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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the movable, physical filter must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 1, 8, 9, 12, 13, and 19-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Perrone et al. (US 2025/0049323 A1, Feb. 13, 2025) (hereinafter “Perrone”) in view of Mykland et al. (US 2024/0382081 A1, Nov. 21, 2024) (hereinafter “Mykland”).
Regarding claim 1: Perrone discloses a system for assessing oral health, the system comprising: an imaging probe comprising a proximal portion configured as a handle and a distal portion comprising an imaging head dimensioned for insertion into an oral cavity of a user ([0076]-[0077], [0080] - oral care device with handle and toothbrush head 100); and an imaging subsystem carried within the imaging head, the imaging subsystem comprising an illumination source positioned to illuminate a tooth within the oral cavity with near infrared (NIR) light and an image sensor operable to capture a single image of the tooth illuminated with the NIR light ([0080] - light emitting device 108 and camera 106, visible and near-infrared, images 110 may be individual images or video sequences); and wherein the illumination subsystem illuminates the at least one tooth with NIR light along an axis and the imaging subsystem detects NIR light along the same axis to produce the single image (fig. 1, [0078], [0080] - light emitting device 108 and camera 106 – the light is emitted and detected along an axis parallel to the bristles and orthogonal to the face of the toothbrush head).
While Perrone discloses that the system comprises a processor (112) and that it is desirable to integrate diagnostic tools into personal oral care devices for at-home diagnostics to allow patients to access diagnostic information with a user-friendly device ([0002]-[0004]), Perrone is silent on any details of such diagnostic processes including an analysis subsystem in communication with the imaging subsystem and operable to detect a dental lesion in the single image of the tooth.
Mykland, in the same field of endeavor, discloses a system for assessing oral health, the system comprising: an imaging probe comprising a proximal portion configured as a handle and a distal portion comprising an imaging head dimensioned for insertion into an oral cavity of a user (fig. 14 and all associated description); an imaging subsystem comprising an illumination source positioned to illuminate a tooth within the oral cavity with near infrared (NIR) light and an image sensor operable to capture a single image of the tooth illuminated with the NIR light (fig. 14 and all associated description, [0104], [0154], [0163]); and an analysis subsystem in communication with the imaging subsystem and operable to detect a dental lesion in the single image of the tooth ([0123]-[0124], [0132]-[0135]). Mykland further teaches that at-home diagnostics may assist patients who are afraid of the dentist, unable to access a dentist or unable to afford dental care ([0002]) by allowing identification of issues without the need to visit a dentist and/or identifying when a dental visit is necessary ([0002], [0015]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Perrone by including an analysis subsystem as taught by Mykland in order to provide access to at-home diagnostics that a patient may access during routine personal care and with a user-friendly device in order to provide the advantages of at-home diagnostics disclosed by Mykland.
Regarding claim 8: While Perrone shows the toothbrush head separately from any handle portion (fig. 1), Perrone does not explicitly state that it is removable. However, Mykland further discloses a removable head which allows the imaging probe to be used by multiple people (e.g. members of a family) ([0107]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Perrone and Mykland by providing the removable head of Mykland in order to allow multiple users to benefit from the system in a sanitary manner.
Regarding claim 9: Mykland further discloses wherein the imaging probe is configured to accept a plurality of different imaging heads ([0107]).
Regarding claim 12: Mykland further discloses wherein the analysis subsystem operates on a user device in wireless communication with the imaging probe (fig. 7, [0123]-[0124], [0050]).
Regarding claim 13: Mykland further discloses wherein the analysis subsystem comprises a machine learning (ML) classifier trained to detect in NIR light images features correlated with oral health conditions ([0134]-[0135], [0198]-[0199]), and wherein the analysis subsystem provides a user with guidance to position the imaging head into a proper orientation to obtain the single image ([0129]-[0130]), wherein the analysis subsystem identifies a particular tooth of a user in the single image ([0132]), wherein the analysis subsystem provides an output indicative of the probability of an oral health condition based on the single image ([0134]-[0135]), wherein the analysis subsystem provides an output to a clinician at a remote site ([0138]-[0143]), and/or wherein the analysis subsystem is housed separate from the imaging probe (fig. 7, [0123]-[0124]), and wherein the imaging probe and analysis subsystem are in wireless communication (fig. 7, [0123]-[0124], [0050]).
