Prosecution Insights
Last updated: August 06, 2026
Application No. 18/855,371

MYOFUNCTIONAL ALIGNER

Final Rejection §103§112
Filed
Oct 09, 2024
Priority
Apr 11, 2022 — DE 10 2022 108 777.8 +1 more
Examiner
EIDE, HEIDI MARIE
Art Unit
3772
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Codonis AG
OA Round
2 (Final)
51%
Grant Probability
Moderate
3-4
OA Rounds
1y 7m
Est. Remaining
83%
With Interview

Examiner Intelligence

Grants 51% of resolved cases
51%
Career Allowance Rate
531 granted / 1050 resolved
-19.4% vs TC avg
Strong +32% interview lift
Without
With
+32.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
39 currently pending
Career history
1092
Total Applications
across all art units

Statute-Specific Performance

§101
2.7%
-37.3% vs TC avg
§103
43.7%
+3.7% vs TC avg
§102
14.1%
-25.9% vs TC avg
§112
32.6%
-7.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1050 resolved cases

Office Action

§103 §112
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 . Claim Objections Claim 23 is objected to because of the following informalities: “at least partially overlap buccal areas of a patient” is believed to be in error for -configured to at least partially overlap buccal areas of a patient-. Appropriate correction is required. Claim Rejections - 35 USC § 112 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. Claims 20-38 are 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. With respect to claim 20, the applicant claims the u-shaped portion and “delimiting an arched inner space complementary to a U-shape of the U-shaped portion”. It is unclear what the applicant is trying to claim with respect the limitation as it is unclear if the “a U-shape” is a different U-shaped portion than the claimed U-shaped portion. It is noted that for examination purposes, the limitation is being interpreted as the U-shaped portion has an inner arched shape space, however, the applicant should amend the claim to clarify what is being claimed. It is further noted that this limitation is being interpreted as functional, such that it is “configured” to lingually cover a row of teeth, however, the applicant should amend the claim to clarify that the limitation is functional as human anatomy cannot be positively claimed. Further with respect to claim 20, the limitation “wherein the tongue anchor point is part of a protrusion extending from an inner wall of the alinger to the arched inner space to lingually cover a row of teeth of the set of teeth” is unclear as to what portion of the claimed device is lingually covering the row of teeth. It is noted that for examination purposes, the limitation is being interpreted as the inner wall is configured to lingually cover the row of teeth, however, the applicant should amend the claim to clarify. With respect to claim 21, the applicant claims “an inner wall”, however, it is noted that in claim 20 claims in the alternative “an inner wall” with respect to the protrusion. It is unclear if the inner wall of claim 21 is the same or different than the inner wall in the alternative in which the protrusion is claimed. It is noted that the applicant should amend the claim to clarify what is being claimed, however, for examination purposes, the claimed inner wall of claim 21 is being interpreted as the same inner wall of claim 20. With respect to claim 23, the limitation of overlapping buccal areas is unclear as if the device is configured to function as claimed or if the applicant is trying to claim human anatomy. Since the applicant cannot claim human anatomy, the limitation is being interpreted as functional, such that the claimed contours of the alinger are “configured” to overlap buccal areas as claimed, however, the applicant should amend the claim to clarify what is being claimed. Claim Rejections - 35 USC § 103 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. Claim(s) 20-23, 26-27, 29-31, 34-35, 37, and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang (CN 109420289) in view of Weber (EP 2614798). With respect to claim 20, Huang teaches an aligner 201/203 configured to align teeth of a set of teeth (see par. 49 of translation, specifically “the cavity has a geometry that repositions the dental arch from a first locality to a predetermined second layout”), wherein the aligner comprises u-shaped portion 201 having a shape specifying a preferred tooth position (see par, 49) and delimiting an arched inner space complementary to a U-shape of the u-shaped portion (the inner space being the lingual side of the appliance in which element 203 is located), and a tongue anchor point extending from the u-shaped portion in a direction of the arches inner space, wherein the tongue anchor point is configured for positioning in an intended state close to a roof of a palate of an oral cavity of the set of teeth (see par. 52 of translation, such that component 203 is pressed against the palate, pars. 47, 65, such that the appliance it designed to be worn on the upper arch), wherein the tongue anchor point is part of a protrusion extending from an inner wall of the alinger to the arched inner space to lingually cover a row of teeth of the set of teeth (such that the inner wall covers the lingual portion of the teeth) or a bridge extending from a first leg of the u-shaped portion to a second leg of the u-shaped portion to bridge the arches inner space, wherein the tongue anchor point has a geometric shape at least partially protruding from a connection area of the tongue anchor point with the protrusion or the bridge (see annotated figure below, such that the protrusion is the elongated member extending from the u-shaped portion and the tongue anchor point is the rounded end, such that it has a geometric shape that partially