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 .
Applicant’s arguments filed in the reply on July 7, 2026 were received and fully considered. Claims 1, 3, 8-9, 13-16, and 20 were amended. Please see below for more detail.
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 1-20 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.
Regarding Claim 1, the claim(s) recites “determining, based at least in part on the audio data and different time of arrival values at the first microphone and the second microphone, that the sound is associated with the user,
determining, based at least in part on the sound being associated with the user, one or more biomarkers associated with the sound,
determining a threshold associated with the user having a pathological or behavioral state, process, or change,
determining, based at least in part on the one or more biomarkers satisfying the threshold, that the sound is indicative of the user having the pathological or behavioral state, process, or change,” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“a first microphone and a second microphone, wherein the first microphone and the second microphone are configured to be spaced apart by a different distance from a mouth of the user when the device is worn by the user;”
“receiving, from the first microphone and the second microphone, audio data associated with sound captured within an environment of the user,”
“causing, based at least in part on the one or more biomarkers satisfying the threshold, output of a first notification on the output component,”
“sending data associated with a second notification to be output on an electronic device associated with a caregiver of the user.”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities and generic postsolution activity.
Furthermore, microphones are general field of use and output components, network interfaces, non-transitory computer-readable media, and processors are generic computer elements used to perform generic computer functions and don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of detecting whether a sound belongs to a user and if so, determining whether the sound has the biomarker of a pathological or behavioral state to determine the occurrence of said pathological or behavioral state and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself. Dependent claims 2-7 also do not add significantly more to the exception as they merely add details to the mental steps, add details to the extrasolution data gathering steps, add general field of use components to facilitate the extrasolution data gathering, and add mental steps.
Regarding Claim 8, the claim(s) recites “determining, based at least in part on different time of arrival values at the first microphone and the second microphone, that the data is indicative of sound generated from a user,
determining, based at least in part on the audio data and different time of arrival values at the first microphone and the second microphone, that the sound is associated with the user,
determining, based at least in part on the data being indicative the sound generated from the user, one or more biomarkers associated with the sound, the one or more biomarkers including at least an amplitude associated with the sound,
determining that the one or more biomarkers fail to satisfy a threshold associated with a pathological or behavioral state or change of the user,” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“sensors comprising a first microphone and a second microphone, wherein the first microphone and the second microphone are spaced apart”
“receiving, from the sensors, data,”
“causing, based at least in part on the one or more biomarkers failing to satisfy the threshold, output of a notification via the one or more output components.”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities and generic postsolution activity.
Furthermore, sensors are general field of use and output components, non-transitory computer-readable media, and processors are generic computer elements used to perform generic computer functions and don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of detecting whether a sound belongs to a user and if so, determining whether the sound has the biomarker of a pathological or behavioral state to determine the occurrence of said pathological or behavioral state and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself. Dependent claims 9-15 also do not add significantly more to the exception as they merely add details to the mental steps, add details to the extrasolution data gathering steps, add general field of use components to facilitate the extrasolution data gathering, and add mental steps.
Regarding Claim 16, the claim(s) recites “determining, based at least in part on the first audio data and the second audio data and different time of arrival values at the first microphone and the second microphone, that the sound is associated with the user,
determining, based at least in part on the sound being associated with the user, one or more characteristics associated with the sound,
determining, based at least in part on the one or more characteristics, that the sound is indicative of a pathological or behavioral state of the user,” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“a first microphone; a second microphone; wherein the first microphone and the second microphone are configured to be spaced apart by a different distance from a mouth of the user when the device is worn by the user;”
“receiving, from the first microphone, first audio data associated with a sound captured in an environment,”
“receiving, from the second microphone, second audio data associated with the sound,”
“causing, based at least in part on the one or more characteristics being indicative of the pathological or behavioral state, output of a notification via the one or more output components.”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities and generic postsolution activity.
Furthermore, microphones are general field of use and output components, non-transitory computer-readable media, and processors are generic computer elements used to perform generic computer functions and don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of detecting whether a sound belongs to a user and if so, determining whether the sound has the characteristic of a pathological or behavioral state to determine the occurrence of said pathological or behavioral state and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself. Dependent claims 17-20 also do not add significantly more to the exception as they merely add details to the mental steps, add details to the extrasolution data gathering steps, add general field of use components to facilitate the extrasolution data gathering, and add mental steps.
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 for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2 and 4-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chan et al (US 2020/0069281) (“Chan”) in view of Guarino et al (US 2009/0312660) (“Guarino”) and further in view of An et al (US 2018/0344212) (“An”).
