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 .
Amendment Entered
In response to the amendment filed on April 27th, 2026, amended claims 1 and 9-10 and new claims 24-30 are entered. Claims 22-23 are canceled. Claims 5, 7, and 25-30 are withdrawn from consideration. Claims 1-4, 6, 8-10, and 24 are currently under examination.
Election/Restrictions
Newly submitted claims 25-30 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The invention of claims 1-4, 6, 8-10, and 24 are drawn to a hearing health monitoring system, comprising a testing device configured to conduct a hearing test, classified in A61B 5/6803. The invention of claims 25-30 are drawn to a hearing health monitoring system configured to determine a cumulative noise exposure of the person and generate a noise exposure intensity score, classified in A61B 2560/0242. The inventions are independent or distinct, each from the other because:
The invention of claims 1-4, 6, 8-10, and 24 and the invention of claims 25-30 are directed to related inventions. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed are mutually exclusive in that the invention of claims 1-4, 6, 8-10, and 24 is not directed to a processor operably coupled to the microphone and configured to—determine, based on the real-time ambient noise monitored by the microphone, a cumulative noise exposure of the person over a period of time, and generate a noise exposure intensity score of the person based, at least in part, on the determined cumulative noise exposure, and the invention of claims 25-30 is not directed to a sound emitter configured to play sounds to test a person's hearing level; a testing device configured to (i) conduct a hearing test by transmitting the sounds to the sound emitter and, (ii) during the hearing test, automatically pause and restart the hearing test in response to the real-time ambient noise monitored by the microphone; and a processor in operative communication with at least one of the testing device or the sound emitter, wherein the processor is configured to send and receive data associated with testing the person's hearing level to and from a cloud server over a network. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(A) Separate classification thereof: This shows that each invention has attained recognition in the art as a separate subject for inventive effort, and also a separate field of search. Patents need not be cited to show separate classification.
(B) A separate status in the art when they are classifiable together: Even though they are classified together, each invention can be shown to have formed a separate subject for inventive effort when the examiner can show a recognition of separate inventive effort by inventors. Separate status in the art may be shown by citing patents which are evidence of such separate status, and also of a separate field of search.
(C) A different field of search: Where it is necessary to search for one of the inventions in a manner that is not likely to result in finding art pertinent to the other invention(s) (e.g., searching different classes/subclasses or electronic resources, or employing different search queries, a different field of search is shown, even though the two are classified together. The indicated different field of search must in fact be pertinent to the type of subject matter covered by the claims. Patents need not be cited to show different fields of search.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 25-30 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Arguments
Applicant's remarks and amendments with respect to the abstract objection have been fully considered. The objection is withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the claim objection have been fully considered. The objection is withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 112(b) have been fully considered. The rejections are withdrawn in view of the amendment.
Applicant's arguments, filed on April 27th, 2026, with respect to the rejections of dependent claims 9-10 under 35 U.S.C. 101 have been fully considered but are not persuasive. Examiner respectfully disagrees. However, the rejections have been withdrawn, in view of the amendments to independent claim 1.
The Examiner would like to emphasize that the withdrawal of the rejections under 35 U.S.C. 101 are not due to the remarks and amendments the Applicant had made specifically for dependent claims 9 and 10. The amendments to claims 9 and 10 would not have made a difference in whether the claims recited an abstract idea or not (if they were looked at individually without considering the independent claim), and the Examiner respectfully disagrees with the Applicant’s views regarding the Alice/Mayo test. In order to provide clarity, the Examiner will explain how the claims were determined to be patent-eligible under the Alice/Mayo test.
The Examiner notes that in the previous Non-Final Office Action, independent claim 1 was not rejected under 35 U.S.C. 101 because it was deemed to not recite an abstract idea. This determination was made in Step 2A Prong One of the 35 U.S.C. 101 analysis. However, dependent claims 9-10 were further considered, and their limitations were deemed to recite an abstract idea, and were thus rejected under 35 U.S.C. 101 in the previous Non-Final Office Action.
In view of the amendment, the Examiner notes that independent claim 1 now recites an abstract idea. Under the 35 U.S.C. 101 analysis, independent claim 1 was further analyzed in Step 2A Prong Two, and it was determined that although the claim recites an abstract idea, it had been integrated into a practical application. Therefore, any dependent claims would also be patent-eligible, as they are dependent from a patent-eligible independent claim. Thus, the rejections under 35 U.S.C. 101 of dependent claims 9-10 have been withdrawn.
Applicant’s arguments, filed on April 27th, 2026, with respect to the rejections under 35 U.S.C. 102 and 103 have been fully 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.
