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 .
DETAILED ACTION
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.
Claim(s) 1, 3, 4, 6, 7, 14, 27, 30, 31, 36, 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sheehan et al. US6,319,199 and Senaras et al. US2019/0216308.
For claim 1, Sheehan discloses “A method of detecting a pathology in an ear of a subject, the method comprising:
capturing, by an otoscope (fig 3), one or more images and/or videos of an ear canal and/or tympanic membrane of the ear of the subject, wherein the otoscope comprises at least one camera (206 with 204; fig 3) to generate at least one captured image and/or video (4:32); and, wherein the otoscope comprises at least one illumination source (multiple light sources 205; fig 3; 5:12, 25-36 describes light sources as visible wavelengths and infrared) that is configured to illuminate at two or more selectable illumination wavelengths (5:25 describes the multiple light sources as individually controlled), wherein the selectable illumination wavelengths comprise at least one visible wavelength and/or at least one infrared wavelength (multiple light sources 205; fig 3; 5:12, 25-36 describes light sources as visible wavelengths and infrared), wherein the illumination source is configured to illuminate in one or more selectable illumination modes (6:12 describes several modes of operation, while 6:60 further describes additional modes of operation, including 6:66 visible and infrared illumination), and wherein the selectable illumination modes comprise at least one pulsed illumination mode (5:34 describes pulsed illumination);
illuminating the ear canal and/or tympanic membrane of the ear of the subject using the illumination source when capturing the images and/or videos of the ear canal and/or tympanic membrane of the ear of the subject (5:7-19 describes illuminating the ear canal for imaging);
selecting at least one of the selectable illumination wavelengths prior to or when capturing the images and/or videos of the ear canal and/or tympanic membrane of the ear of the subject (5:47-52 describes the sequential process of illumination and image capture);
selecting at least one of the selectable illumination modes prior to or when capturing the images and/or videos of the ear canal and/or tympanic membrane of the ear of the subject (5:47-52 describes the sequential process of illumination and image capture while 6:12 describes several modes of operation, while 6:60 further describes additional modes of operation, including 6:66 visible and infrared illumination);
Sheehan does not disclose:
“matching one or more properties of the captured images and/or videos with one or more properties of at least one ear pathology model that is trained on a plurality of reference images and/or videos of ear canals and/or tympanic membranes of ears of reference subjects, which properties of the ear pathology model are indicative of at least one pathology”.
Senaras teaches in the same field of endeavor, matching captured otoscopic images to diagnose pathologies (0065: describes classification based on certain extracted features, i.e. color, texture, and shape using the described processes, e.g. CVF, CMEF. These same processes are used on training images to construct the learning model and therefore when the classification of the captured image is performed, it is ultimately matching features from the captured image with the training images, i.e. known diagnostic pathologies; to further clarify, fig 2 provides an overview for the system for classifying ear pathologies from images 0037 with fig 3A providing more detail, this includes extraction of clinically meaningful eardrum features and classification with decision fusion functions 0042. 0056 further describes the use of feature extraction/detection to define abnormalities and normality, i.e. pathology vs normal. 0058-0065 describes the classification model 208 using multiple techniques including a decision fusion technique using features to detect pathologies and a deep learning technique which involves creating a pathology model via training to classify eardrum pathologies 0061. CBIR is also described as only one aspect of this system 0061.). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Senaras into the invention of Sheehan in order to configure the otoscope device e.g. as claimed because it allows automated diagnosing of pathologies (0065: “methods of classification of the pathologies may also include automated identification of abnormalities”).
For claim 3, modified Sheehan discloses “The method of claim 1, wherein the properties comprise one or more patterns (Senaras: 0065 describes extracting color, texture, and shape information as patterns)”.
For claim 4, modified Sheehan discloses “The method of claim 1, wherein the ear pathology model is generated using one or more machine learning algorithms (Senaras: 0061)”.
For claim 6, modified Sheehan discloses “The method of claim 1, wherein the capturing and matching steps are performed substantially in real-time (Senaras: 0038, 0042 describes the connectivity of the processor with the image capture mechanism and also the software which his executed by the processor such that the analysis is performed “substantially” in real-time since the data is not required to be taken offline and stored for later analysis)”.
For claim 7, modified Sheehan discloses “The method of claim 1, wherein the pathology comprises one or more of: otitis media, otitis media with effusion, mucoid otitis media, otosclerosis, cholesteatoma, direct trauma, infected furuncle, necrotizing otitis externa, herpes zoster, acquired stenosis, osteoma, acute otitis externa, chronic otitis externa, deep impacted wax, retraction pocket, keratosis obturans, granular myringitis, bullous myringitis, tympanosclerosis, perforation, tympanosclerosis, glomus tumour, posterior infection, hemotympanum, foreign body, and temporal bone fracture (Senaras 0007, 0062: “based on the comparison of the test image with images of ear pathologies using CBIR is much greater than the likelihood of a normal ear (37%) or acute otitis media (15%))”.
