DETAILED ACTION
Applicant’s arguments, filed on 01/28/2026, have been fully considered.
Applicants have amended their claims, filed on 01/28/2026.
Claims 1, 3-9, and 11-17 are the current claims hereby under examination.
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 .
Claim Objections
Claims 1 and 15-16 are objected to because of the following informalities:
In claim 1, line 3, “comprising speaker” should read “comprising a speaker”
In claim 1, line 15, “the quality” should read “a quality”, as there is no antecedent basis in the claims for this limitation
In claim 15, line 1, “An ear probe” should read “The ear probe”
In claim 16, line 8, “the quality” should read “a quality”, as there is no antecedent basis in the claims for this limitation
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 9 and 11-13 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 claim 9, claim 9 is depends from claim 2, which has been cancelled. The metes and bounds of the claim cannot be determined when it depends from a canceled claim. For purposes of examination, it is being interpreted as depending from claim 1.
Further regarding claim 9, the claim recites the limitation “a first block sum” in line 4. It is unclear if this limitation is meant to refer to the first block sum from claim 1, line 17, or a different first block sum. If it is meant to refer to the first block sum from claim 1, it needs to refer back to it. If it is meant to refer to a different first block sum, it needs to be distinguished from the first block sum from claim 1. For purposes of examination, it is being interpreted as referring to the first block sum from claim 1.
Further regarding claim 9, the claim recites the limitation “a second block sum” in lines 5-6. It is unclear if this limitation is meant to refer to the second block sum from claim 1, lines 17-18, or a different second block sum. If it is meant to refer to the second block sum from claim 1, it needs to refer back to it. If it is meant to refer to a different second block sum, it needs to be distinguished from the second block sum from claim 1. For purposes of examination, it is being interpreted as referring to the second block sum from claim 1.
Regarding claim 11, the claim recites the limitation “a first block sum” in lines 3-4. It is unclear if this limitation is meant to refer to the first block sum from claim 1, line 17, or a different first block sum. If it is meant to refer to the first block sum from claim 1, it needs to refer back to it. If it is meant to refer to a different first block sum, it needs to be distinguished from the first block sum from claim 1. For purposes of examination, it is being interpreted as referring to the first block sum from claim 1. Claims 12-13 are also rejected due to their dependence on claim 11.
Further regarding claim 11, the claim recites the limitation “a second block sum” in line 4. It is unclear if this limitation is meant to refer to the second block sum from claim 1, lines 17-18, or a different second block sum. If it is meant to refer to the second block sum from claim 1, it needs to refer back to it. If it is meant to refer to a different second block sum, it needs to be distinguished from the second block sum from claim 1. For purposes of examination, it is being interpreted as referring to the second block sum from claim 1. Claims 12-13 are also rejected due to their dependence on claim 11.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 9, claim 9 is depends from canceled claim 2, which is improper. For purposes of examination, it is being interpreted as depending from claim 1.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, 8-9, 11, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Reinholdt-Nielsen (US 20150305678) in view of Choy (US 6610019) and Bertotti (“A simple method to measure phase difference between sinusoidal signals”).
