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 Amendment
This Action is in response to the Amendment filed April 9, 2026 and the Response to Notice of Non-Compliant filed June 10, 2026.
In view of the filings, the objection to the drawings, set forth in the Office Action dated 01/09/2026, is withdrawn.
Claims 1, 10, and 12 are amended.
Claims 8-9 are canceled.
Claim 54 is added.
Claims 1-7, 10-15, 25-28, 30, and 54 are pending.
Response to Arguments
Applicant's arguments filed 04/09/2026 have been fully considered but they are not persuasive.
In response to Applicant’s assertion that Vu in view of Jadidi fail to teach or suggest the subject matter of claim 1, the Examiner notes that claim 1, as amended, does not recite how the systems measures differences between one side of the mouth and the other. Instead, the ear-wearable device is system is capable of identifying differences in dental health related conditions between a left side of the mouth and a right side of the mouth. One of ordinary skill in the art would have recognized that the secondary reference to Jadidi, in the cited passage (column 13, lines 48-58), teaches that electrodes/sensors can be situated on the right or to the left to monitor muscles on one side. But, in the case of bruxism where the bruxism events differ from one side to the other so that both sides of the muscle are monitored. That is, Jadidi teaches that two sets of electrodes may be used to monitor both sides so that differences between bruxism events on the left and right sides can be identified by the respective electrodes/sensors.
The Examiner further notes that only the sensor package of the ear-wearable device is in electrical communication with its control circuit, which evaluates signals from at least one of the microphone and the motion sensor. The second control unit, second microphone, and second sensor package are not connected to the second control unit.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The rejection of claims 25-28 and 30 is Vu in view of Predovich and Giraldez. Predovich was applied for its teaching of comparing signals from one of the microphone and the motion sensor from a time period; and, as acknowledged by Applicant (page 13, lines 1-2), lacks disclosure comparing signals before a procedure and after a procedure. Hence, the reason Giraldez was applied as Giraldez, in the dental procedure art, teaches that it was known in the art to check a patient’s teeth and face to how they progress before and after a dental procedure as taught by Giraldez. Thus, one of ordinary skill in the art the time period/nightly events taught by Predovich could be before and after a dental procedure in view of the teachings of Giraldez.
Priority
Claims 1-15, 25-28, 30, and 54 are deemed to have an effective filing date of March 1, 2023.
Claim Objections
Claim 1 is objected to because of the following informalities: the system has an ear-wearable device and a second ear-wearable device; however, the claim does not recite the conjunction “and” between the two components. In addition, the wherein clause associated with the ear-wearable device (claim 1, line 13) is after the second ear-wearable device (claim 1, lines 7-12). Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claim 54 is 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.
The recitation of “the first ear-wearable device” in lines 2-3 has insufficient antecedent basis as claim 1 refers to an ear-wearable device and a second ear-wearable device.
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.
Claims 1-2, 10-13, and 54 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication No. 2023/0284978 to Vu et al. (hereinafter referred to as “Vu”) in view of US Patent No. 9,149,226 to Jadidi.
Referring to claim 1, Vu discloses an ear-wearable device system (e.g., title and Abstract) comprising: an ear-wearable device (e.g., paragraph [0020]: the system includes a sensor situated behind and/or above the ear of a user where the sensor is part of a wearable device), the ear-wearable device comprising a control circuit (e.g., paragraph [0020]: system includes a processor and a computer readable medium in communication with the processor); a microphone, wherein the microphone is in electrical communication with the control circuit (e.g., paragraphs [0020]: in some cases, the wearable device may include speakers and/or microphones; [0036]: system 100 includes a wearable device, one or more sensors 110; [0040]: sensors 110 may include microphones and other sound detectors); and a sensor package, the sensor package comprising a motion sensor (e.g., paragraph [0040]: sensors may further include motion sensors such as an accelerometer, gyroscope, inertial measurement unit (IMU), global navigation satellite system receiver); a second ear-wearable device, the second ear-wearable device comprising a second control circuit; a second microphone; and a second sensor package; and wherein the second ear-wearable device is configured to be wearable on an opposite ear versus the ear-wearable device (e.g., paragraph [0020]: the wearable device includes one or more other devices, such as another sensor situated behind the other ear of the user); wherein the sensor package is in electrical communication with the control circuit (e.g., paragraph [0020]: system comprises a processor and sensors); and wherein the ear-wearable device system is configured to evaluate signals from at least one of the microphone and the motion sensor to detect an occurrence of a dental health condition (e.g., paragraphs [0047]: ML device 145 may be configured to evaluate dental issues, such as TMJ syndrome). Vu differs from the claimed invention in that it does not expressly disclose that the ear-wearable device system is capable of identifying differences in dental health related conditions between a left side of the mouth and a right side of the mouth.
