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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
2030 in Figures 1, 6, and 8.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
Reference characters "1010" and "2010" have both been used to designate the gum extension in para. 63 of the Specification.
Reference character “E” has been used to designate both a zone of egression movement (Specification para. 52) and a space left free at the implantation site (Specification para. 79).
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 14, 16-17, and 25-26 are objected to because of the following informalities:
Examiner suggests amending claim 14 lines 9-10 to “[[the]] lingual surfaces of the teeth while leaving [[the]] other surfaces of said teeth free”.
Examiner suggests amending claim 16 line 5 to “angle α between”.
Examiner suggests amending claim 17 line 1 to “according to claim 16”.
Examiner suggests amending claim 25 line 1 to “according to
Examiner suggests amending claim 26 line 1 to “according to .
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 14-26 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.
Claim 14 recites the limitation "the flexible strip is in position" in lines 14-15. It is unclear what position is being referred to, as claim 1 recites the limitation “move at least one tooth to a desired position” in line 3, however this position is a position of the tooth and not a position of the flexible strip. For purposes of examination, Examiner will interpret the position of claim 14 lines 14-15 as referring to a position of the flexible strip when the dental appliance is worn by the patient (Claim 14 lines 6-7) and suggests Applicant amend to clarify.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “splint” in claims 22 and 23 is used by the claim to mean “flexible aligner which applies forces,” while the accepted meaning is “material or a device used to protect and immobilize a body part” (Merriam-Webster, https://www.merriam-webster.com/dictionary/splint, definition 2c) The term is indefinite because the specification does not clearly redefine the term. For purposes of examination, Examiner will interpret the limitation “splint” in claims 22 and 23 as referring to a flexible aligner and suggests Applicant amend to clarify.
Claim 23 recites the limitation “their” throughout lines 5 and 6. It is unclear what “their” is referring to. For purposes of examination, Examiner will interpret “their” as referring to the teeth with which said aligner cooperates (claim 23 lines 3-4) and suggests Applicant amend to clarify.
Claims 15-21 and 24-26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for their dependence on one or more rejected base and/or intervening claims.
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 14-15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Cao et al (CN 111839765 A and translated PDF, hereinafter “Cao”).
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In regard to claim 14, Cao discloses a removable dental appliance (appliance in annotated Fig. 2, Figs. 1-6, Abstract), comprising:
- a dental aligner (12 in Fig. 2, para. 0039) capable of cooperating with at least one tooth of a patient's dental arch so as to move the at least one tooth to a desired position (para. 0036),
- connectors (2 in Fig. 6) capable of being attached to teeth of the dental arch and on which the dental aligner detachably engages (paras. 0043-0044), and
- the connectors and the aligner cooperate so as to apply at least one treatment stress on at least the at least one tooth when the dental appliance is worn by the patient (paras. 0043-0044),
wherein,
- the dental aligner is formed from a flexible strip (para. 0037) profiled to cover only the lingual surface of the teeth while leaving the other surfaces of said teeth free (Fig. 2, para. 0009, 0035, and 0039, “and/or” a lingual connection portion),
- the connectors are capable of being attached to the lingual surface of the teeth (Figs. 2 and 6),
- pockets (15 in Fig. 6) into which the connectors fit elastically are shaped in the flexible strip in such a way that said pockets and said strip have no relative movement between them (Fig. 9, para. 0044),
- when the pockets are fitted into the connectors and the flexible strip is in position, the flexibility of said strip enables said strip to exert one or more stresses on said connectors (paras. 0043-0044), and
- the pockets and the connector are configured so that the force for removing the aligner from said connectors is such that said connectors fit into said pockets in a manually detachable manner (para. 0044, snap connection).
Cao does not explicitly disclose that the force for removing the aligner from said connectors is less than 550 g. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Cao to have the force for removing the aligner from said connectors be less than 550 g since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In the instant case, the device of Cao would not operate differently with the claimed force for removing the aligner from said connectors being less than 550 g and since Cao discloses that the pockets and the connector are a snap connection (para. 0044) and the aligner being removably connected to the connectors, would function appropriately with the claimed values.
