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 .
Status of Claims
This action is a non-final rejection
Claims 1-20 are pending
Claims 1-20 are rejected under 35 USC § 101
Claim 1-20 is rejected under 35 USC § 103
Priority
Acknowledgement is made of Applicant’s claim for a domestic priority date of 9-25-2024
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are not patent eligible because the claimed invention is directed to an abstract idea without significantly more.
Analysis
First, claims are directed to one or more of the following statutory categories: a process, a machine, a manufacture, and a composition of matter. Regarding claims 1-20 the claims recite an abstract idea of active monitoring of clients by advisors.
Independent Claims 1, 19, 20 are rejected under 35 U.S.C 101 based on the following analysis.
-Step 1 (Does the claim fall within a statutory category? YES): claims 1, 19, 20 recite respectively a method, system and a non-transitory computer-readable medium respectively.
-Step 2A Prong One (Does the claim fall within at least one of the groupings of abstract ideas?: YES): The claimed invention:
receiving, into a model, values of characteristics associated with a subject, wherein the model is configured to process data for a plurality of clients and to evaluate an effectiveness of a monitoring program, wherein the plurality of clients includes a monitored subset of clients who have been subject to the monitoring program, wherein the monitoring program is configured to send notifications to one or more advisors when sensor data satisfies an alert rule for a client, and wherein the alert rule for the client is customizable by the one or more advisors;
generating, using the model, a classification of the effectiveness of the monitoring program for the subject; and
inputting a status of the subject into the monitoring program using the classification, wherein the status indicates whether to implement the monitoring program for the subject;
belonging to the grouping of mental processes under concepts performed in the human mind (including an observation, evaluation, judgement, opinion) as it recites “active monitoring of clients by advisors”. Alternatively, the selected abstract idea belongs to the grouping of certain methods of organizing human activity under managing personal behavior or relationships or interactions between people as it recites “active monitoring of clients by advisors” (refer to MPP 2106.04(a)(2)). Accordingly this claim recites an abstract idea.
-Step 2A Prong Two (Are there additional elements in the claim that imposes a meaningful limit on the abstract idea? NO).
Claims 1, 19 20 recite:
sensor;
Claim 19 recites:
one or more processors;
one or more processors;
A non-transitory computer-readable medium storing instructions that when executed by one or more processors, cause the one or more processor to perform.
Claim 20 recites:
A non-transitory computer-readable medium storing instructions that when executed by one or more processors, cause the one or more processor to perform.
Amounting to additional elements that are recited at a high-level of generality such that it amounts to no more than mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)). Accordingly, the claim as a whole does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
-Step 2B (Does the additional elements of the claim provide an inventive concept?: NO. As discussed previously with respect to Step 2A Prong Two:
Claims 1, 19 20 recite:
sensor;
Claim 19 recites:
one or more processors;
one or more processors;
A non-transitory computer-readable medium storing instructions that when executed by one or more processors, cause the one or more processor to perform.
Claim 20 recites:
A non-transitory computer-readable medium storing instructions that when executed by one or more processors, cause the one or more processor to perform.
Amount to additional elements that are recited at a high-level of generality such that it amounts to no more than mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)) Accordingly, even in combination the additional elements of the claim do not provide an inventive concept (significantly more than the abstract idea) and hence the claim is ineligible.
Dependent Claims:
Step 2A Prong One: The following dependent claims recite additional limitations that further define the abstract idea of “monitoring, tracking and reporting user emotional states”: claims 2-18.
Step 2A Prong Two (Are there additional elements in the claim that imposes a meaningful limit on the abstract idea? NO). The following dependent claims 3, 5-7, 11-12 recite mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)). Accordingly, the claims as a whole do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Step 2B (Does the additional elements of the claim provide an inventive concept?: NO). As discussed previously with respect to Step 2A Prong Two, the following dependent claims 3, 5-7, 11-12 recite mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)). Accordingly, the claim does not provide an inventive concept (significantly more than the abstract idea) and hence the claim is ineligible.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or
non-obviousness.
Claims 1-4, 8-15, 17-20 are rejected under 35 U.S.C. 103 as being un-patentable by Sadeghzadeh et.al (US 20200246543 A1) hereinafter “Sadeghzadeh” in view of Janssen et.al. (US 20210043326 A1) hereinafter “Janssen”
Regarding claims 1, 11, 20 Curtis teaches:
one or more processors; (See at least [0032] via: “... the processing system may be implemented using any suitable processing system and/or device, such as, for example, one or more processors, central processing units (CPUs), controllers, microprocessors, microcontrollers, processing cores and/or other hardware computing resources configured to support the operation of the processing system and
a non-transitory computer-readable medium storing instructions that when executed by the one or more processors cause the one or more processor to perform a method comprising: (See at least [0032] via: “...The server 102 generally includes a processing system and a data storage element (or memory) capable of storing programming instructions for execution by the processing system, that, when read and executed, cause processing system to create, generate, or otherwise facilitate the applications or software modules configured to perform or otherwise support the processes, tasks, operations, and/or functions described herein..”)
