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 .
Claims Accounting
Arguments filed 01/12/2026 have been fully considered. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicant has amended their claims, filed 01/12/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1, 6, and 24 have been amended.
Claims 4-5 have been canceled.
Claims 55-57 have been added.
Claims 1, 6-7, 10-11, 13-20, 24, and 55-57 are hereby under examination.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/12/2026 has been entered.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 1/12/2026 and 2/24/2026 have been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6-7, 13, and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 6, the claim recites “detect a change in inner ear pressure”, however, it is unclear how this change is detected. The closest recitation in the specification is identified as par. [0101] recites that the device can be configured to detect LVAS based on the detection of properties associated with the pressure of the inner ear, however it does not provide any details or specific steps regarding the functional limitation. The detection of properties associated with the inner ear is not synonymous with detecting a change in inner ear fluid pressure. Therefore, claim 6 fails to comply with the written description requirement.
It is noted that all paragraph references to the instant application are made with respect to the corresponding US Patent Application Publication 2022/0218235.
Regarding claim 7, the claim recites “calculate a change in tympanic membrane stiffness based on the change in the identified resonant vibrational frequency; calculate a change in stiffness of ligament connections between bones in the inner ear based on the change in the identified resonant vibrational frequency”, however, it is unclear how these changes in stiffnesses are calculated. The closest recitations in the specification is identified as par. [0096] recites that the device can be configured to calculate a change in tympanic membrane stiffness or to calculate a change in ligament connections between bones in the inner ear, however it does not provide any details or specific steps regarding the functional limitations. Calculating a change in stiffness requires a mathematical relationship to be used to determine a numerical value. The written description does not provide any such relationship, equation, correlation or the like.
Regarding claim 13, the claim recites “estimate the size of the vestibular aqueduct based on the detect vibrations within or about the ear”, however, it is unclear how this is estimated. The closest recitation in the specification is identified as par. [0100] recites that the device can be configured to estimate the size of the vestibular aqueduct, however it does not provide any details or specific steps regarding the functional limitation. Therefore, claim 13 fails to comply with the written description requirement. Estimating a parameter requires a mathematical relationship to be used to determine a numerical value. The written description does not provide any such relationship, equation, correlation or the like.
Regarding claim 18, the claim recites "detect a gross bony abnormality based on the detected vibrations within or about the ear", however, it is unclear how this is estimated. The closest recitation in the specification is identified as par. [0102] recites that the device can be configured to detect a gross bony abnormality, however it does not provide any details or specific steps regarding the functional limitation. It is unclear if there is a threshold, or range of values stemming from the detected vibrations that would correspond to a gross bony abnormality. Par. [0106] recites details pertaining to detecting SSCD, however, this is completed with the use of VEMP, which measure surface electromyography and is not based on the detected vibrations. Therefore, claim 18 fails to comply with the written description requirement.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 6-7, 11, 13-20, and 55-56 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1, 7, and 11, claim 1 recites “identify a change in fluid in the middle ear over time based on the change in the identified resonant vibrational frequency” in lines 15-16. It is unclear which of the “any changes in the same over time” is being referred to with the phrase “the change”. Clarification is requested. Similar recitations are found in claim 7, lines 7-8 and claim 11, line 3.
For the purposes of examination, “identify a change … based on the change in the identified resonant vibrational frequency” is interpreted as “identify a change … based on one of the changes over time in identified resonant vibrational frequency in the identified resonant vibrational frequency”.
Regarding claims 6-7, 13, and 18, these claims failed to meet the written description requirement, and therefore the scope of the claims are also unclear. For each of these claims, it is unclear how the functional limitations are performed.
For the purposes of examination, any means to perform the functional limitations will read on the limitations of the claims. For example, claim 6 recites the ear-wearable device configured to detect a change in inner ear fluid pressure based on changes in absorbance of the inner ear. Because it is unclear how detecting a change in inner ear fluid pressure may be performed based on based on changes in absorbance of the inner ear, any means to detect a change in inner ear fluid pressure will read on the limitations of the claims.