Regarding independent claim 1, Reinholdt-Nielsen teaches an instrument comprising an ear probe for insertion into an ear canal of a test subject (Abstract: “An audiologic test apparatus includes: a processing unit; a tone generator connected to the processing unit; and a probe interface for connecting the audiologic test apparatus to a test probe; the tone generator configured to provide a first electrical signal representative of a first signal with a first primary frequency component at a first primary frequency”), the ear probe comprising
- an acoustic output unit comprising speaker ([0019]: “An audiologic test system includes the audiologic test apparatus, a first speaker coupled to the tone generator”), the acoustic output unit being configured to provide at least one stimulus into the ear canal of the test subject via said speaker ([0061]: “The first signal may be generated by the first speaker and/or the second speaker”), and
- an acoustic input unit comprising at least one microphone ([0019]: “An audiologic test system includes … a microphone coupled to the processing unit.”), the acoustic input unit being configured to receive a reflected part of said at least one stimulus via said at least one microphone and provide an electrical input signal ([0071]: “The audiologic test system 1 is configured to generate a first signal 14 with a first primary frequency component at a first primary frequency, and receive a first response signal “; [0045]: “The first response signal may at least partly be or comprise a reflection of the first signal. For example, the first response signal is a reflection of the first signal by a tympanic membrane in an ear canal.”; [0082]: “The first microphone 8 transmits a first electrical response signal representative of the first response signal 16 through the probe interface 13 to the audiologic test apparatus 2.”),
- where the instrument further comprises a signal-processing unit connected to the acoustic output unit and to the acoustic input unit ([0055]: “The audiologic test apparatus comprises a processing unit. The processing unit may comprise a microprocessor, an analogue-to-digital converter (ADC), and/or a memory module. The processing unit may be configured to perform signal analysis of one or more input signals, such as the first response signal. The processing unit may be configured to provide one or more output signals, such as control signals. For example, the processing unit may provide a control signal to the tone generator, such as a first and/or second control signal, whereby the tone generator is instructed to generate an electrical signal, such as the first electrical signal and/or the second electrical signal.”),
- where the signal-processing unit is configured to generate at least a first and a second stimulus of said at least one stimulus and to provide said at least first stimulus and second stimulus to said acoustic output unit ([0009]: “The audiologic test comprises generating a second signal with a second primary frequency component at a second primary frequency”),
- where the acoustic input unit is configured to receive the reflected part of said at least first stimulus and second stimulus ([0055]: “the processing unit may provide a control signal to the tone generator, such as a first and/or second control signal, whereby the tone generator is instructed to generate an electrical signal, such as the first electrical signal and/or the second electrical signal.”) and to assess the quality of a fit of the ear probe based on said received reflected part of said at least first stimulus and second stimulus ([0091]: “The first insertion criterion may be indicative of whether the probe is inserted into a cavity, such as an ear canal. The first insertion criterion may be indicative of whether the probe provides a seal between the probe and the ear canal, such as between the probe and the wall of the ear canal. If determination 106 of the first insertion criterion yields that the first insertion criterion is satisfied, the method continues to initiation 114 of the audiologic test. If determination 106 of the first insertion criterion yields that the first insertion criterion is not satisfied, the method returns to the beginning of the method 100, i.e. generation 102 of the first signal. Furthermore, if the first insertion criterion is not satisfied, the method 100 may comprise signaling to reposition the probe, before returning to the beginning of the method 100”).
However, Reinholdt-Nielsen does not teach wherein, assessing the quality of a fit of the ear probe based on said received reflected part of said at least first stimulus and second stimulus, comprises adding the first block sum (ZA) and the second block sum (ZB), and subtracting the second block sum (ZB) from the first block sum (ZA).
Choy discloses a method and apparatus for treatment of tinnitus. Specifically, Choy teaches adding the first block sum (ZA) and the second block sum (ZB) (Column 4, lines 51-56: “The principles of sound wave cancellation by superimposing, e.g. summing, a second sine wave having the same frequency and amplitude, as the first sine wave with a phase shift of 180 degrees is well understood in the electrical and measurement arts and is utilized in many technical fields including audiology, mechanics and electronics generally”; Column 6, lines 16-20: “this phase canceling reciprocal wave form relationship with regard to the respective outputs of sound generators 10 and 16 is depicted as the sum of f.sub.1 +f.sub.n which verifies the identical match between the generated treatment tone of sound generator 10 and the patient selected tinnitus tone”. Choy teaches adding the signals to determine if the signals match, which can therefore be applied to verifying if the signals match to determine if the ear probe fits, as the signals should match if there is a proper fit of the device.). Reinholdt-Nielsen and Choy are analogous art as they are both related to devices that measure properties from the ear.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the sum of the blocks from Choy into the instrument from Reinholdt-Nielsen as Reinholdt-Nielsen is silent on the calculations used to determine the fit of the device, and Choy discloses calculations that can be used to verify if the two signals are identical or not, which verifies if the device is working correctly.
