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 .
Status of Claims
The amendments and remarks filed on 08JUN2026 have been entered and considered.
Claims 1-15 are currently pending.
No claims have been amended.
Claims 1-15 are under examination.
Response to Arguments
Applicant's arguments filed 08JUN2026 regarding the rejections under 35 USC 102(a)(1) have been fully considered and have been found to be not persuasive. Parts deemed not persuasive discussed below:
Applicant states (see Pages 7-9 of the Remarks):
Fung fails to disclose "generating a user interaction audio signal indicative of an interaction of the patient with the hearing prosthesis system and apply perceivable hearing stimulation to the patient according to the user interaction audio signal, wherein the user interaction audio signal is a feedback message signal indicative of a user action on a user interface of the hearing prothesis system; and recording, via the electrode array and the cochlear implant, the neural response to said hearing stimulation according to the user interaction audio signal, thereby utilizing the user interaction audio signal as a test audio signal' as recited in claim 1 (emphasis added).
In particular, Fung describes an electro-acoustic hearing prosthesis 100 that samples, over a period of time, neural activity of a recipient in response to electrical and/or acoustic stimulation signals. Fung, paragraphs [0040]-[0043]. Fung further describes that the sampling can be inter- dispersed with the typical operation of the hearing prosthesis. Id. Because Fung describes using dedicated measurement stimulation signals for neural sampling, Fung fails to disclose that the sampling of the neural activity is in response to a user interaction audio signal that is a feedback message signal indicative of a user action on a user interface of the hearing prothesis system.
On pages 5 and 6 of the Office Action, the Office construed paragraph [0073] of Fung to teach recording a neural response to a hearing stimulation according to a user interaction audio signal. However, paragraph [0073] of Fung describes that a determination of perception changes of the recipient may be based not only on the levels of inner ear responses, but also or alternatively on the phase, shape of the responses, or frequency or indirect user feedback. For example, Fung provides that "a system that observes auditory environmental composition, and correlates a user-induced reduction in volume when the environment is dominated by low frequency content may be used as an indicator of increased sensitivity to low frequency (acoustical) stimulation." Fung, paragraph [0073].
Accordingly, the reduction in volume described by Fung is not based on recording a neural response measurement in response to electrical stimulation. Moreover, the perception of the normal environmental audio signal at the reduced volume setting described in Fung is based on indirect feedback of observed behavior, not a "feedback message signal indicative of a user action on a user interface of the hearing prosthesis system," as recited in claim 1. For example, Fung fails to disclose generating a feedback message signal tied to the user interaction of reducing the volume setting (e.g., the perception does not include a message specifically linked to the user action on the volume button). Fung thereby fails to disclose a feedback message signal indicative of a user action on the user interface that is used as a test audio signal for neural response measurements via the electrode array.
Fung further teaches away from using a feedback message signal as a neural response measurement stimulus. For example, Fung relies on structured electrical stimulation signals that are generated and delivered to a recipient with a predetermined level and/or loudness in accordance with an operational map. Fung, paragraph [0036]. Such structured electrical simulation signals of Fung teach away from using a feedback message signal as a test audio signal (e.g., a feedback message signal is not designed for repeatable neural response testing in the manner of the structured electrical stimulation signals described in Fung) such that one of ordinary skill in the art would not be motivated to substitute a feedback message signal for the electrical stimulation signals described in Fung.
However, the arguments are not persuasive. While the applicant argues that Fung only uses automated indirect feedback (i.e. environmental tracking), Fung encompasses a system that changes internal settings based on how a user reacts to sounds. This system changes in the frequency, intensity, phase, etc. along with directly reducing the devices low frequency sensitivity. Turning down the sensitivity of a hearing aid is equivalent to turning down the volume. Additionally, Fung includes a built in operational map to deliver electrical stimulation signals to a patient at predetermined levels of loudness(See i.e. Fung ¶0036 “to automatically adjust, in real-time, one or more operations that control the conversion of sound signals into acoustic stimulation signals and/or the electrical stimulation signals”). Therefore, the underlying processing instructions to manage volume is already built into the prior art. Adding a standard volume button or screen interface to trigger the pre-mapped loudness setting doesn’t generate unexpected results, this just routes an existing setting through a manual pathway so a user can override volume settings for comfort and the device may adjust the calibration in response to this adjustment.
Applicant's arguments filed 08JUN2026 regarding the rejections under 35 USC 103(a) have been fully considered and have been found to be not persuasive. Parts deemed not persuasive discussed below:
Applicant states (see Page 9 of the Remarks):
Dependent claim 4 was rejected under 35 U.S.C. § 103 as being unpatentable over the combination of Fung and U.S. Patent Application Publication No. 2020/0054877 ("Calixto"). The dependent claims rejected under Section 103 are patentable over the cited art for at least the same reasons presented above with respect to the independent claims. In addition, the dependent claims are further distinguished from the cited art by the additional features recited therein.
