DETAILED ACTION
This office action is based on the claim set filed on 12/08/2025.
Claims 1, 4, 12, 15, 18-19 have been amended.
Claims 10-11 have been canceled. Claim 20 and 21 are new.
Claims 1-9 and 12-21 are currently pending and have been examined.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/08/2026 has been entered.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1-9 and 12-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1-9, 12-16, and 20-21 are drawn to a method, Claim 17 is directed to an art of manufacturer, and Claims 18-19 are drawn to a system, and each of which is within the four statutory categories (i.e., a machine and a process). Claims 1-9 and 12-21 are further directed to an abstract idea on the grounds set out in detail below.
Under Step 2A, Prong 1, the steps of the claim for the invention represents an abstract idea of a series of steps that recite a process for monitoring sleep quality. Collecting a user sleep data to estimate sleep quality index are steps that could have been performed by a human mind but for the fact that the claims recite a general-purpose computer processor to implement the abstract idea for which both the instant claims and the abstract idea are defined as Metal Process that can be performed using human mind with the aid of pencil and paper.
Independent Claim 1 recites the steps of:
“measuring, by means of embedded sensors in a wearable device worn by the user physiological historical data during a period of time, to obtain physiological historical data;
acquiring profile information previously provided from the user;
treating the physiological historical data and the profile information acquired to transform the physiological historical data and the profile information into sleep and daily activity related features; and
processing the sleep and daily activity related features via one or more Machine Learning models trained with a dataset comprising input features calculated from users' measured physiological historical data by a wearable device and the answers to the Pittsburgh Sleep Quality Index (PSQI) questionnaire, the extracted sleep and daily activity related features derived from said physiological historical data and profile information of the user being applied as input to the Machine Learning models;
determining a score for each of one or more sleep quality components using the processed sleep and daily activity related features, wherein the determined scores obtained by one or more Machine Learning models trained with the dataset comprising input features calculated from users' measured physiological historical data by a wearable device classify the sleep quality of the user;
wherein treating the physiological historical data and the profile information to transform the physiological historical data and the profile information into sleep and daily activity related features comprises:
calculating a set of values for new sleep and daily activity related features from processing of the physiological historical data;
aggregating the physiological historical data and the calculated set of values to generate a complete set of sleep and daily activity related features based on sets of data values and aggregation functions set;
wherein the aggregation functions set comprises a list of data manipulations including function definitions from domains of descriptive statistics and trend analysis domain, and the functions definitions include non-linear functions generated by neural networks;
wherein aggregating further comprises:
preparing data by removing invalid values and, as needed, ordering in a sequence for an aggregation function;
traversing the values by going through all available and already prepared data to generate a single value following rules of the aggregation function for each pair of temporal data/aggregation function specified in an input;
applying specific rules of function using the aggregation function definition; and
generating a single value of the aggregation based on the aggregation function”.
Independent Claims 17 and 18 recite similar steps as in Claim 1.
These limitations, as drafted, given the broadest reasonable interpretation cover performance of the limitations by a human mind with aid of pen and paper reciting an abstract idea for Mental Process along with mathematical calculations and relationships that constitute Mathematical Concepts but for the recitation of generic computer components. For example, the limitations encompass a user the ability to collect a user historical data to extract sleep and activity parameters to translate it with a sleep related features along with the individual answer(s) to a questionnaire to be calculated using statistical analysis and determine a score for sleep quality to classify sleep quality index of the user (e.g., bad, good, etc.) using mathematical formulas while applying rule(s) and aggregation for data preparation, which are steps that that could have been performed by a human to implement the abstract idea and are steps reciting mental process that could have been performed using a human mind with aid of pen and paper but other than the mere nominal recitation of "machine learning model, processor, module", to implement the abstract idea for performing the steps of observing, evaluating, judgment and opinion which can be performed using a human mind with the aid of pencil and paper, see MPEP § 2106.04(a)(2)(III). Accordingly, the claim limitations (in BOLD) recite an abstract idea. Any limitations not identified above as part of the Mental Process are deemed "additional elements," and will be discussed in further detail below.
