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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/04/2026 has been entered.
Response to Arguments
35 U.S.C 112(a)
Applicant argues that claims 1-15 and 17-20 overcome the §112(a) written-description rejection because claim 1 was amended to replace the medication with the modification, and the prior §112 rejection was based on the erroneous recitation of the medication.
The examiner agreed that the Applicant’s argument is persuasive as to the §112(a) issue. Accordingly, the §112 written-description rejection of claims 1-15 and 17-20 is withdrawn.
35 U.S.C 103
Applicant's arguments, see pages 8-13, filed 05/04/2026, with respect to amended Claims 5-7, 16-17, 18, and 19-20 have been fully considered. The arguments are not persuasive. The rejections of these claims under 35 U.S.C. § 103 are maintained.
Applicant argues that claims 1 and 21, including generating … a plurality of sleep scores … associated with a plurality of days … generated based on data from a respiratory therapy device, receiving … from an external device … a plurality of activity indicators, determining … correlations, and determining … based on the correlations … a modification for respiratory therapy, are not taught by Molony in view of Kayyali.
Examiner respectfully disagreed. Under BRI, the claim requires the cited data, correlations, and modification to be taught or suggested by the combination, not by either reference alone. Molony teaches the plurality-of-days sleep/activity correlation framework, including activity measurements, sleep-score data points, and correlation between first and second parameters, Molony pars. 0087, 0208, 0211, 0214, 0217. Kayyali supplies the respiratory-therapy modification and command mechanism, Kayyali col. 2, ll. 45-67; col. 3, ll. 40-56; col. 7, ll. 30-45; col. 8, ll. 20-35. The rejection is maintained.
Applicant argues that the claims require modifications for respiratory therapy based on historical sleep scores and their correlation with historical activity indicators, while Kayyali does not disclose historical correlation-based adjustments.
Examiner answers respectfully disagreed because it improperly requires Kayyali to supply the historical correlation feature. The rejection is based on the combined teachings, and nonobviousness is not shown by attacking Kayyali individually. Molony supplies the historical correlation basis, Molony pars. 0144-0148, 0214-0217, and Kayyali supplies the known PAP/CPAP adjustment path, Kayyali col. 7, ll. 30-45; col. 8, ll. 20-35.
Applicant argues that Kayyali’s PAP/CPAP adjustments are immediate reactions to physiological events within a single session, while claim 1 requires a therapy modification based on multi-day sleep-score/activity-indicator correlations.
Examiner answers that the argument is not persuasive because Kayyali is not relied upon for the claimed multi-day correlation input. Molony supplies that input by determining sleep-score/activity-measurement correlations over plural data points/days, Molony pars. 0211, 0214, 0217. Kayyali is relied upon for the missing downstream control mechanism: determining a PAP/CPAP adjustment and sending a command to change pressure or flow, Kayyali col. 2, ll. 45-67; col. 7, ll. 30-45; col. 8, ll. 20-35. Thus, the proposed combination uses Molony’s correlation as the basis for selecting the modification and Kayyali’s known command pathway to execute that modification. Under MPEP 2143 and 2145, the question is what the combined teachings would have suggested to a POSITA, not whether Kayyali independently uses the same input as the claim. The rejection is maintained.
Applicant argues that because Kayyali adjusts based on physiological signals, a POSITA would not look to Kayyali for the claimed correlation-based respiratory-therapy modification.
Examiner respectfully disagreed because Kayyali is reasonably pertinent to the same respiratory-therapy control problem. Molony addresses respiratory-therapy users who may stop therapy absent demonstrated benefit, Molony par. 0003, and Kayyali expressly seeks to adjust treatment gas flow or pressure using diagnostic data and closed-loop CPAP titration, Kayyali col. 2, ll. 45-67. Applying Kayyali’s known automatic PAP/CPAP control technique to Molony’s respiratory-therapy analytics is a proper obviousness rationale under MPEP 2143.
Applicant argues that neither Molony nor Kayyali alone discloses or contemplates modifying respiratory therapy based on historical correlations between sleep scores and activity indicators.
Examiner respectfully disagreed because the rejection relies on Molony for the correlation basis and Kayyali for the missing modification/command execution. The combination would use Molony’s sleep-score/activity-indicator correlation as an input for selecting a therapy modification and Kayyali’s command signal to adjust PAP/CPAP pressure or flow, Kayyali col. 7, ll. 30-45; col. 8, ll. 20-35. The result is a predictable use of known elements according to their established functions.
Applicant argues that claims 2-15, 18-20, and 22 are allowable because they depend from claim 1, and that Futch, Mohammed, and Wright do not cure the alleged deficiency of Molony and Kayyali with respect to claim 1.