Regarding claim 19: Mykland further discloses wherein the analysis subsystem is housed on a user's mobile smart phone (mobile phone 200, [0123]).
Regarding claim 20: Mykland further discloses wherein the analysis subsystem is housed in a base station ([0123] - "...any suitable smart device could be used including a tablet, a laptop, desktop or a purpose-built smart device) and a remote server, e.g. a cloud-based server 300." In the absence of any limitations regarding the necessary structure of a "base station," any listed device could be reasonably considered a "base station").
Regarding claim 21: The “base station” devices of Mykland ("...any suitable smart device could be used including a tablet, a laptop, desktop or a purpose-built smart device) and a remote server, e.g. a cloud-based server 300.") would be capable of communicating with the user’s mobile smart phone because all of the listed devices are capable of network communication (e.g. by internet or other networks) as described in ([0123]).
Regrading claims 22-26: The limitations of claims 22-26 do not appear to be structural limitations of the claimed system, rather they appear to be descriptions of the interaction between the near-infrared (NIR) light and the patient’s teeth and the appearance of the teeth in the resultant images. It is noted that these features (e.g. “wherein in the single image of the tooth, healthy enamel appears transparent” or “wherein in the single image of the tooth, lesions, decay, and/or other abnormalities in tooth dentin appear dark”) appear to be inherent properties of the way in which NIR light interacts with human teeth. This is evidenced by the description in pgs. 10-11 of the instant specification:
During imaging, NIR light travels from the imaging head positioned above the tooth or teeth and is reflected back to the camera where healthy enamel appears transparent while lesions or defects in tooth structure appear dark (black or dark gray) due to the absorbance of light rather than reflectance of light. Healthy dentin appears opaque or white in color while non healthy (lesions, decay, any abnormality) dentin appears dark due to the absorbance of light rather than the reflectance of light. Impurities such as fractures or fillings falling out disperse light in which they show as dark spots or very bright spots due to the scattering of light back to the camera head or not in the camera field of view. (emphasis added)
This is clearly a description of the properties of the NIR light interacting with the teeth rather than any limitation on the structure of the system.
This is further evidenced by Perrone ([0111]); Elbaz et al. (US 2018/0028065 A1, Feb. 1, 2018) (fig. 9, [0189]-[0190]); and Bühler, Christopher M., Patara Ngaotheppitak, and Daniel Fried. "Imaging of occlusal dental caries (decay) with near-IR light at 1310-nm." Optics Express 13.2 (2005): 573-582 (see whole document).
Therefore, because the appearance of the teeth in the acquired NIR image(s) is a result of the interaction between the incident NIR light and the structure/properties of the teeth, the system of Perrone and Mykland would be capable of producing these results.
Claim(s) 3-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Perrone and Mykland as applied to claim 2 above, and further in view of Walsh et al. (US 2013/0034826 A1, Feb. 7, 2013) (hereinafter “Walsh”).
Regarding claim 3: Perrone and Mykland disclose the system of claim 2, including illumination with both visible and NIR light (Perrone – [0080]; Mykland – [0105], [0163]). Mykland further discloses using a filter to capture only the image with NIR light ([0110]) but is silent on the filter being a physical filter to capture the image with only the NIR light.
Walsh, in the same field of endeavor, teaches acquiring images using separate wavelengths including NIR ([0030]-[0031]) including the use of a physical filter to separate each wavelength and acquire an image only of the desired wavelength (wavelength adjusting device 16, [0038]). Walsh teaches that the use of such a filter can isolate the desired wavelength by blocking or attenuating other wavelengths ([0038]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the filter as a physical filter in order to improve acquisition quality by obtaining an image of an isolated, desired wavelength (NIR) without interference or artifacts caused by other wavelengths by blocking or attenuating the other wavelengths of light as taught by Walsh.