Regarding Claim 1, Chan teaches a device to be worn by a user (Abstract, [0019]-[0020], [0037], [0040], [0043]), the device comprising:
A first microphone and a second microphone ([0019]-[0020], [0037], [0040], [0043] one or more microphones can be the sensors of devices 116a, 116b, 116c and wearable electronic device 104, which can all be consolidated into a single device), wherein the first microphone and the second microphone are configured to be spaced apart by a different distance from a mouth of the user when the device is worn by the user (Fig. 1, different distances shown by the microphones from the mouth, such as sensor device with microphone 116c being further from the mouth than sensor device with microphone 116a);
a network interface (Fig. 2, [0049], [0051] communication interfaces 204 / network interface as part of wearable electronic device 104);
one or more processors (Fig. 2, [0049]-[0050] processors 202 / processors as part of wearable electronic device 104); and
one or more non-transitory computer-readable media storing computer-executable instructions that, when executed by the one or more processors, cause the device to perform acts ([0052] non-transitory storage medium that stores instructions enable processor to perform the acts of the invention) comprising:
receiving, from the first microphone and the second microphone, audio data associated with sound captured within an environment of the user (Fig. 4, [0097]-[0098] block 402 sound is measured in a vicinity of a subject by a microphone, representing sound in the subject’s environment),
determining, based at least in part on the audio data, that the sound is associated with the user ([0076]-[0079], [0098] [01000] determination that a sound is associated with a user, i.e. a feature might have occurred, can be made based on received audio data and further clarified by a second data signal,),
determining, based at least in part on the sound being associated with the user, one or more biomarkers associated with the sound ([0079], [0102] block 406 outlines the determining of one or more biomarkers associated with sound to identify sound-producing behaviors, [0033] where feature extraction is adaptive based on power needs of system, [0079] gives an example of identifying power spectral densities, after a significant preliminary event. Together, one can see that certain sound features act as a presence indicator of sound-producing behaviors and other features distinguish the type of sound-producing behaviors),
determining a condition associated with the user having a pathological or behavioral state, process, or change ([0079] determining condition associated with a user having a pathological or behavioral state, process, or change by way of reference power spectral densities, [0080]-[0096] examples of data specific to behavioral states and changes that could be used as reference comparison data),
determining, based at least in part on the one or more biomarkers satisfying the condition, that the sound is indicative of the user having the pathological or behavioral state, process, or change ([0079] measured power spectral densities compared to reference power spectral densities to identify whether the sounds are indicative of the user having a behavioral change like those shown in Figs. 3A-3I, [0080]-[0096], i.e. whether plots shown in Figs. 3A-3I are matched),
causing, based at least in part on the one or more biomarkers satisfying the condition, output of an analysis result ([0043], [0046] data from a wearable user 104 may be processed and transmitted to user device 106), and
sending data associated with the analysis result to a second electronic device ([0043], [0045]-[0046] data may also be sent to a remote server for storage),
Chan fails to teach device comprising the condition characterizing a pathological or behavioral state, process, or change being a threshold.
However Chan teaches that a dataset’s quality may be reviewed and compared to a quality threshold to identify where the quality condition is acceptable or unacceptable ([0105]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the classification of sound-producing behaviors of Chan can be performed using a determined threshold for the features as well as for data quality as taught by Chan as this provides a standardized comparison point in feature analysis, ensuring consistency across applications of the invention.
Yet Chan fails to teach device comprising:
an output component;
determining, based at least in part on the audio data and different time of arrival values at the first microphone and the second microphone, that the sound is associated with the user
causing, based at least in part on the one or more biomarkers satisfying the threshold, output of a first notification on the output component;
However Guarino teaches a human sound recognizing method (Abstract) comprising
Multiple microphones ([0048]);
An output component ([0093] a user interface with a display may be connected to a processing system running the method).
determining, based at least in part on the audio data and different time of arrival values at the first microphone and the second microphone, what source the sound is associated with ([0020]-[0021] sound localization by multiple microphones, [0058] can be applied to a portable system with processing to differentiate between a carrier of the portable device and other individual in the vicinity of the user, [0062]-[0081] process of recognizing a cough further includes using different time of arrival values to identify the source of the sound, [0022], [0088]-[0091] where further confidence can be added if movement data is added, either by an accelerometer or a camera).
