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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/02/2026 has been entered.
Response to Arguments
Applicant’s arguments in combination with amendments, see Remarks and Claims, filed 03/02/2026, with respect to the rejection(s) of claim(s) under 35 USC 101 have been fully considered but they are not persuasive. Beginning on page 6, the applicant argues that the claims as amended are not directed towards an abstract idea, but rather an ear-wearable device configured to detect and alert for abnormal activity patterns. This argument is fully considered but is not persuasive. As presented, the claim recites limitations which are performed in human mind, The claim recites “establish a baseline pattern, the baseline pattern comprising a baseline speech pattern [] monitor signals from the microphone and/or the motion sensor; and compare the monitored signal with the baseline pattern to detect an aberrant pattern, wherein the aberrant pattern comprises an aberrant speech pattern; issue an alert” which are steps that can be performed in human mind (e.g., observation, evaluation, judgment and opinion). Providing an alert as recited is merely outputting the result of an abstract idea. The additional limitations considered both individually and as an ordered combination do not amount to significantly more than the abstract idea because they are mere-extra solution activity (e.g., pre-solution activity to collect data) and the alert being post solution activity of outputting the result of an abstract idea. Furthermore, these limitations are simply appending well-understood, routine and conventional activities previously known in the industry.
On page 7, the applicant further argues that the claimed subject matter provides a convenient and effective way to passively monitor the activity [] and issue an alert. This argument is fully considered but is not persuasive. In order to have a technological improvement, the additional elements, either solely or in combination, need to reflect the improvement. Here, the improvement is in the abstract idea.
The newly added claim 60 states “the baseline speech pattern comprises a baseline number of phonemes reflecting confusion uttered by a wearer of the ear-wearable device per unit time.” The claim as stated does not provide any details regarding the number of phonemes or the unit time. As stated, the claim merely requires the baseline speech pattern to include any number of phonemes. It is understood that one of ordinary skill in the art, listening to the wearer’s speech could observe, evaluate, and render judgment and opinion including the number of phonemes, speech rate, etc. which could reflect confusion uttered by the wearer.
The newly added claim 61 states the same limitations as claim 60 with the addition of “that exceeds the baseline number by at least a predetermined threshold”. The same analysis and reasoning is applied to claim 61. It is further noted that the claim does not provide any details regarding the baseline number, threshold and what the predetermined number is. Therefore, under its broadest reasonable, any number of phonemes (i.e., regular speech) versus a higher number of phonemes (i.e., fast speech) could be detected by the observer, and interpreted to reflect confusion.
Applicant’s arguments in combination with amendments, see Remarks and Claims, filed 03/02/2026, with respect to the rejection(s) of claim(s) under 35 USC 102 and 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the following: See details below.
Applicant's request to hold the double patenting rejection in abeyance until there is an indication of allowable subject matter, filed 03/02/2026 regarding the double patenting rejections have been acknowledged and accepted. The heading for the double patenting rejection will be repeated in this office action.
Election/Restrictions
Newly submitted claims 62-63 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: The newly amended claim 62 recites “to identify an aberrant pattern and [] generate a query when the aberrant pattern is detected; receive a response to the query from a wearer of the ear-wearable device; and assess the cognition of the wearer based on the response to the query” which claim 1 does not require, while claim 1 requires “[] to establish a baseline pattern the baseline pattern comprising a baseline speech pattern; monitor signals from the microphone and/or the motion sensor to identify an aberrant pattern, wherein the aberrant pattern comprises an aberrant speech pattern” which claim 62 does not require.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 62-63 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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, 3-5, 7-9, 12-13, 17-19, 24, 27, 56-57, 60-61 are rejected under 35 U.S.C. 101 because of the following analysis:
1 – statutory category: Claims 1, 3-5, 7-9, 12-13, 17-19, 24, 27, 56-57, 60-61 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 “establish a baseline pattern [], the baseline pattern comprising a baseline speech pattern, monitor signals from the microphone and/or the motion sensor; and compare the monitored signal with the baseline pattern to detect an aberrant pattern; wherein the aberrant pattern comprises an aberrant speech pattern, issue an alert []”. These limitations, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in mind (concepts performed in the human mind including an observation, evaluation, judgment, opinion). Therefore, an abstract idea is involved.
