DETAILED ACTION
This is responsive to application 18/957,527 filed on 11/22/2024 in which claims 1-20 are presented for examination.
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 .
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 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding claim 1:
Step 1: Is the claim to a process, machine, manufacture or composition of matter?” Yes, it’s a machine.
Step 2a Prong 1 (judicial exception)
Step 2A (1): “Does the claim recite an abstract idea, law of nature, or natural phenomenon? Yes , the claim comes under mental processes.
Claim 1 recites:
“A computing device comprising a display screen, the computing device being configured to display on the display screen a menu listing one or more electronic medical records (EMRs) of one or more patients, and additionally being configured to display on the display screen a theranostics graphical user interface (GUI) accessible from the menu, wherein the theranostics GUI displays, for each patient, a pathway tracker indicating status of a corresponding theranostics protocol, wherein the pathway tracker comprises, for each cycle of the corresponding theranostics protocol, a limited snapshot of statuses of steps thereof, wherein each limited snapshot is selectable to launch a pop-up GUI with additional information relating to each of the steps thereof, and wherein the theranostics GUI is displayed while the one or more EMRs are in an un-launched state.”
All the limitations above are abstract idea related to the mental process (concepts performed in the human mind (including an observation, evaluation, judgment, opinion)) with the exception of bold and underlined limitations. Claim language pertains to analyzing patient medical records to track/check the status of therapy . patient’s data can be checked/analyzed for, who are at risk, on target/track , or who have completed their therapy cycle. All of this can be done using pen and paper.
Step 2A(2): Prong Two: evaluate whether the claim recites additional elements that integrate the exception into a practical application of the exception. NO
The claim does recite additional elements; however they don’t integrate the exception into a practical application of the exception.
computing device (Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
display screen(Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
electronic medical records (EMRs)(Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
graphical user interface (GUI) (Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
GUI displays(Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
pop-up GUI (Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
Step 2B: evaluate whether the claim recites additional elements that amount to an inventive concept (aka “significantly more”) than the recited judicial exception? NO
As discussed previously with respect to Step 2A Prong Two, the additional element in the claim amounts to no more than mere instructions to apply the exception using a generic computer component.
The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Dependent claims 2-10 further narrows the abstract idea recited in claim 1.
Regarding claim 11, it is rejected under the same rationale as claim 1.
Dependent claims 12-14 further narrows the abstract idea recited in claim 11.
Regarding claim 15, it is rejected under the same rationale as claim 1. In addition , it adds the additional elements of “system”, “processors”, “memory”, “EMR database”.
Under step 2A, prong two, the additional elements don’t integrate the exception into a practical application of the exception as merely adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f).
As discussed previously with respect to Step 2A Prong Two, the additional elements in the claim amounts to no more than mere instructions to apply the exception using a generic computer component.
The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Regarding claim limitation “receive, at the theranostics system, a feed from an electronic medical record (EMR) database” the courts have recognized the computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (“i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information”); See, MPEP 2106.05 (d)(II)
Dependent claims 16-20 further narrows the abstract idea recited in claim 15.
In addition , the additional elements are “optical character recognition “, “natural language processing”.
Under step 2A, prong two, the additional elements don’t integrate the exception into a practical application of the exception as merely adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f).
As discussed previously with respect to Step 2A Prong Two, the additional elements in the claim amounts to no more than mere instructions to apply the exception using a generic computer component.
The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
.
Claims 1-18 are rejected under 35 U.S.C. 102a(2) as anticipated by Mairs et al. (US 20230368901 A1)
Regarding claim 1, Mairs teaches :
a computing device comprising a display screen, the computing device being configured to display on the display screen a menu listing one or more electronic medical records (EMRs) of one or more patients(para, “[0077] …… As shown in FIG. 4A, the GUI portion 180 comprises a banner including a patient indicator or icon 202, among other function selector icons (e.g., practice, help, etc.), such as a therapy icon 204 and an evaluation icon 206 as further described and illustrated by FIG. 4C. In some examples, the GUI portion 180 is populated using, and/or displays, patient data for a plurality of patients that includes both objective patient data and subjective patient data. The patient data may be populated in a patient identifying region 214, utilization region 220, patient survey region 226, and update region 230 for a group of example patient listings 222 (e.g., patient records for a plurality of patients in the group). In some examples, each patient listing 222 comprises, under patient identifying region 214, a name and/or other identifying information 182. A clinician may select a particular patient for further review, with at least some of those details being illustrated and further described herein.” Note: Also, see para 0123 for patient record, see para 0174 for retrieving patient data.
Also, para “[0077]….The patient data may be populated in a patient identifying region 214, utilization region 220, patient survey region 226, and update region 230 for a group of example patient listings 222 (e.g., patient records for a plurality of patients in the group). …” )
and additionally being configured to display on the display screen a theranostics graphical user interface (GUI) accessible from the menu (para, “[0017] At least some examples of the present disclosure are directed to integrating information from different sources and/or pathways, etc., and displaying the integrated information on a graphic user interface (GUI) associated with a clinician portal in a manner used to enhance patient compliance with treatment, such as treating sleep disordered breathing (SDB). In some examples, the different sources and/or pathways may comprise patient management information, stimulation therapy information, and/or third party diagnostic/monitoring information. In some examples, integrating such information may enhance efficacy of stimulation therapy and/or of patient management. The third party diagnostic/monitoring information may be obtained from third party diagnostic/monitoring devices, which may communicate with the devices used to perform patient management and/or devices used to perform stimulation therapy…….”
Also, para “[0049] In some examples, the main GUI display may be a therapy-based display which is automatically displayed by the processing resource 11 when the clinician logs in to the clinician portal 26 and/or in response to the clinician selecting a therapy icon on one of the GUI portions 17A, 17B, 17B. .…” Note: Also, see para [0091] for therapy GUI display. Also, see para 0077),
wherein the theranostics GUI displays, for each patient, a pathway tracker indicating status of a corresponding theranostics protocol (para, “[0105] In some examples, the update region 230 refers to or includes a region displaying patient data pertaining to a therapy-related update status. The update region 230 may inform a clinician of a therapy effectiveness indication and/or a usage indication, etc., to help the clinician determine which patients are doing well and which may warrant faster or deeper attention. In the particular example, the update region 230 is populated using, and/or displays, information on the last update for the patient, which may include data pertaining to a patient not completing a patient survey within a time period, not providing utilization data within the time period or a second time period, and other updates.”
