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 .
Information Disclosure Statement
The information disclosure statements submitted on November 11, 2025 and January 15, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 15, 2026 has been entered.
Response to Amendment
The amendment filed January 15, 2026 has been entered. Claims 1-4, 7-8, 10, 13-14, 16, 18, 23, 25, 27, 51, and 73-77 are pending in the application, claims 76-77 were newly added, and claims 5-6, 9, 11-12, 15, 17, 19-22, 24, 26, 28-50, and 52-72 were previously cancelled. Applicant’s amendments to the claims necessitate new grounds of rejection, as described in the Response to Arguments and 101, 102, and 103 Rejections below.
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 1-4, 7-8, 10-11, 13-14, 16, 18, 23-25, 27-29, 31, 51, and 73-77 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-4, 7-8, 10-11, 13-14, 16, 18, 23-25, 27-29, 31, 51, and 73-77 are directed to a system for evaluating a wearer using a computational algorithm, which is an abstract idea. Claims 1-4, 7-8, 10-11, 13-14, 16, 18, 23-25, 27-29, 31, 51, and 73-77 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is drawn to a machine.
Step 2A – Prong One: Claim 1 recites an abstract idea. In particular, claim 1 recites the following limitations:
[A1] – “select a vestibular training exercise from the plurality of vestibular training exercises based on the evaluation and the associated intensity index value”
The element [A1] of claim 1 is drawn to an abstract idea since it involves a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 1 recites the following limitations that are beyond the judicial exception:
[A2] – “an ear-worn device comprising: a control circuit;
[B2] – “a microphone in communication with the control circuit”;
[C2] – “a motion sensor in communication with the control circuit”;
[D2] – “an accessory device in wireless communication with the ear-worn device”;
[E2] – “wherein the vestibular rehabilitation management system is configured to: store a plurality of vestibular training exercises wherein each vestibular training exercise comprises an associated difficulty index value in a memory of the ear-worn device or the accessory device”; and
[F2] – “evaluate a wearer of the ear-worn device using the motion sensor”
The elements [A2-E2] of claim 1 do not integrate the exception into a practical application of the exception. In particular, the element [A2] is merely an instruction 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 MPEP 2106.05(f). Also, the elements [B2-E2] are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering and storage at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). Further, the element [F2] merely adds the words “apply it” (or an equivalent) with the judicial exception.
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation “an ear-worn device comprising a control circuit; a microphone in communication with the control circuit; and a motion sensor in communication with the control circuit;” does not qualify as significantly more because this limitation merely describes elements of the vestibular management system and does not require that these elements contribute to the abstract idea of evaluating a wearer and selecting a vestibular training exercise as part of the claimed invention. Also, the recitation “an ear-worn device comprising a control circuit; a microphone in communication with the control circuit; and a motion sensor in communication with the control circuit;” is merely insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well-known elements. In particular, the ear-worn device is nothing more than a microphone and a motion sensor communicating with a processor, and a generic accessory device. Such devices are conventional as evidenced by:
U.S. Patent Application Publication No. US 20190231253 A1 (Ahmed) discloses that microphones, motion sensors, and processors are typical and well-known in ear-worn devices [0010-0011; 0039], and the ear-worn device may function with another electronic device such as personal computer, smartphone, smartwatch, tablet computer, another hearable 110, etc., which can communicate with hearable via network connections [0029].
Further, the element “control circuit” does not qualify as significantly more because this limitation is 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’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and 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 taking 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.
Claims 2-4, 7-8, 10-11, 13-14, 16, 18, 23-25, 27-29, 31, and 75-76 depend from claim 1, and recite the same abstract idea as claim 1. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exception: The limitation “ear-worn device” recited in claims 7, 10, 13-14, 16, 18, 23-25, 27, 31, and 75-76, and a generic “accessory device” in claims 75-76.
Each of these limitations does not recite additional elements that amount to significantly more than the judicial exception itself because they are merely insignificant extra-solution activities to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well-known elements. In particular, the ear-worn device is nothing more than a device with a microphone and motion sensor communicating with a processor. Such devices are conventional as evidenced by Ahmed (as provided above with respect to the rejection of claim 1).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (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.