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 claims 1 recite the additional limitations of “control circuit”, “microphone”, “motion sensor”, “power supply”, 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 3-5, 7-9, 12-13, 17-19, 24, 27, 56-57, 60-61 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 directed to determining various aberrant patterns, etc., are recited at a high level of generality and are mere extra-solution activity i.e., data gathering/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, 3-5, 7-9, 12-13, 17-19, 24, 27, 56-57, 60-61 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.
Claim(s) 1, 3-5, 7-9, 13, 17, 19, 24, 27, 56-57 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20200086133A1 to Wang et al. (hereinafter “Wang”) in view of US 20080275349 to Halperin et al. (hereinafter “Halperin”) and US 20190228179 to Rakshit et al. (hereinafter “Rakshit”)
Regarding claim 1. (Currently Amended) Wang discloses an ear-wearable device (abstract, para 0021, 0023-0029 “ear wearable device”, etc.) comprising: a control circuit (para 0045 “processor 202”); a microphone, wherein the microphone is in electrical communication with the control circuit (para 0049-0050 “one or more sensors 208”, “sensor 208 includes [] a microphone”, fig. 2A); a motion sensor, wherein the motion sensor is in electrical communication with the control circuit (para 0049-0050 “one or more sensors 208”, “sensor 208 includes [] an accelerometer”, fig. 2A); and a power supply, wherein the power supply is in electrical communication with the control circuit (para 0041 “ear mountable device includes a battery”); wherein the ear-wearable device is configured to record data based on signals from the microphone and/or the motion sensor [] a baseline pattern (para 0088-0089, steps 502-504, determine a state of a user”; para 0089 “physical state e.g., normal or baseline physical state []”); monitor signals from the microphone and/or the motion sensor to identify an aberrant pattern (para 0088-0089, “state of the user may be determined from one or more sensor signals”) and compare the monitored signals with the baseline pattern to detect an aberrant pattern (para 0088-0089, steps 502-504, determine a state of a user” and “determine whether the state of the user warrants an intervention”); issue an alert when the aberrant pattern is detected (para 0091-0092 “intervention”, 0066 “alerts”).
Wang fails to explicitly disclose establishing a baseline pattern.
Halperin, from a similar field of endeavor, teaches the baseline parameters received by analyzing the sensed parameters during a baseline measurement period prior to the monitoring of the ongoing parameters (para 0237, 0577 “during a baseline period…”, para 0614, 0728) to provide a patient specific baseline (para 0614). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Wang with the teachings of Halperin to provide the predictable result of calculating patient specific baseline.
Wang as modified by Halperin renders obvious the limitations above but fail to disclose the baseline pattern comprising a baseline speech pattern and to detect an aberrant pattern wherein the aberrant pattern comprises an aberrant speech pattern.
Rakshit, from a similar field of endeavor teaches determining the emotional state of the user by analyzing biometrics such as HRV, heart rate, movement patterns (from accelerometer and gyroscope) and frequency of speech (from microphone) [] and to use data from microphone 125 to analyze speech content, pitch, and loudness of speech in order to evaluate a user's emotional state. For example, speech that is higher in pitch or louder than a threshold (such as a user's typical baseline range) may indicate that the user is upset or angry (para 0021). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Wang with the teachings of Rakshit to provide the predictable result of determining the emotional state using speech analysis.
Regarding claim 3. (Previously Presented) Wang as modified by Halperin and Rakshit renders obvious the ear-wearable device of claim 1, wherein the aberrant pattern indicates an increase in restlessness (Halperin, para 0607, 0641 “monitoring restlessness patterns”).
