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 April 13, 2026 and June 6, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Response to Amendment
The amendment filed June 9, 2026 has been entered. Claims 1-4, 7-8, 10, 13-14, 16, 18, 25, 27, 51, and 73-78 remain pending in the application, with claims 78 being newly added. Applicant’s amendments to the claims have overcome each and every 101, 102, and 103 rejection previously set forth in the Non-Final Office Action mailed March 12, 2026. Applicant’s amendments to the claims necessitate new grounds of rejection, as described in the Response to Arguments and 112 and 103 Rejections below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 7-8, 10, 13-14, 16, 18, 25, 27, and 78 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1, as amended, recites “wherein the selection is performed algorithmically by the vestibular rehabilitation management system” in lines 14-15. The specification does not describe an algorithm used to select a vestibular training exercise. Applicant describes that support for the amendment is recited in [0130] and [0165], however neither paragraph describes the algorithmic selection of a vestibular training exercise.
Claim 78 recites “the vestibular training exercise selection is made only by the ear-worn device and/or the accessory device” in lines 1-3. The specification does not describe that the selection is performed only by the ear-worn device and/or the accessory device. Applicant describes that support for the amendment is recited in [0130] and [0165], however neither paragraph describes using only the ear-worn device and/or the accessory device. Page 45 lines 30-32 of the specification describes an example where “the wearer can be instructed to perform a particular exercise (with or without supervision of a care provider) and the system can record all movement with motion sensors”, however this only specifies that wear may be instructed without a care provider, not that the selection is performed only by the ear-worn device and/or the accessory device.
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, 13-14, 16, 18, 25, 27, 51, and 73-78 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, 13-14, 16, 18, 25, 27, 51, and 73-78 are directed to a system for evaluating a wearer using a computational algorithm, which is an abstract idea. Claims 1-4, 7-8, 10, 13-14, 16, 18, 25, 27, 51, and 73-78 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”;
[F2] – “evaluate a wearer of the ear-worn device using the motion sensor”;
[G2] – “automatically select, by the control circuit … wherein the selection is performed algorithmically by the vestibular rehabilitation management system”.
The elements [A2-G2] of claim 1 do not integrate the exception into a practical application of the exception. In particular, the elements [A2] and [G2] are 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 “automatically select, by the control circuit” and “performed algorithmically” 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, 13-14, 16, 18, 25, 27, 75-76, and 78 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, 25, 27, 75-76, and 78, and a generic “accessory device” in claims 75-76 and 78.
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 51 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 counting a first number of exercise repetitions of the exercise 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 of the exercise 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 § 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, 3-4, 7, 10, 13-14, 16, 18, 25, 75-76, and 78 are rejected under 35 U.S.C. 103 as being unpatentable over US 20160262608 A1 (Krueger, Wesley W.O.) in view of US 20160113551 A1 (Annegarn et al.).
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 ([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 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]).
Krueger does not explicitly teach wherein each vestibular training exercise comprises an associated difficulty index value in a memory of the ear-worn device or the accessory device
automatically select, by the control circuit, a vestibular training exercise from the plurality of vestibular training exercises based on the evaluation and the associated difficult index value, wherein the selection is performed algorithmically by the vestibular rehabilitation management system.
However,
Annegarn teaches wherein each vestibular training exercise comprises an associated difficulty index value in a memory of the ear-worn device or the accessory device ([0093] “each of these movements or exercises can be performed by the user with different levels of difficulty to provide a better indication of the fall risk of the user. These movements and exercises are also typically included as part of a fall prevention exercise program to help the user reduce their risk of falling over time.”; [0104] “the instructions/exercise can be adapted so that the user performs a more difficult version of the exercise next time.”).
automatically select, by the control circuit, a vestibular training exercise from the plurality of vestibular training exercises based on the evaluation and the associated difficult index value, wherein the selection is performed algorithmically by the vestibular rehabilitation management system ([0083]; [0104] “the user device 4 (or optionally a base unit or another electronic device if they are part of the system) provides instructions to the user to assist them in performing the movements or exercises required for the fall risk assessment, it is possible for the movements or exercises to be adapted based on the previous performance of those tests by the user”).
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 an associated difficulty index value with each vestibular training exercise, and automatically and algorithmically selecting a vestibular training exercise. One would have been motivated to make this modification because assessment without assistance from a care provider is desirable and utilizing different levels of exercise difficulty provides a better indication of balance and reduces risk of falling over time, as suggested by Annegarn [0008, 0093, 0104].
Regarding claim 3, Krueger teaches the vestibular rehabilitation management system of claim 1.
Krueger does not explicitly teach wherein the vestibular training exercise selection includes selection of a vestibular training exercise difficulty.
However,
Annegarn teaches wherein the vestibular training exercise selection includes selection of a vestibular training exercise difficulty ([0093] “each of these movements or exercises can be performed by the user with different levels of difficulty to provide a better indication of the fall risk of the user. These movements and exercises are also typically included as part of a fall prevention exercise program to help the user reduce their risk of falling over time.”; [0104]).
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 selecting a vestibular training exercise difficulty. One would have been motivated to make this modification because the instructions/exercise can be adapted to be more or less difficult based on previous performance, as suggested by Annegarn [0104].
