DETAILED ACTION
This action is in response to the RCE filed April 15, 2026 and the amendment filed on April 15, 2026. Claims 1-20 are pending with no claims canceled and claims 1, 4, 6-11, and 13-20 currently amended.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 15, 2026 has been entered.
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 limitations are:
“otoscopy component” in claims 1 and 10;
Based on [0047], [0101], and [0105] of the specification, the Examiner interprets the otoscopy component to be a general-purpose computer programmed to load and display the selected virtual subject’s stored otoscope image.
“tympanometry measuring component” in claims 1 and 10; and
Based on [0102], [0104], and [0105] of the specification, the Examiner interprets the tympanometry measuring component to be a general-purpose computer programmed to display a tympanogram image file upon pressing the “Present” button in the applicable mode.
“audiometer component” in claims 1 and 10.
Based on [0101]-[0104] of the specification, the Examiner interprets the “audiometer component” to be a general-purpose computer programmed to present a tone at a selected frequency and intensity upon pressing the “Present” button in the applicable mode.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they 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 these limitations 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 Objections
Claims 1, 5-11, and 19-20 are objected to because of the following informalities:
Claims 1 and 10: The conjunction “and” appears at the end of both the audiometer limitation and the succeeding “wherein” clause, creating a grammatically inconsistent series.
Claim 5: The claim has been marked as “Previously Presented” despite being amended. Specifically, in the previously presented version of claim 5 as filed on October 9, 2025, the claim recites, “…wherein a graphical interface…”. In the presently presented version of claim 5, the claim recites, “…wherein a the graphical interface…”; however, the Examiner assumes this is an accidental incorporation of the previously removed “the”.
Claim 6: The claim recites duplicative/redundant language in that the phrase “is accessed over a network connection” is recited twice. Furthermore, each recitation introduces a new network connection. The Examiner assumes the Applicant only intended to recite a single network connection.
Claim 7: The claim recites duplicative/redundant language. See the objection of claim 6 above.
Claim 8: The claim recites duplicative/redundant language. See the objection of claim 6 above.
Claim 9: The claim recites duplicative/redundant language. See the objection of claim 6 above.
Claim 11: The claim is labeled as “currently amended”; however, no markings have been presented to identify where these amendments are prevalent.
Claim 19: The claim recites duplicative/redundant language. See the objection of claim 6 above.
Claims 19 and 20: The terms “Otoscope”, “Tympanometry,” and “Audiometer” are improperly capitalized.
Appropriate correction is required.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. As summarized in the 2019 Revised Patent Subject Matter Eligibility Guidance, examiners must perform a Two-Part Analysis for Judicial Exceptions.
Step 1
In Step 1, it must be determined whether the claimed invention is directed to a process, machine, manufacture, or composition of matter. The instant invention encompasses a system (i.e., machine) in claims 1-9 and 19 and method (i.e. process) in claims 10-18 and 20. All claims are directed to one of the four statutory categories and meet the requirements of Step 1.
Step 2A
Prong One
The claimed invention is directed to an abstract idea without significantly more. The instant invention is broadly directed to a system and method for “a software-based simulator to provide speech and hearing students the ability to perform hearing screening training using a realistic interface similar to devices used to perform these tests, which provides results for Otoscopy, Tympanometry, and Audiometry testing, and assesses the students responses for correctness.” (Specification, [0001]).
Claim 1 recites the following (with emphasis added):
A system comprising:
a non-transitory computer-readable medium; and
at least one processor configured to execute instructions stored in the non-transitory computer-readable medium to provide an audiology simulator comprising:
an otoscopy component to provide a visual representation of at least one ear by displaying an actual ear or auditory canal image of a selected virtual subject within a graphical user interface;
a tympanometry measuring component to simulate measuring eardrum movement in the at least one selected ear by generating and displaying a tympanogram corresponding to the selected virtual subject;
an audiometer component to simulate measuring hearing in the at least one selected ear by presenting tones at selected frequencies and recording simulated subject responses on an audiometer chart; and
wherein the otoscopy component, the tympanometry measuring component, and the audiometer component replicate administering and interpreting a hearing test given to a subject by enabling a user to perform the tests for a selected virtual subject, record findings for each test, and receive feedback comparing the findings to stored correct results for that subject;
and wherein the audiology simulator is configured as a virtual software simulation representation of a physical audiology simulator that mimics the look, controls, and display outputs of commercial audiology testing hardware without requiring a physical ear model or physical testing device.
Claim 1 encompasses the abstract idea and had substantially similar features as claim 10, which is also encompassed by the dependent claims 2-9 and 11-20.
Claims 1-20 recite the steps for teaching a student to test a subject’s ears. The system and method are directed to certain methods of organizing human activity and mental processes. The claims are directed towards the mechanisms for teaching a student (certain methods of organizing human activity) and collecting, analyzing, and judging data pertaining to specific charts and recordings (mental processes). Thus, the steps are directed to certain methods of organizing human activity and mental processes.
Prong Two
This judicial exception is not integrated into a practical application because mere instruction to implemented on a computer, or merely using a computer as a tool to perform the abstract idea, adding insignificant extra solution activity, and/or generally linking the use of the abstract idea to a technological environment or field is not considered integration into a practical application. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the present claims include no additional elements other than the abstract idea which include “a non-transitory computer-readable medium” and “at least one processor”. The conventional computers over a generic network as presented are directed to the components of a system that amount to merely field of use type limitations and/or extra solution activity to implement the mental processes and certain methods of organizing human activity for establishing the mechanisms to teach the user.
Step 2B
Step 2B in the analysis requires us to determine whether the claims do significantly more than simply describe that abstract method. Mayo, 132 S. Ct. at 1297. We must examine the limitations of the claims to determine whether the claims contain an "inventive concept" to "transform" the claimed abstract idea into patent-eligible subject matter. Alice, 134 S. Ct. at 2357 (quoting Mayo, 132 S. Ct. at 1294, 1298). The transformation of an abstract idea into patent-eligible subject matter "requires ‘more than simply stat[ing] the [abstract idea] while adding the words ‘apply it.’’" Id. (quoting Mayo, 132 S. Ct. at 1294) (alterations in original). "A claim that recites an abstract idea must include ‘additional features’ to ensure ‘that the [claim] is more than a drafting effort designed to monopolize the [abstract idea].’" Id. (quoting Mayo, 132 S. Ct. at 1297) (alterations in original). Those "additional features" must be more than "well-understood, routine, conventional activity." Mayo, 132 S. Ct. at 1298.
The present claims do not include the additional elements that are sufficient to amount to significantly more than the judicial exception. Any potentially technical aspects of the claims are well-known, generic computational components performing conventional functions. As explicitly disclosed by the application, the disclosure does not provide any improvement to a technical field (“mimic the look, controls, and display outputs of commercial audiology testing hardware” (Claim 1)). The claimed invention is simply a virtualization (i.e., utilizing general-purpose hardware with no inventive step) to implement a well-known system. The present claims have been analyzed both individually and in combination and, the instant claims do not provide any improvement of the functioning of the computer or improvement to computer technology or any other technical field. There do not appear to be any meaningful limitations other than those that are well-understood, routine, and conventional in the field. Thus, the present claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claims are not patent eligible.
The claims are generally linked to implement an abstract idea on a processor and non-transitory computer-readable medium. When looked at individually and as a whole, the claim limitations are determined to be an abstract idea without "significantly more," and thus not patent eligible.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9 and 18-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the claim recites, “a tympanometry measuring component to simulate measuring eardrum movement in the at least one selected ear by generating and displaying a tympanogram corresponding to the selected virtual subject.” The original disclosure describes the tympanometry measuring component only as simulating measurement of eardrum movement ([0006]-[0007]) and does not describe that component generating or displaying a tympanogram. Rather, the tympanogram is described as a “stored imaged file representing the subject’s tympanogram chart” ([0102]) that is “part of the subject profile that is loaded when the subject is selected” ([0105]), and it is displayed by the user interface 100 or its graphic display ([048], [0099], [0104]). The specification expressly contrasts the stored tympanogram with the audiogram, which “is dynamically created based on the technician’s recording of the subject’s responses” ([0105]).
Claims 2-9 and 19 depend from claim 1 and are rejected for the same reason.
Regarding claim 9, the claim recites, “changing an ear indicator when a presented tone is heard by the simulated subject.” The specification describes right and left ear visual cues 404, 406 that show “which ear is receiving sound,” changing “as sound is applied” and ceasing “when the sound is stopped” ([0049]), and describes that the subject’s hearing of the tone is indicated only by the avatar raising its hand ([0049]), [0103], [0104], and Figs 4 and 13). The specification does not describe changing an ear indicator in response to the simulated subject hearing a tone. Claim 18 recites the same limitation and is rejected for the same reason.
Regarding claim 19, the claim recites, “automatically comparing the assessment, diagnosis, and at least one note to stored correct answers.” The specification describes the system checking “the technician’s assessment against the correct answers for that subject” ([0044]) and automatically grading the per-ear results and the final recommendation ([0107]); comments/notes are described only as entries the student may add ([0046, [0107]), and Fig 7B shows correctness indications only for the Status/Type/Screening result selections and not for the Comment rows. The specification does not describe automatically comparing a user’s note to stored answers. Claim 20 recites the same limitation and is rejected for the same reason.
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 1-20 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 1 recites the limitation "the at least one selected ear" in multiple lines. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the graphical interface". There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the simulated hearing test". There is insufficient antecedent basis for this limitation in the claim.
Claims 1-20 appear to re-introduce the same element as previously presented; however, due to the extensiveness of this issue, it is unclear whether this is truly the case or if the Applicant intended to introduce new elements during each recitation.
Specifically, the following claims are examples of this issue – despite the possibility of more of the same issues occurring elsewhere throughout the claims:
Claim 1 recites, “a subject” despite the claim introducing “a selected virtual subject” earlier in the claim.
Claim 1 recites, “a selected virtual subject” despite the claim introducing “a selected virtual subject” earlier in the claim.
Claim 1 recites, “that subject” without any indication of whether the Applicant intends to refer to the “selected virtual subject” or the “subject”.
Claim 4 introduces, “a graphical interface”; however, the element appears to have already been introduced within claim 1 as “a graphical user interface”. This rejection further applies to claim 5 for the same reasoning.
Claim 6 recites, “a network connection” despite the claim introducing “a network connection” earlier in the claim.
Claims 7 and 9 recites, “the subject” without any indication of whether the Applicant intends to refer to the “selected virtual subject” or the “subject” as introduced in claim 1.
Claim 7 recites, “a selected virtual subject” twice despite claim 1 introducing “a selected virtual subject”.
Claim 7 recites, “a subject bio” and “medical details” despite the claim introducing “a subject bio” and “medical details” earlier in the claim.
Claims 8, 9, and 19 recites “a user” despite claim 1 introducing “a user”.
Claim 9 references “the simulated subject” and “the subject” without indication of which “subject” is being referenced.
Claim 9 recites, “a presented tone” despite “a presented tone” being introduced within claim 1.
Claim 19 references “subject Audiometer responses” without indication of which “subject” is being referenced.
Claim 19 references “the user” without indication of which “user” is being referenced.
Similar issues are present in the corresponding claim set of claims 10-18 and 20 and are rejected as well.
Claims 2-9 and 19 recite “The audiology similar of claim 1”, but claim 1 is directed to “A system” comprising, among other things, an audiology simulator; therefore, it is unclear whether these dependent claims are directed to the system of claim 1 or to the audiology simulator subcombination recited therein, rendering the scope of the claims unclear.
Claim 7 recites, “including a subject bio, medical details, or past hearing analysis results for a selected virtual subject including a subject bio and medical details associated with a selected virtual test subject.” However, the limitation recites both alternative (“or”) and conjunctive (“and”) requirements, rendering the metes and bounds of the claim unclear.
Claim 8 recites, “by changing a state of a selected button, illuminating an indicator light, or outputting a representative tone when the action is registered by toggling button states, displaying indicator lights, or outputting a representative tone.” It is unclear what the second “by” clause modifies and whether the second recitation of “a representative tone” refers to the same tone as the first.
Claim 9 recites, “by raising a hand or changing an ear indicator when a presented tone is heard by the simulated subject by changing appearance to indicate that the subject hears a presented tone.” It is unclear whether “changing appearance” is an additional requirement or whether it further defines the recited alternatives, and it is unclear whether the two recitations of “a presented tone” refer to the same tone.
The term “mimics the look … of commercial audiology testing hardware” in claims 1 and 10 is a relative term which renders the claim indefinite. The term “mimics the look” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. No objective standard is introduced to determine the degree of resemblance required and to which “commercial audiology testing hardware” the Applicant intends to copy.
Claim 4 recites, “displayed by the at least one processor on a client device or web browser interface.” It is unclear how a “client device” and a “web browser interface” are mutually exclusive and how one could be practiced without the other. Specifically, a user practicing the claimed invention would be using a client device if practicing the claimed invention on a web browser interface.
Claim Rejections - 35 USC § 112
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.
Claims 2 and 11 are 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. Claim 2 recites, “the audiology simulator provides at least one result of a user's performance using the audiology simulator.” However, claim 1 already requires enabling a user to “receive feedback comparing the findings to stored correct results for that subject,” which is a result of the user’s performance; therefore, claim 2 does not further limit claim 1. Claim 11 likewise fails to further limit claim 10, which already requires enabling a user to “receive feedback comparing the findings to stored correct results.” Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
Claims 1-2, 4-5, 7-11, 13-14, and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by SmartVS as produced by Intelligent Hearing Systems and documented within the slide presentation published on August 19, 2020 on the website of Intelligent Hearing Systems (https://smartvs.ihsys.info/smartvs-brochure/).
Regarding claim 1 (Currently Amended), SmartVS discloses:
A system comprising:
a non-transitory computer-readable medium; and
at least one processor configured to execute instructions stored in the non-transitory computer-readable medium to provide an audiology simulator (SmartVS, Smart Virtual Simulator) comprising:
an otoscopy component to provide a visual representation of at least one ear by displaying an actual ear or auditory canal image of a selected virtual subject within a graphical user interface (SmartVS, Slide 14, A virtual subject is depicted with an otoscopy component being utilized to display an auditory canal image.);
a tympanometry measuring component to simulate measuring eardrum movement in the at least one selected ear by generating and displaying a tympanogram corresponding to the selected virtual subject (SmartVS, Slide 15, A virtual subject is depicted with a tympanometry measuring component being utilized with a tympanogram being generated and displayed.);
an audiometer component to simulate measuring hearing in the at least one selected ear by presenting tones at selected frequencies and recording simulated subject responses on an audiometer chart (SmartVS, Slide 23, Tones and responses are recorded and monitored.); and
wherein the otoscopy component, the tympanometry measuring component, and the audiometer component replicate administering and interpreting a hearing test given to a subject by enabling a user to perform the tests for a selected virtual subject, record findings for each test, and receive feedback comparing the findings to stored correct results for that subject (SmartVS, The following slides depict testing and feedback-providing for users: Slides 21-22, 25, 30-32);
and wherein the audiology simulator is configured as a virtual software simulation representation of a physical audiology simulator that mimics the look, controls, and display outputs of commercial audiology testing hardware without requiring a physical ear model or physical testing device (SmartVS, Although the software is shown throughout the presentation, the Examiner notes the following slides for specifically different views: Slides 6, 8, 12-29, and 32.).
Regarding claim 2 (Previously Presented), SmartVS discloses:
The audiology simulator of claim 1, wherein the audiology simulator provides at least one result of a user's performance using the audiology simulator (SmartVS, Slide 30, “PDF reports can be submitted for grading.”).
Regarding claim 4 (Currently Amended), SmartVS discloses:
The audiology simulator of claim 1, further comprising a graphical interface having interactive controls that mimic dials, knobs, and switches of a physical audiology testing device (As cited in Claim 1) displayed by the at least one processor on a client device or web browser interface (SmartVS, Slide 4, “software”).
Regarding claim 5 (Previously Presented), SmartVS discloses:
The audiology simulator of claim 1, wherein a graphical interface provides at least one display output that includes at least one otoscope image, at least one tympanogram, and at least one audiometer chart (SmartVS, Slide 4, “we are including Audiometry (pure tone and speech), otoscopy images and tympanometry results for each patient, and auditory evoked potentials” Other slides, as cited above, also display the various charts and images.).
Regarding claim 7 (Currently Amended), SmartVS discloses:
The audiology simulator of claim 1, further comprising a subject information section providing information about the subject including a subject bio, medical details, or past hearing analysis results for a selected virtual subject including a subject bio and medical details associated with a selected virtual test subject (SmartVS, Slide 5, “Provides realistic virtual testing simulation including: Patient History, Patient data entry, Patient preparation – electrode and transducer placement, Data recording, Report generation, and Billing”).
Regarding claim 8 (Currently Amended), SmartVS discloses:
The audiology simulator of claim 1, wherein the audiology simulator provides sensory input to a user via interactive objects to confirm an action performed by the audiology simulator by changing a state of a selected button, illuminating an indicator light, or outputting a representative tone when the action is registered by toggling button states, displaying indicator lights, or outputting a representative tone (SmartVS, Slides 12-21 and 31-32, These slides depict the various interactions with the software, including buttons with Response Indicators.).