The analysis of claim 51 is as follows:
Step 1: Claim 51 is drawn to a machine.
Step 2A – Prong One: Claim 51 recites an abstract idea. In particular, claim 1 recites the following limitations:
[A1] – “detect system declared performance of an exercise”
[B1] – “detect wearer declared performance of the exercise”
[C1] – “compare system declared performance of the exercise with wearer declared performance of the exercise by comparing the first number of exercise repetitions to the second number of exercise repetitions.”
These elements [A1]-[C1] of claim 51 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 51 recites the following limitations that are beyond the judicial exception:
[A2] – “an ear-worn device comprising: a control circuit”
[B2] – “monitor signals from the motion sensor to detect system declared performance of an exercise, wherein the system declared performance comprises a first number of exercise repetitions detected by the motion sensor”;
[C2] – “monitor signals from the microphone to detect wearer declared performance of the exercise, wherein the wearer declared performance comprises a second number of exercise repetitions detected by the microphone”
These elements [A2]-[C2] of claim 51 do not integrate the exception into a practical application of the exception. In particular, element [A2] is merely an instruction 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 MPEP 2106.05(f). Also, elements [B2-C2] merely add insignificant extra-solution activities to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Step 2B: Claim 51 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation “an ear-worn device comprising a control circuit; a microphone in communication with the control circuit; and a motion sensor in communication with the control circuit;” does not qualify as significantly more because this limitation is merely insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well-known elements. In particular, the ear-worn device is nothing more than a microphone and a motion sensor communicating with a processor. Such devices are conventional as evidenced by Ahmed (as provided above with respect to the rejection of claim 1).
Further, the element “control circuit” does not qualify as significantly more because this limitation is 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’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Claims 73-74 and 77 depend from claim 51, and recite the same abstract idea as claim 51. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exception: Claim 74 recites “calibration process if the system declared performance of the exercise and the wearer declared performance of the exercise deviates by at least a threshold value”. As written under BRI, the calibration process is not specified to be a process that could not be performed by the human mind, thus embodying a mental process.
In view of the above, the additional elements individually do not integrate the exception into a practical application and 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 taking 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.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-4, 7, 10-11, 13-14, 16, 18, 23, 25, 51, and 73-75 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20160262608 A1 (Krueger, Wesley W.O.).
Regarding claim 1, Krueger teaches a vestibular rehabilitation management system comprising:
an ear-worn device comprising ([0301] “The head tracking inertial system can be mounted to the head in numerous configurations” … “in the ear or attached to the ear”)
a control circuit ([0304] “The processor may receive information from and control the eye tracking system; the head mounted tracking system, the optical system, and peripherals.”);
a microphone in communication with the control circuit ([0315] “the cameras can be located in the lens, framework or eye or head worn device” … “The camera could have a microphone”); and
a motion sensor in communication with the control circuit ([0300] “Head tracking on a head-worn unit can be performed by using an inertial measurement unit (also called an IMU or ‘tracker’). An IMU is an electronic device that measures one or more DOF (such as position, velocity, orientation, and/or gravitational force, as was described previously in this disclosure) by using one or more sensors”); and
an accessory device in wireless communication with the ear-worn device ([0304-0305] “The processor may receive information from and control the eye tracking system; the head mounted tracking system, the optical system, and peripherals. The processor may be configured to execute program instructions stored in the memory unit and to generate a display of images on the user interface.”; [0257]; [0315] “The camera could have a microphone for voice commands, and at least 12 GB of usable storage. The camera could support Bluetooth and/or Wi-Fi. The camera could be part of, or work with an Android or iOS smartphone.”; [0342-0343]);
wherein the vestibular rehabilitation management system is configured to:
