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 .
Election/Restrictions
Claims 22, 23, 25, 27, 28 and 39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on May 19, .
Applicant argues that it would not be unduly burdensome for the examiner to search and examine all of the claims presented, but the examiner respectfully disagrees. There would be an unduly burden on the examiner to search and examine all of the claims presented because the inventions have acquired a separate status in the art in view of their different classification (i.e., group I, claims 1, 4-5, 7-8, 10-17 & 21 are classified in A61B 5/4836, and group II, claims 22-23, 25, 27-28 & 39 are classified in A61B 5/0808), and further the inventions require a different field of search (i.e., searching different classes/subclasses or electronic resources, or employing different search queries).
Claims 1, 4, 5, 7, 8, 10-17, 21-23, 25, 27, 28 and 39 are currently pending with claims 22, 23, 25, 27, 28 and 39 being withdrawn from consideration.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 12-14, 16, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2020/0268315 --as cited by applicant--, hereinafter referenced as "Burwinkel" in view of US Patent Application Publication 2020/0143703 --as cited by applicant--, hereinafter referenced as "Fabry".
With respect to claim 1, Burwinkel teaches an ear-wearable device 102 (i.e., a hearing assistance device) (see Burwinkel, par 0029, 0033, 0035, 0046-0050, 0053-0057, figs. 1-2 & 6-7) comprising:
a control circuit 822 (see Burwinkel, par 0053, 0060, 0112, fig. 8);
a microphone 806, wherein the microphone is in electrical communication with the control circuit (see Burwinkel, par 0033, 0053, 0058, 0074, 0112-0113, fig. 8);
a motion sensor 814, wherein the motion sensor is in electrical communication with the control circuit (see Burwinkel, par 0053, 0058, 0072-0073, 0097, 0112-0113, fig. 8);
and a power supply circuit 804, wherein the power supply circuit is in electrical communication with the control circuit (see Burwinkel, par 0053, 0058, 0104, 0112, fig. 8);
wherein the ear-wearable device is configured to initiate a therapy for a wearer of the ear-wearable device and monitor signals from the microphone and/or the motion sensor to detect execution of the therapy (i.e., the control circuit of the hearing assistance device is configured to prompt the administration of a therapy for a patient, and further evaluate signals from sensors, such as a microphone or motion sensor to detect sound or movement, respectively, that indicate the administration of a therapy for the patient has taken place) (see Burwinkel, abstract, par 0030-0031, 0084, 0090, 0104, 0106).
Burwinkel fails to teach the ear-wearable device is configured to initiate a therapy for a wearer of the ear-wearable device for recovery from an anoxic or hypoxic neurological injury.
Fabry teaches a fixed-gaze movement training systems with visual feedback and related methods comprising a hearing assistance device that comprises a control circuit, a microphone in communication with the control circuit, and a motion sensor (i.e., IMU sensor) in electrical communication with the control circuit (see Fabry, par 0008, 0031-0035, fig. 2) that is used to provide vestibular therapy to a patient/subject, wherein exercises comprising performing a predetermined movement while maintaining a fixed point of eye gaze, tracking the point of gaze of the subject's eyes, and generating data representing a measured deviation between the fixed point of eye gaze and the tracked point of gaze are completed for the vestibular therapy (see Fabry, abstract, par 0004-0006, 0008, 0026-0027, 0066-0067). Vestibular therapy/rehabilitation is designed to improve balance and reduce problems related to dizziness, and can be used to treat patients who have had a stroke or brain injury (i.e., a anoxic or hypoxic neurological injury) (see Fabry, par 0005).
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 system of Burwinkel such that the ear-wearable device is configured to initiate a therapy for a wearer of the ear-wearable device for recovery from an anoxic or hypoxic neurological injury because vestibular therapy/rehabilitation can be initiated/administered using a hearing assistance device for the treatment of stroke (i.e., a anoxic or hypoxic neurological injury) or brain injury of a patient/subject (see Fabry, par 0004-0006, 0008, 0026-0027, 0031-0035, 0066-0067, fig. 2).
With respect to claim 12, Burwinkel as modified by Fabry teaches the ear-wearable device of claim 1, and further teaches the therapy comprises motor skills therapy (see Fabry, par 0027, 0037, 0041-0042, 0044-0047, 0065, 0072-0074, 0087).
With respect to claim 13, Burwinkel as modified by Fabry teaches the ear-wearable device of claim 12, and further teaches the motor skills therapy comprises a movement protocol (see Fabry, par 0027, 0037, 0041-0042, 0044-0047, 0065, 0072-0074, 0087).