Determining one or more biomarkers associated with the sound and comparing it to a threshold to identify whether it belongs to a user ([0058] energy envelope captured of the audio data to differentiate between user and third parties).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to utilize the multiple microphones of Chan and apply time difference of arrival for the data of the various microphones as taught by Guarino as this enables a differentiation between human sounds made by a carrier of a portable device (e.g. a wearable device) and other individual in the vicinity of the user. And Examiner recognizes that Guarino [0048] provides advantages of a non-worn system, but contends these reasons are applicable for the economics of a farmer, not for an individual concerned with their own health. For a personal user, processing that identifies the source of a cough would be beneficial by ensuring a cough of an adjacent individual is not recognized as belonging to the user as outlined in [0058].
Yet their combined efforts fail to teach device comprising:
causing, based at least in part on the one or more biomarkers satisfying the threshold, output of a first notification on the output component;
sending data associated with a second notification to be output on an electronic device associated with a caregiver of the user.
However An teaches a system for monitoring patient health based on sound data (Abstract) comprising
A wearable device (Figs. 1-2, [0062], [0064] ambulatory medical device 110 which can be wearable, system functions performed at ambulatory medical device include a heart sound sensing by a microphone included with the wearable device);
an output component (Fig. 2, [0060], [0062] user interface 250 / output component a system function that can be included with the ambulatory medical device 110);
a condition characterizing a pathological or behavioral state, process, or change being a threshold ([0071] a condition characterized by heart sound can be differentiated by a threshold);
causing, based at least in part on a condition satisfying the threshold, output of a first notification on the output component ([0060], [0080] detected medical events can be output to external device to patient, the external device being the ambulatory medical device 110, such as by a user interface like a display, [0071]0-[0079] detected medical events found by threshold);
sending data associated with a second notification to be output on an electronic device associated with a caregiver of the user ([0060], [0080] detected medical events can be output to remote device to clinician, using an electronic device with a display).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include an output component as taught by An with the wearable electronic device of Chan and causing an output of a first notification on the output component as a way to update a user on their health state and a verification means that the processing in Chan is accurately identifying sounds. Furthermore, it would be obvious that this same notification can be delivered to an electronic device with a caregiver, as a second notification, to ensure a clinician can identify how the patient health state is progressing. Finally, it would be obvious that the classification of sound-producing behaviors of Chan can be performed using a determined threshold as taught by An as this provides a standardized comparison point, ensuring consistency across applications of the invention.
Regarding Claim 2, Chan, Guarino, and An teach the device of claim 1, further comprising a sensor (See Claim 1 Rejection), and Chan teaches the acts further comprising receiving, from the sensor, sensor data, wherein:
determining that the sound is associated with the user is based at least in part on the sensor data; and
determining the one or more biomarkers is based at least in part on the sensor data (See Claim 1 Rejection, [0069] secondary data sets increase confidence that a sound-producing behavior identified by a first sound is accurate, [0074]-[0078] where features / biomarkers are also collected from secondary data sets).
Regarding Claim 4, Chan, Guarino, and An teach the device of claim 1, the acts further comprising:
determining a signature associated with the pathological or behavioral state;
determining, based at least in part on the one or more biomarkers, an audio signature associated with the sound; and
determining a similarity between the audio signature associated with the pathological or behavioral state and the audio signature associated with the sound,
wherein determining that the sound is indicative of the user having the pathological or behavioral state is based at least in part on the similarity (See Claim 1 Rejection¸ reference power spectral densities are the signatures of a behavioral state, where the measured features / biomarkers in Chan includes a first spike as a preliminary feature, leading to the determination of a feature such as power spectral density of the audio data, where the reference power spectral density and the measured spectral density are then compared (for similarity) to distinguish whether a particular sound-producing behavior has occurred).
Regarding Claim 5, Chan, Guarino, and An teach the device of claim 1, further comprising one or more attachment mechanisms for coupling the device to the user (See Claim 1 Rejection, [0043] wearable electronic device 104 has attachment mechanisms such as a wristband or sticker).
Regarding Claim 6, Chan, Guarino, and An teach the device of claim 1, and Chan teaches wherein determining the one or more biomarkers is based at least in part on:
providing, as an input to a machine-learned (ML) model trained to identify the pathological or behavioral state, the audio data ([0062], [0079] machine learning process may be used for the analysis of sound-producing behavior where the audio data is input by way of the audio power spectral density); and
receiving, as an output from the ML model, an indication associated with the one or more biomarkers ([0062], [0079] sound-producing behavior output by machine learning model, the sound-producing behavior being an indication of subject behavioral state/change in association with one or more biomarkers/features).