store a plurality of vestibular training exercises, wherein each vestibular training exercise comprises an associated difficulty index value in a memory of the ear-worn device or the accessory device ([0042] “The first approximately 20 milliseconds of pursuit tends to be the same regardless of target parameters. However, for the next 80 milliseconds or so, target speed and position has a large effect on acceleration.”; [0140]; [0186] “Examples of these variations in the target visual element could include: [0187] A different shape (such as a shape comprising a cross hair); [0188] Different contrast, either more or less; [0189] Different intensity; [0190] Different size; [0191] Different focus, either more in-focus or out of focus; [0192] Having one or more features in the visual element that move relative to the rest of the visual element”; [0268] “As an example, eye tracking and visual or smooth pursuit can be done by visually observing a moving image traditionally in a horizontal or vertical plane or alternatively in a saw-tooth, sinusoidal, square-wave, snake-like, torsional, looped or other non-fixed plane of motion, which is more natural to what the normal person experiences in everyday life.”; [0304-0305]; [0342-0343] “Data on the smartphone could be stored, logged, interpreted, displayed, and/or transmitted to other devices”);
evaluate a wearer of the ear-worn device using the motion sensor ([0309] “The system may include the user interface for providing information to the wearer or receiving input from the wearer”; [0314] “The device can measure the relationship between motion of the head in this environment and VOP.”); and
select a vestibular training exercise from the plurality of vestibular training exercises based on the evaluation and the associated difficulty index value with the ear-worn device or the accessory device ([0352]; [0359] “VOR scoring can also be used more objectively in determining the benefit or improvement with such therapy. The system can include improvement information that can be used by the user, a coach, a medical practitioner, or any other advisor to help interpret the scoring and provide advice and/or exercises to improve ocular reflex” … “if a VOR abnormality is found to exist in the horizontal plane, VOR enhancement rehabilitation therapy is given in the same plane. In this instance, the user focuses on a target of interest and the user rotates the head horizontally, while continuing to look at the target”; [0172] “The processor in the AR/VR system then compares eye movement to timing and appearance/disappearance of visual elements on display, and the location of these visual elements to determine vestibulo-ocular performance 644”; [0304-0305]).
Regarding claim 3, Krueger teaches the vestibular rehabilitation management system of claim 1, wherein the vestibular training exercise selection includes selection of a vestibular training exercise difficulty ([0341] “help a person improve his or her balance by challenging, exercising, enhancing, and/or retraining the VOR (fixation/re-fixation) used during activities in daily living, routine exercise, and high level athletic/vocational activities and therefore improving the retinal visual stability and accuracy of the fovea to remain fixed on the visual element.”).
Regarding claim 4, Krueger teaches the vestibular rehabilitation management system of claim 3, wherein the vestibular training exercise difficulty is selected with respect to a least one of a strength intensity index value, a vestibular function intensity index value, postural stability intensity index value, a reaction speed intensity index value, a stamina intensity index value, a speed intensity index value, a visual intensity index value, an environmental stimulation intensity index value, a proprioception intensity index value, and a cognitive load intensity index value ([0280] “The image of the eye can be tracked and allow the person's horizontal, vertical, and/or torsional (rotary) vestibulo-ocular responses to be measured. A moving visual target or visual element can provide a method for tracking, for optokinetic (OPK) testing, for saccade detection and measurement, for gaze fixation testing, for DVA measurement and for VOR testing.”).
Regarding claim 7, Krueger teaches the vestibular rehabilitation management system of claim 1, wherein the vestibular rehabilitation management system is configured to evaluate the wearer of the ear-worn device by sensing their movement over a time period preceding selection of the vestibular training exercise ([0352] “if an athlete had such an abnormality and could be given some rehabilitation methods prior to play, this could correct the abnormality and increase performance in that activity.”).
Regarding claim 10, Krueger teaches the vestibular rehabilitation management system of claim 7, wherein the time period preceding selection of the vestibular training exercise includes a time period wherein the wearer of the ear-worn device is performing an exercise ([0211] “The subject, could then be asked to turn the head left, right, lie supine, while supine head turns right, head turns left, then turn the body (roll) right and turn the body (roll) left. During each positional change, the eyes are tracked using the AR/VR system to look for abnormal eye movements.”; [0345] ‘use and measure natural movement that normally occurs during normal activities or activities associated with a person's work and to compare that to the eye movement that occurs at the same time using a Fourier transform”).
Regarding claim 13, Krueger teaches the vestibular rehabilitation management system of claim 1, wherein the vestibular rehabilitation management system selects a time to present the selected vestibular training exercise to the wearer of the ear-worn device as a suggestion ([0322] “This can be done with passive head movements or active head movements and an alarm in the device can trigger the timing event of head movement”).
