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 .
Applicant(s) Response to Official Action
The response filed on 04/14/2026 has been entered and made of record.
Response to Arguments/Amendments
Presented arguments have been fully considered but are held unpersuasive. Examiner’s response to the presented arguments follows below.
Summary of Arguments:
Claim Rejections - 35 USC § 102
Regarding claim 1, the Applicant argues Douglas and Shahoian fail to disclose or suggest: “when the ear image data is determined to include at least a portion of the tympanic membrane, determining, by the one or more programmable computing devices based on the ear image data, a region at the tympanic membrane for placing a tympanostomy tube; and (ii) providing, by the one or more programmable computing devices, an output indicative of the region at the tympanic membrane for placing the tympanostomy tube” for the following reasons:
The Applicant asserts that Douglas merely teaches identifying whether a tympanostomy tube is present or was previously placed correctly, however “Douglas does not teach or suggest determining a region at the tympanic membrane for placing a tympanostomy tube.” [Remarks: Page 7]
Douglas does not teach providing an output indicative of the placement region. [Remarks: Pages 7-8]
Claim Rejections - 35 USC § 103
Regarding claims 7-8, the Applicant argues:
Shahoian fails to cure the alleged deficiencies of Douglas and that the combination of Douglas and Shahoian relies on improper hindsight. [Remarks: Page 8]
Examiner’s Response:
Regarding claim 1, the Examiner contends:
Douglas explicitly discloses evaluating "Timpanostomy tube placement" to determine whether the placement is "correct" or "incorrect" (Douglas at ¶ [0220]). As established in the Office Action, evaluating whether a placement is "correct" logically necessitates that the system first determines the specific correct anatomical region where the tube should be placed (Douglas at ¶ [0220], ¶ [0228]). Further, Douglas teaches the specific detection and characterization of the "cone of light" (Douglas at ¶ [0216]). Douglas identifies that this cone of light is a reflection located specifically in the anterior inferior quadrant of the tympanic membrane (Douglas at ¶ [0216]). The Office Action notes that this anterior inferior quadrant is the standard anatomical region associated with the orientation and placement of tympanostomy tubes (Douglas at ¶ [0216], ¶ [0220]). Furthermore, Douglas explicitly discloses determining a region at the tympanic membrane for placing a tympanostomy tube (Douglas: ¶ [0014]: “estimating, for each subregion, a probability that the subregion is part of a tympanic membrane based on an extracted sets of feature values for the subregion”.).
To the contrary, Douglas discloses indicating to a user exactly where the tympanic membrane is located in real-time on a live video (Douglas at ¶ [0326]). Douglas further teaches that this indication can include highlighting the boundaries of the tympanic membrane, highlighting the area of the tympanic membrane, or noting the center of the tympanic membrane with a visual icon (Douglas at ¶ [0326]). Therefore, Douglas teaches providing a visual output indicative of the region, directly mapping to the limitations of independent claim 1 (Douglas at ¶ [0326], ¶ [0338]).
Regarding claims 7-8, the Examiner contends:
The Applicant's primary argument relies on the premise that Douglas is deficient in teaching the determination and output of a placement region. Because Douglas does, in fact, disclose these limitations as explained above, the argument that Shahoian fails to cure a non-existent deficiency is moot. Shahoian explicitly discloses a system for tympanostomy tube placement that features a combined tympanic membrane penetrator and delivery device (Shahoian at ¶ [0071]). Shahoian teaches that this combined device includes an incision tool configured to create an incision and a tube delivery component configured to hold and deploy the pressure equalization tube at the incision site (Shahoian at ¶ [0118], ¶ [0119]). Furthermore, Shahoian teaches a light-based targeting and range finding system that uses light emitting elements to project visible dots or crosshairs directly onto the tympanic membrane (Shahoian at ¶ [0135]). The Office Action clearly establishes that it would have been obvious to modify the otoscope system of Douglas to include the tube placement tools and light-annotated features of Shahoian. The motivation to combine these references is not based on hindsight, but rather on the articulated goal of improving procedural efficiency, accuracy, and safety. Specifically, the combination provides a configuration that enables a projected light annotated guide, allowing the user to seamlessly navigate to the correct quadrant for precise and stable tube deployment.