However, Jadidi, in a related art: method/apparatus for monitoring muscle activity in a patient’s mouth, teaches that a sensor/electrode may be placed on both the left and right sides of a patient’s jaw to identify the muscle activity/bruxism on both sides as bruxism may differ from one side to another (e.g., column 13, lines 48-58 of Jadidi); and that each of the signals from the right/left side of the jaw can be processed independently so that differences can be identified between the left and right sides of the patient’s jaw (e.g., column 19, lines 1-6 and column 22, lines 59-61). Accordingly, one of ordinary skill in the art would have recognized the benefits of having independent sensors on both sides of a patient’s jaw to identify dental health related conditions between a left side of the mouth and a right side of the mouth in view of the teachings of Jadidi. Consequently, one of ordinary skill in the art would have modified the ear-wearable device system of Vu so that signals from the left sensor and the right sensor are processed independently as taught by Jadidi that such was a well-known engineering protocol in the monitoring of muscle activity in a patient’s mouth, and because the combination would have yielded a predictable result.
With respect to claim 2, Vu in view of Jadidi teaches the ear-wearable device system of claim 1, the dental health condition comprising at least one selected from the group consisting of bruxism, a TMJ joint issue, oral pain, and tooth decay (e.g., paragraph [0047] of Vu).
With respect to claim 10, Vu in view of Jadidi teaches the ear-wearable device system of claim 1, wherein the ear-wearable device system is configured to identify an abnormal chewing motion (e.g., paragraph [0046] of Vu: sensor sends bio-signals obtained from the patient and feeds to the ML model that determines abnormal chewing).
As to claim 11, Vu in view of Jadidi teaches the ear-wearable device system of claim 10, the abnormal chewing motion comprising an offset chewing motion (e.g., paragraph [0064] of Vu: for each trial, the onset and offset of each performed activity are annotated – thus, an offset abnormal chewing motion would be identified).
With respect to claim 12, Vu discloses the ear-wearable device system of claim 1, wherein the ear-wearable device system is configured to identify sounds from a patient’s body (e.g., paragraph [0041] of Vu: sensors 110 may be configured to detect one or more-bio-signals including facial muscle activities and sounds from the inner body near the patient’s ear), but does not expressly disclose that differences in sounds originating from a left side of the mouth versus a right side of the mouth can be identified. However, Jadidi, in a related art: method/apparatus for monitoring muscle activity in a patient, teaches that a sensor/electrode may be placed on both the left and right sides of a patient’s jaw to identify the muscle activity on both sides as conditions may differ from one side to another (e.g., column 13, lines 48-58 of Jadidi); and that each of the signals from the right/left side of the jaw can be processed independently so that differences can be identified between the left and right sides of the patient’s jaw. Accordingly, one of ordinary skill in the art would have recognized the benefits of having independent sensors on both sides of a patient’s jaw to identify muscle activity and sounds of dental health related conditions between a left side of the mouth and a right side of the mouth in view of the teachings of Jadidi. Consequently, in order to identify differences in sounds, one of ordinary skill in the art would have modified the ear-wearable device system of Vu so that signals from the left sensor and the right sensor are processed independently as taught by Jadidi that such was a well-known engineering protocol in the monitoring of muscle activity in a patient’s mouth, and because the combination would have yielded a predictable result.
As to claim 13, Vu in view of Jadidi teaches the ear-wearable device system of claim 12, wherein the ear-wearable device system is configured to distinguish between left sided TMJ joint problems and right sided TMJ joint problems (e.g., paragraph [0047] of Vu: ear-wearable device system can identify dental issues, such as TMJ syndrome).