Regarding claim 14, Krueger teaches the vestibular rehabilitation management system of claim 13, wherein the time is based on detected movement patterns of the wearer of the ear-worn device 9 ([0332] “Specifically, the electronic circuit can be triggered or turned on by verbal command (auditory input), by visual means (such as prolonged eyelid closure or other specific eyelid movement), mechanically (such as by the attachment of the head worn device to the head), with timer software programming, and remotely.”).
Regarding claim 16, Krueger teaches the vestibular rehabilitation management system of claim 1, wherein the vestibular rehabilitation management system is configured to evaluate the wearer of the ear-worn device by sensing their ability to complete a preceding exercise ([0072] “The performance of the VOR can be measured by the gain, which is defined as the amplitude ratio between eye and head velocities.”); [0109] “a head-worn augmented reality system for measuring and/or improving vestibular performance, ocular performance, and/or vestibulo-ocular performance”; [0140] “measurement of the eye's ability to focus on the target can easily be measured”).
Regarding claim 18, Krueger teaches the vestibular rehabilitation management system of claim 1, wherein the vestibular rehabilitation management system is configured to evaluate the wearer of the ear-worn device by determining the wearer's performance improvement over a series of preceding exercises ([0348] “there can be a VOR response score that more clearly establishes the vestibulo-ocular response measurement and expresses this response measurement in language that can more appropriately be applied to human performance measurement and improvement”).
Regarding claim 25, Krueger teaches the vestibular rehabilitation management system of claim 1, wherein the vestibular rehabilitation management system is configured to evaluate the wearer of the ear-worn device by measuring a reaction speed of the wearer of the ear-worn device ([0074] The VOR then allows for a faster reaction time even at lower frequencies.”; [0348] “A better method for evaluating the VOR response would be to measure vestibulo-ocular performance on a continuous scale, just like we measure the speed of an athlete. By doing this, one can get a subject's human performance measurement. Specifically, there can be a VOR response score that more clearly establishes the vestibulo-ocular response measurement and expresses this response measurement in language that can more appropriately be applied to human performance measurement and improvement.”).
Regarding claim 51, Krueger teaches a vestibular rehabilitation management system comprising:
an ear-worn device ([0301] “The head tracking inertial system can be mounted to the head in numerous configurations” … “in the ear or attached to the ear”) comprising
a control circuit ([0304] “The processor may receive information from and control the eye tracking system; the head mounted tracking system, the optical system, and peripherals.”);
a microphone in communication with the control circuit ([0315] “the cameras can be located in the lens, framework or eye or head worn device” … “The camera could have a microphone”); and
a motion sensor in communication with the control circuit ([0300] “Head tracking on a head-worn unit can be performed by using an inertial measurement unit (also called an IMU or ‘tracker’). An IMU is an electronic device that measures one or more DOF (such as position, velocity, orientation, and/or gravitational force, as was described previously in this disclosure) by using one or more sensors”);
wherein the ear-worn device is configured to
monitor signals from the motion sensor to detect system declared performance of an exercise ([0213] “head rotation information would typically be measured using the head orientation sensor 108”), wherein the system declared performance comprises a first number of exercise repetitions detected by the motion sensor ([0359] “The head speed can be varied and the target, which the user is focused, can be changed. The process can be repeated as often as necessary until the VOR abnormality is corrected.”; [0160-0172] “The process is repeated as many times as needed 626”);
monitor signals from the microphone to detect wearer declared performance of the exercise ([0309] “the user interface for providing information to the wearer or receiving input from the wearer. The user interface may be associated with displayed images, a touchpad, a keypad, buttons, a microphone, and/or other peripheral input devices”; [0315] “a microphone for voice commands”; [0206] “DVA (dynamic visual acuity) and FVS (foveal visual stability) can be tested”; The subject speaks out the character observed each time it changes.”), wherein the wearer declared performance comprises a second number of exercise repetitions detected by the microphone ([0315] “The camera could have a microphone for voice commands, and at least 12 GB of usable storage.”; [0359]; [0208-0210]; [0267] “operate to some extent interactively and autonomously), eye or other physical response or by voice response”); and
