DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendment filed October 21, 2025 has been entered. Claims 1, 4, 6, 8, 10-11, 16-17, 19, 22-23, 25, 27, 39-41 and 57-59 remain pending in the application.
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 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, 4, 6, 8, 16-17, 22, 25, 27, 39-41 and 57-60 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gran et al. (US 2016/0373869 A1) (“Gran”).
Regarding claim 1, Gran discloses An ear-worn device (Abstract and entire document “hearing aid”, see also at least FIG. 2-3 showing the ear-worn device), comprising:
a control circuit (FIG. 2 and [0160], “signal processor 18” see also [0111 – 0115] defining the processors as control circuitry and either hardware or software);
a clock circuit in electrical communication with the control circuit (FIG. 2 and [0160], “signal processor 18” see also [0111 – 0115] defining the processors as control circuitry and either hardware or software. It is understood that processors inherently disclose clock circuits as is well known within the art);
a motion sensor in electrical communication with the control circuit (FIG. 4 and [0175], “The performance detector 40 is also connected to one or more orientation sensors 44, such as gyroscopes, e.g. MEMS gyros, tilt sensors, roll ball switches, etc., configured for outputting signals for determination of orientation of the head of a user wearing the hearing aid, e.g. one or more of head yaw, head pitch, head roll, or combinations hereof, e.g. tilt, i.e. the angular deviation from the heads normal vertical position, when the user is standing up or sitting down.” As shown in FIG. 4, the motion sensor 44 is connected with the circuitry);
an electroacoustic transducer for generating sound in electrical communication with the control circuit ([0116], “a hearing aid with a microphone for provision of an audio signal in response to sound signals received at the microphone from a sound environment, a processor that is configured to process the audio signal in accordance with a signal processing algorithm F.sub.n(Θ.sub.n), where Θ.sub.n is a set of signal processing parameters of the signal processing algorithm F.sub.n, to generate a hearing loss compensated audio signal, an output transducer for providing an output signal to a user of the each of the hearing aid systems based on the hearing loss compensated audio signal,” it is interpreted that the output transducer is the electroacoustic transducer); and
a power supply circuit in electrical communication with the control circuit (FIG. 2 and [0163], “The BTE hearing aid 12 is powered by battery 28.” It is interpreted that battery 28 is a power supply circuit in communication with the other components including the control circuit/processors/other circuitry.);
wherein the ear-worn device is configured to initiate generation of a stimulus sufficient to generate a response from the ear-worn device wearer ([0116], “a hearing aid with a microphone for provision of an audio signal in response to sound signals received at the microphone from a sound environment, a processor that is configured to process the audio signal in accordance with a signal processing algorithm F.sub.n(Θ.sub.n), where Θ.sub.n is a set of signal processing parameters of the signal processing algorithm F.sub.n, to generate a hearing loss compensated audio signal, an output transducer for providing an output signal to a user of the each of the hearing aid systems based on the hearing loss compensated audio signal,” a sound signal, such as speech from others, is detected in the environment by the microphone and the sound data is processed and the output transducer then provides the processed sound as the stimulus, as the sound is detected and enhanced it is understood that the stimulus is sufficient to generate a response. See also [0176 – 0178]); and
wherein the ear-worn device is configured to monitor for a qualified response to the stimulus, ([0044 – 0045], and [0176 – 0178], “The performance detector comprises a direction of arrival detector configured for determination of the direction of arrival of sound at the hearing aid 12. The performance detector is configured for comparison of the determined direction of arrival of the sound and the time from arrival of speech until the user changes his or her looking direction towards the determined direction of arrival of the speech as indicated by the orientation sensors 44. It is interpreted that the sound in the environment is detected as a stimulus sufficient to generate a response and the device monitors the looking direction of the user which is the qualified response.); and
measure an amount of time between the stimulus and the qualified response ([0178], “The performance detector is configured for comparison of the determined direction of arrival of the sound and the time from arrival of speech until the user changes his or her looking direction towards the determined direction of arrival of the speech as indicated by the orientation sensors 44. The performance detector 40 is configured for transmission of data relating to determined user reaction times or absence of user reaction in response to reception of speech to the at least one server,” reaction time of the qualified response (turning head) to listen to the detected sound.).