Further, Applicant places no criticality on the force being less than 550 g claimed, indicating simply that the value is “for example” less than 550g (Specification para. [48]).
In regard to claim 15, Cao discloses the invention of claim 14. Cao further discloses wherein each connector includes: a base (base in annotated Fig. 6) having an attachment surface (attachment surface in annotated Fig. 6) capable of being attached against the lingual surface of a tooth (Figs. 2 and 6, paras. 0043-0044), and a connection head (3 in Fig. 6, para. 0044) in line with the base and into which one of the pockets of the dental aligner fits (Fig. 6 para. 0044).
In regard to claim 19, Cao discloses the invention of claim 14. Cao further discloses wherein each connector includes: a connection head (3 in Fig. 6) into which one of the pockets of the aligner fits (15 in Fig. 6), an attachment surface (attachment surface in annotated Fig. 6) capable of being attached against the lingual surface of a tooth (Figs. 2 and 6, paras. 0043-0044), and the attachment surface comprises a flat section arranged (flat section in annotated Fig. 6) on the connection head (Fig. 6).
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Cao in view of Knopp et al (U.S. Publication No. 2003/0198911 A1, hereinafter “Knopp”).
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In regard to claim 16, Cao discloses the invention of claim 15, wherein: the connection head (3 in Fig. 6) has an ovoid or ellipsoid shape (Fig. 6). Cao does not disclose where in the connection head has a longitudinal axis of symmetry X-X, and the longitudinal axis of symmetry X-X and the normal to the attachment surface of the base form an angle α between 10° and 90°.
Knopp teaches a similar apparatus comprising a dental aligner (Abstract) and connectors (100 in Figs. 5A-5D), wherein each connector includes a base (102 in Fig. 5C) and a connection head (101 in Fig. 5C), wherein the connection head has an ovoid or ellipsoid shape (Figs. 5A-5D, para. 0081) having a longitudinal axis of symmetry X-X (axis in annotated Fig. 5C), and the longitudinal axis of symmetry X-X and the normal to the attachment surface of the base form an angle α between 10° and 90° (angle in annotated Fig. 5C would be 30°- 80°; this is because angle 135 in Fig. 5C has angle of inclination between 10° and 60° (para. 0081), and the angle between the normal and the base is 90°, angle 2 can be solved since the sum of interior angles of a triangle = 180°, so 180° = 90° + (10°- 60°) + angle 2, solving the equation shows angle 2 = 30°- 80°, and angle 2 and angle are equal since opposite angles are equal, see Fig. 5C Angle Annotation).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of removable orthodontic arch appliances. 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 connector heads of Cao so that the connection head has a an ovoid or ellipsoid shape having a longitudinal axis of symmetry X-X, and the longitudinal axis of symmetry X-X and the normal to the attachment surface of the base form an angle α between 10° and 90°, which is 30°- 80°, as taught by Knopp in order to allow for the tooth to be desirably repositioned (Knopp para. 0081).
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In regard to claim 17, Cao in view of Knopp discloses the invention of claim 16. Cao does not disclose wherein the ovoid-shaped connection head has a first end and a second end that are opposite, said first end being sharper than said second end, said first end being, when in use, directed toward the root of the tooth to which the connector is attached.
The embodiment of Fig. 2 of Knopp teaches wherein an ovoid-shaped connection head (101 in Fig. 2) has a first end (1st end in annotated Fig. 2) and a second end (2nd end in annotated Fig. 2) that are opposite, said first end being sharper than said second end (Fig. 2), said first end being, when in use, directed toward the root of the tooth to which the connector is attached (Fig. 2, para. 0075).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of removable orthodontic arch appliances. 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 connector heads of Cao in view of Knopp by so that the ovoid-shaped connection head has a first end and a second end that are opposite, said first end being sharper than said second end, said first end being, when in use, directed toward the root of the tooth to which the connector is attached as taught by the embodiment of Fig. 2 of Knopp in order to allow for the tooth to be move to an intended position (Knopp para. 0075).
