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 Office Action is responsive to the Amendment filed 09 March 2026. Claims 1, 2, 7, 11-15, 19-22, 25, 27, 28, 30, 31, 44, 51 and 52 are now pending. The Examiner acknowledges the amendments to Claims 1, 2, 7, 11-15, 19-22, 25, 27, 28, 30, 31, 44, 51 and 52.
Claim Rejections - 35 USC § 102
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, 44, and 51 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ogaz (US 20170221336 A1).
Regarding claim 1, Ogaz teaches an ear-wearable stress therapy system (ear piece 120, Fig. 1A, Fig. 1B, Fig. 6) comprising:
A control circuit ("processor may comprise a specially configured application specific integrated circuit", paragraph [0138]; processor 304);
A first sensor package, wherein the first sensor package is in electrical communication with the control circuit ("first sensor may comprise a sensor to collect data associated with sounds transmitted through the air", paragraph [0154]);
A microphone, wherein the microphone is in electrical communication with the control circuit ("ear piece generally includes a speaker and a sensor such as a microphone", paragraph [0112], microphone 132, Fig. 1B); and
An electroacoustic transducer, wherein the electroacoustic transducer is in electrical communication with the control circuit ("audio sensors may include acoustic-to-electric transducers" paragraph [0167]);
Wherein the ear-wearable stress therapy system being configured to initiate administration of desensitization and reprocessing (DR) therapy to a device wearer ("the user may receive audio inputs into the earpiece", paragraph [0112]). The DR therapy consists of audio stimulation.
Regarding claim 44, Ogaz teaches the ear-wearable stress therapy system being configured to detect a level of social engagement of the device wearer (paragraph [0046], [0167]). The system can detect the user's level of social engagement by gauging the user's emotional state (paragraph [0009]), as well as pitch and tone of their voice ("data may include intensity, pitch, pace, frequency, loudness, speech cadence related to the user's voice", paragraph [0008]) during a conversation.
Regarding claim 51, Ogaz teaches an ear-wearable stress therapy system (ear piece 120, Fig. 1A, Fig. 1B, Fig. 6) comprising:
A control circuit ("processor may comprise a specially configured application specific integrated circuit", paragraph [0138]; processor 304);
A first sensor package, wherein the first sensor package is in electrical communication with the control circuit ("first sensor may comprise a sensor to collect data associated with sounds transmitted through the air", paragraph [0154]);
A microphone, wherein the microphone is in electrical communication with the control circuit ("ear piece generally includes a speaker and a sensor such as a microphone", paragraph [0112], microphone 132, Fig. 1B); and
An electroacoustic transducer, wherein the electroacoustic transducer is in electrical communication with the control circuit ("audio sensors may include acoustic-to-electric transducers" paragraph [0167]);
Wherein the ear-wearable stress therapy system being configured to:
Evaluate data from the microphone and/or the sensor package to detect post-traumatic stress disorder (PTSD) symptoms (“sensor is a microphone…sensor detects vibrations caused by the user’s voice”, paragraph [0033], “monitor user’s voice for stress or for a code word…device may provide a notification to another device”, paragraph [0048]);
Initiate administration of desensitization and reprocessing (DR) therapy to a device wearer ("the user may receive audio inputs into the earpiece", paragraph [0112]). The DR therapy consists of audio stimulation.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2, 7, 11-15, 19-22, 25, 27, 28 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Ogaz (US 20170221336 A1) in view of Simon (US 2012015045 A1).
Regarding claim 2, Ogaz in view of Simon teaches all the limitations of claim 1, but does not teach the system administering and delivering binaural stimulation.
However, Simon teaches the ear-wearable stress therapy system being configured to administer and control deliver of binaural stimulation as part of the DR therapy ("auditory stimulation includes binaural beats", paragraph [0146]).
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 ear-wearable stress therapy system of Ogaz with the system of Simon in order to deliver binaural stimulation to the user as it helps reduce anxiety and provides a state of relaxation.