Regarding Claim 7, Chan, Guarino, and An teach the device of claim 1, wherein the one or more biomarkers include at least one of a pitch of the sound, a tone associated with the sound, a pause in the sound, a duration of the sound, or an amplitude of the sound (See Claim 1 Rejection, Figs. 3A-3I, feature specific to each behavior is described and shown, where distinct characteristics are shown in amplitude of the sound, pauses in appearance of the sound, and duration of the sound, and Chan teaches identifying frequencies associated with the sound, where a frequency of the behavior reflects pauses between occurrence of the sound and [0076] sounds durations is described as a feature that by itself may not be enough for prediction but does show clear identifying information when considering Figs. 3A-3I).
Regarding Claim 8, while Chan teaches a device (Abstract, [0019]-[0020], [0037], [0040], [0043] wearable device 104) comprising:
sensors comprising a first microphone and a second microphone ([0019]-[0020], [0037], [0040], [0043] one or more microphones can be the sensors of devices 116a, 116b, 116c and wearable electronic device 104, which can all be consolidated into a single device), wherein the first microphone and the second microphone are spaced apart (Fig. 1, different distances shown between the microphones);
one or more processors (Fig. 2, [0049]-[0050] processors 202 / processors as part of wearable electronic device 104);
one or more non-transitory computer-readable media storing computer-executable instructions that, when executed by the one or more processors, cause the device to perform acts ([0052] non-transitory storage medium that stores instructions enable processor to perform the acts of the invention) comprising:
receiving, from the sensors, data (Fig. 4, [0097]-[0099] blocks 402 and 404 sound is measured in a vicinity of a subject by a microphone, representing sound in the subject’s environment, along with other sensor datasets),
determining that the data is indicative of sound generated from a user ([0076]-[0079], [0098] [01000] determination that a sound is associated with a user, i.e. a feature might have occurred, can be made based on received audio data and further clarified by a second data signal,),
determining, based at least in part on the data being indicative of the sound generated from the user, one or more biomarkers associated with the sound, the one or more biomarkers including at least an amplitude associated with the sound ([0079], [0102] block 406 outlines the determining of one or more biomarkers associated with sound to identify sound-producing behaviors, [0033] where feature extraction is adaptive based on power needs of system, [0079] gives an example of identifying power spectral densities, after a significant preliminary event. Together, one can see that certain sound features act as a presence indicator of sound-producing behaviors and other features distinguish the type of sound-producing behaviors, [0076] sounds amplitude is described as a feature that by itself may not be enough for prediction but does show clear identifying information when considering Figs. 3A-3I),
determining that the one or more biomarkers fail to satisfy a condition associated with a pathological or behavioral state or change of the user ([0079] measured power spectral densities compared to reference power spectral densities to identify whether the sounds are indicative of the user having a behavioral change like those shown in Figs. 3A-3I, [0080]-[0096], i.e. whether plots shown in Figs. 3A-3I are matched),
causing, based at least in part on the one or more biomarkers failing to the condition, output of an analysis result ([0043], [0046] data from a wearable user 104 may be processed and transmitted to user device 106, where failures of data matching one condition for a first sound-producing behavior would be used to confirm data matches a second sound-producing behavior), and
sending data associated with the analysis result to a second electronic device ([0043], [0045]-[0046] data may also be sent to a remote server for storage),
Chan fails to teach device comprising the condition characterizing a pathological or behavioral state, process, or change being a threshold.
However Chan teaches that a dataset’s quality may be reviewed and compared to a quality threshold to identify where the quality condition is acceptable or unacceptable ([0105]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the classification of sound-producing behaviors of Chan can be performed using a determined threshold for the features as well as for data quality as taught by Chan as this provides a standardized comparison point in feature analysis, ensuring consistency across applications of the invention.
Yet Chan fails to teach the device comprising:
one or more output components;
determining, based at least in part on different time of arrival values at the first microphone and the second microphone, that the data is indicative of sound generated from a user;
causing, based at least in part on the one or more biomarkers failing to satisfy the threshold, output of a notification via the one or more output components.
However Guarino teaches a human sound recognizing method (Abstract) comprising
Multiple microphones ([0048]);
One or more output components ([0093] a user interface with a display may be connected to a processing system running the method).
determining, based at least in part on the audio data and different time of arrival values at the first microphone and the second microphone, what source the sound is associated with ([0020]-[0021] sound localization by multiple microphones, [0058] can be applied to a portable system with processing to differentiate between a carrier of the portable device and other individual in the vicinity of the user, [0062]-[0081] process of recognizing a cough further includes using different time of arrival values to identify the source of the sound, [0022], [0088]-[0091] where further confidence can be added if movement data is added, either by an accelerometer or a camera).