Claims 18 is rejected under 35 U.S.C. 103 as being unpatentable over Cao in view of Meley (U.S. Publication No. 2012/0270174 A1).
In regard to claim 18, Cao discloses the invention of claim 15. Cao further discloses wherein the connection head (3 in Fig. 6) is distant from the base (base in annotated Fig. 6). Cao does not disclose a flange connecting said base from said head.
Meley teaches a connector (41 in Fig. 4) including a base (411 in Fig. 4) and a connection head (head in annotated Fig. 4), wherein the connection head is distant from the base (Fig. 4) and a flange (flare in annotated Fig. 4, the transition between base 411 and groove 413 in Fig. 4) connecting said base from said head (Fig. 4).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of removable orthodontic arch appliances. 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 connectors of Cao by adding the flange connecting the base from the head as taught by Meley in order to allow for transmission of forces for a desired displacement of the tooth (Meley para. 0039).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Cao in view of Choi et al (WO 03003935 A1, hereinafter “Choi”).
In regard to claim 20, Cao discloses the invention of claim 14. Cao does not disclose wherein the aligner has a palatal extension configured, when in use, to press against all or part of the patient's palatal arch when said aligner is positioned at said patient's maxillary dental arch.
Choi teaches an aligner (Fig. 7, Abstract) wherein the aligner has a palatal extension (Fig. 7, p. 12 lines 5-6) capable of, when in use, pressing against all or part of the patient's palatal arch when said aligner is positioned at said patient's maxillary dental arch (Fig. 7, p. 12 lines 5-6, Abstract).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of removable orthodontic arch appliances. 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 aligner of Cao by adding a palatal extension capable of pressing against all or part of the patient's palatal arch when the aligner is positioned at said patient's maxillary dental arch as taught by Choi in order to allow for treatment of crowding of several teeth together or arch expansion (Choi p. 12 lines 15-17 and p. 12 line 23-p. 13 line 1).
Claims 21 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Cao in view of Domroese et al (U.S. 2022/0047358 A1, hereinafter “Domroese”).
In regard to claim 21, Cao discloses the invention of claim 14. Cao does not disclose wherein the aligner has a gum extension configured, when in use, to press against all or part of the patient's gum zone when said aligner is positioned at said patient's mandibular dental arch.
Domroese teaches an aligner (Fig. 1H, para. 0027, either maxillary or mandibular) wherein the aligner has a gum extension (102D in Fig. 1H) capable of, when in use, pressing against all or part of the patient's gum zone (para. 0051) when said aligner is positioned at said patient's mandibular dental arch (para. 0027, either maxillary or mandibular).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of removable orthodontic arch appliances. 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 aligner of Cao by adding a gum extension capable of pressing against all or part of the patient's gum zone when said aligner is positioned at said patient's mandibular dental arch as taught by Domroese in order to allow for additional bracing without impeding mobility of teeth for better control of tooth movements without causing unwanted reactionary movements of neighboring teeth (Domroese para. 0051).
In regard to claim 25, Cao discloses the invention of claim 14. Cao does not disclose wherein the aligner is made of thermoformable polyurethane.
Domroese discloses wherein an aligner is made of thermoformable polyurethane (para. 0056).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of removable orthodontic arch appliances. 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 aligner of Cao by fabricating the aligner out of thermoformable polyurethane as taught by Domroese in order to allow for the aligner to have selected force characteristics and displacement characteristics (Domroese para. 0056).
In regard to claim 26, Cao discloses the invention of claim 14. Cao does not disclose wherein the aligner has portions or areas having distinct moduli of elasticity.
Domroese discloses wherein an aligner has portions or areas having distinct moduli of elasticity (para. 0056, multiple layers with different elastic modulus).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of removable orthodontic arch appliances. 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 aligner of Cao by fabricating the aligner with portions or areas having distinct moduli of elasticity as taught by Domroese in order to allow for selection of force characteristics, displacement characteristics, or both (Domroese para. 0056).
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Cao in view of Phan (U.S. Publication No. 2020/0237480 A1).
