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
Claims 5, 7, and 11-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Group II and Species I and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 8th, 2025.
Applicant’s election without traverse of Group I and Species II (Claims 1-4, 6, 8-10) in the reply filed on December 8th, 2025 is acknowledged.
Amendment Entered
In response to the amendment filed on December 8th, 2025, amended claim 1, and new claims 22-23 are entered. Claims 5 and 7 are withdrawn from consideration, and claims 11-21 are canceled.
Abstract
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length. Currently, the abstract is objected to because it is only 16 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Claim Objections
Claim 23 is objected to because of the following informality:
Claim 23 recites “claim 22 wherein” in line 1, but should read “claim 22, 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 § 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 9-10 and 22-23 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.
Claim 9 recites the limitation "the person’s current hearing level" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Further, it is unclear as to whether this limitation is referring to the “person’s hearing level” from line 2 of Claim 1, or a separate element.
Claim 10 recites the limitation "the person’s estimated future hearing level" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation "the hearing test" in line 2. There is insufficient antecedent basis for this limitation in the claim. Although Claim 1 recites “a sound emitter configured to play sounds to test a person’s hearing level”, a “hearing test” was never formally introduced.
Claim 22 recites “wherein the microphone is configured for monitoring real-time ambient noise while performing the hearing test” in lines 2-3. This limitation is unclear, as it seems to imply that the microphone is performing the hearing test, whereas Claim 1 recites that it is actually the “sound emitter” that “play[s] sounds to test a person’s hearing level”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 9-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Each of Claims 9-10 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 1
Claims 9-10 recite a system for monitoring hearing health. Thus, the claims are directed to a machine, which is one of the statutory categories of invention.
Step 2A, Prong 1
Each of Claims 9-10 recites at least one step or instruction for monitoring hearing health, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. Determining the person’s hearing level can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas. Accordingly, each of Claims 9-10 recites an abstract idea.
Examiner notes that although claim 1 recites a system for monitoring hearing health, there is no abstract idea specified in independent claim 1, as all the steps are categorized as data-gathering and/or data-transmission. Rather, the abstract idea is only specified in dependent claims 9-10.
Specifically, Claim 9 recites:
the processor is configured to provide a notification in response to a determination that the person's current hearing level is outside of a predetermined range.
Specifically, Claim 10 recites:
the processor is configured to provide a notification in response to a determination that the person's estimated future hearing level is outside of a predetermined range.
The step of determining the person’s hearing level is only introduced in dependent claims 9-10, as independent claim 1 merely recites data that is “associated with testing the person's hearing level”.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea is not integrated into a practical application under 2019 PEG because the additional elements, either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: “sound emitter”, “testing device”, “processor”, “cloud server” in independent claim 1; and “processor” in dependent claims 9-10 are generically recited computer elements which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in dependent claims 9-10 is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., “processor” as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above is not integrated into a practical application under the 2019 PEG.
Accordingly, dependent claims 9-10 are each directed to an abstract idea under 2019 PEG.
Step 2B
None of dependent claims 9-10 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: “sound emitter”, “testing device”, “processor”, “cloud server” in independent Claim 1; and “processor” in dependent claims 9-10. The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by Applicant’s specification (e.g. paragraphs [0025]-[0035]) which discloses that the processor(s) comprise generic computer components that are configured to perform the generic computer functions (e.g. sending and receiving data) that are well-understood, routine, and conventional activities previously known to the pertinent industry; and the Applicant’s Background in the Specification.
Accordingly, in light of Applicant’s specification, the claimed term “processor” is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “processor”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in dependent claims 9-10 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the system of claims 9-10 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of claims 9-10 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, dependent claims 9-10 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the dependent claims 9-10 amounts to significantly more than the abstract idea itself. Accordingly, dependent claims 9-10 are not patent eligible and rejected under 35 U.S.C. 101.
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, 8-9, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fausti et al (U.S. Publication No. 2013/0274628).