All claims not explicitly addressed above are rejected under 35 U.S.C. 112(b) are rejected by virtue of their dependency on a rejected base claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over WIPO Publication 2020/051546 by Raju et al. – previously cited (hereinafter “Raju”) in view of US Patent Publication 2006/0020239 by Geiger et al. – previously cited (hereinafter “Geiger”).
Regarding claim 1, Fig. 1 of Raju teaches an ear-wearable device (Par. [060] states that while examples are described with reference to smart phones, it is to be understood that techniques may generally be implemented on any computing device, such wearable devices, hearing aids, and smart ear buds) comprising: a control circuit (processor 102); a microphone (microphone 114) in electrical communication with the control circuit (connection shown in Fig. 1 and described in [062]); an electroacoustic transducer (speaker 112) for generating sound in electrical communication with the control circuit (connection shown in Fig 1 and described in [061]); a motion sensor (accelerometer, gyroscope, and/or geomagnetic sensors in the device [105]; the accelerometer may indicate a change in orientation); a power supply in electrical communication with the control circuit (a power supply is inherent to the wearable devices, hearing aids and smart ear buds); wherein the ear-wearable device is configured to:
provide auditory stimulation across a range of frequencies with the electroacoustic transducer (interrogating the ear canal with an acoustic waveform from the speaker with frequency-modulated continuous-wave (FMCW) chirps covering a range of frequencies [071]); detect vibrations within or about the ear with the microphone (reflected acoustic waveform measured by the microphone [072]); and identify a resonant vibrational frequency based on detected vibrations (identify the acoustic dip occurring at the resonant frequency [0072]).
Raju does not teach the motion sensor or the power supply circuit being in electrical communication with the control circuit.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the ear-wearable device taught by Raju to have the power supply circuit and motion sensor in electrical communication with the control circuit. This combination of electrical communication between the power supply circuit and motion sensors with the control circuit would have been obvious as this would be applying a known technique to a known device to yield predictable results. See MPEP 2143.I.C.
Modified Raju does not teach the device configured to record the identified resonant vibrational frequency and calculate any changes in the same over time, or identify a change in fluid in the middle ear space based on the change in the identified resonant vibrational frequency.
Fig. 1 of Geiger teaches a system for obtaining a measurement, where the measurements are stored and trend data related to the measurements are calculated. This system allows for the monitoring of a health parameter and may generate an alert to a care-giver to the presence of a health abnormality is detected ([0048]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the ear-wearable device of modified Raju to be configured to record the identified resonant vibrational frequency and calculate any changes in the same over time and identify a change in fluid in the middle ear space based on the change in the identified resonant vibrational frequency to enable the monitoring of the health parameter and alert a care-giver to the presence of a health abnormality if detected, as taught by Geiger ([0048]). It is noted that Raju teaches that the detected state of the canal may include presence and/or amount of fluid in the ear canal ([068]). The combination of Raju and Geiger results in a system that monitors the state of the ear over time, therefore a change in the amount of fluid in the ear of fluid would indicate an identification of a change in fluid.
Regarding claim 11, Raju in view of Geiger teaches the ear-wearable device of claim 1, configured to detect a temporary occlusion of an ear canal of the device wearer based on the change in the identified resonant vibrational frequency (Raju in view of Geiger as applied to claim 1, teaches how the ear-wearable device can identify the different states of the ear based on changes in the resonant frequency, one of the states being a temporary occlusion (Raju; [0069]). Therefore, as the combination of Raju and Geiger is capable of monitoring the state of the ear canal over time, if the monitored stated is a temporary occlusion, any changes in the resonant frequency would be indicative of a temporary occlusion.).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Raju in view of Geiger, as applied to claim 1, in view of US Patent Publication 2021/0001113 by Smyth – previously cited (hereinafter “Smyth”).
