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 .
Specification
The amendments to the Specification in regard to the Drawings objection were received on 30 March 2026. These amendments are acceptable.
Claim Objections
Claim 19 is objected to because of the following informalities:
Examiner suggests amending claim 19 line 10 to “and wherein [[and]] the arm”.
Examiner suggests amending claim 20 lines 1-2 to “wherein the implant comprises
Examiner suggests amending claim 21 line 2 to “[[the]]that extends over a portion of the buccal shelf”.
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.
Claim 20 is 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.
Claim 20 recites the limitation "the one or more retention sockets have a recessed surface" in lines 4-5. This limitation is unclear as it is unclear if recessed surface of claim 20 refers to the partially recessed surface as recited in claim 19 lines 9-10, or if a separate recessed surface is being referred to. For purposes of examination, in light of the Specification para. 0165, Examiner will interpret the recessed surface of claim 20 as referring to the partially recessed surface of claim 19 and suggests amending to clarify.
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.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Baughman (U.S. Patent No. 8,444,412 B2) in view of Boronkay (U.S. Publication No. US 2017/0007363 A1) in view of Chang et al (Temporary skeletal anchorage devices to correct challenging malocclusions with clear aligners, see attached PDF, hereinafter “Chang”).
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In regard to claim 1, Baughman discloses a dental appliance (Figs. 3-5b and 10c) comprising: a unibody aligner (110 in Fig. 4a) having a top surface (top surface in annotated Fig. 4a) and a bottom surface (bottom surface in annotated Fig. 4a), the unibody aligner comprising:
an alignment portion (alignment portion in annotated Fig. 4a) shaped to fit over multiple teeth of a patient (Fig. 5a, col. 2 lines 65-66), the alignment portion having a buccal side (buccal side in annotated Fig. 4a) and a lingual side (lingual side in annotated Fig. 4a); and
a buccal vestibule portion (14 in Fig. 4a) integrally formed with the buccal side of the alignment portion (Fig. 4a, col. 2 lines 62-67), the buccal vestibule portion including one or more retention sockets (16 in Fig. 4a, col. 2 line 64-col. 3 line 7), each of the one or more retention sockets shaped for fitment over an implanted temporary anchorage device (TAD) (12 in Fig. 3 and 5a, col. 2 lines 62-66).
Baughman does not disclose that the alignment portion is shaped to fit over multiple lower teeth, and that the TAD is implanted in a mandibular buccal shelf of the patient.
Boronkay teaches a similar apparatus (Figs. 1A-1C and 24) comprising an aligner (2400 in Fig. 24) comprising an alignment portion (alignment portion in annotated Fig. 24, para. 0244) shaped to fit over multiple lower teeth (para. 0084, an appliance can fit over all teeth present in an upper or lower jaw), and one or more retention structures (2406 in Fig. 24), each of the one or more retention structures shaped for fitment over an implanted TAD (para. 0244, anchoring device such as a TAD) implanted on the mandible (para. 0244, can be attached to the jawbone).
Chang teaches an apparatus (Fig. 2, p. 103 right column lines 15-19) comprising an aligner (Fig. 2 Tx, p. 103 right column line 16) for connection to a TAD implanted on a mandibular buccal shelf (Fig. 2 Tx, p. 103 right column lines 44-47).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of dental aligners.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dental appliance of Baughman by specifying the alignment portion is shaped to fit over multiple lower teeth, and that the TADs are implanted in a mandible as taught by Boronkay in order to allow for the appliance and the TADS to provide a desired force to extrude teeth or control overbite or underbite (Boronkay para. 0244) to achieve repositioning of teeth in the jaw (Boronkay para. 0084).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the TADs of Baughman in view of Boronkay by specifying the TADs are implanted in a mandibular buccal shelf of the patient as taught by Chang in order to allow for effectively retracting mandibular dentition, correcting buccal crossbite or recovering mandibular impactions (Chang p. 110, right column lines 4-7).
In regard to claim 2, Baughman in view of Boronkay in view of Chang discloses the invention of claim 1. Baughman further discloses wherein the buccal vestibule portion (14 in Fig. 4a) comprises a cap (col. 1 lines 45-56, complementary female pocket) that snaps over the implanted TAD (col. 1 lines 45-56).
Baughman does not disclose that the buccal vestibule portion comprises a thermoformed cap.