A non-transitory computer-readable medium storing instructions that when executed by one or more processors, cause the one or more processor to perform a method comprising: (See at least [0032] via: “...The server 102 generally includes a processing system and a data storage element (or memory) capable of storing programming instructions for execution by the processing system, that, when read and executed, cause processing system to create, generate, or otherwise facilitate the applications or software modules configured to perform or otherwise support the processes, tasks, operations, and/or functions described herein..”)
receiving, into a model (patient monitoring application 110 ), values of characteristics associated with a subject (obtains patient data), (See at least [0034] via: “...patient monitoring application 110 that receives or otherwise obtains patient data 120, 122 and monitoring settings data 124 from the database 104 and generates or otherwise provides a dashboard GUI display using the patient data 120, 122 in accordance with the monitoring settings data 124....”; in addition see at least [0035] via: “...the server 102 may receive, from a medical device via the network 108, measurement data values associated with a particular patient (e.g., sensor glucose measurements, acceleration measurements, and the like) that were obtained using a sensing element, and the server 102 stores or otherwise maintains the historical measurement data as patient data 120 in the database 104 in association with the patient (e.g., using one or more unique patient identifiers). Additionally, the server 102 may also receive, from or via a client device 106, meal data or other event log data that may be input or otherwise provided by the patient (e.g., via a client application at the client device 106) and store or otherwise maintain historical meal data and other historical event or activity data associated with the patient in the database 104....”)
wherein the model is configured to process data for a plurality of clients (multiple patients concurrently for monitoring ) and to evaluate an effectiveness (reducing the amount of time required) of a monitoring program, (See at least [0037] via: “...systems for presenting information pertaining to the real-time physiological condition of multiple patients concurrently for monitoring by a physician or other healthcare provider...”; in addition see at least [0059] via: “... not only may the doctor's time may be more effectively devoted to patients most in need of attention, but the patient monitoring GUI display 200, 400 also facilitates expeditious analysis and/or intervention with those patients, thereby reducing the amount of time required for dealing with those patients, which, in turn, further increases the available time for attending to additional patients)
wherein the plurality of clients includes a monitored subset (a subset of patients having associated data in one of the data sets 120, 122) of clients who have been subject to the monitoring program, (See at least [0033] via: “...the database 104 is utilized to store or otherwise maintain historical observational patient data 120 (e.g., measurement data, event log data, and the like) and electronic medical records data 122 for a plurality of different patients. In this regard, a subset of patients having associated data in one of the data sets 120, 122, may also have associated data in another one of the data sets 120, 122. That is, some but not necessarily all of the patients having associated with one of the data sets 120, 122 may be common to another of the data sets 120, 122. ..”; in addition see at least [0042] via: “...the subset of patients exhibiting the highest priority events may be ordered first, with those patients being ordered within that respective subset being ordered in accordance with their relative number or severity of adverse events, with the subset of patients exhibiting medium priority events being ordered after the highest priority subset, with those patients being ordered within that respective subset being ordered in accordance with their relative number or severity of adverse events..”)
wherein the monitoring program is configured to send notifications (automatically generate a text message) to one or more advisors (text message to be sent to a ... doctor) when sensor data satisfies an alert (a hypoglycemic event) rule for a client, (See at least [0051] via: “... the server 102 and/or the monitoring application 110 may automatically generate a text message configured to notify Bob Evans that he is currently experiencing a hypoglycemic event and should consume rescue carbohydrates or take other action, and the server 102 and/or the monitoring application 110 may automatically configure the text message to be sent to a stored phone number associated with Bob Evans in the database 104. The doctor or healthcare provider may then briefly review the text message and modify it as desired before sending it to the patient
wherein the alert rule for the client is customizable by the one or more advisors (See at least [0051] via: “...notification rules may be created in conjunction with the prioritization rules to automatically generate messages or notifications to be provided to a symptomatic patient..”)
generating, using the model, a classification of the effectiveness of the monitoring program for the subject; (See at least [0042] via: “...fourth column 316 is utilized to assign a ranking or priority to the respective adverse event being utilized for prioritization. In this regard, patient's exhibiting adverse events assigned higher levels of priority may be ordered in the patient list region 204 ahead of other patient's that are asymptomatic or exhibiting adverse events assigned relatively lower levels of priority. In situations where multiple patients may be exhibiting multiple different prioritizable adverse events concurrently, the subset of patients exhibiting the highest priority events may be ordered first, with those patients being ordered within that respective subset being ordered in accordance with their relative number or severity of adverse events, with the subset of patients exhibiting medium priority events being ordered after the highest priority subset, with those patients being ordered within that respective subset being ordered in accordance with their relative number or severity of adverse events, and so on...”; in addition see at least [0043] via: “...The prioritization rules region 302 in FIG. 3 depicts prioritization rules for assigning the highest level of priority to patients exhibiting a hypoglycemic event with a measured glucose level below 55 mg/dL for more than 10 minutes or a hyperglycemic event with a measured glucose level above 300 mg/dL for more than 20 minutes. The prioritization rules depicted in FIG. 3 also assign a medium level of priority to patients exhibiting a hypoglycemic event with a measured glucose level below 80 mg/dL for more than 20 minutes, a hyperglycemic event with a measured glucose level above 260 mg/dL for more than 20 minutes, or a time in range percentage of less than 60%. Lastly, the lowest level or priority may be assigned to patients exhibiting a time in range of less than 80%...”) The examiner notes in Fig. 3 there is classification of patients in column 310 whether the patient displays hypoglycemia or is in range and addition ally in column 316 regarding the ranking of priority of adverse effects...”) and
However, Sadeghzadeh is silent the following limitation that is taught by Janssen:
inputting a status of the subject into the monitoring program using the classification, wherein the status indicates whether to implement the monitoring program for the subject. (See at least [0148] via: “...As an example of the categorization of the patients, the telemetry management system may first determine whether a given patient is connected to a monitor (e.g., a telemetry monitoring sensor, such as the telemetry monitoring sensors described above). If the patient is not connected to the monitor, a physician order for telemetry monitoring has not been made, and the patient meets guidelines to be unmonitored, the patient may be categorized in the “no action; no monitor needed” category. If the patient is not connected to the monitor, a physician order for telemetry monitoring has not been made, and the patient does not meet guidelines to be unmonitored, the patient is categorized in the “need physician order and connect” category. If the patient is not connected to the monitor, a physician order for telemetry monitoring has been made, and the patient meets guidelines for monitoring, the patient is categorized in the “requires hookup to monitor” category...”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Sadeghzadeh to incorporate the teachings of Janssen. Those in the art would have recognized that Sadeghzadeh’s teaching regarding monitoring a plurality of patients, obtaining measurement data for the plurality of patients from a database, obtaining one or more prioritization rules from the database, generating a prioritized list of the plurality of patients based on the measurement data in accordance with the one or more prioritization rules, and providing a dashboard graphical user interface (GUI) display including the prioritized list, and dynamically updating the prioritized list in response to updated measurement data in the database, could be modified to include Janssen’s teaching regarding categorization of the patients such that they are either monitored or not depending on whether they meet the guidelines to be monitored or not. This combination would be beneficial in that the patients that don’t need to be monitored are not monitored and those that do require monitored are monitored.