Under Step 2A, Prong 2, this judicial exception is not integrated into a practical application because the remaining elements amount to no more than general purpose computer components programmed to perform the abstract ideas, linking the abstract idea to a particular technological environment. In particular, the claims recite the additional elements such as “ computer-readable medium, processor, data module, features module, component prediction module, wearable device, machine learning model, processor, memory, sensor(s)” that iteratively takes input data and analyzes said data to determine an output to performing generic computer functions for determining sleep score such that it amounts no more than adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea, see MPEP 2106.05(f), “i.e., applying input to a ready trained machine learning model to process and obtain recited in the claims at a high level of generality and is described in the specification in an arbitrary form without disclosing a specific algorithm using available data for allowing the model to learn patterns and relationships within the data and implement it to perform the claimed function”, generally linking the use of the judicial exception to a particular technological environment or field of use, see MPEP 2106.05(h), adding insignificant extra-solution activity to the judicial exception, (i.e. “measuring, by means of embedded sensors in a wearable device worn by the user physiological historical data during a period of time...”), and mere data gathering that does not add a meaningful limitation to the above abstract idea, see MPEP 2106.05(d)-(g). As set forth in the 2019 Eligibility Guidance, 84 Fed. Reg. at 55 "merely include[ing] instructions to implement an abstract idea on a computer" is an example of when an abstract idea has not been integrated into a practical application. Accordingly, looking at the claim as a whole, individually and in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Under step 2B, the claims do not include additional elements that are sufficient to amount to "significantly more" than the judicial exception because as mentioned above, the additional elements amount to no more than generic computing components, recited at a high level of generality, do not present improvements to another technology or technical field, nor do they affect an improvement to the functioning of the computer itself, that amount to no more than mere instruction to perform the abstract idea such that it amounts no more than adding the words "apply it" (or an equivalent) to apply the exception using generic computer component, see MPEP 2106.05(f), adding insignificant extra-solution activity to the judicial exception, (i.e., “measuring, by means of embedded sensors in a wearable device worn by the user physiological historical data during a period of time …”), and mere data gathering that does not add a meaningful limitation to the above abstract idea, see MPEP 2106.05(d)-(g). There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and mere instructions to apply an exception using a generic computer component cannot provide an inventive concept, See Alice, 573 U.S. at 223 ("mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention."). The claims are not patent eligible.
Dependent Claims 2-9, 12-16 and 19-21 include all of the limitations of claim(s) 1, 17, and 18, and therefore likewise incorporate the above-described abstract idea. While the depending claims add additional limitations, such as
As for claims 2 and 13-14, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human mind with the aid of pen and paper, reciting an abstract idea for Mental Process along with mathematical calculations and relationships that constitute Mathematical Concepts but for the recitation of generic computer components. For example, calculating sleep quality index, normalization by mean and standard deviation, is/are Mathematical Concepts. The claims are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more").
As for claims 3, 6-7, and 9, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human mind with the aid of pen and paper, “Mental Process” but for, the recitation of the generic computer components which are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more").
As for claims 4-5, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human mind with the aid of pen and paper, “Mental Process”, but for, the recitation of the generic computer components which are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible. The claims recite additional elements “wearable device machine learning model, coaching system module, processor, memory” that implement the identified abstract idea. These hardware components are recited at a high level of generality to perform the steps, e.g., “displaying..., storing...” that amounts to no more than the words "apply it" with a computer because it appears to intend to do so, which would still amount to mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Additionally, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional elements amount to more than mere instruction to apply the exception using generic computer component and have been re-evaluated under the “significantly more” analysis. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more").
