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 .
Election/Restrictions
Applicant’s election without traverse of Invention II pertaining to claims 8-13 in the reply filed on 20 October 2025 is acknowledged.
Claims 1-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention II, there being no allowable generic or linking claim. Election was made without traverse in the reply.
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.
Claim Rejections - 35 USC § 101
Claims 8-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception related to a mental process which can be performed by a pen and paper including data gathering, observation, evaluation/analysis, and judgment without significantly more.
Each of claims 8-13 have been analyzed to determine whether it is directed to any judicial exceptions.
Step 1
The claims recite a computer implemented interface (device, claims 8-10) and system (claims 11-13) configured to perform analysis and display result thus the claims are directed to the eligible statutory categories.
Step 2A, Prong 1
Though the claims are eligible under Step 1, the claims have been found to be directed to a judicial exception. The claim(s) recite(s):
receiving analyzed patient data;
determining medical conditions or disorders;
determining medical interventions;
determining a risk profile and recommended due dates;
creating action items based on the determinations; and
displaying the action items and allowing user interaction and scheduling.
These limitations collectively recite organizing, analyzing, and displaying medical information to guide patient actions, which constitutes an abstract idea. Specifically, the claim is directed to collecting information, analyzing the information, and displaying the results to guide user actions, which falls within the judicial exceptions for mental processes and methods of organizing human activity, including care coordination, treatment planning, and scheduling.
The steps of determining medical conditions, interventions, risk categories, due dates, and priority status are clinical decision-support and administrative determinations that can be performed mentally by a healthcare provider or by use of pen and paper. Presenting such determinations in the form of action items and schedules merely automates these mental processes. This is similar to Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016).
Step 2A, Prong 2
The judicial exception is not integrated into a practical application.
Although the claim recites a “computer implemented interface,” a “server,” a “medical intelligence module,” and a “patient device,” these elements are generic computing components used only to receive, process, display, and transmit information. The claim does not recite any specific technological improvement to computer functionality, user interfaces, data processing techniques, or medical device operation.
The recited user interface merely displays medical information, priorities, and schedules, and allows a user to initiate scheduling. Such presentation and interaction do not impose meaningful limits on the abstract idea and constitute insignificant extra-solution activity.
Further, the claim does not control or alter the operation of any medical device, does not improve physiological measurement accuracy, does not change how data is generated, and does not apply treatment. The claimed interface merely supports human decision-making, which is insufficient to confer patent eligibility.
Accordingly, the abstract idea is not integrated into a practical application.
Step 2B
Claims 8–13 do not recite additional elements that amount to significantly more than the abstract idea.
The recited components—including processors, servers, user interfaces, patient devices, and patient-operated medical devices (e.g., weight scales, blood pressure monitors, ECGs, and smartwatches)—are well-understood, routine, and conventional in the art. The claims do not recite any unconventional arrangement or non-routine use of these components. The use of the computer components is merely a tool for carrying out the analysis.
The receipt of physiological parameters from known medical devices and the display of those parameters to a patient (claims 9-10 AND 11-13) merely constitute routine data acquisition and presentation, which does not add an inventive concept. The claims continue to rely on the same abstract determinations of conditions, risks, interventions, and scheduling.
Therefore, when considered individually and in combination, the claims do not amount to significantly more than the judicial exception.
Therefore, claims 8–13 are directed to an abstract idea of organizing, analyzing, and presenting medical information for patient guidance and scheduling, without integration into a practical application and without an inventive concept. Accordingly, claims 8–13 are not patent-eligible under 35 U.S.C. § 101.
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) 8-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aoun et al. (US Publication no. 2022/0101989) in view of McCabe et al. (US Publication no. 2022/0230715).
