Prosecution Insights
Last updated: October 02, 2026
Application No. 19/321,085

DENTAL APPLIANCE ETCH TEMPLATE

Non-Final OA §103§112§DP
Filed
Sep 05, 2025
Priority
Dec 16, 2016 — continuation of 10/548,700 +3 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
2y 7m
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

§103 §112 §DP
DETAILED ACTION Notice of Pre-AIA or AIA Status 1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Claim Objections 2. Claim 17 is objected to because of the following informalities: Claim 17 recites “the wafter” (line 8) which is a typographical error of “the wafer”. Claim 17 recites “the reservoir and has a volume” (lines 9-10) which should be “the reservoir . Appropriate correction is required. Claim Rejections - 35 USC § 112 3. The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 4. Claims 3, 13, 9-11, and 19, rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 3, 13 and 19, each recites “at a bottom of the well” which is indefinite because such “bottom” direction is arbitrary in the claimed dental etching template appliance which is configured for either the upper dentition or the lower dentition. That is, a “bottom” direction have different meanings for the upper dentition vs the lower dentition. Claim 9 recites “a first tooth” and “a second tooth” which are two distinct teeth. Dependent claim 11 recites “wherein the first tooth is the same as the second tooth” which contradicts claim 9, rendering the claims indefinite. Applicant is suggested to amend the claims to make claim 9 a genus (broad scope of the first and second locations on the dentition), and claims 10-11 species (first and second locations on different teeth, first and second locations on one same tooth). All dependent claims are rejected herein based on dependency. Claim Rejections - 35 USC § 103 5. 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. 6. Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kopelman et al. (US 2005/0233276) in view of Kuo et al. (US 2003/0211440), and further in view of Darnell (US 2001/0019817). Regarding claim 1, Kopelman discloses a dental etching template appliance 100, 600 (Figs. 1 and 10) comprising: a body (shell 110, 610) configured to be removably placed on a dentition 200, the body 110, 610 is shaped to engage with one or more teeth 90 of the dentition (Fig. 1). In Fig. 10 Kopelman discloses the appliance 600 includes a well (cavities 620) including a wafer/pad 650 with etching material absorbed therein (Fig. 10; [0104] “transfer means 650 may comprise a pad containing a transfer material including… etch acid”). Kopelman discloses the well 620/650 is arranged to position the wafer 650 at a desired attachment location on a tooth of the one or more teeth while the body is placed on the dentition, wherein the etching material on the wafer is configured to etch the desired attachment location in preparation for bonding a dental attachment (Fig. 10; [0088]-[0090] “the part 60 is etched through the window 50”; [0104] “transfer means 650 … to transfer target information to the corresponding tooth regarding where the bracket 70 is to be located and bonded… transfer means 650 may comprise a pad containing a transfer material including… etch acid”). In the case that Kopelman’s well/cavity 620 does not meet the claimed “well” as disclosed by Applicant, i.e. a well formed within the wall of the shell/cavities: Kuo et al. discloses a dental appliance shell 12 having cavities 14 configured to receive teeth, wherein a well 60 containing treatment agent 15 is formed within the wall of cavities 14 (see Kuo Figs. 6-7, [0064] “a reservoir 60 formed in the polymer shell 12 in addition to the cavity 14 which receives the teeth”). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Kopelman by including a discrete well within the shell’s cavities as taught by Kuo et al. in order to establish a distinct well/storage area within the shell’s cavities for containing treatment agent. More particular to claims 1-5, regarding the reservoir to retain excess etching material, Kopelman/Kuo fails to disclose the well further includes a reservoir for containing excess etching material from the wafer. Darnell discloses a removable dental shell 230 having a well 226 containing an absorbent wafer retaining material 226 therein for holding an agent 240 (Fig. 7, [0089] “absorbent retaining material 226”; [0096] “retaining material 226… inserted into a selected portion of stint 230”). Referring to Fig. 10, Darnell discloses the internal surface 331 of the shell having a well (large indentation 346L) and a plurality of adjacent indentations 346 for containing excess treatment material (column 3 lines 25-30 “indentations… provide a reservoir for excess quantities of the active agent”; column 11 lines 1-52 “plurality of indentations 346… the enlarged indentation 346L is in register with the selected portion 322S of the tooth 322”). As to claims 2-5, regarding further limitations of the reservoir within the well, note that Darnell discloses the reservoir/indentions 346 are all over the internal surface, including the surface of the well 226; thereby the reservoir is contained in the well, at the bottom of the well, by bowed side walls of the well capable of retaining (i.e. prevent exiting of) the etching material as claimed. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Kopelman/Kuo by providing a well (enlarged indentation) for retaining absorbent wafer of treatment agent, and further providing adjacent indentations in order to effectively retain excess treatment agent as taught by Darnell. As to claim 6, Kopelman discloses the well 50/pad 650 is to position the etching material at a desired attachment location on the tooth (Kopelman Figs. 1, and 10-13; [0088]-[0090] “the part 60 is etched through the window 50”; [0104] “transfer means 650 … to transfer target information to the corresponding tooth regarding where the bracket 70 is to be located and bonded… transfer means 650 may comprise a pad containing a transfer material including… etch acid”), thereby keeping excess etching material away from other areas on the tooth. As to claim 7, Kopelman et al. fails to disclose a liner across an opening of the well. Kuo et al. discloses the well 60 including a removable liner/membrane 62 across an opening of the well 60 (see Kuo et al. Fig. 7). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Kopelman by including a removable liner/membrane across an opening of the well as taught by Kuo et al. in order to effectively retain the treatment material within the well for storage or transport of the appliance until treatment time. As to claim 8, Kopelman discloses the wafer/pad 650 containing transfer material such as etching acid therein (Kopelman [0104] “transfer means 650 may comprise a pad containing a transfer material including… etch acid”). However, Kopelman is not explicit that the wafer comprising compressible material as claimed. Kuo et al. discloses that the treatment agent 15 may be absorbed in a carrier such as a compressible sponge-like material (see Kuo et al. [0060] “the agent may be released from the controlled-release material… from the pores”; [0065] “agent 15 is supported by a carrier”; [0068]-[0070] “Agents may be encapsulated or entrapped by… controlled-release material…encapsulating material may… resin… MICROSPONGE”), which is of compressible as claimed. Darnell also discloses the wafer/retaining material 226 to be of fibrous absorbent retaining material (see Darnell [0086] “retaining material 226 is shown as a thin sheet of fibrous absorbent retaining material”; [0116] “conventional filters for drip coffee makers have been found to be effective fibrous retaining material”), which is of compressible material, as claimed. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Kopelman by utilizing compressible sponge-like material as the wafer/carrier of treatment agent as taught by Kuo and Darnell in order to effectively carry and controlled-release of the agent. Furthermore, note that such modification to use a compressible sponge for the wafer/pad would be been an obvious selection of a known material based on its suitability for its intended use which has been held to be within the routine skill of an artisan. As to claims 9-11, Kopelman discloses multiple wells/desired attachment locations 50 on multiple teeth (Kopelman Figs. 1 and 13). Kuo et al. also discloses the wells 60 may be anywhere (see Kuo et al. Fig. 7 shows two wells on the same cavity/tooth; [0064] “reservoirs 60 may be located anywhere in the shell 12”). Darnell discloses wells/indentations within the same tooth (Darnell Fig. 10). As such, arranging the wells on multiple teeth or on the same tooth of the dentition would have been obvious to one of ordinary skill in the art as dependent on the dental treatment on the desired locations on the dentition to deliver the etching material. Note that such modification of position of the wells on the teeth would have been an obvious design choice or rearrangement of parts that is well within the skill of an artisan in order to obtain optimum results. Regarding claims 12-16, Kopelman in combination with Kuo and Darnell disclose the dental etching template appliance having the body/shell with a well, wafer, and reservoir as detailed above with respect to claims 1-6. Particularly to claim 12 regarding an absorbent material positioned adjacent the wafer to catch excess etching material: Kuo et al. discloses the well/reservoir 60 comprising a membrane 62 adjacent the wafer material 15 (see Kuo et al. Figs. 7-8). Darnell discloses the internal surface 331 of the shell having a well (large indentation 346L) and a plurality of adjacent indentations 346 for containing excess treatment material (see Darnell Figs. 9-10; column 3 lines 25-30 “indentations… provide a reservoir for excess quantities of the active agent”; column 11 lines 1-52 “plurality of indentations 346… the enlarged indentation 346L is in register with the selected portion 322S of the tooth 322”). Particularly Darnell discloses a layer of absorbent material 226, 340 thereon the surfaces, including the surfaces of the well, for retaining treatment agent (see Darnell Figs. 6 and 9). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Kopelman by including an absorbent material in the well, e.g. absorbent liner 62 adjacent wafer 15 as taught by Kuo et al., or absorbent layer 226 as taught by Darnell, in order to effectively retain excess material. Regarding claims 17-20, Kopelman et al. in view of Kuo et al. and Darnell discloses the dental etching template appliance having the body/shell with a well, wafer, and reservoir, as detailed above with respect to claim 1. Particularly, Kopelman discloses the method of manufacturing/forming the appliance as claimed (Kopelman [0083] “tray 100 may then by manufactured using CNC machining methods”). Note that claimed method steps of “forming a body…”, “forming a well…”, “securing the wafer to the well…”, would have been naturally carried out in manufacturing or forming the appliance as disclosed by Kopelman, Kuo, and Darnell. Double Patenting 7. 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. 8. Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 and 23-27 of U.S. Patent No. 10,548,700. Although the application claims and the corresponding patent claims are not identical, they are not patentably distinct from each other because the presently pending claims are obvious in view of the invention previously set forth in the corresponding patent claims. Application appliance claims 1-16 correspond to patent ‘700 appliance claims 1-16. Application method claims 17-20 correspond to patent ‘700 method claims 23-27. Particularly, regarding application claim 1 reciting a reservoir which is not recited in the patent claim 1; however, note that the patent claim 12 recites “a catch area” which is equivalent to such reservoir for collecting the excess liquid etch material. More particularly, claim 8 recites “compressing” which is not recited in the patent claims; however, one of ordinary skill in the art would have readily recognize that the typical absorbent materials as set forth in the patent claims 13-14 to be sponge-like or compressible. The minor differences would have been obvious to one of ordinary skill in the art; and the application claims fail to set forth a patentably distinct invention from that of the patent claims. 9. Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 and 19-20 of U.S. Patent No. 11,382,730. Although the application claims and the corresponding patent claims are not identical, they are not patentably distinct from each other because the presently pending claims are obvious in view of the invention previously set forth in the corresponding patent claims. Application appliance claims 1-16 correspond to patent 11382730 appliance claims 1-14. Application method claims 17-20 correspond to patent 11382730 method claims 19-20. Particularly, regarding application claim 1 reciting a well including reservoir which is equivalent to the patent claim 1 reciting a well including an absorbent material to catch excess material. The minor differences would have been obvious to one of ordinary skill in the art; and the application claims fail to set forth a patentably distinct invention from that of the patent claims. 10. Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 and of U.S. Patent No. 11,950,976. Although the application claims and the corresponding patent claims are not identical, they are not patentably distinct from each other because the presently pending claims are obvious in view of the invention previously set forth in the corresponding patent claims. Application appliance claims 1-16 correspond to patent ‘976 claims 1-16. Particularly, regarding application claim 1 reciting a well including reservoir which is equivalent to the patent claim 1 reciting a well including an absorbent material to catch excess material. The minor differences would have been obvious to one of ordinary skill in the art; and the application claims fail to set forth a patentably distinct invention from that of the patent claims. 11. Claims 17-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,433,730. 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 element(s) and are thus much specific. For example, the patent independent claims 1 and 13 include virtual steps which are excluded from the application corresponding claims. Thus the invention of the patent claims is 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. Conclusion 12. 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 Mon-Fri 8:00-4:30. 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, Eric Rosen can be reached at (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 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. /Hao D Mai/ Examiner, Art Unit 3772
Read full office action

Prosecution Timeline

Sep 05, 2025
Application Filed
Jul 23, 2026
Non-Final Rejection mailed — §103, §112, §DP (current)

Precedent Cases

Applications granted by this same examiner with similar technology

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3y 10m to grant Granted May 26, 2026
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 (~2y 7m 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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