However, the Reinholdt-Nielsen/Choy combination does not teach subtracting the second block sum (ZB) from the first block sum (ZA).
Bertotti discloses methods for analyzing sine waves. Specifically, Bertotti teaches subtracting the second block sum (ZB) from the first block sum (ZA) (Abstract, pg. 2: “the method consists of subtracting two sinusoidal signals with same frequencies and measuring the resulting signal amplitude”). Reinholdt-Nielsen, Choy, and Bertotti are analogous art as they are all related to devices that analyze measured signals.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the subtraction of the blocks from Bertotti into the Reinholdt-Nielsen/Choy combination as it allows the combination to introduce an additional calculation that can be used to determine a difference between the measured signals, which can indicate whether the device is functioning correctly or not and is the correct fit, as this can be used to determine if the signals match, which can therefore be applied to verifying if the signals match to determine if the ear probe fits, as the signals should match if there is a proper fit of the device.
Regarding claim 3, the Reinholdt-Nielsen/Choy/Bertotti combination teaches the instrument according to claim 1, wherein the characteristics of the first stimulus is different from the characteristics of the second stimulus (Reinholdt-Nielsen, [0043]: “the first signal has a first primary frequency component at a first primary frequency”; [0051]: “The second signal has a second primary frequency component at a second primary frequency”).
Regarding claim 8, the Reinholdt-Nielsen/Choy/Bertotti combination teaches the instrument according to claim 1, wherein the signal-processing unit generates the at least first stimulus and second stimulus consecutively (Reinholdt-Nielsen, [0085]: “Generation of the first and second electrical signal 15, 19 may be simultaneous or differentiated in time”).
Regarding claim 9, the Reinholdt-Nielsen/Choy/Bertotti combination teaches the instrument according to claim 2.
However, the Reinholdt-Nielsen/Choy/Bertotti combination does not teach wherein, assessing the quality of a fit of the ear probe based on said received reflected part of said at least first stimulus and second stimulus, comprises adding the first blocks of the first and second stimuli which are aligned in time in a first block sum (ZA), and adding the second blocks of the first and second stimuli which are aligned in time in a second block sum (ZB).
Choy teaches adding first blocks of the first and second stimuli which are provided at corresponding locations in time in a first block sum (ZA), and adding second blocks of the first and second stimuli which are provided at corresponding locations in time in a second block sum (ZB) (Column 4, lines 51-56: “The principles of sound wave cancellation by superimposing, e.g. summing, a second sine wave having the same frequency and amplitude, as the first sine wave with a phase shift of 180 degrees is well understood in the electrical and measurement arts and is utilized in many technical fields including audiology, mechanics and electronics generally”; Column 6, lines 16-20: “this phase canceling reciprocal wave form relationship with regard to the respective outputs of sound generators 10 and 16 is depicted as the sum of f.sub.1 +f.sub.n which verifies the identical match between the generated treatment tone of sound generator 10 and the patient selected tinnitus tone”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the sum of the blocks from Choy into the instrument from the Reinholdt-Nielsen/Choy/Bertotti combination as Choy discloses calculations that can be used to verify if the two signals are identical or not, which verifies if the device is working correctly.
Regarding claim 11, the Reinholdt-Nielsen/Choy/Bertotti combination teaches the instrument according to claim 1.
However, the Reinholdt-Nielsen/Choy/Bertotti combination does not teach wherein, assessing the quality of a fit of the ear probe based on said received reflected part of said at least first stimulus and second stimulus, comprises determining one or more audiological parameters based on the first block sum (ZA) and/or the second block sum (ZB).
Choy teaches determining one or more audiological parameters based on a first block sum (ZA) and/or a second block sum (ZB) (Column 7, lines 28-36: “the respective output wave forms of sound generators 10 and 16 may be algebraically added or summed to produce wave form or tone cancellation as shown in FIG. 2. Such total tone cancellation feature of this embodiment is significant for Applicant's improved monofrequency tinnitus patient treatment because it conveniently verifies the identical match between the treatment tone and amplitude with the subjective patient determined tinnitus tone and amplitude or loudness which has been found to be useful”; Column 9, lines 1-4: “Step 8 is intended to enable the attending physician and the patient to subjectively evaluate the effectiveness of a phase shift treatment in minimizing or alleviating entirely the deleterious patient tinnitus condition.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the determination of audiological parameters from Choy into the instrument from the Reinholdt-Nielsen/Choy/Bertotti combination as Choy discloses calculations that can be used to verify if the two signals are identical or not, which verifies if the device is working correctly.