In regard to claim 8, Aoun et al. discloses:
A computer implemented interface (i.e., smart screen 102 of medical system 120 described in para 23 and 41 (smart screen) and para 25, 37, and 82 (medical system)) for medical action guidance configured to perform a method comprising:
receiving, for a patient, analyzed patient data from a medical intelligence module operating on a server (flow chart of figure 5, step 400, para 87, medical system receives patient data wherein the receipt includes patient’s current medical data compared to data of the medical data of the general population, wherein this comparison step is considered to be analyzed data; para 55 and 57 employes machine learning (i.e., medical intelligence) to implement one or more neural networks and/or machine learning models to perform one or more machine learning tasks for analysis of medical data to form medical diagnosis, health monitoring, decision making, health metrics analytics, medical testing analytics, optimization, etc; para 25 teaches that one or more computing components of the medical system 120 may be implemented on a server; Additionally, the embodiment of figure 6 at step 602 is considered to read on this step, para 94-96);
determining one or more medical conditions or disorders that a patient has been diagnosed with (step 502 of figure 5, para 87, the medical system can analyze all or some of this data to determine whether a notable condition is present; the embodiment of figure 6 also reads on this, para 97);
determining one or more medical interventions for each medical condition or disorder, wherein the medical interventions comprise procedures, tests, screenings or courses of action (step 506/508 figure 5, para 87, the medical system can analyze all or some of this data to determine whether a notable condition is present, and if so, which appropriate medical treatment 406 is necessary or recommended at this time….the medical system 120 can provide the determined medical treatment 406 to the patient 408 for immediate action; para 85-86the treatment plan comprises actions or tasks that include nutritional plans, referrals, record requests, scans, suggested tests, measurements, diet plans, medications, treatments, procedures, examinations, orders, action which are all considered to be associated with the medical condition or disorder; para 88, the medical system 120 can determine if the patient has a condition worth noting and pursuing a customized treatment plan; figure 6 embodiment step 608, para 99);
determining a risk profile for the patient, wherein the risk profile comprises a risk category for each of the patient's medical conditions or disorders (para 83, The general population medical data 402 can include information regarding all or some variants of diseases, conditions, ailments, symptoms, etc. such that the comparison 404 can quickly determine whether the current patient is at risk for any given numbers of conditions; figure 6 embodiment step 606, para 98, the patient data is compared with general population which is considered to comprise a risk analysis (e.g., the step of capering the measured data against established, pre-defined criteria to determine their significance and acceptability);
creating one or more action items, wherein each action item is associated with a medical condition or disorder, a medical intervention, a risk category (para 45, smart screen 102 can dynamically display suggestions, tasks, relevant and/or contextual data, health metrics, agenda items, action items; step 508, figure 5; para 85-86, the treatment plan comprises actions or tasks that include nutritional plans, referrals, record requests, scans, suggested tests, measurements, diet plans, medications, treatments, procedures, examinations, orders, action which are all considered to be associated with the medical condition or disorder; para 86, additional actions or tasks are discussed; figure 6 embodiment is encompassed by step 610).
It is noted that with respect to the risk determination step above, Auon et al. is silent with respect to further creating a risk profile or risk category for a determined medical condition when determining the risk. However, determining a risk profile or category is considered obvious to one of ordinary skill in the art as mere organization and categorization of data.
Auon et al. is considered to disclose various aspects of the present invention, however does not teach the steps of:
determining a recommended due date for each of the determined procedures, tests, screenings and courses of action associated with the patient's medical condition or disorder based on the analyzed patient data;
displaying, by a user interface on a patient device, the one or more action items associated with the patient, wherein the action items comprise a visual representation of priority, status, risk category, recommended due date and an indication of the an amount of time until the recommended due date or an indication of how overdue a patient action is based on the recommended due date; receiving, from the user interface, a selection of a displayed action item;
displaying to the patient, through the user interface, a detailed view of the action item;
initiating, from the detailed view, a scheduling process associated with the corresponding action item's medical condition or disorder.