Regarding claim 2 Sadeghzadeh and Janssen teach the invention as claimed and detailed above with respect to claim 1. Sadeghzadeh is silent the following claim that is taught by Janssen:
the plurality of clients includes an unmonitored subset of clients who have not been subject to the monitoring program. (See at least [0148] via: “...As an example of the categorization of the patients, the telemetry management system may first determine whether a given patient is connected to a monitor (e.g., a telemetry monitoring sensor, such as the telemetry monitoring sensors described above). If the patient is not connected to the monitor, a physician order for telemetry monitoring has not been made, and the patient meets guidelines to be unmonitored, the patient may be categorized in the “no action; no monitor needed” category...”)
Regarding claims 3 Sadeghzadeh and Janssen teach the invention as claimed and detailed above with respect to claim 1. Sadeghzadeh also teaches:
the status indicates implementing the monitoring program for the subject, and implementing includes comparing sensor data to a set of subject alert rules. (See at least [0104] via: “...The sensing arrangement 1004 generally represents the components of the infusion system 1000 configured to sense, detect, measure or otherwise quantify a condition of the user, and may include a sensor, a monitor, or the like, for providing data indicative of the condition that is sensed, detected, measured or otherwise monitored by the sensing arrangement. In this regard, the sensing arrangement 1004 may include electronics and enzymes reactive to a biological or physiological condition of the user, such as a blood glucose level, or the like, and provide data indicative of the blood glucose level to the infusion device 1002, the CCD 1006 and/or the computer 1008..; in addition see at least [0028] via: “...the listing of patients on the dashboard GUI display is prioritized in accordance with one or more prioritization rules and dynamically updated in real-time in response to changes to the physiological condition to one or more patients. In this regard, infusion devices, continuous glucose monitoring (CGM) devices, or other medical devices associated with the patients may periodically or continually obtain new measurements of a respective patient's glucose level and upload the measurement data to a remote server or database substantially in real-time. As the glycemic state of different patients change, they move up or down in the prioritized list according to the prioritization rule..”)
Regarding claims 4 Sadeghzadeh and Janssen teach the invention as claimed and detailed above with respect to claim 1. Sadeghzadeh also teaches:
the status indicates implementing the monitoring program for the subject, and implementing includes sending a notification to a target advisor. (See at least [0058] via: “...As described above in the context of FIGS. 2-4, the loop defined by tasks 706, 708 and 710 may periodically or continually repeat during presentation of the patient monitoring dashboard GUI display to dynamically update the patient list region in real-time in response to changes in the measurement data associated with one or more patients. For example, in response to an updated sensor glucose measurement below 55 mg/dL for patient Bob Evans that indicates a hypoglycemic event below 55 mg/dL for a duration that exceeds 10 minutes, the server 102 and/or the patient monitoring application 110 dynamically updates the prioritized patient list to rank Bob Evans first among the doctor or care provider's associated patients since Bob Evans is currently exhibiting a higher priority adverse event than any of the doctor or care provider's other patients. The server 102 and/or the patient monitoring application 110 then updates the patient list region 204 in a corresponding manner to repopulate the first row in the patient list region 204 with values for the fields or columns corresponding to the newly highest priority patient Bob Evans, while repopulating the second row in the patient list region 204 with values for the fields or columns corresponding to the previous highest priority patient Kevin Adams, and so on until reaching the display threshold. Thus, the doctor or care provider may be readily apprised of the change in the status of the physiological condition of Bob Evans substantially in real-time...”)