Regarding claim 14, the Reinholdt-Nielsen/Choy/Bertotti combination teaches the instrument according to claim 1, wherein the ear probe comprises a further speaker ([0020]: “the audiologic test system further includes a second speaker coupled to the tone generator”), and where said speaker is configured to provide said first stimulus and said further speaker is configured to provide said second stimulus (Reinholdt-Nielsen, [0061]: “The first signal may be generated by the first speaker and the second signal may be generated by the second speaker.”).
Regarding claim 15, the Reinholdt-Nielsen/Choy/Bertotti combination teaches an ear probe for insertion into the ear canal of the test subject and for use with the instrument according to claim 1 (Reinholdt-Nielsen, Abstract: “An audiologic test apparatus includes: a processing unit; a tone generator connected to the processing unit; and a probe interface for connecting the audiologic test apparatus to a test probe; the tone generator configured to provide a first electrical signal representative of a first signal with a first primary frequency component at a first primary frequency”), where the ear probe comprises the acoustic output unit comprising the speaker (Reinholdt-Nielsen, [0019]: “An audiologic test system includes the audiologic test apparatus, a first speaker coupled to the tone generator”), the acoustic output unit being configured to provide the at least one stimulus into the ear canal of the test subject via said speaker (Reinholdt-Nielsen, [0061]: “The first signal may be generated by the first speaker and/or the second speaker”), the acoustic input unit comprising the at least one microphone (Reinholdt-Nielsen, [0019]: “An audiologic test system includes … a microphone coupled to the processing unit.”), the acoustic input unit being configured to receive the reflected part of said at least one stimulus via said microphone and provide the electrical input signal (Reinholdt-Nielsen, [0071]: “The audiologic test system 1 is configured to generate a first signal 14 with a first primary frequency component at a first primary frequency, and receive a first response signal “; [0045]: “The first response signal may at least partly be or comprise a reflection of the first signal. For example, the first response signal is a reflection of the first signal by a tympanic membrane in an ear canal.”; [0082]: “The first microphone 8 transmits a first electrical response signal representative of the first response signal 16 through the probe interface 13 to the audiologic test apparatus 2.”), a control unit connected to the acoustic output unit and to the acoustic input unit (Reinholdt-Nielsen, [0055]: “The audiologic test apparatus comprises a processing unit. The processing unit may comprise a microprocessor, an analogue-to-digital converter (ADC), and/or a memory module. The processing unit may be configured to perform signal analysis of one or more input signals, such as the first response signal. The processing unit may be configured to provide one or more output signals, such as control signals. For example, the processing unit may provide a control signal to the tone generator, such as a first and/or second control signal, whereby the tone generator is instructed to generate an electrical signal, such as the first electrical signal and/or the second electrical signal.”), where the control unit is configured to receive the at least first and second stimulus and to provide said first stimulus and said second stimulus to said acoustic output unit (Reinholdt-Nielsen, [0009]: “The audiologic test comprises generating a second signal with a second primary frequency component at a second primary frequency”), and where the acoustic input unit is configured to receive the reflected part of said at least first stimulus and second stimulus (Reinholdt-Nielsen, [0055]: “the processing unit may provide a control signal to the tone generator, such as a first and/or second control signal, whereby the tone generator is instructed to generate an electrical signal, such as the first electrical signal and/or the second electrical signal.”).