Examiner respectfully disagreed persuasive because it presents no separate patentability argument for the dependent claims and rests on the same unsuccessful challenge to claim 1. The alleged deficiency of claim 1 has not been established because Molony and Kayyali teach or suggest the base-claim correlation and respiratory-therapy adjustment features as explained above; Futch, Mohammed, and Wright are relied upon only for the additional dependent-claim features. To the extent separately considered, Molony also supports claim 22 by teaching sleep-score and activity-measurement trends, correlation between the first and second parameters, and weighting adjustments based on trends or inferences, Molony pars. 0144-0148, 0182-0183, 0196, 0198, 0214-0217. Therefore, the dependent-claim arguments do not overcome the rejection, and the rejection is maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 17 and 21 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 is rejected under 35 U.S.C. 112(b) as being indefinite.
The claim makes reference to a preceding claim (Claim 16) to define its scope. Because Claim 16 is canceled, the metes and bounds of Claim 17 cannot be ascertained. Additional, claim also recite the respiratory therapy system that represent insufficient antecedent basis, for purposes of examination, you will interpret claim 17 as being dependent on claim 1.
Claim 21 is rejected under 35 U.S.C. 112(b) as being indefinite.
The claim recites the limitation the respiratory therapy system in the final paragraph of the claim. There is insufficient antecedent basis for this limitation in the claim. The claim previously defines and refers to 'a respiratory therapy device.' The introduction of 'the respiratory therapy system' at the conclusion of the claim creates uncertainty as to whether the 'system' is intended to be the 'device' or a broader collection of components not previously recited.
Note: Claims 2-15 and 17 -20 are also rejected on this basis because they dependent on claim 1.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-4, 8-15 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over US-20230245780A1- Molony and further in view of Kayyali- US7942824.
Claim 1. Molony teaches, A method comprising:
generating, by a control system, a plurality of sleep scores for a user, wherein the plurality of sleep scores for the user are associated with a plurality of days, wherein the sleep scores are generated based on data from a respiratory therapy device;
Molony describes a "control system 110" with processors and memory ([0042], [0043]) that generates a "set of component scores" including a "sleep score" and a "total health score" (which incorporates the sleep score) for each "sleep session" or "given day" ([0004], [0125], [0170]). These scores are presented in a "calendar portion 510" showing scores for a "plurality of date indications" (e.g., May 23-29), thus associating them with a "plurality of days" ([0119], [0120]). The "sleep score" is explicitly stated to be associated with therapy from a "respiratory therapy system 120" and can be based on "medical device usage data" from such a system, including usage, interface, and event scores ([0176], [0182]).
receiving, by the control system from an external device, a plurality of activity indicators, wherein the plurality of activity indicators are associated with the plurality of days;
Molony's "control system 110" receives "physiological data" from sources including an "activity tracker 190" (a wearable external device) ([0045], [0161], [0041], [0087], [0088]). This data is used to determine an "activity measurement" which includes a plurality of indicators like "number of steps, distance traveled, heart rate, calories burned" ([0087]). The system calculates a "total health score for given day" based in part on an "activity measurement for that day," and trends for activity measurements are shown over multiple days in a calendar view, thus associating these indicators with a "plurality of days" ([0125], [0145]).
determining, by the control system based on the plurality of sleep scores and the plurality of activity indicators, correlations between the plurality sleep scores and the plurality of activity indicators;( Molony, par. 0042: “control system 110 … analyze data … can be used to carry out one or more steps of any of the methods”; par. 0208: “the first parameter is a sleep score”; par. 0214: “the determined first parameter can have a plurality of data points, where each data point corresponds to one day in the time period”; par. 0087: “activity measurement can include … a number of steps, a distance traveled … duration … type … intensity … or any combination thereof”; par. 0211: “the determined second parameter is … an activity measurement”; par. 0217: “determining a relationship between the determined first parameter … and the determined second parameter … based on a statistical analysis, such as a correlation … or a regression analysis.”)
Molony’s sleep score is the first parameter, that parameter has “a plurality of data points,” the second parameter can be “an activity measurement,” activity measurement includes multiple activity indicators, and the control system determines a relationship using “correlation” or “regression analysis.”
generating, by the control system based on the correlations between the plurality sleep scores and the plurality of activity indicators, a visual presentation, wherein the visual presentation indicates the correlations between the plurality of sleep scores and the plurality of activity indicators; (Molony, par. 0087: “activity measurement can include … a number of steps, a distance traveled … duration … type … intensity … or any combination thereof”; par. 0211: “the determined second parameter is … an activity measurement”; par. 0214: “the determined first parameter can have a plurality of data points”; par. 0217: “determining a relationship between the determined first parameter … and the determined second parameter … such as a correlation”; par. 0222: “the control system 110 generates the custom message based at least in part on … the determined relationship” and the message can include “a fifth indication associated with the determined relationship” using “alphanumeric text, image(s), video(s), graphic(s), symbol(s), color(s), or any combination thereof”; par. 0227: “control system 110 can cause the generated custom message to [be] communicated to the user via the display device 172 … using one or more visual indications.”)