Regarding claims 8 Sadeghzadeh and Janssen teach the invention as claimed and detailed above with respect to claim 1. Sadeghzadeh also teaches:
the model determines the monitoring program is effective for a cohort of clients; (See at least [0037] via: “...FIG. 2 depicts an exemplary embodiment of a patient monitoring dashboard GUI display 200 that may be presented on a display device associated with an electronic device, such as, for example, a computing device, a portable medical device, a sensor device, or the like...The patient list region 204 includes a listing of patients associated with the doctor or other healthcare provider utilizing the electronic device viewing the dashboard GUI display 200. In this regard, in one or more embodiments, the patient list tab 202 is selected or otherwise activated by default, with the patient list region 204 being populated with a listing of patients associated with the user of the electronic device in response to authenticating the user of the electronic device (e.g., upon a doctor or other healthcare provider logging in to the patient monitoring application 110 provided by the server 102)..”)
the cohort of clients is distinguished from other patients by having values of characteristics in specific ranges associated with the characteristics; (See at least [0037] via: “...As described in greater detail below, in exemplary embodiments, the listing of patients presented within the patient list region 204 is prioritized or otherwise ordered in accordance with one or more prioritization rules associated with the particular doctor or healthcare provider..”) and
generating the classification of the effectiveness of the monitoring program includes comparing the values of the characteristics associated with the subject with the values of the characteristics associated with the cohort of clients. (See at least [0042] via: “...fourth column 316 is utilized to assign a ranking or priority to the respective adverse event being utilized for prioritization. In this regard, patient's exhibiting adverse events assigned higher levels of priority may be ordered in the patient list region 204 ahead of other patient's that are asymptomatic or exhibiting adverse events assigned relatively lower levels of priority. In situations where multiple patients may be exhibiting multiple different prioritizable adverse events concurrently, the subset of patients exhibiting the highest priority events may be ordered first, with those patients being ordered within that respective subset being ordered in accordance with their relative number or severity of adverse events, with the subset of patients exhibiting medium priority events being ordered after the highest priority subset, with those patients being ordered within that respective subset being ordered in accordance with their relative number or severity of adverse events, and so on...”; in addition see at least [0043] via: “...The prioritization rules region 302 in FIG. 3 depicts prioritization rules for assigning the highest level of priority to patients exhibiting a hypoglycemic event with a measured glucose level below 55 mg/dL for more than 10 minutes or a hyperglycemic event with a measured glucose level above 300 mg/dL for more than 20 minutes. The prioritization rules depicted in FIG. 3 also assign a medium level of priority to patients exhibiting a hypoglycemic event with a measured glucose level below 80 mg/dL for more than 20 minutes, a hyperglycemic event with a measured glucose level above 260 mg/dL for more than 20 minutes, or a time in range percentage of less than 60%. Lastly, the lowest level or priority may be assigned to patients exhibiting a time in range of less than 80%...”) The examiner notes in Fig. 3 there is classification of patients in column 310 whether the patient displays hypoglycemia or is in range and addition ally in column 316 regarding the ranking of priority of adverse effects...”)
Regarding claims 9 Sadeghzadeh and Janssen teach the invention as claimed and detailed above with respect to claim 1. Sadeghzadeh also teaches:
the model determines the monitoring program is effective for a cohort of patients; (See at least [0037] via: “...FIG. 2 depicts an exemplary embodiment of a patient monitoring dashboard GUI display 200 that may be presented on a display device associated with an electronic device, such as, for example, a computing device, a portable medical device, a sensor device, or the like...The patient list region 204 includes a listing of patients associated with the doctor or other healthcare provider utilizing the electronic device viewing the dashboard GUI display 200. In this regard, in one or more embodiments, the patient list tab 202 is selected or otherwise activated by default, with the patient list region 204 being populated with a listing of patients associated with the user of the electronic device in response to authenticating the user of the electronic device (e.g., upon a doctor or other healthcare provider logging in to the patient monitoring application 110 provided by the server 102)..”)
the cohort of patients is distinguished from other patients by having values of characteristics in specific ranges associated with the characteristics; (See at least [0037] via: “...As described in greater detail below, in exemplary embodiments, the listing of patients presented within the patient list region 204 is prioritized or otherwise ordered in accordance with one or more prioritization rules associated with the particular doctor or healthcare provider..”) and
generating the classification of the effectiveness of the monitoring program includes determining the subject is categorized as being in the cohort of patients. (See at least [0042] via: “...fourth column 316 is utilized to assign a ranking or priority to the respective adverse event being utilized for prioritization. In this regard, patient's exhibiting adverse events assigned higher levels of priority may be ordered in the patient list region 204 ahead of other patient's that are asymptomatic or exhibiting adverse events assigned relatively lower levels of priority. In situations where multiple patients may be exhibiting multiple different prioritizable adverse events concurrently, the subset of patients exhibiting the highest priority events may be ordered first, with those patients being ordered within that respective subset being ordered in accordance with their relative number or severity of adverse events, with the subset of patients exhibiting medium priority events being ordered after the highest priority subset, with those patients being ordered within that respective subset being ordered in accordance with their relative number or severity of adverse events, and so on...”; in addition see at least [0043] via: “...The prioritization rules region 302 in FIG. 3 depicts prioritization rules for assigning the highest level of priority to patients exhibiting a hypoglycemic event with a measured glucose level below 55 mg/dL for more than 10 minutes or a hyperglycemic event with a measured glucose level above 300 mg/dL for more than 20 minutes. The prioritization rules depicted in FIG. 3 also assign a medium level of priority to patients exhibiting a hypoglycemic event with a measured glucose level below 80 mg/dL for more than 20 minutes, a hyperglycemic event with a measured glucose level above 260 mg/dL for more than 20 minutes, or a time in range percentage of less than 60%. Lastly, the lowest level or priority may be assigned to patients exhibiting a time in range of less than 80%...”) The examiner notes in Fig. 3 there is classification of patients in column 310 whether the patient displays hypoglycemia or is in range and addition ally in column 316 regarding the ranking of priority of adverse effects...”)
