Prosecution Insights
Last updated: October 02, 2026
Application No. 18/954,503

METHODS OF DESIGNING DENTAL ATTACHMENT FORMATION APPARATUSES

Non-Final OA §101§103§DP
Filed
Nov 20, 2024
Priority
Nov 12, 2015 — continuation of 11/554,000 +1 more
Examiner
MAI, HAO D
Art Unit
3772
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Align Technology Inc.
OA Round
1 (Non-Final)
49%
Grant Probability
Moderate
1-2
OA Rounds
1y 9m
Est. Remaining
89%
With Interview

Examiner Intelligence

Grants 49% of resolved cases
49%
Career Allowance Rate
354 granted / 718 resolved
-20.7% vs TC avg
Strong +39% interview lift
Without
With
+39.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 8m
Avg Prosecution
28 currently pending
Career history
762
Total Applications
across all art units

Statute-Specific Performance

§101
2.4%
-37.6% vs TC avg
§103
43.8%
+3.8% vs TC avg
§102
24.5%
-15.5% vs TC avg
§112
25.8%
-14.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 718 resolved cases

Office Action

§101 §103 §DP
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 . Election/Restrictions 2. Applicant’s election without traverse of Group I, claims 1-19, in the reply filed on 05/04/2026 is acknowledged. Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claim Rejections - 35 USC § 101 3. 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. 4. Claims 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 1 recites a method of designing a dental attachment formation apparatus, comprising the steps “accessing a virtual dentition…”, and “generating a 3D model of the dental attachment formation…”, all of which can be done mentally, without being tangibly tied to a product or machine. Claims 2-11 also recite steps of designing the 3D model, which can be done mentally, without being tangibly tied to a product or machine. Claims 1-11 are pertaining to collecting and analyzing information which are purely mental steps, i.e. can practically be performed in the human mind, or with pen and paper. Therefore, these steps are merely abstract ideas, which have been considered to be a judicial exception by the courts. This judicial exception is not integrated into a practical application because there is no recitation of a manufacturing step of a tangible product base on the designing steps. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Double Patenting 5. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp. 6. Claims 1-2, 5-10, 12-13, and 16-19, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-8, 10, and 12, of U.S. Patent No. 12,213,851. Although the claims at issue are not identical, they are not patentably distinct from each other because: the difference between the application claims and the patent claims lies in the fact that the patent claims include more elements and are thus much specific. Thus the invention of the patent claims are in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims. CHART 1: Application claims 1-2 and 5-10 correspond to the patent claims 1, 4-8, 10, and 12 as detailed herein the chart below: Instant Application Claims Patent US 12,213,851 Claims Although not identical, the claims are not patentably distinct because: 1. Method of designing (generating a 3D model base on virtual dentition). 1. Method of designing (creating a virtual model based on virtual model of dentition) + manufacturing a physical apparatus + coupling light source. Application claim 1 covers only the designing steps, while patent claim 1 includes steps of designing + manufacturing physical device + coupling light source. Both application claim 1 and patent claim 1 recite the apparatus having essentially the same structures (body, well, light path, light transmissive and opaque portions). Application claim 1 is essentially a genus of (i.e. broader than, and anticipated by) the species of the patent claim 1. 2. “configured for manufacturing … via rapid prototyping or direction fabrication” 1. “manufacturing, via rapid prototyping or direction fabrication” Application claim 2’s configured-for-manufacturing step is covered by patent claim 1’s positive/actual manufacturing step. 5. “a first well and a second well” 5. “a first well… a second well” Application claim 5 is broader than (and anticipated by) patent claim 5. 6: “opaque portion is arranged [to] separate the first and second wells”, 6-7: opaque portion is arranged to keep light from first well/light pat from illuminating second well/light path. Application claim 6 substantially overlap in scope with patent claims 6-7. 7. “a fitting attachment structure arranged at a terminus of the light path” 4. “one terminus of the light path at a fitting attachment region…configured to direct light into the light path The corresponding claims substantially overlap in scope. 