Regarding claim 7, a modified ear-wearable stress therapy system of Ogaz in view of Simon teaches all the limitations of claim 2.
Furthermore, Simon teaches the ear-wearable stress therapy system being configured to automatically adjust properties of the binaural stimulation to maintain device wearer engagement ("binaural beats were output. with beat frequency ranging from 10 to 20 Hz, which corresponded to optimized pitch frequencies from the program of from 10 Hz to 200 Hz", paragraph [0239]). The binaural stimulation can be automatically adjusted within a program.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the ear-wearable stress therapy system of Ogaz in view of Simon and configure the binaural stimulation to be automatically adjusted to different frequencies according to the user's mental state.
Regarding claim 11, a modified ear-wearable stress therapy system of Ogaz in view of Simon teaches the system being configured to detect post-traumatic stress disorder (PTSD) symptoms. Ogaz does teach the system being configured to detect health data and any type of physical characteristic of the user ("system may be able to determine a medical state of the user and react to that data and determine when the user is experiencing a health-related condition", paragraph [0189]).
Furthermore, Simon teaches the ear-wearable stress therapy system being configured to detect post-traumatic stress disorder (PTSD) symptoms ("assessment of behavioral disorders such as post- traumatic stress disorder", paragraph [0184], "detection and monitoring of brain dysfunction brain injury disease onset", paragraph [0064]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the ear-wearable stress therapy system of Ogaz in view of Simon and configure the ear-wearable stress therapy system to be more focused to patients with PTSD and detect early signs or symptoms of PTSD.
Regarding claims 12 and 28, Ogaz in view of Simon teaches the ear-wearable stress therapy system being configured to initiate administration of DR therapy to a device wearer subsequent to detection of PTSD symptoms or when a PTSD symptom causing trigger has been detected ("the audio I/O interface may provide signals to generate an alert selected by the user for that emotional state...alert may include an audible message", paragraph [0182]).
Regarding claim 13, Ogaz in view of Simon teaches the ear-wearable stress therapy system being configured to record microphone and/or sensor data ("the first sensor is a microphone to collect data associated with the user's voice", paragraph [0020]) over a look-back period when PTSD symptoms are detected.
Regarding claim 14, Ogaz in view of Simon teaches the ear-wearable stress therapy system being configured to use the recorded microphone and/or sensor data to characterize at least one of a sound from an environment of the device wearer ("the user may be in a public area where the ambient noise level is high", paragraph [0106]),
A physical activity level of the device wearer ("configured to measure user activity", paragraph [0076]),
A conversation pattern of the device wearer ("audio input from the user may correspond to voice commands, conversations of others around the feedback device", paragraph [0167]),
A level of irritability of the device wearer, an aggression level of the device wearer ("system may determine that the user is angry or scared", paragraph [0165]), and
An emotional state of the device wearer ("data may be received by a processor and analyzed to determine the emotional state of the user", paragraph [0009]).
Regarding claims 15 and 27, Ogaz in view of Simon teaches the ear-wearable stress therapy device being configured to identify a triggering event or a PTSD symptom causing trigger selected from at least one a sound environment, a physical geolocation, a physical activity, and a conversation pattern. The system must detect a trigger that causes PTSD symptoms and high levels of stress in order to send feedback or audio stimulus to the user ("when the stress or code word are detected, the device may provide a notification", paragraph [0048]). The combination of Ogaz in view of Simon would teach the system being able to detect various triggers in order to provide feedback to the user.
Regarding claim 19, Ogaz in view of Simon teaches the detection of the PTSD symptoms being based on at least one of a heart rate, a blood pressure, a physiologic temperature ("obtain or track health data a heart rate, a blood pressure, a temperature", paragraph [0189]), the device wearer's voice (paragraph [0015]), and a motion pattern ("sensors...may detect motion", paragraph [0162]).