Regarding claim 4. (Previously Presented) Wang as modified by Halperin and Rakshit renders obvious the ear-wearable device of claim 1, wherein the aberrant pattern comprises an aberrant sleeping pattern (Halperin, para 0607 “sleep cycle”). .
Regarding claim 5. (Previously Presented) Wang as modified by Halperin and Rakshit renders obvious the ear-wearable device of claim 4, wherein the aberrant sleeping pattern comprises an aberrant sleep duration (Halperin, para 0732, monitor for insomnia … monitor the duration subject 12 is in bed before falling asleep, the total duration of quiet sleep, a number of awakenings during sleep, sleep efficiency, and/or REM sleep duration and timing… []”).
Regarding claim 7. (Previously Presented) Wang as modified by Halperin and Rakshit renders obvious the ear-wearable device of claim 4, wherein the aberrant sleeping pattern comprises an aberrant number of times getting up (Halperin, para 0732, monitor for insomnia … monitor []a number of awakenings during sleep”).
Regarding claim 8. (Previously Presented) Wang as modified by Halperin and Rakshit renders obvious the ear-wearable device of claim 4, wherein the aberrant sleeping pattern comprises an aberrant time to falling asleep (Halperin, para 0732, monitor for insomnia … monitor the duration subject 12 is in bed before falling asleep”).
Regarding claim 9. (Previously Presented) Wang as modified by Halperin and Rakshit renders obvious the ear-wearable device of claim 4, wherein the aberrant sleeping pattern comprises an aberrant duration from waking to rising in the morning (Halperin, para 0732, monitor for insomnia … monitor [] sleep efficiency”).
Regarding claim 13. (Previously Presented) Wang as modified by Halperin and Rakshit renders obvious the ear-wearable device of claim 1, wherein the aberrant pattern comprises an aberrant movement pattern (Halperin, para 0022, 0108-0115, 0125-0129, etc. “sensed large body movements of the subject, and to monitor the condition of the subject”).
Regarding claim 17. (Previously Presented) Wang as modified by Halperin and Rakshit renders obvious the ear-wearable device of claim 1, wherein the aberrant pattern comprises an aberrant head movement pattern (para 0094, 0108-0110).
Regarding claim 19. (Previously Presented) Wang as modified by Halperin and Rakshit renders obvious the ear-wearable device of claim 1, wherein the aberrant pattern comprises an aberrant bathroom use pattern (Halperin, para 0806 “urine output sensor”).
Regarding claim 24. (Previously Presented) Wang as modified by Halperin and Rakshit renders obvious the ear-wearable device of claim 1, wherein the aberrant pattern is associated with safety, nutritional/hydration status, or new or deteriorating health conditions of a wearer of the ear-wearable device (Wang, para 0089, “head impact”, “fallen down”, etc., are associated with safety).
Regarding claim 27. (Previously Presented) Wang as modified by Halperin and Rakshit renders obvious the ear-wearable device of claim 1, wherein the alert includes a last-known location of a wearer of the ear-wearable device (Wang, para 0093, 0094, 0129 “contacting an emergency response service to notify the emergency response service that the user is in need of assistance”, would include the location to allow the emergency response services to find the user).
Regarding claim 56. Wang as modified by Halperin and Rakshit renders obvious the ear-wearable device of claim 1, wherein the ear-wearable device is configured to generate a query when the aberrant pattern is detected (Wang, para 0038, 0053).
Regarding claim 57. (New) Wang as modified by Halperin and Rakshit renders obvious the ear-wearable device of claim 56, wherein the query comprises a prompt to execute a specific movement protocol (para 0053, 0078-0079 “response to a query received …tapping the ear-mountable device 103 with a predetermined number and/or pattern of taps, or providing other input suitable for a given implementation of the input device 213”).
Claim(s) 12, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Halperin and Rakshit as applied to claims 1, 3-5, 7-9, 13, 17, 19, 24, 27, 56-57 above, and further in view of US 20110106627 to LeBoeuf (previously presented).
