Prosecution Insights
Last updated: July 17, 2026
Application No. 18/465,848

ORTHODONTIC DISTALIZER APPARATUS AND METHODS

Final Rejection §102§103
Filed
Sep 12, 2023
Priority
Sep 12, 2022 — provisional 63/405,857
Examiner
SAUNDERS, MATTHEW P
Art Unit
3772
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Align Technology Inc.
OA Round
2 (Final)
47%
Grant Probability
Moderate
3-4
OA Rounds
4m
Est. Remaining
85%
With Interview

Examiner Intelligence

Grants 47% of resolved cases
47%
Career Allowance Rate
260 granted / 550 resolved
-22.7% vs TC avg
Strong +38% interview lift
Without
With
+37.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
40 currently pending
Career history
596
Total Applications
across all art units

Statute-Specific Performance

§101
0.2%
-39.8% vs TC avg
§103
81.5%
+41.5% vs TC avg
§102
10.3%
-29.7% vs TC avg
§112
3.2%
-36.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 550 resolved cases

Office Action

§102 §103
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 Applicant’s election without traverse of Group I directed to claims 1-16 in the reply filed on 01/29/2026 is acknowledged. Newly submitted claims 47-50 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claims 47-50 are directed to an orthodontic system which would have been restricted from claims 1-16 are being a combination (47-50) and sub combination (1-16) where the combination of claims 47-50 are broader than the limitations of the sub-combination claim limitations and do not require the specifics of the sub-combination (a first tooth engagement region and a second tooth engagement region) and the sub-combination would have utility by itself without the requirements of the combination (the sub-combination being able to be able to function as a single appliance). Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 47-50 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03. To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention. Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention. Response to Arguments Applicant's arguments filed 01/29/2026 have been fully considered but they are not persuasive. Applicant has argued that the prior art of Boronkay et al. (US 2017/0007363 A1) and Martz (US 2015/0257856 A1) fail to provide for the new claim limitations, however upon further review embodiments of Boronkay and Martz do show the where the attachment site is anterior to an anterior edge of a their transpalatal regions as cited in the following action. Further the new dependent claims are further taught by Boronkay alone and in combination with new prior art of Hung et al. (US 2017/0258554 A1). Claim Rejections - 35 USC § 102 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. Claims 1-7, 9-12, 14-16, 41, 42, 43 , 45, and 46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boronkay et al. (US 2017/0007363 A1). Regarding claim 1, Boronkay discloses an orthodontic distalizer apparatus (fig. 19 element 1900), comprising: a first tooth engagement region having one or more cavities shaped to accommodate one or more molar and one or more canine and/or premolar teeth (Fig. 19, left or right side of 1900 which would cover the molars, premolars and canines), the first tooth engagement region comprising an outer buccal surface, an outer lingual surface and an outer occlusal surface (Fig 19 showing the occlusal, lingual and buccal walls); a second tooth engagement region having one or more cavities shaped to accommodate one or more teeth (Fig. 19, two opposite sides for posterior teeth engagement); a trans-palatal region extending between the first tooth engagement region and the second tooth engagement region (Fig. 19 element 1902), having an anterior edge that is posterior to a premolar region of the first tooth engagement region (Fig. 19 element 1902 having an anterior edge the is between the second and third molars and thus behind any premolars); and an attachment site for an elastic band on the outer buccal surface (Fig. 26 element 2604 or Fig. 11fg element 1168, paragraph [0363] all disclosing that any features discussed in one embodiment are considered to be combined with other embodiments and are considered to be part of the disclosure), wherein the attachment site is anterior to the anterior edge of the transpalatal region (Fig. 19 the anterior edge of 1902 is posterior to the anterior edge of the 2nd molar and Fig. 11f element 1168 is at the 2nd incisor or Fig. 26 showing the attachment site being anterior to the first molar and thus the attachment site of either Fig. 11f or Fig. 19 is anteriorly located to the anterior edge of the transpalatal region) Regarding claims 2, Boronkay further discloses a disoccluder on the outer occlusal surface configured to prevent or reduce intercuspation when the apparatus is worn (paragraph [0085] lines 7-8 disclosing bite blocks and ramps). Regarding claim 3, Boronkay further discloses wherein the disoccluder comprises a bite ramp or bite block (paragraph [0085] lines 7-8). Regarding claim 4, Boronkay further discloses wherein the disoccluder comprises one or more of: an anterior bite ramp (Fig. 2b element 256a portion over the anterior teeth), a canine bite ramp (fig. 2b element 256a portion over canine teeth), and a posterior bite block (Fig. 2a element 204a over posterior teeth, Fig. 18.element 1802). Regarding claim 5, Boronkay further discloses wherein the attachment site is configured to be positioned proximate to a canine tooth when the apparatus is worn (Fig. 26 element 2604 and Fig. 11f element 1168 are proximate a canine tooth location). Regarding claim 6, Boronkay further discloses wherein the attachment site comprises a button or hook (paragraph [0166] line 6 disclosing “a hook, button”). Regarding claim 7, Boronkay further discloses wherein the attachment site is configured to be positioned over a gingival region when the apparatus is worn (paragraph [0249] lines 13-14). Regarding claim 9, Boronkay further discloses wherein the one or more cavities of the second tooth engagement region is shaped to accommodate one or more molar, premolar and canine teeth (Fig. 19, left or right side of 1900 which would cover the molars, premolars and canines). Regarding claim 10, Boronkay further discloses wherein the apparatus is configured as a unilateral distalizer having only one attachment site for the elastic band (paragraph [0250] lines 1-3 disclosing that the apparatus would have a hook thus being singular, paragraph [0168] lines 11-12 disclosing the hook is for an elastic band attachment). Regarding claim 11, Boronkay further discloses a lower jaw aligner apparatus configured to fit over the subject's mandibular teeth and comprising a complimentary elastic band attachment site (Fig. 26 element 2606 with attachment site 2608 of band 2610). Regarding claim 12, Boronkay further discloses an anterior segment region configured to couple between the first tooth engagement region and the second tooth engagement region and to engage with a lingual surface of one or more incisor teeth (Fig. 19 anterior cavities of element 1900 that would engage the incisor teeth and connects the left and right regions). Regarding claim 14, Boronkay further discloses wherein an anterior region of the first tooth engagement region and an anterior region of the second tooth engagement region have a wall thickness that is greater than the wall thickness of a posterior region of the first tooth engagement region and the second tooth engagement region (Fig. 2b showing the anterior regions having greater wall thicknesses than the poster walls). Regarding claim 15, Boronkay further discloses wherein the trans-palatal region does not extend beyond an anterior premolar region of the first tooth engagement region and the second tooth engagement region (Fig. 19 element 1902 does not extend beyond even the molars and thus not beyond the anterior premolars). Regarding claim 16, Boronkay discloses an orthodontic distalizer apparatus(fig. 19 element 1900), comprising a first tooth engagement region having one or more cavities shaped to accommodate one or more molar and one or more canine and/or premolar teeth (Fig. 19, left or right side of 1900 which would cover the molars, premolars and canines), the first tooth engagement region comprising an outer buccal surface, an outer lingual surface and an outer occlusal surface that extends between the outer buccal and outer lingual surfaces (Fig 19 showing the occlusal, lingual and buccal walls); a second tooth engagement region having one or more cavities shaped to accommodate one or more molar teeth(Fig. 19, opposite side from above); a trans-palatal region extending between the first tooth engagement region the second tooth engagement region(Fig. 19 element 1902), the trans-palatal region having an anterior edge that is posterior to a canine region and/or a premolar region of the first tooth engagement region (Fig. 19 element having an anterior edge the is between the second and third molars and thus behind any premolars), wherein the first tooth engagement region, the second tooth engagement region and the trans-palatal region are formed of a continuous polymeric material (Fig. 19 elements 1904 and 1902 are a single continuous material, paragraph [0007] disclosing the appliance and features can all be directly fabricated in a single fabrication step and thus being a continuous polymer material); wherein the first tooth engagement region, the second tooth engagement region and the trans-palatal region are formed of a continuous polymeric material; an attachment site for an elastic on the outer buccal surface configured to be positioned proximate to a canine tooth or premolar tooth when the apparatus is worn (Fig. 26 element 2604, Fig. 11 element 1168 , paragraph [0363] all disclosing that any features discussed in one embodiment are considered to be combined with other embodiments and are considered to be part of the disclosure), wherein the attachment site is anterior to the anterior edge of the transpalatal region (Fig. 19 the anterior edge of 1902 is posterior to the anterior edge of the 2nd molar and Fig. 11f element 1168 is at the 2nd incisor or Fig. 26 showing the attachment site being anterior to the first molar and thus the attachment site of either Fig. 11f or Fig. 19 is anteriorly located to the anterior edge of the transpalatal region) ; and a disoccluder on the first tooth engagement region configured to prevent or reduce intercuspation when the apparatus is worn (Fig. 18 element 1802, further the occlusal surface of the apparatus having a thickness would cause disocclusion by being between the cusps of the jaws). Regarding claim 41, Boronkay further discloses where the orthodontic distalizer apparatus is configured to be worn on a subject’s upper jaw (Fig. 11f element 1160 in an upper jaw appliance, paragraph [0054] disclosing Fig. 26 is un upper appliance). Regarding claims 42 and 46, Boronkay wherein when the apparatus would be worn the elastic