With respect to claim 14, Burwinkel as modified by Fabry teaches the ear-wearable device of claim 12, and further teaches the motor skills therapy comprises at least one of range of motion therapy, mobility training, limb movement, and virtual reality therapy (see Fabry, par 0027, 0037, 0041-0042, 0044-0047, 0065, 0072-0074, 0087).
With respect to claim 16, Burwinkel as modified by Fabry teaches the ear-wearable device of claim 1, and further teaches initiating the therapy is triggered based on at least one of detection of an acoustic environment, detection of motion, and an occurrence of a specific date and/or time (see Burwinkel, par 0106).
With respect to claim 21, Burwinkel as modified by Fabry teaches the ear-wearable device of claim 1, and Burwinkel further teaches the ear-wearable device is configured to receive an input from the wearer of the ear-wearable device to delay, reschedule, or cancel the therapy (i.e., a patient can delay a prompt to take their medication by pushing a button) (see Burwinkel, par 0069).
Claim(s) 1, 12-14, 16, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent 9,848,273 --as cited by applicant--, hereinafter referenced as "Helwani" in view of US Patent Application Publication 2017/0007167 --as cited by applicant--, hereinafter referenced as "Kostic".
With respect to claim 1, Helwani teaches an ear-wearable device 801, 802 (i.e., a hearing system comprising hearing devices) (see Helwani, Col. 11, lines 21-49, Col. 20, lines 26-45, figs. 3, 4A-4B, 6 & 8A-8D) comprising:
a control circuit (i.e., control circuitry) (see Helwani, Col. 14, lines 18-67 - Col. 15, lines 1-30, Col. 15, lines 36-67 - Col. 16, lines 1-11);
a microphone, wherein the microphone is in electrical communication with the control circuit (see Helwani, Col. 9, lines 35-48, Col. 10, lines 39-60, Col. 14, lines 18-42, figs. 2A-2B, 6, 9A-9B);
a motion sensor, wherein the motion sensor is in electrical communication with the control circuit (see Helwani, Col. 6, lines 16-67 - Col. 7, lines 1-20, Col. 9, lines 66-67 - Col. 10, lines 1-25, Col. 14, lines 42-67 - Col. 15, lines 1-3, Col. 15, lines 36-58);
and a power supply circuit, wherein the power supply circuit is in electrical communication with the control circuit (i.e., the hearing system receives electrical signals representing sounds, thus the hearing system comprising the hearing devices has a power supply that permits it to receive electrical signals) (see Helwani, Col. 5, lines 56-65);
wherein the ear-wearable device is configured to initiate a therapy for a wearer of the ear-wearable device and monitor signals from the microphone and/or the motion sensor to detect execution of the therapy (i.e., the hearing devices of the hearing system are configured to track the motion of a user as the user moves in a direction of a perceived location that the user perceives to be the location of a sound presented to them through the hearing devices, and further evaluate signals from sensors, such as a microphone that picks up acoustic sounds or a motion sensor to detect movement, respectively, that aid in the development of a head related transfer function specific to a user that when created, enables a user to better identify the location of sound sources in a hearing device that the user wears) (see Helwani, Col. 1, lines 12-19, Col. 1, lines 23-67, Col. 1, lines 47-67, Col. 2, lines 1-13, Col. 4, lines 35-63, Col. 4, lines 64-67 - Col. 5, lines 1-26, Col. 6, lines 64-67 - Col. 7, lines 1-20, Col. 9, lines 35-48).
Helwani fails to teach the ear-wearable device is configured to initiate a therapy for a wearer of the ear-wearable device for recovery from an anoxic or hypoxic neurological injury.
Kostic teaches systems and methods for stroke detection, wherein sensors such as a microphone, camera, and/or an accelerometer are used to detect characteristics that are indicative of a stroke of a user (see Kostic, par 0010-0011, 0022, 0024, 0026, 0029, 0063, 0067, fig. 1). The use of sensors such as a microphone, camera, or accelerometer to detect characteristics that are indicative of a stroke of a user permits the passive monitoring of symptoms of a stroke such that the user is able to timely seek medical assistance (see Kostic, par 0004-0011).
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 system of Helwani such that the ear-wearable device is configured to initiate a therapy for a wearer of the ear-wearable device for recovery from an anoxic or hypoxic neurological injury because the use of sensors such as a microphone and/or accelerometer detects characteristics that are indicative of a stroke injury of a user, and permits monitoring of stroke symptoms to enable a user to timely seek medical assistance for their symptoms as needed (see Kostic, par 0004-0011, 0022, 0024, 0026, 0029, 0063, 0067, fig. 1).