8. “wells is configured to shape an attachment material therein” 8. “filling the well with a dental attachment material” Application claim 8’s configured-to-shape limitation corresponds to patent claim 8’s positive/actual filling the well with material. 9. “a volume calculated based on an amount and/or type of attachment material” 10. calculating a volume of the well based on an amount and/or type of attachment material” The corresponding claims substantially overlap in scope. 10. “virtually testing a shape, location, orientation and/or type of the dental attachment” 12. “virtually testing a shape, location, orientation and/or type of the dental attachment” The corresponding claims substantially overlap in scope. CHART 2: Application claims 12-13 and 16-19 correspond to patent claims 1 and 5-9 as detailed herein the chart below: Instant Application Claims Patent US 12,213,851 Claims Although not identical, the claims are not patentably distinct because: 12. Method includes designing (generating a 3D model base on virtual dentition) + manufacturing. 1. Method includes designing (creating a virtual model based on virtual model of dentition) + manufacturing a physical apparatus + coupling light source. The corresponding claims substantially overlap in scope, with patent claim 1 reciting more elements and therefore anticipates application claim 12 13. “manufacturing… using rapid prototyping or direction fabrication” 1. “manufacturing, via rapid prototyping or direction fabrication” Application claim 13 is covered/anticipated by patent claim 1. 16. “a first well and a second well” 5. “a first well… a second well” Application claim 16 is broader than (and anticipated by) patent claim 5. 17: “opaque portion separates the first and second wells”, 6-7: opaque portion is arranged to keep light from first well/light pat from illuminating second well/light path. Application claim 17 substantially overlap in scope with patent claims 6-7. 18-19: “filling one or more well… with an attachment material… using direct fabrication” 8-9: “filling the well with a dental attachment material… using direct fabrication Application claim 18-19 substantially overlap in scope with patent claims 8-9. Claim Rejections - 35 USC § 103 7. 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. 8. Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Phan et al. (2002/0106604) in view of Nikodem (5,813,854). Regarding claim 1, Phan et al. discloses a method of designing a dental attachment formation apparatus 105 (Figs. 13-15), the method comprising: accessing a virtual dentition, the virtual dentition corresponding to a patient's dentition prior to an orthodontic treatment or at an intermediate stage of the orthodontic treatment ([0020] “… an image of the dental surface” ; page 7 claim 1 “providing a digital model of a patient’s dentition”); generating a 3D model of the dental attachment formation apparatus 105 based on the virtual dentition (Figs. 13-15; [0020] “3D computerized image of the attachment device is virtually placed in a desired location on an image of the dental surface”, wherein generating the 3D model includes: forming a body 105 having a surface 401 shaped to conform to contours of the virtual dentition, wherein the body 105 is configured to include a light transmissive portion (Fig. 14D; ¶0007] “polymeric positioning appliances are generally transparent”); forming one or more wells 302 in the body, wherein each well 302 of the one or more wells is shaped to receive a dental attachment 101 (Fig. 7), or dental attachment 400 (Fig. 14D; ¶0056] “ a malleable polymerizing material 400 may be placed into the negative impression 302 in the appliance 105”). Note that Phan et al. discloses alternative embodiments (Figs. 16-17; ¶0057-00558]) of the attachment formation apparatus having the claimed elements as detailed above. Phan et al. discloses at least a portion of the body 105 is made of material that is transparent to transmit light 402 (Fig. 14D, paragraph 7). However, Phan et al. fails to disclose a light path through the body to the one or more wells, and an opaque portion to keep light from illuminating portions of the body other than the wells. Nikodem discloses a dental lighting device 12 comprising a light source attachment structure 46 having a fitting (adapter 48) configured to attach to a light conduit 44/42; the fitting 48 includes an aperture, i.e. the hollow inner diameter of 48 corresponds to diameter of light conduit 44, to direct light from the light conduit 44 through a light path 48 (Figs. 4; column 5 lines 1-5 “device 10 includes attachment means 46 for attaching housing 12 to end 44 of cable 42 for light transmitted through the cable to be directed into the housing”). Nikodem also discloses the body 48 and 16 around the light path is opaque (“an interior portion of this face is of a light reflective material” column 4 lines 18-21). Particularly, Nikodem discloses a light source 40, a light conduit 42 having a first end attached to the light source 40 and a second end (toward 44) connected to the fitting 48 of the adapter 46 (Figs. 3-4). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Phan et al. by including a light path and an opaque portion, e.g. around the light path, in order to effectively direct light to the target polymerizing material as taught by Nikodem. As to claim 2, Phan et al. discloses the 3D model of the dental attachment formation apparatus 105 is configured for manufacturing of the dental attachment formation apparatus via rapid prototyping or direct fabrication (¶0020] “A mold is produced from the images using any computer-guided model fabrication system, such as stereolithography, CNC machining, and laser machining”). As to claims 3-4, Phan et al. Figs. 17A-17B an embodiment of the apparatus wherein the body includes forming a registration surface (abutting to the tooth surface) that is configured to engage with a tooth of the patient's dentition, wherein the registration surface has a shape that mirrors a contour of a front surface and a bottom edge of the tooth without engaging with a back surface of the tooth; the registration (abutting adjacent to the tooth surface) is further shaped to engage with a first side edge of the tooth, a second side edge of the tooth and a top edge of the tooth (see Phan et al. Figs. 17A-17B). As to claim 5, Phan et al. in Fig. 7 discloses the well is a first well 302 configured to form a first dental attachment, wherein the virtual model of the dental attachment formation apparatus includes a second well 302 shaped to form a second dental attachment (Fig. 7). As to claims 6, Nikodem also discloses the body 48 and 16 around the light path is opaque (see Nikodem column 4 lines 18-21 “an interior portion of this face is of a light reflective material”) that separates the first and second wells to keep light within the light path from illuminating the second well. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Phan et al. to arrange the opaque portion to separate the first and second wells, keeping light to illuminate the target polymerizing material in the target well only as taught by Nikodem. As to claim 7, Nikodem discloses a fitting attachment structure 46 having a fitting (adapter 48) arranged at a terminus of light path 44/42. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Phan et al. by including such fitting attachment structure at a terminus of the light path in order to effectively attach the light path to the device. As to claims 8-11, Phan et al. discloses each well 302 is configured to shape an attachment material 400 therein (Fig. 14A); wherein forming each well of the one or more wells based on a volume calculated based on an amount and/or type of attachment material used to fill each well, and virtually testing a shape, location, orientation and/or type of the dental attachment (see Phan et al. [0018] “computer-aided casting with polymerizing material”); and wherein each well 302 of the one or more wells is shaped to enclose an attachment material 400 therein against a tooth 103 of the patient's dentition (Figs. 14A-14C). Regarding claims 12-19, Phan et al. in view of Nikodem discloses the invention substantially as claimed as detailed above with respect to claims 1-11. Particularly to claims 12-13, Phan et al. discloses designing and manufacturing steps are part of a computer-guided model fabrication system; note that stereolithography is rapid prototyping (see Phan et al. [0020]). Conclusion 9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAO D MAI whose telephone number is (571)270-3002. The examiner can normally be reached on Mon-Fri 8:00-4:30. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eric Rosen can be reached on (571) 270-7855. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /HAO D MAI/ Examiner, Art Unit 3772
Read full office action

Prosecution Timeline

Nov 20, 2024
Application Filed
Aug 13, 2026
Non-Final Rejection mailed — §101, §103, §DP (current)

Precedent Cases

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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
49%
Grant Probability
89%
With Interview (+39.3%)
3y 8m (~1y 9m remaining)
Median Time to Grant
Low
PTA Risk
Based on 718 resolved cases by this examiner. Grant probability derived from career allowance rate.

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