DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of claims 1-9 in the reply filed on August 10, 2026 is acknowledged.
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention(s), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 10, 2026.
Response to Amendment
The amendment filed August 10, 2026 has been entered.
Examiner acknowledges Applicant’s cancellation of withdrawn claims 10-20 and addition of new claims 21-31.
Claims 1-9 and 21-31 are pending.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-9, 21-24, and 26-31are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Henriksen et al. (US 20120029383 A1) (disclosed by Applicant) (hereinafter – Henriksen).
Re. Claim 1: Henriksen teaches a method, comprising:
while attenuating noise from a physical environment at a first device (Paragraph 0062: “Embodiments of the device might typically comprise a sealing section (for preventing noise from reaching the user's eardrum), such as a hearing protection device…;” Paragraph 0063: “Such devices could also be configured for optional active noise reduction (for example, in addition to passive noise reduction provided by the sealing section/hearing protection device), by using the outer microphone to detect external sounds and/or the inner microphone to detect sound at the eardrum, processing the detected sound to provide a signal for active noise cancellation, and using the loudspeaker to generate the acoustic cancellation signal;” Paragraph 0068: “The insert portion 110 includes a sealing element 112 that forms a secure fit within the user's ear canal to passively block sound infiltration into the user's eardrum, serving as a passive attenuation hearing protection device;” Paragraph 0082: “It is also possible that the audiometric testing could be performed even in loud environments that are not sufficiently attenuated by the hearing protection device by using additional sound attenuation (such as active noise reduction and/or passive noise reduction earmuffs over the earplug-type hearing protection device)”),
outputting, by the first device, an audio signal for detection by a user (Figs. 7-13; Paragraph 0066: “When the user wishes to initiate an audiometric test, the electronics unit would transmit one or more signals to the sound generator (while the earplugs are still inserted in the user's ear canal), running the audiometric test. In response to the signal(s) from the electronics unit, the sound generator would generate one or more sound stimulus, creating a sound field in the user's meatus to implement the audiometric test;” Paragraph 0069: “The external electronics unit would typically include a user interface, storage memory with the audiometric testing protocol/procedures, and storage memory for the user's responses during the test and the test results, and would be configured to run the audiometric test (by for example generating sound stimulus signals to direct the speaker 103 to generate sound stimulus within the user's ear, recording responses, iteratively modifying the sound stimulus level based on user responses, determining the estimated hearing threshold, and remembering which frequency to test for a given test session)”); and
providing,
by the first device and to a second device (Fig. 1, as described in Paragraph 0064: a first device may be earplug 20 and a second device may be electronics unit 24; Fig. 14, as described in Paragraphs 0068-0069: external electronics unit acting as a second device),
an indication of an estimated noise level of the attenuated noise at the first device for storage in association with an indication of whether the audio signal was detected by the user (Paragraph 0069: “The external electronics unit would typically include a user interface, storage memory with the audiometric testing protocol/procedures, and storage memory for the user's responses during the test and the test results, and would be configured to run the audiometric test (by for example generating sound stimulus signals to direct the speaker 103 to generate sound stimulus within the user's ear, recording responses, iteratively modifying the sound stimulus level based on user responses, determining the estimated hearing threshold, and remembering which frequency to test for a given test session)… The electronics unit would then be configured to assess noise exposure based on the signal from the inner microphone 105, and store noise exposure data on memory;” Paragraph 0062: analysis of noise exposure levels and then administration of a test related to one or more of frequencies of concern based on noise levels; Paragraph 0074: “The memories E8, E9, E10, and E13 are used for storing computer programs, filter coefficients, test responses, test results, noise exposure data, analysis data, and/or other relevant data;” Paragraph 0081: “The noise level may also be measured and/or recorded. Optionally, the noise level may then be used to determine if conditions are appropriate for an audiometric test (i.e. checking to ensure that the background noise level is not too high for effective testing). If noise conditions are too loud, then the user may be warned, or the audiometric test may be disabled”).