Claim Objections
Claims 1 and 24 are objected to because of the following informalities:
Claim 1 recites “test a person’s hearing level” in line 3, but should read “test a hearing level of a person”
Claim 24 recites “claim 1 wherein” in line 1, but should read “claim 1, wherein”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“testing device” in Claims 1 and 6: [0027] of the Applicant’s Specification recites wherein the testing device “includes the audiometry controlling equipment, which may be provided in the form of any one or more of an audiometer, microprocessor audiometer, computer, laptop, tablet, phone or other instruments used to perform audiometric testing”
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-4, 6, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Crowley et al (U.S. Publication No. 2021/0068714).
Regarding Claim 1, Crowley discloses a hearing health monitoring system comprising: a microphone (microphone 113) configured to monitor real-time ambient noise (detecting, via the one or more microphones, an ambient noise level that includes an audio characteristic; [0016]);
a sound emitter (speaker 111) configured to play sounds to test a person's hearing level;
a testing device (portable multifunction device 100; [0049]) configured to (i) conduct a hearing test by transmitting the sounds to the sound emitter (Audio circuitry 110, speaker 111, and microphone 113 provide an audio interface between a user and device 100. Audio circuitry 110 receives audio data from peripherals interface 118, converts the audio data to an electrical signal, and transmits the electrical signal to speaker 111. Speaker 111 converts the electrical signal to human-audible sound waves; [0056]) and, (ii) during the hearing test, automatically pause and restart the hearing test in response to the real-time ambient noise monitored by the microphone (in response to detecting the ambient noise level: in accordance with a determination that the audio characteristic of the ambient noise level exceeds a first threshold value, suspending the hearing test and displaying, via the display device, a restart affordance that, when selected, restarts the hearing test; and in accordance with a determination that the audio characteristic of the ambient noise level does not exceed the first threshold value, proceeding with the hearing test and forgoing display of the restart affordance; [0016]; the ambient noise level cannot exceed the threshold level during the entire period of the test (e.g., the test period must be restarted if the threshold is exceeded). In some embodiments, the test pauses if ambient noise level exceeds the threshold, but the check process automatically resumes (e.g., the filled portion continues to fill) once the noise level drops below the threshold; [0323]); and
a processor in operative communication with at least one of the testing device or the sound emitter (Device 100 includes memory 102 (which optionally includes one or more computer-readable storage mediums), memory controller 122, one or more processing units (CPUs) 120, peripherals interface 118, RF circuitry 108, audio circuitry 110, speaker 111, microphone 113; [0049]), wherein the processor is configured to send and receive data associated with testing the person's hearing level to and from a cloud server over a network ([0055]).
Regarding Claim 2, Crowley discloses wherein the sound emitter includes headphones ( The headset jack provides an interface between audio circuitry 110 and removable audio input/output peripherals, such as output-only headphones or a headset with both output (e.g., a headphone for one or both ears) and input (e.g., a microphone); [0056]).
Regarding Claim 3, Crowley discloses wherein the testing device includes an audiometer (Device 100 includes memory 102 (which optionally includes one or more computer-readable storage mediums), memory controller 122, one or more processing units (CPUs) 120, peripherals interface 118, RF circuitry 108, audio circuitry 110, speaker 111, microphone 113, input/output (I/O) subsystem 106, other input control devices 116, and external port 124…Audio circuitry 110, speaker 111, and microphone 113 provide an audio interface between a user and device 100. Audio circuitry 110 receives audio data from peripherals interface 118, converts the audio data to an electrical signal, and transmits the electrical signal to speaker 111. Speaker 111 converts the electrical signal to human-audible sound waves. Audio circuitry 110 also receives electrical signals converted by microphone 113 from sound waves. Audio circuitry 110 converts the electrical signal to audio data and transmits the audio data to peripherals interface 118 for processing; [0049-0056]).
Regarding Claim 4, Crowley discloses wherein the processor includes a Digital Signal Processor (DSP) (RF circuitry 108 optionally includes well-known circuitry for performing these functions, including but not limited to an antenna system, an RF transceiver, one or more amplifiers, a tuner, one or more oscillators, a digital signal processor; [0055]).
Regarding Claim 6, Crowley discloses wherein the processor is integrated with the testing device (Device 100 includes memory 102 (which optionally includes one or more computer-readable storage mediums), memory controller 122, one or more processing units (CPUs) 120, peripherals interface 118, RF circuitry 108, audio circuitry 110, speaker 111, microphone 113, input/output (I/O) subsystem 106, other input control devices 116, and external port 124…Audio circuitry 110, speaker 111, and microphone 113 provide an audio interface between a user and device 100. Audio circuitry 110 receives audio data from peripherals interface 118, converts the audio data to an electrical signal, and transmits the electrical signal to speaker 111. Speaker 111 converts the electrical signal to human-audible sound waves. Audio circuitry 110 also receives electrical signals converted by microphone 113 from sound waves. Audio circuitry 110 converts the electrical signal to audio data and transmits the audio data to peripherals interface 118 for processing; [0049-0056]).