Regarding independent claim 16, Reinholdt-Nielsen teaches a method of performing a fit assessment of an ear probe ([0002]: “The present disclosure relates to a method, a system and an apparatus for initiating and/or performing an audiologic test”; Abstract: “An audiologic test apparatus includes: a processing unit; a tone generator connected to the processing unit; and a probe interface for connecting the audiologic test apparatus to a test probe; the tone generator configured to provide a first electrical signal representative of a first signal with a first primary frequency component at a first primary frequency”), the method comprising:
- generating a first stimulus and a second stimulus by a signal-processing unit ([0055]: “The audiologic test apparatus comprises a processing unit. The processing unit may comprise a microprocessor, an analogue-to-digital converter (ADC), and/or a memory module. The processing unit may be configured to perform signal analysis of one or more input signals, such as the first response signal. The processing unit may be configured to provide one or more output signals, such as control signals. For example, the processing unit may provide a control signal to the tone generator, such as a first and/or second control signal, whereby the tone generator is instructed to generate an electrical signal, such as the first electrical signal and/or the second electrical signal.”),
- providing said first and second stimuli to an ear canal of a test subject, via at least one speaker of the ear probe ([0019]: “An audiologic test system includes the audiologic test apparatus, a first speaker coupled to the tone generator”; [0061]: “The first signal may be generated by the first speaker and/or the second speaker”),
- receiving a response of the first and second stimuli from the ear canal of the test subject, via at least one microphone of the ear probe ([0019]: “An audiologic test system includes … a microphone coupled to the processing unit.”; [0071]: “The audiologic test system 1 is configured to generate a first signal 14 with a first primary frequency component at a first primary frequency, and receive a first response signal “; [0045]: “The first response signal may at least partly be or comprise a reflection of the first signal. For example, the first response signal is a reflection of the first signal by a tympanic membrane in an ear canal.”; [0082]: “The first microphone 8 transmits a first electrical response signal representative of the first response signal 16 through the probe interface 13 to the audiologic test apparatus 2.”),
- assessing the quality of a fit of the ear probe based on the received stimuli response by said signal-processing unit ([0091]: “The first insertion criterion may be indicative of whether the probe is inserted into a cavity, such as an ear canal. The first insertion criterion may be indicative of whether the probe provides a seal between the probe and the ear canal, such as between the probe and the wall of the ear canal. If determination 106 of the first insertion criterion yields that the first insertion criterion is satisfied, the method continues to initiation 114 of the audiologic test. If determination 106 of the first insertion criterion yields that the first insertion criterion is not satisfied, the method returns to the beginning of the method 100, i.e. generation 102 of the first signal. Furthermore, if the first insertion criterion is not satisfied, the method 100 may comprise signaling to reposition the probe, before returning to the beginning of the method 100”).
However, Reinholdt-Nielsen does not teach wherein, assessing the quality of a fit of the ear probe based on said received reflected part of said at least first stimulus and second stimulus, comprises adding the first block sum (ZA) and the second block sum (ZB), and subtracting the second block sum (ZB) from the first block sum (ZA).
Choy teaches adding the first block sum (ZA) and the second block sum (ZB) (Column 4, lines 51-56: “The principles of sound wave cancellation by superimposing, e.g. summing, a second sine wave having the same frequency and amplitude, as the first sine wave with a phase shift of 180 degrees is well understood in the electrical and measurement arts and is utilized in many technical fields including audiology, mechanics and electronics generally”; Column 6, lines 16-20: “this phase canceling reciprocal wave form relationship with regard to the respective outputs of sound generators 10 and 16 is depicted as the sum of f.sub.1 +f.sub.n which verifies the identical match between the generated treatment tone of sound generator 10 and the patient selected tinnitus tone”. Choy teaches adding the signals to determine if the signals match, which can therefore be applied to verifying if the signals match to determine if the ear probe fits, as the signals should match if there is a proper fit of the device.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the sum of the blocks from Choy into the method from Reinholdt-Nielsen as Reinholdt-Nielsen is silent on the calculations used to determine the fit of the device, and Choy discloses calculations that can be used to verify if the two signals are identical or not, which verifies if the device is working correctly.
However, the Reinholdt-Nielsen/Choy combination does not teach subtracting the second block sum (ZB) from the first block sum (ZA).