Determining one or more biomarkers associated with the sound and comparing it to a threshold to identify whether it belongs to a user ([0058] energy envelope captured of the audio data to differentiate between user and third parties).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to utilize the multiple microphones of Chan and apply time difference of arrival for the data of the various microphones as taught by Guarino as this enables a differentiation between human sounds made by a carrier of a portable device (e.g. a wearable device) and other individual in the vicinity of the user. And Examiner recognizes that Guarino [0048] provides advantages of a non-worn system, but contends these reasons are applicable for the economics of a farmer, not for an individual concerned with their own health. For a personal user, processing that identifies the source of a cough would be beneficial by ensuring a cough of an adjacent individual is not recognized as belonging to the user as outlined in [0058].
Yet their combined efforts fail to teach device comprising:
causing, based at least in part on the one or more biomarkers failing to satisfy the threshold, output of a notification via the one or more output components.
However An teaches a system for monitoring patient health based on sound data (Abstract) comprising
A wearable device (Figs. 1-2, [0062], [0064] ambulatory medical device 110 which can be wearable, system functions performed at ambulatory medical device include a heart sound sensing by a microphone included with the wearable device);
an output component (Fig. 2, [0060], [0062] user interface 250 / output component a system function that can be included with the ambulatory medical device 110);
causing, based at least in part on a one or more condition failing to satisfy a threshold, output of a notification on the output component ([0060], [0080] received data and analysis results can be output to external device to patient, the external device being the ambulatory medical device 110, such as by a user interface like a display, [0071]-[0079] detected medical events evaluated by threshold, where failing to satisfy the threshold will still lead to monitoring results being transmitted to patient).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include an output component as taught by An with the wearable electronic device of Chan and causing an output of a first notification on the output component as a way to update a user on their health state and a verification means that the processing in Chan is accurately identifying sounds.
Regarding Claim 9, Chan, Guarino, and An teach the device of claim 8, and Chan teaches wherein the sensors further comprise
at least one of an internal measurement unit (IMU), an accelerometer, a gyroscope, or a piezoelectric sensor (See Claim 8 Rejection, Guarino [0022] further teaches the use of an accelerometer for characterizing sampled audio data).
Regarding Claim 10, Chan, Guarino, and An teach the device of claim 8, wherein the one or more output components comprise at least one of a lighting element or a speaker (See Claim 8 Rejection, display is a lighting element).
Regarding Claim 11, Chan, Guarino, and An teach the device of claim 8, the acts further and An teaches the device comprising sending a second notification to an electronic device ([0060], [0080] detected medical events can be output to remote device to clinician, using an electronic device with a display).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the same notification sent to the patient can be delivered to an electronic device with a caregiver, as a second notification, to ensure a clinician can identify how the patient health state is progressing.
Regarding Claim 12, Chan, Guarino, and An teach the device of claim 8, wherein the device is configured to be worn by the user (See Claim 8 Rejection, [0043] wearable electronic device 104 has attachment mechanisms such as a wristband or sticker).
Regarding Claim 13, Chan, Guarino, and An teach the device of claim 8, the acts further comprising:
receiving, from the sensors, second data;
determining that the second data is indicative of second sound generated from the user;
determining, based at least in part on the second data being indicative the second sound generated from the user, one or more second biomarkers associated with the second sound;
determining that the one or more second biomarkers satisfy the threshold, and
causing, based at least in part on the one or more second biomarkers satisfying the threshold, output of a third notification via the one or more output components (See Claim 8 Rejection, [0056] data is collected and analyzed for multiple frames, thus the same analysis outlined above can be applied to a second data in a new frame. If a sound-producing behavior is present in the new frame, the claim language above will be met).
Regarding Claim 14, Chan, Guarino, and An teach the device of claim 8, and Chan teaches wherein determining the one or more biomarkers is based at least in part on:
providing, as an input to a machine-learned (ML) model trained to identify the pathological or behavioral state, the data ([0062], [0079] machine learning process may be used for the analysis of sound-producing behavior where the audio data is input by way of the audio power spectral density); and
receiving, as an output from the ML model, an indication associated with the one or more biomarkers ([0062], [0079] sound-producing behavior output by machine learning model, the sound-producing behavior being an indication of subject behavioral state/change in association with one or more biomarkers/features).