Regarding claim 4, Gran discloses The ear-worn device of claim 1, the stimulus comprising an auditory stimulus ([0116], “an output transducer for providing an output signal to a user of the each of the hearing aid systems based on the hearing loss compensated audio signal,” the output transducer provides the processed sound as the stimulus, See also [0176 – 0178], wherein the speech is interpreted as the stimulus and speech is an auditory stimulus).
Regarding claim 6, Gran discloses The ear-worn device of claim 1, the stimulus comprising audible words ([0116], “an output transducer for providing an output signal to a user of the each of the hearing aid systems based on the hearing loss compensated audio signal,” the output transducer provides the processed sound as the stimulus, See also [0176 – 0178], wherein the speech is interpreted as the stimulus and speech comprises audible words).
Regarding claim 8, Gran discloses The ear-worn device of claim 6, wherein the audible words are time-compressed ([0116], “an output transducer for providing an output signal to a user of the each of the hearing aid systems based on the hearing loss compensated audio signal,” the output transducer provides the processed sound as the stimulus, See also [0176 – 0178], wherein the speech is interpreted as the stimulus and speech comprises audible words as a compensated audio signal, see also [0180], “The signal processing algorithms of the processor 18 may perform various forms of noise reduction and dynamic range compression as well as a range of other signal processing tasks.” The output audio signal is optimized for the wearer. See further, [0006], “here, the higher performing subjects benefit from syllabic compression whereas the lower performing patients benefit more from longer time constants in the compression.” The device outputs time compressed audio signals. See further [0183], “Examples of signal processing parameters include: Amount of noise reduction, amount of gain and amount of HF gain, algorithm control parameters controlling whether corresponding signal algorithms are selected for execution or not, corner-frequencies and slopes of filters, compression thresholds and ratios of compressor algorithms, filter coefficients, including adaptive filter coefficients, adaptation rates and probe signal characteristics of adaptive feedback cancellation algorithms, etc.” the output audio signals, speech, audible words, are optimized using compression algorithms including time compression).
Regarding claim 16, Gran discloses The ear-worn device of claim 1, wherein the ear-worn device is configured to monitor for the qualified response using the motion sensor ([0178], “The performance detector is configured for comparison of the determined direction of arrival of the sound and the time from arrival of speech until the user changes his or her looking direction towards the determined direction of arrival of the speech as indicated by the orientation sensors 44. The performance detector 40 is configured for transmission of data relating to determined user reaction times or absence of user reaction in response to reception of speech to the at least one server,” motion sensors 44 detect the qualified response).
Regarding claim 17, Gran discloses The ear-worn device of claim 16, wherein the qualified response comprises a reaction motion ([0178], “The performance detector is configured for comparison of the determined direction of arrival of the sound and the time from arrival of speech until the user changes his or her looking direction towards the determined direction of arrival of the speech as indicated by the orientation sensors 44. The performance detector 40 is configured for transmission of data relating to determined user reaction times or absence of user reaction in response to reception of speech to the at least one server,” It is interpreted that turning the head to listen is a reaction motion).
Regarding claim 22, Gran discloses The ear-worn device of claim 16, wherein the ear-worn device is configured to evaluate the measured amount of time between the stimulus and the qualified response longitudinally and determine longitudinal trends ([0043], “The performance detector may relate a current user response to speech to a statistical model based on previous performance of the user and other users for determination of the user's performance.” See also [0066] and [0176 – [0178] discussing reaction time as the parameter measured by the performance detector for the trend).