Molony’s “activity measurement” reads on activity indicators because it includes steps, distance, duration, type, intensity, and combinations; Molony’s first parameter has a “plurality of data points” and the first/second parameters can be related by “a correlation.” Molony then reads on generating … a visual presentation because the “control system 110 generates the custom message based … on the determined relationship,” the message includes an indication of that relationship, and the control system displays it using “visual indications.”
causing presentation, by the control system via a display device of a user device, the visual presentation.
Molony states its "control system 110... can cause the generated custom message... to be communicated to the user via the display device 172" ([0227]). The "user device 170" includes this "display device 172" and can be a "smart phone" or "tablet" ([0084]). The "generated custom message" is the visual presentation indicating the correlations;
determining, by the control system automatically based on the correlations between the plurality sleep scores and the plurality of activity indicators, a (Molony, par. 0207-0208, 0211, 0217, 0224)
Molony describes a system that calculates correlations between sleep scores and other health indicators (such as blood pressure or activity measurements).
(Molony, par. 0044, “The medical information can include, for example, including indicative of one or more medical conditions associated with the user, medication usage by the user, or both”)
and
causing, by the control system . (Molony, par. 0054 “The APAP system automatically varies the air pressure delivered to the user based on, for example, respiration data associated with the user.”)
35 U.S.C 103 Rationale:
Molony teaches determining correlations between sleep scores and activity indicators, as shown by Molony par. 0211, 0214, 0222, 0217.
However, Molony does not teach determining a modification for respiratory therapy on the respiratory therapy device for the user; generating … a command to adjust one or more parameters of the respiratory therapy; and causing … the respiratory therapy device to adjust the one or more parameters.
Kayyali teaches the missing machine-control part. In Kayyali, the treatment device can be adjusted automatically by a closed-loop control system using data or signals from the diagnostic device to operate the treatment system. Kayyali also describes calculating a command signal to titrate or adjust the PAP or CPAP device, and sending that command signal periodically to adjust the flow of pressurized gas. In simpler terms, Kayyali shows three things: deciding what therapy change is needed, generating a command for that change, and causing the PAP/CPAP device to make the adjustment. Refer to col. 3, ll. 40-56, col. 7, ll. 30-45, and col. 8, ll. 15-35
A POSITA would have combined Molony with Kayyali before the filing date to make Molony’s sleep-score/activity correlation not only shown to the user, but also used to adjust PAP/CPAP therapy.
Molony supplies the need and starting system: users may stop respiratory therapy when they do not see benefit, APAP already automatically changes delivered pressure, and the control system determines correlations involving sleep and activity measurements, Molony pars. 0003, 0054, 0211, 0217.
Kayyali supplies the missing control action: adjusting treatment gas flow or pressure using multi-night diagnostic data and closed-loop CPAP titration, Kayyali col. 2, ll. 27-67.
The modification would use Molony’s correlation as an input for selecting a therapy change, then use Kayyali’s command path to adjust PAP/CPAP pressure or flow, Kayyali col. 7, ll. 30-45; col. 8, ll. 20-35. This would predictably produce Molony’s correlation-based insight with Kayyali’s known automatic therapy adjustment.
Note: Claim 21 is rejected with claim 1 for being very similar and in the view of the following different limitations in claim 21 rejected below:
determining, by the control system automatically based on the correlations between the plurality sleep scores and the plurality of activity indicators, a recommendation; (Molony, par. 0222 “The control system 110 generates the custom message based at least in part on... the determined relationship...”)
causing transmission, by the control system, of the recommendation; (Molony, par. 0228, “Step 1309 of the method 1300 includes causing the generated custom message to be communicated to the user”)
;
and
.
35 U.S.C 103 Rational:
Molony teaches receiving, in response to the causing the transmission of the recommendation, by stating “the recommendation can communicate recommended steps or actions for improving the determined first parameter” (para. [0224]) and “causing the generated custom message to be communicated to the user via the display device 172” (para. [0227]). However, Molony fails to disclose the specific bidirectional handshake of receiving... a command to adjust one or more parameters of the respiratory therapy that is generated specifically as a response to that transmission.
Kayyali teaches the receiving... a command... in response to the... transmission, describing a system where a “remote monitoring station” receives a “processed signal” (the recommendation/report) and sends back a response: “a remote monitoring station comprising a transceiver for receiving the processed signal from the data acquisition system and transmitting a command signal based at least in part on the transmitted processed signal to the CPAP device” (col. 5, ll. 45–67). Kayyali further specifies the device receives a command signal via an “electrical connection” (col. 6, ll. 40-50, col. 8, ll. 1–35) to perform the adjustment (col. 6, ll. 1–5). In simple terms, this means that instead of just showing a message on a screen for a person to read, the system sends data out and then waits to receive back a specific instruction to change its own settings. This describes exactly what is missing in Molony, which only sends a one-way notification to a user but lacks the two-way "handshake" needed for the machine to receive a return command to fix the treatment.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Molony with Kayyali because both references are directed to the shared field of respiratory therapy and address the common problem of providing clinical oversight for machine setting changes (Molony, para. [0003]; Kayyali, col. 2, ll. 55–65). Molony identifies that health correlations result in recommendations for “improving the determined first parameter” (Molony, para. [0224]). Kayyali teaches that setting modifications are most safely and accurately performed when a system “remotely evaluat[es] and approv[es] the set of final values” before the device is programmed (Kayyali, col. 8, ll. 40–60). A PHOSITA would have been motivated to integrate Kayyali’s bidirectional “handshake” protocol into Molony’s recommendation engine to ensure that machine adjustments are verified by an external monitor (such as a clinician) before the command is received and executed by the therapy device.