Regarding Claim 15, Chan, Guarino, and An teach the device of claim 8, wherein the sensors further comprise at least one of a GPS, or a temperature sensor (See Claim 8 Rejection, [0020], [0040]).
Regarding Claim 16, while Chan teaches a device (Abstract, [0019]-[0020], [0037], [0040], [0043]) comprising:
A first microphone; a second microphone, wherein the first microphone and the second microphone are configured to be spaced apart by a different distance from a mouth of the user when the device is worn by the user (Fig. 1, different distances shown by the microphones from the mouth, such as sensor device with microphone 116c being further from the mouth than sensor device with microphone 116a);
one or more processors (Fig. 2, [0049]-[0050] processors 202 / processors as part of wearable electronic device 104); and
one or more non-transitory computer-readable media storing computer-executable instructions that, when executed by the one or more processors, cause the device to perform acts ([0052] non-transitory storage medium that stores instructions enable processor to perform the acts of the invention) comprising:
receiving, from the first microphone, first audio data associated with a sound captured in an environment (Fig. 4, [0097]-[0098] block 402 sound is measured in a vicinity of a subject by a microphone, representing sound in the subject’s environment),,
receiving, from the second microphone, second audio data associated with the sound (if you are sampling from multiple microphones, you would presumably receive second audio data),
determining, based at least in part on the first audio data, that the sound is associated with a user ([0076]-[0079], [0098] [01000] determination that a sound is associated with a user, i.e. a feature might have occurred, can be made based on received audio data and further clarified by a second data signal,),
determining, based at least in part on the sound being associated with the user, one or more characteristics associated with the sound ([0079], [0102] block 406 outlines the determining of one or more charactertistics associated with sound to identify sound-producing behaviors, [0033] where feature extraction is adaptive based on power needs of system, [0079] gives an example of identifying power spectral densities, after a significant preliminary event. Together, one can see that certain sound features act as a presence indicator of sound-producing behaviors and other features distinguish the type of sound-producing behaviors),
determining, based at least in part on the one or more characteristics, that the sound is indicative of a pathological or behavioral state of the user ([0079] measured power spectral densities compared to reference power spectral densities to identify whether the sounds are indicative of the user having a behavioral change like those shown in Figs. 3A-3I, [0080]-[0096], i.e. whether plots shown in Figs. 3A-3I are matched),
causing, based at least in part on the one or more characteristics being indicative of the pathological or behavioral state, output of an analysis result ([0043], [0046] data from a wearable user 104 may be processed and transmitted to user device 106), and
Chan fails to teach determining, based at least in part on the first audio data and the second audio data, that the sound is associated with a user.
However Chan teaches the acts further comprising that audio data can be obtained in different orientations and will reflect different features for the same sound-producing behavior ([0072], [0074] audio data collected from a different orientation provides distinct characteristics when consider the same sound-producing behavior, [0069] where secondary data sets increase confidence that a sound-producing behavior identified by a first sound is accurate),
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to utilize a second microphone in Chan with a distinct orientation from the first microphone and identify whether the characteristics of the ambient environment match the same expected sounds for a sound-producing behavior as this provides an increased confidence in the identification of a sound-producing behavior, the goal outlined in Chan
Yet Chan fails to teach the device comprising one or more output components;
causing, based at least in part on the one or more characteristics being indicative of the pathological or behavioral state, output of a notification via the one or more output components.
Yet Chan fails to teach the device comprising:
one or more output components;
determining, based at least in part on different time of arrival values at the first microphone and the second microphone, that the data is indicative of sound generated from a user;
causing, based at least in part on the one or more biomarkers failing to satisfy the threshold, output of a notification via the one or more output components.
However Guarino teaches a human sound recognizing method (Abstract) comprising
Multiple microphones ([0048]);
One or more output components ([0093] a user interface with a display may be connected to a processing system running the method).
determining, based at least in part on the audio data and different time of arrival values at the first microphone and the second microphone, what source the sound is associated with ([0020]-[0021] sound localization by multiple microphones, [0058] can be applied to a portable system with processing to differentiate between a carrier of the portable device and other individual in the vicinity of the user, [0062]-[0081] process of recognizing a cough further includes using different time of arrival values to identify the source of the sound, [0022], [0088]-[0091] where further confidence can be added if movement data is added, either by an accelerometer or a camera).