As for claims 8, 12, 15-16 and 19-21, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human mind with the aid of pen and paper, reciting an abstract idea for Mental Process along with mathematical calculations and relationships that constitute Mathematical Concepts but for the recitation of generic computer components. For example, scaling data summing scores, calculating index and using formulas, are Mathematical Concepts. The claims recite additional elements “wearable device machine learning model, coaching system module, neural networks, processor, memory, photoplethysmography, accelerometer, gyroscope, magnetometer, pedometer, heart rate sensor, calorie expenditure sensor, sleep stage detection sensor, SpO2 sensor” that implement the identified abstract idea. These hardware components are recited at a high level of generality to perform the steps of the claims that amounts to no more than the words "apply it" with a computer because it appears to intend to do so, which would still amount to mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Additionally, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional elements amount to more than mere instruction to apply the exception using generic computer component and have been re-evaluated under the “significantly more” analysis. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more").
Subject Matter Free of Prior Art
Claims 1-9 and 12-21 have been found by the examiner to be free of prior art. A thorough search of the prior art was conducted and the examiner could not find a single reference or combination of references with adequate rationale to combine that would teach the claimed invention. Specifically, the examiner, for example, finds that the language “preparing data by removing invalid values and, as needed, ordering in a sequence for an aggregation function;
traversing the values by going through all available and already prepared data to generate a single value following rules of the aggregation function for each pair of temporal data/aggregation function specified in an input;
applying specific rules of function using the aggregation function definition; and
generating a single value of the aggregation based on the aggregation function” in claim 1 and 17, to be free of prior art. In the examiner's search of prior art. The closest prior art(s) was/were found are:
US 2020/0009349- “Shouldice” discloses collecting user sleep information, such as sleep stages, hypnograms, activity, for evaluating and calculating sleep score index and provide recommendation to promote good sleep habits.
US 2023/0170097- “Yang” discloses sleep-related evaluation machine learning model using information such as questions and answers to detect sleep irregularity or difficulty.
“An approach for continuous sleep quality monitoring integrated in the SmartWork system”- “Konstantoulas” discloses Pittsburgh Sleep Quality Index (PSQI) as sleep assessment tool comprising 7 components and calculating scores.
US 2023/0274814 “Molony” discloses receive physiological data associated with a sleep session and generating a score based on the physiological data and feedback data.
US 2016/0058429 “Shinar” discloses calculating sleep score.
US 2020/0214308 “MURPHY” discloses assessing sleep disturbances and measuring sleep quality using Pittsburgh Sleep Quality Index (PSQI).
MENDONCA et al. “A Review of Approaches for Sleep Quality Analysis.
However, the cited references fail to individually disclose, or suggest when combined, the limitations of the claim.
No prior art was found teaching individually, or suggesting in combination, all of the features of the applicants' invention, as disclosed in the claimed invention.
Response to Arguments
Applicant's arguments filed 12/08/2025 have been fully considered by the Examiner and addressed as the following:
In the remarks, Applicant argues the substance:
Applicant's arguments with respect to the 35 U.S.C. § 112(f) interpretation page 9-11.
In light of the claims amendment, Examiner withdraws the 112(f) interpretation.
Applicant's arguments with respect to the 35 U.S.C. § 112(a) rejection on page 11-12.
In light of the claims amendment, Examiner withdraws the 112(a) rejection.
Applicant's arguments with respect to the 35 U.S.C. § 112(b) rejection on page 12.
In light of the claims amendment, Examiner withdraws the 112(b) rejection.
Applicant's arguments with respect to the 35 U.S.C. § 101 rejection on page 12-20.
On page 12 of the remarks, the Applicant argues “The claimed invention is not directed to an abstract idea but instead to a specific, technological solution rooted in the technical field of wearable-sensor-based sleep analytics ... This is a technological improvement in the field of wearable sleep analytics, not a mental process or mere mathematics”, Examiner respectfully disagree. As described in the above rejection, the claims, given their broadest reasonable interpretation, recite an abstract idea which have been analyzed under Step 2A, Prong One reciting a process for obtaining/collecting an individual physiological data, using the individual profile and his/her profile to transform into a sleep and activity features along with the individual answer(s) to a questionnaire to be calculated using statistical analysis and determine a score for sleep quality to classify the quality while applying rule and aggregation for data preparation, which are steps of observing, evaluating, judgment, and opinion that are citing a process for which can be performed using a human mind with the aid of pencil and paper, see MPEP § 2106.04(a)(2)(III), in addition to mathematical calculation but for the fact that the claims recite a general-purpose computer processor to implement the abstract idea for which both the instant claims and the abstract idea are defined as Mental Process.
