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 in reply to the amendments filed on 10/27/2025.
Claims 1-13, 15 and 18-20 were amended.
Claims 1-20 are currently pending and have been examined.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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.
Claims 1-9 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Dittmer et al., WIPO Application Publication WO 2022/246267 A1 in view of Yoo et al., U.S. Patent Application Publication US 2019/0126039 A1.
Claim 1:
Dittmer discloses the limitations as shown in the rejections below:
present a graphical user interface (GUI) associated with a clinician portal, the GUI including a plurality of GUI portions that are individually and selectively displayable to present patient data for a plurality of patients based on at least one filter for different classes of the plurality of patients (see at least Fig. 6A, Compliance Monitor, selectively displayable and filter by Patient Details, Days on Therapy, Days on Compliance, etc.; Compliance Forecast; Paragraph 12, Another implementation is where the method includes displaying the compliance prediction of the patient. Another implementation is where the compliance prediction is displayed in a calendar showing the period of treatment. Another implementation is where the calendar shows past days of compliance. Another implementation is where the calendar shows the end of a projected compliance period based on the compliance prediction; Paragraph 15, The compliance prediction model outputs a prediction of compliance for the patient for using the respiratory pressure therapy device; Paragraph 48, With a limited number of staff and hours in a day, the compliance predictions produced by the system allows HME staff to focus their efforts on those patients are who at risk of non-compliance in a more efficient way and more easily identify that particular cohort of patients; Paragraph 132, FIG. 6A is an example interface 600 generated by a diagnosis, compliance and therapy management application accessible by a healthcare provider based on the prediction and patient data from the compliance API),
Dittmer may or may not specifically disclose the following limitations, but Yoo as shown does:
the different classes of the plurality of patients comprising a plurality of classes of non-compliant patients having implantable medical devices and the patient data comprising objective patient data indicative of stimulation therapy activity applied by the implantable medical devices to the plurality of patients (see at least Paragraph 128, Treatment points can be defined to contribute to different treatment point categories, such as compliance … The set of treatment points are calculated upon to generate ratings or user status levels such as “Excellent patient”, “Very good patient”, “Good patient”, “Late Patient”, “Uncooperative Patient”, etc. or are used to calculate one or more scores. The treatment points can be assessed over an interval such as a day, week, or month; Paragraph 234, Other types of non-compliance may be defined to cause the system to restrict use. The compliance module 200 is further configured to operate according to compliance rules that are defined to cause the compliance module to cause the control module to disable the stimulation operations provided by a stimulation module 54 of the neurostimulator if at least one compliance criterion is assessed as false because the criterion was not met. At home therapy requires the cooperation of a patient, and use can be restricted, for example, if a user fails to provide patient input data about symptoms so that therapy benefit can be tracked accurately by a physician monitoring a user remotely. Accordingly, the compliance module is further configured to operate according to compliance rules defined for non-compliance operations; Paragraph 236, The establishment of a treatment regimen 302 and monitoring of compliance 304 may be done using a treatment regimen that is defined for an implanted neurostimulator, an external neurostimulator, or the combination, as may be defined by selecting appropriate controls; Paragraph 257, Treatment goals may be defined for the patient and related to various treatment event types such as user adherence to the provision of treatment according to a regimen, compliance with answering survey item data, provision of sensed data with the assistance of the user, and other treatment event types; Paragraph 260, This includes electrical, magnetic, microwave or other forms of energy directed either to implantable components that stimulate tissue or to the tissue itself. This can include cranial electrotherapy, transcranial stimulation (e.g., direct-current or alternating current), ultrasonic neuromodulation. Stimulation provided by at least one of TENS, eTENS, percutaneous, external, partially or fully implantable systems can be operated to provide stimulation using the protocols and nerve targets disclosed herein).
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of graphical user interface of Dittmer with the compliance features of Yoo with the motivation of providing the benefit of “… monitoring, recording, displaying, reporting, sending and operating upon usage data related to treatment times, durations, compliance, non-compliance, and other characteristics of patient use” and “… augments compliance, and rewards the user for providing treatment in the intended manner” (Yoo, see at least Paragraph 17).
Claim 2:
The combination of Dittmer/Yoo discloses the limitations as shown in the rejection above. Dittmer further discloses the following limitations:
wherein the GUI is presented on a display screen (see at least Fig. 6A, Compliance Monitor, selectively displayable and filter by Patient Details, Days on Therapy, Days on Compliance, etc.; Compliance Forecast; Paragraph 132, FIG. 6A is an example interface 600 generated by a diagnosis, compliance and therapy management application accessible by a healthcare provider based on the prediction and patient data from the compliance API. The example interface 600 may be generated on the display of a workstation of a user device such as the user device 170 used by a healthcare provider),
Dittmer may or may not specifically disclose the following limitations, but Yoo as shown does:
and wherein the objective patient data indicative of stimulation therapy activity applied by the implantable medical devices comprises average rates of use of the implantable medical devices or stimulation amplitude changes for the stimulation therapy activity applied by the implantable medical devices (see at least Paragraph 100, A report of usage can include such statistics as number of weeks since start of therapy, total stimulation sessions, average number of stimulation sessions scheduled or provided each week, average length of stimulation sessions, average strength of stimulation sessions. A table can also be generated where the date, time, duration, and stimulation settings for each session are listed).
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of graphical user interface of Dittmer with the usage features of Yoo for at least the same reasons given for claim 1.