Regarding claim 25, Gran discloses The ear-worn device of claim 16, wherein the ear-worn device is configured to compare the amount of time between the stimulus and the qualified response for the ear-worn device wearer to an average amount of time between stimuli and a plurality of qualified responses for a population of ear-worn device wearers ([0149], “In the illustrated in situ fitting system 100, at least one of the servers 110 has access to a statistical performance model (not shown) based on determined listening performance of a plurality of users of the plurality of hearing aid systems, and the at least one server 110 is configured for determination of a signal processing parameter value of a hearing aid 12A, 12B based on the determined listening performance of the user of the hearing aid system 10 and the performance model.” and [0176 – [0178] discussing reaction time as the parameter measured by the performance detector for the trend).
Regarding claim 27, Gran discloses A method of measuring a response time of a hearing device wearer (Abstract and entire document “hearing aid”, see also at least FIG. 2-3 showing the ear-worn device and see [0178] discussing response time), comprising:
initiating the provision of a stimulus to the hearing device wearer with a hearing device ([0116], “a hearing aid with a microphone for provision of an audio signal in response to sound signals received at the microphone from a sound environment, a processor that is configured to process the audio signal in accordance with a signal processing algorithm F.sub.n(Θ.sub.n), where Θ.sub.n is a set of signal processing parameters of the signal processing algorithm F.sub.n, to generate a hearing loss compensated audio signal, an output transducer for providing an output signal to a user of the each of the hearing aid systems based on the hearing loss compensated audio signal,” a sound signal, such as speech from others, is detected in the environment by the microphone and the sound data is processed and the output transducer then provides the processed sound as the stimulus, as the sound is detected and enhanced it is understood that the stimulus is sufficient to generate a response. See also [0176 – 0178]),
the hearing device comprising: a control circuit (FIG. 2 and [0160], “signal processor 18” see also [0111 – 0115] defining the processors as control circuitry and either hardware or software);
a clock circuit in electrical communication with the control circuit (FIG. 2 and [0160], “signal processor 18” see also [0111 – 0115] defining the processors as control circuitry and either hardware or software. It is understood that processors inherently disclose clock circuits as is well known within the art);
an electroacoustic transducer for generating sound in electrical communication with the control circuit ([0116], “a hearing aid with a microphone for provision of an audio signal in response to sound signals received at the microphone from a sound environment, a processor that is configured to process the audio signal in accordance with a signal processing algorithm F.sub.n(Θ.sub.n), where Θ.sub.n is a set of signal processing parameters of the signal processing algorithm F.sub.n, to generate a hearing loss compensated audio signal, an output transducer for providing an output signal to a user of the each of the hearing aid systems based on the hearing loss compensated audio signal,” it is interpreted that the output transducer is the electroacoustic transducer); and
a power supply circuit in electrical communication with the control circuit (FIG. 2 and [0163], “The BTE hearing aid 12 is powered by battery 28.” It is interpreted that battery 28 is a power supply circuit in communication with the other components including the control circuit/processors/other circuitry.); and
monitoring for a qualified response to the stimulus using at least one of a motion sensor and a microphone, the qualified response comprising a non-reflexive reaction to the stimulus ([0044 – 0045], and [0176 – 0178], “The performance detector comprises a direction of arrival detector configured for determination of the direction of arrival of sound at the hearing aid 12. The performance detector is configured for comparison of the determined direction of arrival of the sound and the time from arrival of speech until the user changes his or her looking direction towards the determined direction of arrival of the speech as indicated by the orientation sensors 44.” It is interpreted that the sound in the environment is detected as a stimulus sufficient to generate a response and the device monitors the looking direction of the user which is the qualified response and is interpreted as non-reflexive. FIG. 4 and [0175], “The performance detector 40 is also connected to one or more orientation sensors 44, such as gyroscopes, e.g. MEMS gyros, tilt sensors, roll ball switches, etc., configured for outputting signals for determination of orientation of the head of a user wearing the hearing aid, e.g. one or more of head yaw, head pitch, head roll, or combinations hereof, e.g. tilt, i.e. the angular deviation from the heads normal vertical position, when the user is standing up or sitting down.” As shown in FIG. 4, the motion sensor 44 is connected with the circuitry).