The combination makes the full limitation obvious because it establishes a closed-loop interactive feedback mechanism. A PHOSITA would integrate the receiving... in response... a command into the control system of Molony—utilizing Molony’s recommendation output as the trigger—to achieve the benefit of safe, verified therapy titration. As Kayyali teaches, this ensures that the device “is titrated or adjusted based on at least in part the retransmitted or transmitted signal and at least in part on the user input” or remote command (Kayyali, col. 6, ll. 12–21).
A PHOSITA would have had a reasonable expectation of success because the technical implementation of bidirectional command-response protocols is routine in networked medical systems. Molony establishes that the “control system 110” (para. [0042]) is capable of transmitting data over networks, and Kayyali describes the specific hardware, such as an “electrical connection for receiving the... transmitted signal” (Kayyali, col. 6, ll. 1–15), needed to facilitate the response. The integration requires only standard digital "handshake" logic to wait for and receive a return command after a recommendation is issued.
Molony teaches a respiratory therapy system where the "APAP system automatically varies the air pressure delivered to the user based on... respiration data" (para. [0054]) and the control system causes a "custom message to be communicated to the user" (para. [0227]). However, Molony fails to disclose causing, by the control system via the command, the respiratory therapy device to adjust the one or more parameters of the respiratory therapy system.
Kayyali teaches causing... the respiratory therapy device to adjust the one or more parameters, specifically describing a system that is "periodically delivering a command signal from the remote monitoring station to the PAP or CPAP device to adjust the flow of pressurized gas delivered by the PAP or CPAP device to the subject" (col. 8, ll. 19–35). Kayyali further specifies that the system is responsible for "programming the treatment device to deliver the set of final treatment values" (col. 25, ll. 50–55).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Molony with Kayyali because both references are directed to respiratory therapy systems aimed at optimizing patient treatment (Molony, para. [0003]; Kayyali, col. 2, ll. 45–67). Molony identifies the need for "dynamic adjustments" based on health correlations to improve therapy (Molony, Abstract). Kayyali teaches that issuing a direct command to the machine provides "more accurate control" and ensures symptoms are treated "as they occur" (Kayyali, col. 4, ll. 15–25; col. 21, ll. 55–60). A PHOSITA would have been motivated to utilize Kayyali's command-delivery mechanism to execute the adjustments identified by Molony, transforming a passive notification system into an active, self-correcting device.
The combination makes the full limitation obvious because it provides the execution step for the control system's analysis. A PHOSITA would integrate the causing... via the command... to adjust into Molony's architecture to achieve the benefit of immediate, automated parameter updates. As Kayyali teaches, "the treatment device can be adjusted by either a closed loop control system (automatically)... to actuate a physical... treatment system" (Kayyali, col. 3, ll. 34–56), allowing the control system to exert direct control over the therapy parameters.
A PHOSITA would have had a reasonable expectation of success because the technical integration is routine. Molony discloses a "control system 110" and "respiratory therapy device 122" (para. [0042], [0046]), and Kayyali confirms such devices are "capable of receiving the... transmitted signal and delivering a flow of pressurized gas" (Kayyali, col. 6, ll. 65–67). Using standard digital commands to modify machine variables is a straightforward implementation of known interfaces.
Claim 2. Molony in view of Kayyali teaches, The method of claim 1, wherein the external device is one or more of the user device, a smartphone, a smartwatch, a fitness tracker, a step counter, a blood pressure monitor, a heartrate monitor, and a sleep tracker. (Molony, paras. [0041], [0084], [0087], [0088], [0086])
Molony's system 100 explicitly includes a "user device 170" (which can be a "smart phone" or "smart watch"), an "activity tracker 190" (which can be a "smartwatch" or "wristband" and is used to determine metrics like "number of steps" and "heart rate", thus functioning as a fitness tracker, step counter, and heartrate monitor), and a "blood pressure device 180" (a blood pressure monitor). These devices are external to the respiratory therapy system and provide data to the control system, fully meeting the specified list of external devices.
Claim 3. Molony in view of Kayyali teaches, The method of claim 1, wherein the activity indicators include one or more of step count, heartrate, calories burned, calories consumed, sleep quality, sleep duration, workouts, active minutes, stand hours, respiration rate, walking distance, and blood oxygen levels.
Molony's "activity measurement" obtained from the "activity tracker 190" explicitly includes "a number of steps", "heart rate", "a number of calories burned", "time spent standing", "respiration rate", "distance traveled" (which is walking distance), and "blood oxygen saturation" ([0087]).