Raju in view of Geiger teaches the ear-wearable device of claim 1, but does not teach the device configured to detect a change in inner ear fluid pressure based on changes in absorbance of the inner ear.
Fig. 3A of Smyth teaches a device that evaluates the pressure changes in the cochlea (inner portion of the ear). Detecting the pressure changes can enable further monitoring of the health state of the patient, potentially being indicative of an ailment or infection ([0070]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the ear-wearable device of Raju in view of Geiger to be configured to detect a change in inner ear pressure by combining the devices of modified Raju and Lawrence to create a more comprehensive ear-wearable device, capable of monitoring more health conditions of the ear of a patient, such as ailment or infection as taught by Smyth ([0070]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Raju in view of Geiger, as applied to claim 1, in view of US Patent Publication 2015/0314124 by Masaki – previously cited (hereinafter “Masaki”).
Raju in view of Geiger teaches the ear-wearable device of claim 1, but does not teach the device configured to perform at least one of calculate a change in tympanic membrane stiffness based on the change in the identified resonant vibrational frequency; calculate a change in stiffness of ligament connections between bones in the inner ear based on the change in the identified resonant vibrational frequency; or identify a change in the placement position of the ear-wearable device within an ear canal of the device wearer based on the change in the identified resonant vibrational frequency.
Masaki teaches a device that detects changes in the tympanic membrane using a probe frequency at or close to the resonant frequency. Measuring changes in the tympanic membrane at the resonant frequency decreases the time it takes for the stapedius reflex to be detected, which may increase patient safety, especially among pediatric patients ([0022]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the ear-wearable device of Raju in view of Geiger to be configured to detect a change tympanic membrane stiffness by combining the device taught by Raju in view of Geiger with the device taught by Masaki to create a more comprehensive ear-wearable device, capable of monitoring more health conditions, as taught by Masaki. This combination would also decrease the time it takes for the stapedius reflex to be detected, which may increase patient safety, especially among pediatric patients (Masaki; [0022]).
Claims 10, 19-20, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Raju in view of Geiger, as applied to claim 1, in view of US Patent Publication 2010/0166197 by Fukuda et al. – previously cited (hereinafter “Fukuda”).
Regarding claims 10 and 19-20, Raju in view of Geiger teaches the ear-wearable device of claim 1, further comprising a second microphone (the device may include one or more microphones [0062]).
Raju in view of Geiger does not teach wherein at least one of the microphones is configured to be positioned within the external auditory canal or wherein both microphones are configured to be positioned within the ear canal, wherein the microphones are configured to be positioned at two different positions along a lengthwise axis within the external auditory canal, or wherein the ear-wearable device is configured to calculate the location of a standing wave within an ear canal of a wearer of the ear-wearable device.
Figs. 6-7 of Fukuda teaches a resonance tube 501 to be inserted into an external ear canal containing multiple microphones in different positions along a lengthwise axis. The varied locations of the microphones allow for microphones can be located (e.g., positioned) at antinodes of a standing waves corresponding to resonance peaks within the ear canal ([0060]). is easier to specify the frequency characteristics at the resonance peak (Fukuda, [0061]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the microphones of Raju in view of Geiger to include the resonance tube and placement of Fukuda to be positioned within the external auditory canal and be positioned at two different positions along a lengthwise axis within the external auditory canal and to wherein the ear-wearable device is configured to calculate the location of a standing wave within an ear canal of a wearer of the ear-wearable device, in order to enable detecting the peak of the standing wave and make it easier to specify the frequency characteristics at the resonance peak, as taught by Fukuda ([0061]).