Re. Claim 2: Henriksen teaches the invention according to claim 1, and further teaches the invention wherein the audio signal is a first audio signal (Paragraph 0007: “…generating one or more test signals directed to the sound generator means in order to cause generation of sound stimuli for an audiometric test…”),
further comprising:
when the estimated noise level of the attenuated noise satisfies a threshold, outputting, by the first device, a second audio signal for detection by the user, wherein the first audio signal and the second audio signal have different frequencies (testing is restricted if a noise level is too high, as described at Paragraphs 0076, 0081; if noise level is below the restriction level, a full audiometric test comprises multiple differing frequencies as described at Paragraph 0064: “This electronic coupling allows the electronics unit 24 to transmit electrical signals to the speaker, directing/causing the speaker 22 to generate sound stimulus at one or more frequencies in order to implement an audiometric test;” Paragraph 0065 “… the electronics unit might automatically administer an audiometric test (which might focus on detected frequencies of concern);” claim 3: “…a sound generation means operable to produce sound stimuli at various frequencies and sound pressure levels; and an electronics unit configured to be operable to generate one or more test signals directed to the sound generator means in order to cause generation of sound stimuli for an audiometric test”).
Re. Claim 3: Henriksen teaches the invention according to claim 1, and further teaches the invention further comprising:
when the estimated noise level of the attenuated noise does not satisfy a threshold and when a number of attempts for outputting the audio signal is below a target number, outputting, by the first device, the audio signal again for detection by the user (Paragraph 0051: “Another concern is the possibility that the user might fail to respond to a particular sound stimulus, even though they can hear the sound stimulus, due to inattention. This type of error might lead to an estimated hearing threshold that is significantly above the actual threshold. To correct such possible errors, it might be advisable to repeat the test in an attempt to achieve a more accurate result if too high a threshold is detected. So for example, the criteria for retest might be if the estimated hearing threshold is determined to be more than about 15-20 dB from the assumed threshold. In such instances, then the test could be re-run two additional times (on the assumption that the user would be unlikely to be inattentive over multiple tests), with the closest two test results being averaged to determine the ultimate estimated hearing threshold. FIG. 13 illustrates an embodiment of an exemplary procedure for detecting and addressing possible inattention”).
Re. Claim 4: Henriksen teaches the invention according to claim 1, and further teaches the invention wherein the first device comprises
an audio input device (Fig. 1: jack or terminal 26 which allows external unit 24 to supply signals to sound generator 22; see also – any other audio signal generating component in each other figure),
an audio output device (Fig. 1: sound generator 22; see also – any other audio output component in each other figure), and
a sealing member between the audio input device and the audio output device (Fig. 1: earplug 20; see also – any other sealing component in each other figure), and
wherein the estimated noise level of the attenuated noise is based at least in part on an estimated performance of the sealing member (Paragraph 0081: in addition to measuring and recording noise level, the quality of the seal may be checked against criteria corresponding to an adequate seal).
Re. Claim 5: Henriksen teaches the invention according to claim 4, and further teaches the invention further comprising:
prior to outputting the audio signal, executing a test to obtain the estimated performance of the sealing member (Paragraph 0081: “This might be accomplished by generating a pre-determined sound stimulus in the user's ear canal (underneath the hearing protection device), measuring the transfer from the input of the loudspeaker SG to the output of the inner microphone M2, and comparing the transfer function to criteria corresponding to an adequate seal. If the seal is inadequate, the user might then be warned”).
Re. Claim 6: Henriksen teaches the invention according to claim 1, and further teaches the invention wherein the noise includes ambient stationary noise and ambient instantaneous noise (see citations of claim 1 – the step of using a device which attenuates noise, e.g., via a sealing section or by active noise attenuation, at an environment such as a work site (as described in 0079, 0082) would be understood by the skilled artisan to attenuate both stationary and ambient noise depending upon the environment of use).
Re. Claim 7: Henriksen teaches the invention according to claim 1, and further teaches the invention wherein the audio signal corresponds to a hearing test tone (Paragraph 0061: “While any type of sound stimulus might be used during testing (so long as it represents approximately the required frequency and sound pressure level), more typically the sound stimulus would be pure tone. Alternatively, the sound stimulus could be a chirp. A chirp sound stimulus may be easier to detect in the presence of background noise, which would allow for more effective testing within the workplace environment”).