compare system declared performance of the exercise with wearer declared performance of the exercise by comparing the first number of exercise repetitions to the second number of exercise repetitions ([0218-0219] When the VOR or DVA are abnormal, which occurs during the early stage after unilateral vestibular loss”; [0224] “To measure specific eye responses, such as the VOR, DVA and/or DVS both eye tracking and head tracking measurements are required”; [0152-0159]; The microphone is used to test DVA response and motion sensors are used to test VOR, which involves user input from the microphone and user response to the prompt to look at a target measurement, which also requires comparing the eye movement response to the head tracking measurements determined by the head orientation sensor.; [0359] “Repetitive head movement in the abnormal plane of rotation, while the eye remains fixed on a target of interest, can provide a means for improving or enhancing the VOR or other eye responses. Specifically, if a VOR abnormality is found to exist in the horizontal plane, VOR enhancement rehabilitation therapy is given in the same plane. In this instance, the user focuses on a target of interest and the user rotates the head horizontally, while continuing to look at the target. If a VOR abnormality is found to exist in the vertical plane, VOR enhancement rehabilitation therapy is also given in the similar plane of the abnormality. In this instance, the user focuses on a target of interest and the user rotates the head vertically, while continuing to look at the target”; [0267] “The person can then provide feedback regarding what they see via an on-screen gesture, keyboard, smart device (e.g. defined as an electronic device, generally connected to other devices or networks via different wireless protocols such as Bluetooth, NFC, Wi-Fi, 3G, etc., that can operate to some extent interactively and autonomously), eye or other physical response or by voice response. The comparison of the smallest image, visual image or optotypes correctly identified or the comparison of the correct numbers of images, visual elements or optotypes in both the DVA and SVA tests can determine if the person has a defect in his or her vestibulo-ocular reflex functions.”).
Regarding claim 73, Krueger teaches the vestibular rehabilitation management system of claim 51, wherein the vestibular rehabilitation management system configured to initiate a report to a third party if the system declared performance of the exercise and the wearer declared performance of the exercise deviates by at least a threshold value ([0332] “This eye response (or reflex) output could be reported as a binary (normal or abnormal) value or it could be reported as a score on a continuous scale”; [0081]; If the user is asked to look at an object, they provide feedback by tracking the object as closely as they can, which is analyzed by the system. If the performance deviates from “normal”, it is reported as “abnormal”; [0359]).
Regarding claim 74, Krueger teaches the vestibular rehabilitation management system of claim 51, wherein the vestibular rehabilitation management system configured to initiate a calibration process if the system declared performance of the exercise and the wearer declared performance of the exercise deviates by at least a threshold value ([0157] “This process of dimming the target visual element of interest on one side and displaying it on the other side is repeated as many times as needed … The processor in the AR/VR system then compares eye movement to timing and appearance/disappearance of visual elements on display, and the location of these visual elements to determine vestibulo-ocular performance 644. Performance could be measured as accuracy, gain, phase, symmetry, velocity, saccades, and/or visual acuity.”; The calibration test repeats when the system’s detection and the user’s performance differ from the target until the performance meets accuracy measurements.).
Regarding claim 75, Krueger teaches the vestibular rehabilitation management system of claim 1, wherein the vestibular rehabilitation management system is further configured to receive information regarding an environment of the wearer of the ear-worn device from an accessory device, wherein the information regarding the environment of the wearer comprises information regarding obstacles in the environment of the wearer of the ear-worn device ([0297] “The projectors may be at least partly transparent, so that the wearer can see external objects”; “The lenses may be configured to correct the focus and/or brightness of the external objects for the comfort and vision needs of the wearer.”).
Regarding claim 76, Kruger teaches the vestibular rehabilitation management system of claim 1, wherein the ear-worn device is configured to automatically filter out motion data corresponding to head movements associated with looking downward at the accessory device during exercise ([0227] “The video images obtained by the infrared camera regarding the position of the eye of the wearer may help determine where the wearer may be looking within a field of view of the head mounted display used in the system.”; [0308] “Calibrated wearer eye pupil positions may include, for instance, information regarding extents or range of an eye pupil movement (right/left and upwards/downwards), and relative position of eyes of the wearer with respect to the HMD.”; [0140]).
