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 06/02/2026 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 06/02/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1 and 18 have been amended.
Claims 58-60 have been newly presented.
Claims 1, 6-7, 10-11, 13-20, 24, and 55-60 are hereby under examination.
Claim Objections
Claim 58 objected to because of the following informalities:
Claim 58 recites “configured to: detect positions of one or more nodes and/or antinodes of the standing wave; calculate changes to the positions of the one or more nodes and/or antinodes over time” in lines 2-4. This should read “configured to: detect positions of one or more nodes and/or antinodes of the standing wave; and calculate changes to the positions of the one or more nodes and/or antinodes over time.”
Appropriate correction is required.
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 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 contain 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 pressure of 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] which 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.
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 6-7 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 6-7, 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 a change in the identified resonant vibrational frequency 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 a change in the resonant vibrational frequency 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, 24, and 58 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.
Regarding claim 58, the combination of Raju, Fukuda, and Geiger teaches the ear-wearable device of claim 24, wherein the ear-wearable device is configured to: detect positions of one or more nodes and/or antinodes of the standing wave (The resonance tube of Fukuda is placed at the node/anti-nodes of at least two standing waves (see Fig. 6 of Fukuda). The differences in the frequency characteristics of the response acoustic signals identifies (i.e., detects) at least the position of node of the standing wave at microphone 202 (See Fig. 7 of Fukuda)); calculate changes to the positions of the one or more nodes and/or antinodes over time (The modification in view of Geiger teaches monitoring the changes to the health parameters over time. As the position of the standing wave is important to the detection of the resonant frequency (See Fig. 7 of Fukuda), a change in the detected identified resonant frequency over time can also indicate a change in the position of the node of the standing wave over time, as this effects the detected identified resonant frequency).
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. – previously cited, (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. – previously cited, (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 configured to measure a vestibular evoked myogenic potential (VEMP), wherein the device is configured to detect gross bony abnormality based on the measured VEMP. 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.
Claim 59 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 2007/0195979 by Thomasson et al., hereinafter “Thomasson”.
The combination of Raju and Geiger teaches the ear-wearable device of claim 1, but does not teach the device further comprising an external microphone mounted on a housing of the ear-wearable device, wherein signals from the external microphone are used to at least one of subtract or normalize ambient sound contributions from signals of a microphone positioned within the external auditory canal.
Thomasson teaches that hearing tests can be completed by using ear-wearable devices such as hearing aids. An external microphone can be coupled to the hearing aid in order to filter out sounds during an auditory test. By using noise cancellation, a hearing test can be made more accurate because the threshold to hearing is lowered ([0018]).
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 further comprises an external microphone mounted on a housing of the ear-wearable device, wherein signals from the external microphone are used to at least one of subtract or normalize ambient sound contributions from signals of a microphone positioned within the external auditory canal, in order to make a hearing test more accurate, as taught by Thomasson ([0018]). It is noted that Raju also teaches that noises may be cancelled by using noise cancelling techniques in order to not impact the techniques taught by Raju ([0104]).
Claim 60 is rejected under 35 U.S.C. 103 as being unpatentable over Raju in view of Geiger in view of Noij in view of Cheng, as applied to claims 16-18, in view of Toward Optimizing Vestibular Evoked Myogenic Potentials… by Noij et al. (2017), hereinafter “Noij ‘17” in view of US Patent Publication 2015/0032186 by Cushing et al., hereinafter “Cushing”.
The combination of Raju, Geiger, Noij, and Cheng, as applied to claims 16-18, teaches the ear-wearable device of claim 1, wherein the ear-wearable device is configured to: measure an evoked response of a sternocleidomastoid muscle (Noij, Pg. 3, Vestibular Evoked Myogenic Potentials; “cVEMP and oVEMP can be obtained during acoustic or vibrational stimulation of the ear while responses are recorded and averaged using surface electromyography of the contracted ipsilateral sternocleidomastoid muscle for cVEMP”); but does not teach the device being configured to use signals from the motion sensor to determine a head position that causes the sternocleidomastoid muscle to tense.
Noij ’17 teaches that during cVEMP testing, subjects sit straight up and turn their heads away from the stimulated ear in order to contract the sternocleidomastoid muscle (SCM) (Page 3, Methods, cVEMP testing). The use of this head motion allows for cVEMP to be obtained without the need for maximal or high muscle contractions, which is especially beneficial in patients for whom reaching high levels of SCM contractions can be challenging (Pg. 9, Conclusion).
Steinmetz teaches a method of using a motion/orientation sensor in order to determine the user’s head position, and based on the user’s head position, directing or instructing the user to turn their head to be in a direction required to complete a particular task ([0051]).