With respect to claim 54, Vu in view of Jadidi teaches the ear-wearable device system of claim 1, wherein the ear-wearable device system is configured to measure (capable of measuring) timing differences between signals as gathered from the first ear-wearable device versus the second ear-wearable device to determine if the signal relates to the right side of the mouth versus the left side of the mouth (e.g., column 16, lines 1-20: the duration of the bruxism pattern determines the feedback/stimulation for treating the bruxism; column 18, line 9 – column 19, line 6: each of the signals from the right/left side of the jaw can be processed independently, and two independent stimulation signals can be sent out on each side of the jaw, respectively). Accordingly, one of ordinary skill in the art would have recognized the benefits of measuring time differences/duration between signals to determine whether the signal relates to the right side of the mouth versus the left side of the mouth in view of the teachings of Jadidi. Consequently, one of ordinary skill in the art would have modified the ear-wearable system of Vu in view of Jadidi to measure time differences between signals as gathered from the right and the left side of the mouth in order to determine the feedback/treatment as taught by Jadidi, and because the combination would have yielded predictable results.
Claims 3 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Vu in view of Jadidi as applied to claim 1 above, and further in view of US Patent Application Publication No. 2022/0061767 to Goldstein et al. (hereinafter referred to as “Goldstein”).
With respect to claim 3, Vu in view of Jadidi teaches the ear-wearable device system of claim 1, but does not expressly disclose that the ear-wearable device is a hearing-assistance device. However, Goldstein, in a related art: wearables for monitoring health or status of a patient, teaches that such a wearable monitor can be an integrated miniaturized earpiece, which includes sensors (motion and microphones) and a processor providing hearing loss correction and prevention (e.g., paragraphs [0117], [0188], [0215], and [0286] of Goldstein). Accordingly, one of ordinary skill in the art would have recognized the benefits of an ear-wearable device being a hearing assistance device as well as a health monitoring device in view of the teachings of Goldstein. Consequently, one of ordinary skill in the art would have modified the ear-wearable system of Vu in view of Jadidi to include a processor for providing hearing loss correction and prevention (a hearing-assistance device) in view of the teachings of Goldstein that such was a known engineering expedient in the ear-wearable monitoring art, and because the combination would have yielded a predictable result.
As to claim 14, Vu in view of Jadidi teaches the ear-wearable device system of claim 1, but does not expressly disclose that the ear-wearable device system is further configured to detect abnormal breathing. However, Goldstein, in a related art, teaches EEG electrodes within the exterior auditory canal (EAC) can be used to monitor or measure a level of sleep quality, or, monitor stoppage of breathing (e.g., paragraphs [0240]-[0241] of Goldstein). Accordingly, one of ordinary skill in the art would have recognized the benefits of an ear-wearable device system further configured to detect abnormal breathing in view of the teachings of Goldstein. Consequently, one of ordinary skill in the art would have modified the ear-wearable system of Vu in view of Jadidi to be configured to also detect abnormal breathing in view of the teachings of Goldstein that such was a known engineering expedient in the ear-wearable monitoring art, and because the combination would have yielded a predictable result.
With respect to claim 15, Vu in view of Jadidi and Goldstein discloses the ear-wearable device system of claim 14, the abnormal breathing comprising at least one selected from the group consisting of snoring and sleep apnea (e.g. paragraph [0242] of Goldstein: a single earpiece can serve to detect various disorders or conditions including sleep apnea and snoring). Accordingly, one of ordinary skill in the art would have recognized the benefits of an ear-wearable device system further configured to detect sleep apnea or snoring in view of the further teachings of Goldstein. Consequently, one of ordinary skill in the art would have modified the ear-wearable system of Wu in view of Jadidi and Goldstein to be configured to also detect sleep apnea or snoring in view of the further teachings of Goldstein that such was a known engineering expedient in the ear-wearable monitoring art, and because the combination would have yielded a predictable result.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Vu in view of Jadidi as applied to claim 1 above, and further in view of US Patent Application Publication No. 2021/0053313 to Predovich.
Vu in view of Jadidi teaches the ear-wearable device system of claim 1, but does not expressly disclose that the ear-wearable device system is configured to issue an alert or notification regarding detected occurrences of the dental health condition. However, Predovich, in a related art: sensor apparatus for measurement of muscle activity in the detection and treatment of bruxism, teaches that once bruxism is detected, a patient is notified and uses bio-feedback to curtain the grinding of the teeth (abstract), that the notification can be a buzzing sound or haptic vibrations that are output by a microprocessor of the wearable device (e.g., paragraph [0099] of Predovich). Accordingly, one of ordinary skill in the art would have recognized the benefits of an ear-wearable device system being configured to issue a notification regarding detected occurrences of the dental health condition (bruxism) in view of the teachings of Predovich. Consequently, one of ordinary skill in the art would have modified the ear-wearable device system of Vu in view of Jadidi to be configured to issue such a notification in view of the teachings of Predovich that such was a known engineering expedient in the ear-wearable monitoring art, and because the combination would have yielded a predictable result.