Claim 4. Molony in view of Kayyali teaches, The method of claim 1, wherein the control system determines the correlations between the sleep scores and the plurality of activity indicators based on a machine learning algorithm.
Molony teaches that the control system determines operative relationships (correlations) between sleep scores and activity indicators based on a machine learning algorithm when it describes using a machine learning algorithm to adjust weighting values for component scores (which include sleep and activity scores) to achieve a desired health goal. (Molony, paras. [0170], [0202]). This process of the ML algorithm deriving how to treat or combine these scores based on learned patterns to achieve an objective constitutes "determining correlations... based on a machine learning algorithm" under BRI.
Claim 8. Molony in view of Kayyali teaches, The method of claim 1, further comprising:
identifying, by the control system, a trend in the plurality of sleep scores;
Molony describes displaying a "sleep score trend 830" which is "used to indicate a trend" ([Molony, Paragraph 0145]) and determining a "trend indication" from data points of the sleep score trend ([Molony, Paragraph 0148]). Molony's method 1300 further includes "determining a first trend associated with the determined first parameter," where that parameter can be a sleep score ([Molony, Paragraphs 0214, 0208]).
determining, by the control system, one or more of the activity indicators that correlate with the trend in the plurality of sleep scores;
Molony's method includes "determining a relationship" (which can be a "correlation" per [Molony, Paragraph 0207]) between a "first parameter" (e.g., sleep score, as per [Molony, Paragraph 0208]) and a "second parameter" (e.g., an activity indicator such as an "activity score" or an activity-influenced "blood pressure measurement", as per [Molony, Paragraphs 0170, 0211]). This determination is made "based at least in part on the determined first trend" (the sleep score trend) [Molony, Paragraph 0207].
generating, by the control system based on the one or more activity indicators that correlate with the trend in the plurality of sleep scores, a recommendation;
Molony's control system "generates a custom message" which "includes a recommendation" ([Molony, Paragraphs 0222, 0224]). This generation is explicitly stated to be "based at least in part on... the determined second parameter [which can be an activity indicator, see [Molony, Paragraph 0211]], the determined first trend [e.g., sleep trend, see [Molony, Paragraph 0214]] ... and the determined relationship (step 1306) [the correlation between the sleep score and activity indicator, considering the sleep trend, see [Molony, Paragraph 0207]] ..." ([Molony, Paragraph 0222]). Therefore, Molony teaches that the recommendation is generated based on the activity indicators that have been determined to correlate (via the "determined relationship") with the identified sleep score trend.
and causing presentation, by the control system via the display device of the user device, of the recommendation.
Molony's method includes "causing the generated custom message (step 1308) to be communicated to the user... via the display device 172" ([Molony, Paragraph 0227]). Since the custom message generated in step 1308 includes the "recommendation" (as per [Molony, Paragraph 0224]), this constitutes causing presentation of the recommendation.
Claim 9. Molony in view of Kayyali teaches, The method of claim 8, wherein the recommendation is associated with one or more of the activity indicators.
Molony's system generates a "recommendation" that "can communicate recommended steps or actions for improving... the determined second parameter (step 1303)" ([Molony, Paragraph 0224]). The "second parameter" is disclosed to be potentially "an activity measurement" ([Molony, Paragraph 0211]), which itself is based on activity indicators like "a count of steps" ([Molony, Paragraph 0181]). Thus, a recommendation for improving an "activity measurement" is directly associated with activity indicators.
Claim 10 Molony in view of Kayyali teaches, The method of claim 9, wherein the recommendation is one or more of to increase an activity associated with one or more of the activity indicators and decrease and activity associated with one or more of the activity indicators.
Molony's system identifies an "activity component" as a "component to be improved" if a user "regularly exhibits low activity" ([Molony, Paragraph 0199]). A recommendation to improve low activity would inherently be a recommendation to increase that activity. The system generates "custom message[s] to aid in encouraging a behavioral response" ([Molony, Paragraph 0222]) through "recommended steps or actions for improving" parameters ([Molony, Paragraph 0224]), which would logically include increasing beneficial activities or decreasing those found to be detrimental in the context of the user's overall health goals and data correlations.
Claim 11. Molony in view of Kayyali teaches, The method of claim 1, further comprising:
identifying, by the control system, a trend in the plurality of activity indicators;
Molony describes displaying an "activity level measurement trend 850" which is "used to indicate a trend" ([Molony, Paragraph 0145]) and determining a "trend indication" from data points of the activity level trend ([Molony, Paragraph 0148]). Additionally, Molony's method 1300 includes "determining a second trend associated with the determined second parameter," where that parameter can be an activity measurement ([Molony, Paragraphs 0215, 0211]).