Regarding claim 77, Krueger teaches the vestibular rehabilitation management system of claim 74, wherein the vestibular rehabilitation management system configured to initiate a calibration process if the first number of exercise repetitions and the second number of exercise repetitions deviates by at least a threshold number ([0249]; [0267] “The person can then provide feedback regarding what they see via an on-screen gesture, keyboard, smart device (e.g. defined as an electronic device, generally connected to other devices or networks via different wireless protocols such as Bluetooth, NFC, Wi-Fi, 3G, etc., that can operate to some extent interactively and autonomously), eye or other physical response or by voice response. The comparison of the smallest image, visual image or optotypes correctly identified or the comparison of the correct numbers of images, visual elements or optotypes in both the DVA and SVA tests can determine if the person has a defect in his or her vestibulo-ocular reflex functions.”; [0278] “Target or visual element fixation and image gaze data may be used within a gaze-based user interface enabled by an interaction model used with augmented reality or virtual reality. Such a user interface may also be multimodal incorporating head movement, hand movement, voice, and other physical or measurable brain-generated signals.”; [0301] “reducing the lag”)
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 2, 8, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over US 20160262608 A1 (Krueger, Wesley W.O.) in view of US 20200245920 A1 (Kuusik et al.).
Regarding claim 2, Krueger teaches the vestibular rehabilitation management system of claim 1.
Krueger does not teach wherein the vestibular training exercise selection includes selection of a dominant leg.
However,
Kuusik teaches wherein the vestibular training exercise selection includes selection of a dominant leg ([0028] “User raises hip as quickly and as high as possible predefined amount of times, e.g., three to ten times. User ends test in step 205. User repeats the exercise with the second leg and terminates the test with step 205.”; Fig 6B depicts the differences between the left and right legs, which can show which leg has greater range and speed of motion [0036]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the system taught by Krueger to include selection of a dominant leg. Krueger describes that the vestibular system controls people’s ability to walk ([0070]). One would have been motivated to make this modification because assessing the abilities of user’s legs allows for detection of limb range of motion and body stability, as suggested by Kuusik ([0035]).
Regarding claim 8, Krueger teaches the vestibular rehabilitation management system of claim 7.
Krueger does not explicitly teach wherein movement is analyzed to detect at least one of swaying, stumbles, balance recovery, falls, and near-falls.
However,
Kuusik teaches wherein movement is analyzed to detect at least one of swaying, stumbles, balance recovery, falls, and near-falls ([0002] “Wearable motion sensors are also used for single purpose assessment the risk of falls in older adults”); [0016] “postural sway signal”; [0033]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the system taught by Krueger to include detecting swaying. Krueger describes that the vestibular system controls people’s ability to walk ([0070]). One would have been motivated to make this modification because postural sway tests are known tests to assess the physical abilities of people’s balance and detecting falls using wearable sensors can monitor elderly or disabled people, as suggested by Kuusik ([0003]).
Regarding claim 24, Kruger teaches the vestibular rehabilitation management system of claim 1.
Krueger does not teach wherein the vestibular rehabilitation management system is configured to evaluate the wearer of the ear-worn device by evaluating maximum lean before imbalance occurs.
However,
Kuusik teaches wherein the vestibular rehabilitation management system is configured to evaluate the wearer of the ear-worn device by evaluating maximum lean before imbalance occurs ([0033] “Postural sway measure as a maximum displacement of upper body, average swing or any other similar parameter is calculated in step 411.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the system taught by Krueger to include evaluating maximum lean before imbalance. Krueger describes that the vestibular system controls people’s ability to walk ([0070]). One would have been motivated to make this modification because postural sway tests are known tests to assess the physical abilities of people’s balance, as suggested by Kuusik ([0003]).
Claims 27-29 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over US 20160262608 A1 (Krueger, Wesley W.O.) in view of US 20190232113 A1 (Zets et al.).
Regarding claim 27, Krueger teaches the vestibular rehabilitation management system of claim 1.