Regarding claim 10 Sadeghzadeh and Janssen teach the invention as claimed and detailed above with respect to claim 1. Sadeghzadeh also teaches:
the monitoring program includes a plurality of instructions, and the plurality of instructions includes receiving, from the one or more advisors, a plurality of sets of alert rules for the monitored subset of clients. (See at least [0044] via: “... although not illustrated in FIG. 3, in some embodiments, prioritization rules region 302 may also include additional columns for defining automated actions to be performed in response to detecting certain types of adverse events. In this regard, for each adverse event defined by the user for prioritization, the user may also define one or more notification rules that may be stored in association with the prioritization rules in the monitoring settings data 124 in the database 104, which, in turn, may be utilized to automatically provide notifications on behalf of the user to the particular patient exhibiting the adverse event. For example, user may specify that the patient should automatically receive a text message, an email, a push notification, or the like in response to detecting a particular adverse event. The body or content of the automated communication may also be configured or otherwise defined by the user. For example, a doctor or other healthcare provider may create a template message requesting the patient schedule an appointment or perform some other action, when the time in range falls below 60% and then create a notification rule associated with the time in range below 60% adverse event that results in the remote server 102 and/or the monitoring application 110 automatically initiating the desired type of communication with the autopopulated content to a particular patient in real-time in response to that patient's time in range falling below 60%. In this regard, automated notifications may be configured by the doctor or other healthcare provider to reduce the amount of time he or she spends on otherwise routine communications, thereby allowing the doctor or other healthcare provider to maintain focus on monitoring or assessing..”)
Regarding claim 11 Sadeghzadeh and Janssen teach the invention as claimed and detailed above with respect to claim 1. Sadeghzadeh also teaches:
the monitoring program includes a plurality of instructions, the plurality of instructions includes receiving a plurality of sensor data from a plurality of sensors, and the plurality of sensor data provides information about the monitored subset of clients. (See at least [0044] via: “... although not illustrated in FIG. 3, in some embodiments, prioritization rules region 302 may also include additional columns for defining automated actions to be performed in response to detecting certain types of adverse events. In this regard, for each adverse event defined by the user for prioritization, the user may also define one or more notification rules that may be stored in association with the prioritization rules in the monitoring settings data 124 in the database 104, which, in turn, may be utilized to automatically provide notifications on behalf of the user to the particular patient exhibiting the adverse event. For example, user may specify that the patient should automatically receive a text message, an email, a push notification, or the like in response to detecting a particular adverse event. The body or content of the automated communication may also be configured or otherwise defined by the user. For example, a doctor or other healthcare provider may create a template message requesting the patient schedule an appointment or perform some other action, when the time in range falls below 60% and then create a notification rule associated with the time in range below 60% adverse event that results in the remote server 102 and/or the monitoring application 110 automatically initiating the desired type of communication with the autopopulated content to a particular patient in real-time in response to that patient's time in range falling below 60%. In this regard, automated notifications may be configured by the doctor or other healthcare provider to reduce the amount of time he or she spends on otherwise routine communications, thereby allowing the doctor or other healthcare provider to maintain focus on monitoring or assessing..”)
Regarding claim 12 Sadeghzadeh and Janssen teach the invention as claimed and detailed above with respect to claim 1. Sadeghzadeh also teaches:
the monitoring program includes a plurality of instructions, and the plurality of instructions includes comparing the plurality of sensor data to a plurality of sets of alert rules for the monitored subset of clients. (See at least [0044] via: “... although not illustrated in FIG. 3, in some embodiments, prioritization rules region 302 may also include additional columns for defining automated actions to be performed in response to detecting certain types of adverse events. In this regard, for each adverse event defined by the user for prioritization, the user may also define one or more notification rules that may be stored in association with the prioritization rules in the monitoring settings data 124 in the database 104, which, in turn, may be utilized to automatically provide notifications on behalf of the user to the particular patient exhibiting the adverse event. For example, user may specify that the patient should automatically receive a text message, an email, a push notification, or the like in response to detecting a particular adverse event. The body or content of the automated communication may also be configured or otherwise defined by the user. For example, a doctor or other healthcare provider may create a template message requesting the patient schedule an appointment or perform some other action, when the time in range falls below 60% and then create a notification rule associated with the time in range below 60% adverse event that results in the remote server 102 and/or the monitoring application 110 automatically initiating the desired type of communication with the autopopulated content to a particular patient in real-time in response to that patient's time in range falling below 60%. In this regard, automated notifications may be configured by the doctor or other healthcare provider to reduce the amount of time he or she spends on otherwise routine communications, thereby allowing the doctor or other healthcare provider to maintain focus on monitoring or assessing.