Also, para “[0095]….. As shown by FIG. 4C, in some examples, the utilization region 220 is populated using, and/or displays, data for patients that are compliant and patients that are non-compliant. More particularly, each patient listing 222, in the utilization region 220, may comprise data indicative of the patient use of an associated IMD. As shown at 224-1 and 224-2 of FIG. 4C, the utilization region 220 may include graphs with bars representing the IMD use per day and over the time period (e.g., 30 days). For patients that are non-compliant, the utilization region 220 may include a graph with a visual indication of the IMD utilization being below the threshold (e.g., an attention icon or indicator), as shown by 224-3, or absence of graph that visual indicates IMD utilization below the threshold (or other criteria), as shown by 224-2. More particularly, as shown by 224-2, for a patient with no utilization region 220 uploaded for the time period, a link may be displayed which is selectable to cause or initiate a communication to be output to a patient communication device to request upload of data (e.g., “Request upload”)……”
Also, para “[0018]…… In some examples, a method, device, and/or system to facilitate patient care may comprise arrangements which provide for enhanced communication and workflows between and among: (1) a patient and a clinician regarding the status or progress of their therapy and/or evaluation as a patient candidate; and (2) multiple clinicians (e.g., caregiver entities) forming a patient care team. In some examples, a device manufacturer or service provider may also communicate via such workflows with the care team and/or the patient to facilitate patient care and clinician performance.”),
wherein the pathway tracker comprises, for each cycle of the corresponding theranostics protocol, a limited snapshot of statuses of steps thereof(para, “[0149] As further shown in FIG. 5A, in some examples, a nightly utilization graph 443 may comprise a time scale 440 (e.g., hourly markers on a Y axis) relative to which each night's stimulation therapy usage may be displayed. The graph 443 also may comprise a selectable time period scale 442 (e.g., days, weeks, months, and the like on an X axis) for which the nightly usage data is displayed. More particularly, in some examples, the GUI portion 400 is displayed in response to the 30 day icon 434 being selected.”
“[0257] Similarly, in the example of FIG. 13B, the stimulation amplitude (line 3003), which may be patient's selected, rapidly and significantly deviates from (e.g., is much higher than) the reference (e.g. line 3001) within the first 5-10 days of use, and still differs from the reference (line 3001) up through about day 50, and again from about day 50 through the end of the initial use period (e.g., 90 days). As in the example FIG. 13A, among other potential factors, this deviation shown in FIG. 13B may be quantified as a percentage difference (or other metric) from the reference (line 3001) and upon the deviation meeting a criteria (e.g., exceeding a threshold deviation), the patient may be flagged as a patient which is non-compliant or likely to become non-compliant due to overly-aggressively titrating, e.g. overly-aggressively increasing their stimulation amplitude within a given time frame (e.g., 5, 10, 20, 50, 90 days).” Note: see Fig. 5A below.
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Also, “[0091]….. As shown in FIG. 4C, in some examples, the GUI portion 200 comprises a banner including a patient icon 202, among other function selector icons (e.g., practice, help, etc.). With the patient icon 202 selected, the example GUI portion 200 may comprise a therapy icon 204 and an evaluation icon 206. FIG. 4C represents an example implementation upon selection of the therapy icon 204, which includes patient data populated and/or displayed in different regions of the GUI portion 200, including a patient identifying region 214, utilization region 220, patient survey region 226, and update region 230 for a group of example patient listings 222 (e.g., patient records for a plurality of patients in the group)….”
wherein each limited snapshot is selectable to launch a pop-up GUI with additional information relating to each of the steps thereof(para, “[0169] It will be understood that upon selection of one of the other milestones, other expanded windows may be populated in GUI portion 600 with details particular to that milestone. For example, in response to selecting an initial consult milestone from the timeline, an expanded window may be populated using, and/or displays, scheduling details (e.g., date, completed, etc.), related files (e.g., patient assessment notes, images, etc.), a file upload input, and note input portion. The expanded windows may be referred to as pop-up windows.”
Also, para “[0152] In some examples, the GUI portion 400 may be populated using, and/or displays, a key 460 of the indicators, which may comprise a clinician visit or note indicator 462, a patient survey indicator 464, a sleep study AHI indicator 466, a therapy adjustment indicator 467, and/or other type indicators. The key 460 may provide additional information, such as indicating the different colors or other visual indications of the nightly usage indicator, e.g., the therapy start portion 468, therapy on 470, and therapy paused 472 portions. The key may additionally provide information on amplitude changes, such as identifying different lines representing amplitude 474 and amplitude limits 476.”)
and wherein the theranostics GUI is displayed while the one or more EMRs are in an un-launched state(para, “[0050] In some examples, respective ones of the plurality of GUI portions 17A, 17B, 17C may be represented (by the processing resource 11 and display screen 13) on other ones of the plurality of GUI portions 17A, 17B, 17C via a corresponding icon, each of which is user selectable to cause transitions between respective ones of the GUI portions 17A, 17B, 17C. For example, as further illustrated by the GUI portion 180 in connection with FIG. 4A and/or the GUI portion 200 in connection with FIG. 4C, the main GUI display may include different icons which are user selectable to cause transition to other GUI portions which expand on features of the patient data.” Note: Also, see para, 0045, 0048. Also, transition makes one window/portion in unlaunched state.)
Regrading claim 2, Mairs teaches the computing device of claim 1.
further teaches wherein the pathway tracker includes an element that indicates a status of a current cycle of the corresponding theranostics protocol(para, “[0142] In some examples, a processing resource (e.g., of a cloud computing system, such as service provider 30 of FIG. 1 or processing resource 830 of FIG. 7) may track the various data displayed, such as the total nights which the patient used the stimulation therapy device within the selected time period (e.g., 30 days). This total may be displayed as a percentage, such as the number of days used relative to the total number of days within the selected period. One example implementation of the total nights the IMD is used parameter 420 is displayed in the summary region 418. As a particular non-limiting example, the total nights the IMD is used parameter 420 may include a percentage, such as 92%.”
Also, para “[0144] In some examples, the processing resource may similarly track the average hours used per night and the average number of pauses in therapy per night parameters associated with the stimulation therapy device within the selected time period (e.g., 30 days). Both may be displayed as an average quantity, such as shown by 424 and 426 being displayed as parameters (of summary region 418).”)
Regarding claim 3, Mairs teaches the computing device of claim 2.
Mairs does not explicitly teach wherein the status of the current cycle is one of on track and at risk based on data obtained from the one or more EMRs (para, “[0132] Among other features associated with the patient education region 348, a clinician may quickly determine whether the patient is making adequate progress[on track] in patient education, which in turn, may facilitate the type and manner of care provided by the clinician. In addition, this progress information may be filtered, sorted, and/or flagged according to the at least one filter and/or the filter icons (as previously described in connection with FIGS. 4C and 4L) to help the clinician quickly identify a patient which may need more encouragement to complete their evaluations[at risk].”)