Kruger does not explicitly teach wherein the vestibular rehabilitation management system is configured to evaluate the wearer of the ear-worn device by evaluating imbalance recovery speed.
However,
Zets teaches wherein the vestibular rehabilitation management system is configured to evaluate the wearer of the ear-worn device by evaluating imbalance recovery speed ([0064] “the hip strategy involves activation of the larger hip muscles and is used when the center of gravity must be moved more quickly back over the base of support as the speed or distance of sway increases”; [0083] “combinations of similar feedback cues presented in different sensory modes results in improved task reaction time and accuracy”; [0125] “During assessment, the time to respond and the number of correctly identified targets would be used as a basis for a functional visual acuity test”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the system taught by Krueger to include evaluating imbalance recovery speed. One would have been motivated to make this modification because exercising can accelerate the recovery of balance after a peripheral vestibular lesion and subject response to motion and visual exercises may be affected by vestibular deficit, as suggested by Zets [0018], [0123].
Regarding claim 28, Krueger teaches the vestibular rehabilitation management system of claim 27.
Krueger does not explicitly teach wherein evaluating imbalance recovery speed includes measuring a degree of head or body sway after imbalance.
However,
Zets teaches wherein evaluating imbalance recovery speed includes measuring a degree of head or body sway after imbalance ([0063] “it is generally known that for subjects with vestibular deficit, moving their head during postural tasks greatly increases the difficulty of the motional task.”; “trunk sway data for the subject can be readily calculated”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the system taught by Krueger to include evaluating imbalance recovery speed by measuring head or body sway. One would have been motivated to make this modification because sways and head movement perturbations are symptoms of vestibular ocular reflex issues, which can be evaluted via VOR exercises, as suggested by Zets [0045].
Regarding claim 29, Krueger teaches the vestibular rehabilitation management system of claim 27, wherein evaluating imbalance recovery speed includes measuring foot impact magnitude after imbalance.
Krueger does not teach wherein evaluating imbalance recovery speed includes measuring foot impact magnitude after imbalance.
However,
Zets teaches wherein evaluating imbalance recovery speed includes measuring foot impact magnitude after imbalance ([0053] “The force plates 11a and 11b provide a technique for measuring body sway in terms of displacement of the center of foot pressure (COP)”; [0101] “movement of the biomechanical state measure sample point 163 can be caused when the subject sways, and movement by foot or other significant movement is not required).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the system taught by Krueger to include measuring foot impact magnitude. One would have been motivated to make this modification because the body’s posture is controlled by pressure in the foot soles, as suggested by Zets [0005].
Regarding claim 31, Krueger teaches the vestibular rehabilitation management system of claim 1.
Kruger does not teach wherein the vestibular rehabilitation management system is configured to evaluate the wearer of the ear-worn device by initiating imbalance and then evaluating imbalance recovery.
However,
Zets teaches wherein the vestibular rehabilitation management system is configured to evaluate the wearer of the ear-worn device by initiating imbalance and then evaluating imbalance recovery ([0043] “that the rehabilitation exercises should preferably be progressive in difficulty; by pushing the subject's head movement rate to a level just slower than when the target falls off visual focus. Further, it is known that rehabilitation exercises should preferably be diverse; for example, adaptation of the VOR can be complicated by moving the target in the opposite direction of the head movement. Therefore, preferable rehabilitation exercises may also include activities such as arm and head movements that are intentionally in opposite directions, thereby forcing a doubling of the VOR gain needed for the eyes to stay on target”; [0113]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the system taught by Krueger to include initiating imbalance and then evaluating imbalance recovery. One would have been motivated to make this modification because unbalancing the patient by moving their head during postural tasks is more difficult for subjects with vestibular deficit, evaluating response to the movements can be used in vestibular therapy or as part of an assessment, as suggested by Zets [0113-0114].
Response to Arguments
Applicant's arguments filed January 15, 2026 have been fully considered but they are not persuasive. With respect to the 101 Rejections in the Non-Final Office Action (See Pages 7-9 of Applicant’s Response “Rejections under 35 U.S.C. §101”), Applicant argues that the ear-worn device and the accessory device are configured to perform particular functions and, therefore, claim 1 is directed to a particular machine. Applicant also argues that the ear-worn device having a microphone and motion sensor are configured to perform particular functions and, therefore, claim 51 is directed to a particular machine. Additionally, Applicant argues that the claimed system is configured to overcome the challenges with selecting an appropriate vestibular training exercise, and are therefore not an abstract idea.