Re. Claim 8: Henriksen teaches the invention according to claim 1, and further teaches the invention wherein the noise is attenuated at a location between the first device and an ear of the user (see citations of claim 1 – passive noise isolation and active noise cancellation both cause a reduced level of noise between a first device and the user’s ear).
Re. Claim 9: Henriksen teaches the invention according to claim 1, and further teaches the invention wherein the estimated noise level of the attenuated noise at the first device represents an estimated attenuated noise level at an eardrum of the user (Paragraph 0010: “In another embodiment, the device might further comprise a microphone for detecting sound levels in the ear canal (near the eardrum) under the sealing element. This would allow for noise exposure levels to be determined and recorded”).
Re. Claim 21: Henriksen teaches a device, comprising:
an audio output device (Fig. 1: sound generator 22; see also – any other audio output component in each other figure);
an audio input device (Fig. 1: jack or terminal 26 which allows external unit 24 to supply signals to sound generator 22; see also – any other audio signal generating component in each other figure);
one or more processors (Paragraph 0039: “Typically, the electronics unit would comprise a computer processor programmed/configured to run one or more audiometric test protocols, generating appropriate signals to cause the sound generator to generate one or more sound stimulus in the user's meatus in accordance with the programmed test protocols”); and
memory storing instructions that, when executed by the one or more processors, cause the device to:
while attenuating noise from a physical environment at the device, output an audio signal for detection by a user (see previous citation and citations of claim 1); and
provide, to a second device, an indication of an estimated noise level of the attenuated noise at the device to be stored in association with an indication of whether the audio signal was detected by the user (both test results and noise exposure are recorded to memory, whereby information from the memory may be uploaded to an external computer, as described in Paragraph 0069: “The external electronics unit would typically include a user interface, storage memory with the audiometric testing protocol/procedures, and storage memory for the user's responses during the test and the test results… The electronics unit would then be configured to assess noise exposure based on the signal from the inner microphone 105, and store noise exposure data on memory. And the electronics unit might also optionally have an interface for uploading of information from the memory/storage to an external computer system;” alternatively or additionally, Henriksen teaches that a processor-implemented method where a more thorough test is warranted when potentially damaging noise levels are detected (Paragraph 0062) and further blocks testing when a noise level is too high (Paragraph 0076); thus, conveying test results to an external computer (Paragraph 0083) is providing an indication of an estimated noise level and reception of audiometric test results carried out are an indication of whether audio signals thereof were detected by the user).
Re. Claim 22: Henriksen teaches the invention according to claim 21, and further teaches the invention wherein the audio signal is a first audio signal (Paragraph 0007: “…generating one or more test signals directed to the sound generator means in order to cause generation of sound stimuli for an audiometric test…”), and
wherein the instructions further cause the device to:
when the estimated noise level of the attenuated noise satisfies a threshold, output a second audio signal for detection by the user, wherein the first audio signal and the second audio signal have different frequencies (testing is restricted if a noise level is too high, as described at Paragraphs 0076, 0081; if noise level is below the restriction level, a full audiometric test comprises multiple differing frequencies as described at Paragraph 0064: “This electronic coupling allows the electronics unit 24 to transmit electrical signals to the speaker, directing/causing the speaker 22 to generate sound stimulus at one or more frequencies in order to implement an audiometric test;” Paragraph 0065 “… the electronics unit might automatically administer an audiometric test (which might focus on detected frequencies of concern);” claim 3: “…a sound generation means operable to produce sound stimuli at various frequencies and sound pressure levels; and an electronics unit configured to be operable to generate one or more test signals directed to the sound generator means in order to cause generation of sound stimuli for an audiometric test”).
