DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/01/2026 has been entered.
Response to Amendment
Amendment received on 05/01/2026 is acknowledged and entered. Claims 12-13, 15-16, 19, 22-23, 26-27, 29-34 and 38-41 have been previously canceled. Claims 1, 35 and 42 have been amended. Claims 1-11, 14, 17-18, 20-21, 24-25, 28, 35-37 and 42-43 are currently pending in the application.
Claim Rejections - 35 USC § 101
Claim Rejections under 35 USC § 101 have been withdrawn due to the Applicant’s amendment.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/26/2026 is being considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
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, 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 1-10, 14, 17-20, 21, 28, 35-37 and 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Dees et al. (US 2015/0112722 A1) (IDS of 01/24/2023) in view of Armitstead et al. (US 2017/0311879 A1) (IDS of 01/24/2023), further in view of Dawson et al. (US 2019/0355271 A1) (IDS of 01/24/2023) and further in view of Tarumi et al. (US 2019/0156956 A1).
Claims 1 and 42. Dees et al. (Dees) discloses a method comprising:
causing by a control system that includes one or more processors, one or more sensors to generate physiological data associated with a sleep session, the physiological data including first physiological data collected during the sleep session and second physiological data collected during a duration adjacent the sleep session; (a trend; a real-time status) [0052]; [0053]; [0056]
While Dees discloses various examples of physiological data received, such as the patient's heart rate as measured by a heart rate sensor, the patient's oxygen levels as measured by an oxygen level sensor, and/or the like, Dees does not specifically teach the one or more sensors including a flow rate sensor and/or a pressure sensor integrated in a respiratory therapy system, which is disclosed in Armitstead et al. (Armitstead) [0067].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as disclosed in Armitstead, for the benefit of presenting a therapy quality indicator of a session, such as a number derived from contributions of a plurality of parameters for the session associated with the patient, as specifically stated in Armitstead. [0034]
Dees, as modified by Armitstead, further teaches:
receiving by the control system subjective feedback data associated with the sleep session; Dees, [0052]; [0056]
generating by the control system a set of component (events) scores based on the physiological data and the subjective feedback data; Dees, [0053]; [0056]; [0057]
calculating by the control system a total (evaluation or overall) health score associated with the sleep session using the set of component scores; Dees, [0057]
adjusting by the control system a pressure setting associated with the respiratory therapy system based at least in part on the physiological data associated with the sleep session; Armitstead, [0033]
causing, by the control system via the respiratory therapy system, pressurized air to be supplied to a user using the adiusted pressure settings; Armitstead, [0033], and
presenting the total health score. Dees, Fig. 5; [0057]
Further, Dawson et al. (Dawson) discloses presenting the total score. cl. 68; [0166]; [0251]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as disclosed in Dawson, for the benefit of better engaging patients and improving of patients wellbeing, as specifically stated in Dawson. [0011]; [0229]
Dees, as modified by Dawson, further teaches:
presenting the total health score in a graphical user interface, the graphical user interface having a dashboard view, Dees; Fig. 5; [0053]; [0054]; Dawson; [0049];
wherein when selected on the graphical user interface, the dashboard view presents the total health score as a total health score indication having a plurality of graphical health score component indications associated with the set of component scores, Dees; [0087]; [0088]; Dawson; Figs. 1-99, 102, with each respective graphical score component indication tailored to a respective accuracy associated with a respective component score in the set of component scores [0006]
Further, Armitstead discloses a GUI configured to provide a numerical health score indication and a plurality of graphical health score component indications, the plurality of graphical health score component indications provided as sub-areas of a shaped area with each respective graphical health score component indication sized proportionally to an amount associated with a respective component score. Figs. 9 and 10.
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as disclosed in Dawson, for the benefit of presenting a therapy quality indicator of a session, such as a number derived from contributions of a plurality of parameters for the session associated with the patient, as specifically stated in Armitstead. [0034]
Further, Tarumi discloses displaying a plurality of graphical health score component indications provided as sub-areas of a total shaped area with each respective graphical health score component indication sized proportionally to an amount associated with a respective component score contributing to the total health score (a pie-shaped chart) Fig. 16B; [0136],
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wherein each respective graphical score component indication tailored to a respective accuracy associated with a respective component score in the set of component scores [0170]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as disclosed in Tarumi, because it would advantageously allow even uninformed readers to see a data comparison at a glance and to make an immediate analysis or to understand information quickly, and even without need to examine or measure underlying numbers.