Regrading claim 4, Mairs teaches the computing device of claim 1.
Mairs further teaches wherein the pop-up GUI includes a plurality of step elements, wherein each of the plurality of step elements includes an information panel detailing one or more of a scheduled date, a completion date, and an issue of a corresponding step based on one or more patient parameters received from the one or more EMRs (para, “[0107] More particularly and in some examples, each patient listing 222, in the update region 230, is populated using update parameters indicative of the last therapy-related update status or lack of a therapy-related update status in the time period, as shown at 232-1, 232-2, 232-3, 232-4. The update region 230 may be further populated using, and/or displays, data that tracks whether or not a patient has completed a survey as part of a virtual check-in. For patients that are non-compliant, the update parameters may include a visual indication of the update not being provided in the threshold time period (e.g., utilization data and/or survey not being provided), a date the update was due, and/or an link that is selectable to cause or initiate a communication to be output to a patient communication device to request upload of data (e.g., “Request upload”, “No data uploads for over 30 days from patient remote”), as shown by 232-2.” Note: Fig. 4L teaches status of each step, and as can be seen, the entire cycle can’t be completed unless previous step is complete.
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Regarding claim 5, Mairs teaches the computing device of claim 4.
Mairs does not explicitly teach wherein the determined status of the corresponding step is one of on track, at risk, completed, and irrelevant and wherein the determined status of the corresponding step is determined based on one or more patient parameters received from the one or more EMRs ((para, “[0132] Among other features associated with the patient education region 348, a clinician may quickly determine whether the patient is making adequate progress[on track] in patient education, which in turn, may facilitate the type and manner of care provided by the clinician. In addition, this progress information may be filtered, sorted, and/or flagged according to the at least one filter and/or the filter icons (as previously described in connection with FIGS. 4C and 4L) to help the clinician quickly identify a patient which may need more encouragement to complete their evaluations[at risk].” Fig. 4M teaches 100% completed status. Fig. 4L teaches which steps have been completed, and which are still remaining.)
Regarding claim 6, Mairs teaches the computing device of claim 4.
Mairs does not explicitly teach wherein the status of the current cycle is at risk when one or more of the plurality of step elements indicate the determined status of the corresponding step is at risk (para, “[0107] More particularly and in some examples, each patient listing 222, in the update region 230, is populated using update parameters indicative of the last therapy-related update status or lack of a therapy-related update status in the time period, as shown at 232-1, 232-2, 232-3, 232-4. The update region 230 may be further populated using, and/or displays, data that tracks whether or not a patient has completed a survey as part of a virtual check-in. For patients that are non-compliant, the update parameters may include a visual indication of the update not being provided in the threshold time period (e.g., utilization data and/or survey not being provided), a date the update was due, and/or an link that is selectable to cause or initiate a communication to be output to a patient communication device to request upload of data (e.g., “Request upload”, “No data uploads for over 30 days from patient remote”), as shown by 232-2.” Note: Fig. 4L teaches status of each step, and as can be seen, the entire cycle can’t be completed unless previous step is complete.
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Regrading claim 7, Mairs teaches the computing device of claim 1.
Mairs further teaches wherein the theranostics GUI further displays one or more selectable elements for each patient, each of the one or more selectable elements being selectable to launch a second pop-up GUI(para, “[0091] FIG. 4C is a block diagram schematically representing an example GUI portion 200, and which may comprise one example implementation of the patient management app 860 (FIG. 7), control portion 900 (FIG. 8A), and/or user interface 940 (FIG. 8), and/or the GUI portion 180 of FIG. 4A or GUI portion 181 of FIG. 4B. As shown in FIG. 4C, in some examples, the GUI portion 200 comprises a banner including a patient icon 202, among other function selector icons (e.g., practice, help, etc.). With the patient icon 202 selected, the example GUI portion 200 may comprise a therapy icon 204 and an evaluation icon 206. FIG. 4C represents an example implementation upon selection of the therapy icon 204, which includes patient data populated and/or displayed in different regions of the GUI portion 200, including a patient identifying region 214, utilization region 220, patient survey region 226, and update region 230 for a group of example patient listings 222 (e.g., patient records for a plurality of patients in the group). In some examples, each patient listing 222 may comprise, in patient identifying region 214: (i) a name, (ii) a date of birth (DOB), (iii) a de-identified identifier (ID) 216, and/or (iv) a patient ID 218. A clinician may select a particular patient for further review, with at least some of those details being illustrated and further described herein in association with FIGS. 5A-5G.”)
Regrading claim 8, Mairs teaches the computing device of claim 7.
Mairs further teaches wherein the one or more selectable elements include one or more of alert elements, therapy cycle elements indicate scheduled dates of therapy cycles, flags, and icons(para, “[0122] FIG. 4K is a block diagram schematically representing an example GUI portion 280 for patient care. The GUI portion 280 is an example implementation of a display from selection of the alarm icon 282 on GUI portion 200 of FIG. 4C (which is not illustrated by FIG. 4C but may be implemented as part of GUI portion 200) and/or from any other GUI portions containing an alarm icon 282 in a banner. As shown by FIG. 4K, in some examples and in response to user selection of the alarm icon 282, the GUI portion 280 is populated using, and/or displays, an expanded window that visually displays the different attentions, such as those selected in the attention settings region 324 of the GUI portion 300 of FIG. 4J. For example, the GUI portion 280 is further populated using, and/or displays, different attentions 286-1, 286-2 and an icon 284 which marks the attentions as read. [0111] As described above, among other criteria by which a patient listing 222 may be filtered and/or flagged, the GUI portion 200 may enable sorting and/or flagging patient listings according to those patients which have missed appointments, are no longer seeking care, as well as other parameters further addressed in later Figures, such as the patient stopping use of the device, underutilization, discomfort, and the like.”
[0124] As further shown in FIG. 4L, GUI portion 303 may further be populated using, and/or displays, for each patient listing 222, “last care team update” region 336, by which the clinician may become informed of a therapy effectiveness indication, usage indication, etc., to help the clinician determine which patients are doing well and which may warrant faster or deeper attention (e.g., may be non-compliant). In some examples, the content of the region 336 for each patient listing 222 may be sorted (manually or automatically) per the at least one filter for different classes of the plurality of patients and/or may be flagged (manually or automatically) per the at least one filter, in a manner similar to that previously described for GUI portion 200 in associated with FIG. 4C. The “last care team update” region 336 may include similar or identical data to the therapy-related status update data, as previously described, and as shown at 338-1, 338-2, 338-3, 338-4.” Note: Also, see para 0093, 0101)
Regrading claim 9, Mairs teaches the computing device of claim 7.
