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 .
Response to Arguments
Applicant's arguments filed 02/02/2026 with respect to rejection of claims under 35 USC 101 have been fully considered but they are not persuasive. The applicant argues that the claim rather than being directed towards an abstract idea, is directed towards an ear-wearable system that performs a specific function. This argument is fully considered but is not persuasive. The claims recite a step that under its broadest reasonable interpretation, covers performance of the limitation in mind or by a person using a pen and paper. Therefore, an abstract idea is involved. The claim is further evaluated to see whether include additional elements that are sufficient to amount to significantly more than the judicial exception. The mentioned limitation, “control circuit”, “microphone”, “sensor package”, etc. are recited at a high level of generality and are considered to be data gathering/processing which are mere extra-solution activity. See analysis under 2A prongs 1 and 2. See details below.
The applicant further argues that the use of machine learning model can enhance the system’s ability to monitor and treat stress and anxiety. This argument, although true, is not sufficient to overcome the 101 rejection. The claims as presented do not recite any details regarding building or training a machine learning model. The claims merely recite using a model. Therefore, the use of a model falls under processing data and is an extra-solution activity.
Applicant's arguments filed 02/02/2026 with respect to rejection of claims under 35 USC 103 have been fully considered but they are not persuasive. The applicant argues that the recited reference does not update the machine learning classification model. This argument is fully considered but is not persuasive. The claim as recited does not provide any details regarding the structure, parameters, details of the machine learning classification model. The claim does not recite any details regarding what indicators are used to update the model and how often the model is updated. Furthermore, the claim does not even require using the updated model. As recited, and under its broadest reasonable interpretation, the claim merely recites using a generic classification model that can update. Walsh discloses the computing system may use the stress-related information to determine a stress level of the user of hearing instruments. For example, the computing system may apply a neural network to the stress-related information to generate information indicative of the emotional stress level [](para 0201), and teaches training the machine learning model (e.g., neural network). Such training is understood to be the “updating” of the model since models are continuously and repeatedly trained to improve the model. For at least the reasons recited above, the rejection is maintained.
Applicant's arguments filed 02/02/2026 with respect to rejection of claims under 35 USC 103 with regard to rejection of claim 8 have been fully considered and are persuasive. The 103 rejection of claim 8 has been withdrawn.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3, 7-16, 19-20 are rejected under 35 U.S.C. 101 because of the following analysis:
1 – statutory category: Claims 1-3, 7-16, 19-20 recite a system, and therefore, falls under the statutory category of being a thing or products. See MPEP 2106.03.
2A – Prong 1: The independent claims 1 recite a judicial exception by reciting the limitations of “evaluate data from at least one of the microphone and the sensor package and classify a stress level of a device wearer”. These limitations, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in mind or by a person using a pen and paper. Therefore, an abstract idea is involved.
Regarding the limitations of “machine learning classification model; and periodically update the machine learning classification model”, It is noted that the act of inputting training data into a learning model falls under the judicial exception of mathematical calculations. Additionally or alternatively, the training/updating of the learning model by inputting training data, and adjusting the model accordingly additionally represents mathematical calculations or mental observations or evaluation to iteratively adjust the model.
2A – Prong 2: The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. The independent claim 1 recite the additional limitations of “a control circuit”, “microphone”, “sensor package”, “motion sensor”, etc. The mentioned limitations are recited at a high level of generality and are considered to be data gathering/processing which are mere extra-solution activity. The elements amount to 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 2106.04(d) and 2106.05(f)). Accordingly, each of the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea.
2B: The emphasized elements cited above do not amount to significantly more than the judicial exception because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’I, 110 USPQ2d 1976 (2014)).
In view of the above, the additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
Claims 2-3, 7-16, 19-20 depend on claim 1. The mentioned dependent claims recite the same abstract idea as the independent claims. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process). For example, the dependent claim recites the limitations “correlate”, “send information”, etc., are recited at a high level of generality and are mere extra-solution activity, and recited as performing generic computer functions. i.e., data processing. The elements amount to 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 2106.04(d) and 2106.05(f)).
The additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Thus, claims 1-3, 7-16, 19-20 are directed to an abstract idea and are therefore rejected.
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 (i.e., changing from AIA to pre-AIA ) 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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 7, 9-12, 16-, 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020176533 to Walsh et al. (hereinafter “Walsh”).
Regarding claim 1. (Original) Walsh discloses an ear-wearable stress and/or anxiety monitoring system (e.g., para 0039, system 100, fig. 11, para 0145-0146) comprising: a control circuit (para 0145 “processor 1108”); a microphone (para 0145 “microphone 1110”), wherein the microphone is in electrical communication with the control circuit (Fig. 11); and a sensor package para 0145 “sensors 1112”), the sensor package comprising a motion sensor (para 0145 “IMU 1118”); wherein the sensor package is in electrical communication with the control circuit (fig. 11); wherein the ear-wearable system is configured to evaluate data from at least one of the microphone and the sensor package and classify a stress level of a device wearer (para 0147 “determine an emotional stress level”, para 0210-0211, 0217-0218”) using a machine learning classification model; and periodically update the machine learning classification model based on indicators of stress experienced by the device wearer (para 0193, 0210, 0225 “implement a machine learning model”).
