retrieve the clinical information; in response to retrieving the clinical information, generating the first downgrade recommendation of the first patient; and displaying a first graphical downgrade recommendation summarizing the first downgrade recommendation in the UI.
Vasudevan discloses in response to clinical information of the second, smaller set of patient data of the first patient being unavailable, the clinical information relied on for applying a rule to the patient data: displaying a textual indication in the UI that the first downgrade recommendation of the first patient is pending an availability of the clinical information that is unavailable; periodically attempting to retrieve the clinical information; in response to retrieving the clinical information, generating the first downgrade recommendation of the first patient; and displaying a first graphical downgrade recommendation summarizing the first downgrade recommendation in the UI (Figures 3A-4A and para. 108, 109, & 154 of Vasudenvan).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned features of Vasudenvan within Badawi, Vanier, Perry, Nikolova-Simons, and Volosin. The motivation for doing so would have been to alert a healthcare practitioner of the patients' priority category (para. 154 of Vasudevan).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Badawi (US 2014/0136225 A1) in view of Vanier et al. (US 2014/0297302 A1), in view of Perry (US 2017/0185930 A1), in view of Nikolova-Simons et al. (US 2013/0325515 A1), in view of Volosin et al. (US 2021/0035674 A1), and further in view of Paraschiv et al. (US 11,049,607 B1).
(A) Referring to claim 6, Badawi discloses wherein the UI further displays, for the first patient of the plurality of selected patients, one or more of: an alert generated for the first patient by a patient management system coupled to the patient downgrade recommendation system via the network; and a discharge milestone indicating a task pending completion for discharging the first patient from the ICU (Figs. 1, 3 & 4 and para. 22, 28, & 30-32 of Badawi).
Badawi and Vanier do not expressly disclose wherein, once the downgrade from the first status to the second status is excluded for that patient due to the respective second, smaller set of patient data for that patient not meeting conditions imposed by one rule of the respective set of rules, data collection and rule analysis for that patient is performed in background processing.
Perry discloses wherein, once the downgrade from the first status to the second status is excluded for that patient due to the respective second, smaller set of patient data for that patient not meeting conditions imposed by one rule of the respective set of rules, data collection and rule analysis for that patient is performed (para. 75 and Fig. 7 of Perry).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned features of Perry within Badawi and Vanier. The motivation for doing so would have been to use collected data to determine a change of a status of the patients (para. 75 of Perry).
Perry, Nikolova-Simons, and Volosin do not expressly disclose that the data collection and rule analysis for that patient is performed in background processing.
Paraschiv discloses data collection and rule analysis for that patient is performed in background processing (col. 17, line 51- col. 18, line 20 and col. 14, lines 26-51 of Paraschiv).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned feature of Paraschiv within Badawi, Vanier, Perry, Nikolova-Simons, and Volosin. The motivation for doing so would have been so that by coordinating data exchange from a plurality of parties involved in patient discharge in a secure and efficient manner, patient discharge can be significantly accelerated and costs associated with discharge delays significantly reduced (col. 12, lines 22-30 of Paraschiv).
Insofar as the claim recites “one or more of,” it is immaterial whether or not the other element is disclosed.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Badawi (US 2014/0136225 A1) in view of Vanier et al. (US 2014/0297302 A1), in view of Perry (US 2017/0185930 A1), in view of Nikolova-Simons et al. (US 2013/0325515 A1), in view of Volosin et al. (US 2021/0035674 A1), and further in view of Stein et al. (US 2012/0029932 A1).
(A) Referring to claim 10, Badawi, Vanier, Perry, Nikolova-Simons, and Volosin do not expressly disclose wherein the information of the second display panel includes one or more prior values of the first criterion obtained from an electronic health record of the first patient, wherein the first display panel is displayed in response to the user selecting the selected graphical downgrade recommendation with a first type of user input, and further comprising displaying a third display panel, different from the first display panel, in response to the user selecting the selected graphical downgrade recommendation with a second type of user input different from the first type of user input.
Stein discloses wherein the information of the second display panel includes one or more prior values of the first criterion obtained from an electronic health record of the first patient (para. 29, 35, 37, & 49-52 of Stein), wherein the first display panel is displayed in response to the user selecting the selected graphical downgrade recommendation with a first type of user input, and further comprising displaying a third display panel, different from the first display panel, in response to the user selecting the selected graphical downgrade recommendation with a second type of user input different from the first type of user input (Fig. 10 & para. 62 of Stein).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned features of Stein within Badawi, Vanier, Perry, Nikolova-Simons, and Volosin. The motivation for doing so would have been to improve the display of patient-specific data and provide a positive effect on caregivers' job satisfaction because useful information is readily available to them to improve patient care (para. 6 of Stein).
Response to Arguments
Applicant's arguments filed 8/13/26 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed hereinbelow in the order in which they appear in the response filed 8/13/26.
(1) Applicant respectfully requests the rejections of claim 1 and all claims depending therefrom be withdrawn.