Claims 2 and 43. The method of claim 1, wherein, for at least one of the set of component scores, the generating the component score includes: determining a measurement score associated with one or more measurements associated with a component being scored; determining a compliance score based on a number of measurement instances or a duration of measurement associated with the one or more measurements associated with the component being scored; and calculating the component score based on the measurement score and the compliance score. Dees; [0052]
Claim 3. The method of claim 1, further comprising causing the respiratory therapy system to generate medical device usage data, the medical device usage data being associated with usage of the respiratory therapy system during the sleep session, the generating the set of component scores being further based on the medical device usage data. Dees; [0052]; Armitstead; Figs. 1, 3, 7A-B.
Claim 4. The method of claim 3, wherein the presenting the total health score includes presenting a therapy of whether or not the respiratory therapy system was used during the sleep session, the therapy indication at least partially overlaid on the total health score indication. Dees discloses a report module that generates one or more reports for the patient based on a state of the patient's medical condition and a subjective feedback being received from a client device associated with the patient, wherein the report module 306 may report the patient's wellness status to the patient's doctor via an interface, electronic message, or the like. [0009]; [0010]; [0057]; [0076], thereby at least suggesting the recited limitations. Armitstead; Figs. 1, 3, 7A-B, 9 and 10.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as suggested in Dees, because it would advantageously allow the doctor to use the wellness status to determine a course of action for the patient, as specifically stated in Dees.
Claim 5. The method of claim 1, wherein each component score in the set of component scores is associated with a weighting value, and wherein the calculating the total health score includes, for each component score in the set of component scores, applying the weighting value to the component score. Dees; [0043]; [0062]; [0066]; [0088]
Claim 6. The method of claim 5, further comprising adjusting one or more of the weighting values based on a number of data sources used to generate the set of component scores. (changing weighting values based on historical data of patent’s reactions and other patients’ reaction on changes in environmental conditions) Dees; [0067]
Claim 7. The method of claim 5, further comprising adjusting one or more of the weighting values based on one or more historical component scores. (changing weighting values based on historical data of patent’s reactions on change in environmental conditions) Dees; [0067]
Claim 8. The method of claim 7, wherein the adjusting the one or more of the weighting values includes: identifying a component to be improved or maintained based on the one or more historical component scores, the component represented by one component score of the set of component scores; and modifying the one or more weighting values to increase a weighting value associated with the one of the set of component scores relative to one or more weighting values associated with other components of the set of component scores. Dees discloses changing weighting values based on historical data of a particular patent’s reactions on change in environmental conditions, and changing accordingly component scores to reflect a factor of importance for the patient, [0067]; [0043]; [0062]; [0066]; [0067]; [0088], thereby suggesting the recited limitations.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as suggested in Dees, because it would advantageously allow the doctor to use the received data to determine a course of action for the patient, as specifically stated in Dees.
Claim 9. While Dees discloses the use of a regression analysis, Dees does not explicitly teach applying the set of component scores to a machine learning algorithm, which is disclosed in Dawson. [0014]; [0153]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as disclosed in Dawson, because it would advantageously allow to readily identify an unexpected pattern in data stream, and to identify which data streams and types are tightly correlated and what the relationship might be, as specifically stated in Dawson. [0163]
Claim 10. The method of any one of claim 5, further comprising: receiving demographic information, medical history information, or family health information; and adjusting one or more of the weighting values based on the demographic information, the medical history information, the family health information, or any combination thereof. Dees; [0059]; [0060]; [0062]; [0066]
Claim 14. The method of any one of claims claim 1, wherein the set of component scores includes a blood pressure score based on the second physiological data, wherein the blood pressure score is based at least in part on (i) a blood pressure measurement score that is based at least in part on one or more blood pressure measurements taken during the duration adjacent to the sleep session, (ii) a blood pressure compliance score that is based at least in part on a number of times one or more blood pressure measurements were taken during the duration adjacent to the sleep session, or (iii) both (i) and (ii). Dees; [0050]; Dawson; [0041]; [0045]; [0150]; [0155]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as disclosed in Dawson, for the benefit better engaging patients and improving of health reporting, as specifically stated in Dawson. [0009]
Claim 17. The method of claim 1, wherein the set of component scores includes an activity score based on the second physiological data. Dees; [0052]; [0053]; [0056]
Claim 18. The method of claim 17, wherein the activity score is based at least in part on (i) an activity measurement score that is based at least in part on a value associated with an amount of activity tracked during the duration adjacent to the sleep session, (ii) an activity compliance score that is based at least in part on a length of time activity was tracked during the duration adjacent to the sleep session, or (iii) both (i) and (ii). Dees; [0052]; [0053]; [0056]
Claim 20. The method of claims claim 1, wherein the set of component scores includes a sleep score based on the first physiological data. Dees; [0053]; [0056]; [0057] Same rationale as applied to claim 1.