Regarding claim 20, a modified ear-wearable stress therapy system of Ogaz in view of Simon teaches the all the limitations of claim 11.
Furthermore, Simon teaches the ear-wearable stress therapy system being configured to detect medication administration events and determine a correlation between detected medication administration events and detected PTSD symptoms ("monitoring of disease onset and progression, drug therapy", paragraph [0174], paragraph [0004]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Ogaz in view of Simon and configure the system to detect medication administration events and its effects on the user by monitoring the user's PTSD symptoms.
Regarding claim 21, a modified ear-wearable stress therapy system of Ogaz in view of Simon teaches all the limitations of claim 20.
Furthermore, Simon teaches the ear-wearable stress therapy system being configured to titrate medication dosage based on an observed correlation between detected medication administration events and detected PTSD symptoms ("tracking disease progression, guiding treatment and therapy (e.g. dose, timing, types of medicines), and as therapy via biofeedback", paragraph [0073]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Ogaz in view of Simon and configure the system to titrate medication dosage and in turn provide a suggestion to the user and/or clinician to either increase or decrease medication dosage.
Regarding claim 22, Ogaz in view of Simon teaches the ear-wearable stress therapy system being configured to provide audio stimulation when PTSD symptoms are detected ("audio I/O interface is configured to provide signals that are converted into sounds by speakers of devices", paragraph [0182]).
Regarding claim 25, Ogaz in view of Simon teaches the ear-wearable stress therapy system being configured to query the device wearer about their perceived stress level when PTSD symptoms are detected ("alert may include an oral message played by a speaker or a visual message on display", "when the user's emotional state is abnormal (such as on of anger or fear), the alert may include a message", paragraph [0141]).
Regarding claim 52, Ogaz teaches an ear-wearable stress therapy system (ear piece 120, Fig. 1A, Fig. 1B, Fig. 6) comprising:
A control circuit ("processor may comprise a specially configured application specific integrated circuit", paragraph [0138]; processor 304);
A first sensor package, wherein the first sensor package is in electrical communication with the control circuit ("first sensor may comprise a sensor to collect data associated with sounds transmitted through the air", paragraph [0154]);
A microphone, wherein the microphone is in electrical communication with the control circuit ("ear piece generally includes a speaker and a sensor such as a microphone", paragraph [0112], microphone 132, Fig. 1B); and
An electroacoustic transducer, wherein the electroacoustic transducer is in electrical communication with the control circuit ("audio sensors may include acoustic-to-electric transducers" paragraph [0167]);
Wherein the ear-wearable stress therapy system being configured to initiate administration of desensitization and reprocessing (DR) therapy to a device wearer ("the user may receive audio inputs into the earpiece", paragraph [0112]). The DR therapy comprising:
Providing one or more prompts to the device wearer (“the housing may provide haptic feedback, an audible signal, or a voice prompt to the user”, paragraph [0110])
Ogaz does not teach the ear-wearable stress therapy system being configured to provide bilateral stimulation to the device wearer.
However, Simon teaches the ear-wearable stress therapy system being configured to initiate administration of desensitization and reprocessing (DR) therapy to a device wearer comprising providing bilateral stimulation to the device wearer (“auditory stimulation includes…binaural beats”, paragraph [0146]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the ear-wearable stress therapy system of Ogaz with the system of Simon in order to also provide bilateral stimulation to the device wearer, as another form of administering desensitization and reprocessing (DR) therapy.
Claims 30 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Ogaz in view of Simon and further in view of Malchano et al. (US 20180133507 A1).
Regarding claims 30 and 31, Ogaz in view of Simon teaches the ear-wearable stress therapy system with an electroacoustic transducer, but does not teach the attenuation of a PTSD symptom causing trigger.