Regarding claim 24, Raju teaches an ear-wearable device (See the rejection of claim 1) comprising: a control circuit (See the rejection of claim 1); a microphone (See the rejection of claim 1) in electrical communication with the control circuit (See the rejection of claim 1); an electroacoustic transducer for generating sound in electrical communication with the control circuit (See the rejection of claim 1); a motion sensor in electrical communication with the control circuit (See the rejection of claim 1); a power supply circuit in electrical communication with the control circuit (See the rejection of claim 1); wherein the ear-wearable device is configured to: provide auditory stimulation as a sweep across a range of frequencies (See the rejection of claim 1), and detect vibrations within or about an ear with the microphone (See the rejection of claim 1); identify a resonant vibrational frequency based on detected vibrations (See the rejection of claim 1); compare the identified resonant vibrational frequency to a baseline value (The reflected wave is adjusted by using a baseline signal to obtain a calibrated waveform [122-123]. The calibrated waveform may further by used to determine impaction of the ear. The resonant frequency is compared to a baseline value of 3kHz. An alert may be displayed and/or provided when a feature (e.g., the acoustic dip) is identified outside of this range. Therefore, the position of the resonant frequency is compared to a baseline value of 3kHz).
Modified Raju does not teach the ear-wearable device configured to calculate the location of a standing wave within an ear canal of a wearer of the ear-wearable device.
Figs. 6-7 of Fukuda teaches a resonance tube 501 to be inserted into an external ear canal containing multiple microphones in different positions along a lengthwise axis. The varied locations of the microphones allow for microphones can be located (e.g., positioned) at antinodes of a standing waves corresponding to resonance peaks within the ear canal ([0060]). is easier to specify the frequency characteristics at the resonance peak (Fukuda, [0061]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the microphones of Raju in view of Geiger to include the resonance tube and placement of Fukuda to be positioned within the external auditory canal and to have configured the ear-wearable device to calculate the location of a standing wave within an ear canal of a wearer of the ear-wearable device, in order to enable detecting the peak of the standing wave and make it easier to specify the frequency characteristics at the resonance peak, as taught by Fukuda ([0061]).
Raju in view of Fukuda does not teach the ear-wearable device configured to calculate any changes to the location of the standing wave over time.
Fig. 1 of Geiger teaches a system for obtaining a measurement, where the measurements are stored and trend data related to the measurements are calculated. This system allows for the monitoring of a health parameter and may generate an alert to a care-giver to the presence of a health abnormality is detected ([0048]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the ear-wearable device of modified Raju to be configured to calculate any changes to the location of the standing wave over time to enable the monitoring of the health parameter and alert a care-giver to the presence of a health abnormality if detected, as taught by Geiger ([0048]).
It is noted that Raju in view of Fukuda teaches that position of the standing wave can be used to determine resonant frequencies, and therefore the combination with Fukuda allows the resonant frequency to be determined in an easier manner. The combination with Geiger results in a system that monitors the standing wave over time, therefore a change in the standing wave would result in a change in the identified resonant frequency, which is used to monitor the state of the ear.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Raju in view of Geiger, as applied to claim 1, in view of Correlation of Vestibular Aqueduct Size… (2015) by Seo et al. – previously cited (hereinafter “Seo”).
Raju in view of Geiger teaches the ear-wearable device of claim 1, but does not teach the device configured to estimate the size of the vestibular aqueduct based on the detected vibrations within or about the ear.
Seo teaches a model that estimates three different measures of vestibular aqueduct size based on the results of pure tone analysis. This model allows for the estimation of vestibular aqueduct size based on audiometry (Abstract: Objectives, Conclusions).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the ear-wearable device of Raju in view of Geiger to include the model of Seo to be configured to estimate the size of the vestibular aqueduct based on the detected vibrations within or about the ear. This combination would allow for additional monitoring of large aqueducts, which would create a more comprehensive ear-wearable device, capable of monitoring more health conditions.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Raju in view of Geiger, as applied to claim 1, in view of Inner ear pressure evaluation using wideband… (2020) by Zhang et al., (hereinafter “Zhang”).
Raju in view of Geiger teaches the ear-wearable device of claim 1, but does not teach the device is configured to determine absorbance for a human detectable sound frequency falling within a frequency range of at least one of below 500 Hz, 500 Hz to 4000 Hz, and above 4000 Hz, or the device configured to identify a presence of large vestibular aqueduct syndrome (LVAS) based on the determined absorbance.