Regarding claim 4: Walsh further discloses wherein the filter is moveable between a first position whereby the imaging subsystem is operable to capture the image of the tooth with the NIR light and a second position whereby the imaging system images the tooth in the visible spectrum (white light) ([0030]-[0031], [0038]-[0040], [0042], [0046]-[0047]).
Regarding claim 5: Perrone, Mykland and Walsh further disclose wherein the system further comprises a non-NIR light source (Perrone – [0080]; Mykland – [0105], [0163]; Walsh – [0030]-[0031]).
Regarding claim 6: Perrone, Mykland and Walsh further disclose wherein the non-NIR light source provides illumination in a visible spectrum (Perrone – [0080]; Mykland – [0105], [0163]; Walsh – [0030]-[0031]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Perrone and Mykland as applied to claim 8 above, and further in view of Ortiz et al. (US 2020/0196871 A1, Jun. 25, 2020) (hereinafter “Ortiz”).
Regarding claim 10: Perrone and Mykland disclose the system of claim 8, but are silent on wherein the imaging probe is configured such that the imaging head may be replaced with a different tool.
Ortiz, in the same field of endeavor, teaches an imaging probe having at least three interchangeable heads ([0007], [0017] - diagnostic brush head 24, camera brush head 28, and standard brush head 10).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the probe of Perrone and Mykland to accept multiple tools as taught by Ortiz in order to provide greater versatility including routine care and multiple diagnostics.
Response to Arguments
Applicant’s arguments with respect to the drawings, filed 11/10/2025, have been fully considered but are not persuasive because the identified feature (the movable, physical filter) is also present in claims 3-4 and these claims were not addressed. The objection is maintained.
Applicant’s arguments with respect to rejection of all pending claims under 35 U.S.C. §103, filed 11/10/2025, have been fully considered but are not persuasive.
Applicant argues that Perrone discloses a system that is only for detecting the spectral signature of adjuvants, such as toothpaste, on teeth and does not teach or suggest that the devices described therein are able to detect dental lesions on teeth.
Examiner respectfully disagrees. While it is true that the disclosure of Perrone is directed to an aspect of the imaging system which is used to segment and remove adjuvants (e.g. toothpaste) from images, this is not the sole purpose of the system of Perrone. The system of Perrone is intended as a diagnostic tool for imaging the anatomy and physiology of the user’s teeth and gums ([0002], [0028], [0110]-[0112], [0133]) where toothpaste may occlude the view of the patient’s teeth and gums ([0006]) and the disclosed system produces a reconstruction without occlusion ([0088]-[0089]). It is therefore considered to be obvious that a person having skill in the art would be motivated to use those reconstructions for diagnostic purposes.
Applicant further argues that because Mykland does not perform imaging along a single axis that Mykland teaches away from the claimed invention.
Examiner respectfully disagrees. First, the fact that Mykland acquires the data in a different manner does not constitute “teaching away.” See MPEP 2145 (“a reference does not teach away if it merely expresses a general preference for an alternative invention but does not criticize, discredit or otherwise discourage investigation into the invention claimed.”) (internal quotations omitted) (quoting DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009)). It is noted that the rejection relies only on the use of NIR images for performing diagnostics and providing a processing subsystem for generating diagnostic information. The rejection does not require acquisition of images in the manner taught by Mykland nor does it require bodily incorporation of Mykland.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Farkash et al. (US 2022/0189611 A1, Jun. 16, 2022) – discloses an epi-illumination NIR diagnostic intra-oral scanner.
Fried et al. (US 2006/0223032 A1, Oct. 5, 2006) – discloses a trans-illumination NIR diagnostic intra-oral scanner where the NIR light is illuminated and detected along the same axis (see at least fig. 3).
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 CAROLYN A PEHLKE whose telephone number is (571)270-3484. The examiner can normally be reached 9:00am - 5:00pm (Central Time), Monday - Friday.
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/CAROLYN A PEHLKE/ Primary Examiner, Art Unit 3799