Mairs further teaches wherein the second pop-up GUI, when launched in response to a first type of user input to a selectable element, displays additional information relating to the selectable element(para, “[0071]….. As shown at 104 in FIG. 3B, the method 100 may further include presenting the GUI by displaying selected ones of the plurality of GUI portions on a display screen of a clinician-controlled device. As previously and further described herein, the clinician portal may be accessible by the clinician and may provide automatic display of non-compliant patients on respective ones of the GUI portions in a manner that is efficient for the clinician to see and to transition between different GUI portions to obtain additional information and to interact with the patient(s). For example, as shown at 106 in FIG. 3C, the method 100 may further comprise, based on the patient data and the different classes of the plurality of patients, presenting a visual identification of respective ones of the plurality of patients on at least one of the plurality of GUI portions as being non-compliant patients and/or predicted non-compliant patients based on the at least one filter for different classes of the plurality of patients. In some examples, as shown at 108 in FIG. 3D, the plurality of GUI portions are displayed to expand features visually displayed on a display screen (e.g., of a clinician-controlled device) to manage the plurality of patients by exception based on a non-compliant criteria associated with the at least one filter, as further described herein.”)
Regrading claim 10, Mairs teaches the computing device of claim 7.
Mairs further teaches wherein the second pop-up GUI, when launched in response to a second type of user input to a selectable element, displays one or more management elements that when selected manage the selectable element(para, “[0227] With further reference to FIG. 10, the patient management engine 1300 comprises a display tools sub-engine 1350 by which the engine 1300 is to cause display of patient management information as a GUI on a display screen of a clinician-controlled device. As shown in FIG. 10, in some examples the display tools sub-engine 1350 may include a filter display function 1351 to provide the display of various attentions or alerts indicative of non-compliant patients, such as the attention icon(s) 224-2, 224-3 and resulting filters for the filter icons 208, 210, 212 illustrated by the GUI portion 200 of FIG. 4C and the attention icon(s) 404, 430, 482 illustrated by GUI portion 400 of FIG. 5A, among others.”
Also, para “[0177] By clicking on the different filter icons and/or in different combinations, the clinician may efficiently view non-compliant patients, which may be used to improve patient compliance. For example, the clinician may efficiently and effectively become informed of potential issues which may contribute to patient compliance or adherence, therapy efficacy, and improved patient outcomes, and may communicate with the patient to pro-actively resolve or mitigate the issues and/or to prevent the patient from becoming non-compliant and/or to improve patient compliance.”)
Regarding claim 11, Mairs teaches a method for a theranostics system, comprising:
displaying a menu listing one or more options for retrieving data of a plurality of patients from a plurality of data repositories of a hospital system, the plurality of data repositories including one or more electronic medical record (EMR) systems(para, “[0077] …… As shown in FIG. 4A, the GUI portion 180 comprises a banner including a patient indicator or icon 202, among other function selector icons (e.g., practice, help, etc.), such as a therapy icon 204 and an evaluation icon 206 as further described and illustrated by FIG. 4C. In some examples, the GUI portion 180 is populated using, and/or displays, patient data for a plurality of patients that includes both objective patient data and subjective patient data. The patient data may be populated in a patient identifying region 214, utilization region 220, patient survey region 226, and update region 230 for a group of example patient listings 222 (e.g., patient records for a plurality of patients in the group). In some examples, each patient listing 222 comprises, under patient identifying region 214, a name and/or other identifying information 182. A clinician may select a particular patient for further review, with at least some of those details being illustrated and further described herein.” Note: Also, see para 0080);
displaying a theranostics graphical user interface (GUI) that displays, for one or more of the plurality of patients(para, “[0017] At least some examples of the present disclosure are directed to integrating information from different sources and/or pathways, etc., and displaying the integrated information on a graphic user interface (GUI) associated with a clinician portal in a manner used to enhance patient compliance with treatment, such as treating sleep disordered breathing (SDB). In some examples, the different sources and/or pathways may comprise patient management information, stimulation therapy information, and/or third party diagnostic/monitoring information. In some examples, integrating such information may enhance efficacy of stimulation therapy and/or of patient management. The third party diagnostic/monitoring information may be obtained from third party diagnostic/monitoring devices, which may communicate with the devices used to perform patient management and/or devices used to perform stimulation therapy…….”
Also, para “[0049] In some examples, the main GUI display may be a therapy-based display which is automatically displayed by the processing resource 11 when the clinician logs in to the clinician portal 26 and/or in response to the clinician selecting a therapy icon on one of the GUI portions 17A, 17B, 17B. .…” Note: Also, see para [0091] for therapy GUI display. Also, see para 0077),
a pathway tracker indicating a first status of a current cycle of a theranostics protocol determined from the retrieved data from the one or more EMR systems para, “[0105] In some examples, the update region 230 refers to or includes a region displaying patient data pertaining to a therapy-related update status. The update region 230 may inform a clinician of a therapy effectiveness indication and/or a usage indication, etc., to help the clinician determine which patients are doing well and which may warrant faster or deeper attention. In the particular example, the update region 230 is populated using, and/or displays, information on the last update for the patient, which may include data pertaining to a patient not completing a patient survey within a time period, not providing utilization data within the time period or a second time period, and other updates.”
Also, para “[0095]….. As shown by FIG. 4C, in some examples, the utilization region 220 is populated using, and/or displays, data for patients that are compliant and patients that are non-compliant. More particularly, each patient listing 222, in the utilization region 220, may comprise data indicative of the patient use of an associated IMD. As shown at 224-1 and 224-2 of FIG. 4C, the utilization region 220 may include graphs with bars representing the IMD use per day and over the time period (e.g., 30 days). For patients that are non-compliant, the utilization region 220 may include a graph with a visual indication of the IMD utilization being below the threshold (e.g., an attention icon or indicator), as shown by 224-3, or absence of graph that visual indicates IMD utilization below the threshold (or other criteria), as shown by 224-2. More particularly, as shown by 224-2, for a patient with no utilization region 220 uploaded for the time period, a link may be displayed which is selectable to cause or initiate a communication to be output to a patient communication device to request upload of data (e.g., “Request upload”)……”),
wherein the pathway tracker includes a snapshot element for each cycle of the theranostics protocol(para, “[0091]….. As shown in FIG. 4C, in some examples, the GUI portion 200 comprises a banner including a patient icon 202, among other function selector icons (e.g., practice, help, etc.). With the patient icon 202 selected, the example GUI portion 200 may comprise a therapy icon 204 and an evaluation icon 206. FIG. 4C represents an example implementation upon selection of the therapy icon 204, which includes patient data populated and/or displayed in different regions of the GUI portion 200, including a patient identifying region 214, utilization region 220, patient survey region 226, and update region 230 for a group of example patient listings 222 (e.g., patient records for a plurality of patients in the group)….”