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.
Claims 1-6, 9-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Douglas et al hereinafter referred to as Douglas (US 2015/0065803 A1).
As per claim 1, Douglas discloses a method of identifying a location for tympanostomy tube placement at a tympanic membrane of a patient (Douglas: Abstract.), the method comprising the steps of:
receiving, at one or more programmable computing devices, ear image data (Douglas: Paras. [0014], [0032] disclose receiving the image of the subject's ear canal.);
determining, by the one or more programmable computing devices, whether the ear image data includes at least a portion of the tympanic membrane (Douglas: Paras. [0014], [0035] disclose estimating, for each subregion, a probability that the subregion is part of a tympanic membrane and identifying and/or detecting a tympanic membrane region from the image of a subject's ear canal.);
when the ear image data is determined to include at least a portion of the tympanic membrane, determining, by the one or more programmable computing devices based on the ear image data, a region at the tympanic membrane for placing a tympanostomy tube (Douglas: Para. [0014] discloses identifying a tympanic membrane region from the image using the estimated probabilities; Douglas: Paras. [0216], [0220] further disclose detection and characterization of the “cone of light”, which is the reflection of the otoscope light source in the anterior inferior quadrant of the TM, which can be used to identify anatomical landmarks/regions associated with orientation/placement of tympanostomy tubes (e.g., N/A, correct, incorrect, absent, present).); and
providing, by the one or more programmable computing devices, an output indicative of the region at the tympanic membrane for placing the tympanostomy tube (Douglas: Para. [0029] discloses identifying the tympanic membrane region from the image on a representation of the image by circling/outlining, highlighting, coloring; Douglas: Para. [0338] further discloses indicating to the user where, in the live video, the TM is located and highlighting the boundaries.).
As per claim 2, Douglas discloses the method of claim 1, wherein the determined region at the tympanic membrane for placing the tympanostomy tube corresponds to a quadrant, within the ear image data, determined to include the at least the portion of the tympanic membrane (Douglas: Paras. [0216], [0398] disclose identifying specific quadrants within the tympanic membrane image data, such as the anterior inferior quadrant or superior posterior quadrant.).
As per claim 3, Douglas discloses the method of claim 2, wherein the quadrant determined to include the at least the portion of the tympanic membrane comprises an anterior or interior quadrant within the ear image data determined to include the at least the portion of the tympanic membrane (Douglas: Para. [0216] discloses a typical otoscopic examination of a healthy TM exhibits a phenomenon known as 'cone of light', which is the reflection of the otoscope light source in the anterior inferior quadrant of the TM Detection and characterization of the cone of light may therefore be useful.).
As per claim 4, Douglas discloses the method of claim 2, wherein the provided output indicative of the region at the tympanic membrane for placing the tympanostomy tube comprises a visual annotation included at the quadrant determined to include the at least the portion of the tympanic membrane (Douglas: Paras. [0216], [0326] disclose identifying quadrants of the ear anatomy, indicating to the user, in real time, (a) that the TM has been detected and (b) where, in the live video, the TM is located. The interface for indicating the TM might include: highlighting the boundaries of the TM, highlighting the area of the TM, noting the center of the TM, e.g., with an icon.).
As per claim 5, Douglas discloses the method of claim 4, wherein the visual annotation is included in association with, and at a relative location within, the ear image data (Douglas: Paras. [0326], [0379] disclose teaching the indication of location within the live video or Automatic Feature Annotation image displayed with salient features automatically labeled, which might include: highlighting the boundaries of the TM, noting the center of the TM, e.g., with an icon such as a checkmark, smiley face, etc.).
As per claim 6, Douglas discloses the method of claim 4, wherein the one or more programmable computing devices comprise an otoscope assembly and a remote programmable computing device, and wherein the visual annotation is included at the quadrant at the tympanic membrane for visual perception at the tympanic membrane (Douglas: Paras. [0167], [0258], [0365] disclose an otoscope assembly comprising an otoscope component coupled to a smartphone which communicates with a data analytics server or remote server (i.e., a remote programmable computing device) to process exams. Further, Douglas: Paras. [0216], [0379] disclose the visual annotation at the quadrant of the tympanic membrane for visual perception.).