Claim 21. The method of claim 20, wherein the sleep score is based at least in part on (i) a sleep measurement score that is based at least in part on a value associated with a quality of sleep during the sleep session, (ii) a sleep compliance score that is based at least in part on whether or not the first physiological data was collected during the sleep session, or (iii) both(i) and (ii). Dawson. [0086]; [0193] – [0195]; [0199]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as disclosed in Dawson, for the benefit better engaging patients and improving of patients wellbeing, as specifically stated in Dawson. [0011]; [0229]
Claim 28. The method of claim 1, further comprising: (i) presenting, for at least one of the set of components scores, a target value associated with the component score,(ii) presenting, for each of the set of component scores, an indicator of an amount the component score contributed to the total health score; or (iii) both (i) and (ii). Dawson; cl. 68; [0166]; [0251].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as disclosed in Dawson, for the benefit better engaging patients and improving of patients wellbeing, as specifically stated in Dawson. [0011]; [0229]
Claim 35. Dees discloses a method comprising:
receiving by the control system that includes one or more processors a set of existing component scores associated with a sleep session or a previous sleep session; (a trend; a real-time status) [0052]; [0053]; [0056]
receiving by the control system data associated with the sleep session, wherein receiving data associated with the sleep session comprises: receiving physiological data associated with the sleep session, the physiological data including first physiological data collected during the sleep session and second physiological data collected during a duration adjacent the sleep session; (a trend; a real-time status) [0052]; [0053]; [0056], with each respective graphical score component indication tailored to a respective accuracy associated with a respective component score in the set of component scores [0006]
Dees does not specifically teach:
adjusting by the control system a pressure setting associated with the respiratory therapy system based at least in part on the physiological data associated with the sleep session;
causing, by the control system via the respiratory therapy system, pressurized air to be supplied to a user using the adiusted pressure settings; Armitstead, [0033]; [0067]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as disclosed in Armitstead, for the benefit of presenting a therapy quality indicator of a session, such as a number derived from contributions of a plurality of parameters for the session associated with the patient, as specifically stated in Armitstead. [0034]
Dees, as modified by Armitstead, further teaches:
generating by the control system a set of updated component (events) scores based on the set of existing component scores and the received data; [0053]; [0056]; [0057]
calculating by the control system a total health score associated with the sleep session using the set of updated component scores; [0057] and
presenting the total health score. Fig. 5; [0057]
Further, Dawson discloses presenting the total score. cl. 68; [0166]; [0251]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as disclosed in Dawson, for the benefit better engaging patients and improving of patients wellbeing, as specifically stated in Dawson. [0011]; [0229]
Dees, as modified by Dawson, further teaches:
presenting the total health score in a graphical user interface, the graphical user interface having a dashboard view, Dees; Fig. 5; [0053]; [0054]; Dawson; [0049]
wherein the dashboard view presents the total health score as a total health score indication having a health score indication and a plurality of graphical health score component indications associated with the set of component scores, Dees; [0087]; [0088]; Dawson; Figs. 1-99, 102
Further, Armitstead discloses a GUI configured to provide a numerical health score indication and a plurality of graphical health score component indications, the plurality of graphical health score component indications provided as sub-areas of a shaped area with each respective graphical health score component indication sized proportionally to an amount associated with a respective component score. Figs. 9 and 10.
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as disclosed in Dawson, for the benefit of presenting a therapy quality indicator of a session, such as a number derived from contributions of a plurality of parameters for the session associated with the patient, as specifically stated in Armitstead. [0034]
Dees, as modified by Dawson and Armitstead, further teaches:
wherein when selected on the graphical user interface, the displayed data indicates the total health score on a measurement indicator (e.g. for a selected day), and wherein the plurality of graphical health score component indications are dynamically sized. Dees; Fig. 5; [0055]; Dawson; Figs. 1-99; Armitstead; Figs. 9 and 10.
Further, Tarumi discloses displaying a plurality of graphical health score component indications provided as sub-areas of a total shaped area with each respective graphical health score component indication sized proportionally to an amount associated with a respective component score contributing to the total health score. (a pie-shaped chart), wherein the plurality of graphical score component indications are dynamically sized, Fig. 16B; [0136]
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wherein each respective graphical score component indication tailored to a respective accuracy associated with a respective component score in the set of component scores [0170]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as disclosed in Tarumi, because it would advantageously allow even uninformed readers to see a data comparison at a glance and to make an immediate analysis or to understand information quickly, and even without need to examine or measure underlying numbers.
Claim 36. The method of claim 35, wherein the receiving the data associated with the sleep session further comprises: receiving subjective feedback data associated with the sleep session. (a trend; a real-time status) Dees; [0052]; [0053]; [0056]. Same rationale as applied to claim 35.