Also, para “[0135] As shown in FIG. 5A, in some examples, the GUI portion 400 is populated using, and/or displays, a general region 403 and utilization region 416, which in turn includes a summary region 418, a nightly utilization region 428, an amplitude changes region 450, and a patient survey region 480. The GUI portion 400 may be further be populated using, and/or displays, selectable time period icons 434, 436, 438. For example, the GUI portion 400 may be displayed in response to selecting the particular patient from another GUI portion with a patient listing, such as GUI portion 200 of FIG. 4C, with the GUI portion 200 being the default display and/or being displayed in response to clinician selection of the therapy (report) icon 204 and the time period icon of 30 days icon 434.”);
and in response to a user selection of the snapshot element for a selected cycle, adding additional display elements to the theranostics GUI(para, “[0169] It will be understood that upon selection of one of the other milestones, other expanded windows may be populated in GUI portion 600 with details particular to that milestone. For example, in response to selecting an initial consult milestone from the timeline, an expanded window may be populated using, and/or displays, scheduling details (e.g., date, completed, etc.), related files (e.g., patient assessment notes, images, etc.), a file upload input, and note input portion. The expanded windows may be referred to as pop-up windows.”
Also, para “[0152] In some examples, the GUI portion 400 may be populated using, and/or displays, a key 460 of the indicators, which may comprise a clinician visit or note indicator 462, a patient survey indicator 464, a sleep study AHI indicator 466, a therapy adjustment indicator 467, and/or other type indicators. The key 460 may provide additional information, such as indicating the different colors or other visual indications of the nightly usage indicator, e.g., the therapy start portion 468, therapy on 470, and therapy paused 472 portions. The key may additionally provide information on amplitude changes, such as identifying different lines representing amplitude 474 and amplitude limits 476.”),
the additional display elements identifying a second status of each step of the selected cycle determined from the retrieved data from the one or more EMR systems, wherein the theranostics GUI is displayed while the one or more EMR systems are in an un-launched state (para, “[0127] Among other features, the patient timeline region 352 may conveniently provide a summary and sequence by which a clinician may immediately recognize which evaluation milestones have been met by the patient and which milestones have yet to been achieved. Accordingly, in some examples, the patient timeline region 352 aids the clinician in quickly determining on what path to proceed to help the particular patient, and/or may help the clinician to quickly determine which care team member to communicate with to facilitate progression of the patient through the various milestones. The clinician may select one of the listed milestones to be taken to another GUI portion to obtain more detailed information regarding the selected milestone. As an example, upon selection of the initial consult milestone or the add new entry icon 354, the clinician is taken to GUI portion 650 in FIG. 5G, which is further described herein.”)
Regrading claim 12, Mairs teaches the computing device of claim 1.
Mairs further teaches wherein the first status of the current cycle of the theranostics protocol is determined based on a set of rules applied to the retrieved data, the set of rules identifying demanded steps of the theranostics protocol and the second status of each step of the current cycle(para, “[0127] Among other features, the patient timeline region 352 may conveniently provide a summary and sequence by which a clinician may immediately recognize which evaluation milestones have been met by the patient and which milestones have yet to been achieved. Accordingly, in some examples, the patient timeline region 352 aids the clinician in quickly determining on what path to proceed to help the particular patient, and/or may help the clinician to quickly determine which care team member to communicate with to facilitate progression of the patient through the various milestones. The clinician may select one of the listed milestones to be taken to another GUI portion to obtain more detailed information regarding the selected milestone. As an example, upon selection of the initial consult milestone or the add new entry icon 354, the clinician is taken to GUI portion 650 in FIG. 5G, which is further described herein.”)
Regrading claim 13, Mairs teaches the computing device of claim 1.
Mairs further teaches wherein the theranostics GUI includes, for a first patient, an alert element indicating a detected issue with a step of a cycle of the theranostics protocol(para, “[0093] Each patient may include information for the different non-compliance classes, with respective patients visually identified or flagged based on at least one filter for different classes of the plurality of patients. In some examples, a filter, as used herein, refers to or includes a criteria, such as a threshold, a rate, or a reference, indicating a patient is compliant or non-compliant with respect to the particular compliance class. Patients which do not comply with or are outside the criteria, e.g., are below the threshold(s) or rate or deviate from a reference, may be visually identified or flagged on the GUI portion 200, such that the clinician may easily view non-compliant patients and/or predicted non-compliant patients.”)
Regrading claim 14, Mairs teaches the computing device of claim 1.
Mairs further teaches wherein the alert element is selectable to add a second additional display element to the theranostics GUI, the second additional display element including information specific to the alert obtained from the retrieved data from the one or more EMR systems(para, “[0171] The above-described various features of the GUI portions, as driven via the various functions and parameters, provide a rich environment by which a clinician may manage patient care. For instance, in some examples, upon a clinician viewing the various displayed patient data in GUI portions of FIGS. 4A-4H regarding non-compliant patients of multiple different compliance classes which are visually highlighted or flagged, and GUI portions of FIGS. 5A-5C regarding nightly usage, amplitude changes, and/or patient survey answers, the clinician may make an assessment regarding patient symptoms, patient adherence, and/or therapy efficacy (e.g. patient outcomes). Based on the assessment, the clinician may order further patient education, changes to stimulation therapy programming, and the like, as desired. At least some further details regarding this information-rich environment for patient management are described in association with at least FIG. 7, among other examples throughout the present disclosure.” Note: Also , see para 0027 for multiple/second GUI display and 0174 for patient data retrieval. )
Regrading claim 15, Mairs teaches a theranostics system, comprising:
one or more processors(see para 0213);
and memory storing instructions executable by the one or more processors to(see para 0213):
receive, at the theranostics system, a feed from an electronic medical record (EMR) database, where one or more patient parameters for each of a plurality of patients are sent over the feed(para, “[0032] In some examples, respective regions of the GUI portions may exclusively present objective patient data and other respective regions may exclusively present subjective patient data. In some examples, the region(s) presenting objective patient data are juxtaposed with the region(s) presenting subjectively patient data. In some examples, at least one region may present both objective patient data and subjective patient data. For example, at least one region of a GUI portion may be automatically populated using visual identification of patients of a plurality of patients that exhibit non-compliance and/or a highest degree of non-compliance for a class of non-compliance represented within the respective region (e.g., column).