Regarding claim 13 Sadeghzadeh and Janssen teach the invention as claimed and detailed above with respect to claim 1. Sadeghzadeh also teaches:
the monitoring program includes a plurality of instructions the plurality of instructions includes receiving, from the one or more advisors, a plurality of sets of alert rules for the monitored subset of clients and the plurality of sets of alert rules includes different sets of alert rules. (See at least [0044] via: “... although not illustrated in FIG. 3, in some embodiments, prioritization rules region 302 may also include additional columns for defining automated actions to be performed in response to detecting certain types of adverse events. In this regard, for each adverse event defined by the user for prioritization, the user may also define one or more notification rules that may be stored in association with the prioritization rules in the monitoring settings data 124 in the database 104, which, in turn, may be utilized to automatically provide notifications on behalf of the user to the particular patient exhibiting the adverse event. For example, user may specify that the patient should automatically receive a text message, an email, a push notification, or the like in response to detecting a particular adverse event. The body or content of the automated communication may also be configured or otherwise defined by the user. For example, a doctor or other healthcare provider may create a template message requesting the patient schedule an appointment or perform some other action, when the time in range falls below 60% and then create a notification rule associated with the time in range below 60% adverse event that results in the remote server 102 and/or the monitoring application 110 automatically initiating the desired type of communication with the autopopulated content to a particular patient in real-time in response to that patient's time in range falling below 60%. In this regard, automated notifications may be configured by the doctor or other healthcare provider to reduce the amount of time he or she spends on otherwise routine communications, thereby allowing the doctor or other healthcare provider to maintain focus on monitoring or assessing..”).
Regarding claim 14 Sadeghzadeh and Janssen teach the invention as claimed and detailed above with respect to claim 1. Sadeghzadeh also teaches:
the monitoring program includes a plurality of instructions, and the plurality of instructions includes receiving, from the one or more advisors an instruction for whether to send a follow-up notifications to the client after an initial notification to the client. (See at least [0040] via: “...In the illustrated embodiment of FIG. 2, another column 218 adjacent to the patient status column 216 corresponds to notifications or other graphical indicia pertaining to the patient's current physiological condition. As described in greater detail below in the context of FIGS. 3-4, in exemplary embodiments, the listing of patients in the patient region 204 are prioritized or otherwise ordered in accordance with one or more prioritization rules, where the column 218 may utilized to provide a notification pertaining to the patient's physiological condition or other indication of the underlying reason that dictated or otherwise influenced the respective patient's ranking in the list...”; in addition see at least [0059] via: “...For example, a doctor may identify patient Kevin Adams has having a relatively low time in range percentage than other patients, select the report button 228 to navigate directly to the report GUI display 500 for Kevin Adams from a patient monitoring GUI display 200, 400. The doctor may review the report GUI display 500 utilize GUI elements 512 provided on the report GUI display 500 to contact Kevin Adams to provide recommendations or therapy modifications to improve his time in range, and/or navigate back to the patient monitoring GUI display 200, 400 to utilize other GUI elements 222, 224, 226 to contact Kevin Adams...”)
Regarding claim 15 Sadeghzadeh and Janssen teach the invention as claimed and detailed above with respect to claim 1. Sadeghzadeh also teaches:
implementing the monitoring program for the subject, and sending an initial notification and a follow-up notification to the subject. (See at least [0040] via: “...In the illustrated embodiment of FIG. 2, another column 218 adjacent to the patient status column 216 corresponds to notifications or other graphical indicia pertaining to the patient's current physiological condition. As described in greater detail below in the context of FIGS. 3-4, in exemplary embodiments, the listing of patients in the patient region 204 are prioritized or otherwise ordered in accordance with one or more prioritization rules, where the column 218 may utilized to provide a notification pertaining to the patient's physiological condition or other indication of the underlying reason that dictated or otherwise influenced the respective patient's ranking in the list...”; in addition see at least [0059] via: “...For example, a doctor may identify patient Kevin Adams has having a relatively low time in range percentage than other patients, select the report button 228 to navigate directly to the report GUI display 500 for Kevin Adams from a patient monitoring GUI display 200, 400. The doctor may review the report GUI display 500 utilize GUI elements 512 provided on the report GUI display 500 to contact Kevin Adams to provide recommendations or therapy modifications to improve his time in range, and/or navigate back to the patient monitoring GUI display 200, 400 to utilize other GUI elements 222, 224, 226 to contact Kevin Adams...”)
Regarding claim 17 Sadeghzadeh and Janssen teach the invention as claimed and detailed above with respect to claim 1. Sadeghzadeh also teaches:
receiving a selection of a profile for the subject, wherein the profile includes a set of alert rules. (See at least [0044] via: “... although not illustrated in FIG. 3, in some embodiments, prioritization rules region 302 may also include additional columns for defining automated actions to be performed in response to detecting certain types of adverse events. In this regard, for each adverse event defined by the user for prioritization, the user may also define one or more notification rules that may be stored in association with the prioritization rules in the monitoring settings data 124 in the database 104, which, in turn, may be utilized to automatically provide notifications on behalf of the user to the particular patient exhibiting the adverse event. For example, user may specify that the patient should automatically receive a text message, an email, a push notification, or the like in response to detecting a particular adverse event. The body or content of the automated communication may also be configured or otherwise defined by the user. For example, a doctor or other healthcare provider may create a template message requesting the patient schedule an appointment or perform some other action, when the time in range falls below 60% and then create a notification rule associated with the time in range below 60% adverse event that results in the remote server 102 and/or the monitoring application 110 automatically initiating the desired type of communication with the autopopulated content to a particular patient in real-time in response to that patient's time in range falling below 60%. In this regard, automated notifications may be configured by the doctor or other healthcare provider to reduce the amount of time he or she spends on otherwise routine communications, thereby allowing the doctor or other healthcare provider to maintain focus on monitoring or assessing..”)