As mentioned above, the steps recited in independent claims, when viewed as a whole, recite a Mental process and the recitation of machine learning model have been analyzed under Step 2A, Prong Two as an additional element cited as a tool (e.g., already trained model) for implementing claim steps that amounts to no more than mere instructions to implement “apply” the exception using a generic computer component and no more than adding the words "apply it" (or an equivalent) with the judicial exception.
On page 13-14 of the remarks, the Applicant argues “Multi-Stage Computational Processing, Beyond Any Abstract Idea ... Aggregation Functions ... the claimed invention is not merely directed to an abstract mental process or mathematical calculation. Instead, it is directed to a specific, technological method for improving the accuracy and reliability of sleep-quality evaluation correlated with PSQI questionnaire, based on physiological signals collected via a wearable device automatically”, Examiner respectfully disagree. As mentioned above, the claim steps, under BRI, recite a process that can be performed by a human mind such as calculation using mathematical algorithms and formulas, while using computing components recited at a high level of generality and as tool to perform the steps of the claim and not configured in a manner other than what any off-the-shelf, commercially available processor is capable of being programmed for performing generic computer functions in relation to an abstract concept. Moreover, the aggregation functions is/are considered part of the abstract idea describing collection and combining of data to derive an outcome.
The Applicant argument that the claimed invention is directed to technical improvement for accuracy and reliability of sleep evaluation which Examiner disagrees to the Applicant argument. As described above and in the prior response to such argument, the claim must include more than mere instructions to perform the method on a generic component or machinery to qualify as an improvement to an existing technology, however, the claim(s) as amended, recites steps that define a judicial exception in addition to additional elements recited at a high level of generality and as a tool that amounts to no more than adding the words "apply it" (or an equivalent) with the judicial exception. The fact that the judicial exception, identified in the rejection above, relies upon collecting user data, analyzing the data and performing mathematical process for calculating sleep score, does not impart an improvement to any existing computer, or any other technology or technical field. At best, this gathering of data to be used by the computing device may improve the abstract idea of improving managing administrative resources. However, improving upon an abstract idea does not make the abstract idea any less abstract.
On page 15-16 of the remarks, the Applicant argues “Even if a judicial exception were implicated, the claims are integrated into a practical application ... This is not an abstract mathematical manipulation but a technological process improving the functioning of wearable-based sleep quality assessment ... This is a practical, real-world application with clear utility in health monitoring, not an abstract intellectual exercise ... Further, the claimed invention provides a technical solution to long-standing gaps ... In particular, the Specification expressly details these concrete shortcomings of prior art...”, Examiner respectfully disagrees to the Applicant arguments. As discussed above, nowhere in the claim or the specification describes any improvement alleged by the Applicant improving function of wearable-based assessment rather describing a process for calculating score for evaluating sleep quality based on collected data values. Moreover, stripping the claim of any generic computing element performing the abstract idea, to include the general use of machine learning to arrive at an iterative value, i.e. "sleep score" which is a calculation, the following limitations set forth the abstract idea, “... obtain physiological historical data; acquiring profile information previously provided from the user; treating the physiological historical data and the profile information acquired to transform the physiological historical data and the profile information into sleep and daily activity related features; and processing the sleep and daily activity related features via ... input features calculated from users' measured physiological historical data ... and the answers to the Pittsburgh Sleep Quality Index (PSQI) questionnaire, the extracted sleep and daily activity related features derived from said physiological historical data and profile information of the user...; determining a score for each of one or more sleep quality components using the processed sleep and daily activity related features, wherein the determined scores obtained by ... input features calculated from users' measured physiological historical data ... classify the sleep quality of the user; wherein treating the physiological historical data and the profile information to transform the physiological historical data and the profile information into sleep and daily activity related features comprises: calculating a set of values for new sleep and daily activity related features from processing of the physiological historical data; aggregating the physiological historical data and the calculated set of values to generate a complete set of sleep and daily activity related features based on sets of data values and aggregation functions set; wherein the aggregation functions set comprises a list of data manipulations including function definitions from domains of descriptive statistics and trend analysis domain, and the functions definitions include non-linear functions ...; wherein aggregating further comprises: preparing data by removing invalid values and, as needed, ordering in a sequence for an aggregation function; traversing the values by going through all available and already prepared data to generate a single value following rules of the aggregation function for each pair of temporal data/aggregation function specified in an input; applying specific rules of function using the aggregation function definition; and generating a single value of the aggregation based on the aggregation function”. Clearly, and in light of the specification, the claims are directed to an issue of sleep quality to determine a user good and/or bad sleep behavior and provide a coaching program to help sleep quality, see (Applicant [0032-0033]). As such, this is considered a process of observing, evaluating, judgment, and opinion and therefore an abstract idea. At best, this gathering of data to be used by the computing device may improve the abstract idea of improving managing administrative resources. However, improving upon an abstract idea does not make the abstract idea any less abstract.
