Prosecution Insights
Last updated: April 19, 2026
Application No. 18/536,052

IMAGE-BASED DEFECT DETECTION OF DIRECTLY FABRICATED DENTAL APPLIANCES

Non-Final OA §103
Filed
Dec 11, 2023
Examiner
BILODEAU, DUSTIN E
Art Unit
2664
Tech Center
2600 — Communications
Assignee
Align Technology, Inc.
OA Round
1 (Non-Final)
88%
Grant Probability
Favorable
1-2
OA Rounds
3y 3m
To Grant
93%
With Interview

Examiner Intelligence

Grants 88% — above average
88%
Career Allow Rate
71 granted / 81 resolved
+25.7% vs TC avg
Moderate +5% lift
Without
With
+5.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
30 currently pending
Career history
111
Total Applications
across all art units

Statute-Specific Performance

§101
8.9%
-31.1% vs TC avg
§103
75.7%
+35.7% vs TC avg
§102
9.9%
-30.1% vs TC avg
§112
2.8%
-37.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 81 resolved cases

Office Action

§103
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 . Information Disclosure Statement The information disclosure statement (IDS) submitted on 05/28/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered and attached by the examiner. 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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. Claims 1-2, 4-7, 9-12, 14-15, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Salah (U.S. Patent Pub. No. 2019/0105129) in view of Jones (U.S. Patent Pub. No. 2019/0239987). Regarding Claim 1, Salah teaches a non-transitory computer readable medium comprising instructions that, when executed by a processing device, cause the processing device to perform operations (Salah 20190105129 ¶37-39 The invention also relates to: a computer program, and in particular an application specifically for mobile phones, comprising program code instructions for the execution of one or more, preferably all, of the steps 2) to 4), when said program is run by a computer, and a computer medium on which is stored such a program, for example a memory or a CD-ROM) for detecting one or more defects in a customized dental appliance (¶27 preferably inform an operator if a defect cannot be corrected, and in particular if this defect has a potential prejudicial effect,) the customized dental appliance customized for a specific arch of a specific patient, the operations comprising (¶43 A “defect” is a part of a model of a dental arch which does not correctly represent this arch. For instance, the model may represent asperities or recesses which, in reality, i.e. in the dental arch, do not exist. Preferably, the length of a defect is less than 5 mm, 3 mm, 2 mm or 1 mm:) comparing an area of one or more images of the customized dental appliance (Figure 2; ¶129 At step 3), the reference image is compared with the updated image. Differences correspond to defects to be corrected; This method compares reference image taken with updated images that were taken not a digital model, see secondary art) (¶32 The corrected reference model may in particular be used to manufacture an orthodontic part;) determining a difference between a representation of the customized dental appliance in the area of the one or more images (¶130 Preferably, to compare the reference and updated images, the corresponding reference and updated maps are compared. A superimposition of these two maps makes the differences, i.e. the defects, visible since the defects appear on the reference map, but not on the updated map) responsive to determining that the difference satisfies a defect criterion, determining that the customized dental appliance has a manufacturing defect at the region of the customized dental appliance associated with the difference (¶136-138 To compare the first updated image with the first reference image, the first updated map Ca.sub.1 is superimposed with the first reference map Cr.sub.1. The superimposition makes the defect 22 visible. The superimposition also provides a first correct outline portion, which should replace the defect 22, i.e. the points of the first updated outline which were not visible on the first reference map.) Salah does not explicitly disclose comparing an area of one or more images of the customized dental appliance with a digital model of the customized dental appliance; determining a difference between a representation of the customized dental appliance in the area of the one or more images and the digital model of the customized dental appliance. Jones is in the same field of art of image analysis. Further, Jones teaches comparing an area of one or more images (¶43 instructing the software to generate the retainer or scan mesh (images)) of the customized dental appliance with a digital model of the customized dental appliance (¶43 importing the digital model (scan STL) of the patient into the software; instructing the software to generate the retainer or scan mesh and place it on top of the digital model;) determining a difference between a representation of the customized dental appliance in the area of the one or more images and the digital model of the customized dental appliance at a region of the customized dental appliance; and responsive to determining that the difference satisfies a defect criterion, determining that the customized dental appliance has a manufacturing defect at the region of the customized dental appliance associated with the difference (¶43 correcting errors in the digital model and overlay; there errors are interpreted as defects from the overlay comparison.) Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Salah by comparing the model with images for defects that is taught by Jones; thus, one of ordinary skilled in the art would be motivated to combine the references to quickly and cheaply produce dental apparatuses in house (Jones¶8). Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention. Regarding Claim 2, Salah in view of Jones discloses the non-transitory computer readable medium of claim 1, the operations further comprising: applying a filter to an image of the one or more images of the customized dental appliance to obtain a modified image of the customized dental appliance including an accentuated contour and suppressed reflections; and determining the area of the one or more images to be compared to the digital model based on the modified image (Salah, ¶96 A person skilled in the art knows how to process an updated image to show the discriminating information. This processing comprises, for example, the application of masks or filters that are well known, supplied with the image processing software.) Regarding Claim 4, Salah in view of Jones discloses the non-transitory computer readable medium of claim 1, the operations further comprising: generating the digital model of the customized dental appliance based on a digital model of the specific arch of the specific patient (Salah, ¶1 The present invention relates to a method to correct a three-dimensional digital model of an arch of a patient, a computer program for implementing this method, an acquisition apparatus provided with this program, and a method to manufacture an orthodontic part from said model.) Regarding Claim 5, Salah in view of Jones discloses the non-transitory computer readable medium of claim 1, wherein the direct fabrication is performed via three-dimensional (3D) printing based on the digital 3D model