Boronkay teaches an apparatus (Figs. 1A-1C and Fig. 24) comprising a thermoformed dental aligner (2400 in Fig. 24, paras. 0083, 0244, and 0333) comprising an integrally formed vestibule portion (2404 in Fig. 24, para. 0244) and retention structure (para. 0244, integrally formed component can include other types of structures to mount onto the device).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of dental aligners. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the buccal vestibule portion and cap of Baughman in view of Boronkay in view of Chang by specifying they are formed by thermoforming as taught by Boronkay in order to allow for the appliance and the TADS to provide a desired force to extrude teeth or control overbite or underbite (Boronkay para. 0244) to achieve repositioning of teeth in the jaw (Boronkay para. 0084).
In regard to claim 3, Baughman in view of Boronkay in view of Chang discloses the invention of claim 1. Baughman further discloses wherein the one or more retention sockets (16 in Fig. 4a) have a partial recessed surface (col. 1 lines 45-56, complementary female pocket), and buccal vestibule portion (14 in Fig. 4a) comprises a flange extending from the buccal side of the alignment portion (annotated Fig. 4a, col. 2 lines 62-67).
Baughman does not disclose that the buccal vestibule portion comprises an arm.
Boronkay teaches an apparatus (Figs. 1A-1C and 24) comprising a thermoformed dental aligner (2400 in Fig. 24, paras. 0083, 0244, and 0333) comprising a vestibule portion (2404 in Fig. 24, para. 0244) which comprises an arm (arm in annotated Fig. 24) extending from the alignment portion (Fig. 24, para. 0244).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of dental aligners. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the buccal vestibule portion of Baughman in view of Boronkay in view of Chang by specifying the buccal vestibule portion comprises an arm as taught by Boronkay in order to allow for the appliance and the TADS to provide a desired force to extrude teeth or control overbite or underbite (Boronkay para. 0244) to achieve repositioning of teeth in the jaw (Boronkay para. 0084).
In regard to claim 4, Baughman in view of Boronkay in view of Chang discloses the invention of claim 3. Baughman further discloses wherein the one or more retention sockets (16 in Fig. 4a) are shaped to removably attach with a head of the implanted TAD (Figs. 3-5b, col. 1 lines 45-54), wherein the TAD is implanted (Figs. 3-5b, col. 1 lines 45-54).
Baughman does not disclose wherein the TAD is implanted in the buccal shelf adjacent to a molar tooth.
Chang teaches an apparatus (Fig. 2, p. 103 right column lines 15-19) comprising an aligner (Fig. 2 Tx, p. 103 right column line 16) for connection to a TAD wherein the TAD is implanted on the buccal shelf (Fig. 2 Tx, p. 103 right column lines 44-47) adjacent to a molar tooth (Fig. 2 Tx).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of dental aligners. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the TADs of Baughman in view of Boronkay in view of Chang by specifying the TADs are implanted in the buccal shelf adjacent to a molar tooth as taught by Chang in order to allow for effectively retracting mandibular dentition, correcting buccal crossbite or recovering mandibular impactions (Chang p. 110, right column lines 4-7).
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In regard to claim 5, Baughman in view of Boronkay in view of Chang discloses the invention of claim 4. Baughman further discloses wherein the implanted TAD (12 in Fig. 3 and 5a) has a spherical head (34 in Fig. 10c, col. 3 lines 37-42) and the partial recessed surface (col. 1 lines 45-56, complementary female pocket) has a spherical shape (col. 3 lines 37-42, complementary with the male mating portion).
Baughman does not disclose wherein the head is connected to a collar which is connected to a threaded body.
Chang teaches wherein the implanted TAD (Figs. 1-2, p. 103) has a head (head in annotated Fig. 1B) which is connected to a collar (collar in annotated Fig. 1B) which is connected to a threaded body (body in annotated Fig. 1B).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of dental aligners. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the TADs of Baughman in view of Boronkay in view of Chang by specifying the head is connected to a collar which is connected to a threaded body as taught by Chang in order to allow for effectively retracting mandibular dentition, correcting buccal crossbite or recovering mandibular impactions (Chang p. 110, right column lines 4-7) and prevent soft tissue irritation while providing good access for oral hygiene (Chang Fig. 1 caption C).
In regard to claim 6, Baughman in view of Boronkay in view of Chang discloses the invention of claim 3. Baughman further discloses wherein the implanted TAD (12 in Fig. 3 and 5a) has a head (34 in Fig. 10c, col. 3 lines 37-42) and the partial recessed surface (col. 1 lines 45-56, complementary female pocket) has a shape of a sphere (col. 3 lines 37-42, complementary with the male mating portion).
In regard to claim 7, Baughman in view of Boronkay in view of Chang discloses the invention of claim 3. Baughman does not disclose wherein the arm is capable of applying a force from the implanted TAD to move the multiple lower teeth in a posterior direction toward the implanted TAD.