Re. Claim 23: Henriksen teaches the invention according to claim 21, and further teaches the invention wherein the instructions further cause the device to:
when the estimated noise level of the attenuated noise does not satisfy a threshold and when a number of attempts for outputting the audio signal is below a target number, output the audio signal again for detection by the user (Paragraph 0051: “Another concern is the possibility that the user might fail to respond to a particular sound stimulus, even though they can hear the sound stimulus, due to inattention. This type of error might lead to an estimated hearing threshold that is significantly above the actual threshold. To correct such possible errors, it might be advisable to repeat the test in an attempt to achieve a more accurate result if too high a threshold is detected. So for example, the criteria for retest might be if the estimated hearing threshold is determined to be more than about 15-20 dB from the assumed threshold. In such instances, then the test could be re-run two additional times (on the assumption that the user would be unlikely to be inattentive over multiple tests), with the closest two test results being averaged to determine the ultimate estimated hearing threshold. FIG. 13 illustrates an embodiment of an exemplary procedure for detecting and addressing possible inattention”).
Re. Claim 24: Henriksen teaches the invention according to claim 21, and further teaches the invention further comprising a sealing member disposed between the audio input device and the audio output device (Fig. 1: earplug 20; see also – any other sealing component in each other figure),
wherein the estimated noise level of the attenuated noise is based at least in part on an estimated performance of the sealing member (Paragraph 0081: in addition to measuring and recording noise level, the quality of the seal may be checked against criteria corresponding to an adequate seal).
Re. Claim 26: Henriksen teaches the invention according to claim 21, and further teaches the invention wherein the audio signal corresponds to a hearing test tone (Paragraph 0061: “While any type of sound stimulus might be used during testing (so long as it represents approximately the required frequency and sound pressure level), more typically the sound stimulus would be pure tone. Alternatively, the sound stimulus could be a chirp. A chirp sound stimulus may be easier to detect in the presence of background noise, which would allow for more effective testing within the workplace environment”).
Re. Claim 27: Henriksen teaches the invention according to claim 21, and further teaches the invention wherein the estimated noise level of the attenuated noise represents an estimated attenuated noise level at an eardrum of the user (Paragraph 0010: “In another embodiment, the device might further comprise a microphone for detecting sound levels in the ear canal (near the eardrum) under the sealing element. This would allow for noise exposure levels to be determined and recorded”).
Re. Claim 28: Henriksen teaches a non-transitory computer-readable medium storing instructions that, when executed by one or more processors of a device, cause the device to:
while attenuating noise from a physical environment at the device, output an audio signal for detection by a user (see citations of claim 1; Paragraph 0039: “Typically, the electronics unit would comprise a computer processor programmed/configured to run one or more audiometric test protocols, generating appropriate signals to cause the sound generator to generate one or more sound stimulus in the user's meatus in accordance with the programmed test protocols”); and
provide, to a second device, an indication of an estimated noise level of the attenuated noise at the device to be stored in association with an indication of whether the audio signal was detected by the user (see explanation provided in rejection of claim 21).
Re. Claim 29: Henriksen teaches the invention according to claim 28, and further teaches the invention wherein the instructions further cause the device to:
when the estimated noise level of the attenuated noise does not satisfy a threshold and when a number of attempts for outputting the audio signal is below a target number, output the audio signal again for detection by the user (Paragraph 0051: “Another concern is the possibility that the user might fail to respond to a particular sound stimulus, even though they can hear the sound stimulus, due to inattention. This type of error might lead to an estimated hearing threshold that is significantly above the actual threshold. To correct such possible errors, it might be advisable to repeat the test in an attempt to achieve a more accurate result if too high a threshold is detected. So for example, the criteria for retest might be if the estimated hearing threshold is determined to be more than about 15-20 dB from the assumed threshold. In such instances, then the test could be re-run two additional times (on the assumption that the user would be unlikely to be inattentive over multiple tests), with the closest two test results being averaged to determine the ultimate estimated hearing threshold. FIG. 13 illustrates an embodiment of an exemplary procedure for detecting and addressing possible inattention”).