Determining one or more biomarkers associated with the sound and comparing it to a threshold to identify whether it belongs to a user ([0058] energy envelope captured of the audio data to differentiate between user and third parties).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to utilize the multiple microphones of Chan and apply time difference of arrival for the data of the various microphones as taught by Guarino as this enables a differentiation between human sounds made by a carrier of a portable device (e.g. a wearable device) and other individual in the vicinity of the user. And Examiner recognizes that Guarino [0048] provides advantages of a non-worn system, but contends these reasons are applicable for the economics of a farmer, not for an individual concerned with their own health. For a personal user, processing that identifies the source of a cough would be beneficial by ensuring a cough of an adjacent individual is not recognized as belonging to the user as outlined in [0058].
Yet their combined efforts fail to teach device comprising:
causing, based at least in part on the one or more biomarkers failing to satisfy the threshold, output of a notification via the one or more output components.
However An teaches a system for monitoring patient health based on sound data (Abstract) comprising
A wearable device (Figs. 1-2, [0062], [0064] ambulatory medical device 110 which can be wearable, system functions performed at ambulatory medical device include a heart sound sensing by a microphone included with the wearable device);
an output component (Fig. 2, [0060], [0062] user interface 250 / output component a system function that can be included with the ambulatory medical device 110);
causing, based at least in part on a one or more condition failing to satisfy a threshold, output of a notification on the output component ([0060], [0080] received data and analysis results can be output to external device to patient, the external device being the ambulatory medical device 110, such as by a user interface like a display, [0071]-[0079] detected medical events evaluated by threshold, where failing to satisfy the threshold will still lead to monitoring results being transmitted to patient).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include an output component as taught by An with the wearable electronic device of Chan and causing an output of a first notification on the output component as a way to update a user on their health state and a verification means that the processing in Chan is accurately identifying sounds.
However An teaches a system for monitoring patient health based on sound data (Abstract) comprising
A wearable device (Figs. 1-2, [0062], [0064] ambulatory medical device 110 which can be wearable, system functions performed at ambulatory medical device include a heart sound sensing by a microphone included with the wearable device);
an output component (Fig. 2, [0060], [0062] user interface 250 / output component a system function that can be included with the ambulatory medical device 110);
causing, based at least in part on a one or more condition failing to satisfy a threshold, output of a notification on the output component ([0060], [0080] received data and analysis results can be output to external device to patient, the external device being the ambulatory medical device 110, such as by a user interface like a display, [0071]-[0079] detected medical events evaluated by threshold, where failing to satisfy the threshold will still lead to monitoring results being transmitted to patient).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include an output component as taught by An with the wearable electronic device of Chan and causing an output of a first notification on the output component as a way to update a user on their health state and a verification means that the processing in Chan is accurately identifying sounds.
Regarding Claim 17, Chan, Guarino, and An teach the device of claim 16, and An teaches the acts further comprising sending data associated with the one or more characteristics to an electronic device ([0060], [0080] detected medical events can be output to remote device to clinician, using an electronic device with a display).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the same notification sent to the patient can be delivered to an electronic device with a caregiver, as a second notification, to ensure a clinician can identify how the patient health state is progressing.
Regarding Claim 18, Chan, Guarino, and An teach the device of claim 16, further comprising one or more sensors that include at least one of an accelerometer, a gyroscope, an internal measurement unit (IMU), or a piezoelectric sensor (See Claim 16 Rejection, Chan: [0020], [0040]), the acts further comprising receiving, from the one or more sensors, sensor data, wherein:
determining that the sound is associated with the user is based at least in part on the sensor data; and
determining the one or more characteristics associated with the sound is based at least in part on the sensor data (See Claim 16 Rejection, [0069] secondary data sets increase confidence that a sound-producing behavior identified by a first sound is accurate, [0074]-[0078] where features / biomarkers are also collected from secondary data sets).
Regarding Claim 19, Chan, Guarino, and An teach the device of claim 16, and Guarino teaches the acts further comprising determining one or more characteristics associated with an environment of the user, and wherein determining that the sound is indicative of the pathological or behavioral state is based at least in part on the one or more characteristics associated with the environment ([0063]-[0064] energy envelope / characteristic associated with environmental sound, sound is considered noise based on characteristic, i.e. if energy envelope is above an energy envelope and is only then determined whether the sound is indicative of the pathological or behavioral state).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to perform the steps of determining one or more characteristics associated with an environment of the user, wherein determining that the sound is indicative of the pathological or behavioral state is based at least in part on the one or more characteristics as taught by Guarino in the audio analysis of Chan as this provides another test with which to identify the occurrence of significant biomarkers and differentiate them from noise data.