Regarding claim 39, Gran discloses The method of claim 27, further comprising changing at least one of a hearing device configuration or a signal processing setting ([0178], “The performance detector 40 is configured for transmission of data relating to determined user reaction times or absence of user reaction in response to reception of speech to the at least one server, and the at least one server determines one or more signal processing parameters for improved listening performance of the user based on the received data and the performance model, whereby obtained listening performance of other users of hearing aid systems possibly with hearing losses similar to the hearing loss of the user in question is included in the determination of signal processing parameters of the hearing aid of the user in question. The at least one server may for example increase a gain value at a frequency of the received speech so that the time used for responding to speech from another direction than the looking direction is decreased. The at least one server may also adjust complex gain values, e.g. in order to perform filtering.” See also [0179 – 0183]. The hearing device adjusts the signal processing algorithms); and
monitoring for a second qualified response to the stimulus; and using a second response time to determine if the change benefits the device wearer, wherein a decrease in the second response time over a previously measured response time is indicative of a benefit to the device wearer ([0178], “The performance detector 40 is configured for transmission of data relating to determined user reaction times or absence of user reaction in response to reception of speech to the at least one server, and the at least one server determines one or more signal processing parameters for improved listening performance of the user based on the received data and the performance model, whereby obtained listening performance of other users of hearing aid systems possibly with hearing losses similar to the hearing loss of the user in question is included in the determination of signal processing parameters of the hearing aid of the user in question. The at least one server may for example increase a gain value at a frequency of the received speech so that the time used for responding to speech from another direction than the looking direction is decreased. The at least one server may also adjust complex gain values, e.g. in order to perform filtering.” See also [0068], “The at least one server may be configured for updating the performance model based on received performance determinations. The performance determinations may be performed frequently during use, e.g. once every hour, e.g. once every 10 minutes, e.g. once every 5 minutes, e.g. once every 2 minutes, e.g. once every minute.” The performance of the device wearer is measured frequently and the device can adjust the signal processing parameters. It is generally understood that a decreased reaction time is beneficial, see [0178], “The at least one server may for example increase a gain value at a frequency of the received speech so that the time used for responding to speech from another direction than the looking direction is decreased.”).
Regarding claim 40, Gran discloses The method of claim 27, further comprising measuring the response time at a plurality of time points following at least one event; determining whether the at least one event has caused an improvement, a decline, or no change to the device wearer, wherein a longitudinal decrease in the measured response time is indicative of the improvement ([0178], “The performance detector 40 is configured for transmission of data relating to determined user reaction times or absence of user reaction in response to reception of speech to the at least one server, and the at least one server determines one or more signal processing parameters for improved listening performance of the user based on the received data and the performance model, whereby obtained listening performance of other users of hearing aid systems possibly with hearing losses similar to the hearing loss of the user in question is included in the determination of signal processing parameters of the hearing aid of the user in question. The at least one server may for example increase a gain value at a frequency of the received speech so that the time used for responding to speech from another direction than the looking direction is decreased. The at least one server may also adjust complex gain values, e.g. in order to perform filtering.” See also [0068], “The at least one server may be configured for updating the performance model based on received performance determinations. The performance determinations may be performed frequently during use, e.g. once every hour, e.g. once every 10 minutes, e.g. once every 5 minutes, e.g. once every 2 minutes, e.g. once every minute.” The performance of the device wearer is measured frequently and the device can adjust the signal processing parameters. The event can be interpreted as the first change to the parameters and then monitors every minute for example to check reaction time again. It is generally understood that a decreased reaction time is beneficial, see [0178], “The at least one server may for example increase a gain value at a frequency of the received speech so that the time used for responding to speech from another direction than the looking direction is decreased.”).