For claim 14, Sheehan does not disclose “The method of claim 1, wherein the otoscope is operably connected to a database comprising an electronic medical record of the subject and wherein the method further comprises retrieving data from the electronic medical record and/or populating the electronic medical record with at least one of the images and/or videos, and/or information related thereto. Senaras teaches in the same field of endeavor, “otoscope is wirelessly connected, or connectable, to a database (database 925; fig 9) comprising an electronic medical record of the subject (0060 describes using patient’s data – image and meta data e.g. age and sex of patient), wherein the otoscope device and/or the database is wirelessly connected (0038), or connectable, to one or more communication devices of one or more remote users (interface 927; fig 9; 0073). Additionally, 0067-0071, specifically, from 0071 “Database 925 may include one or more software and/or hardware components that cooperate to store, organize, sort, filter, and/or arrange data used by the computer and/or processor 921. For example, database 925 may store digital images of an eardrum along with computer-executable instructions for preprocessing the one or more images; extracting clinically meaningful eardrum features (CMEF) from the one or more images; extracting computer vision features (CVF) from the one or more images; and, classifying pathologies of the eardrum with decision fusion using the CMEF and CVF and/or computer-executable instructions for automated identification of abnormalities using deep learning and/or CBIR that utilizes deep learning features and training a pairwise ranking model” where the storing the images related to the subject is also considered part of the electronic medical record along with any subject/session identifying information correlating the image with the subject/imaging session)”. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Senaras into the invention of Sheehan in order to configure the method e.g. as claimed because it provides additional metadata related to a patient and allows remote access to the system.
For claim 27,
Sheehan discloses “An otoscope device, comprising:
a body structure (housing shown in fig 3);
at least one speculum (202; fig 3) operably connected to the body structure;
at least one camera (206 with 204; fig 3) at least partially disposed within the speculum, which camera is configured to capture one or more images and/or videos of an ear canal and/or tympanic membrane of an ear of a subject when the speculum is disposed at least proximal to the ear canal and/or tympanic membrane of the ear of the subject (5:7-24);
at least one illumination source (multiple light sources 205; fig 3; 5:12, 25-36 describes light sources as visible wavelengths and infrared) that is configured to illuminate at two or more selectable illumination wavelengths (5:25 describes the multiple light sources as individually controlled), wherein the selectable illumination wavelengths comprise at least one visible wavelength and/or at least one infrared wavelength (multiple light sources 205; fig 3; 5:12, 25-36 describes light sources as visible wavelengths and infrared), wherein the illumination source is configured to illuminate in one or more selectable illumination modes (6:12 describes several modes of operation, while 6:60 further describes additional modes of operation, including 6:66 visible and infrared illumination), and wherein the selectable illumination modes comprise at least one pulsed illumination mode (5:34 describes pulsed illumination);
at least one display screen (220; fig 3) operably connected to the body structure, which display screen is configured to display the images and/or videos of the ear canal and/or tympanic membrane of the ear of the subject when the speculum is disposed at least proximal to the ear canal and/or tympanic membrane of the ear of the subject (4:56-65);
at least one controller (208; fig 2) at least partially disposed within the body structure, which controller is operably connected at least to the camera, to the illumination source (5:25 describes individually controlled light sources) and to the display screen, wherein the controller comprises, or is capable of accessing, computer readable media (210) comprising non-transitory computer executable instructions which, when executed by at least one electronic processor, perform at least:
capturing the images and/or videos of the ear canal and/or tympanic membrane of the ear of the subject when the speculum is disposed at least proximal to the ear canal and/or tympanic membrane of the ear of the subject (4:57-5:24);
illuminating the ear canal and/or tympanic membrane of the ear of the subject using the illumination source when capturing the images and/or videos of the ear canal and/or tympanic membrane of the ear of the subject (5:7-19 describes illuminating the ear canal for imaging);
selecting at least one of the selectable illumination wavelengths prior to or when capturing the images and/or videos of the ear canal and/or tympanic membrane of the ear of the subject (5:47-52 describes the sequential process of illumination and image capture);
selecting at least one of the selectable illumination modes prior to or when capturing the images and/or videos of the ear canal and/or tympanic membrane of the ear of the subject (5:47-52 describes the sequential process of illumination and image capture while 6:12 describes several modes of operation, while 6:60 further describes additional modes of operation, including 6:66 visible and infrared illumination);
displaying the captured images and/or videos of the ear canal and/or tympanic membrane of the ear of the subject on the display screen at least when the speculum is disposed at least proximal to the ear canal and/or tympanic membrane of the ear of the subject (4:56-65); and
at least one power source (224; fig 3) operably connected, or connectable, to one or more of the controller, the camera, and the display screen”.