Claim 3:
The combination of Dittmer/Yoo discloses the limitations as shown in the rejection above. Dittmer further discloses the following limitations:
the patient data further comprises subjective patient data indicative of patient feedback (see at least Paragraph 57, the display device 128 can provide information regarding the status of the respiratory device 122 (e.g., whether the respiratory device 122 is on/off, the pressure of the air being delivered by the respiratory device 122, the temperature of the air being delivered by the respiratory device 122, etc.) and/or other information (e.g., a sleep score or a therapy score (such as a my Air™ score), etc.; Paragraph 62, The system 100 allows for monitoring respiratory related data for the patient 110. The system 100 thus includes an optional external device such as a user device 132, and a body mounted health monitoring device 134. The user device 132 and possibly the monitoring device 134 and the respiratory device 122 may be in communication with a network 136; Paragraph 66, The self-reported patient feedback can include information indicative of a self-reported subjective sleep score (e.g., poor, average, excellent), a self-reported subjective stress level of the patient, a self-reported subjective fatigue level of the patient, a self-reported subjective health status of the patient, a recent life event experienced by the user, or any combination thereof), and
further comprising instructions that when executed, cause the processing resource to present the GUI displaying at least one of the plurality of GUI portions populated using at least portions of the objective patient data juxtaposed with at least portions of the subjective patient data for the plurality of patients (see at least Fig. 6A, Compliance Monitor, selectively displayable and filter by Patient Details, Days on Therapy, Days on Compliance, etc.; Compliance Forecast; Fig. 6C; Fig. 8B; Fig. 8D; Paragraph 15, The compliance prediction model outputs a prediction of compliance for the patient for using the respiratory pressure therapy device; Paragraph 132, FIG. 6A is an example interface 600 generated by a diagnosis, compliance and therapy management application accessible by a healthcare provider based on the prediction and patient data from the compliance API; Paragraph 133, Each patient listed in the window 602 may be selected and a detailed patient data window 604 may be displayed for the selected patient. The patients displayed in the summary window 602 may be filtered by selecting one of a search tab 610, a patient details tab 612, a days in therapy tab 614, a days to compliance tab 616, a compliance tab 618 and a more tab 620. The default display will list all patients in the patient summary window 602. Each of the patients listed may be ordered by selecting a sort by field 622. In this example, the patients with the lowest compliance forecast are displayed at the top of the list in the window 602),
Dittmer may or may not specifically disclose the following limitations, but Yoo as shown does:
wherein the different classes of the plurality of patients further comprises a class of compliant patients having implantable medical devices (see at least Paragraph 128, Treatment points can be defined to contribute to different treatment point categories, such as compliance … The set of treatment points are calculated upon to generate ratings or user status levels such as “Excellent patient”, “Very good patient”, “Good patient”, “Late Patient”, “Uncooperative Patient”, etc. or are used to calculate one or more scores. The treatment points can be assessed over an interval such as a day, week, or month; Paragraph 236, The establishment of a treatment regimen 302 and monitoring of compliance 304 may be done using a treatment regimen that is defined for an implanted neurostimulator, an external neurostimulator, or the combination, as may be defined by selecting appropriate controls),
the plurality of GUI portions including visual identification of respective ones of the patients that are categorized as at least one of the plurality of classes of non-compliant patients having implantable medical device based on the filters for the different classes of patients (see at least Fig. 16, Calculate/display compliance for 1 or more characteristics of treatment; Paragraph 112, Although the device 50 may communicate with a physician or patient programmer 70, or external patient device 72, such as may be realized by a specialized device, smartphone, tablet computer or wearable device, the device 50 may also have at least one signaling module 78 (which can be part of the alerting module 204) with related circuitry and control a display 79 for presenting visual data in both text and graphical format; Paragraph 128, Treatment points can be defined to contribute to different treatment point categories, such as compliance … The set of treatment points are calculated upon to generate ratings or user status levels such as “Excellent patient”, “Very good patient”, “Good patient”, “Late Patient”, “Uncooperative Patient”, etc. or are used to calculate one or more scores. The treatment points can be assessed over an interval such as a day, week, or month).
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of graphical user interface of Dittmer with the compliance features of Yoo for at least the same reasons given for claim 1.
Claim 4:
The combination of Dittmer/Yoo discloses the limitations as shown in the rejection above. Dittmer further discloses the following limitations:
receive the patient data for the plurality of patients, the patient data further comprising objective patient data indicative of patient feedback (see at least Paragraph 66, The input interface can be, for example, a touchscreen or touch-sensitive substrate, a mouse, a keyboard, or any sensor system configured to sense inputs made by a human user interacting with the user devices 132 and 170. In some implementations, one or more user devices can be used by and/or included in the system 100; Paragraph 67, The profile can include, for example, demographic information associated with the patient, biometric information associated with the patient, medical information associated with the patient, self-reported patient feedback, sleep parameters associated with the patient (e.g., sleep-related parameters recorded from one or more earlier sleep sessions), or any combination thereof),
present the GUI by displaying selective ones of the plurality of GUI portions on a display screen (see at least Fig. 6A, Compliance Monitor, selectively displayable and filter by Patient Details, Days on Therapy, Days on Compliance, etc.; Compliance Forecast; Fig. 6C; Fig. 8B; Fig. 8D; Paragraph 133, The patients displayed in the summary window 602 may be filtered by selecting one of a search tab 610, a patient details tab 612, a days in therapy tab 614, a days to compliance tab 616, a compliance tab 618 and a more tab 620; Paragraph 48, With a limited number of staff and hours in a day, the compliance predictions produced by the system allows HME staff to focus their efforts on those patients are who at risk of non-compliance in a more efficient way and more easily identify that particular cohort of patients; Paragraph 132, FIG. 6A is an example interface 600 generated by a diagnosis, compliance and therapy management application accessible by a healthcare provider based on the prediction and patient data from the compliance API);
in response to user selection of a filter icon on the GUI associated with one filter of the filters, present a revised GUI by (see at least Fig. 6A, Compliance Monitor, selectively displayable and filter by Patient Details, Days on Therapy, Days on Compliance, etc.; Compliance Forecast; Fig. 6C; Fig. 8B; Fig. 8D; Paragraph 133, The patients displayed in the summary window 602 may be filtered by selecting one of a search tab 610, a patient details tab 612, a days in therapy tab 614, a days to compliance tab 616, a compliance tab 618 and a more tab 620; Paragraph 48, With a limited number of staff and hours in a day, the compliance predictions produced by the system allows HME staff to focus their efforts on those patients are who at risk of non-compliance in a more efficient way and more easily identify that particular cohort of patients; Paragraph 132, FIG. 6A is an example interface 600 generated by a diagnosis, compliance and therapy management application accessible by a healthcare provider based on the prediction and patient data from the compliance API):
and not displaying patient data for the remaining patients which are compliant with the criteria associated with the one filter (Fig. 6C; Fig. 8B; Fig. 8D; Paragraph 133, The patients displayed in the summary window 602 may be filtered by selecting one of a search tab 610, a patient details tab 612, a days in therapy tab 614, a days to compliance tab 616, a compliance tab 618 and a more tab 620; Paragraph 48, With a limited number of staff and hours in a day, the compliance predictions produced by the system allows HME staff to focus their efforts on those patients are who at risk of non-compliance in a more efficient way and more easily identify that particular cohort of patients; Paragraph 132, FIG. 6A is an example interface 600 generated by a diagnosis, compliance and therapy management application accessible by a healthcare provider based on the prediction and patient data from the compliance API).