band applies a distalizing force to one or more of the molar teeth, one or more of the premolar teeth and/or one or more of the canine teeth, and the trans-palatal region produces a counter force to prevent or limit crown tipping and rotation of the one or more of the molar teeth (the elastic band is not recited as part of the apparatus in claim 1 from which claim 42 depends and as such the recitation of the application of a distalizing force when used with such an elastic band is an intended use limitation and as such the apparatus of Boronkay would be able to be used as recited, further the transpalatal region would by applying an expansion force would be able to limit crown tipping and rotation by the resistance to deformation by the transpalatal portion due to being a solid object with a given rest state that would resist tipping that would occur under forces to deform from its rest state. Further the exact distalizing force and tipping would depend on the particular patient anatomy and as such the disclosed structure of Boronkay would by having a transpalatal rest state, would resist tipping and rotation for some patient’s anatomy). Regarding claim 43, Boronkay further discloses where the attachment site is on a premolar region of the first tooth engagement region (Fig. 26 element 2604 is on the premolar region). Regarding claim 45, Boronkay further discloses where the transpalatal region spans more than one molar cavity of the first tooth engagement region in an anterior to posterior direction (fig. 19 showing element 1902 spanning mor than one molar cavity by spanning across the 2n and 3rd molars). Claims 1, 6, 7, 10, 12, 13, 15, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Martz et al. (US 2015/0257856 A1). Regarding claim 1, Martz discloses an orthodontic apparatus capable of distal movement of teeth (figs. 2 and 8-10), comprising: a first tooth engagement region having one or more cavities shaped to accommodate one or more molar and one or more canine and/or premolar teeth (Fig. 2 elements 80), the first tooth engagement region comprising an outer buccal surface, an outer lingual surface and an outer occlusal surface (Fig. 1 showing the occlusal, lingual and buccal walls); a second tooth engagement region having one or more cavities shaped to accommodate one or more teeth(Fig. 9, showing two opposite posterior teeth engagement segments on both sides of jaw); a trans-palatal region extending between the first tooth engagement region and the second tooth engagement region (Figs. 8-10 element 87), having an anterior edge that is posterior to a premolar region of the first tooth engagement region (Figs. 8-10 element 87 having an anterior edge the is between the second and third molars and thus behind any premolars); and an attachment site for an elastic band on the outer buccal surface (Fig. 2 element 85 for elastic band 86), and wherein the attachment site is anterior to the anterior edge of the transpalatal region (fig. 8 anterior edge of 87 is posterior to where element 85 is in figure 2 and thus the attachment site 85 is anterior to the anterior edge of 87), wherein the attachment site is anterior to the anterior edge of the transpalatal region (fig. 2 showing the location of the attachment site on the pre-molar, and Fig. 8 showing the anterior edge of the transpalatal region 87 is posterior to the first molar and thus its anterior edge is posterior the attachment site on the pre-molar). Regarding claim 6, Martz further discloses wherein the attachment site comprises a button or hook (paragraphs [0051] disclosing “ hooks or buttons 84, 85”). Regarding claim 7, Martz further discloses wherein the attachment site is configured to be positioned over a gingival region when the apparatus is worn (Fig. 2 showing element 85 over the gingival area). Regarding claim 10, Martz further discloses wherein the apparatus is configured as a unilateral distalizer having only one attachment site for the elastic band (paragraph [0049] all disclosing that the apparatus could be configured to move only a single tooth). Regarding claim 12, Martz further discloses an anterior segment region configured to couple between the first tooth engagement region and the second tooth engagement region and to engage with a lingual surface of one or more incisor teeth (Figs. 9-10 element 82a). Regarding claim 13, Martz further discloses wherein the anterior segment region is slidably coupled to the first and/or second tooth engagement regions (figs. 2, 9-10 element 82 slides by element 83 connected to slots 81). Regarding claim 15, Martz further discloses wherein the trans-palatal region does not extend beyond an anterior premolar region of the first tooth engagement region and the second tooth engagement region (Figs. 9 and 10 element 87 does not extend beyond even the molars and thus not beyond the anterior premolars). Regarding claim 16, Martz discloses an orthodontic apparatus capable of distal movement of teeth (figs. 2 and 8-10), comprising: a first tooth engagement region having one or more cavities shaped to accommodate one or more molar and one or more canine and/or premolar teeth Fig. 2 elements 80), the first tooth engagement region comprising an outer buccal surface, an outer lingual surface and an outer occlusal surface that extends between the outer buccal and outer lingual surfaces ((Fig. 1 showing the occlusal, lingual and buccal walls); a second tooth engagement region having one or more cavities shaped to accommodate