Re. Claim 30: Henriksen teaches the invention according to claim 28, and further teaches the invention wherein the instructions further cause the device to:
model frequency characteristics of the estimated noise level; and select the audio signal based on the frequency characteristics of the estimated noise level (Paragraph 0039: “The audiometric test regimen could be… a partial test profile of only a portion of the hearing range (such as 3-6 kHz, for example, which tends to be the range in which damage is most likely to occur from exposure to noisy environments). Indeed, a partial test profile could even be targeted towards the specific frequencies of concern at a particular worksite environment (such that the audiometric test could be customized for the specific noise environment at issue, possibly based on previously measured noise levels);” Paragraph 0062: “The electronics unit could optionally analyze the noise exposure data to determine the specific frequency (or frequencies) of most concern, and then administer a test session related to one or more of these frequencies;” Paragraph 0065: “Alternatively, the electronics unit might automatically administer an audiometric test (which might focus on detected frequencies of concern)”).
Re. Claim 31: Henriksen teaches the invention according to claim 28, and further teaches the invention wherein the audio signal corresponds to a hearing test tone (Paragraph 0061: “While any type of sound stimulus might be used during testing (so long as it represents approximately the required frequency and sound pressure level), more typically the sound stimulus would be pure tone. Alternatively, the sound stimulus could be a chirp. A chirp sound stimulus may be easier to detect in the presence of background noise, which would allow for more effective testing within the workplace environment”)
and wherein the estimated noise level of the attenuated noise represents an estimated attenuated noise level at an eardrum of the user (Paragraph 0010: “In another embodiment, the device might further comprise a microphone for detecting sound levels in the ear canal (near the eardrum) under the sealing element. This would allow for noise exposure levels to be determined and recorded”).
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.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over:
Henriksen et al. (US 20120029383 A1) (disclosed by Applicant) (hereinafter – Henriksen) in view of
Margolis et al. (US 20230032147 A1) (hereinafter – Margolis).
Re. Claim 25: Henriksen teaches the invention according to claim 21. Henriksen teaches uploading of test results to an external computer, whereby such test results are indicative of a level of attenuated noise. Henriksen does not explicitly teach wherein the instructions further cause the device to:
when the indication of the estimated noise level of the attenuated noise does not satisfy a threshold based on an instantaneous noise in a physical environment of the device, store an indication that the estimated noise level did not satisfy the threshold based on a distraction-type noise; and
when the indication of the estimated noise level of the attenuated noise does not satisfy the threshold based on an auditory filter of noise in the physical environment of the device, store an indication that the noise level did not satisfy the threshold based on a masking-type noise.
Margolis teaches analogous art in the technology of audiometric systems (Title; Abstract). Margolis teaches the invention wherein the instructions further cause the device to:
when the indication of the estimated noise level of the attenuated noise does not satisfy a threshold based on an instantaneous noise in a physical environment of the device, store an indication that the estimated noise level did not satisfy the threshold based on a distraction-type noise; and
when the indication of the estimated noise level of the attenuated noise does not satisfy the threshold based on an auditory filter of noise in the physical environment of the device, store an indication that the noise level did not satisfy the threshold based on a masking-type noise
(Paragraph 0013; Paragraph 0020; Paragraph 0021: “Based upon the threshold levels from audiometer 12 and the digitized sensed ambient noise measurements from noise measurement module 44, a test report is generated by report generator 50 in conjunction with masking alert 46 and distraction alert 48. In one embodiment, computer 20 identifies threshold levels that require retesting due to presence of distraction created by ambient noise when 50% or greater of peak levels in one second (1-s) segments exceed 72.5 dB SPL”).
That is, Margolis teaches identifying audiometric testing results while taking into consideration noise levels which cause masking and distraction. Thus, lack of such alerts indicates indications of not satisfying thresholds which qualify as masking or distraction.
It would have been obvious to one having skill in the art before the effective filing date to have modified Henriksen to include test results further including masking and distraction alerts as taught by Margolis, the motivation being that doing so enables a practitioner to identify which portions of the audiometric test require retesting due to either alert type (Abstract).
Conclusion
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/JUSTIN XU/Primary Examiner, Art Unit 3791