Regarding Claim 1, Fausti discloses a hearing health monitoring system (Systems and methods for the screening and monitoring of inner ear function; Abstract) comprising:
a sound emitter (headphones) configured to play sounds to test a person's hearing level (The OtoID system can comprise a small handheld portable computing device (PDA) and audiometer-like base unit with headphones; [0065]; The OtoID includes a modified set of Sennheiser HDA 200 audiometric headphones. The Sennheiser HDA 200 is a closed-back, stereo headphone providing a wide frequency response suitable for high frequency audiometry. The “around the ear” ear cup design of the HDA 200 is based on PELTOR hearing protectors, and provides a high level of ambient noise isolation; [0115]);
a testing device (audiometer-like base unit) configured to transmit the sounds to the sound emitter (The OtoID system can comprise a small handheld portable computing device (PDA) and audiometer-like base unit with headphones. A base unit, such as is shown in FIG. 1 and described in more detail below, can be a battery-powered, audiometric-type stimulus generator with sufficient stimulus frequency range (e.g., 500 Hz to 20 kHz at ⅙ octave stepping) and quality (−10 to 105 dBSPL spurious-free acoustic transducer dynamic-range output measured with IEC318 artificial ear). The base unit, together with an audiometer-like stimulus control application, can function to obtain reliable full-frequency range hearing thresholds. The base unit can also be capable of measuring background ambient noise and verifying acoustical performance at ⅓ octave band intervals; [0065]; [0097-0098]; Figures 7-8); and
a processor (small handheld portable computing device (PDA)) in operative communication with at least one of the testing device or the sound emitter (The OtoID system can comprise a small handheld portable computing device (PDA) and audiometer-like base unit with headphones…the OtoID system can include SRO-monitoring specific software applications running on the PDA device. Such applications can wirelessly control the audiometric base unit. In one implementation, a main program, referred to herein as “OtoID.exe”, can be used for hearing testing. Two other supporting applications, referred to herein as “OtoIDcal.exe” and “OtoIDchk.exe”, can be used for acoustic calibration. Acoustic calibration actions (e.g., OtoIDcal.exe) can involve access to a sound level meter and artificial ear with acoustic headphone coupling device, and acoustic performance checking (e.g., OtolDchk.exe) can involve an acoustic performance verification in the field; [0065-0067]; the base unit and PDA can communicate via a communication protocol using respective wireless interfaces. The PDA can run various programs which can control the operation of the base unit and receive data from the base unit; [0096]; Figure 7), wherein the processor is configured to send and receive data associated with testing the person's hearing level (Procedures…Data Analysis; [0139-0144]) to and from a cloud server over a network (The Windows Mobile®-based PDA environment has extensive built-in operating system support for networked data transfer and remote-application development-tools supporting tele-health models of care-delivery. Results of any test, including, for example, an audiogram, can be output to a printer or other display mechanism or exported to another program or system for analysis and/or storage; [0068]).
Regarding Claim 2, Fausti discloses wherein the sound emitter includes headphones (The OtoID system can comprise a small handheld portable computing device (PDA) and audiometer-like base unit with headphones; [0065]; The OtoID includes a modified set of Sennheiser HDA 200 audiometric headphones. The Sennheiser HDA 200 is a closed-back, stereo headphone providing a wide frequency response suitable for high frequency audiometry. The “around the ear” ear cup design of the HDA 200 is based on PELTOR hearing protectors, and provides a high level of ambient noise isolation; [0115]).
Regarding Claim 3, Fausti discloses wherein the testing device includes an audiometer (The OtoID system can comprise a small handheld portable computing device (PDA) and audiometer-like base unit with headphones; [0065]; The OtoID includes a portable audiometer with high frequency test functionality that meets ANSI/ASA S3.6-2010 standards and that is capable of reliably detecting a person's drug-related hearing changes relative to a baseline period (i.e., before they have received ototoxic drugs) using an automated test; [0087]; [0097-0098]; Figures 7-8).
Regarding Claim 4, Fausti discloses wherein the processor includes a Digital Signal Processor (DSP) (The OtoID system can comprise a small handheld portable computing device (PDA) and audiometer-like base unit with headphones…the OtoID system can include SRO-monitoring specific software applications running on the PDA device. Such applications can wirelessly control the audiometric base unit. In one implementation, a main program, referred to herein as “OtoID.exe”, can be used for hearing testing; [0065-0068]; FIG. 7 illustrates an exemplary schematic architecture of a system comprising a PDA and a base unit. As noted above, the base unit and PDA can communicate via a communication protocol using respective wireless interfaces. The PDA can run various programs which can control the operation of the base unit and receive data from the base unit. The implementation and operation of the novel methods disclosed herein (e.g., the exemplary software applications) can efficiently guide a trained practitioner in administering the SRO protocol to individuals at risk for hearing damage in remote locations; [0096]; The software utilized a CardDeluxe digital signal processing board (Digital Audio Laboratories) to generate stimuli and record responses; [0236]).
Regarding Claim 6, Fausti discloses wherein the processor is integrated with the testing device ([0097-0098]; Figures 7-8).
Regarding Claim 8, Fausti discloses wherein the data includes an audiogram report (Results of any test, including, for example, an audiogram, can be output to a printer or other display mechanism or exported to another program or system for analysis and/or storage; [0068]).