Applicant's remaining arguments amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. Rejections are maintained – and no allowable subject matter can be identified at this time.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-3 & 5-15 are rejected under 35 U.S.C. 103 as being anticipated by Fung et al. (US Publication No. 20180085581; Previously Cited).
Regarding claim 1, Fung discloses a hearing prosthesis system (Fung Title “Perception Change-Based Adjustments In Hearing Prostheses”; Abstract) comprising: an electrode array configured to be implanted within a patient (Fung contact array 140; ¶0030 “Elongate stimulating assembly 126 is configured to be at least partially implanted in the recipient's cochlea 120 and includes a plurality of longitudinally spaced intra-cochlear electrical stimulating contacts (electrodes) 138 that collectively form a contact array 140 for delivery of electrical stimulation (current) to the recipient's cochlea.”); a cochlear implant (Fung Cochlear implant 100 as seen in Figure 1) coupled to the electrode array and configured to be implanted within the patient (Fung Figure 1 Showing implant 100 is connected to the stimulating assembly 124 which includes electrode array 140); and a processing unit (Fung Processor 112 as seen in Figure 1B) communicatively coupled to the cochlear implant (Fung Figure 1B showing coils 106/136 which are used to connect the sound processing unit including processor 112 to the implant)wherein the processing unit is configured to: direct the cochlear implant to apply stimulation to a cochlea of the patient via the electrode array (Fung ¶0038 “As such, the sound processor 112 is generally configured to execute sound processing and coding, defined by the recipient's operational map, to convert received sound signals into output signals that represent the acoustical or electrical stimulation signals for delivery to the recipient.”); detect, via the electrode array, a neural response of the patient to the stimulation (Fung ¶0008 “one or more processors configured to: sample, via one or more of the stimulating contacts, neural activity of the recipient in response to measurement stimulation signals delivered by the hearing prosthesis, analyze the sampled neural activity to determine that the recipient has experienced a sound perception change, “);and perform active objective neural response measurements during normal use of the hearing prothesis system (Fung ¶0042 “The sampling can also be inter-dispersed with the typical operation of the hearing prosthesis such that the inner ear responses and can be obtained at a substantially regular rate.” Showing the measurements are performed during normal use of the hearing system; ¶0023 “Presented herein are substantially automated techniques that enable an electro-acoustic or other hearing prosthesis implanted in a recipient to use objective measurements to determine when the recipient is likely experiencing sound perception changes” Showing the device performing automated objective response measuring; ¶0036); generating a user interaction audio signal indicative of an interaction of a patient with a hearing prosthesis system (Fung ¶0073 “these determinations can be made based not only on the levels (i.e., magnitude/amplitude), but also or alternatively on the phase, shape of the responses (morphology), frequency, indirect user feedback, or other aspects of the responses. In certain examples, a system that observes auditory environmental composition, and correlates a user-induced reduction in volume when the environment is dominated by low frequency content may be used an indicator of increased sensitivity to low frequency (acoustical) stimulation.” Showing the user interaction on the system (volume change) is additionally used in consideration of perception changes along with a recorded neural response, such that the volume change indicates to the device that the perception map needs recalibration and uses this input as a basis for the recalibration. This is tied to ¶0043 where the interaction is integrated into normal use of the device for streamlined calibrations. The device would therefore change the audio signal due to the volume change and test if the device is operating optimally with the new volume) applying perceivable hearing stimulation to the patient according to the user interaction audio signal, wherein the user interaction audio signal is a feedback message signal indicative of a user action on a user interface of the hearing prothesis system (Fung ¶0073 “In certain examples, a system that observes auditory environmental composition, and correlates a user-induced reduction in volume when the environment is dominated by low frequency content may be used an indicator of increased sensitivity to low frequency (acoustical) stimulation.” Where it has been established that calibrations are performed during normal device operations (see ¶0043) so as to not interrupt the user’s hearing ability, and the change in volume of the device is user feedback which provides a audio signal indicative of the user interaction on the system; ¶0036 “In particular, in response to detection of a perception change, the perception monitoring module 118 is configured to automatically adjust, in real-time, one or more operations that control the conversion of sound signals into acoustic stimulation signals and/or the electrical stimulation signals in a manner that ensures the recipient will again perceive sound signals inline with the original perceptions selected in the fitting process.”); and(Fung Figure 2B showing the steps for the objective adjustments to the hearing system. This shows the process of recording neural responses (step 252), determining a sound perception change (step 254) which the examiner notes ¶0073 shows an example of this determination using a user change in volume as a interaction on the system, and the new volume level can be interpreted as the resulting audio signal induced by the user interaction. This is looped back to recording a new signal in step 278 which leads back to the beginning of the process, recording of responses based on a new perception map.).