Sheehan does not disclose:
“matching one or more properties of the captured images and/or videos with one or more properties of at least one ear pathology model that is trained on a plurality of reference images and/or videos of ear canals and/or tympanic membranes of ears of reference subjects, which properties of the ear pathology model are indicative of at least one pathology”.
Senaras teaches in the same field of endeavor, matching captured otoscopic images to diagnose pathologies (0065: describes classification based on certain extracted features, i.e. color, texture, and shape using the described processes, e.g. CVF, CMEF. These same processes are used on training images to construct the learning model and therefore when the classification of the captured image is performed, it is ultimately matching features from the captured image with the training images, i.e. known diagnostic pathologies. to further clarify, fig 2 provides an overview for the system for classifying ear pathologies from images 0037 with fig 3A providing more detail, this includes extraction of clinically meaningful eardrum features and classification with decision fusion functions 0042. 0056 further describes the use of feature extraction/detection to define abnormalities and normality, i.e. pathology vs normal. 0058-0065 describes the classification model 208 using multiple techniques including a decision fusion technique using features to detect pathologies and a deep learning technique which involves creating a pathology model via training to classify eardrum pathologies 0061. CBIR is also described as only one aspect of this system 0061.). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Senaras into the invention of Sheehan in order to configure the otoscope device e.g. as claimed because it allows automated diagnosing of pathologies (0065: “methods of classification of the pathologies may also include automated identification of abnormalities”).
Modified Sheehan discloses for claim 30, “The otoscope device of claim 27, wherein the properties comprise one or more patterns (Senaras: 0065 “color, texture and shape information” as patterns)”.
Modified Sheehan discloses for claim 31, “The otoscope device of claim 27, wherein the ear pathology model is generated using one or more machine learning algorithms (Senaras: 0061: “machine learning can be used to retrieve images of similar eardrum cases for classification of eardrum pathologies”)”.
Modified Sheehan discloses for claim 36, “The otoscope device of claim 27, wherein the controller is operably connected, or connectable, to a database comprising an electronic medical record of the subject and wherein the computer executable instructions further perform retrieving data from the electronic medical record and/or populating the electronic medical record with at least one of the images and/or videos, and/or information related thereto (Senaras: 0067-0071: specifically, from 0071 “Database 925 may include one or more software and/or hardware components that cooperate to store, organize, sort, filter, and/or arrange data used by the computer and/or processor 921. For example, database 925 may store digital images of an eardrum along with computer-executable instructions for preprocessing the one or more images; extracting clinically meaningful eardrum features (CMEF) from the one or more images; extracting computer vision features (CVF) from the one or more images; and, classifying pathologies of the eardrum with decision fusion using the CMEF and CVF and/or computer-executable instructions for automated identification of abnormalities using deep learning and/or CBIR that utilizes deep learning features and training a pairwise ranking model” where the storing the images related to the subject is also considered part of the electronic medical record along with any subject/session identifying information correlating the image with the subject/imaging session)”.