Regarding Claim 9, Fausti discloses wherein the processor is configured to provide a notification in response to a determination that the person's current hearing level is outside of a predetermined range (The OtoID system is capable of evaluating the hearing of a person across a broad range of frequencies (0.5-20 kHz), sound pressure levels, and specific ⅙ octave step sizes desired to evaluate a patient's SRO during ototoxicity monitoring. The OtoID system is capable of storing baseline measurements and detecting changes from the baseline which may be due to ototoxicity damage. If changes are detected, the system is designed with a cellular modem installed that can notify health care personnel so that the oncology medical team can consider changes in treatment; [0131]).
Regarding Claim 22, Fausti discloses a microphone, wherein the microphone is configured for monitoring real-time ambient noise while performing the hearing test (The headphones were modified by building an omnidirectional electret microphone (CUI Inc., CMA-6542TF-K) into each ear cup for the purpose of sensing ambient noise. The electret microphones are flush mounted in the ear cup housing to maintain an airtight integrity of the cup, and face into the test room. A cable is run from the microphone to the OtoID audiometer where the signal is amplified, converted to a DC signal with a rectifier circuit, and then digitized using a 10-bit analog-to-digital converter. A firmware algorithm in the audiometer processes the digitized microphone signal using a “leaky integrator” topology where the signal is continually integrated, with a small portion of the result subtracted on a continuous basis, effectively resetting the integrator over time. Finally, the firmware algorithm traps particular events where the integrated signal exceeds a set level, which can be adjusted to suit the particular needs for a given test environment; [0115]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Fausti in view of Makino et al (U.S. Publication No. 2024/0281199).
Regarding Claim 10, although Fausti discloses wherein the processor is configured to provide a notification in response to a determination that the person's hearing level is outside of a predetermined range (The OtoID system is capable of evaluating the hearing of a person across a broad range of frequencies (0.5-20 kHz), sound pressure levels, and specific ⅙ octave step sizes desired to evaluate a patient's SRO during ototoxicity monitoring. The OtoID system is capable of storing baseline measurements and detecting changes from the baseline which may be due to ototoxicity damage. If changes are detected, the system is designed with a cellular modem installed that can notify health care personnel so that the oncology medical team can consider changes in treatment; [0131]), Fausti fails to specifically disclose wherein the processor is configured to provide a notification in response to a determination that the person's estimated future hearing level is 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 a determination that the person's estimated future hearing level is 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).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Fausti in view of Rix et al (U.S. Publication No. 2015/0358745).
Regarding Claim 23, although Fausti discloses a microphone configured for monitoring real-time ambient noise while performing the hearing test (The headphones were modified by building an omnidirectional electret microphone (CUI Inc., CMA-6542TF-K) into each ear cup for the purpose of sensing ambient noise. The electret microphones are flush mounted in the ear cup housing to maintain an airtight integrity of the cup, and face into the test room. A cable is run from the microphone to the OtoID audiometer where the signal is amplified, converted to a DC signal with a rectifier circuit, and then digitized using a 10-bit analog-to-digital converter. A firmware algorithm in the audiometer processes the digitized microphone signal using a “leaky integrator” topology where the signal is continually integrated, with a small portion of the result subtracted on a continuous basis, effectively resetting the integrator over time. Finally, the firmware algorithm traps particular events where the integrated signal exceeds a set level, which can be adjusted to suit the particular needs for a given test environment; [0115]), Fausti fails to specifically teach wherein the testing device is configured for automatically pausing and restarting the hearing test in response to the monitored real-time ambient noise via the microphone.
In a similar technical field, Rix teaches a self administered calibrated hearing kit, system and method of testing (Abstract), wherein the testing device is configured for automatically pausing and restarting the hearing test in response to the monitored real-time ambient noise via the microphone (if the ambient noise level is <40 dB the test is allowed to proceed. However, If the environment ambient noise level is not <40 dB, the test will not start. If ambient noise level is >40 dB the user is informed the environment is not suitable and the user is instructed to move locations or to shut off various devices that might be making the unwanted noise (by frequency). Another sweep ambient noise test is done to determine the ambient noise level. This is continued until the proper testing conditions are achieved. Additionally, a quick tone test may be conducted prior to the start of the actual hearing test to double check the earpieces are on the designated ear; [0050]; If the measured ambient noise is equal to or below a determined amount, such as for example 40 dB the hearing test may proceed, as previously described. The testing parameters allow for the test to proceed unencumbered provided that the ambient noise is at or below the presentation level+/−5% at the given test frequency. If the ambient noise exceeds the test parameters defined by the software a warning is provided to the user to lessen the ambient noise until the requirement is met, e.g. turn off appliances, etc. Sampling rate is determined to ensure fidelity is adhered to during the test; [0055]).
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 ambient noise level threshold teachings of Rix into the invention of Fausti in order to ensure the environment is suitable to achieve proper testing conditions ([0050, 0055] of Rix).
Conclusion
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/CHANEL J JHIN/Examiner, Art Unit 3791