Dittmer may or may not specifically disclose the following limitations, but Yoo as shown does:
displaying respective patient data for respective patients which are non-compliant with a criteria associated with the one filter, and are thereby classified as one of the plurality of classes of non-compliant patients (see at least Paragraph 128, Treatment points can be defined to contribute to different treatment point categories, such as compliance … The set of treatment points are calculated upon to generate ratings or user status levels such as “Excellent patient”, “Very good patient”, “Good patient”, “Late Patient”, “Uncooperative Patient”, etc. or are used to calculate one or more scores. The treatment points can be assessed over an interval such as a day, week, or month;),
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of graphical user interface of Dittmer with the compliance features of Yoo for at least the same reasons given for claim 1.
Claim 5:
The combination of Dittmer/Yoo discloses the limitations as shown in the rejection above. Dittmer further discloses the following limitations:
categorize each of plurality of patients as at least one of the different classes based on the filters (see at least Fig. 6A, Compliance Monitor, selectively displayable and filter by Patient Details, Days on Therapy, Days on Compliance, etc.; Compliance Forecast; Paragraph 12, Another implementation is where the method includes displaying the compliance prediction of the patient. Another implementation is where the compliance prediction is displayed in a calendar showing the period of treatment. Another implementation is where the calendar shows past days of compliance. Another implementation is where the calendar shows the end of a projected compliance period based on the compliance prediction),
implement the clinician portal and to selectively integrate the patient data comprising the objective patient data indicative of stimulation therapy activity and subjective patient data indicative of patient feedback (see at least Fig. 6A; Fig. 6C; Fig. 8B; Fig. 8D; Paragraph 62, By allowing patients to track their nightly sleep data and through tailored coaching, the application empowers patients to stay engaged with therapy to assist in compliance. The patient application may interface with the RPT device 122 and display compliance related operational data such as usage hours, mask leaks, events based on apnea-hypopnea index (AHI) and mask on/mask off events. The patient application may also display surveys to collect patient input data; Paragraph 123, Specifically, compliance is defined as the patient used the device for at least four hours for 21 non-consecutive days in a 30 day window within the first 90 days of treatment. If a patient hits this criteria at least once in their first 90 days, they have reached compliance and are labeled “compliant.” If a patient does not reach the criteria, they are labeled as “non-compliant.”; Paragraph 131, The compliance data for a set of patients may be provided to a health care provider allowing the health care provider to prioritize patients by the probability of non-compliance. The compliance prediction data is an objective prediction that eliminates subjective judgement from a healthcare provider. Specific features that contribute to potential non-compliance may be provided as a notification to a health care provider to allow devising strategies to address such features; Paragraph 133, Each patient listed in the window 602 may be selected and a detailed patient data window 604 may be displayed for the selected patient. The patients displayed in the summary window 602 may be filtered by selecting one of a search tab 610, a patient details tab 612, a days in therapy tab 614, a days to compliance tab 616, a compliance tab 618 and a more tab 620. The default display will list all patients in the patient summary window 602. Each of the patients listed may be ordered by selecting a sort by field 622. In this example, the patients with the lowest compliance forecast are displayed at the top of the list in the window 602; Paragraph 135, the gender, the average duration of the usage, and multiple factors determined by the patient responding to a survey on the application interface on the user device such as the user device 132 in FIG. 1); and
in response, present the plurality of GUI portions which are populated using at least a portion of the selectively integrated patient data (see at least Fig. 6A; Fig. 6C; Fig. 8B; Fig. 8D; Paragraph 133, Each patient listed in the window 602 may be selected and a detailed patient data window 604 may be displayed for the selected patient. The patients displayed in the summary window 602 may be filtered by selecting one of a search tab 610, a patient details tab 612, a days in therapy tab 614, a days to compliance tab 616, a compliance tab 618 and a more tab 620. The default display will list all patients in the patient summary window 602. Each of the patients listed may be ordered by selecting a sort by field 622. In this example, the patients with the lowest compliance forecast are displayed at the top of the list in the window 602; Paragraph 134, In this example, each of the listings in the patient summary window 602 include a compliance score 630, a name field 632, a days in treatment field 634, a days to complete compliance field 636, and a compliance trend graph 638. The compliance score 630 is the compliance prediction output of the machine learning model based on the specific patient data and usage data. The days in treatment field 634 shows the day the patient is at in the 90 day treatment timeline. The days to complete compliance field 636 shows the number of days that the patient may use the RPT device 122 to complete compliance. The trend graph 638 shows whether the prediction for compliance is increasing or decreasing).