With respect to claim 12, Helwani as modified by Kostic teaches the ear-wearable device of claim 1, and Helwani further teaches the therapy comprises motor skills therapy (i.e., the hearing devices of the hearing system are configured to track the motion of a user as the user moves in a direction of a perceived location that the user perceives to be the location of a sound presented to them through the hearing devices, and wherein the user is guided to perform motions such as translational and rotational motions of their head) (see Helwani, Col. 4, lines 64-67 - Col. 5, lines 1-26, Col. 11, lines 8- 60, figs. 4A-4B, 8A-8D).
With respect to claim 13, Helwani as modified by Kostic teaches the ear-wearable device of claim 12, and Helwani further teaches the motor skills therapy comprises a movement protocol (i.e., the user is guided to perform motions such as translational and rotational motions of their head) (see Helwani, Col. 4, lines 64-67 - Col. 5, lines 1-26, Col. 11, lines 8- 60, figs. 4A-4B, 8A-8D).
With respect to claim 14, Helwani as modified by Kostic teaches the ear-wearable device of claim 12, and Helwani further teaches the motor skills therapy comprises at least one of range of motion therapy (i.e., the user is guided to perform motions such as translational and rotational motions of their head), mobility training, limb movement, and virtual reality therapy (see Helwani, Col. 4, lines 64-67 - Col. 5, lines 1-26, Col. 11, lines 8- 60, figs. 4A-4B, 8A-8D).
With respect to claim 16, Helwani as modified by Kostic teaches the ear-wearable device of claim 1, and Helwani further teaches initiating the therapy is triggered based on at least one of detection of an acoustic environment, detection of motion, and an occurrence of a specific date and/or time (i.e., an occurrence of instructions playing sounds instructs the user to move a portion of their body) (Helwani, Col. 4, lines 64-67 - Col. 5, lines 1-26).
With respect to claim 21, Helwani as modified by Kostic teaches the ear-wearable device of claim 1, and Helwani as modified by Kostic further teaches the ear-wearable device is configured to receive an input from the wearer of the ear-wearable device to delay, reschedule, or cancel the therapy (i.e., a user can press a cancel button on a display to retake an image of themselves that is used to determine parameters associated with a stroke) (see Kostic, par 0096, figs. 2A-2B).
Claim(s) 4-5 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burwinkel as modified by Fabry as applied to claim 1 above, and further in view of US Patent Application Publication 2019/0304329 --as cited by applicant--, hereinafter referenced as "Webb".
With respect to claim 4, Burwinkel as modified by Fabry teaches the ear-wearable device of claim 1, but fails to teach the therapy comprises speech-language therapy.
Webb teaches a tool for rehabilitating language skills, wherein an interactive tool/game is used to improve/rehabilitate speech and language skills (see Webb, abstract, par 0004-0005, 0008, 0021-0022, 0027-0030, 0060-0061). The tool used to improve/rehabilitate speech and language skills can be used to treat aphasia that is caused by brain injuries such as stroke, wherein aphasia causes difficulties with word retrieval for patients (see Webb, par 0005, 0007-0008, 0082).
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 system of Burwinkel as modified by Fabry such that the therapy comprises speech-language therapy because speech-language therapy can be used to treat aphasia caused by brain injuries resulting from stroke in a patient (see Webb, abstract, par 0004-0005, 0008, 0021-0022, 0027-0030, 0060-0061).
With respect to claim 5, Burwinkel as modified by Fabry teaches the ear-wearable device of claim 1, but fails to teach the ear-wearable device is configured to evaluate a nature or quality of a response from the ear-wearable device wearer in response to the therapy, wherein the nature or quality of the response includes at least one of fricative stopping, liquid gliding, lisping, dysphonia, and disfluency.
Webb teaches a tool for rehabilitating language skills, wherein an interactive tool/game is used to improve/rehabilitate speech and language skills (see Webb, abstract, par 0004-0005, 0008, 0021-0022, 0027-0030, 0060-0061). The tool used to improve/rehabilitate speech and language skills can be used to treat aphasia that is caused by brain injuries such as stroke, wherein aphasia causes difficulties with word retrieval for patients (see Webb, par 0005, 0007-0008, 0082).