one or more molar teeth(Fig. 9, showing two opposite posterior teeth engagement segments on both sides of jaw); a trans-palatal region extending between the first tooth engagement region and the second tooth engagement region (Figs. 8-10 element 87), having an anterior edge that is posterior to a canine region and/or a premolar region of the first tooth engagement region (Figs. 8-10 element 87 having an anterior edge the is between the second and third molars and thus behind any premolars); wherein the first tooth engagement region, the second tooth engagement region and the trans-palatal region are formed of a continuous polymeric material (paragraph [0054] disclosing the posterior teeth regions and the trans-palatal element are all made of polymer material and can be printed thus being a continuous polymer material); and an attachment site for an elastic on the outer buccal surface configured to be positioned proximate to a canine tooth or premolar tooth when the apparatus is worn (Fig. 2 element 85 for elastic band 86). a disoccluder on the first tooth engagement region configured to prevent or reduce intercuspation when the apparatus is worn (Fig. 2 element 80, the thickness of the shell apparatus would cause disocclusion that would reduce intercuspation by being between the cusps of the jaws). Regarding claim 41, Martz further discloses where the orthodontic distalizer apparatus is configured to be worn on a subject’s upper jaw (Fig. 2 is on the upper jaw, paragraph [0025] disclosing figure 2 is on the upper right quadrant). 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 8 is rejected under 35 U.S.C. 103 as being unpatentable over Boronkay et al. (US 2017/0007363 A1). Regarding claim 8, Boronkay discloses the claimed invention except for the attachment site being within 5mm of the a trim line of the first tooth engagement region, however it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to having positioned the attachment component within 5mm of the a trim line of the first tooth region since it has been held that rearranging parts of an invention involves only routine skill in the art( In re Japikse, 86 USPQ 70) and Boronkay discloses that it would have been obvious to place the attachment site at any location on the appliance shell based on the need of the patient (paragraph [0216] lines 14-18 disclosing the hook can be located based on treatment need). Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Boronkay et al. (US 2017/0007363 A1) in view of Hung et al. (US 2017/0258554 A1). Regarding claim 44, Boronkay discloses structure substantially identical to the instant application as discussed above, and further discloses where the apparatus has a first attachment site (Fig. 26 element 2604 or Fig. 11fg element 1168) that is on a canine region (Fig. 26 element 2604 and Fig. 11f element 1168 are on a canine region) and where further includes a second attachment site for an elastic on an outer buccal surface (Fig. 11e element 1148, or Fig. 25 elements 2506/2508 being a first and second buccal attachment site) and further discloses that the integrally formed attachment sites can be formed at any location on any appliance (paragraph [0251] lines 20-22), but fails to explicitly disclose where the second attachment site is on the premolar of the first tooth engagement region. However, Hung discloses an orthodontic apparatus (Fig. 3 element 100/400) with a first tooth engagement region that accommodates canine and pre-molar teeth (Fig. 3 element 100 accommodating canines 12 and premolars 13) and a first attachment site for an elastic band on the outer buccal surface of the first tooth engagement region on a canine region (Fig. 3 element 102 on element 12) and a second attachment site on the premolar region of the first tooth engagement region (Fig. 3 element 102 on element 13). Therefore 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 arrangement of the first attachment site being located on the canine region of the first engagement region and the second attachment site being located on the pre-molar region of the first engagement region as taught by Hung into the locations of the first and second attachment sites of the first tooth engagement region as taught by Boronkay for the purpose of providing for attachment which would allow for both controlling both horizontal and vertical correction of teeth simultaneously during use as taught by Hung (paragraph [0050] lines 7-16). Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See form PTO-892. 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 MATTHEW P SAUNDERS whose telephone number is (571)270-3250. The examiner can normally be reached M-F 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, Edelmira Bosques can be reached at (571)-270-5614. 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. /M.P.S/ Examiner, Art Unit 3772 05/20/2026 /EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772
Read full office action

Prosecution Timeline

Sep 12, 2023
Application Filed
Oct 01, 2025
Non-Final Rejection mailed — §102, §103
Jan 29, 2026
Response Filed
May 28, 2026
Final Rejection mailed — §102, §103 (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

3-4
Expected OA Rounds
47%
Grant Probability
85%
With Interview (+37.7%)
3y 2m (~4m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 550 resolved cases by this examiner. Grant probability derived from career allowance rate.

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