McCabe et al. is directed to systems and methods for managing monitoring, and treating patient conditions. McCabe et al. is considered to teach and suggest the following techniques:
determining a recommended due date for each of the determined procedures, tests, screenings and courses of action associated with the patient's medical condition or disorder based on the analyzed patient data (para 240, a deadline is established for the patient goals; para 137, McCabe et al. may display on patient overview screen 50 information related to overdue actions indicator (considered to suggest a due date (such as the deadline taught in para 240) with a clock timer was initially set for an action or goal);
creating one or more action items, wherein each action item is associated with a medical condition or disorder, a medical intervention, a risk category (para 121, a treatment protocol is devised (e.g., see para 85 and 102), wherein the treatment protocol include establishing of patient goals, wherein the goals are considered to comprise items for patient action);
displaying, by a user interface on a patient device, the one or more action items associated with the patient, wherein the action items comprise a visual representation of priority, status, risk category, recommended due date and an indication of the an amount of time until the recommended due date or an indication of how overdue a patient action is based on the recommended due date; receiving, from the user interface, a selection of a displayed action item (para 132, screens may be configured to display data identifying the patient's status, goals, risk profile, and/or potential outcomes for an individual patient; additionally, para 137, screen 50 display information related to overdue actions; para 146 and 230, the goals are displayed in a screen title 54 labeled GOALS which may be selectable option on the user interface);
receiving, from the user interface, a selection of a displayed action item (para 146 and 230, the goals are displayed in a screen title 54 labeled GOALS which may be selectable option on the user interface; para 231, the goal portion or pane 154 may have one or more selectable features configured to facilitate a user viewing, adjusting, and/or setting goals for the selected patient);
displaying to the patient, through the user interface, a detailed view of the action item (para 239, in response to selecting (e.g., scrolling over, clicking on, etc.) a goal listed in the goal portion or pane 154, a goal summary 164 may be displayed that is associated with the selected goal);
initiating, from the detailed view, a scheduling process associated with the corresponding action item's medical condition or disorder (para 120, an outputted indication of a condition includes a control signal to initiate an appointment invite or other suitable scheduling mechanism to schedule a medical provider to initiate or perform a treatment, wherein establishment of the control signal implies action to be taken by the user).
It is considered to have been obvious to one of ordinary skill in the art to modify the computer readable medium of Aoun et al. to include instructions to display a diagnosis, patient actions derived from the treatment plan, associated risk profiles, and due data for such action, and to allow for scheduling of events related thereto as taught by McCabe et al. because such features represent routine presentation and organization of medical information to improve usability, compliance, and care coordination, yielding predictable results without requiring undue experimentation. The modification would comprise the application of a known technique to a known device to yield a predictable result.
In regard to claim 9, Aoun et al. further discloses that the patient device is configured to: establish a connection to one or more patient operated medical devices (e.g., biometric subsystems 106 and/or devices 102-116 as taught in para 27-36); receive, from the one or more patient operated medical devices, one or more physiological parameters for the patient; create one or more action items corresponding to the received physiological parameters (para 64); and display to the patient, through the user interface, a visual representation of the received physiological parameters (para 30 and 44, the system 120 may be enabled to collect data from various biometric and computing subsystems such data includes collecting test results, health metrics, physiological parameters (e.g., heart rate, blood pressure, temperature etc) and display them; also see para 80 and 96).