Zhang teaches a method of determining absorbance under ambient pressures, and using the absorbances to discriminate between individuals with LVAS and individuals without LVAS (i.e., identify a presence of large vestibular aqueduct syndrome). Zhang teaches that the absorbance of individuals with LVAS was lower than that of normative data over the frequency range of between 700 and 2000 Hz (i.e., between 500 Hz and 4000 Hz) . Zhang further teaches that the absorbance of individuals with LVAS was higher than that of normative data at frequencies above 4000 Hz and below 500 Hz at ambient pressures (Page 3, 3. Results, Characteristics of absorbance at ambient pressure and peak pressure in children with LVAS). This allows absorbance to be a useful diagnostic tool for assessing patients with LVAS (Pages 6-7, 5. Conclusion).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the ear-wearable device taught by Raju in view of Geiger such that the device is configured to determine absorbance for a human detectable sound frequency falling within a frequency range of at least one of below 500 Hz, 500 Hz to 4000 Hz, and above 4000 Hz, and the device is configured to identify a presence of large vestibular aqueduct syndrome (LVAS) based on the determined absorbance. This combination would allow for additional detecting LVAS, which would create a more comprehensive ear-wearable device, capable of monitoring more health conditions, as taught by Zhang (5. Conclusion).
It is noted that this method of discriminating between individuals with normal vestibular aqueducts and LVAS used the absorbance at ambient pressures therefore, a tympanometry device such as the one utilized by Zhang is not necessary. Any device capable of providing sounds at the frequencies of below 500 Hz, 500 Hz to 4000 Hz, and above 4000 Hz at ambient pressures is capable of determining the absorbance at these frequencies.
Claims 16-18 and 55-56 are rejected under 35 U.S.C. 103 as being unpatentable over Raju in view of Geiger, as applied to claim 1, in view of Vestibular Evoked Myogenic Potential (VEMP) Testing… (2020) by Noij et al. – previously cited (hereinafter “Noij”) and Acoustic, mechanical and galvanic stimulation modes… (2009) by Cheng et al., (hereinafter “Cheng”).
Raju in view of Geiger teaches the ear-wearable device of claim 1, but does not teach the device comprising electrodes configured to detect a third window abnormality; a presence of a semi-circular canal dehiscence; or a gross bony abnormality based on the detected vibrations within or about the ear. Raju in view of Geiger does not teach the ear-wearable device further comprising an electrical stimulation electrode in electrical communication with the control circuit, wherein the electrical stimulation electrode is configured to deliver electrical stimulation within or about the ear, or wherein the ear wearable device is further configured to measure vestibular evoked myogenic potential (VEMP) based on an evoked response to the ear from the electrical stimulation.
Noij teaches that cervical vestibular evoked myogenic potential (cVEMP) and ocular vestibular evoked myogenic potential (oVEMP) can be obtained using surface electromyography (Vestibular Evoked Myogenic Potentials, par. 1). The cVEMP and oVEMP can be used to differentiate healthy patients from those with superior semicircular canal syndrome (SCDS) (Vestibular Evoked Myogenic Potentials, par. 3). Therefore, it would be advantageous to measure VEMP to differentiate healthy patients from those with superior semicircular canal syndrome (SCDS).