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 the combination of Raju, Geiger, Noij, and Cheng such that the device was configured to use signals from the motion sensor to determine a head position that causes the sternocleidomastoid muscle to tense, as using motion sensors can detect the current position of the user’s head and direct the user to assume a target position as taught by Steinmetz ([0051]) and a target head position of turning the user’s head away from the stimulated ear causes the SCM to contract (i.e. tense) without the need for maximal or high muscle contractions (Noij ’17, Pg. 9, Conclusion). It is noted that motion sensor of Steinmetz can detect (i.e., determine) whether the user is in the position causing the SCM to contract.
Response to Arguments
Applicant's arguments filed 06/02/2026 have been fully considered.
Applicant’s arguments regarding the rejection of claim 6 under 35 U.S.C. 112(a) is acknowledged. This argument is not found persuasive. Applicant argues that par. [0101] teaches that inner ear pressure can be monitored as a function of absorbance. Par. [0101] states "In various embodiments, large vestibular aqueduct syndrome (LVAS) can be detected based on the detection of properties associated with the pressure of the inner ear." This means that LVAS is determined based on properties associated with inner ear pressure. Par. [0101] describes the use of absorbance in detecting LVAS. This indicates that absorbance is a property associated with inner ear pressure. There is no recitation regarding using the absorbance to detect changes in inner ear fluid pressure. Further, there is no recitation of inner ear fluid pressure in par. [0101]. Therefore, the rejections of claim 6 under 35 U.S.C. 112(a) and 112(b) are maintained.
Applicant’s arguments regarding the rejection of claim 7 under 35 U.S.C. 112(a) is acknowledged. Applicant argues that par. [0089] describes how changes in the resonant vibrational frequency of the ear can be indicative of changes in the ear anatomy and/or properties, and that par. [0096] describes the ear-wearable device being configured to complete the functional limitations of claim 7. Examiner agrees that one of ordinary skill in the art, at the time of the effective filing date of the filed invention would be able to 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. This is because a change only requires a difference in the identified resonant vibrational frequency to relate to a change in the placement position of the ear-wearable device within an ear canal of the device wearer. However, based on the written description, there is insufficient information such that one of ordinary skill in the art would be able to perform the other limitations of claim 7 (“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”). 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 of claim 13 under 35 U.S.C.112(a) are acknowledged. These arguments are found persuasive. The detection of LVAS at least estimates the size of the vestibular aqueduct to be large or of normal size. Therefore, the rejections of claim 13 under 35 U.S.C. 112(a) and 112(b) are withdrawn.
The amendments to claim 18 overcomes the rejections to the claims under 35 U.S.C. 112(a) and 112(b).
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). Applicant argues that because Geiger teaches a monitor that will alert the caregiver to the presence of a blockage or an undesirably high or low flow rate and that Geiger's device measures the current CSF flow rate and compares it to a threshold value. This is not found persuasive. Examiner points to Geiger teaching that "External monitor 18 may be configured to apply additional processing to CSF flow information… to generate average, maximum, minimum, and trend data". The calculation of these measure requires the device to compare the current measurement with previously measured values. Applicant argues that Geiger does not explicitly describe measuring changes in CSF flow rate over time. This argument is not found persuasive. The generation of average, maximum, minimum, and trend data requires the use of data points over different periods of time. 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 arguments regarding the rejection of claim 24 under 35 U.S.C. 103 is acknowledged. Applicant argues that the static configuration of the Fukuda microphones means that it does not teach calculating changes to the location of the standing wave over time. This argument is not found persuasive. The device of Fukuda is capable of calculating a location of the standing wave of the ear canal based on a specific configuration, therefore, and changes to the detection of the standing wave would correspond to a change in the location of the standing wave. Geiger teaches the analysis of trend data, and therefore changes/deviations to the location of the standing wave comprises calculating a change to the location of the standing wave over time. The modification of the detection of the location of the standing wave of Fukuda in view of Geiger is similar to that of the modification of Raju in view of Geiger as applied to claim 1.
Applicant’s arguments regarding the rejection of claim 57 under 35 U.S.C. 103 is acknowledged. Applicant argues that Zhang does not use absorbance measurements to identify LVAS in patients, but rather uses wideband tympanometry to assess the middle ear function of subjects that have already been diagnosed with LVAS. This argument is not found persuasive. Zhang teaches that the presence of LVAS was determined with wideband tympanometry, and that the absorbance of the individuals' ears could also be used to determine (i.e., classify) the individuals as having LVAS or not. Therefore, the use of absorbance to determine if an individual has LVAS is taught by Zhang. It would be obvious to one of ordinary skill in the art to use either wideband tympanometry, or absorbance measurements to determine LVAS in an individual.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Publication 2021/0236339 by Bonnet et al. teaches a method of using measurements from microphones in multiple locations in the ear canal to determine standing wave minimums (nodes) and maximums (anti-nodes).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/NELSON ALEXANDER GLOVER/
Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