determining, by the control system, one or more of the sleep scores that correlate with the trend in the plurality of activity indicators;
Molony's method includes "determining a relationship" (which can be a "correlation" per [Molony, Paragraph 0207]) between a "first parameter" (e.g., sleep score, as per [Molony, Paragraph 0208]) and a "second parameter" (e.g., an activity indicator, as per [Molony, Paragraph 0211]). This determination is made "based at least in part on... the determined second trend" (the activity indicator trend) [Molony, Paragraph 0207].
generating, by the control system based on the one or more sleep scores that correlate with the trend in the plurality of activity indicators, a recommendation;
Molony explicitly states that its control system "generates the custom message [which includes a recommendation per [Molony, Paragraph 0224]] based at least in part on... the determined first parameter [which can be a sleep score per [Molony, Paragraph 0208]] ... the determined second trend [which can be an activity trend per [Molony, Paragraph 0215]] ... and the determined relationship [correlation] (step 1306)" ([Molony, Paragraph 0222]). This establishes that the recommendation is based on sleep scores as they correlate with the activity trend.
and causing presentation, via the display device of the user device, of the recommendation.
Molony clearly states that the control system causes the "generated custom message (step 1308)" (which contains the "recommendation" per [Molony, Paragraph 0224]) "to be communicated to the user via the display device 172" of the user device ([Molony, Paragraph 0227]).
Claim 12. Molony in view of Kayyali teaches, The method of claim 11, wherein the recommendation is associated with one or more of the activity indicators.
Molony's system is designed to provide recommendations that can target various parameters for improvement, including an "activity measurement" (which comprises activity indicators) ([Molony, Paragraphs 0211, 0224]). The system generates custom messages with recommendations based on an analysis that includes the "determined second parameter" (e.g., activity indicator) and its trend ([Molony, Paragraph 0222]).
Claim 13. Molony in view of Kayyali teaches, The method of claim 12, wherein the recommendation is one or more of to increase an activity associated with one or more of the activity indicators and decrease and activity associated with one or more of the activity indicators.
Molony's system identifies an "activity component" as a "component to be improved" if a user "regularly exhibits low activity" ([Molony, Paragraph 0199]); a recommendation for such improvement logically involves advising an increase in activity. The broader aim to provide "recommended steps or actions for improving" parameters ([Molony, Paragraph 0224]) to "encourage a behavioral response" ([Molony, Paragraph 0222]) supports that such recommendations would be directional, i.e., to increase or decrease specific activities as needed for health improvement.
Claim 14. Molony in view of Kayyali teaches, The method of claim 1, further comprising:
determining, by the control system based on the correlations between the plurality of sleep scores and the plurality of activity indicators, a trend in the plurality of sleep scores;
Molony teaches determining a trend in sleep scores ([Molony, Paragraph 0145]), and also teaches determining correlations between sleep scores and activity indicators where such determination considers the sleep trend ([Molony, Paragraph 0207]). Furthermore, Molony generates custom messages based on a holistic understanding of parameters, their trends, and the relationships between them ([Molony, Paragraph 0222]). For the system to act upon or message about a sleep trend in a manner that also reflects its correlation with activity (e.g., "sleep score improved while blood pressure improved" [Molony, Paragraph 0223].
and determining, by the control system based on the trend in the plurality of sleep scores one or more of motivational content and congratulatory content to present to the user;
Molony's system "generates a custom message" that can include "positive... reinforcement" such as "'Well done, you're taking steps towards better health!'" (), which is motivational/congratulatory. This message generation is "based at least in part on... the determined first trend", which can be the sleep score trend. (Molony, paragraph 0222, 0224)
and causing presentation, by the control system via the display device of the user device, of one or more of the motivational contents and the congratulatory content.
Molony's method includes "causing the generated custom message (step 1308) to be communicated to the user... via the display device 172" (Molony paragraphs 0227-0228). Since the "custom message" generated in step 1308 is based on trends and can include motivational/congratulatory feedback ([Molony, Paragraphs 0222, 0224]), this constitutes causing presentation of such content.
Claim 15. Molony in view of Kayyali teaches, The method of claim 14, wherein one or more of the motivational contents and the congratulatory content includes one or more of articles, messages, awards, and media.
Molony explicitly teaches that its system generates "custom messages" [Molony, Paragraph 0222] which include "positive... reinforcement" such as "'Well done, you're taking steps towards better health!'" [Molony, Paragraph 0224]. These clearly fall under the category of "messages." Molony also describes that when a patient achieves a high score, the device may present a "celebration, for example a fireworks animation" [Molony, Paragraph 0173]; a "fireworks animation" is a form of "media" and can also be interpreted as a type of "award" in a gamified context, serving a congratulatory purpose. Additionally, the "educational information" included in custom messages [Molony, Paragraph 0224] can take the form of short textual "articles" or textual "media."
Claim 17. Molony in combination with Kayyali teaches, The method of claim 16, wherein the control system causes the respiratory therapy device to adjust one or more parameters of the respiratory therapy by:
transmitting, by the control system via a communications network, the command to the respiratory therapy system. (Kayyali, Col. 3, ll. 57-67, “wireless link or some combination thereof “, Col. 25, ll. 5-26 “calculate the next appropriate treatment setting… signal… to determine that the PAP pressure should be increased…”)
Kayyali read on, a processing assembly managing a medical ventilator by sending digital instructions across a wireless or wired data infrastructure to modify pressure or flow settings
Claim 22.