Claim 37. The method of claim 35, wherein the calculating the total health score comprises updating an existing total health score, and wherein the presenting the total health score comprises updating a presentation of an existing total health score using the total health score. Dees; [0052]; [0053]; [0056]
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Dees in view of Armitstead, further in view of Dawson, further in view of Tarumi, and further in view of KUSUKAME et al. (CN 106361270 A).
Claim 11. Dees does not specifically teach: wherein the set of component scores includes a sleepiness score, wherein the sleepiness score is based at least in part on (i) a sleepiness measurement score selected from a range based on the subjective feedback data, (ii) a sleepiness compliance score that is based on whether or not the subjective feedback data is provided, or (iii) both (i) and (ii), which is disclosed in KUSUKAME et al. (KUSUKAME). (Thus, in order to use the wakefulness degree of user to correct the drowsiness level 2 of wakefulness degree. The wakefulness degree drowsiness level 3 or the gradient of the straight line represented by a dotted line of FIG. 10 of the value, the processing part 13 may also perform feedback, the wakefulness degree of the user using the calculated as a sleepiness level 4 of time point detected by the bio-information of the user (such as blood pressure, heart rate) is judged.)
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as disclosed in KUSUKAME, for the benefit of analyzing sources of wakefulness, and decreasing the wakefulness degree of the user, in order to improve the user waking degree (awake) and, thereby, increase safety of a driver during driving, as specifically stated in KUSUKAME.
Claims 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Dees in view of Armitstead, further in view of Dawson, further in view of Tarumi, and further in view of Heneghan et al. (US 2016/0270718 A1).
Claim 24. The method of claim 20, further comprising receiving medical device usage data, the sleep score being calculated using the medical device usage data, wherein the calculating the sleep score comprises: determining at least one sub-score selected from the group consisting of: determining a usage score representing a duration of time a respiratory therapy system was used during the sleep session based on the medical device usage data, determining an interface score representing an effectiveness of a user interface seal of the respiratory therapy system during the sleep session based on the medical device usage data, and determining an interruption score representing a number and/or duration of times the user interface was removed during the sleep session based on the medical device usage data; and using the determined sub-score to calculate the sleep score. Armitstead; [0017]; [0065]; [0210]; [0255]; Heneghan et al. (Heneghan) [0119]; [0125]; [0198] Further, Heneghan discloses improving accuracy of the obtained results. [0109]; [0114]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as disclosed in Heneghan, for the benefit of determining a severity of contributing factors to fatigue, such as poor sleep quality (e.g., due to family/recreational factors, stress, noise, respiratory disorders and other health issues), as specifically stated in Heneghan. [0020]; [0021]
Claim 25. The method of claim 24, wherein the calculating the sleep score further includes determining an event score representing a number of events that occurred during the sleep session based on the medical device usage data to calculate the sleep score, wherein the event score is further combined with one or more of the usage score, the interface score, and the interruption score to calculate the sleep score. Same rationale as applied to claims 24 and 20.
Response to Arguments
Applicant's arguments filed 5/01/2026 have been fully considered but they are not persuasive.
Applicant arguments regarding 101 rejections have been considered but are moot, the claim rejections under 35 USC 101 have been withdrawn due to the Applicant’s amendment.
Applicant argues that the cited references fail to disclose "displaying a plurality of graphical health score component indications provided as sub-areas of a total shaped area with each respective graphical health score component indication sized proportionally to an amount associated with a respective component score contributing to the total health score", and "wherein at least two sub-areas are dynamically resized to maintain a same size of the total shaped area.
The Examiner respectfully points out that Dees discloses total health score as a total health score indication having a plurality of graphical health score component indications associated with the set of component scores, [0087]; [0088]; Dawson; Figs. 1-99, 102. Armitstead discloses a GUI configured to provide a numerical health score indication and a plurality of graphical health score component indications, the plurality of graphical health score component indications provided as sub-areas of a shaped area with each respective graphical health score component indication sized proportionally to an amount associated with a respective component score. Figs. 9 and 10.
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Further, Tarumi discloses displaying a plurality of graphical health score component indications provided as sub-areas of a total shaped area with each respective graphical health score component indication sized proportionally to an amount associated with a respective component score contributing to the total health score. (a pie-shaped chart) Fig. 16B; [0136]
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Citations of pertinent art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Karan Aggarwal et al. “A Structured Learning Approach with Neural Conditional Random Fields for Sleep Staging” 2018 IEEE International Conference on Big Data (Big Data; pp. 1318-1327, discloses discloses CPAP flow signal used to generate sleep metrics from respiratory therapy data.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Igor Borissov whose telephone number is 571-272-6801. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor Kambiz Abdi can be reached on 571-272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IGOR N BORISSOV/Primary Examiner, Art Unit 3685 7/18/2026
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