Bertotti teaches subtracting the second block sum (ZB) from the first block sum (ZA) (Abstract, pg. 81: “the method consists of subtracting two sinusoidal signals with same frequencies and measuring the resulting signal amplitude”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the subtraction of the blocks from Bertotti into the Reinholdt-Nielsen/Choy combination as it allows the combination to introduce an additional calculation that can be used to determine a difference between the measured signals, which can indicate whether the device is functioning correctly or not and is the correct fit, as this can be used to determine if the signals match, which can therefore be applied to verifying if the signals match to determine if the ear probe fits, as the signals should match if there is a proper fit of the device.
Claims 4-7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over the Reinholdt-Nielsen/Choy/Bertotti combination as applied to claim 1 above, and further in view of Schwarz (CN 105992607). Citations to CN 105992607 will refer to the English Machine Translation that accompanies this Office Action.
Regarding claim 4, the Reinholdt-Nielsen/Choy/Bertotti combination teaches the instrument according to claim 1.
However, the Reinholdt-Nielsen/Choy/Bertotti combination does not teach wherein the first stimulus and the second stimulus each comprises a first block/part and a second block/part.
Schwarz discloses methods for determining acoustic path in an ear. Specifically, Schwarz teaches wherein the first stimulus and the second stimulus each comprises a first block and a second block ([0018]: “the multidimensional features may include functions, where the multidimensional polynomial includes different stimulation electrodes, different recording electrodes, different interphase gaps, different pulse shapes (e.g., two-phase, three-phase, etc.)”; [0029]: “The tissue stimulation module 401 generates electrical stimulation pulses, and the control interface module 403 sends the electrical stimulation pulses to the cochlear implant 404, which delivers stimulation pulses (e.g., biphasic or triphasic stimulation pulses) to neural tissue in the auditory pathway (all or selected portions, such as the inner ear)”. The different pulses are the different blocks.). Reinholdt-Nielsen and Schwarz are analogous arts as they both provide a stimulation pulse to an ear and measure the response to determine physiological parameters of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to split the stimuli into multiple parts as it allows for additional, different stimuli to be provided to the user, which can measure more parameters and allow for a more comprehensive analysis of the user’s health.
Regarding claim 5, the Reinholdt-Nielsen/Choy/Bertotti/Schwarz combination teaches the instrument according to claim 4, wherein the first block and the second block of the first stimulus or of the second stimulus are provided at corresponding locations in time (Reinholdt-Nielsen, [0085]: “Generation of the first and second electrical signal 15, 19 may be simultaneous or differentiated in time”).
However, the Reinholdt-Nielsen/Choy/Bertotti/Schwarz combination does not teach wherein the first block and the second block of the first stimulus or of the second stimulus are aligned in phase.
Choy teaches wherein their phases are aligned (Fig. 2). Reinholdt-Nielsen, Schwarz, and Choy are analogous arts as they are all related to providing signals to a user’s ear to determine physiological parameters of the user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the phases from Choy into the Reinholdt-Nielsen/Choy/Bertotti/Schwarz combination as it allows for additional stimuli to be provided to the user, which can measure more parameters and allow for a more comprehensive analysis of the user’s health.
Regarding claim 6, the Reinholdt-Nielsen/Choy/Bertotti/Schwarz combination teaches the instrument according to claim 4, wherein the first block and the second block of the first stimulus or the second stimulus are provided at corresponding locations in time (Reinholdt-Nielsen, [0085]: “Generation of the first and second electrical signal 15, 19 may be simultaneous or differentiated in time”).
However, the Reinholdt-Nielsen/Choy/Bertotti/Schwarz combination does not teach their phases are inverted.
Choy teaches their phases are of reversed operational sign (Fig. 2).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the phases from Choy into the Reinholdt-Nielsen/Choy/Bertotti/Schwarz combination as it allows for additional stimuli to be provided to the user, which can measure more parameters and allow for a more comprehensive analysis of the user’s health.