Claim 5-6 is rejected under 35 U.S.C. 103 as being unpatentable over Vu in view of Jadidi as applied to claim 1 above, and further in view of US Patent No. 6,093,158 to Morris.
With respect to claim 5, Vu in view of Jadidi teaches the ear-wearable device system of claim 1, but does not expressly disclose that the ear-wearable device is configured to time stamp detected occurrences of dental health related conditions and identify time-related patterns of the same. However, Morris, in a related art: systems for modifying behavioral disorders including bruxism, jaw clenching and snoring (e.g., title and abstract of Morris), teaches a recording system 130 that receives data from processor 110 and stores the data including duration, rate, intensity, and time of day for each episode of undesired behavior so that the patient can correlate the times and dates during which the behavior occurred with other life events (e.g., column 6, lines 1-20 of Morris). Accordingly, one of ordinary skill in the art would have recognized the benefits of an ear-wearable device being configured to detect abnormal breathing in view of the teachings of Morris. Consequently, one of ordinary skill in the art would have modified the ear-wearable system of Vu in view of Jadidi to time stamp detected occurrences of dental health related conditions and identify time-related patterns of the same in view of the teachings of Morris that such was a known engineering expedient in the ear-wearable monitoring art, and because the combination would have yielded a predictable result.
As to claim 6, Vu in view of Jadidi and Morris teaches the ear-wearable device system of claim 5, wherein the ear-wearable device is configured to identify sleep bruxism (e.g., Jadidi – column 12, lines 25-50: bruxism is identified while the patient sleeps; column 21, lines 20-38)). Accordingly, one of ordinary skill in the art would have recognized the benefits of identifying sleep bruxism in view of the dental treatment taught by Jadidi. Consequently, one of ordinary skill in the art would have modified the ear-wearable device of Vu in view of Jadidi and Morris so that it is configured to identify bruxism in view of the teachings of Jadidi that symptoms and treatment for sleep bruxism were known, and because the modification would have yielded a predictable result.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Vu in view of Jadidi and US Patent Application Publication No. 2022/0313153 to Shahmiri.
Vu in view of Jadidi teaches the ear-wearable device system of claim 1, but does not expressly state that the ear-wearable device system is configured to distinguish between awake bruxism and sleep bruxism. However, Shahmiri teaches that differences between the two types of bruxism were known (e.g., paragraphs [0033]-[0034]: besides occurring when one is asleep and one is wake, sleep bruxism and awake bruxism have different kinematic properties: grinding (sleep) and clenching (awake) and [0023], [0043] and Fig. 3 – acoustic profiles of orofacial activities show how the system is capable of being programmed to discriminate between clenching and grinding). Accordingly, one of ordinary skill in the art would have recognized the benefits of distinguishing between awake bruxism and sleep bruxism in view of the dental consequences taught by Shahmiri. Consequently, one of ordinary skill in the art would have modified the ear-wearable device of Vu in view of Jadidii so that it is configured to distinguish between awake bruxism and sleep bruxism in view of the teachings of Shahmiri that differences were known and its ear-wearable device are unobtrusive and allow for longer periods of time monitoring of orofacial activities (e.g., paragraph [0040] of Shamiri), and because the modification would have yielded a predictable result.
Claims 25-28, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Vu in view of Predovich and US Patent Application Publication No. 2021/0228276 to Giraldez et al. (hereinafter referred to as “Giraldez”).