On page 16-17 of the remarks, the Applicant argues “The claims recite specific technical arrangements beyond generic computer use: ... These are not conventional steps; they reflect domain-specific programming tied to wearable data characteristics and PSQl-aligned outputs. The Final Office Action itself recognizes that multiple claimed operations (e.g., removing invalid values, ordering temporal data, traversing all available data, applying aggregation-function rules, generating a single aggregated value per data/function pair) are "free of prior art", underscoring that the claimed subject matter is not routine or conventional.... The Examiner already acknowledged that many of these operations are "free of prior art," reinforcing that they are not routine or conventional. Under Step 2B, such an acknowledgment strongly supports eligibility”, Examiner respectfully disagree. First, “ack of novelty under 35 U.S.C. 102 or obviousness under 35 U.S.C. 103 of a claimed invention does not necessarily indicate that additional elements are well-understood, routine, conventional elements. Because they are separate and distinct requirements from eligibility, patentability of the claimed invention under 35 U.S.C. 102 and 103 with respect to the prior art is neither required for, nor a guarantee of, patent eligibility under 35 U.S.C. 101”, see MPEP 2106.05(I).
On page 16-17 of the remarks, the Applicant argues “Claim 14 adds rules for computing ... Such constraints are rooted in real-world sleep assessment practice, not in abstract mathematics”, Examiner respectfully disagrees. The claim 14 recites the feature “generate a single value following rules and aggregation...”, and similarly the specification [0060-0061] discloses applying rules to generate values, however no particular rule(s) is/are described as being particular and unique to be provide an output other than the recitation of general rules.
Furthermore, while nowhere in the claims or specification discloses the use of feature engineering, the paragraphs presented in the Applicant argument describes a process for formulating a calculation process for evaluating calculated score(s) but does not describe a process to improve model interpretability and/or predictive function associated with features to a specific domain. Furthermore, the argued use of neural network-based aggregation function, as mentioned above, amounts to no more than mere instructions to implement “apply” the exception using a generic computer component and no more than adding the words "apply it" (or an equivalent) with the judicial exception. As for the normalization and feature weighting which are steps that would be part of the identified abstract idea.
Finally, as described above, the claims at issue when viewed as a whole, do not require any nonconventional computer, network, or other components, or even a non-conventional and non-generic arrangement of known, conventional pieces but merely call for performance of the claimed functions on a set of generic computer components. The elements of the instant process, when taken alone, each execute in a manner conventionally expected of these elements. The elements of the instant underlying process, when taken in combination, together do not offer substantially more than the sum of the functions of the elements when each is taken alone.
Therefore, the Applicant argument(s) is/are not found to be persuasive. Hence, Examiner remains the 101 rejections of claims which have been updated to address Applicant's amendments.
Applicant's arguments with respect to the 35 U.S.C. § 103 rejection on page 20-22.
In light of the claim amendment, Examiner withdraws the art rejection as mentioned in the above section “claims free of art”.
Conclusion
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/ALAAELDIN M. ELSHAER/Primary Examiner, Art Unit 3687