of the customized dental appliance (Jones, ¶45 In the preferred embodiment, the 3D printer or Galvanometer Guided Laser Milling is used to directly mill or create 3 dimensional objects, specifically dental appliances.) Regarding Claim 6, Salah in view of Jones discloses the non-transitory computer readable medium of claim 1, the operations further comprising: assigning a visual indicator to one or more points in the region associated with the difference that satisfies the defect criterion, wherein the visual indicator indicates that the one or more points comprise the manufacturing defect (Salah, ¶137-138 The superimposition makes the defect 22 visible. The superimposition also provides a first correct outline portion, which should replace the defect 22, i.e. the points of the first updated outline which were not visible on the first reference map.) Regarding Claim 7, Salah in view of Jones discloses the non-transitory computer readable medium of claim 1, the operations further comprising: determining one or more corrective actions (Salah, ¶129 At step 3), the reference image is compared with the updated image. Differences correspond to defects to be corrected; ¶131-132 At step 4), the reference model is corrected accordingly. The correction might be done manually, with a computer enabling the modification of the reference model.) Regarding Claim 9, Salah in view of Jones discloses the non-transitory computer readable medium of claim 1, wherein the difference comprises at least one of: a) a first line in the one or more images that is not depicted in the digital model, wherein the first line represents a crack in the customized dental appliance; or b) a difference in curvature between a second line in the one or more images and a corresponding line in the digital model (Jones, Claim 2: reducing the curvature of the scan mesh by smoothing out concave curves of the scan mesh.) Regarding Claim 10, Salah in view of Jones discloses the non-transitory computer readable medium of claim 1, wherein the customized dental appliance is an orthodontic aligner (Salah, ¶26 Such an updated reference model may in particular be used to evaluate an orthodontic treatment and/or modify an orthodontic treatment. In particular when the orthodontic appliance is an aligner, the updated reference model may be used to design new aligners.) Regarding claim 11, claim 11 has been analyzed with regard to claim 1 and is rejected for the same reasons of obviousness as used above as well as in accordance with Salah further teaching on: A system comprising: a memory comprising instructions; and a processing device operably coupled to the memory (¶37-39 The invention also relates to: a computer program, and in particular an application specifically for mobile phones, comprising program code instructions for the execution of one or more, preferably all, of the steps 2) to 4), when said program is run by a computer, and a computer medium on which is stored such a program, for example a memory or a CD-ROM.) Claim 12 recites limitations similar to claim 2 and is rejected under the same rationale and reasoning. Regarding Claim 14, Salah in view of Jones discloses the system of claim 11, wherein the processing device is further to: register the one or more images to the digital model, wherein the digital model was used to directly fabricate the customized dental appliance (Salah, ¶32 The corrected reference model may in particular be used to manufacture an orthodontic part.) Claim 15 recites limitations similar to claim 6 and is rejected under the same rationale and reasoning. Claim 17 recites limitations similar to claim 9 and is rejected under the same rationale and reasoning. Regarding claim 18, claim 18 has been analyzed with regard to claim 1 and is rejected for the same reasons of obviousness as used above as well as in accordance with Salah further teaching on: A method for detecting one or more defects in a customized dental appliance (¶11 The invention provides a method of correction of a three-dimensional digital model of an arch of a patient; ¶129 Differences correspond to defects to be corrected.) Regarding Claim 19, Salah in view of Jones discloses the method of claim 18, further comprising: directly fabricating the customized dental appliance based on the digital model of the customized dental appliance (Salah, ¶32 The corrected reference model may in particular be used to manufacture an orthodontic part.) Allowable Subject Matter Claims 3, 8, 13, 16, and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Regarding claims 3 and 13, No prior art teaches the non-transitory computer readable medium of claim 2, the operations further comprising: generating a mask of the customized dental appliance based on the modified image; and refining the mask by extracting a contour of the mask; wherein the mask is used to determine the area of the one or more images to be compared to the digital model. Regarding claims 8 and 16, No prior art teaches wherein the defect criterion is associated with a first class of manufacturing defect, the operations further comprising: applying the one or more images to a machine learning model trained to identify a second class of manufacturing defect; determining whether an output of the machine learning model indicates a presence of any manufacturing defects of the second class of manufacturing defect; and responsive to determining that the output indicates the presence of a manufacturing defect of the second class of manufacturing defect, determining that the customized dental appliance has a manufacturing defect. Regarding claim 20, No prior art teaches applying a filter to an image of the one or more images of the customized dental appliance to obtain a modified image of the customized dental appliance including an accentuated contour and suppressed reflections, wherein the modified image is used to determine the area of the one or more images to be compared to the digital model; generating a mask of the customized dental appliance based on the modified image; and refining the mask by extracting a contour of the mask; wherein the mask is used to determine the area of the one or more images to be compared to the digital model. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ajri 2019/0318479 discloses defect explicitly being one of improper size, cracks, chips, steps, etc., that can be detected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DUSTIN BILODEAU whose telephone number is (571)272-1032. The examiner can normally be reached 9am-5pm. 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, Jennifer Mehmood can be reached at (571) 272-2976. 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. /DUSTIN BILODEAU/Examiner, Art Unit 2664 /JENNIFER MEHMOOD/Supervisory Patent Examiner, Art Unit 2664
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Prosecution Timeline

Dec 11, 2023
Application Filed
Jan 12, 2026
Non-Final Rejection — §103
Apr 01, 2026
Examiner Interview Summary
Apr 01, 2026
Applicant Interview (Telephonic)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
88%
Grant Probability
93%
With Interview (+5.2%)
3y 3m
Median Time to Grant
Low
PTA Risk
Based on 81 resolved cases by this examiner. Grant probability derived from career allow rate.

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