Regarding claim 7, the Reinholdt-Nielsen/Choy/Bertotti/Schwarz combination teaches the instrument according to claim 4, wherein the first blocks of the first and second stimuli are provided at corresponding locations in time, and the second blocks of the first and second stimuli are provided at corresponding locations in time (Reinholdt-Nielsen, [0085]: “Generation of the first and second electrical signal 15, 19 may be simultaneous or differentiated in time”).
Regarding claim 17, the Reinholdt-Nielsen/Choy/Bertotti/Schwarz combination teaches the method of claim 16.
However, the Reinholdt-Nielsen/Choy/Bertotti/Schwarz combination does not teach a computer program comprising instructions which, when the program is executed by a computer, cause the computer to carry out the method of claim 16.
Schwarz teaches a computer program comprising instructions which, when the program is executed by a computer, cause the computer to carry out the method of claim 16 ([0042]: “Embodiments may be implemented in part as a computer program product for use with a computer system”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the computer program from Schwarz as the Reinholdt-Nielsen/Choy/Bertotti/Schwarz combination is silent on the type of device used to execute the method, and Schwarz discloses a suitable device in an analogous device.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over the Reinholdt-Nielsen/Choy/Bertotti combination as applied to claim 11 above, and further in view of Schwarz and Pangarkar (US 20220370249).
Regarding claim 12, the Reinholdt-Nielsen/Choy/Bertotti combination teaches the instrument according to claim 11.
However, the Reinholdt-Nielsen/Choy/Bertotti combination does not teach wherein the signal-processing unit compares the determined one or more audiological parameters with predetermined similar audiological parameters and provides a comparison signal.
Pangarkar discloses a device and method for managing hearing disorders. Specifically, Pangarkar teaches wherein the signal-processing unit compares the determined one or more audiological parameters with predetermined similar audiological parameters and provides a comparison signal ([0018]: “One device can generate a recommendation to the user based on the results. For example, a device can compare the user's assessed sensitivity to sounds at different frequencies with a predetermined set of thresholds. Based on the comparison, the same or another device can recommend, for example, that the user consult a hearing specialist (e.g., physician or audiologist). One device can establish a communication link for conveying the audiogram to the hearing professional over a communication network.”). Reinholdt-Nielsen, Choy, and Pangarkar are analogous arts as they all provide a stimulation pulse to an ear and measure the response to determine physiological parameters of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the comparison from Pangarkar in Reinholdt-Nielsen/Choy/Bertotti combination as it allows the instrument to compare the determined parameters to known parameters, which can give information about the user’s health compared to known ones, which can allow for a further analysis of their health condition.
Regarding claim 13, the Reinholdt-Nielsen/Choy/Bertotti/Pangarkar combination teaches the instrument according to claim 12, wherein the signal-processing unit generates the first stimulus and the second stimulus consecutively until the comparison signal fulfills predetermined requirements (Reinholdt-Nielsen, [0028]: “A method for performing an audiologic test includes: generating a first signal with a first primary frequency component at a first primary frequency; detecting a first response signal; determining if a first insertion criterion is satisfied, wherein the first insertion criterion is based on the first signal and the first response signal; initiating the audiologic test if at least the first insertion criterion is satisfied; and generating a second signal with a second primary frequency component at a second primary frequency during the audiologic test, the first primary frequency being lower than the second primary frequency.”).
Response to Arguments
All of applicant’s argument regarding the rejections and objections previously set forth have been fully considered and are persuasive unless directly addressed subsequently.
Applicant has amended the claims to attempt to overcome the objections and rejections, however one objection to claim 15 has been reiterated as the issue has not been resolved. Additionally, the amendments have introduced new objections and 112(b) rejections.
Applicant's arguments filed 01/28/2026have been fully considered but they are not persuasive. Applicant argues that Choy does not teach the limitation of assessing the quality of fit of the ear probe. 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). The combination of Reinholdt-Nielson and Choy are relied upon to teach this limitation, as Choy discloses comparing the measured responses to verify if they are identical or not and that this process is known in audiology, and therefore can be used in the combination to determine if the fit is correct.
Applicant’s arguments with respect to the subtraction limitation have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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