Dittmer may or may not specifically disclose the following limitations, but Yoo as shown does:
wherein respective ones of the plurality of patients as at least one of the plurality of classes of non-compliant patients having implantable medical devices based on the filters and at least one of the filters comprises a criteria associated with a stimulation amplitude change of the stimulation therapy activity applied by the implantable medical devices that differs from a reference (see at least Paragraph 128, Treatment points can be defined to contribute to different treatment point categories, such as compliance … The set of treatment points are calculated upon to generate ratings or user status levels such as “Excellent patient”, “Very good patient”, “Good patient”, “Late Patient”, “Uncooperative Patient”, etc. or are used to calculate one or more scores. The treatment points can be assessed over an interval such as a day, week, or month; Paragraph 234, Other types of non-compliance may be defined to cause the system to restrict use. The compliance module 200 is further configured to operate according to compliance rules that are defined to cause the compliance module to cause the control module to disable the stimulation operations provided by a stimulation module 54 of the neurostimulator if at least one compliance criterion is assessed as false because the criterion was not met. At home therapy requires the cooperation of a patient, and use can be restricted, for example, if a user fails to provide patient input data about symptoms so that therapy benefit can be tracked accurately by a physician monitoring a user remotely. Accordingly, the compliance module is further configured to operate according to compliance rules defined for non-compliance operations; Paragraph 236, The establishment of a treatment regimen 302 and monitoring of compliance 304 may be done using a treatment regimen that is defined for an implanted neurostimulator, an external neurostimulator, or the combination, as may be defined by selecting appropriate controls; Paragraph 257, Treatment goals may be defined for the patient and related to various treatment event types such as user adherence to the provision of treatment according to a regimen, compliance with answering survey item data, provision of sensed data with the assistance of the user, and other treatment event types; Paragraph 260, This includes electrical, magnetic, microwave or other forms of energy directed either to implantable components that stimulate tissue or to the tissue itself. This can include cranial electrotherapy, transcranial stimulation (e.g., direct-current or alternating current), ultrasonic neuromodulation. Stimulation provided by at least one of TENS, eTENS, percutaneous, external, partially or fully implantable systems can be operated to provide stimulation using the protocols and nerve targets disclosed herein);
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of graphical user interface of Dittmer with the patient features of Yoo for at least the same reasons given for claim 1.
Claim 6:
The combination of Dittmer/Yoo discloses the limitations as shown in the rejection above. Dittmer further discloses the following limitations:
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 as being at least one of non-compliant patients or predicted non-compliant patients based on at least one of the filters (see at least Fig. 6A, Compliance Monitor, Compliance Forecast; Paragraph 12, Another implementation is where the method includes displaying the compliance prediction of the patient. Another implementation is where the compliance prediction is displayed in a calendar showing the period of treatment. Another implementation is where the calendar shows past days of compliance. Another implementation is where the calendar shows the end of a projected compliance period based on the compliance prediction; Paragraph 15, The compliance prediction model outputs a prediction of compliance for the patient for using the respiratory pressure therapy device; Paragraph 48, With a limited number of staff and hours in a day, the compliance predictions produced by the system allows HME staff to focus their efforts on those patients are who at risk of non-compliance in a more efficient way and more easily identify that particular cohort of patients; Paragraph 132, FIG. 6A is an example interface 600 generated by a diagnosis, compliance and therapy management application accessible by a healthcare provider based on the prediction and patient data from the compliance API),
to the plurality of patients for treatment of sleep disordered breathing (see at least Paragraph 5, Many such patients utilize respiratory pressure therapy devices to assist in treating respiratory or sleep ailments. For example, CPAP devices provide air pressure when needed to keep air passageways open during sleep. Such devices may be used to treat a range of respiratory disorders; Paragraph 49, The respiratory system 120 is generally used to treat individuals suffering from one or more sleep-related respiratory disorders (e.g., obstructive sleep apnea, central sleep apnea, or mixed sleep apnea).
Dittmer may or may not specifically disclose the following limitations, but Yoo as shown does:
wherein the objective patient data indicative of the stimulation therapy activity is associated with stimulation by the implantable medical devices (see at least Paragraph 100, A report of usage can include such statistics as number of weeks since start of therapy, total stimulation sessions, average number of stimulation sessions scheduled or provided each week, average length of stimulation sessions, average strength of stimulation sessions. A table can also be generated where the date, time, duration, and stimulation settings for each session are listed)
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of graphical user interface of Dittmer with the patient features of Yoo for at least the same reasons given for claim 1.
Claim 7:
The combination of Dittmer/Yoo discloses the limitations as shown in the rejection above. Dittmer further discloses the following limitations:
further comprising instructions that when executed, cause the processing resource to display the plurality of GUI portions with expanded features visually displayed on a display screen to manage the plurality of patients by exception based on a non-compliant criteria associated with the filters (see at least Fig. 6A; Paragraph 123, Specifically, compliance is defined as the patient used the device for at least four hours for 21 non-consecutive days in a 30 day window within the first 90 days of treatment. If a patient hits this criteria at least once in their first 90 days, they have reached compliance and are labeled “compliant.” If a patient does not reach the criteria, they are labeled as “non-compliant.”; Paragraph 131, The compliance data for a set of patients may be provided to a health care provider allowing the health care provider to prioritize patients by the probability of non-compliance; Paragraph 132, FIG. 6A is an example interface 600 generated by a diagnosis, compliance and therapy management application accessible by a healthcare provider based on the prediction and patient data from the compliance API 558 in FIG. 5B. The example interface 600 may be generated on the display of a workstation of a user device such as the user device 170 used by a healthcare provider. The example interface 600 allows relevant prediction data from the machine learning model to be presented in a useful format to a healthcare provider; Paragraph 133, In this example the interface 600 includes a patient summary window 602 that includes a listing of patients associated with the healthcare provider. Each patient listed in the window 602 may be selected and a detailed patient data window 604 may be displayed for the selected patient. Each of the patients listed may be ordered by selecting a sort by field 622. In this example, the patients with the lowest compliance forecast are displayed at the top of the list in the window 602).