Regarding claim 41, Gran discloses An ear-worn device (Abstract and entire document “hearing aid”, see also at least FIG. 2-3 showing the ear-worn device), comprising:
a control circuit (FIG. 2 and [0160], “signal processor 18” see also [0111 – 0115] defining the processors as control circuitry and either hardware or software);
a clock circuit in electrical communication with the control circuit (FIG. 2 and [0160], “signal processor 18” see also [0111 – 0115] defining the processors as control circuitry and either hardware or software. It is understood that processors inherently disclose clock circuits as is well known within the art);
an electroacoustic transducer for generating sound in electrical communication with the control circuit ([0116], “a hearing aid with a microphone for provision of an audio signal in response to sound signals received at the microphone from a sound environment, a processor that is configured to process the audio signal in accordance with a signal processing algorithm F.sub.n(Θ.sub.n), where Θ.sub.n is a set of signal processing parameters of the signal processing algorithm F.sub.n, to generate a hearing loss compensated audio signal, an output transducer for providing an output signal to a user of the each of the hearing aid systems based on the hearing loss compensated audio signal,” it is interpreted that the output transducer is the electroacoustic transducer);
a power supply circuit in electrical communication with the control circuit (FIG. 2 and [0163], “The BTE hearing aid 12 is powered by battery 28.” It is interpreted that battery 28 is a power supply circuit in communication with the other components including the control circuit/processors/other circuitry.);
wherein the ear-worn device is configured to detect a stimulus sufficient to generate a response from the ear-worn device wearer ([0116], “a hearing aid with a microphone for provision of an audio signal in response to sound signals received at the microphone from a sound environment, a processor that is configured to process the audio signal in accordance with a signal processing algorithm F.sub.n(Θ.sub.n), where Θ.sub.n is a set of signal processing parameters of the signal processing algorithm F.sub.n, to generate a hearing loss compensated audio signal, an output transducer for providing an output signal to a user of the each of the hearing aid systems based on the hearing loss compensated audio signal,” a sound signal, such as speech from others, is detected in the environment by the microphone and the sound data is processed and the output transducer then provides the processed sound as the stimulus, as the sound is detected and enhanced it is understood that the stimulus is sufficient to generate a response. See also [0176 – 0178]), It is interpreted that the sound in the environment is detected as a stimulus sufficient to generate a response and the device monitors the looking direction of the user which is the response.);
monitor for a qualified response to the stimulus, the qualified response comprising any actual reaction to the stimulus ([0044 – 0045], and [0176 – 0178], “The performance detector comprises a direction of arrival detector configured for determination of the direction of arrival of sound at the hearing aid 12. The performance detector is configured for comparison of the determined direction of arrival of the sound and the time from arrival of speech until the user changes his or her looking direction towards the determined direction of arrival of the speech as indicated by the orientation sensors 44. It is interpreted that the sound in the environment is detected as a stimulus sufficient to generate a response and the device monitors the looking direction of the user which is the qualified response.); and
measure an amount of time between the stimulus and the qualified response ([0178], “The performance detector is configured for comparison of the determined direction of arrival of the sound and the time from arrival of speech until the user changes his or her looking direction towards the determined direction of arrival of the speech as indicated by the orientation sensors 44. The performance detector 40 is configured for transmission of data relating to determined user reaction times or absence of user reaction in response to reception of speech to the at least one server,” reaction time of the qualified response (turning head) to listen to the detected sound.).
Regarding claim 57, Gran discloses The ear-worn device of claim 1, the qualified response comprising a non-reflexive reaction to the stimulus ([0178], “The performance detector is configured for comparison of the determined direction of arrival of the sound and the time from arrival of speech until the user changes his or her looking direction towards the determined direction of arrival of the speech as indicated by the orientation sensors 44. The performance detector 40 is configured for transmission of data relating to determined user reaction times or absence of user reaction in response to reception of speech to the at least one server,” It is interpreted that turning the head to listen is a non-reflexive reaction.).