Cheng teaches that oVEMPs can be obtained through the use of air-conducted sound (ACS) (i.e., acoustic stimulation), bone-conducted vibration (BCS) (i.e., vibrational stimulation), and galvanic vestibular stimulation (GVS) (i.e., electrical stimulation). Cheng teaches that oVEMPs from the ACS and GVS modes may help to differentiate the saccular from the retrosaccular lesions (Abstract), and identify lesions that may affect the afferents between the otolithic organs and vestibular nuclei (Page 1843, 4. Discussion, par. 1). To measure the oVEMPs from the ACS and GVS, electrodes are placed on the face of the subject (Page 1842, 2.1 ACS-oVEMP, par. 1). To deliver the galvanic stimulation, electrical stimulation electrodes configured to deliver electrical stimulation were placed on the mastoid process of the subjects (Page 1842, 2.3 GVS-oVEMP).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the ear-wearable device as taught by Raju in view of Geiger to comprise electrodes and to be configured to identify of third window abnormalities, semicircular canal dehiscence, and gross bony abnormalities, and to have modified the ear-wearable device further comprising an electrical stimulation electrode in electrical communication with the control circuit, wherein the electrical stimulation electrode is configured to deliver electrical stimulation within or about the ear, or wherein the ear wearable device is further configured to measure vestibular evoked myogenic potential (VEMP) based on an evoked response to the ear from the electrical stimulation, as taught by Noij and Cheng. These modifications would allow the ear-wearable device to be a more comprehensive ear-wearable device, capable of monitoring SCDS (Noij) and lesions that may affect the afferents between the otolithic organs and vestibular nuclei (Cheng). Being capable of monitoring more health conditions would result in a more comprehensive ear-wearable device.
It is noted that surface electromyography requires electrodes, therefore is it implied that Noij teaches that the detection of SCDS requires electrodes. Noij further teaches that SCDS is a bony defect (i.e., gross bony abnormality) (Abstract), and that the symptoms caused by SCDS occur due a third window mechanism, caused by the dehiscence (i.e., third window abnormality). It is further noted that the electrical stimulation electrodes must be in electrical communication with a control circuit in order to receive the electrical signals indicative of the electrical stimulation to be delivered.
Claim 57 is rejected under 35 U.S.C. 103 as being unpatentable over Raju in view of Zhang.
Fig. 1 of Raju teaches an ear-wearable device (See the rejection of claim 1) comprising: a control circuit (See the rejection of claim 1); a microphone in electrical communication with the control circuit (See the rejection of claim 1); an electroacoustic transducer for generating sound in electrical communication with the control circuit (See the rejection of claim 1); a motion sensor in electrical communication with the control circuit (See the rejection of claim 1); a power supply in electrical communication with the control circuit (See the rejection of claim 1); wherein the ear-wearable device is configured to:
provide auditory stimulation across a range of frequencies with the electroacoustic transducer (See the Rejection of claim 1); detect vibrations within or about the ear with the microphone (See the rejection of claim 1).
Raju does not teach wherein the ear-wearable device is configured to determine absorbance for a human detectable sound frequency falling within a first frequency range and a second frequency range; and identify a presence of large vestibular aqueduct syndrome (LVAS) based on the determined absorbance.
Zhang teaches a method of determining absorbance under ambient pressures, and using the absorbances to discriminate between individuals with LVAS and individuals without LVAS (i.e., identify a presence of large vestibular aqueduct syndrome). Zhang teaches that the absorbance of individuals with LVAS was lower than that of normative data over the frequency range of between 700 and 2000 Hz (i.e., between 500 Hz and 4000 Hz) . Zhang further teaches that the absorbance of individuals with LVAS was higher than that of normative data at frequencies above 4000 Hz (i.e., first frequency range) and below 500 Hz (i.e., second frequency range) at ambient pressures (Page 3, 3. Results, Characteristics of absorbance at ambient pressure and peak pressure in children with LVAS). This allows absorbance to be a useful diagnostic tool for assessing patients with LVAS (Pages 6-7, 5. Conclusion).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the ear-wearable device taught by Raju in view of Geiger such that the device is configured to determine absorbance for a human detectable sound frequency falling within a first frequency range and a second frequency range; and identify a presence of large vestibular aqueduct syndrome (LVAS) based on the determined absorbance. This combination would allow for additional detecting LVAS, which would create a more comprehensive ear-wearable device, capable of monitoring more health conditions, as taught by Zhang (5. Conclusion).
It is noted that this method of discriminating between individuals with normal vestibular aqueducts and LVAS used the absorbance at ambient pressures therefore, a tympanometry device such as the one utilized by Zhang is not necessary. Any device capable of providing sounds at the frequencies of below 500 Hz, 500 Hz to 4000 Hz, and above 4000 Hz at ambient pressures is capable of determining the absorbance at these frequencies.