Regarding claim 18 Sadeghzadeh and Janssen teach the invention as claimed and detailed above with respect to claim 1. Sadeghzadeh also teaches:
receiving, from a target advisor to the subject, a modification to a default set of alert rules for the subject. (See at least [0044] via: “... although not illustrated in FIG. 3, in some embodiments, prioritization rules region 302 may also include additional columns for defining automated actions to be performed in response to detecting certain types of adverse events. In this regard, for each adverse event defined by the user for prioritization, the user may also define one or more notification rules that may be stored in association with the prioritization rules in the monitoring settings data 124 in the database 104, which, in turn, may be utilized to automatically provide notifications on behalf of the user to the particular patient exhibiting the adverse event. For example, user may specify that the patient should automatically receive a text message, an email, a push notification, or the like in response to detecting a particular adverse event. The body or content of the automated communication may also be configured or otherwise defined by the user. For example, a doctor or other healthcare provider may create a template message requesting the patient schedule an appointment or perform some other action, when the time in range falls below 60% and then create a notification rule associated with the time in range below 60% adverse event that results in the remote server 102 and/or the monitoring application 110 automatically initiating the desired type of communication with the autopopulated content to a particular patient in real-time in response to that patient's time in range falling below 60%. In this regard, automated notifications may be configured by the doctor or other healthcare provider to reduce the amount of time he or she spends on otherwise routine communications, thereby allowing the doctor or other healthcare provider to maintain focus on monitoring or assessing..”)
Claim 5 is rejected under 35 U.S.C. 103 as being un-patentable by Sadeghzadeh, in view of Janssen, in view of Janssen et.al. (US 20210267555 A1) hereinafter “Janssen2”
Regarding claim 5 Sadeghzadeh and Janssen teach the invention as claimed and detailed above with respect to claim 1. However, Sadeghzadeh and Janssen are silent the following claim that is taught by Janssen2:
the status indicates implementing the monitoring program for the subject, implementing includes receiving, from a target advisor, a set of subject alert rules, and a subject alert rule includes determining a time period when the sensor data is not being received. (See at least [0055] via: “...ECG data, NIBP data, SpO2 data, and temperature data are sent to the analyzer module 208. The analyzer module 208 monitors and summarizes the status of each parameter during a monitoring session, and thus receives the patient monitoring data (e.g., from the ECR sensor, NIBP sensor, SpO2 sensor, and temperature sensor). The analyzer module 208 continuously analyzes, aggregates, and summarizes the patient monitoring data to determine a number of factors such as but not limited to each parameter's data collection initiation time and duration, clinical and technical alarm states and durations, etc. (e.g., whether any of the sensors/devices are in a threshold based alarm state and for how long), determine if any of the sensors are not currently monitoring the patient due to the sensors/devices being disconnected from the patient, ascertain whether offline (e.g., not communicating with the analyzer), etc. The analyzer module 208 may be part of the management system 100 and/or part of the compliance module 118 or may work with the compliance module 118 to track patient monitoring compliance, as explained below...”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Sadeghzadeh and Janssen to incorporate the teachings of Janssen2. Those in the art would have recognized that Sadeghzadeh’s teaching regarding monitoring a plurality of patients, obtaining measurement data for the plurality of patients from a database, obtaining one or more prioritization rules from the database, generating a prioritized list of the plurality of patients based on the measurement data in accordance with the one or more prioritization rules, and providing a dashboard graphical user interface (GUI) display including the prioritized list, and dynamically updating the prioritized list in response to updated measurement data in the database, could be modified to include Janssen’s2 teaching regarding providing an alert if any of the sensors are not currently monitoring the patient due to the sensors/devices being disconnected from the patient . This combination would be beneficial in that a notification is sent in case sensors become disconnected from patients that should be monitored.
Claims 6-7 are rejected under 35 U.S.C. 103 as being un-patentable by Sadeghzadeh, in view of Janssen, in view of Rajasekhar et.al. (US 20200135334 A1) hereinafter “Rajasekhar”
Regarding claim 6 Sadeghzadeh and Janssen teach the invention as claimed and detailed above with respect to claim 1. However, Sadeghzadeh and Janssen are silent the following claim that is taught by Rajasekhar:
the model is a machine learning model, the model is trained by receiving training data, and the training data includes training values of characteristics associated with the plurality of clients and a set of labels indicating the effectiveness of the program for the plurality of clients (See at least [0088] via: “...the patient data may be analyzed via machine learning and/or other artificial intelligence techniques..”; in addition see at least [0218] via: “...The training data for training the model includes the patient sequence data as inputs and patient sequence data and flare events as labels. Data may, for example, be collected for more than 1000 patients over a period of at least a month to train the initial model. In an exemplary variation, on the day of a flare, the patient data for that day is labeled as a 2. For six days before each flare event, the time event for that day is labeled as a 1 indicating that a flare will occur within seven days. Days where no flare occurs in seven days are labeled as 0. However, specific labels may be adjusted appropriate for other variations..”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Sadeghzadeh and Janssen to incorporate the teachings of Rajasekhar. Those in the art would have recognized that Sadeghzadeh’s teaching regarding monitoring a plurality of patients, obtaining measurement data for the plurality of patients from a database, obtaining one or more prioritization rules from the database, generating a prioritized list of the plurality of patients based on the measurement data in accordance with the one or more prioritization rules, and providing a dashboard graphical user interface (GUI) display including the prioritized list, and dynamically updating the prioritized list in response to updated measurement data in the database, could be modified to include Rajasekhar’s teaching regarding the use of training data that includes labels. This combination would be beneficial in classifying the patient output data regarding which specific events occurred during the monitoring of the patient.