In regard to claim 10 (interpreted as a proper Markush claim), Aoun et al. discloses that the one or more patient operated medical devices includes: a weight scale; a blood pressure monitor, wherein the blood pressure monitor includes a sleave sensor unit; a thermometer; an electrocardiogram; and a smartwatch (para 35, 44, and 96), worn by the patient, wherein the smartwatch includes one or more biosensors and wherein the smartwatch is configured to determine one or more physiological parameters of the patient (US 2019/0209022 demon that smartwatches have this capacity), the physiological parameters including: heart rate variability; general variability; pulse rate; pulse oximetry; and skin conductance response (para 30, one or more biometrics systems 106 in the medical care site 100 can include one or more biometrics sensors and/or devices such as, for example, a heart rate sensor, a blood pressure sensor, a temperature sensor, a pulse oximeter, a blood glucose sensor, a weight scale, a body composition machine/analyzer, and/or any other sensor or system for measuring biometrics. The one or more biometric systems 106 can include one or more communication interfaces (e.g., wired and/or wireless) for communicating test results and/or measurements to other devices such as the medical system 120, the collaborative smart screen 102; para 33, 44, 64, 80, 82,96)
In regard to claim 11, Aoun et al. discloses: A system (i.e., smart screen 102 of medical system 120 described in para 23 and 41 (smart screen) and para 25, 37, and 82 (medical system)) comprising one or more processors, and a non-transitory computer-readable medium including one or more sequences of instructions that, when executed by the one or more processors, cause the system to perform operations comprising (para 108-112 discusses the system processors and non-transitory computer readable medium): receiving, for a patient, analyzed patient data from a medical intelligence module operating on a server (flow chart of figure 5, step 400, para 87, medical system receives patient data wherein the receipt includes patient’s current medical data compared to data of the medical data of the general population, wherein this comparison step is considered to be analyzed data; para 55 and 57 employes machine learning (i.e., medical intelligence) to implement one or more neural networks and/or machine learning models to perform one or more machine learning tasks for analysis of medical data to form medical diagnosis, health monitoring, decision making, health metrics analytics, medical testing analytics, optimization, etc; para 25 teaches that one or more computing components of the medical system 120 may be implemented on a server; Additionally, the embodiment of figure 6 at step 602 is considered to read on this step, para 94-96); determining one or more medical conditions or disorders that a patient has been diagnosed with (step 502 of figure 5, para 87, the medical system can analyze all or some of this data to determine whether a notable condition is present; the embodiment of figure 6 also reads on this, para 97); determining one or more medical interventions for each medical condition or disorder, wherein the medical interventions comprise procedures, tests, screenings or courses of action (step 506/508 figure 5, para 87, the medical system can analyze all or some of this data to determine whether a notable condition is present, and if so, which appropriate medical treatment 406 is necessary or recommended at this time….the medical system 120 can provide the determined medical treatment 406 to the patient 408 for immediate action; para 85-86the treatment plan comprises actions or tasks that include nutritional plans, referrals, record requests, scans, suggested tests, measurements, diet plans, medications, treatments, procedures, examinations, orders, action which are all considered to be associated with the medical condition or disorder; para 88, the medical system 120 can determine if the patient has a condition worth noting and pursuing a customized treatment plan; figure 6 embodiment step 608, para 99); determining a risk profile for the patient, wherein the risk profile comprises a risk category for each of the patient's medical conditions or disorders (para 45, smart screen 102 can dynamically display suggestions, tasks, relevant and/or contextual data, health metrics, agenda items, action items; step 508, figure 5; para 85-86, the treatment plan comprises actions or tasks that include nutritional plans, referrals, record requests, scans, suggested tests, measurements, diet plans, medications, treatments, procedures, examinations, orders, action which are all considered to be associated with the medical condition or disorder; para 86, additional actions or tasks are discussed; figure 6 embodiment is encompassed by step 610). It is noted that with respect to the risk determination step above, Auon et al. is silent with respect to further creating a risk profile or risk category for a determined medical condition when determining the risk. However, determining a risk profile or category is considered obvious to one of ordinary skill in the art as mere organization and categorization of data. Auon et al. is considered to disclose various aspects of the present invention, however does not teach the steps of:
determining a recommended due date for each of the determined procedures, tests, screenings and courses of action associated with the patient's medical condition or disorder based on the analyzed patient data;
displaying, by a user interface on a patient device, the one or more action items associated with the patient, wherein the action items comprise a visual representation of priority, status, risk category, recommended due date and an indication of the an amount of time until the recommended due date or an indication of how overdue a patient action is based on the recommended due date; receiving, from the user interface, a selection of a displayed action item;
displaying to the patient, through the user interface, a detailed view of the action item;
initiating, from the detailed view, a scheduling process associated with the corresponding action item's medical condition or disorder.