Response to Arguments
Applicant's arguments filed 1/12/2026 have been fully considered.
Applicant’s arguments regarding the rejections under 35 U.S.C. 112(a) regarding claims 1 (previous claim 5) and 11 are found persuasive, and the rejections for these claims are withdrawn. Applicant’s arguments regarding the rejections under 35 U.S.C. 112(a) regarding claims 6, 7, 13, and 18 are not found persuasive.
Applicant’s arguments regarding claims 6, 7, 13, and 18 directed towards par. [0089] of the published application describing how changes in the resonant frequency of the ear can be indicative of changes in the ear anatomy are acknowledged. One of ordinary skill in the art would understand, from this recitation, that changes in the identified resonant frequency may be indicative of a change in a property of the ear. However, based on the written description, there is insufficient information such that one of ordinary skill in the art would be able to calculate changes in a specific parameter (claim 7) or estimate a parameter (claim 13). See MPEP 2163.03 V. (“An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved”). Calculating changes and estimating parameters indicates that there is a clear understanding of how the changes in identified resonant frequency are correlated to changes or values in the identified parameter, which is not found in the written description.
Applicant’s arguments regarding the rejection under 35 U.S.C.112(a) of claim 6 are further directed towards par. [0101], which describes how LVAS can be detected based on the detection of properties associated with the pressure of the inner ear. This argument is not found persuasive as the recitation does not provide details on how the device may detect a change in inner ear fluid pressure. See MPEP 2163.03 V. (“An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved”). It is noted that changes in properties associated with pressure of the inner ear is not analogous to changes in inner ear pressure, and also that detection/determination of LVAS does not equate to changes in pressure of the inner ear.
Applicant’s arguments regarding claim 7 is directed towards par. [0096], however the specification does not provide adequate support to determine how changes in tympanic membrane stiffness or stiffness of ligament connections are determined. To calculate a change, there must be a relationship between these parameters and the identified resonant vibrational frequency. One of ordinary skill in the art would understand, based on the written description, that “the identified resonant vibrational frequencies, frequency bands, spectral patterns, frequency or band intensities, and the like” are related to a change in tympanic membrane stiffness, however, it would not be understood how to calculate a change in the stiffness. See MPEP 2163.03 V. (“An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved”). It is noted that Applicant’s argument regarding the rejection of the limitations “identify a change in the placement position of the ear-wearable device within an ear canal of the device wearer based on the change in the identified resonant vibrational frequency” is found persuasive, however the issues under 112(a) for other limitations in the claim result in a 112(a) rejection of claim 7.
Applicant’s arguments regarding claim 18 are directed toward par. [0106] and the device being configured to detect third window abnormalities. It is unclear if there is a threshold, or range of values stemming from the detected vibrations that would correspond to a gross bony abnormality. Par. [0106] recites details pertaining to detecting SSCD, however, this is completed with the use of VEMP, which measure surface electromyography and is not based on the detected vibrations. Therefore, there is not sufficient written support in the specification for the limitations of claim 18.
Applicant’s arguments regarding the rejection of claim 1 under 35 U.S.C. 103 is acknowledged and is not found persuasive. In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). It is reiterated that Raju teaches using the resonant frequency to determine the state of the ear and analyzing the state of the ear, including an amount of fluid in the ear canal. Therefore, Raju teaches determining an amount of fluid in the ear based on the identified resonant vibrational frequency. The modification in view of Geiger provides the analysis of trend data, where parameters related to the health of the patient are monitored over time to determine changes in the parameters.
Applicant’s assertion regarding the rejection of claim 24 under 35 U.S.C. 103 is acknowledged. This assertion is moot as it is based on amendments to the claims not entered at the time of the previous Office action. The newly presented limitations are rejected on new grounds above.
Conclusion
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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791