Regarding claim 2, claim 1 is anticipated by Fung. Fung further discloses wherein the user interaction audio signal includes a status message signal indicative of a change in a condition of the hearing prosthesis system. (Fung Claim 9 “triggering at least one of an audible or visual alert indicative of the sound perception change.”).
Regarding claim 3, claim 1 is anticipated by Fung. Fung further discloses wherein the user interaction audio signal is selected such that it is perceivable by the patient as a standard sound associated with the respective feedback message or a status message. (Fung ¶0019 “The addition of the acoustic stimulation can, in some cases, also provide improved pitch and music perception and/or appreciation, as the acoustic signals may contain a more salient lower frequency (e.g., fundamental pitch, F0) representation than is possible with electrical stimulation.” Showing that the acoustic stimulation is performed as a harmonic).
Regarding claim 5, claim 1 is anticipated by Fung. Fung further discloses wherein a feedback message signal is indicative of a user action resulting in a volume reduction (Fung ¶0073 “In certain examples, a system that observes auditory environmental composition, and correlates a user-induced reduction in volume when the environment is dominated by low frequency content may be used an indicator of increased sensitivity to low frequency (acoustical) stimulation.”).
Regarding claim 6, claim 1 is anticipated by Fung. Fung further discloses wherein the feedback message signal is in response to a user action on an operator control. (Fung ¶0073 “In certain examples, a system that observes auditory environmental composition, and correlates a user-induced reduction in volume when the environment is dominated by low frequency content may be used an indicator of increased sensitivity to low frequency (acoustical) stimulation.”).
Regarding claim 7, claim 1 is anticipated by Fung. Fung further discloses wherein the processing unit is configured to apply the perceivable hearing stimulation corresponding to the user interaction audio signal at a level within a comfort range (Fung ¶0071 “This strategy may be developed based on adjustments made for other recipients experiencing the same disease and, possibly, sharing common attributes (e.g., age, type of deafness, etc.) with the recipient. In one embodiment, the electro-acoustic hearing prosthesis 100 temporarily reduces the acoustic stimulation level, monitors the situation, and notifies a hearing professional or other medical practitioner”; ¶0073; The Examiner notes that adjusting the volume based on the sensitivity of the user is adjusting the volume to be more comfortable for the user).
Regarding claim 8, claim 1 is anticipated by Fung. Fung further discloses wherein the audio signal includes sinusoidal tones (Fung ¶0019 “The addition of the acoustic stimulation can, in some cases, also provide improved pitch and music perception and/or appreciation, as the acoustic signals may contain a more salient lower frequency (e.g., fundamental pitch, F0) representation than is possible with electrical stimulation. Other benefits of electro-acoustic hearing prosthesis may include, for example, improved sound localization, binaural release from unmasking, the ability to distinguish acoustic signals in a noisy environment, etc.”).
Regarding claim 9, claim 1 is anticipated by Fung. Fung further discloses wherein the recording of the neural response to the audio signal includes one or more of electrocochleography (ECochG) threshold measurements, cortical response measurements, or electrode impedance measurements (Fung ¶0056 “ As noted above, the inner ear responses may include physiological potentials, such as acoustically-evoked potentials (i.e., an ECoG response) and electrically-evoked potentials (e.g., ECAP, EABR, stapedial reflex threshold (ESRT), etc.), and/or physiological electrical potentials (e.g., EVT, impedances, etc.).”).
Regarding claim 10, claim 1 is anticipated by Fung. Fung further discloses wherein the processing unit is configured to apply said perceivable hearing stimulation to the patient according to the user interaction audio signal as electrical stimulation via the electrode array (Fung ¶0056 “ the electro-acoustic hearing prosthesis 100 also implements process 250 as described above. In particular, at 252 the electro-acoustic hearing prosthesis 100 samples, over a period of time, the recipient's neural activity based on acoustic and electrical stimulation (i.e., receives and stores inner ear responses evoked by acoustic and/or electrical stimulation via one or more of the stimulating contacts 138”).
Regarding claim 11, claim 1 is anticipated by Fung. Fung further discloses wherein the hearing prosthesis system is an electric acoustic stimulation (EAS) system (Fung ¶0025 “FIG. 1A is schematic diagram of an exemplary electro-acoustic hearing prosthesis 100 configured to implement embodiments of the present invention, while FIG. 1B is a block diagram of the electro-acoustic hearing prosthesis. The electro-acoustic hearing prosthesis 100 includes an external component 102 and an internal/implantable component 104.”) including an electroacoustic output transducer (Fung ¶0027 “The receiver 142 is an acoustic transducer that is configured to deliver acoustic signals (acoustic stimulation signals) to the recipient via the recipient's ear canal and middle ear.”), and wherein the processing unit is configured to apply said perceivable hearing stimulation to the patient according to the user interaction audio signal as acoustic stimulation via the electroacoustic output transducer (Fung ¶0038 “As such, the sound processor 112 is generally configured to execute sound processing and coding, defined by the recipient's operational map, to convert received sound signals into output signals that represent the acoustical or electrical stimulation signals for delivery to the recipient.”).