As per claim 9, Douglas discloses the method of claim 1,
wherein determining, by the one or more programmable computing devices, whether the ear image data includes at least a portion of the tympanic membrane comprises determining, by the one or more programmable computing devices, a first predetermined probability range that the ear image data includes at least a portion of the tympanic membrane and a second, lower predetermined probability range that the ear image data includes at least a portion of the tympanic membrane (Douglas: Para. [0173] discloses determining a segmentation likelihood map with values from 0 to 1 and applying a threshold, effectively defining a first range above the threshold and a second, lower range below the threshold.),
when the one or more programmable computing devices determine that the ear image data includes at least a portion of the tympanic membrane within the first predetermined probability range, the one or more programmable computing devices determine that the ear image data includes at least a portion of the tympanic membrane (Douglas: Para. [0173] discloses that pixels over the threshold are set to 1 (True/includes TM).), and
when the one or more programmable computing devices determine that the ear image data includes at least a portion of the tympanic membrane within the second, lower predetermined probability range, the one or more programmable computing devices determine that the ear image data does not include at least a portion of the tympanic membrane (Douglas: Para. [0173] discloses that pixels below the threshold are set to 0 (False/does not include TM).).
As per claim 10, Douglas discloses the method of claim 9, when the one or more programmable computing devices determine that the ear image data includes at least a portion of the tympanic membrane within the second, lower probability range, outputting, by the one or more programmable computing devices an insufficient ear image data capture notification indicative of the determination by the one or more programmable computing devices that the ear image data does not include at least a portion of the tympanic membrane (Douglas: Paras. [0029], [0039, [0173], [0339] disclose the system may indicate when the image quality is low The target output is a continuous value probability that the pixel-of-interest is a part of the TM segmentation likelihood map which may be thresholded. Evaluating these probabilities against thresholds determine if the region is sufficiently captured or if the quality is low, indicating that the image includes such a region (e.g., above a threshold minimum amount of tympanic membrane region). Further, a threshold could be determined wherein, when the area of the tympanic membrane is sufficiently large, an indication is displayed that the TM has been successfully captured.).
As per claim 11, Douglas discloses the method of claim 9, wherein, when the one or more programmable computing devices determine that the ear image data includes at least a portion of the tympanic membrane by determining that the ear image data includes at least a portion of the tympanic membrane within the first predetermined probability range, the one or more programmable computing devices then determine the region at the tympanic membrane for placing a tympanostomy tube (Paras. [0016]-[0017] disclose identifying the tympanic membrane region using estimated probabilities and Para. [0220] discloses detecting the “cone of light” within the tympanic membrane, which is the standard anatomical region for tube placement. Further, Para. [0228] explicitly discusses determining “Timpanostomy tube placement” (noting correct vs. incorrect placement), which necessitates the system determining the specific region where the tube should be placed.).
As per claim 12, Douglas discloses the method of claim 11,
wherein determining, by one or more programmable computing devices, the region at the tympanic membrane for placing a tympanostomy tube comprises determining, by the one or more programmable computing device, a first predetermined probability range that the output indicative of the region at the tympanic membrane for placing the tympanostomy tube is accurate and a second, lower predetermined probability range that the output indicative of the region at the tympanic membrane for placing the tympanostomy tube is accurate, when the one or more programmable computing devices determine that the output indicative of the region at the tympanic membrane for placing the tympanostomy tube is within the first predetermined probability range, the one or more programmable computing devices determine that the output indicative of the region at the tympanic membrane for placing the tympanostomy tube is accurate, and when the one or more programmable computing devices determine that the output indicative of the region at the tympanic membrane for placing the tympanostomy tube is within the second, lower predetermined probability range, the one or more programmable computing devices determine that the output indicative of the region at the tympanic membrane for placing the tympanostomy tube is not accurate (Paras. [0173], [0186], [0189] disclose generating a probability image containing values (e.g., from 0 to 1) indicating the likelihood a region is part of the tympanic membrane and applying a pre-determined threshold to this data.).