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 system of Burwinkel as modified by Fabry such that the ear-wearable device is configured to evaluate a nature or quality of a response from the ear-wearable device wearer in response to the therapy, wherein the nature or quality of the response includes at least one of fricative stopping, liquid gliding, lisping, dysphonia, and disfluency because doing so permits the evaluation and treatment of aphasia, which is caused by brain injuries such as stroke, that causes difficulty in fluency of speech of a patient (see Webb, abstract, par 0004-0005, 0007-0008, 0021-0022, 0027-0030, 0060-0061, 0082).
With respect to claim 15, Burwinkel as modified by Fabry teaches the ear-wearable device of claim 1, but fails to teach the therapy comprises cognitive therapy.
Webb teaches a tool for rehabilitating language skills, wherein an interactive tool/game is used to improve/rehabilitate speech and language skills (see Webb, abstract, par 0004-0005, 0008, 0021-0022, 0027-0030, 0060-0061). The tool used to improve/rehabilitate speech and language skills can be used to treat aphasia that is caused by brain injuries such as stroke, wherein aphasia causes difficulties with word retrieval for patients (see Webb, par 0005, 0007-0008, 0082).
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 system of Burwinkel as modified by Fabry such that the therapy comprises cognitive therapy because cognitive therapy, such as speech/language therapy permits the evaluation and treatment of aphasia, which is caused by brain injuries such as stroke and causes difficulty in fluency of speech of a patient (see Webb, abstract, par 0004-0005, 0007-0008, 0021-0022, 0027-0030, 0060-0061, 0082).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burwinkel as modified by Fabry as applied to claim 1 above, and further in view of US Patent Application Publication 2003/0036041, hereinafter referenced as "Evangelisti".
With respect to claim 7, Burwinkel as modified by Fabry teaches the ear-wearable device of claim 1, but fails to teach the ear-wearable device is configured to evaluate the ear-wearable device wearer's response to the therapy as observed by their speech outside of therapy sessions.
Evangelisti teaches a portable speech therapy device that is used in an initial therapy session where a speech language pathologist (SLP) that teaches a patient how to use it, and that is used outside of the SLP's presence (i.e., at the patient's home) (see Evangelisti, par 0006). The use of the portable speech therapy device outside of sessions with the SLP permits a reduced recovery time for the patient recovering from a condition (i.e., cancer of the tongue or vocal organs) (see Evangelisti, par 0006).
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 system of Burwinkel as modified by Fabry such that the ear-wearable device is configured to evaluate the ear-wearable device wearer's response to the therapy as observed by their speech outside of therapy sessions because evaluating speech of a user outside of therapy sessions (i.e., via the use of a speech therapy device outside of sessions) permits a reduced recovery time for patients that need the speech therapy to remedy a condition (see Evangelisti, par 0006).
Claim(s) 8 and 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burwinkel as modified by Fabry as applied to claim 1 above, and further in view of US Patent Application 2019/0029588 --as cited by applicant--, hereinafter referenced as "Weffers-Albu".
With respect to claim 8, Burwinkel as modified by Fabry teaches the ear-wearable device of claim 1, but fails to teach the therapy comprising swallow therapy, wherein the swallow therapy comprises a swallow protocol.
Weffers-Albu teaches a device, system, and method for detection and monitoring of dysphagia of a subject, comprising a device 30 that comprises a microphone 52 and a motion sensor 51 (i.e., an accelerometer) that is used to acquire an audio signal and a mastication signal respectively as a patient swallows during a protocol to detect any dysphagia-related abnormalities in the patient's swallowing (see Weffers-Albu, par 0020-0030, 0038-0048, figs. 1 & 2).
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 system of Burwinkel as modified by Fabry such that the therapy comprises swallow therapy, wherein the swallow therapy comprises a swallow protocol because doing so permits the early detection of the onset of dysphagia in a patient, as well as to monitor the progression of dysphagia in a patient at home (see Weffers-Albu, par 0020-0030, 0038-0048, figs. 1 & 2).
With respect to claim 10, Burwinkel as modified by Fabry and Weffers-Albu teaches the ear-wearable device of claim 8, and Burwinkel further teaches the ear-wearable device is configured to use signals from the microphone and/or the motion sensor to detect head position, swallowing, and/or drinking during execution of the swallow protocol (see Burwinkel, par 0035, 0113).