Modified Sheehan discloses for claim 48 (as provided in claim 27), “A system, comprising:
at least one otoscope device (fig 2, 3) that comprises at least one camera (206 with 204; fig 3) and at least one illumination source (multiple light sources 205; fig 3; 5:12, 25-36 describes light sources as visible wavelengths and infrared), wherein the camera is configured to capture one or more images and/or videos of an ear canal and/or tympanic membrane of an ear of a subject when the camera is disposed at least proximal to the ear canal and/or tympanic membrane of the ear of the subject (5:47-52 describes the sequential process of illumination and image capture) and wherein the illumination source is configured to illuminate at two or more selectable illumination wavelengths (multiple light sources 205; fig 3; 5:12, 25-36 describes light sources as visible wavelengths and infrared), wherein the selectable illumination wavelengths comprise at least one visible wavelength and/or at least one infrared wavelength (multiple light sources 205; fig 3; 5:12, 25-36 describes light sources as visible wavelengths and infrared), wherein the illumination source is configured to illuminate in one or more selectable illumination modes (6:12 describes several modes of operation, while 6:60 further describes additional modes of operation, including 6:66 visible and infrared illumination), and wherein the selectable illumination modes comprise at least one pulsed illumination mode (5:34 describes pulsed illumination);
at least one controller (208; fig 2) that is operably connected, or connectable, at least to the camera, wherein the controller comprises, or is capable of accessing, computer readable media (210) comprising non-transitory computer executable instructions which, when executed by at least one electronic processor, perform at least:
capturing the images and/or videos of the ear canal and/or tympanic membrane of the ear of the subject when the speculum is disposed at least proximal to the ear canal and/or tympanic membrane of the ear of the subject (4:57-5:24); and,
illuminating the ear canal and/or tympanic membrane of the ear of the subject using the illumination source when capturing the images and/or videos of the ear canal and/or tympanic membrane of the ear of the subject (5:7-19 describes illuminating the ear canal for imaging);
selecting at least one of the selectable illumination wavelengths prior to or when capturing the images and/or videos of the ear canal and/or tympanic membrane of the ear of the subject (5:47-52 describes the sequential process of illumination and image capture);
selecting at least one of the selectable illumination modes prior to or when capturing the images and/or videos of the ear canal and/or tympanic membrane of the ear of the subject (5:47-52 describes the sequential process of illumination and image capture while 6:12 describes several modes of operation, while 6:60 further describes additional modes of operation, including 6:66 visible and infrared illumination);
matching one or more properties of the captured images and/or videos with one or more properties of at least one ear pathology model that is trained on a plurality of reference images and/or videos of ear canals and/or tympanic membranes of ears of reference subjects, which properties of the ear pathology model are indicative of at least one pathology (Senaras: 0065: describes classification based on certain extracted features, i.e. color, texture, and shape using the described processes, e.g. CVF, CMEF. These same processes are used on training images to construct the learning model and therefore when the classification of the captured image is performed, it is ultimately matching features from the captured image with the training images, i.e. known diagnostic pathologies)”.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sheehan and Senaras as applied to claim 1 above, and further in view of Saemundsdottir US2010/0070054.
For claim 8, Sheehan does not disclose “The method of claim 1, further comprising administering one or more therapies to the subject to treat the pathology. Saemundsdottir teaches in the same field of endeavor, providing an otitis media therapy (0014). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Saemundsdottir into the invention of Senaras in order to configure the method e.g. as claimed because it allows curing or treating the detected pathology.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sheehan and Senaras as applied to claim 1 above, and further in view of Smart US2015/0015692.
For claim 13, Sheehan does not disclose “The method of claim 1, comprising using hyperspectral imaging and/or optical coherence tomography (OCT) to capture the images and/or videos of the ear canal and/or tympanic membrane of the ear of the subject”. Smart teaches in the same field of endeavor, providing hyperspectral imaging with otoscopes (0005: describes in the background section a high level description of hyperspectral imaging with otoscopes, 0048: describes the schematic figure, 0049-0052 describes a particular detailed embodiment of such). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Smart into the invention of Senaras in order to configure the method e.g. as claimed because it enhances the information that may be derived from an image (0008: “Hyperspectral imaging provides various improvements over other imaging techniques, including: (1) enhanced spatial and spectral resolution by image either akin to the saccadic behavior of the human eye, (2) improved signal-to-noise ratio by using more than one spectral distribution of illuminant, (3) optimized spatial distribution of individual pixel filters according to specifically designed criteria, and (4) exploitation of inelastic scatter by using one or more narrow-band illuminants”).
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sheehan and Senaras as applied to claim 27 above, and further in view of Elliott US2002/0019583.
For claim 28, Sheehan does not disclose “A kit comprising the otoscope device of claim 27”. Elliot teaches in the same field of endeavor, providing an otoscope as a kit (0015: “FIG. 1 shows one embodiment of the kit as it would be assembled on the otoscope 1”). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Elliot into the invention of Sheehan in order to configure the otoscope device e.g. as claimed because it “enhances the utility of the otoscope for both the inspection of a nose and an ear and also enhances the utility for removal of foreign bodies from either a nose or an ear” (0003).
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sheehan and Senaras as applied to claim 27 above, and further in view of Kempanna et al. US2019/0221317.
Sheehan does not disclose for claim 33, “The otoscope device of claim 27, wherein the ear pathology model comprises one or more selected therapies indexed to the pathology”. Kempanna teaches in the same field of endeavor, providing associated therapies for detected pathologies (0003, 0014: “system 100 is configured to, via one or more predictive models, provide results of best effective therapies based on matching of similar patients”). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Kempanna into the invention of Sheehan in order to configure the otoscope device e.g. as claimed because provides automated therapeutic information.
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sheehan and Senaras as applied to claim 27 above, and further in view of Smart.