Boronkay teaches wherein the arm (arm in annotated Fig. 24) is capable of applying a force from the implanted TAD to move the multiple lower teeth in a posterior direction toward the implanted TAD (para. 0244, rigid or elastic, used to control over and/or underbite).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of dental aligners. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the arm of Baughman in view of Boronkay in view of Chang by specifying the arm is capable of applying a force from the implanted TAD to move the multiple lower teeth in a posterior direction toward the implanted TAD as taught by Boronkay in order to allow for the appliance and the TADS to provide a desired force to extrude teeth or control overbite or underbite (Boronkay para. 0244) to achieve repositioning of teeth in the jaw (Boronkay para. 0084).
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In regard to claim 8, Baughman in view of Boronkay in view of Chang discloses the invention of claim 3. Baughman further discloses wherein the buccal vestibule portion (14 in Fig. 4a) is curved in shape to remain close to a buccal surface of a tooth (Figs. 4a-5b).
Baughman does not disclose that the arm remains close to a molar tooth.
Boronkay teaches an apparatus (Figs. 1A-1C and 24) comprising a vestibule portion (2404 in Fig. 24, para. 0244) which comprises an arm (arm in annotated Fig. 24).
Chang teaches a buccal vestibule portion (portion in annotated Fig. 2 Tx) remaining close to a molar tooth (Fig. 2 Tx).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of dental aligners.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the buccal vestibule portion of Baughman in view of Boronkay in view of Chang by specifying the buccal vestibule portion comprises an arm as taught by Boronkay in order to allow for the appliance and the TADS to provide a desired force to extrude teeth or control overbite or underbite (Boronkay para. 0244) to achieve repositioning of teeth in the jaw (Boronkay para. 0084).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the arm of Baughman in view of Boronkay in view of Chang by specifying the arm remains close to a molar tooth as taught by Chang in order to allow for effectively retracting mandibular dentition, correcting buccal crossbite or recovering mandibular impactions (Chang p. 110, right column lines 4-7).
In regard to claim 9, Baughman in view of Boronkay in view of Chang discloses the invention of claim 3. Baughman further discloses wherein the buccal vestibule portion (14 in Fig. 4a) is formed in an arch or curved shape (Figs. 4a-5b) that extends from the buccal side of the alignment portion (Figs. 4a-5b). Baughman does not disclose the arm.
Boronkay teaches an apparatus (Figs. 1A-1C and 24) comprising an arm (arm in annotated Fig. 24) extending from the alignment portion (Fig. 24, para. 0244).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of dental aligners. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the buccal vestibule portion of Baughman in view of Boronkay in view of Chang by specifying the buccal vestibule portion comprises an arm as taught by Boronkay in order to allow for the appliance and the TADS to provide a desired force to extrude teeth or control overbite or underbite (Boronkay para. 0244) to achieve repositioning of teeth in the jaw (Boronkay para. 0084).
In regard to claim 10, Baughman in view of Boronkay in view of Chang discloses the invention of claim 3. Baughman does not disclose wherein the arm is made from the same material as the unibody aligner.
Boronkay further discloses wherein the arm is made from the same material as the unibody aligner (para. 0244, integrally formed component).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of dental aligners. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the arm of Baughman in view of Boronkay in view of Chang by specifying the arm is made from the same material as the unibody aligner as taught by Boronkay in order to allow for the appliance and the TADS to provide a desired force to extrude teeth or control overbite or underbite (Boronkay para. 0244, rigid or elastic) to achieve repositioning of teeth in the jaw (Boronkay para. 0084).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Boronkay in view of Baughman.
In regard to claim 19, Boronkay discloses a dental appliance (Figs. 1A-1C and 24) comprising:
an alignment portion (alignment portion in annotated Fig. 24, para. 0244) shaped to fit over multiple lower teeth of a patient (para. 0084, an appliance can fit over all teeth present in an upper or lower jaw), the alignment portion having a buccal side (buccal side in annotated Fig 24) and a lingual side (Fig. 1A, lingual side of aligner);
the buccal side having integrally formed portions (2406 in Fig. 24, para. 0244) capable of fitting over an implant that is implanted in a mandibular buccal shelf of a patient (para. 0244); and
a buccal vestibule portion (2404 in annotated Fig. 24) integrally formed with the buccal side of the alignment portion (para. 0244), wherein the buccal vestibule portion comprises a thermoformed arm (arm in annotated Fig. 24, paras. 0083 and 0244), and wherein the arm applies a force to move the multiple lower teeth in a posterior direction toward the implant (para. 0244, rigid or elastic, control over and/or underbite).
Boronkay does not disclose the buccal vestibule portion including one or more retention sockets, each of the one or more retention sockets shaped for fitment over the implant, and a partial recessed surface that snaps over the implant.