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 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 78, Krueger teaches the vestibular rehabilitation management system of claim 1.
Krueger does not explicitly teach wherein the vestibular training exercise selection is made only by the ear-worn device and/or the accessory device.
However,
Annegarn teaches wherein the vestibular training exercise selection is made only by the ear-worn device and/or the accessory device ([0008] “it is desirable to be able to obtain an objective measurement of a user's fall risk while they are in their home environment without assistance from or visiting a care provider or healthcare professional”; [0022] “the processing unit being configured to provide instructions to the user via the display for one or more exercises and/or movements for the user to perform while the processing unit is operating in the data collection mode.”; [0083] “the user interface 16 can present information indicating the specific movement(s) and/or exercise(s) that the user should perform, and/or provide instructions to the user on how to perform the movement or exercise.”).
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 only using a device to select a vestibular training exercise. One would have been motivated to make this modification because assessment without assistance from a care provider is desirable and allows for in-home fall detection and exercise, as suggested by Annegarn [0008, 0083].
Claims 2 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over US 20160262608 A1 (Krueger, Wesley W.O.) in view of US 20160113551 A1 (Annegarn et al.), further 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]).
Claims 27 is rejected under 35 U.S.C. 103 as being unpatentable over US 20160262608 A1 (Krueger, Wesley W.O.) in view of US 20160113551 A1 (Annegarn et al.), further in view of US 20190232113 A1 (Zets et al.).
Regarding claim 27, Krueger in view of Annegarn teaches the vestibular rehabilitation management system of claim 1.
Krugerin view of 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].
Claims 51, 73-74, and 77 are rejected under 35 U.S.C. 103 as being unpatentable over US 20160262608 A1 (Krueger, Wesley W.O.) in view of US 20140333543 A1 (Yanev et al.).
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 counting a first number of exercise repetitions of the exercise 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”); 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.”).
Krueger does not explicitly teach monitor signals from the microphone to detect wearer declared performance of the exercise, wherein the wearer declared performance comprises counting a second number of exercise repetitions of the exercise detected by the microphone.
However,
Yanev teaches monitor signals from the microphone to detect wearer declared performance of the exercise, wherein the wearer declared performance comprises counting a second number of exercise repetitions of the exercise detected by the microphone ([0079] “The microphone may be configured to receive sound from a user and generate an output signal that represents the received sound. The received sound may include, for example, a verbal repetition count associated with an exercise performed by the user, verbal control inputs from the user, and/or other sound.”).
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 a wear declared performance comprising counting exercise repetitions with a microphone. One would have been motivated to make this modification because the microphone can record repetition count of an exercise in combination with a pedometer motion sensor in which the system determines a number of steps taken in an exercise to output exercise and biometric data to a user, as suggested by Yanev [0072-0073, 0078-0079].
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 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”).
Response to Arguments
Applicant's arguments filed June 9, 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 U.S.C. § 101”), Applicant argues that the ear-wearable device and accessory device are configured to perform particular function, and therefore claim 1 is directed to a particular machine. Applicant also argues that claim 51 requires an ear-worn device configured to perform particular functions, and therefore claim 51 is directed to a particular machine. Applicant states that the claims are tied to a practical application and not an abstract idea, and are therefore patentable subject matter under prong 1/II of Step 2A.
Regarding the 101 rejection of claims 1 and 51, the structure of the ear worn device and accessory device are generic as described above by Ahmed, and therefore are not a particular machine. The process performed by the system in claim 1 is done so “algorithmically”, however, this algorithm is not specified, and is therefore interpreted to be a mental process under BRI. Additionally, the automatic selection recited in the amended claim 1 is merely an extra-solution activity of generic computer function and output. There is nothing in claim 1 that prevents the claim from being performed in the human mind, but for the recitation of generic computer components and extra-solution activities. Similarly, the process performed by the system of claim 51 involves counting exercise repetitions and comparing the system-declared performance we the wearer-declared performance. This comparison is able to be performed by the human mind, as it is merely comparing the results and does not specify how the comparison contributes to a practical application in a way that could not be performed by a mental process.
With respect to the 102/103 Rejections in the Non-Final Office Action (See Pages 9-13 of Applicant’s Response “Rejections under U.S.C. § 102” and “Rejections under U.S.C. § 103”), Applicant argues that Krueger does not teach wherein each vestibular training exercise comprises an associated difficulty index value, as required by claim 1, or automatically selecting a vestibular training exercise, and Kuusik and Zets fail to cure the deficiencies of Krueger. Applicant also states that Krueger does not teach the amended limitations of claim 51.
There are new grounds of claim rejections that were necessitated by the claim amendments. Claim 1 is rejected as being unpatentable over Krueger in view of Annegarn as described in the 103 rejection above. Claim 51 is rejected as being unpatentable over Krueger in view of Yanev as described in the 103 rejection above.
Claims 2-4, 7-8, 10, 13-14, 16, 18, 25, 27, and 73-78 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 103 Rejections.
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 EVELYN GRACE PARK whose telephone number is (571)272-0651. The examiner can normally be reached Monday - Friday, 9AM - 5:00PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571)272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patenxt-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EVELYN GRACE PARK/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights