DETAILED ACTION
This action is in response to the Applicant Remarks received on October 9, 2025. Claims 1-20 are pending with no claims canceled, claims 1, 2, 5, 10, and 11 currently amended, and claims 19 and 20 newly presented.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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 1-9 and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims are directed to non-statutory subject matter because the claims as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. 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 virtual software simulation” (Claim 1), in claims 1-9 and 19 (as amended), which fails to fall within one of the four statutory categories of invention because claims 1-9 and 19 are directed to software per se, which is ineligible subject matter under 35 U.S.C. 101 (MPEP 2106.03, Section I, “Products that do not have a physical or tangible form, such as information (often referred to as "data per se") or a computer program per se (often referred to as "software per se") when claimed as a product without any structural recitations;”). As such, claims 1-9 and 19 are not directed to one of the four statutory categories and do not meet the requirements of Step 1.
The instant invention also encompasses a method (i.e., process) in claims 10-18 and 20 for simulating a hearing test given to a subject. Claims 10-18 and 20 are directed to one of the four statutory categories and meet the requirements of Step 1.
Thus claims 1-9 and 19 are rendered unpatentable.
The Examiner recommends the Applicant amends claim 1 to recite, “A system, comprising: a non-transitory computer-readable medium, at least one processor, wherein the at least one processor is configured to execute instructions embodied in the computer-readable medium to perform operations comprising: an otoscopy component…” (or any suitable variation) to abrogate the rejection of claims 1-9 and 19 under 35 U.S.C. 101 as software per se.
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.
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.
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.
Claims 1-8, 10-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over OtoSim Inc (hereinafter “OtoSim”) as published on OtoSim Inc’s YouTube channel [https://www.youtube.com/@OtosimInc/videos] under the titles “OtoSim 2 Otoscopy Training and Simulation” on May 4, 2020 [https://youtu.be/llYBC-GKBlY?si=iXmmLy8PsL_JpeGD] and “OtoSim Otoscopy Training & Simulation – Intro” on January 20, 2012 [https://www.youtube.com/watch?v=BloUtzVUSZ4].
Regarding claim 1 (Currently Amended), OtoSim discloses:
An audiology simulator (OtoSim 2, 0:01 of 0:58, “A Complete Otoscopy Skill Trainer”) comprising:
an otoscopy component to provide a visual representation of at least one ear (OtoSim 2, 0:03 of 0:58, A visual representation of an ear is seen as hardware on the table and as a picture on the computer’s graphical interface.);
a tympanometry measuring component to simulate measuring eardrum movement in the at least one ear (OtoSim 2, 0:45 of 0:58, “Pneumatic Otoscopy Simulator Add-On” and OtoSim 2, 0:10 of 0:58, The computer’s graphical interface displays components of simulating the measuring of eardrum movement within the ear.); and
an audiometer component to simulate measuring hearing in the at least one ear (OtoSim 2, 0:42 of 0:58, “Built for OSCE testing and SP Programs”);
wherein the otoscopy component, the tympanometry measuring component, and the audiometer component replicate administering and interpreting a hearing test given to a subject (OtoSim 2, 0:42 of 0:58, “Built for OSCE testing and SP Programs”); and
wherein the audiology simulator is configured as a virtual software simulation representation of a physical audiology simulator (Please see Examiner’s note below.).
OtoSim does not explicitly disclose replicating administering and interpreting a hearing test given to a subject.
However, OtoSim is intended to be used for OSCE testing, as cited above. Geeky Medics published an article titled “Hearing/Ear Examination – OSCE Guide” on December 15, 2015 (hereinafter “Geeky Medics”), as documented by the Internet Archive WayBack Machine [https://web.archive.org/web/20151215021047/http://geekymedics.com/hearing-ear-examination-osce-guide], that teaches “Hearing/Ear examination frequently appears in OSCEs” (Geeky Medics, para 1). Therefore, it is concluded that the ability to replicate administering and interpreting a hearing test given to a subject is necessarily present in OtoSim.
Furthermore, OtoSim does not explicitly disclose a system that is solely intended as a “virtual software simulation” (claim 1) as OtoSim provides a physical model for students to perform various tests. However, an omission of an element and its function (e.g., a physical model to test upon) is obvious if the function of the element is not desired (MPEP 2144.04, Section II, A). Modifying a previously existing system to perform purely in a digital realm is insufficient to distinguish a claimed invention from a prior art reference. MPEP 2144.04, Section II, A in its entirety have been provided below for ease of reference for the Applicant:
Ex parte Wu, 10 USPQ 2031 (Bd. Pat. App. & Inter. 1989) (Claims at issue were directed to a method for inhibiting corrosion on metal surfaces using a composition consisting of epoxy resin, petroleum sulfonate, and hydrocarbon diluent. The claims were rejected over a primary reference which disclosed an anticorrosion composition of epoxy resin, hydrocarbon diluent, and polybasic acid salts wherein said salts were taught to be beneficial when employed in a freshwater environment, in view of secondary references which clearly suggested the addition of petroleum sulfonate to corrosion inhibiting compositions. The Board affirmed the rejection, holding that it would have been obvious to omit the polybasic acid salts of the primary reference where the function attributed to such salt is not desired or required, such as in compositions for providing corrosion resistance in environments which do not encounter fresh water.). See also In re Larson, 340 F.2d 965, 144 USPQ 347 (CCPA 1965) (Omission of additional framework and axle which served to increase the cargo carrying capacity of prior art mobile fluid carrying unit would have been obvious if this feature was not desired.); and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (deleting a prior art switch member and thereby eliminating its function was an obvious expedient).
Regarding claim 2 (Currently Amended), OtoSim 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 (OtoSim 2, 0:27 of 0:58, “Verify Learning Outcomes” and OtoSim 2, 0:29 of 0:58, “Tracked Otoscope aids Educator in Assessing Student” and OtoSim 2, 0:42 of 0:58, “Built for OSCE testing and SP Programs”.).
Regarding claim 3 (Original), OtoSim discloses:
The audiology simulator of claim 1, wherein the audiology simulator enables cross-sectional data analysis across multiple users to compare different users' results using the audiology simulator (OtoSim 1, 1:52-2:00 of 3:51, “…the ability to teach on mass as well so one instructor can have multiple students simultaneously.” and OtoSim 1, 2:00-2:22 of 3:51, OtoSim 1 displays the ability to perform cross-sectional data analysis across multiple users to compare different users’ results using the simulator by displaying the Diagnostic Accuracy of a Control Group and an OtoSim Group.).
Regarding claim 4 (Original), OtoSim discloses:
The audiology simulator of claim 1, further comprising a graphical interface (OtoSim 2, 0:03 of 0:58, The computer’s graphical interface is shown.).
Regarding claim 5 (Currently Amended), OtoSim discloses:
The audiology simulator of claim 1, wherein a graphical interface provides at least one display output that includes at least one otoscope image (OtoSim 2, 0:17 of 0:58, The graphical interface displays an otoscope image on screen.), at least one tympanogram, and at least one audiometer chart.
OtoSim does not explicitly disclose the use of a tympanogram or an audiometer chart, however, as discussed in MPEP 2112.01, Section III, “Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004)”. As the tympanogram and the audiometer chart do not functionally relate to the claimed invention, the use of a tympanogram or an audiometer chart does not distinguish the claimed invention from OtoSim.
Regarding claim 6 (Original), OtoSim discloses:
The audiology simulator of claim 1, wherein the audiology simulator is web-based (OtoSim 2, 0:36 of 0:58, “Link Units for Group Learning”, which thereby creates a network (i.e., web) of units.).
Regarding claim 7 (Currently Amended), OtoSim discloses:
The audiology simulator of claim 1, further comprising a subject information section providing information about the subject (OtoSim 2, 0:09 of 0:58, This section directs the student to view certain portions of the subject’s ear. In other words, the section provides information on the subject (i.e., anatomy of the subject).).
Regarding claim 8 (Original), OtoSim 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 (OtoSim 2, 0:09-0:25, First, the referenced device provides sensory input to a user by verbally informing the user to locate a specific component of the ear. Secondly, on the graphical interface, the graphical interface provides visual feedback to “see exact position in ear student is looking”.).
Regarding claim 19 (New), OtoSim 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 (See Examiner’s note below.) and
having the user provide an assessment, diagnosis (OtoSim 1, 1:05-1:28 of 3:51, The speaker discusses the user utilizing the system to train and perform assessments/diagnoses.), and at least one note related to the images (OtoSim 1, 1:38-1:42 of 3:51, The user can be seen communicating with the instructor/professional regarding the images.).
OtoSim does not explicitly disclose the use of a tympanogram or an audiometer chart, however, as discussed in MPEP 2112.01, Section III, “Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004)”. As the tympanogram and the audiometer chart do not functionally relate to the claimed invention, the use of a tympanogram or an audiometer chart does not distinguish the claimed invention from OtoSim.
Claims 9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over OtoSim as applied to claims 1-8, 10-17, and 19 above, and further in view of Hamrick [US9223786B1].
Regarding claim 9 (Original), OtoSim discloses an audiology simulator operated by a user to simulating testing subjects.
OtoSim does not explicitly disclose an avatar representing the subject providing visual cues to a user to show the avatar receiving sensory input.
Hamrick, however, discloses:
An avatar representing the subject wherein the avatar provides visual cues to a user to show the avatar receiving sensory input (Hamrick, col 1, lines 48-54, “A sensory immersion motion capture simulation system can facilitate creating believable virtual characters in the sensory immersion motion capture simulation environment. The virtual characters can recognize the same types of sensory input its physical counterpart recognizes, and then adapt its behavior in response to a combination of the cues derived from the sensory input in a believable manner.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have represented a virtual subject via an avatar to provide visual cues as the avatar received sensory input as taught by Hamrick in the audiology simulator disclosed by OtoSim with the motivation of simulating human behavior to offer a more personable training experience as the user prepares to perform the examinations on physical subjects.
Regarding claims 10-18 and 20, the claims share similar limitations to claims 1-9 and 19. For citations on the rejection of claims 10-18 and 20, see the rejection of claims 1-9 and 19 above.
Response to Arguments
Applicant’s arguments, see page 6 of the Remarks, filed October 9, 2025, with respect to the drawing objection have been fully considered and are persuasive. The objection of the drawings has been withdrawn.
Applicant’s arguments, see page 6 of the Remarks, filed October 9, 2025, with respect to the claim objections of claims 5 and 7 have been fully considered and are persuasive. The objections of claims 5 and 7 have been withdrawn.
Applicant’s arguments, see page 6 of the Remarks, filed October 9, 2025, with respect to the rejection of claims 3, 8, 9, 12, 13, 17, and 18 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claims 3, 8, 9, 12, 13, 17, and 18 under 35 U.S.C. 112(b) has been withdrawn.
Applicant's arguments, see page 6 of the Remarks, filed October 9, 2025, with respect to the rejection of claims 1-9 under 35 U.S.C. 101 have been fully considered but they are not persuasive.
The Examiner respectfully submits, the claims have not been amended in such a way as to sufficiently display the claimed invention as more than software per se. Please see the corresponding section above for further details.
The rejection now incorporates the newly presented claim 19 as it depends from claim 1.
Applicant's arguments, see pages 6-7 of the Remarks, filed October 9, 2025, with respect to the rejections of claims 1-18 under 35 U.S.C. 102 and 35 U.S.C. 103 have been fully considered but they are not persuasive.
Regarding the Applicant’s argument that, “Applicant provides a virtual twin of a physical device”, the Examiner respectfully submits, although, OtoSim does not explicitly disclose a system that is solely intended as a “virtual software simulation” (claim 1) as OtoSim provides a physical model for students to perform various tests, an omission of an element and its function (e.g., a physical model to test upon) is obvious if the function of the element is not desired (MPEP 2144.04, Section II, A). Modifying a previously existing system to perform purely in a digital realm is insufficient to distinguish a claimed invention from a prior art reference.
MPEP 2144.04, Section II, A in its entirety have been provided below for ease of reference for the Applicant:
Ex parte Wu, 10 USPQ 2031 (Bd. Pat. App. & Inter. 1989) (Claims at issue were directed to a method for inhibiting corrosion on metal surfaces using a composition consisting of epoxy resin, petroleum sulfonate, and hydrocarbon diluent. The claims were rejected over a primary reference which disclosed an anticorrosion composition of epoxy resin, hydrocarbon diluent, and polybasic acid salts wherein said salts were taught to be beneficial when employed in a freshwater environment, in view of secondary references which clearly suggested the addition of petroleum sulfonate to corrosion inhibiting compositions. The Board affirmed the rejection, holding that it would have been obvious to omit the polybasic acid salts of the primary reference where the function attributed to such salt is not desired or required, such as in compositions for providing corrosion resistance in environments which do not encounter fresh water.). See also In re Larson, 340 F.2d 965, 144 USPQ 347 (CCPA 1965) (Omission of additional framework and axle which served to increase the cargo carrying capacity of prior art mobile fluid carrying unit would have been obvious if this feature was not desired.); and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (deleting a prior art switch member and thereby eliminating its function was an obvious expedient).
Regarding the Applicant’s argument that the functionality of incorporating “an automated standards-based assessment” (Remarks, page 7, para 2), the Examiner respectfully submits that OtoSim discloses being “built for OSCE testing and SPE programs” (OtoSim 2, 0:42 of 0:58). For further information regarding how this teaches the standards-based assessments as claimed, see claims 1 and 19 in the corresponding section above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY JOSEPH POLLOCK whose telephone number is (703)756-5952. The examiner can normally be reached Monday-Friday 10:00am-8:00pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, XUAN THAI can be reached at (571) 272-7147. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Z.J.P./Examiner, Art Unit 3715
/XUAN M THAI/Supervisory Patent Examiner, Art Unit 3715