Regarding claim 9 (Currently Amended), SmartVS discloses:
The audiology simulator of claim 1, further comprising an avatar representing the subject being tested by the audiology simulator wherein the avatar provides visual cues to a user to show the avatar receiving sensory input from the audiology simulator by raising a hand or changing an ear indicator when a presented tone is heard by the simulated subject by changing appearance to indicate that the subject hears a presented tone (SmartVS, Slide 31, A Response Indicator (i.e., ear indicator) is presented when the patient hears the signal.).
Regarding claim 14, the claim recites limitations substantially similar to claim 5 as addressed above; however, claim 14 further requires the following limitations, which can be found in the prior art:
at least one otoscope image, at least one tympanogram, and at least one audiometer chart for a selected virtual subject and for user interpretation during the simulated hearing test (SmartVS, Slides 5, 6, 30, The slides illustrate where a user can write reports during the testing process, which includes, “add[ing] report text and comments” for “grading”.).
Regarding claim 19 (Currently Amended), SmartVS discloses:
The audiology simulator of claim 1, wherein the audiology simulator provides a check of a user using the audiology simulator via having the user assess a series of Otoscope images, Tympanometry traces, and subject Audiometer responses and having the user provide an assessment, diagnosis, and at least one note related to the images through a technician notes section and automatically comparing the assessment, diagnosis, and at least one note to stored correct answers for the selected virtual subject and automatically comparing the assessment, diagnosis, and at least one note to stored correct answers for a selected virtual subject to provide feedback (SmartVS, Slides 5, 6, 30, The slides illustrate where a user can write reports during the testing process, which includes, “add[ing] report text and comments” for “grading”.).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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.
Claims 3 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over SmartVS and Toly [US20040126746A1].
Regarding claim 3 (Original), SmartVS discloses the audiology simulator of claim 1 as detailed above, but SmartVS does not explicitly disclose cross-sectional data analysis across multiple users to compare different users' results using the audiology simulator.
Toly, however, discloses:
Cross-sectional data analysis across multiple users to compare different users' results (Toly, [0218], “The concept of saving old scores and comparing older scores with current scores can be extended to include a comparison of a current score with scores of other trainees”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to allow instructors the ability to perform cross-sectional data analysis across multiple users to compare different users’ results as taught by Toly in the system executing the method of SmartVS with the motivation of offering the same data in an aggregated manner to evaluate how well a simulated procedure was executed across all classmates as taught by Toly over that of SmartVS.
Claims 6 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over SmartVS and “AvatarAudiometer: an online simulation platform for pure-tone audiometry” as authored by Weidman, et al and published by Case Western Reserve University in the Scolarly Commons in the Fall of 2020 (hereinafter “Case”).
Regarding claim 6 (Currently Amended), SmartVS discloses the audiology simulator of claim 1 as detailed above, but SmartVS does not explicitly disclose access over a network connection or disclose access via a web browser.
Case, however, discloses:
The audiology simulator is web-based such that the simulator is accessed over a network connection through a web browser rather than installed as a local desktop application and is accessed over a network connection using a web browser interface (Case, TECH, “AvatarAudiometer is built as a web app with a Python Flask server backend and a frontend built with HTML/CSS/JavaScript.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide users with the ability to access the system taught by SmartVS via a web app as taught by Case with the motivation of streamlining access to the content through a web browser, instead of requiring users to follow an installation process, as taught by Case over that of SmartVS.
Regarding claims 10-18 and 20, the claims recite limitations substantially similar to claims 1-9 and 19 as addressed above. For the rationale and/or citations relevant to the rejection, please see the rejection of claims 1-9 and 19.
Response to Arguments
Applicant's arguments filed April 15, 2026, regarding the rejection of the claims under 35 U.S.C. 101, have been fully considered but they are not persuasive.
Specifically, regarding the rejection of the claims under 35 U.S.C. 101, although the claims have been amended to be a statutory category, the claims have not been amended in a manner sufficient to satisfy the requirements under 35 U.S.C. 101. In response to the Applicant’s arguments to the respective rejection, the corresponding section above has been provided in detail.
Applicant’s arguments, see pages 10-19 of the Remarks, filed April 15, 2026, with respect to the rejection of claims 1-20 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of the substantial amendments made to the claims resulting in new prior art being better suited to express the lack of novelty as currently claimed by the instant application.
Conclusion
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/Z.J.P./Examiner, Art Unit 3715
/XUAN M THAI/Supervisory Patent Examiner, Art Unit 3715