With respect to claim 11, Burwinkel as modified by Fabry and Weffers-Albu and teaches the ear-wearable device of claim 8, and further teaches the ear-wearable device is configured to use signals from the microphone and/or the motion sensor to detect aspiration during execution of the swallow protocol (see Weffers-Albu, par 0020-0021, 0025-0027, 0045-0046, 0075).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burwinkel as modified by Fabry as applied to claim 1 above, and further in view of US Patent Application Publication 2021/0037867, hereinafter referenced as "Tristram".
With respect to claim 17, Burwinkel as modified by Fabry teaches the ear-wearable device of claim 1, and Burwinkel further teaches the ear-wearable device is configured to provide an adaptive recommendation (i.e., recommendations or guidance) (see Burwinkel, par 0052, 0089), but fails to teach the adaptive recommendation comprises liquid thickening.
Tristram teaches an ingredient for liquid thickening to feed subjects suffering from a mastication or deglutition disorder, such as dysphagia that slows down a patient's swallowing so that issues such as aspiration pneumonia are prevented (see Tristram, par 0003-0005).
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 system of Burwinkel as modified by Fabry such that the ear-wearable device is configured to provide an adaptive recommendation for liquid thickening because liquid thickening prevents patients suffering from swallowing disorders such as dysphagia from contracting issues such as aspiration pneumonia by slowing down a patient's swallowing (see Tristram, par 0003-0005).
Claim(s) 4-5 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Helwani as modified by Kostic as applied to claim 1 above, and further in view of US Patent Application Publication 2019/0304329 --as cited by applicant--, hereinafter referenced as "Webb".
With respect to claim 4, Helwani as modified by Kostic teaches the ear-wearable device of claim 1, but fails to teach the therapy comprises speech-language therapy.
Webb teaches a tool for rehabilitating language skills, wherein an interactive tool/game is used to improve/rehabilitate speech and language skills (see Webb, abstract, par 0004-0005, 0008, 0021-0022, 0027-0030, 0060-0061). The tool used to improve/rehabilitate speech and language skills can be used to treat aphasia that is caused by brain injuries such as stroke, wherein aphasia causes difficulties with word retrieval for patients (see Webb, par 0005, 0007-0008, 0082).
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 system of Helwani as modified by Kostic such that the therapy comprises speech-language therapy because speech-language therapy can be used to treat aphasia caused by brain injuries resulting from stroke in a patient (see Webb, abstract, par 0004-0005, 0008, 0021-0022, 0027-0030, 0060-0061).
With respect to claim 5, Helwani as modified by Kostic teaches the ear-wearable device of claim 1, but fails to teach the ear-wearable device is configured to evaluate a nature or quality of a response from the ear-wearable device wearer in response to the therapy, wherein the nature or quality of the response includes at least one of fricative stopping, liquid gliding, lisping, dysphonia, and disfluency.
Webb teaches a tool for rehabilitating language skills, wherein an interactive tool/game is used to improve/rehabilitate speech and language skills (see Webb, abstract, par 0004-0005, 0008, 0021-0022, 0027-0030, 0060-0061). The tool used to improve/rehabilitate speech and language skills can be used to treat aphasia that is caused by brain injuries such as stroke, wherein aphasia causes difficulties with word retrieval for patients (see Webb, par 0005, 0007-0008, 0082).
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 system of Helwani as modified by Kostic such that the ear-wearable device is configured to evaluate a nature or quality of a response from the ear-wearable device wearer in response to the therapy, wherein the nature or quality of the response includes at least one of fricative stopping, liquid gliding, lisping, dysphonia, and disfluency because doing so permits the evaluation and treatment of aphasia, which is caused by brain injuries such as stroke, that causes difficulty in fluency of speech of a patient (see Webb, abstract, par 0004-0005, 0007-0008, 0021-0022, 0027-0030, 0060-0061, 0082).
With respect to claim 15, Helwani as modified by Kostic teaches the ear-wearable device of claim 1, but fails to teach the therapy comprises cognitive therapy.
Webb teaches a tool for rehabilitating language skills, wherein an interactive tool/game is used to improve/rehabilitate speech and language skills (see Webb, abstract, par 0004-0005, 0008, 0021-0022, 0027-0030, 0060-0061). The tool used to improve/rehabilitate speech and language skills can be used to treat aphasia that is caused by brain injuries such as stroke, wherein aphasia causes difficulties with word retrieval for patients (see Webb, par 0005, 0007-0008, 0082).