Regarding claim 7 Sadeghzadeh and Janssen teach the invention as claimed and detailed above with respect to claim 1. However, Sadeghzadeh and Janssen are silent the following claim that is taught by Rajasekhar:
the model is a machine learning model, and wherein the model is trained by: optimizing parameters of the model based on outputs of the model matching or not matching labels of a set of labels when training values are input into the model, wherein the set of labels indicate the effectiveness of the program for the plurality of clients, and wherein an output of the model specifies whether the monitoring program is effective (See at least [0088] via: “...the patient data may be analyzed via machine learning and/or other artificial intelligence techniques..”; in addition see at least [0218] via: “...The training data for training the model includes the patient sequence data as inputs and patient sequence data and flare events as labels. Data may, for example, be collected for more than 1000 patients over a period of at least a month to train the initial model. In an exemplary variation, on the day of a flare, the patient data for that day is labeled as a 2. For six days before each flare event, the time event for that day is labeled as a 1 indicating that a flare will occur within seven days. Days where no flare occurs in seven days are labeled as 0. However, specific labels may be adjusted appropriate for other variations..”) and
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Sadeghzadeh and Janssen to incorporate the teachings of Rajasekhar. Those in the art would have recognized that Sadeghzadeh’s teaching regarding monitoring a plurality of patients, obtaining measurement data for the plurality of patients from a database, obtaining one or more prioritization rules from the database, generating a prioritized list of the plurality of patients based on the measurement data in accordance with the one or more prioritization rules, and providing a dashboard graphical user interface (GUI) display including the prioritized list, and dynamically updating the prioritized list in response to updated measurement data in the database, could be modified to include Rajasekhar’s teaching regarding the use of training data that includes labels. This combination would be beneficial in classifying the patient output data regarding which specific events occurred during the monitoring of the patient.
Claim 16 is rejected under 35 U.S.C. 103 as being un-patentable by Sadeghzadeh, in view of Janssen, in view of Dettinger et.al. (US 20160098536 A1) hereinafter “Dettinger”
Regarding claim 16 Sadeghzadeh and Janssen teach the invention as claimed and detailed above with respect to claim 1. However, Sadeghzadeh and Janssen are silent the following claim that is taught by Dettinger:
implementing the monitoring program for the subject, and sending a message commending activity by the subject. (See at least [0090] via: “...In the event the care plan management application 111 determines that the patient's adherence level for all assigned tasks is equal to or greater than the threshold level(s), the care plan management application 111 provides positive feedback to the patient (block 850) and the method 800 ends. For example, the care plan management application 111 could transmit a message for display on the mobile device 135, praising the patient's adherence to the assigned tasks and encouraging the patient to continue his efforts..”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Sadeghzadeh and Janssen to incorporate the teachings of Dettinger. Those in the art would have recognized that Sadeghzadeh’s teaching regarding monitoring a plurality of patients, obtaining measurement data for the plurality of patients from a database, obtaining one or more prioritization rules from the database, generating a prioritized list of the plurality of patients based on the measurement data in accordance with the one or more prioritization rules, and providing a dashboard graphical user interface (GUI) display including the prioritized list, and dynamically updating the prioritized list in response to updated measurement data in the database, could be modified to include Dettinger’s teaching regarding providing positive feedback to the patient, including praising the patient. This combination would be beneficial in providing emotional support to patients who need monitoring so that they feel encouraged to continue participating with the monitoring.
Prior Art Made of Record
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure, and is listed in the attached form PTO-892 (Notice of References Cited). Unless expressly noted otherwise by the Examiner, all documents listed on form PTO-892 are cited in their entirety.
Rajput (US 20230395235 A1)- System And Method For Delivering Personalized Cognitive Intervention - teaches: A computational personalized cognitive therapeutic system for treating patients with Mild Cognitive Impairment, Alzheimer's Disease, dementia and related conditions is described. The system includes a patient clinical database, a data aggregation layer and data pre-processor module, a digital cognitive therapy delivery module, a cognitive analytics engine, and a personalised cognitive platform configured to personalize a personalised cognitive digital therapy model. The personalised cognitive digital therapy model defines specific digital treatments to be delivered to the patient using the digital cognitive therapy delivery module each with a different mechanism of action. A range of digital cognitive biomarkers are collected along with behavioural and physiological biomarkers from wearable and medical devices which are processed by the cognitive analytics engine and uses AI/ML methods which are configured to estimate metrics and generate alerts. The metrics are used to assess treatment progress and then personalize the personalised cognitive digital therapy model for the patient including adjustment of digital therapies and medication. Alerts may be generated if adverse side effects are observed. This process is iteratively repeated to provide improved treatment over time.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PIERRE L MACCAGNO whose telephone number is (571)270-5408. The examiner can normally be reached M-F 8:00 to 5:00.
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/PIERRE L MACCAGNO/Examiner, Art Unit 3687
/MAMON OBEID/Supervisory Patent Examiner, Art Unit 3687
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