Regarding claim 58, Gran discloses The ear-worn device of claim 41, wherein the ear-worn device is configured to operate in a passive mode wherein the stimulus is an event detected by the ear-worn device ([0044 – 0045], and [0176 – 0178], “The performance detector comprises a direction of arrival detector configured for determination of the direction of arrival of sound at the hearing aid 12. The performance detector is configured for comparison of the determined direction of arrival of the sound and the time from arrival of speech until the user changes his or her looking direction towards the determined direction of arrival of the speech as indicated by the orientation sensors 44. It is interpreted that the sound in the environment is detected as an event).
Regarding claim 59, Gran discloses The ear-worn device of claim 58, the event comprising any of a sound exceeding a threshold value of loudness, the ear-worn device wearer's name, and an utterance matching an individual's voice selected from a group of predetermined individuals familiar to the ear-worn device wearer ([0044 – 0045], and [0176 – 0178], “The performance detector comprises a direction of arrival detector configured for determination of the direction of arrival of sound at the hearing aid 12. The performance detector is configured for comparison of the determined direction of arrival of the sound and the time from arrival of speech until the user changes his or her looking direction towards the determined direction of arrival of the speech as indicated by the orientation sensors 44. It is interpreted that the sound in the environment is detected as an event that is a sound exceeding a threshold value of loudness, as the sensor detects the sound, it is interpreted that the loudness is above a threshold value since it is sensed and then triggers the monitoring of the user. See also [0037] discussing voice recognition and separation. See also [0153] describing speech, restaurant clatter, music, etc.).
Regarding claim 60, Gran discloses The ear-worn device of claim 1, wherein the ear-worn device is configured to establish a baseline of normal movement for the ear-worn device wearer, and wherein the qualified response comprises a direct reaction to the stimulus outside of the baseline of normal movement ([0175 – 0178] the models monitor the data with a performance model to understand how the user is improving over time or compares to similar users or baseline normal users, one of the monitoring being movement to a stimulus such as turning the head to listen to speech).
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Gran et al. (US 2016/0373869 A1) (“Gran”) in view of Goodall et al. (US 2017/0113057 A1) (“Goodall”).
Regarding claim 10, Gran discloses The ear-worn device of claim 1, Gran fails to disclose the stimulus comprising a tactile stimulus.
However, in the same field of endeavor, Goodall teaches the stimulus comprising a tactile stimulus (Para. [0189], “In various aspects, recommendation 2522 is for a secondary stimulus 2632 to be delivered in association with the neural stimulus. In various aspects, secondary stimulus 2632 includes music, an auditory stimulus, a video stimulus, a tactile stimulus, a haptic stimulus, an olfactory stimulus, a pharmaceutical, a nutraceutical, a secondary neural stimulus, an experience (including, but not limited to a virtual reality experience, a game experience, a virtual therapist experience, an augmented reality experience, and/or an interactive experience).”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device as taught by Gran to include the stimulus comprising a tactile stimulus as taught by Goodall in order to diagnose health states (Para. [0115], “In particular, values of any such parameters that are indicative of worsening mental or physical/physiological status of the subject can be reported to a medical care provider so that an appropriate intervention can be made, and/or used as a basis for modulating the delivery of neural stimulation.”).
Regarding claim 11, Gran discloses The ear-worn device of claim 1, Gran fails to disclose the stimulus comprising a game event.