Claim 8:
The combination of Dittmer/Yoo discloses the limitations as shown in the rejection above. Dittmer further discloses the following limitations:
wherein the plurality of GUI portions include a main GUI display which automatically presents the plurality of non-compliance classes for each of the plurality of patients and a degree of each of the non-compliance classes based on the filters and as juxtaposed together, wherein areas of the main GUI display are selectable to transition to other respective ones of the GUI portions that expand on respective features (see at least 6E; Fig. 6F; Fig 6G; Paragraph 133, In this example the interface 600 includes a patient summary window 602 that includes a listing of patients associated with the healthcare provider. Each patient listed in the window 602 may be selected and a detailed patient data window 604 may be displayed for the selected patient. Each of the patients listed may be ordered by selecting a sort by field 622. In this example, the patients with the lowest compliance forecast are displayed at the top of the list in the window 602; Paragraph 143, FIG. 6E shows the interface 600 when the days in compliance tab 616 is selected. The compliance tab 616 causes a popup window 684 to be displayed. The popup window 686 has a days in compliance slider that allows a user to set the range of days in therapy. Once the days in compliance range is selected, an apply button 686 may be selected and the patients that meet the days in compliance range may be displayed in the patient summary window 60).
Claim 9:
The combination of Dittmer/Yoo discloses the limitations as shown in the rejection above. Dittmer further discloses the following limitations:
wherein the plurality of non-compliance classes include: under-utilizing patients which utilize an implantable medical device at a rate less than a threshold; under-surveying patients which complete a patient survey outside a threshold time period; under-updating patients which provide a therapy-related update status outside a threshold time period; attention-warranting-answer patients which provide an answer to a patient survey that is indicative of an issue; and attention-warranting-titration patients exhibiting stimulation amplitude change behavior deviating from a stimulation amplitude change reference (Dittmer, see at least Paragraph 134, In this example, each of the listings in the patient summary window 602 include a compliance score 630, a name field 632, a days in treatment field 634, a days to complete compliance field 636, and a compliance trend graph 638. The compliance score 630 is the compliance prediction output of the machine learning model based on the specific patient data and usage data. The days in treatment field 634 shows the day the patient is at in the 90 day treatment timeline. The days to complete compliance field 636 shows the number of days that the patient may use the RPT device 122 to complete compliance. The trend graph 638 shows whether the prediction for compliance is increasing or decreasing).
Claim 18:
The combination of Dittmer/Yoo discloses the limitations as shown in the rejection above. Dittmer further discloses the following limitations:
wherein the plurality of classes of non-compliant patients comprise: under-surveying patients which complete a patient survey outside a threshold time period; under-updating patients which provide a therapy-related update status outside a threshold time period; attention-warranting-answer patients which provide an answer to a patient survey that is indicative of an issue; or attention-warranting-titration patients exhibiting stimulation amplitude change behavior deviating from a stimulation amplitude change reference (see at least Paragraph 16, Another implementation is where the machine learning compliance prediction model includes an output based on the classification of the patient; Paragraph 48, personalized to identify and prioritize patients who may be approaching non-compliance with a respiratory treatment plan or regimen requiring operation of home medical equipment (HME), such as a respiratory pressure therapy device; Paragraph 62, By allowing patients to track their nightly sleep data and through tailored coaching, the application empowers patients to stay engaged with therapy to assist in compliance. The patient application may interface with the RPT device 122 and display compliance related operational data such as usage hours, mask leaks, events based on apnea-hypopnea index (AHI) and mask on/mask off events. The patient application may also display surveys to collect patient input data; Paragraph 113, The summary data post-processing may determine whether the most recent time period is a compliant session by comparing the usage time with the minimum duration from the compliance rule. The results of such post-processing are referred to as “compliance data.”; Paragraph 123, Specifically, compliance is defined as the patient used the device for at least four hours for 21 non-consecutive days in a 30 day window within the first 90 days of treatment. If a patient hits this criteria at least once in their first 90 days, they have reached compliance and are labeled “compliant.” If a patient does not reach the criteria, they are labeled as “non-compliant.”; Paragraph 131, The compliance data for a set of patients may be provided to a health care provider allowing the health care provider to prioritize patients by the probability of non-compliance. The compliance prediction data is an objective prediction that eliminates subjective judgement from a healthcare provider. Specific features that contribute to potential non-compliance may be provided as a notification to a health care provider to allow devising strategies to address such features; Paragraph 135, the gender, the average duration of the usage, and multiple factors determined by the patient responding to a survey on the application interface on the user device such as the user device 132 in FIG. 1).
Dittmer may or may not specifically disclose the following limitations, but Yoo as shown does:
under-utilizing patients which utilize the implantable medical devices at a rate less than a threshold and of a respective implantable medical device of the implantable medical devices (see at least Paragraph 100, A report of usage can include such statistics as number of weeks since start of therapy, total stimulation sessions, average number of stimulation sessions scheduled or provided each week, average length of stimulation sessions, average strength of stimulation sessions. A table can also be generated where the date, time, duration, and stimulation settings for each session are listed);
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of graphical user interface of Dittmer with the patient features of Yoo for at least the same reasons given for claim 1.
Claim 19:
The combination of Dittmer/Yoo discloses the limitations as shown in the rejection above. Dittmer further discloses the following limitations:
wherein the patient data comprises the objective patient data and subjective patient data, and further comprising instructions that when executed, cause the processing resource to: receive the objective patient data from patient communication devices, the objective patient data comprising at least one of sensed physiologic information or externally monitored information including at least one of: cardiac information; respiratory information; chest motion; oxygen desaturation information; peripheral arterial information; blood pressure; body position; acoustic information including snoring; sleep information including at least one of time spent in bed, total sleep time, start time, stop time, or a sleep stage; or sleep disordered breathing (SDB)-related index information (see at least Paragraph 57, the display device 128 can provide information regarding the status of the respiratory device 122 (e.g., whether the respiratory device 122 is on/off, the pressure of the air being delivered by the respiratory device 122, the temperature of the air being delivered by the respiratory device 122, etc.) and/or other information (e.g., a sleep score or a therapy score (such as a my Air™ score), etc.; Paragraph 62, The system 100 allows for monitoring respiratory related data for the patient 110. The system 100 thus includes an optional external device such as a user device 132, and a body mounted health monitoring device 134. The user device 132 and possibly the monitoring device 134 and the respiratory device 122 may be in communication with a network 136; Paragraph 66, The self-reported patient feedback can include information indicative of a self-reported subjective sleep score (e.g., poor, average, excellent), a self-reported subjective stress level of the patient, a self-reported subjective fatigue level of the patient, a self-reported subjective health status of the patient, a recent life event experienced by the user, or any combination thereof).
Dittmer may or may not specifically disclose the following limitations, but Yoo as shown does:
the objective patient data comprising implantable medical device usage (see at least Paragraph 100, A report of usage can include such statistics as number of weeks since start of therapy, total stimulation sessions, average number of stimulation sessions scheduled or provided each week, average length of stimulation sessions, average strength of stimulation sessions. A table can also be generated where the date, time, duration, and stimulation settings for each session are listed)
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of graphical user interface of Dittmer with the usage features of Yoo for at least the same reasons given for claim 1.
Claim 20:
The combination of Dittmer/Yoo discloses the limitations as shown in the rejection above. Dittmer further discloses the following limitations:
wherein the patient data comprises the objective patient data and subjective patient data, and further comprising instructions that when executed, cause the processing resource to receive the subjective patient data from patient communication devices, the subjective patient data comprising patient survey information including at least one of: implantable medical device usage; comfort levels; usage hindrances; device visible indicators; snoring levels; or energy levels (see at least Paragraph 57, the display device 128 can provide information regarding the status of the respiratory device 122 (e.g., whether the respiratory device 122 is on/off, the pressure of the air being delivered by the respiratory device 122, the temperature of the air being delivered by the respiratory device 122, etc.) and/or other information (e.g., a sleep score or a therapy score (such as a my Air™ score), etc.; Paragraph 62, The system 100 allows for monitoring respiratory related data for the patient 110. The system 100 thus includes an optional external device such as a user device 132, and a body mounted health monitoring device 134. The user device 132 and possibly the monitoring device 134 and the respiratory device 122 may be in communication with a network 136; Paragraph 66, The self-reported patient feedback can include information indicative of a self-reported subjective sleep score (e.g., poor, average, excellent), a self-reported subjective stress level of the patient, a self-reported subjective fatigue level of the patient, a self-reported subjective health status of the patient, a recent life event experienced by the user, or any combination thereof).
Claims 10-17 are rejected under 35 U.S.C. 103 as being unpatentable over Dittmer et al., WIPO Application Publication WO 2022/246267 A1 in view of Yoo et al., U.S. Patent Application Publication US 2019/0126039 A1 and further in view of Stahmann et al., U.S. Patent Application Publication US 2011/0061647 A1.
Claim 10:
The combination of Dittmer/Yoo discloses the limitations as shown in the rejection above. Dittmer may or may not specifically disclose the following limitations, but Stahmann as shown does:
wherein the patient data comprises objective patient data and subjective patient data, and the objective patient data comprises compliance with a prescribed usage and/or therapy interactions, for example. In various embodiments described herein, sensors coupled to the implantable monitoring device sense conditions used to monitor therapy parameters. For example, the sensed conditions may be used to evaluate the effectiveness of the breathing therapy the impact of the therapy on the patient and/or therapy interactions between the external breathing therapy and other therapies delivered to the patient. The external breathing therapy may be adjusted to enhance therapy effectiveness, to reduce an impact of the therapy and/or to reduce therapy interactions. The implantable device may monitor the patient's use of the external breathing therapy and/or compliance with a prescribed usage of the breathing therapy, for example).
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of graphical user interface of Dittmer and the compliance features of Yoo with the medical device of Stahmann with the motivation “… to enhance patient monitoring, diagnosis and/or therapy” (Stahmann, see at least Paragraph 12).
Claim 11:
The combination of Dittmer/Yoo discloses the limitations as shown in the rejection above. Dittmer may or may not specifically disclose the following limitations, but Stahmann as shown does:
wherein the patient data is associated each respective patient of the plurality of patients as received from a plurality of sources selected from: the implantable medical devices; patient communication devices; and clinician input to the clinician portal, wherein each of the patient communication device comprises at least one of: a dedicated patient remote control; or a consumer electronic device (see at least Fig. 1A; Paragraph 175, The data stored on the APM patient information server 170 may be accessible by the patient and the patient's physician through terminals 150, e.g., remote computers located in the patient's home or the physician's office. The APM patient information server 170 may be used to communicate to one or more of the patient-internal and patient-external medical devices 110, 120 to effect remote control of the monitoring, diagnosis, and/or therapy functions of the medical devices 110, 120; Paragraph 977, The parameters monitored by the monitoring system may include therapy effectiveness, impact of the therapy on the patient, therapy usage, compliance with a prescribed usage and/or therapy interactions, for example. In various embodiments described herein, sensors coupled to the implantable monitoring device sense conditions used to monitor therapy parameters. For example, the sensed conditions may be used to evaluate the effectiveness of the breathing therapy the impact of the therapy on the patient and/or therapy interactions between the external breathing therapy and other therapies delivered to the patient. The external breathing therapy may be adjusted to enhance therapy effectiveness, to reduce an impact of the therapy and/or to reduce therapy interactions. The implantable device may monitor the patient's use of the external breathing therapy and/or compliance with a prescribed usage of the breathing therapy, for example).
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of graphical user interface of Dittmer and the compliance features of Yoo with the medical device of Stahmann for at least the same reasons given for claim 10 above.
Claim 12:
The combination of Dittmer/Yoo/Stahmann discloses the limitations as shown in the rejection above. Dittmer may or may not specifically disclose the following limitations, but Stahmann as shown does:
wherein the patient data comprises the objective patient data and subjective patient data, and the patient remote controls are in communication with, and is to at least receive the objective patient data from, the implantable medical devices and the consumer electronic devices are in communication with, and is to at least receive the objective patient data, from the patient remote controls (see at least Fig. 1A; Fig. 1C; Table 2; The data stored on the APM patient information server 170 may be accessible by the patient and the patient's physician through terminals 150, e.g., remote computers located in the patient's home or the physician's office. The APM patient information server 170 may be used to communicate to one or more of the patient-internal and patient-external medical devices 110, 120 to effect remote control of the monitoring, diagnosis, and/or therapy functions of the medical devices 110, 120; Paragraph 282, Respiration patterns may be used to determine the type of disordered breathing. Respiration patterns may be used to detect that the patient is asleep. Patency of upper airway is related to obstructive airway sleep apnea and may be used to detect episodes of obstructive sleep apnea; Paragraph 437, an automated method for providing disordered breathing therapy involves detecting disordered breathing and adapting a cardiac electrical therapy to mitigate the disordered breathing. The adapted therapy is delivered to the patient. At least one of detecting the disordered breathing, adapting the therapy to mitigate the disordered breathing, and delivering the therapy is performed at least in part implantably),
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of graphical user interface of Dittmer with the medical device of Stahmann for at least the same reasons given for claim 10 above.
Dittmer may or may not specifically disclose the following limitations, but Yoo as shown does:
wherein the objective patient data indicative of stimulation therapy activity applied by the implantable medical devices comprises average rates of use of the implantable medical devices and stimulation amplitude changes for the stimulation therapy activity applied by the implantable medical devices (see at least Paragraph 74, A stimulation protocol that is defined for providing stimulation for longer periods (e.g. several hours at night) can use different stimulation signals than those used during a 30-minute therapy session. For example, the amplitude and/or pulse duration of the signals may be lower those used for 30-minute sessions; Paragraph 100, A report of usage can include such statistics as number of weeks since start of therapy, total stimulation sessions, average number of stimulation sessions scheduled or provided each week, average length of stimulation sessions, average strength of stimulation sessions. A table can also be generated where the date, time, duration, and stimulation settings for each session are listed; Paragraph 236, The establishment of a treatment regimen 302 and monitoring of compliance 304 may be done using a treatment regimen that is defined for an implanted neurostimulator, an external neurostimulator, or the combination, as may be defined by selecting appropriate controls; Paragraph 257, Treatment goals may be defined for the patient and related to various treatment event types such as user adherence to the provision of treatment according to a regimen, compliance with answering survey item data, provision of sensed data with the assistance of the user, and other treatment event types; Paragraph 260, This includes electrical, magnetic, microwave or other forms of energy directed either to implantable components that stimulate tissue or to the tissue itself. This can include cranial electrotherapy, transcranial stimulation (e.g., direct-current or alternating current), ultrasonic neuromodulation. Stimulation provided by at least one of TENS, eTENS, percutaneous, external, partially or fully implantable systems can be operated to provide stimulation using the protocols and nerve targets disclosed herein).
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of graphical user interface of Dittmer and the medical device of Stahmann with the features of Yoo for at least the same reasons given for claim 10 above.
Claim 13:
The combination of Dittmer/Yoo discloses the limitations as shown in the rejection above. Dittmer may or may not specifically disclose the following limitations, but Stahmann as shown does:
based on the patient data for a patient of the plurality of patients, perform patient care by determining, within the clinician portal, a stimulation therapy to be delivered to upper airway by a respective implantable medical device of the implantable medical devices patency-related tissue to treat sleep disordered breathing (see at least Fig. 1A; Fig. 1C; Table 2; Paragraph 175, The data stored on the APM patient information server 170 may be accessible by the patient and the patient's physician through terminals 150, e.g., remote computers located in the patient's home or the physician's office. The APM patient information server 170 may be used to communicate to one or more of the patient-internal and patient-external medical devices 110, 120 to effect remote control of the monitoring, diagnosis, and/or therapy functions of the medical devices 110, 120; Paragraph 176, the patient's physician may access patient data transmitted from the medical devices 110, 120 to the APM patient information server 170. After evaluation of the patient data, the patient's physician may communicate with one or more of the patient-internal or patient-external devices 110, 120 through the APM system 170 to initiate, terminate, or modify the monitoring, diagnostic, and/or therapy functions of the patient-internal and/or patient-external medical systems 110, 120; Paragraph 282, Respiration patterns may be used to determine the type of disordered breathing. Respiration patterns may be used to detect that the patient is asleep. Patency of upper airway is related to obstructive airway sleep apnea and may be used to detect episodes of obstructive sleep apnea; Paragraph 437, an automated method for providing disordered breathing therapy involves detecting disordered breathing and adapting a cardiac electrical therapy to mitigate the disordered breathing. The adapted therapy is delivered to the patient. At least one of detecting the disordered breathing, adapting the therapy to mitigate the disordered breathing, and delivering the therapy is performed at least in part implantably).