Regarding Claim 24, Crowley discloses wherein the processor is further configured to generate a noise exposure intensity score of the person based at least in part on a cumulative noise exposure of the person over a period of time (Interface 1004 d includes ambient noise level indication 1011 that visual depicts the current ambient noise level relative to a threshold level that is required to proceed with the test. Indicator 1011 includes a level indicator 1011 a that grows as the ambient noise level increases. Indicator 1011 also includes a ring portion 1011 b that depicts the threshold level of noise cannot be exceed (e.g., level indicator 1011 a cannot grow outside the bounds of the ring portion) if the test is to continue. Indicator 1011 also includes a filled portion 1011 c that traverses the ring to indicate the time remaining in the ambient noise level check process. The ambient noise level check of interface 1004 d is complete when the filled portion extends across the entire ring. Interface 1004 d includes start affordance 1012 that is currently in a disabled state because the ambient noise level check is not complete; [0322-0323]; Figures 10E-10F; an initial ambient noise level assessment (e.g., see FIGS. 10E to 10H) that includes detecting, via the one or more microphones, an initial ambient noise level (In some embodiments, the initial ambient noise level is determined based on a single measurement; in some embodiments, the initial ambient noise level is determined based on a plurality of measurements (e.g., an average of a set of measurements taken over a period of time)) that includes a second audio characteristic (e.g., an intensity (e.g., in decibels) or a frequency (e.g., in hertz) of the ambient noise); [0362]).
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.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Crowley in view of Makino et al (U.S. Publication No. 2024/0281199; previously cited).
Regarding Claim 8, although Crowley discloses wherein the device displays results of the speech and noise test ([0334]), Crowley fails to specifically disclose wherein the data includes an audiogram report.
In a similar technical field, Makino teaches an information processing method, information processing system, and data collecting method, and data collecting system (Abstract), wherein the data includes an audiogram report (the data collecting system 200 collects, as the user-specific data D3, an auditory capacity test result (audiogram) of the user; [0046]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the audiogram teachings of Makino into the invention of Fausti in order to constitute an auditory disorder determination model capable of classifying the user into auditory disorder or non-auditory disorder ([0048] of Makino).
Regarding Claim 9, although Crowley discloses wherein the device displays results of the speech and noise test ([0334]) and providing notifications ([0334, 0340]), Crowley fails to specifically disclose wherein the processor is configured to provide a notification in response to a current hearing level of the person falling outside of a predetermined range.
In a similar technical field, Makino teaches an information processing method, information processing system, and data collecting method, and data collecting system (Abstract), configured to provide a notification in response to a current hearing level of the person falling outside of a predetermined range (the processing device estimates the auditory capacity of the user by the AI from the information acquired (Step S12), performs auditory disorder determination as to whether or not the user has auditory disorder (Step S13), and presents a notification (auditory disorder or normal hearing) based on the result of the auditory disorder determination to the user as a feedback (Step S14), thereby encouraging the user to wear a hearing aid; [0031-0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the notification teachings of Makino into the invention of Fausti in order to notify the user of whether the user has auditory disorder or normal hearing, or that the auditory capacity has decreased, or of the estimated auditory capacity (e.g., an audiogram). In this manner, the user can be notified before the user or a person around the user notices the decrease in auditory capacity of the user. As a result, the user can notice auditory disorder at an early stage, and, for example, quality of life (QOL) is improved by wearing a hearing aid ([0032-0033] of Makino).
Regarding Claim 10, although Crowley discloses wherein the device displays results of the speech and noise test ([0334]) and providing notifications ([0334, 0340]), Crowley fails to specifically disclose wherein the processor is configured to provide a notification in response to an estimated future hearing level of the person falling outside of a predetermined range.
In a similar technical field, Makino teaches an information processing method, information processing system, and data collecting method, and data collecting system (Abstract), comprising an auditory capacity estimation model ([0052]; Figure 8) configured to provide a notification in response to an estimated future hearing level of the person falling outside of a predetermined range (a case where the auditory capacity level obtained as the future prediction value of the auditory capacity indicates auditory disorder, it is possible to prompt the user to perform an action change to reconsider the Vol setting by issuing a warning, and to help preventing auditory disorder; [0053]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the person’s estimated future hearing level teachings of Makino into the invention of Fausti in order to prompt the user to perform an action to help prevent auditory disorders in the future ([0053] of Makino).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANEL J YOON whose telephone number is (571). The examiner can normally be reached on Monday-Friday PM.
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/CHANEL J YOON/Examiner, Art Unit 3791
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