Also, para “[0174] In some examples, the clinician may log into a clinician portal on a clinician-controlled communication device, which is in communication with or includes a processing resource that tracks patient data, such as illustrated further herein. The clinician-controlled communication device may communicate with the processing resource to authenticate the clinician and retrieve patient data associated with patients of the clinician. In response, as shown at 702 of FIG. 6, the clinician-controlled communication device may display a main GUI, such as the main therapy GUI portion 180, 181, and/or 200 in FIGS. 4A-4C.”);
identify one or more patients of the plurality of patients associated with a theranostics protocol based on the received feed( para, “[0032] In some examples, respective regions of the GUI portions may exclusively present objective patient data and other respective regions may exclusively present subjective patient data. In some examples, the region(s) presenting objective patient data are juxtaposed with the region(s) presenting subjectively patient data. In some examples, at least one region may present both objective patient data and subjective patient data. For example, at least one region of a GUI portion may be automatically populated using visual identification of patients of a plurality of patients that exhibit non-compliance and/or a highest degree of non-compliance for a class of non-compliance represented within the respective region (e.g., column).;
output, for display on a display device, a theranostics graphical user interface (GUI) that includes, for the one or more patients of the plurality of patients, a pathway tracker comprising a plurality of cycle elements( para, “[0105] In some examples, the update region 230 refers to or includes a region displaying patient data pertaining to a therapy-related update status. The update region 230 may inform a clinician of a therapy effectiveness indication and/or a usage indication, etc., to help the clinician determine which patients are doing well and which may warrant faster or deeper attention. In the particular example, the update region 230 is populated using, and/or displays, information on the last update for the patient, which may include data pertaining to a patient not completing a patient survey within a time period, not providing utilization data within the time period or a second time period, and other updates.”
Also, para “[0095]….. As shown by FIG. 4C, in some examples, the utilization region 220 is populated using, and/or displays, data for patients that are compliant and patients that are non-compliant. More particularly, each patient listing 222, in the utilization region 220, may comprise data indicative of the patient use of an associated IMD. As shown at 224-1 and 224-2 of FIG. 4C, the utilization region 220 may include graphs with bars representing the IMD use per day and over the time period (e.g., 30 days). For patients that are non-compliant, the utilization region 220 may include a graph with a visual indication of the IMD utilization being below the threshold (e.g., an attention icon or indicator), as shown by 224-3, or absence of graph that visual indicates IMD utilization below the threshold (or other criteria), as shown by 224-2. More particularly, as shown by 224-2, for a patient with no utilization region 220 uploaded for the time period, a link may be displayed which is selectable to cause or initiate a communication to be output to a patient communication device to request upload of data (e.g., “Request upload”)……”
Also, para “[0018]…… In some examples, a method, device, and/or system to facilitate patient care may comprise arrangements which provide for enhanced communication and workflows between and among: (1) a patient and a clinician regarding the status or progress of their therapy and/or evaluation as a patient candidate; and (2) multiple clinicians (e.g., caregiver entities) forming a patient care team. In some examples, a device manufacturer or service provider may also communicate via such workflows with the care team and/or the patient to facilitate patient care and clinician performance.”),
wherein each of the plurality of cycle elements is selectable and displays a snapshot of steps of a given cycle, wherein each snapshot of steps is generated by applying a set of rules specific to the theranostics protocol to a set of patient data obtained from the feed (para, “[0169] It will be understood that upon selection of one of the other milestones, other expanded windows may be populated in GUI portion 600 with details particular to that milestone. For example, in response to selecting an initial consult milestone from the timeline, an expanded window may be populated using, and/or displays, scheduling details (e.g., date, completed, etc.), related files (e.g., patient assessment notes, images, etc.), a file upload input, and note input portion. The expanded windows may be referred to as pop-up windows.”
Also, para “[0045] As further described herein, the clinician portal 26 may be accessible by the clinician and may provide automatic display of non-compliant patients on respective ones of the GUI portions 17A, 17B, 17C in a manner that is efficient for the clinician to see and to transition between different GUI portions 17A, 17B, 17C to obtain additional information and to interact with the patient(s). For example, the display screen 13 and processing resource 11 may be configured to, based on the patient data and the different classes of the plurality of patients, present a visual identification of respective ones of the plurality of patients on at least one of the plurality of GUI portions 17A, 17B, 17C as being non-compliant patients and/or predicted non-compliant patients based on the at least one filter for different classes of the plurality of patients….”
Also, para “[0152] In some examples, the GUI portion 400 may be populated using, and/or displays, a key 460 of the indicators, which may comprise a clinician visit or note indicator 462, a patient survey indicator 464, a sleep study AHI indicator 466, a therapy adjustment indicator 467, and/or other type indicators. The key 460 may provide additional information, such as indicating the different colors or other visual indications of the nightly usage indicator, e.g., the therapy start portion 468, therapy on 470, and therapy paused 472 portions. The key may additionally provide information on amplitude changes, such as identifying different lines representing amplitude 474 and amplitude limits 476.”);
and display, on the theranostics GUI, for a selected patient of the one or more patients, a risk element that indicates whether a current cycle of the theranostics protocol is at risk(para, “[0132] Among other features associated with the patient education region 348, a clinician may quickly determine whether the patient is making adequate progress[on track] in patient education, which in turn, may facilitate the type and manner of care provided by the clinician. In addition, this progress information may be filtered, sorted, and/or flagged according to the at least one filter and/or the filter icons (as previously described in connection with FIGS. 4C and 4L) to help the clinician quickly identify a patient which may need more encouragement to complete their evaluations[at risk].”)
Regrading claim 16, Mairs teaches the theranostics system of claim 15.