Sheehan does not disclose for claim 42 “The otoscope device of claim 27, wherein the controller is configured to capture the images and/or videos of the ear canal and/or tympanic membrane of the ear of the subject using hyperspectral imaging and/or optical coherence tomography (OCT)”. Smart teaches in the same field of endeavor, providing hyperspectral imaging with otoscopes (0005: describes in the background section a high level description of hyperspectral imaging with otoscopes, 0048: describes the schematic figure, 0049-0052 describes a particular detailed embodiment of such). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Smart into the invention of Senaras in order to configure the method e.g. as claimed because it enhances the information that may be derived from an image (0008: “Hyperspectral imaging provides various improvements over other imaging techniques, including: (1) enhanced spatial and spectral resolution by image either akin to the saccadic behavior of the human eye, (2) improved signal-to-noise ratio by using more than one spectral distribution of illuminant, (3) optimized spatial distribution of individual pixel filters according to specifically designed criteria, and (4) exploitation of inelastic scatter by using one or more narrow-band illuminants”).
Claim(s) 50, 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sheehan and further in view of Senaras as applied to claim 1 above, and further in view of Abramoff US 20200037930.
Sheehan does not disclose for claim 50, “The method of claim 1, wherein the ear pathology model comprises one or more selected therapies indexed to the pathology in the ear of the subject”. Abramoff teaches in the same field of endeavor, autonomously diagnosing an ear disease and generating a therapy (fig 1; 0011). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Abramoff into the invention of Sheehan in order to configure the method e.g. as claimed because it provides autonomous therapy guidance.
Sheehan does not disclose for claim 51, “The method of claim 1, wherein the otoscope is wirelessly connected, or connectable, to a database comprising an electronic medical record of the subject, wherein the otoscope device and/or the database is wirelessly connected, or connectable, to one or more communication devices of one or more remote users, wherein the remote users view at least one of the images and/or videos of the canal and/or tympanic membrane of the ear of the subject and/or the electronic medical record of the subject using the communication devices”.
Senaras teaches in the same field of endeavor, “otoscope is wirelessly connected, or connectable, to a database (database 925; fig 9) comprising an electronic medical record of the subject (0060 describes using patient’s data – image and meta data e.g. age and sex of patient), wherein the otoscope device and/or the database is wirelessly connected (0038), or connectable, to one or more communication devices of one or more remote users (interface 927; fig 9; 0073), wherein the remote users view at least one of the images and/or videos of the canal and/or tympanic membrane of the ear of the subject and/or the electronic medical record of the subject using the communication devices (0038 describes image capture mechanism 102 located remotely from the computing device). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Senaras into the invention of Sheehan in order to configure the method e.g. as claimed because it provides additional metadata related to a patient and allows remote access to the system.
Sheehan further does not disclose “wherein the users input one or more entries into the electronic medical record of the subject in view of the detected pathology in the ear of the subject using the communication devices, and wherein the users order one or more therapies and/or additional analyses of the subject in view of the detected pathology in the ear of the subject using the communication devices, and/or wherein a system that comprises the database automatically orders one or more therapies and/or additional analyses of the subject in view of the detected pathology in the ear of the subject when the users input the entries into the electronic medical record of the subject”. Abramoff teaches in the same field of endeavor, autonomously diagnosing an ear disease and generating a therapy (fig 1; 0011). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Abramoff into the invention of Sheehan in order to configure the method e.g. as claimed because it provides autonomous therapy guidance.
Response to Arguments
Applicant's arguments filed 1/20/2026 have been fully considered but they are not persuasive.
Applicant’s first argument at para B. 1.) asserts that Senaras relies on CBIR, implying that CBIR is the only technique that Senaras uses. This has been refuted in the clarification of the rejection above to further describe in detail the complete system.
Applicant’s next argument at para B. 2.) asserts that there is no teaching of properties indicative of the pathology. The system that Senaras discloses identifying ear drum feature abnormalities 0042, i.e. features/properties of a pathology.
Applicant’s next argument at para B. 3.) asserts that no detection or diagnosis is performed by Senaras. The abstract state the point of the disclosure is for systems and methods to detect a wide range of eardrum abnormalities by using high-resolution otoscope images. This is further supported at 0037, 0041, 0042 for example that describes the classification of pathology, i.e. detection. These functions are also disclosed as being able to be automatic at 0065, 0077.
Applicant’s next argument at para C. claiming that there is no motivation to combine is also not persuasive since the detection and classification of abnormalities/pathologies clearly provides an advantage to a system that is incapable of performing this function.
Applicant’s other arguments are addressed in the rejection and rebuttal above and are not deemed persuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO892.
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/Jae Woo/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
7/24/26
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