However, in the same field of endeavor, Goodall teaches the stimulus comprising a game event (Para. [0189], “In various aspects, recommendation 2522 is for a secondary stimulus 2632 to be delivered in association with the neural stimulus. In various aspects, secondary stimulus 2632 includes music, an auditory stimulus, a video stimulus, a tactile stimulus, a haptic stimulus, an olfactory stimulus, a pharmaceutical, a nutraceutical, a secondary neural stimulus, an experience (including, but not limited to a virtual reality experience, a game experience, a virtual therapist experience, an augmented reality experience, and/or an interactive experience).”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device as taught by Gran to include the stimulus comprising a game event as taught by Goodall in order to diagnose health states (Para. [0115], “In particular, values of any such parameters that are indicative of worsening mental or physical/physiological status of the subject can be reported to a medical care provider so that an appropriate intervention can be made, and/or used as a basis for modulating the delivery of neural stimulation.”).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Gran et al. (US 2016/0373869 A1) (“Gran”) in view of Simon et al. (US 2016/0015289 A1) (“Simon”).
Regarding claim 19, Gran discloses The ear-worn device of claim 16, Gran fails to disclose wherein the qualified response comprises a balance recovery event.
However, in the same field of endeavor, Simon teaches wherein the qualified response comprises a balance recovery event (Para. [0059], “5) built-in accelerometer, gyrometer and magnetic compass that enables assessment of balance and stability;”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device as taught by Gran to include wherein the qualified response comprises a balance recovery event as taught by Simon in order to monitor more modalities of brain health during assessment (Para. [0059]).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Gran et al. (US 2016/0373869 A1) (“Gran”) in view of Naylor (US 2016/0038738 A1) (“Naylor”).
Regarding claim 23, Gran discloses The ear-worn device of claim 22, Gran fails to disclose wherein the ear-worn device issues an alert in response to a determined longitudinal trend crossing a threshold value.
However, in the same field of endeavor, Naylor teaches wherein the ear-worn device issues an alert in response to a determined longitudinal trend crossing a threshold value ([0032], “In an embodiment, the alarm indication unit is adapted to issue an alarm signal, if a hearing threshold (or a rate of change (difference/time ratio)) exceeds a predefined threshold value (indicating that the user's hearing ability has deteriorated, possibly over a relatively short, or alternatively over a relatively long, period of time, and that the user should act to verify the cause of such deterioration and identify a proper remedy).”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device as taught by Gran to include wherein the ear-worn device issues an alert in response to a determined longitudinal trend crossing a threshold value as taught by Naylor to notify the user of changes to identify cause and fix the issue ([0032], “the user should act to verify the cause of such deterioration and identify a proper remedy).”).
Response to Arguments
Applicant's arguments filed October 21, 2025 have been fully considered but they are not persuasive. With respect to the arguments regarding Gran, the arguments are not persuasive. Gran generates stimulus from the hearing aid itself as is discussed in the rejection, See [0116], “a hearing aid with a microphone for provision of an audio signal in response to sound signals received at the microphone from a sound environment, a processor that is configured to process the audio signal in accordance with a signal processing algorithm F.sub.n(Θ.sub.n), where Θ.sub.n is a set of signal processing parameters of the signal processing algorithm F.sub.n, to generate a hearing loss compensated audio signal, an output transducer for providing an output signal to a user of the each of the hearing aid systems based on the hearing loss compensated audio signal,” a sound signal, such as speech from others, is detected in the environment by the microphone and the sound data is processed and the output transducer then provides the processed sound as the stimulus, as the sound is detected and enhanced it is understood that the stimulus is sufficient to generate a response. See also [0176 – 0178]. Applicant is correct in that the ear worn device detects a stimulus. However, the ear worn device then additionally generates a stimulus sufficient to generate a response from an ear worn device wearer. Thus, the arguments are not persuasive.
With respect to the arguments regarding claims 10-11, the arguments are not persuasive. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Gran discloses an ear worn device for improved hearing and health monitoring and for monitoring reaction time to a stimulus and the secondary reference Goodall teaches an ear worn device for health monitoring and for monitoring reaction time to a stimulus. Goodall teaches the use of the other recited stimuli and teaches the benefit of the data received from the tests, i.d. [0115]. Thus, the arguments are not persuasive.
The arguments regarding claims 19 and 23 are moot.
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 JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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/J.A.T./Examiner, Art Unit 3791
/TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791