Regarding Claim 20, Chan, Guarino, and An teach the of claim 16, and Chan teaches wherein determining the one or more characteristics is based at least in part on:
providing, as an input to a machine-learned (ML) model trained to identify the pathological or behavioral state, the first audio data and the second audio data (See Claim 16 Rejection, [0062], [0079] machine learning process may be used for the analysis of sound-producing behavior where the audio data is input by way of the audio power spectral density); and
receiving, as an output from the ML model, an indication associated with the one or more characteristics ([0062], [0079] sound-producing behavior output by machine learning model, the sound-producing behavior being an indication of subject behavioral state/change in association with one or more characteristics/features).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chan in view of Guarino and further in view of An and further in view of Zhou (US 2020/0221223).
Regarding Claim 3, while Chan, Guarino, and An teach the device of claim 1, and Guarino teaches the acts further comprising:
receiving, from the first microphone and the second microphone, second audio data associated with a second sound captured within the environment (See Claim 1 Rejection);
determining, based at least in part on the second audio data, that the second sound is associated with the environment ([0063]-[0064]); their combined efforts fail to teach
determining one or more second biomarkers associated with the second sound,
wherein determining that the sound is indicative of the user having the pathological or behavioral state is based at least in part on the one or more second biomarkers.
However Zhou teaches an subject audio monitoring device (Abstract) comprising multiple microphones ([0040], [0044]), where subject sound-produced behavior audio can be differentiated by second audio data ([0008], [0044], [0098]), where audio data can be analyzed to determined whether it should be categorized as first subject data or second environment data ([0098]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to utilize a second ambient microphone as taught by Zhou with the device of Chan, Guarino, and An as this can provide improved analysis in identifying when a sound-produced behavior is a subject speaking. Furthermore, biomarkers / features in an ambient microphone that can help differentiate sound-producing behavior is already recognized in Chan ([0072]), just not positively incorporated into the invention so Zhou’s teachings just motivate a user to set two of the sensors from the sensors 116 and the wearable device 104 to be microphones, determine which better serves as sound from an environment, and then identify the necessary features to improve the classification of sound-producing behaviors.
Response to Arguments
Applicant’s amendments and arguments filed July 7, 2026 with respect to the claim objections have been fully considered and are persuasive. The objection(s) is/are withdrawn.
Applicant’s amendments and arguments filed July 7, 2026 with respect to the 35 USC 101 rejections have been fully considered, but are not persuasive.
Applicant argues on pages 8-9 of the Remarks that the added different time of arrival calculation leads to an improvement in the art. Examiner respectfully notes that this limitation is solely limited to a mental step (specifically, a determining step) and thus cannot act as the basis for improvement as the improvement cannot be limited to the judicial exception. There is nothing specific to the extrasolution limitations (i.e. microphones) beyond the fact that they must be spaced apart.
Applicant argues on pages 9-10 of the Remarks that the generated sound data represents physical impulses in the medium and thus is a concrete instantiation of the signals, not abstract. Examiner respectfully disagrees. Thus the claims do not recite a judicial exception. Examiner notes that in the above analysis, this portion of the claim is not stated as part of the mental process, but as an additional limitation that does not provide significantly more. And Examiner maintains that even if the limitations are directed to physical impulses in the medium, they would still fall under necessary data gathering activity to enable a mental process.
Applicant argues on page 10 of the Remarks that the claims are not drawn to a mental process that can be performed in the human mind as the claim requires the use of microphones and audio sampling. As stated above, the included audio sampling and microphones are additional elements considered outside of the judicial exception, to consider whether they amount to significantly more. Examiner maintains that they don’t as they are generic microphones being utilized.
Applicant’s amendments and arguments filed July 7, 2026 with respect to the 35 USC 103 rejections of Claims 1, 9, and 16 have been fully considered and are persuasive. The rejection(s) is/are withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Chan, Guarino, and An. Consequently, claims 2-8, 10-15, and 17-20 remain rejected due to their dependency on rejected claims 1, 9, and 16.
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 JAIRO H PORTILLO whose telephone number is (571)272-1073. The examiner can normally be reached M-F 9:00 am - 5:15 pm.
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, Jacqueline Cheng can be reached at (571)272-5596. 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/patent-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.
/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/PUYA AGAHI/Primary Examiner, Art Unit 3791