Mairs further teaches wherein each of the snapshot of steps is a selectable element that, when selected, launches a pop-up GUI displaying a plurality of step elements, wherein each of the plurality of step elements is displayed in a color corresponding to a status thereof(para [0123] FIG. 4L is a block diagram schematically representing an example GUI portion 303 for patient care, which comprises at least some of substantially the same features and attributes of the GUI portion 200 of FIG. 4C, except being an example implementation in response to selection of the evaluation icon 206 instead of the therapy icon 204. FIG. 4L represents an example implementation upon selection of the evaluation icon 206, in which the GUI portion 303 is populated using, and/or displays, a patient identifying region 214 and a visit region 330 fora group of example patient listings 222 (e.g., patient record). In some examples, the patient identifying region 214 is populated using, and/or displays, at least some of the same type of information as previously described in connection with FIG. 4A. In some examples, each patient listing 222 may further comprise the visit region 330 which may be populated using, and/or may display, timeline graph 332 with different types of visits (e.g., Initial consult 334-1, ENT consult 334-2, Airway exam 334-3, Insurance consult 334-4, and Implant 334-5) and visual indication of the status of each respective visit within the graph 332. In the particular example, each of the different types of visits are illustrated for each respective patient of the patient listing 222 with the status being provided by a color or other visual indication associated with the visit being completed, as shown by 334-1, the visit not being completed or scheduled, as shown by 334-2, and/or the visit being scheduled but not completed, as shown by 334-6. It will be understood, of course, that for the many different types of patient care which may be provided, the types of visit may vary greatly and accordingly the types of visits (e.g., ENT consult, Airway exam) shown here are merely examples and are not limiting.”
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Regrading claim 17, Mairs teaches the theranostics system of claim 16.
Mairs further teaches wherein a first step element of the plurality of step elements is displayed with a first color indicating that a corresponding first step is at risk(para [0123] FIG. 4L is a block diagram schematically representing an example GUI portion 303 for patient care, which comprises at least some of substantially the same features and attributes of the GUI portion 200 of FIG. 4C, except being an example implementation in response to selection of the evaluation icon 206 instead of the therapy icon 204. FIG. 4L represents an example implementation upon selection of the evaluation icon 206, in which the GUI portion 303 is populated using, and/or displays, a patient identifying region 214 and a visit region 330 fora group of example patient listings 222 (e.g., patient record). In some examples, the patient identifying region 214 is populated using, and/or displays, at least some of the same type of information as previously described in connection with FIG. 4A. In some examples, each patient listing 222 may further comprise the visit region 330 which may be populated using, and/or may display, timeline graph 332 with different types of visits (e.g., Initial consult 334-1, ENT consult 334-2, Airway exam 334-3, Insurance consult 334-4, and Implant 334-5) and visual indication of the status of each respective visit within the graph 332. In the particular example, each of the different types of visits are illustrated for each respective patient of the patient listing 222 with the status being provided by a color or other visual indication associated with the visit being completed, as shown by 334-1, the visit not being completed or scheduled, as shown by 334-2, and/or the visit being scheduled but not completed, as shown by 334-6. It will be understood, of course, that for the many different types of patient care which may be provided, the types of visit may vary greatly and accordingly the types of visits (e.g., ENT consult, Airway exam) shown here are merely examples and are not limiting.”
Also, para “[0152] In some examples, the GUI portion 400 may be populated using, and/or displays, a key 460 of the indicators, which may comprise a clinician visit or note indicator 462, a patient survey indicator 464, a sleep study AHI indicator 466, a therapy adjustment indicator 467, and/or other type indicators. The key 460 may provide additional information, such as indicating the different colors or other visual indications of the nightly usage indicator, e.g., the therapy start portion 468, therapy on 470, and therapy paused 472 portions. The key may additionally provide information on amplitude changes, such as identifying different lines representing amplitude 474 and amplitude limits 476.”)
Regrading claim 18, Mairs teaches the theranostics system of claim 16.
Mairs further teaches wherein a second step element of the plurality of step elements is displayed with a second color indicating that a corresponding second step is on target para [0123] FIG. 4L is a block diagram schematically representing an example GUI portion 303 for patient care, which comprises at least some of substantially the same features and attributes of the GUI portion 200 of FIG. 4C, except being an example implementation in response to selection of the evaluation icon 206 instead of the therapy icon 204. FIG. 4L represents an example implementation upon selection of the evaluation icon 206, in which the GUI portion 303 is populated using, and/or displays, a patient identifying region 214 and a visit region 330 fora group of example patient listings 222 (e.g., patient record). In some examples, the patient identifying region 214 is populated using, and/or displays, at least some of the same type of information as previously described in connection with FIG. 4A. In some examples, each patient listing 222 may further comprise the visit region 330 which may be populated using, and/or may display, timeline graph 332 with different types of visits (e.g., Initial consult 334-1, ENT consult 334-2, Airway exam 334-3, Insurance consult 334-4, and Implant 334-5) and visual indication of the status of each respective visit within the graph 332. In the particular example, each of the different types of visits are illustrated for each respective patient of the patient listing 222 with the status being provided by a color or other visual indication associated with the visit being completed, as shown by 334-1, the visit not being completed or scheduled, as shown by 334-2, and/or the visit being scheduled but not completed, as shown by 334-6. It will be understood, of course, that for the many different types of patient care which may be provided, the types of visit may vary greatly and accordingly the types of visits (e.g., ENT consult, Airway exam) shown here are merely examples and are not limiting.”
Also, para “[0152] In some examples, the GUI portion 400 may be populated using, and/or displays, a key 460 of the indicators, which may comprise a clinician visit or note indicator 462, a patient survey indicator 464, a sleep study AHI indicator 466, a therapy adjustment indicator 467, and/or other type indicators. The key 460 may provide additional information, such as indicating the different colors or other visual indications of the nightly usage indicator, e.g., the therapy start portion 468, therapy on 470, and therapy paused 472 portions. The key may additionally provide information on amplitude changes, such as identifying different lines representing amplitude 474 and amplitude limits 476.”)
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.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Mairs in view of SAKASHITA et al. (US 20240285959 A1)
Regrading claim 19, Mairs teaches the theranostics system of claim 16.
Mairs further teaches wherein the instructions are executable to display, on the theranostics GUI, a lab flag indicating [detection of a lab abnormality](para, “[0093] Each patient may include information for the different non-compliance classes, with respective patients visually identified or flagged based on at least one filter for different classes of the plurality of patients. In some examples, a filter, as used herein, refers to or includes a criteria, such as a threshold, a rate, or a reference, indicating a patient is compliant or non-compliant with respect to the particular compliance class. Patients which do not comply with or are outside the criteria, e.g., are below the threshold(s) or rate or deviate from a reference, may be visually identified or flagged on the GUI portion 200, such that the clinician may easily view non-compliant patients and/or predicted non-compliant patients.”
para, “[0101] For instance, in some examples, a patient may increase the stimulation amplitude of the IMD too quickly compared to the reference for a given time period (e.g. day(s), week(s), month(s)). This patient may be flagged as an attention-warranting-titration patient, which may then be displayed in a GUI portion (e.g., FIGS. 4A-4B, etc.) in accordance with various examples of the present disclosure. In some examples, a patient may increase the stimulation amplitude of the IMD too slowly compared to the reference for a given period of time (e.g., day(s), week(s), month(s)), and may be flagged as an attention-warranting-titration patient. In some examples, the stimulation amplitude changes may be displayed in an amplitude changes region 450 of a GUI portion 400, as illustrated further herein at least in connection with FIG. 5A.”)