McCabe et al. is directed to systems and methods for managing monitoring, and treating patient conditions. McCabe et al. is considered to teach and suggest the following functions: determining a recommended due date for each of the determined procedures, tests, screenings and courses of action associated with the patient's medical condition or disorder based on the analyzed patient data para 240, a deadline is established for the patient goals; para 137, McCabe et al. may display on patient overview screen 50 information related to overdue actions indicator (considered to suggest a due date (such as the deadline taught in para 240) with a clock timer was initially set for an action or goal); creating one or more action items, wherein each action item is associated with a medical condition or disorder, a medical intervention, a risk category and a recommended due date (para 121, a treatment protocol is devised (e.g., see para 85 and 102), wherein the treatment protocol include establishing of patient goals, wherein the goals are considered to comprise items for patient action); displaying, by a user interface on a patient device, the one or more action items associated with the patient, wherein the action items comprise a visual representation of priority, status, risk category, recommended due date and an indication of the an amount of time until the recommended due date or an indication of how overdue a patient action is based on the recommended due date (para 132, screens may be configured to display data identifying the patient's status, goals, risk profile, and/or potential outcomes for an individual patient; additionally, para 137, screen 50 display information related to overdue actions; para 146 and 230, the goals are displayed in a screen title 54 labeled GOALS which may be selectable option on the user interface); receiving, from the user interface, a selection of a displayed action item (para 146 and 230, the goals are displayed in a screen title 54 labeled GOALS which may be selectable option on the user interface; para 231, the goal portion or pane 154 may have one or more selectable features configured to facilitate a user viewing, adjusting, and/or setting goals for the selected patient); displaying to the patient, through the user interface, a detailed view of the action item (para 239, in response to selecting (e.g., scrolling over, clicking on, etc.) a goal listed in the goal portion or pane 154, a goal summary 164 may be displayed that is associated with the selected goal)); initiating, from the detailed view, a scheduling process associated with the corresponding action item's medical condition or disorder para 120, an outputted indication of a condition includes a control signal to initiate an appointment invite or other suitable scheduling mechanism to schedule a medical provider to initiate or perform a treatment, wherein establishment of the control signal implies action to be taken by the user).
It is considered to have been obvious to one of ordinary skill in the art to modify the system of Aoun et al. to include instructions in the computer readable medium to display a diagnosis, patient actions derived from the treatment plan, associated risk profiles, and due data for such action, and to allow for scheduling of events related thereto as taught by McCabe et al. because such features represent routine presentation and organization of medical information to improve usability, compliance, and care coordination, yielding predictable results without requiring undue experimentation. The modification would comprise the application of a known technique to a known device to yield a predictable result.
In regard to claim 12, Aoun et al. further discloses that the patient device is configured to: establish a connection to one or more patient operated medical devices (e.g., biometric subsystems 106 and/or devices 102-116 as taught in para 27-36); receive, from the one or more patient operated medical devices, one or more physiological parameters for the patient; create one or more action items corresponding to the received physiological parameters (para 64); and display to the patient, through the user interface, a visual representation of the received physiological parameters (para 30 and 44, the system 120 may be enabled to collect data from various biometric and computing subsystems such data includes collecting test results, health metrics, physiological parameters (e.g., heart rate, blood pressure, temperature etc) and display them; also see para 80 and 96).
In regard to claim 13 (interpreted as a proper Markush claim), Aoun et al. discloses that the one or more patient operated medical devices includes: a weight scale; a blood pressure monitor, wherein the blood pressure monitor includes a sleave sensor unit; a thermometer; an electrocardiogram; and a smartwatch (para 35, 44, and 96), worn by the patient, wherein the smartwatch includes one or more biosensors and wherein the smartwatch is configured to determine one or more physiological parameters of the patient (US 2019/0209022 demon that smartwatches have this capacity), the physiological parameters including: heart rate variability; general variability; pulse rate; pulse oximetry; and skin conductance response (para 30, one or more biometrics systems 106 in the medical care site 100 can include one or more biometrics sensors and/or devices such as, for example, a heart rate sensor, a blood pressure sensor, a temperature sensor, a pulse oximeter, a blood glucose sensor, a weight scale, a body composition machine/analyzer, and/or any other sensor or system for measuring biometrics. The one or more biometric systems 106 can include one or more communication interfaces (e.g., wired and/or wireless) for communicating test results and/or measurements to other devices such as the medical system 120, the collaborative smart screen 102; para 33, 44, 64, 80, 82,96)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 2 February 2026