Baughman teaches a similar apparatus (Figs. 3-5b and 10c) comprising a buccal vestibule portion (14 in Fig. 4a) including one or more retention sockets (16 in Fig. 4a, col. 2 line 64-col. 3 line 7), each of the one or more retention sockets shaped for fitment over an implanted temporary anchorage device (TAD) (12 in Fig. 3 and 5a, col. 2 lines 62-66), and a partial recessed surface (col. 1 lines 45-56, complementary female pocket) that snaps over the implant (col. 1 lines 45-56).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of dental aligners.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the buccal vestibule portion of Boronkay by adding one or more retention sockets, each of the one or more retention sockets shaped for fitment over the implant, and a partial recessed surface that snaps over the implant as taught by Baughman in order to allow for facilitation of removable engagement of the appliance (Baughman, Abstract) and enable the appliance to be accurately positioned in place and be loaded more heavily for improved orthodontic results (Baughman para. 0006).
Claims 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Boronkay in view of Baughman in view of Chang.
In regard to claim 20, Boronkay in view of Baughman discloses the invention of claim 19. Boronkay further discloses wherein the implant comprises a temporary anchorage device (TAD) (para. 0244, anchoring device such as a TAD). Boronkay does not disclose wherein the TAD has a spherical head connected to a collar which is connected to a threaded body and the one or more retention sockets have a recessed surface.
Baughman teaches an apparatus (Figs. 3-5b and 10c) wherein a TAD has a spherical head (34 in Fig. 10c, para. 0029) and the one or more retention sockets (16 in Fig. 4a) have a recessed surface (paras. 0007 and 0029, complimentary female pocket).
Chang teaches wherein the implanted TAD (Figs. 1-2, p. 103) having a head (head in annotated Fig. 1B) connected to a collar (collar in annotated Fig. 1B) which is connected to a threaded body (body in annotated Fig. 1B).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of dental aligners.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the TADs of Boronkay in view of Baughman by specifying the head is spherical and the one or more retention sockets have a recessed surface as taught by Baughman in order to allow for facilitation of removable engagement of the appliance (Baughman, Abstract) and enable the appliance to be accurately positioned in place and be loaded more heavily for improved orthodontic results (Baughman para. 0006).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the TADs of Boronkay in view of Baughman by specifying the head is connected to a collar which is connected to a threaded body as taught by Chang in order to allow for effectively retracting mandibular dentition, correcting buccal crossbite or recovering mandibular impactions (Chang p. 110, right column lines 4-7) and prevent soft tissue irritation while providing good access for oral hygiene (Fig. 1 caption C).
In regard to claim 21, Boronkay in view of Baughman discloses the invention of claim 19. Boronkay does not disclose wherein the buccal vestibule portion has a surface that extends over a portion of the buccal shelf of the patient when dental appliance is worn by the patient.
Chang teaches wherein a buccal vestibule portion (portion in annotated Fig. 2 Tx) has a surface that extends over a portion of the buccal shelf of the patient when dental appliance is worn by the patient (Fig. 2 Tx).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of dental aligners.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the arm of Boronkay in view of Baughman in view of Chang by specifying the buccal vestibule portion has a surface that extends over a portion of the buccal shelf of the patient when dental appliance is worn by the patient as taught by Chang in order to allow for effectively retracting mandibular dentition, correcting buccal crossbite or recovering mandibular impactions (Chang p. 110, right column lines 4-7).
In regard to claim 22, Boronkay in view of Baughman discloses the invention of claim 19. Boronkay further disclose wherein the arm (arm in annotated Fig. 24) extends from the buccal side of the alignment portion (Fig. 24). Boronkay does not disclose wherein the arm extends about a molar tooth.
Chang teaches a buccal vestibule portion (portion in annotated Fig. 2 Tx) extending about a molar tooth (Fig. 2 Tx).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of dental aligners.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the arm of Boronkay in view of Baughman in view of Chang by specifying it extends about a molar tooth as taught by Chang in order to allow for effectively retracting mandibular dentition, correcting buccal crossbite or recovering mandibular impactions (Chang p. 110, right column lines 4-7).
Response to Arguments
Applicant’s arguments filed 30 March 2026 with respect to the rejections of the claims 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.
Applicant is directed to the rejections in view of the amendments.
Conclusion
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 COURTNEY N HUYNH whose telephone number is (571)272-7219. The examiner can normally be reached M-F 7:30AM-5:00PM (EST) flex, 2nd Friday off.
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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.
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/COURTNEY N HUYNH/Examiner, Art Unit 3772
/ERIC J ROSEN/Supervisory Patent Examiner, Art Unit 3772