MPEP § 2111 discusses proper claim interpretation, including giving claims their broadest reasonable interpretation in light of the specification during examination. Under broadest reasonable interpretation (BRI), the words of a claim must be given their plain meaning unless such meaning is inconsistent with the specification, and it is improper to import claim limitations from the specification into the claim. The requirements for anticipation are discussed in MPEP § 2131. MPEP § 2131 notes that “To reject a claim as anticipated by a reference, the disclosure must teach every element required by the claim under its broadest reasonable interpretation.”
Under BRI, the ear-worn device and accessory device are merely generic sensors used to acquire data. The 101 rejection above describes that these sensors are routine, well-understood, and conventional in the art and are therefore not directed toward a particular machine. As written, the limitations of claim 1 to “store”, “evaluate”, and “select” are merely collecting data from conventional sensors and outputting a vestibular training exercise, which would be performed in the human mind given the data from the conventional sensors and devices. As written, the limitations of claim 51 to “monitor” and “compare” could be performed by the human mind given the data from the conventional sensors. As written, the claims do not include structural limitations for the ear-worn device and accessory device to be considered particular machines, as they are conventional as evidenced by Ahmed above.
With respect to the 102 Rejections in the Non-Final Office Action (See Pages 9-12 of Applicant’s Response “Rejections under 35 U.S.C. §102”), Applicant argues that Krueger does not teach wherein each vestibular training exercise comprises an associated difficulty index value” as required by claim 1. Applicant also argues that Krueger does not explicitly describe a system that both measures VOR performance and recommends a particular therapy based on the measured VOR performance, as Krueger suggests that a human advisor should interpret the VOR score data and recommend exercises to the user. Applicant argues that Krueger does not compare system declared performance of the exercise with wearer declared performance of the exercise” as required by claim 51.
With respect to the 103 Rejections in the Non-Final Office Action (See Page 13 of Applicant’s Response “Rejections under 35 U.S.C. §102”), Applicant describes that Kuusik and Zets do not cure the deficiencies of Krueger.
There are new grounds of claim rejections that were necessitated by the claim amendments.
With respect to claim 1, the “associated difficulty index value” is not defined by the claim, and therefore, can be interpreted to be any representation of a level of difficulty of the exercises. Krueger teaches different types of testing in [0220] and describes that these tests can have different characteristics [0267]. These characteristics may cause difference responses from the user, meaning that they have different levels of difficulty. For example, the target speed of the test can be altered, as described in [0042] and [0140], and affect the ability of the user to follow or identify the target, which reads on the claim language of the difficulty index value of claim 1.
Additionally, under BRI, the “comprising” language of claim 1 is open-ended, meaning that the system must include all the limitations of the claim under BRI, but may also include additional elements. As written, the “select[ing]” step of claim 1 is “based on the evaluation and the associated difficulty index value”. Krueger discloses that “The system can include improvement information that can be used by the user, a coach, a medical practitioner, or any other advisor to help interpret the scoring and provide advice and/or exercises to improve ocular reflex” [0359], which reads on the claim language under BRI, as the selection is able to be aided by a human advisor. As written, there is nothing in the claim that precludes human involvement in the selection process.
With respect to claim 51, the comparison of the system declared performance with the wearer declared performance under BRI is taught by Krueger [0267]. Krueger describes that the wearer can provide voice feedback in response to the test, and the system will compare the correct numbers of images [0267]. The wearer declared performance is the wearer’s voice response to the repeated images shown in the test, and the system declared performance is the system’s scoring of the correctly identified images, which reads on the claim language of claim 51 as written under BRI.
Claims 2-4, 7-8, 10, 13-14, 16, 18, 23, 25, 27, and 73-77 are rejected because the rejection of claims 1 and 51 are proper and the prior art teaches or suggests all the features of these claims for the reasons described in the 102 and 103 Rejections.
Conclusion
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/EVELYN GRACE PARK/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791