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of graphical user interface of Dittmer and the compliance features of Yoo with the action of Stahmann for at least the same reasons given for claim 10 above.
Claim 14:
The combination of Dittmer/Yoo/Stahmann discloses the limitations as shown in the rejection above. Dittmer may or may not specifically disclose the following limitations, but Stahmann as shown does:
further comprising instructions that when executed, cause the processing resource to send a signal to a stimulation element to cause delivery of a stimulation signal to the upper airway patency-related tissue (Stahmann, see at least Fig. 1C; Table 2; Paragraph 282, Respiration patterns may be used to determine the type of disordered breathing. Respiration patterns may be used to detect that the patient is asleep. Patency of upper airway is related to obstructive airway sleep apnea and may be used to detect episodes of obstructive sleep apnea; Paragraph 437, an automated method for providing disordered breathing therapy involves detecting disordered breathing and adapting a cardiac electrical therapy to mitigate the disordered breathing. The adapted therapy is delivered to the patient. At least one of detecting the disordered breathing, adapting the therapy to mitigate the disordered breathing, and delivering the therapy is performed at least in part implantably).
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of graphical user interface of Dittmer and the compliance features of Yoo with the action of Stahmann for at least the same reasons given for claim 10 above.
Claim 15:
The combination of Dittmer/Yoo/Stahmann discloses the limitations as shown in the rejection above. Dittmer may or may not specifically disclose the following limitations, but Stahmann as shown does:
further comprising instructions that when executed, cause the processing resource to communicate the stimulation therapy to the implantable medical device of the patient via at least one of: a dedicated patient remote control; or a consumer electronic device (see at least Paragraph 979, The patient management system may adjust breathing therapy delivery based on the information. In one implementation, the patient management system transmits control signals to the breathing therapy device to adjust the breathing therapy. Further, the patient and/or the patient's physician may access the information through the patient management system).
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of graphical user interface of Dittmer and the compliance features of Yoo with the medical device of Stahmann for at least the same reasons given for claim 10 above.
Claim 16:
The combination of Dittmer/Yoo discloses the limitations as shown in the rejection above. Dittmer may or may not specifically disclose the following limitations, but Stahmann as shown does:
further comprising instructions that when executed, cause the processing resource to, based on the patient data, perform patient care by determining at least one patient management action and communicating the at least one patient management action to a patient communication device (see at least Paragraph 979, The patient management system may adjust breathing therapy delivery based on the information. In one implementation, the patient management system transmits control signals to the breathing therapy device to adjust the breathing therapy. Further, the patient and/or the patient's physician may access the information through the patient management system).
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of graphical user interface of Dittmer and the compliance features of Yoo with the action of Stahmann for at least the same reasons given for claim 10 above.
Claim 17:
The combination of Dittmer/Yoo/Stahmann discloses the limitations as shown in the rejection above. Dittmer may or may not specifically disclose the following limitations, but Stahmann as shown does:
wherein the at least one patient management action comprises at least one of: scheduling a patient office visit; implementing at least one of a communication or a command to adjust parameters of stimulation therapy; implementing at least one of a communication or a command to adjust parameters of sensing; or implementing at least one of a communication or a command to adjust parameters of external patient monitoring (see at least Paragraph 979, The patient management system may adjust breathing therapy delivery based on the information. In one implementation, the patient management system transmits control signals to the breathing therapy device to adjust the breathing therapy. Further, the patient and/or the patient's physician may access the information through the patient management system).
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of graphical user interface of Dittmer and the compliance features of Yoo with the action of Stahmann for at least the same reasons given for claim 10 above.
Response To Arguments
Applicant’s arguments from the response filed on 10/27/2025 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed below in the order in which they appeared.
In the remarks, Applicant asserts that (1) Dittmer does not describe each and every claim limitation as recited by the amended limitations of independent claim 1; (2) Amended claims 2 and similarly amended claim 12 provide further distinction over Dittmer with their amended limitations that include “the objective patient data indicative of stimulation therapy activity applied by the implantable medical devices comprises average rates of use of the implantable medical devices or stimulation amplitude changes for the stimulation therapy activity applied by the implantable medical devices”; (3) Dittmer does not describe the amended limitations “categorize each of plurality of patients as at least one of the different classes based on the filters, wherein respective ones of the plurality of patients are categorized as at least one of the plurality of classes of non-compliant patients having implantable medical devices based on the filters and at least one of the filters comprises a criteria associated with a stimulation amplitude change of the stimulation therapy activity applied by the implantable medical devices that differs from a reference” of claim 5; and (4) Dittmer does not describe “the objective patient data indicative of the stimulation therapy activity is applied by the implantable medical devices to the plurality of patients for treatment of sleep”, the amended limitations of claim 6; (5) Dittmer does not describe receiving objective patient data comprising implantable medical device usage, as recited by the amended limitations of claim 19; (6) Dittmer does not describe the amended limitations of claim 3 and claim 4; (7) Dittmer does not specifically recite the non-compliance classes as recited by amended claim 9 and amended claim 18; (8) Dittmer does not describe, teach, or suggest the claimed invention as whole, at least as recited by independent claim 1 as amended and from which claims 10-17 depend. Stahmann is not cited for and does not cure the deficiencies of Dittmer.
In response to applicant’s arguments (1) - (8) as listed above, the examiner respectfully disagrees. Applicant’s arguments pertain to newly amended limitations, and have been addressed in the rejections above. As such, Applicant’s arguments have been considered but are not found to be persuasive.
Conclusion
Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Joy Chng whose telephone number is 571.270.7897. The examiner can normally be reached on Monday-Thursday and every other Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, JASON DUNHAM can be reached on 571.272.8109. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Joy Chng/
Primary Examiner, Art Unit 3686