protrudes from the connection area, i.e. the connection between the rounded tongue anchor point and the elongated protrusion, see annotated figure). Huang teaches the invention as substantially claimed and discussed above, however, does not specifically teach the tongue anchor point is detachable from and replaceable with respect to the protrusion or the bridge. PNG media_image1.png 191 356 media_image1.png Greyscale Weber teaches a dental shell, wherein the shell comprises a u-shaped portion and delimiting an arches inner space complementary to the u-shaped portion (see fig. 1, par. 26, such that the device 1 is a split for the teeth and therefore it is u-shaped since it would follow the arch on the teeth in order to fit on the teeth), a tongue anchor point (the elements of figure 2, par. 28) extending from the u-shaped portion in a direction of the arched inner space (see figs. 1-2, pars. 12, 26, such that the elements of figure 2 are to be fastened to element 6 on the u-shaped portion and are for training the tongue, therefore, the tongue anchor point is within the arches inner space since the tongue is located in the arched inner space), wherein the tongue anchor point is a part of a protrusion extending from the shell (see fig. 1, such that the protrusion is the post from which element 6 is attached), wherein the tongue anchor point has a geometric shape at least partially protruding from a connection area of the tongue anchor point with the protrusion and wherein the tongue anchor point is detachable from and replaceable with respect to the protrusion (see figs. 1-2, pars. 26-28, such that the different tongue anchor points illustrated in fig 6 are removably connected to the connection 6 of the projection, it is noted that the connection area is the post and ball element on the tongue anchor points in figure 2). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the integral tongue anchor point taught by Huang to be a removably and replaceable tongue anchor point taught as taught by Weber in order to easily change out the tongue anchor point to allow for different training functions (see pars. 29, 34-35). With respect to claim 21 Huang/Weber teaches the invention as substantially claimed and discussed above, Huang further teaches the u-shaped portion has an inner wall configured to lingually cover a row of teeth of the set of teeth (see fig. 1a, such that the inner wall is the wall on the inner portion of the arch shape, see annaoted figure below). PNG media_image2.png 191 325 media_image2.png Greyscale With respect to claim 22, Huang/Weber teaches the invention as substantially claimed and discussed above, Huang further teaches wherein the u-shaped portion has an outer wall configured to labially cover the row of teeth of the set of teeth (see fig. 1a, the outer wall of element 201 that is on the outer portion of the arch, see annotated figure above). With respect to claim 23, Huang/Weber teaches the invention as substantially claimed and discussed above, Huang further teaches, wherein the u-shaped portion has individual tooth contours with a predefined tooth position (see fig. 1, such that the overall shape has tooth contours, par. 49 of translation regarding the tooth position) and the individual tooth contours have areas at least partially overlapping buccal areas of a patient (such that the cavities accept the buccal side of the teeth and therefore partially overlap a buccal area). With respect to claim 26, Huang/Weber teaches the invention as substantially claimed and discussed above, Huang further teaches wherein the tongue anchor point has a round body (see fig. 1a, annotated figure above with respect to claim 20, such that the tongue anchor point is the rounded). With respect to claim 27, Huang/Weber teaches the invention as substantially claimed and discussed above, Weber further teaches wherein the tongue anchor point has a different surface texture compared to other areas of the shell that are adjacent to the tongue anchor point (see fig. 2, such that the tongue anchor point 12 has bristles which have a different texture than the rest of the device). With respect to claim 29, Huang/Weber teaches the invention as substantially claimed and discussed above, Huang further teaches wherein the protrusion or the bridging piece is arranged detachably in relation to the basic shape (see annotated figure above with respect to claim 20 regarding the structure that is the claimed protrusion, see figs. 1b-1c, par. 47 regarding the protrusion of being detachable). With respect to claim 30, Huang/Weber teaches the invention as substantially claimed and discussed above, Weber further teaches wherein the tongue anchor point has a different surface haptic compared to neighboring areas of the bridge or the protrusion (see fig. 2, such that the tongue anchor point 12 has bristles which have a different texture than the protrusion). With respect to claim 31, Huang/Weber teaches the invention as substantially claimed and discussed above, Weber further teaches wherein the tongue anchor point has a chemical compound that is at least partially soluble in saliva (pars. 19, 28, such that element 15 on the tongue anchor point has a chemical compound that is at least partially soluble). With respect to claim 34, Huang/Weber teaches the invention as substantially claimed and discussed above, Weber further teaches wherein a material of a different chemical composition is arranged in an area of the tongue anchor point (see pars. 19, 28, such that element 15 is of a material having a different chemical composition than the rest of the device). With respect to claim 35, Huang/Weber teaches the invention as substantially claimed and discussed above, Weber further teaches wherein the tongue anchor point has moveable elements which are moveable by a tongue (see fig. 2, such that element 12 has bristles which are moveable elements that are moveable by a tongue). With respect to claim 37, Huang/Weber teaches the invention as substantially claimed and discussed above, Huang further sensors configured to determine physical or a chemical variable in saliva or in an oral cavity (see pars. 52, 56, such that the pressure sensor determined a physical variable). With respect to claim 39, Huang/Weber teaches the invention as substantially claimed and discussed above, Weber further teaches the tongue anchor point is latchable to the protrusion or the bridge (see pars. 22, 23). Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang (CN 109420289) in view of Weber (EP 2614798) as applied to claim 20 above, and further in view of Gerber (3,187,746). Huang/Gerber teaches the invention as substantially claimed and discussed above, however, does not specifically teach the tongue anchor point has a coating applied to a carrier material. Gerber teaches a dental device (entire device) comprising a basic shape 2/28 having a u-shape (see fig. 3), and a tongue anchor point 20/21/26 directed from the basic shape in a direction of the arched inner space (see figs. 3, 5), wherein the tongue anchor point is configured for positioning in an intended state close to a roof of a palate of an oral cavity of the set of teeth (see fig. 1). With respect to claim 32, Gerber further teaches wherein the tongue anchor point has a coating 26 applied to a carrier material 20/21 (see fig. 5). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Huang/Gerber with a coating applied to a carrier material in order to provide a more secure connection for the lozenge. Such that by providing it as a coating on a firmly connected piece, it would prevent accidental dislodgment of the lozenge/flavoring. Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang (CN 109420289) in view of Weber (EP 2614798) as applied to claim 20 above, and further in view of Farrell (2020/0215384). Huang/Weber teaches the invention as substantially claimed and discussed above, however, does not specifically teach the aligner has a shield segment configured to cover certain areas a row of teeth of the set of teeth, wherein the shield segment has at least one protrusion configured for lip stimulation on a side facing away from the teeth. Farrell teaches a dental device comprising a basic shape having a u-shape delimiting an arched inner space (see figs. 1, 5), and a tongue anchor point 44 directed from the basic shape in a direction of the arched inner space, wherein the tongue anchor point is configured for positioning in an intended state close to a roof of a plate of an oral cavity of the set of teeth (pars. 142-144). Farrell further teaches with respect to claim 36, wherein the alinger has a shield segment (outer wall 22) configured to cover certain areas a row of teeth of the set of teeth, wherein the shield segment has at least one protrusion 38 configured for lip stimulation on a side facing away from the teeth (see fig. 1, par. 83). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the alinger taught by Huang/Weber to include protrusions in order to inhibit overactivity of the mentalis muscle. Claim(s) 33 and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang (CN 109420289) in view of Weber (EP 2614798) as applied to claim 20 above, and further in view of Choo (2024/0066291). Huang/Weber teaches the invention as substantially claimed and discussed above, however, does not specifically teach the alinger further comprises actuators configured to generate and transmit stimulus signals and the tongue anchor point having openings. Choo teaches a dental device comprising a basic shape 22/26 having a u-shape delimiting an arched inner space and a tongue anchor point 24/25 directed from the basic shape in a direction of the arched inner space. With respect to claim 33, Choo further teaches openings within the tongue anchoring point (see par. 48, 52). It would have been obvious to one having ordinary skill in the art to modify the tongue anchor point taught by Huang/Weber to include holes as taught by Choo in order to provide desired tactile identification and guide certain positioning or movements. With respect to claim 38, Choo further teaches actuators 32 configure to generate and transmit stimulus signals (see abstract, pars. 40, 43, 49). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Huang/Weber to include the actuators taught by Choo in order to activate contractions, stimulate salivation or other desired outcomes for the desired treatment outcome for the myofunctional therapy. Response to Arguments Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The prior art of Liao teaching an orthodontic expander with a tongue bead, i.e. a tongue anchor point. The prior art of Stiene teaching a tongue training orthodontic device. 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 HEIDI MARIE EIDE whose telephone number is (571)270-3081. The examiner can normally be reached Mon-Fri 9:00-4:00. 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. /HEIDI M EIDE/Primary Examiner, Art Unit 3772 6/30/2026
Read full office action

Prosecution Timeline

Oct 09, 2024
Application Filed
Feb 06, 2026
Non-Final Rejection mailed — §103, §112
May 06, 2026
Response Filed
Jul 02, 2026
Final Rejection mailed — §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
51%
Grant Probability
83%
With Interview (+32.5%)
3y 4m (~1y 7m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 1050 resolved cases by this examiner. Grant probability derived from career allowance rate.

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