Regarding claim 12, claims 1 & 11 are anticipated by Fung. Fung further discloses wherein the recording of the neural response to the audio signal includes measurement of ECochG signals (Fung ¶0056 “ As noted above, the inner ear responses may include physiological potentials, such as acoustically-evoked potentials (i.e., an ECoG response) and electrically-evoked potentials (e.g., ECAP, EABR, stapedial reflex threshold (ESRT), etc.), and/or physiological electrical potentials (e.g., EVT, impedances, etc.).”).
Regarding claim 13, claim 1 is anticipated by Fung. Fung further discloses wherein the processing unit is configured to automatically adjust fitting parameters of the hearing prosthesis system according to the recorded neural response. (Fung ¶0036 “In particular, in response to detection of a perception change, the perception monitoring module 118 is configured to automatically adjust, in real-time, one or more operations that control the conversion of sound signals into acoustic stimulation signals and/or the electrical stimulation signals in a manner that ensures the recipient will again perceive sound signals inline with the original perceptions selected in the fitting process.”; ¶0057 “At 254 the perception monitoring module 118 analyzes the sampled neural activity to objectively determine perception changes that the recipient may be experiencing. If it is determined at 254 that the recipient is not experiencing perception changes, then the method returns to 252 where the electro-acoustic hearing prosthesis 100 will continue to sample the neural activity. However, if it is determined at 254 that the recipient is likely experiencing perception changes, then the method proceeds to 256 where the perception monitoring module 118 determines one or more adjustments to the recipient's operational map to remediate the perception changes.”).
Regarding claim 14, claims 1 & 13 are anticipated by Fung. Fung further discloses wherein the processing unit is configured to automatically adjust stimulation threshold levels of the hearing prosthesis system according to the recorded neural response and wherein the user interaction audio signal results in hearing stimulation suitable for determining the respective threshold from the recorded neural response (Fung¶0057 “At 254 the perception monitoring module 118 analyzes the sampled neural activity to objectively determine perception changes that the recipient may be experiencing. If it is determined at 254 that the recipient is not experiencing perception changes, then the method returns to 252 where the electro-acoustic hearing prosthesis 100 will continue to sample the neural activity. However, if it is determined at 254 that the recipient is likely experiencing perception changes, then the method proceeds to 256 where the perception monitoring module 118 determines one or more adjustments to the recipient's operational map to remediate the perception changes.”).
Regarding claim 15, claims 1 & 13-14 are anticipated by Fung. Fung further discloses wherein the recording of the neural response includes cortical response measurements for adjustment of electrical stimulation thresholds (Fung ¶0040-0041; ¶0041 “As used herein, “inner ear responses” or “inner ear potentials” refer to any voltage potential associated with either the electrical properties of the inner ear or its physiological function and/or potentials obtained via measurements at the inner ear. Potentials of a physiological nature (i.e., potentials relating to the physiological function of the inner ear), include ….and cortical responses.”).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Fung et al. (US Publication No. 20180085581; Previously Cited) as detailed in the 102(a)(1) section above, and further in view of Calixto et al. (US Publication No. 20200054877).
Regarding claim 4, claims 1-2 are anticipated by Fung. Fung does not disclose wherein the status message signal is indicative of a low battery status. Calixto in a similar field of endeavor of adaption cochlear implant stimulation parameters teaches wherein the status message signal is indicative of a low battery status. (Calixto ¶0155 “Thus, for example, if it is determined that a particular electrode impedance, if reached, will cause the cochlear implant system to consume battery life too rapidly (e.g., fast enough to not meet the prespecified minimum battery life limit specified for the cochlear implant system), the baseline impedance may be designated to be the particular electrode impedance and the predetermined threshold may be set close enough to the particular electrode impedance to indicate that the cochlear implant system is likely to consume more than the maximum amount of battery power required for the battery life to meet the prespecified minimum battery life limit (e.g., allowing an alert to be sent to a user associated with the cochlear implant system or another suitable operation to be performed).”).
Before the effective filing date, one of ordinary skill in the art would think to combine the cochlear implant of Fung with the instructions for generating a status message signal that’s is indicative of a low battery status, as taught in Calixto, since The sampling can also be inter-dispersed with the typical operation of the hearing prosthesis such that the inner ear responses and can be obtained at a substantially regular rate (Fung ¶0042), such as through operational notifications for the user.Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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 date of this final action.
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/MEGAN T FEDORKY/
Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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