Molony in view of Kayyali teaches,
The method of claim 1, further comprising: identifying, by the control system, a trend in the plurality of sleep scores; (Molony pars. 0144-0146, 0211, 0214-0217)
Molony discloses a sleep score trend and an activity level measurement trend over a plurality of dates, determines a first trend from plural sleep-score data points using a fitted line/slope, determines a second trend for the activity parameter, and determines a relationship using a correlation between the first parameter and the second parameter
determining, by the control system, one or more of the activity indicators that correlate with the trend in the plurality of sleep scores; (Molony, par. 0087, 0148, 0217)
Molony’s activity measurements read on activity indicators, the displayed sleep-score and activity-measurement data are used to determine trends, and Molony expressly determines a relationship/correlation between the first trend and second trend; where the first parameter is the sleep score and the second parameter is the activity measurement, this reads on determining activity indicators that correlate with the trend in the plurality of sleep scores.
and adjusting, by the control system based on the correlations between the sleep scores and the plurality of activity indicators, weights of the data from the respiratory therapy device to generate the plurality of sleep scores. (Molony, par. 0182-0183, 0196, 0198)
Molony teaches using respiratory-therapy-system data to generate or modify the sleep score, and teaches adjusting weighting values based on trends or inferences; because Molony also determines sleep/activity correlations, those correlations are reasonably read as the identified inference used to adjust the weights.
Claim(s) 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over US-20230245780-A1- Molony, and further in view of Kayyali- US7942824 and US20170132395- Futch.
Claim 5. Molony in view of Kayyali teaches, The method of claim 1, further comprising:
and determining, by the control system based on
Molony teaches a method where a control system determines correlations between an individual user's sleep scores (derived from a respiratory therapy device) and their activity indicators (from an external device) over multiple days, and presents these individual correlations and does not describes aggregating these individually determined correlations (or the underlying data from which these correlations are derived) for a plurality of users, nor does it teach determining group correlations based on such an aggregation of multi-user data.
Futch teaches the analysis of aggregated data from a plurality of users to derive population-level insights and "best paths," which are group correlations. References paragraph 0030, 0076,0082 It would have been obvious to combine Molony's individual analysis with Futch's population-level analytics to enhance the system's capabilities by deriving group correlations, as both references pertain to digital health platforms leveraging user data for health improvement insights. A person of ordinary skill in the art, seeking to enhance the insights provided by Molony's individual-focused system, would have been motivated to incorporate Futch's population-level data aggregation and group correlation analysis techniques to “to provide unique recommendations to the user that steer the user onto the optimal path to reach their goal.” Par. 0076 Futch
Claim 6.Molony in combination with Kayyali and Futch teaches, The method of claim 5, further comprising:
generating, by the control system for the user based on the group correlations, insights for the user;
Futch describes its system analyzing "input data... together with data from other users on the platform" (which represents the basis for group correlations) to provide "unique recommendations to the user" [Futch, Paragraph 0076]. These "unique recommendations" derived from analyzing collective user data are "insights for the user based on the group correlations." Furthermore, Futch mentions that "artificial intelligence and personalized data analytics feedback provides the user with... insights that the system has gained from analyzing the data points of users" (plural) [Futch, Paragraph 0029]. Deriving "best paths for health improvement" from grouped user data and sharing these predictively also constitutes generating insights based on group correlations [Futch, Paragraph 0082].
and causing presentation, via the display device of the user device, the insights for the user.
Futch explicitly states that "recommendations are determined for the user... and are transmitted... to the user device and displayed on the user device" [Futch, Paragraph 0081]. These recommendations, which are based on analysis including data from other users (group correlations), are presented on the user's device via a "user application" and "user interface" [Futch, Paragraphs 0077, 0113].
Claim 7. Molony in combination with Kayyali and Futch teaches, The method of claim 6, wherein the insights for the user include descriptions of why one or more of the activity indicators are correlated with one or more of the plurality of sleep scores.
Futch describes providing users with "insight comments" [Futch, Paragraph 0023] and "educational tips from health experts and relevant expert articles, videos and blogs relating to their specific health improvement goals" [Futch, Paragraph 0033]. These insights and educational materials are informed by an "artificial intelligence and personalized data analytics" system that analyzes "data points of users " ([Futch, Paragraph 0029]) and data "from other users on the platform" ([Futch, Paragraph 0076]). Given that Futch addresses health pillars including "physical activity" and "sleep" ([Futch, Paragraph 0040, Table 1]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US-20230245780-A1- Molony, and further in view of Kayyali- US7942824 and US-20210050089-A1. MOHAMMED
Claim 18. Molony in view of Kayyali teaches, The method of claim 1, further comprising:
adjusting, by the control system based on the correlations between the sleep scores and the plurality of activity indicators, weights of the data from the respiratory therapy device to generate the plurality of sleep scores.