As per claim 13, Douglas discloses the method of claim 1, wherein determining, by one or more programmable computing devices, whether the ear image data includes at least a portion of the tympanic membrane comprises using a machine learning classifier trained to determine whether pixels of image data depict a portion of the tympanic membrane (Paras. [0022], [0186] disclose features extracted from the image may then be applied to an implementation of a pre-trained supervised machine learning classification model (e.g., a support vector machine or random forest model) included as part of the apparatus to predict whether the given pixel is part of the tympanic membrane or not. Furthermore, estimating may comprise using a trained classification model to predict if a subregion within the subset of subregions is part of a tympanic membrane.).
As per claim 14, Douglas discloses the method of claim 13, wherein the machine learning classifier has been trained with prior myringotomy-related surgical findings (Paras. [0231], [0234], [0253] disclose extracting features determined from procedures, including Tests for viruses or bacteria from tympanocentesis or directly from the middle ear in the case of tympanostomy tubes and assembling these features into vectors to train a machine learning system for diagnosis.).
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.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Douglas in view of Shahoian (US 2014/0194891 A1).
As per claim 7, Douglas discloses the method of claim 6,
wherein the otoscope assembly comprises:
an otoscope, an otoscope speculum configured to couple to the otoscope, a camera configured to capture image data when the otoscope speculum is inserted into an ear canal, a light source configured to illuminate an ear canal when the otoscope speculum is inserted into the ear canal (Douglas: Paras. [0026], [0417], [0418] disclose an otoscope assembly with an otoscope component speculum, mobile phone camera, and an LED light guide.),
wherein the visual annotation, included at the quadrant at the tympanic membrane for visual perception at the tympanic membrane, is provided by the light source of the otoscope assembly (Douglas: Paras. [0436], [0441] disclose using the light source for structured or offset illumination to highlight features, supporting the use of the light source for visual feedback.).
However, Douglas does not explicitly disclose “… an incision tool that is configured to create an incision at the tympanic membrane, and a tube placement tool that is configured to hold a tympanostomy tube and to place the tympanostomy tube at the incision at the tympanic membrane …”.
Further, Shahoian is in the same field of endeavor and teaches an incision tool that is configured to create an incision at the tympanic membrane, and a tube placement tool that is configured to hold a tympanostomy tube and to place the tympanostomy tube at the incision at the tympanic membrane (Shahoian: Paras. [0006], [0071], [0113] disclose a system for tympanostomy tube placement comprising a combined TM penetrator and delivery device which includes a cutting/incision tool and a component that deploys the PE (pressure equalization) tube (e.g., the actuator system including a cutting tool and PE tube riding on it). Furthermore, Shahoian: Para. [0135] discloses targeting/visual annotation (visible dots/cross hairs) is provided by LEDs on the device.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, and having the teachings of Douglas and Shahoian before him or her, to modify the otoscope system of Douglas to include the tube placement tool holding tympanostomy tube at the incision at the tympanic membrane feature as described in Shahoian. The motivation for doing so would have been to improve procedural efficiency, accuracy and safety by providing a configuration that enables a projected light annotated guide for the user to navigate the correct quadrant for precise and stable deployment.
As per claim 8, Douglas-Shahoian disclose the method of claim 7, wherein the tube placement tool comprises a mechanical arm (200) that is movable relative to otoscope (Shahoian: Paras. [0116], [0118], [0123] disclose mechanical actuator devices 200 are inserted into a working channel of the guide block system (otoscope assembly) and are linearly actuated or movable relative to the guide block to penetrate the tympanic membrane and place the tube.).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and can be viewed in the list of references.
THIS ACTION IS MADE FINAL. 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 PEET DHILLON whose telephone number is (571)270-5647. The examiner can normally be reached M-F: 5am-1:30pm.
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, Sath V. Perungavoor can be reached at 571-272-7455. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PEET DHILLON/Primary Examiner
Art Unit: 2488
Date: 06-03-2026
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