(A) As per the first argument: In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Examiner relied upon Badawi to teach in response to a user selecting a selected graphical downgrade recommendation of the UI corresponding to a first downgrade recommendation of a first patient of the plurality of selected patients, displaying a first display panel with information of the first downgrade recommendation and controls associated with the selected graphical downgrade recommendation. See Figures 3 & 4 and para. 29-32, 39, & 40 of Badawi. For example, Badawi discloses: “The report includes a plurality of rows, each including patient data for a different patient. Each row includes a patient name, a ROD, a ROR, age, prognosis, and so on. The ROD and the ROR are presented as probabilities and textual severity indicators (i.e., "L", "M", and "H" for low, medium and high, respectively). With reference to FIG. 4, an example user interface for patient data is illustrated. Similar to the report, the user interface includes a plurality of rows, each including patient data for a different patient. Further, each row includes a ROD and a ROR represented as an icon with a probability overlaid thereon. Notably, the backgrounds of the icons are color coded based on severity, where severity increases with the darkness of background color. Based on the calculations, a risk of discharge is determined 162 for a selected one of the plurality of patients. The risk of discharge can be selected with a user input device, such as the user input devices 42. The risk of discharge for the selected patient is presented 164 to a clinician via a report or a user interface. For example, a clinician is presented an ROD for a patient on the display devices 44.” Examiner relied upon Volosin to teach in response to the user selecting a selected downgrade element of the UI, displaying a second display panel with information and controls associated with the selected downgrade element. See para. 110, 129, and 130 of Volosin. For example, Volosin discloses: “As illustrated in FIG. 7C, the user interface screen 715 includes user interface controls 716, 718, 720, and 722. In some examples, the user interface control 716 provides access to patient specific information such as the cardiac patient's name and an identifier associated with the cardiac patient. The user interface control 718 can include a button or other selectable control. In some examples, the processor responds to input selecting the user interface control by automatically generating a recommended cardiac rehabilitation plan for the patient. This recommended rehabilitation plan can be based on a plan template (e.g., a plan template selected from the one or more plan templates 316 of FIG. 3). For instance, the processor can be configured to recommend a rehabilitation plan from the one or more plan templates that correspond with the ACC/AHA classification of the patient. FIG. 7E illustrates a sample user interface screen 735 that the processor can provide to a physician in response to, for example, receiving a selection of the plan control 718 of FIG. 7C by the physician to generate a recommended plan based upon starting information and goal information provided by a patient's physician.” Examiner relied upon Nikolova-Simons to teach wherein the selected graphical downgrade recommendation summarizes the first downgrade recommendation, and wherein the selected downgrade element is associated with first downgrade recommendation such that the selected downgrade element indicates a first criterion that was not satisfied when generating the first downgrade recommendation. See para. 23, 29-32, and 37 of Nikolova-Simons which disclose: “The discharge criteria evaluation function may be defined as shown in FIG. 9. For example, the green discharge criteria score (e.g., satisfied) is defined as where all of the selected patient data parameters have a green flag (e.g., normal), the yellow score (e.g., somewhat satisfied) is defined as where at least one selected patient data parameter has a yellow flag (e.g., close to normal) and the red score (e.g., unsatisfied) is defined as where at least one selected patient data parameter has a red flag (e.g., abnormal). It will be understood by those of skill in the art, however, that the discharge criteria evaluation function may define each of the discharge criteria scores in any of a number of ways. The discharge criteria score definitions may be predefined for all patients. Alternatively, the user may define the discharge criteria scores for a particular patient. The discharge criteria score may indicate whether each of the discharge criteria is considered satisfied, somewhat satisfied or unsatisfied. Similarly to the evaluation flags described above in regard to the method 200, the satisfied discharge criteria may be represented by a green color (or a full pie-chart), the somewhat satisfied criteria may be represented by a yellow color (or a partially-filled pie chart) and the unsatisfied criteria may be represented by a red color (or an empty pie-chart). It will be understood by those of skill in the art that the discharge criteria may be displayed using other scoring methods besides the green, yellow and red color codes. For example, the scores may be represented using any predetermined color code, graphical representation, using descriptive terms such as "satisfied", "somewhat satisfied" and "not satisfied," numerical values, which may fall within defined ranges indicating a level of satisfaction, or any combination thereof. In a step 330, the individual discharge criteria scores are used to generate a discharge score indicating whether the patient is ready to be discharged. The discharge score indicates a patient response to treatment and a level of readiness to be discharged. The recommendation may, for example, be displayed on the display 106 as "Ready to Discharge Now." As will be understood by those of skill in the art, however, the readiness for discharge may be indicated to the user in any of a variety of ways so long as it clear to the user that the decisions manager 118 recommends that the patient be discharged, i.e., the patient has been stabilized under the current treatment. Where the current discharge score is not satisfactory in the step 530, the method 500 proceeds to a step 550, in which the decisions manager 118 evaluates whether modifications in the current treatment could potentially increase the patient's readiness for discharge.” As such, it is unclear how the language of the claim differs from the applied prior art. Note that the claim lacks detail regarding the argued “summarizing.”
Applicant is reminded that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited but not applied prior art teaches managing insulin administration (US 2017/0351842 A1).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENA NAJARIAN whose telephone number is (571)272-7072. The examiner can normally be reached Monday - Friday 9:30 am-6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached at (571)270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LENA NAJARIAN/Primary Examiner, Art Unit 3687