Regarding claim 2. (Previously Presented) Walsh discloses the ear-wearable system of claim 1, wherein the indicators of stress experienced by the device wearer are derived from data produced by at least one of the microphone and the sensor package (para 0147 “determine an emotional stress level”, para 0210-0211, 0217-0218”).
Regarding claim 3. (Previously Presented) Walsh discloses the ear-wearable system of claim 1, wherein the indicators of stress experienced by the device wearer are derived from inputs provided by the device wearer (para 0075 “user input”; para 0147 “determine an emotional stress level”, para 0210-0211, 0217-0218”; it is noted that data captured by the microphone, imu, etc., are understood to be received by the device from the user).
Regarding claim 7. (Previously Presented) Walsh discloses the ear-wearable system of claim 1, wherein the indicators of stress experienced by the device wearer are received by the ear-wearable system from an external source (para 0089, “communicate with one or more other remote devices”).
Regarding claim 9. (Previously Presented) Walsh discloses the ear-wearable system of claim 1, wherein the ear-wearable system is configured to weight certain possible detected stressors in the machine learning classification model more heavily based on the correlation (para 0058, etc., “computing system 104 determines the weights”).
Regarding claim 10. (Previously Presented) Walsh discloses the ear-wearable system of claim 1, wherein data from the microphone is processed to distinguish a voice of the device wearer from a voice of a third party (para 0237 “voice recognition toolkit”).
Regarding claim 11. (Previously Presented) Walsh discloses the ear-wearable system of claim 10, wherein the voice of the device wearer is treated as an indicator of stress experienced by the device wearer (para 0212, 0222).
Regarding claim 12. (Previously Presented) Walsh discloses the ear-wearable system of claim 10, wherein the voice of the third party is treated as a possible detected stressor (para 0237 “voice recognition toolkit”; it is understood that the voice recognition would separate the voices of the wearer and others).
Regarding claim 16. (Previously Presented) Walsh discloses the ear-wearable system of claim 1, wherein the ear-wearable system is configured to detect displacement behaviors and correlate classified stress levels with detected displacement behaviors (para 0210 “Higher respiration rates, especially when not associated with physical movement, are often a sign of emotional stress”).
Regarding claim 19. (Previously Presented) Walsh discloses the ear-wearable system of claim 1, wherein the ear-wearable system is configured to send information regarding classified stress levels to an electronic medical record system (para 0089 “computing device 400 may use communication unit(s) 404 to communicate with one or more other remote devices”).
Regarding claim 20. (Previously Presented) Walsh discloses the ear-wearable system of claim 1, wherein the ear-wearable system is configured to send information regarding classified stress levels to a third party (para 0089 “computing device 400 may use communication unit(s) 404 to communicate with one or more other remote devices”; it is noted that remote devices are being understood as belonging to a third party).
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walsh as applied to claims 1-3, 7, 9-12, 16-, 19-20 above, and further in view of US Pat Pub No 20220167916 to Mohanty et al. (hereafter “Mohanty”).
Regarding claim 13. (Previously Presented) Walsh discloses the ear-wearable system of claim 1, but fails to disclose wherein the ear-wearable system is configured to correlate sleep of the device wearer with subsequent classified stress levels of the device wearer.
Mohanty, from a similar field of endeavor, teaches monitoring sleep habit to determine an estimated stress level (para 0003-0007). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Walsh with the teachings of Mohanty to provide the predictable result of determining stress level.
Regarding claim 14. (Previously Presented) Walsh discloses the ear-wearable system of claim 1, but fails to disclose wherein the ear-wearable system is configured to detect meals and correlate classified stress levels with detected meals.
Mohanty, from a similar field of endeavor, teaches monitoring food consumption to determine an estimated stress level (para 0007). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Walsh with the teachings of Mohanty to provide the predictable result of determining stress level.
Regarding claim 15. (Previously Presented) Walsh discloses the ear-wearable system of claim 1, but fails to disclose wherein the ear-wearable system is configured to correlate stress levels with a time since a last meal.
Mohanty, from a similar field of endeavor, teaches monitoring food consumption, food already consumed, etc. (para 0004-0007, 0040) to determine an estimated stress level (para 0007). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Walsh with the teachings of Mohanty to provide the predictable result of determining stress level.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANA SAHAND whose telephone number is (571)272-6842. The examiner can normally be reached M-Th 8:30 am -5:30 pm; F 9 am-3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer S McDonald can be reached at (571) 270- 3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SANA SAHAND/Examiner, Art Unit 3796
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