Regarding claim 25, Vu discloses an ear-wearable device system (e.g., title and Abstract) comprising: an ear-wearable device (e.g., paragraph [0020]: the system includes a sensor situated behind and/or above the ear of a user where the sensor is part of a wearable device), the ear-wearable device comprising a control circuit (e.g., paragraph [0020]: system includes a processor and a computer readable medium in communication with the processor); a microphone, wherein the microphone is in electrical communication with the control circuit (e.g., paragraphs [0020]: in some cases, the wearable device may include speakers and/or microphones; [0036]: system 100 includes a wearable device, one or more sensors 110; [0040]: sensors 110 may include microphones and other sound detectors); and a sensor package, the sensor package comprising a motion sensor; wherein the sensor package is in electrical communication with the control circuit (e.g., paragraph [0040]: sensors may further include motion sensors such as an accelerometer, gyroscope, inertial measurement unit (IMU), global navigation satellite system receiver); but does not expressly disclose that the ear-wearable device system is configured to compare signals from at least one of the microphone and the motion sensor from a time period prior to a dental procedure with signals from at least one of the microphone and the motion sensor from a time period after the dental procedure. However, Predovich, in a related art, teaches that a patient could compare nightly events of a dental issue over the course of several days or weeks in order to see how the dental issue is progressing or if any adjustments are necessary (e.g., paragraph [0095] of Predovich). Giraldez, in a related art: medical procedures resulting in changes to patient, teaches a computer system that provides procedure simulations for each step of procedure by comparing a pre-operative model generated before the procedure with one or more 3D post-operative models (e.g., paragraph [0032] of Giraldez); [0116]: procedure simulations include orthodontics and other dental procedures; and that the computing system can generate 3D simulations of orthodontic and other dental procedures so that a user can compare teeth and face before the procedure and after the procedure (e.g., paragraph [0121] of Giraldez). Thus, Giraldez teaches that a user should check a dental issue before a procedure and after a procedure. Accordingly, one of ordinary skill in the art would have recognized the benefits of comparing measured signals of a dental issue over the course of days or weeks to see how the dental issue is progressing in view of the teachings of Predovich, and, check how the patient’s teeth and face are doing before and after a dental procedure as taught by Giraldez. Consequently, one of ordinary skill in the art would have modified the ear-wearable device system of Vu so that its device is capable of comparing signals from at least one of the microphone and the motion sensor from a time period prior to a dental procedure with such signals after the dental procedure in view of the teachings of Predovich and Giraldez that dental issues should be checked before and after a procedure to check for progression of the dental issue and if any adjustments are needed, and because the combination would have yielded a predictable result.
With respect to claim 26, Vu in view of Predovich and Giraldez teaches the ear-wearable device system of claim 25, the dental procedure comprising at least one selected from the group consisting of a dental implant, a crown, an orthodontic adjustment, and a tooth filling (e.g., paragraph [0003] of Predovich: common dental restorations/procedures include crowns and fillings to teeth). Accordingly, one of ordinary skill in the art would have recognized that dental procedures include dental restorations, such as crowns and fillings, to teeth in view of the teachings of Predovich. Consequently, one of ordinary skill in the art would have modified the ear-wearable device system of Vu in view of Predovich and Giraldez to monitor the patient’s mouth area with respect to sound and motion before and after either a crown or a tooth filling in view of the teachings of Predovich that such were well-known dental procedures, and because the combination would have yielded a predictable result.
As to claim 27, Vu in view of Predovich and Giraldez teaches the ear-wearable device system of claim 26, wherein the ear-wearable device system is capable of receiving an input regarding a type of dental procedure from a system user (e.g., paragraph [0053] of Vu: the computer system of Fig. 1, can include one or more input device 315, which can include a mouse or a keyboard that would be capable of entering the type of dental procedure).
With respect to claim 28, Vu in view of Predovich and Giraldez teaches the ear-wearable device system of claim 25, wherein the ear-wearable device system is capable of issuing an alert or notification when a worsening of a dental condition is detected based on the signals from at least one of the microphone and the motion sensor (e.g., paragraphs [0092]-[0093] and [0095] of Predovich: buzzer/vibration/electric impulse can be used to alert wearer that dental condition is detected). Accordingly, one of ordinary skill in the art would have recognized the benefits of issuing an alert or notification when a dental condition is worsening (e.g., patient is grinding or clenching) in view of the teachings of Predovich. Consequently, one of ordinary skill in the art would have modified the ear-wearable device system of Vu so that it is capable of issuing an alert when a worsening of a dental issue is detected as taught by Predovich, and because the combination would have yielded a predictable result.
As to claim 30, Vu in view of Predovich and Giraldez teaches the ear-wearable device system of claim 25, further comprising: a second ear-wearable device, the second ear-wearable device comprising a second control circuit; a second microphone; and a second sensor package; and wherein the second ear-wearable device is configured to be wearable on an opposite ear versus the ear-wearable device (e.g., paragraph [0020] of Vu: the wearable device includes one or more other devices, such as another sensor situated behind the other ear of the user).
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 CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 PM.
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/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792