Regarding claim 12. (Previously Presented) Wang as modified by Halperin renders obvious the ear-wearable device of claim 1, but fails to disclose wherein the aberrant pattern comprises a change in eating or drinking habits.
LeBoeuf, from a similar field of endeavor teaches monitoring a subject by measuring physiological parameters and environmental factors, including calories intake (para 0006, 0080 “caloric intake, caloric metabolism, metabolomics, []”; the claim does not provide any details regarding “change in eating or drinking habits” and whether the ear-wearable device monitors the content, the calories, the time, etc., for determining changes in “eating or drinking habits”. Under its BRI, it could be any changes including caloric intake) to provide biofeedback to the user (para 0004). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Wang as modified by Halperin and Rakshit with the teachings of LeBoeuf to provide the predictable result of improving biofeedback to the user by collecting the additional information.
Regarding claim 18. (Previously Presented) Wang as modified by Halperin and Rakshit renders obvious the ear-wearable device of claim 1, but fails to disclose wherein the aberrant pattern comprises an aberrant ambulation pattern.
LeBoeuf, from a similar field of endeavor teaches monitoring a subject by measuring physiological parameters and environmental factors, including measuring the number of steps walked during a day (para 0159) to provide biofeedback to the user (para 0004). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Wang as modified by Halperin and Rakshit with the teachings of LeBoeuf to provide the predictable result of improving biofeedback to the user by collecting the additional information.
Claim(s) 60-61 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Halperin and Rakshit as applied to claims 1, 3-5, 7-9, 13, 17, 19, 24, 27, 56-57 above, and further in view of CN112106381B to Yin et al. (hereinafter “Yin”).
Regarding claim 60. (New) Wang as modified by Halperin and Rakshit renders obvious the ear-wearable device of claim 1, wherein the baseline speech pattern comprises a baseline number of phonemes reflecting confusion uttered by a wearer of the ear-wearable device per unit time.
Yin, from a similar field of endeavor teaches analyzing the speech to detect one or more phonological elements (i.e., phonemes), such as stress, value, pitch, speech rate, or one or more other elements that may provide content information about the detected text 424 , such as a particularly long duration. In an illustrative example, duration is an aspect of phonology: if speech has a longer or shorter duration than usual, the user may be in an emotional state, such as sadness, dissatisfaction, hesitation, etc. Other phonological elements like pitch value and pitch contour, where the dynamic range is higher or lower than the usual dynamic range, can indicate whether the user is happy or frustrated with the experience. It would have been obvious before the filing date of the claimed invention to modify the disclosure of Wang as modified by Halperin and Rakshit with the teachings of Yin to provide the predictable result of determining the state of the user.
Regarding claim 61. (New) Wang as modified by Halperin, Rakshit and Yin renders obvious the ear-wearable device of claim 60, wherein the ear-wearable device detects the aberrant pattern upon detecting a number of phonemes reflecting confusion uttered by the wearer per unit time that exceeds the baseline number by at least a predetermined threshold (see rejection of claims 1 and 60; Yin-yi, see Description regarding “phonological analysis 430”).
Double Patenting
Claim 1, 4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 9-11, 29-30 of copending Application No. 17/786,673 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they use similar device having similar components to monitor similar user characteristics.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 27 rejected on the ground of nonstatutory double patenting as being unpatentable over claim1, 34 of U.S. Patent No. 12,313,762. Although the claims at issue are not identical, they are not patentably distinct from each other because they use similar device having similar components to monitor similar user characteristics.
Claim 1, 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 6, 11, 15, 21 of copending Application No. 18/073,069 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they use similar device having similar components to monitor similar user characteristics.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 15, 25 of copending Application No. 18587564 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they use similar device having similar components to monitor similar user characteristics.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US20210354300A1 to Nagao et al. US20180000685A1 to Maloney et al.; WO2016176494A1 to Hudson et al.
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