Mairs does not explicitly teach [wherein the instructions are executable to display, on the theranostics GUI, a lab flag indicating] detection of a lab abnormality.
SAKASHITA teaches [wherein the instructions are executable to display, on the theranostics GUI, a lab flag indicating] detection of a lab abnormality(para, “0082] When an abnormality is detected by the abnormality detection unit 52d, the warning unit 52c issues an alert. When the earliest abnormal waveform or cardiac arrest is detected by the abnormality detection unit 52c, the warning unit 52d causes the display unit 54 to display an alert and causes the speaker 56 to output a warning sound. The warning unit 52d may cause the display unit 54 to display information indicating an electrocardiographic waveform, an electrode group, or an electrode from which the earliest abnormal waveform has been detected. ....”)
It would have been obvious for a person of ordinary skill in the art to incorporate lab abnormality teachings of Buisson into the teachings of Mairs at the time the application was filed in order to issue an alert. SAKASHITA , para “[0082] When an abnormality is detected by the abnormality detection unit 52d, the warning unit 52c issues an alert. When the earliest abnormal waveform or cardiac arrest is detected by the abnormality detection unit 52c, the warning unit 52d causes the display unit 54 to display an alert and causes the speaker 56 to output a warning sound. The warning unit 52d may cause the display unit 54 to display information indicating an electrocardiographic waveform, an electrode group, or an electrode from which the earliest abnormal waveform has been detected. ...”)
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Mairs in view of RAMACHANDIRAN et al. (US 20250029730 A1)
Regrading claim 20, Mairs teaches the theranostics system of claim 15.
Mairs further teaches wherein data in the feed comprises data obtained from the EMR database and data obtained from one or more third parties, wherein the data obtained from the one or more third parties is processed [via optical character recognition and natural language processing to reformat the data](para, “[0174] In some examples, the clinician may log into a clinician portal on a clinician-controlled communication device, which is in communication with or includes a processing resource that tracks patient data, such as illustrated further herein. The clinician-controlled communication device may communicate with the processing resource to authenticate the clinician and retrieve patient data associated with patients of the clinician. In response, as shown at 702 of FIG. 6, the clinician-controlled communication device may display a main GUI, such as the main therapy GUI portion 180, 181, and/or 200 in FIGS. 4A-4C.” Note: see para 0123 for patient record.
Also, para “[0017] At least some examples of the present disclosure are directed to integrating information from different sources and/or pathways, etc., and displaying the integrated information on a graphic user interface (GUI) associated with a clinician portal in a manner used to enhance patient compliance with treatment, such as treating sleep disordered breathing (SDB). In some examples, the different sources and/or pathways may comprise patient management information, stimulation therapy information, and/or third party diagnostic/monitoring information. In some examples, integrating such information may enhance efficacy of stimulation therapy and/or of patient management. The third party diagnostic/monitoring information may be obtained from third party diagnostic/monitoring devices, which may communicate with the devices used to perform patient management and/or devices used to perform stimulation therapy. ....”
Also, para “[0253] In some examples, the determined parameters 2500 may comprise a home sleep test (HST) parameter 2550, which may comprise information obtained from a sleep study performed in a home study using at least some of the sensed parameters 2400 in FIG. 11 obtainable via third party diagnostic/monitoring portion (e.g., device). In some such examples, the home sleep study may approximate a formal polysomnongraphy (PSG) study.”)
Mairs does not explicitly teach [wherein data in the feed comprises data obtained from the EMR database and data obtained from one or more third parties,] wherein the data obtained from the one or more third parties is processed via optical character recognition and natural language processing to reformat the data.
RAMACHANDIRAN teaches [wherein data in the feed comprises data obtained from the EMR database and data obtained from one or more third parties,] wherein the data obtained from the one or more third parties is processed via optical character recognition and natural language processing to reformat the data(para, [0067] In a preferred embodiment, a method for the chart review workflow comprises the following steps: [0068] 1. Inputting of the documents in the form of a patient medical chart wherein the said input may include: unstructured documents such as PDF files (machine-readable, scanned files, faxed files) of medical charts; or structured data in HL7, FHIR, CCDA format, pulled from HER (Electronic Health Record) system, HIE (Health Information Exchange) system, from third party Health IT companies. The said input is passed into the NLP pipeline to convert unstructured information into structured format. In this step, if the input file is in PDF format, the said file is converted into a text format using an OCR (Optical Character Recognition) engine. [0069] 2. The said inputted documents are passed into the Application Recommendation system which is the ICD-10-CM code recommendation system to identify the evidence from the patient's unstructured report (input text) and make the system explainable. [0070] 3. Input is taken from the master knowledge graphs for the NLP module to add clinical context and relations with other entities found. [0071] 4. The output from the NLP module is given to the Application module. [0072] 5. Input is added from the ICD-10-CM knowledge graph to add context to the findings of the Application module....”
It would have been obvious for a person of ordinary skill in the art to apply optical character recognition and natural language processing teachings of RAMACHANDIRAN into the teachings of Mairs at the time the application was filed in order to convert unstructured information into structured format. RAMACHANDIRAN, para , “[0067] In a preferred embodiment, a method for the chart review workflow comprises the following steps: [0068] 1. Inputting of the documents in the form of a patient medical chart wherein the said input may include: unstructured documents such as PDF files (machine-readable, scanned files, faxed files) of medical charts; or structured data in HL7, FHIR, CCDA format, pulled from HER (Electronic Health Record) system, HIE (Health Information Exchange) system, from third party Health IT companies. The said input is passed into the NLP pipeline to convert unstructured information into structured format. In this step, if the input file is in PDF format, the said file is converted into a text format using an OCR (Optical Character Recognition) engine....”))
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20180268937 A1 “A method, apparatus, and computer program product for analyzing biological data with an application that provides a graphical user interface are disclosed. A method in accordance with the disclosure may include receiving patient data associated with various patient attributes, determining an interrelationship between any one of those attributes, performing a therapeutic regime analysis, and displaying at least one graphical user interface. The method may further include assisting in providing patient care based on the interrelationships displayed on the graphical user interface. Patient attributes may include biomarker status that corresponds with the expression, sequence, or other state, of various biomarkers. The method, apparatus, and computer program product are useful for analyzing molecular profiling data.”
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/HUMA WASEEM/Examiner, Art Unit 3686
/JASON B DUNHAM/Supervisory Patent Examiner, Art Unit 3686