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 system of Helwani as modified by Kostic such that the therapy comprises cognitive therapy because cognitive therapy, such as speech/language therapy permits the evaluation and treatment of aphasia, which is caused by brain injuries such as stroke and causes difficulty in fluency of speech of a patient (see Webb, abstract, par 0004-0005, 0007-0008, 0021-0022, 0027-0030, 0060-0061, 0082).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Helwani as modified by Kostic as applied to claim 1 above, and further in view of US Patent Application Publication 2003/0036041, hereinafter referenced as "Evangelisti".
With respect to claim 7, Helwani as modified by Kostic teaches the ear-wearable device of claim 1, but fails to teach the ear-wearable device is configured to evaluate the ear-wearable device wearer's response to the therapy as observed by their speech outside of therapy sessions.
Evangelisti teaches a portable speech therapy device that is used in an initial therapy session where a speech language pathologist (SLP) that teaches a patient how to use it, and that is used outside of the SLP's presence (i.e., at the patient's home) (see Evangelisti, par 0006). The use of the portable speech therapy device outside of sessions with the SLP permits a reduced recovery time for the patient recovering from a condition (i.e., cancer of the tongue or vocal organs) (see Evangelisti, par 0006).
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 system of Helwani as modified by Kostic such that the ear-wearable device is configured to evaluate the ear-wearable device wearer's response to the therapy as observed by their speech outside of therapy sessions because evaluating speech of a user outside of therapy sessions (i.e., via the use of a speech therapy device outside of sessions) permits a reduced recovery time for patients that need the speech therapy to remedy a condition (see Evangelisti, par 0006).
Claim(s) 8 and 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Helwani as modified by Kostic as applied to claim 1 above, and further in view of US Patent Application 2019/0029588 --as cited by applicant--, hereinafter referenced as "Weffers-Albu".
With respect to claim 8, Helwani as modified by Kostic teaches the ear-wearable device of claim 1, but fails to teach the therapy comprises swallow therapy, wherein the swallow therapy comprises a swallow protocol.
Weffers-Albu teaches a device, system, and method for detection and monitoring of dysphagia of a subject, comprising a device 30 that comprises a microphone 52 and a motion sensor 51 (i.e., an accelerometer) that is used to acquire an audio signal and a mastication signal respectively as a patient swallows during a protocol to detect any dysphagia-related abnormalities in the patient's swallowing (see Weffers-Albu, par 0020-0030, 0038-0048, figs. 1 & 2).
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 system of Helwani as modified by Kostic such that the therapy comprises swallow therapy, wherein the swallow therapy comprises a swallow protocol because doing so permits the early detection of the onset of dysphagia in a patient, as well as to monitor the progression of dysphagia in a patient at home (see Weffers-Albu, par 0020-0030, 0038-0048, figs. 1 & 2).
With respect to claim 10, Helwani as modified by Kostic and Weffers-Albu teaches the ear-wearable device of claim 8, and Helwani further teaches the ear-wearable device is configured to use signals from the microphone and/or the motion sensor to detect head position, swallowing, and/or drinking during execution of the swallow protocol (see Helwani, Col. 4, lines 64-67 - Col. 5, lines 1-26, Col. 11, lines 8- 60, figs. 4A-4B, 8A-8D).
With respect to claim 11, Helwani as modified by Kostic and Weffers-Albu teaches the ear-wearable device of claim 8, and further teaches the ear-wearable device is configured to use signals from the microphone and/or the motion sensor to detect aspiration during execution of the swallow protocol (see Weffers-Albu, par 0020-0021, 0025-0027, 0045-0046, 0075).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Helwani as modified by Kostic as applied to claim 1 above, and further in view of US Patent Application Publication 2021/0037867, hereinafter referenced as "Tristram".
With respect to claim 17, Helwani as modified by Kostic teaches the ear-wearable device of claim 1, and Helwani further teaches the ear-wearable device is configured to provide an adaptive recommendation (i.e., recommendations or guidance) (see Helwani, Col. 4, lines 56-63), but fail to teach the adaptive recommendation comprises liquid thickening.
Tristram teaches an ingredient for liquid thickening to feed subjects suffering from a mastication or deglutition disorder, such as dysphagia that slows down a patient's swallowing so that issues such as aspiration pneumonia are prevented (see Tristram, par 0003-0005).
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 system of Helwani as modified by Kostic such that the ear-wearable device is configured to provide an adaptive recommendation for liquid thickening because liquid thickening prevents patients suffering from swallowing disorders such as dysphagia from contracting issues such as aspiration pneumonia by slowing down a patient's swallowing (see Tristram, par 0003-0005).
Conclusion
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/D.J.C./Examiner, Art Unit 3791
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