Molony does not explicitly teach adjusting, based on these specific correlations, the internal weights of the data from the respiratory therapy device that are used to generate the sleep score itself.
MOHAMMED teaches a health management platform utilizing machine-learned models, such as a "Sleep Twin Module 655" ([MOHAMMED, Paragraph 0107, Figure 6]), where model "Parameter values" that "describe the weight that is associated with at least one of the featured input values" ([MOHAMMED, Paragraph 0119]) are "continuously updated" through model training based on "input biosignals and metabolic state outcomes" ([MOHAMMED, Paragraph 0124]).
It would have been obvious to one of ordinary skill in the art to modify Molony's system, which determines relevant sleep/activity correlations, by incorporating MOHAMMED's advanced machine learning approach of continuously training and updating models. This would involve using the correlations found by Molony to dynamically adjust the weights of the input data from the respiratory therapy device when generating Molony's sleep scores, thereby making these scores more accurate and reflective of the user's holistic health state as understood through MOHAMMED's adaptive modeling techniques. The motivation would be to improve the precision and clinical relevance of the sleep scores by making their calculation adaptive to learned interrelations with other health factors like activity, a known goal in developing sophisticated health monitoring systems as shown by MOHAMMED's pursuit of "precision treatment" ([MOHAMMED, Paragraph 0006]).
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US-20230245780-A1- Molony, and further in view of Kayyali- US7942824 and US-11134888-B2- Wright.
Claim 19. Molony in view of Kayyali teaches, The method claim 1, further comprising:
determining, by the control system based on the correlations between the sleep scores and the plurality of activity indicators, one or more modifications to automation polices; and
causing, by the control system, one or more automated devices to alter their operation based on the one or more modifications to automation policies.
However, Molony does not explicitly teach using these specific correlations to determine "modifications to automation polices" for general automated devices, nor causing such general automated devices to alter their operation based on these policies. Molony's system provides insights and recommendations to the user ([Molony, Paragraph 0224]).
Wright teaches a smart home control system that determines "an appliance control schedule" (an automation policy) for "one or more appliances in a user environment" (such as "lights or lighting systems, and heating, air conditioning and/or ventilation (HVAC) systems" [Wright, Paragraph 0012]) based on "data indicative of a sleep state of the user" and "environmental stimuli" to "reduce sleep disruption" ([Wright, Paragraphs 0010, 0017, 0046]), and then "controls the one or more appliances in dependence on the determined control actions" or schedule ([Wright, Paragraph 0010]), for example, "The Appliance Schedule is sent to the Connected Appliances, which enact the desired functions at the scheduled times" ([Wright, Paragraph 0035]).
It would have been obvious to one of ordinary skill in the art to modify Molony's system, which determines correlations between sleep scores and external activity indicators, to further incorporate Wright's teachings of using health-related data (sleep states) to determine and implement modifications to automation policies for general automated devices. One of ordinary skill would be motivated to enhance Molony's system by incorporating the environmental control capabilities taught by Wright. Wright discloses a system that actively "controls one or more appliances in a user environment" like "lights or lighting systems, and heating, air conditioning and/or ventilation (HVAC) systems" ([Wright, Paragraphs 0010, 0012]) based on "data indicative of a sleep state of the user" with the explicit goal to "reduce sleep disruption" and "improve sleep quality" ([Wright, Paragraphs 0010, 0046]).
20. Molony in combination with Wright teaches, The method of claim 19, wherein the automated devices include one or more of lights, alarm systems, audio systems, entertainment systems, and mobile devices.
Wright teaches that the automated devices controlled by its appliance control schedule include "lights or lighting systems" ([Wright, Paragraph 0012]), "Smart Speaker[s]" (audio systems) ([Wright, Figure 4]), and "TV" or "radio" (entertainment/audio systems) ([Wright, Paragraph 0052]).
Relevant Prior Arts:
US 20220273233 A1
[0101] Sleep routine module 1002 may then correlate the sleep tracking data for the particular night with the brain activity data for the day that follows the night to determine how the various attributes of the user's sleep may have influenced how well the user was able to function during the following day. Such correlation may be performed in any suitable manner.
[0112] Presentation module 1004 may be configured to generate content based on the sleep routine data generated by sleep routine module 1002. The content may include any suitable information associated with the sleep routine data that may be presented to the user. For example, the content may include information that summarizes the target sleep routine (e.g., that lists a number of actions that the user should take throughout the day to adhere to the target sleep routine), a score indicative of how well the user adheres to the target sleep routine, a reminder to perform a task associated with the target sleep routine, a suggestion to adjust one or more settings of a device (e.g., a temperature setting of a heating and/or cooling device, a color tone or intensity of a light, a noise level of a noise machine, etc.), and/or any other type of content as may serve a particular implementation.
Conclusion
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/JOSHUA DAMIAN RUIZ/Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684
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