However, Malchano et al. teaches the ear-wearable stress therapy system being configured to attenuate the PTSD symptom causing trigger by modulating an output from the electroacoustic transducer ("audio source can include a speaker, and the audio generation module (or the audio signaling component) can include a transducer that converts electrical energy to sound waves or acoustic waves", paragraph [0388]) and attenuates the PTSD symptom causing trigger by reducing a volume of sound outputted by the electroacoustic transducer ("modulate the volume by increase and decreasing the amplitude of the acoustic wave or sound track to create the rhythmic stimulus corresponding to the stimulation frequency for inducing brainwave entrainment", paragraph [0423]). The system of Malchano et al. would be able to detect stress which would help with identifying PTSD symptoms ("sensor data indicates that the subject is experiencing stress", paragraph [0720]).
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 ear-wearable stress therapy system of Ogaz in view of Simon with the transducer of Malchano et al. and attenuate the sounds of surrounding triggers, to prevent PTSD symptoms, including anxiety or shock in the user.
Response to Arguments
Applicant’s arguments, see page 7, filed 09 March 2026, with respect to claim objections have been fully considered and are persuasive in light of the amendments. The claim objections have been withdrawn.
Applicant’s arguments, see page 7, filed 09 March 2026, with respect to 35 U.S.C. 112(b) rejections have been fully considered and are persuasive in light of the amendments. The 35 U.S.C. 112(b) rejections of 09 March 2026 have been withdrawn.
Applicant's arguments, see page 8, filed 09 March 2026, with respect to 35 U.S.C. 102 have been fully considered but they are not persuasive. In regards to claim 1, Ogaz teaches an ear-wearable system with a speaker that produces an audio to the user, which can be DR therapy. The earpiece that contains a speaker of Ogaz is capable of providing DR therapy which is the use of alternating bilateral and/or binaural stimulation, resulting in the reduction of PTSD symptoms. Additionally, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Therefore, Ogaz does teach the subject matter of claim 1 and its dependent claims.
Applicant’s arguments, see page 9, filed 09 March 2026, with respect to 35 U.S.C. 103 have been fully considered but they are not persuasive.
In regards to claim 7, the claim does not positively recite that the binaural stimulation cannot be optimized before being delivered to the user. In paragraph [0147] of Simon, it recites, “binaural beats can be output…beat frequency ranging from 10 to 20 Hz, which correspond to optimized pitch frequencies from NP3 of 10 Hz to 200Hz, meaning that the pitch frequencies will automatically select corresponding binaural beats to be outputted to the user, in order to maintain device wearer engagement. Therefore, Ogaz in view of Simon does teach the subject matter of claim 7.
In regards to claim 12, Ogaz in view of Simon does teach the ear-wearable stress therapy system being configured to administrate DR therapy to a device wearer subsequent to detection of PTSD symptoms. Ogaz teaches the device being able to monitor the user’s voice for stress, which is a symptom of PTSD in paragraph [0048]. Ogaz also teaches the device being able to determine the user’s emotional and medical state of the user with a sensor and then using that information to output audio which can be DR therapy in paragraph [0182], based off the detected PTSD symptoms. Therefore, Ogaz in view of Simon does teach the subject matter of claim 12.
In regards to claim 13, Ogaz in view of Simon does teach the ear-wearable stress therapy system to be configured to record microphone and/or sensor data necessary when detecting a user’s voice. It is also capable of detecting and analyzing the collected data over a lookback period, whenever PTSD symptoms are being monitored. Therefore, Ogaz in view of Simon does teach the subject matter of claim 13.
In regards to claim 15, Ogaz in view of Simon teaches the system detecting a trigger that causes PTSD symptoms and high levels of stress in order to send feedback or audio stimulus to the user in paragraph [0048]. The system is capable of sensing external triggers and detecting distress in the user.
Conclusion
THIS ACTION IS MADE FINAL. 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 LARA LINH TRAN whose telephone number is (571)272-3598. The examiner can normally be reached 7:30am-5:00pm M-F.
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/L.L.T./Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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