In regard to claim 22, Cao discloses the invention of claim 14. Cao does not disclose further comprising a flexible and removable splint, profiled, when in use, to cover the patient's teeth, said splint having a portion engaging on at least a part of the aligner so as to apply on said aligner at least one force tending to stress it toward the lingual surface of the teeth to be moved, though Cao does disclose that the front or posterior segments may wrap to fully cover the tooth (para. 0038).
Phan teaches an apparatus (Abstract, Figs. 1-3) comprising an aligner (14 in Fig. 2) and a flexible and removable splint (18 in Fig. 2), profiled, when in use, to cover the patient's teeth (Fig. 2, para. 0057), said splint having a portion engaging on at least a part of the aligner (Fig. 3A, para. 0060-0062) so as to apply on said aligner at least one force tending to stress it toward the lingual surface of the teeth to be moved (paras. 0052-0053 and 0057).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of removable orthodontic arch appliances. 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 appliance of Cao by adding a flexible and removable splint, profiled, when in use, to cover the patient's teeth, said splint having a portion engaging on at least a part of the aligner so as to apply on said aligner at least one force tending to stress it toward the lingual surface of the teeth to be moved as taught by Phan in order to allow for maximizing working elasticity and therefore greater break time between wear periods and increased efficacy (Phan para. 0046).
In regard to claim 23, Cao discloses the invention of claim 14. Cao further discloses that, when in use, for the teeth with which said aligner (12 in Fig. 2, para. 0039) cooperates: the main part of their lingual surface is covered by said aligner (Figs. 2 and 6).
Cao does not disclose further comprising a flexible and removable splint, profiled, when in use, to cover the patient's teeth, said splint having a complementary portion with the aligner such that, when in use, for the teeth with which said aligner cooperates: the main part of their lingual surface is covered by said aligner, and another part of their lingual surface, their occlusal/incisal surface and their vestibular surface are covered by said splint, though Cao discloses that the front or posterior segments may wrap to fully cover the tooth (para. 0038).
Phan teaches an apparatus (Abstract, Figs. 1-3) comprising an aligner (14 in Fig. 2) and a flexible and removable splint (18 in Fig. 2), profiled, when in use, to cover the patient's teeth (Fig. 2, para. 0057), said splint having a complementary portion with the aligner (Fig. 3A, para. 0060-0062) such that, when in use, for the teeth with which said aligner cooperates: the main part of their lingual surface is covered by said aligner, and another part of their lingual surface, their occlusal/incisal surface and their vestibular surface are covered by said splint (Fig. 3A, para. 0060-0062, edge location may be adjusted so that layers may have varying surface area to adjust elasticity).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of removable orthodontic arch appliances. 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 appliance of Cao by adding a flexible and removable splint, profiled, when in use, to cover the patient's teeth, said splint having a complementary portion with the aligner such that, when in use, for the teeth with which said aligner cooperates: the main part of their lingual surface is covered by said aligner, and another part of their lingual surface, their occlusal/incisal surface and their vestibular surface are covered by said splint as taught by Phan in order to allow for maximizing working elasticity and therefore greater break time between wear periods and increased efficacy (Phan para. 0046).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Cao in view of Ho et al (Effects of different aligner materials and attachments on orthodontic behavior, see attached PDF, hereinafter “Ho”.).
In regard to claim 24, Cao discloses the invention of claim 14. Cao does not disclose wherein the aligner is made of a material having a modulus of longitudinal elasticity less than 1000MPa.
Ho teaches wherein an aligner is made of a material having a modulus of longitudinal elasticity less than 1000MPa (p. 1007, Table 2, BENQ material has Young’s modulus of 134 x 106 Pa, which is 134 MPa).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of removable orthodontic arch appliances. 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 aligner of Cao by fabricating the aligner of a material having a modulus of longitudinal elasticity less than 1000MPa as taught by Ho in order to allow for tightly wrapping the tooth and increased aligner retention (Ho p. 1007, left column para. 2).
Conclusion
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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/COURTNEY N HUYNH/Examiner, Art Unit 3772
/HEIDI M EIDE/Primary Examiner, Art Unit 3772 9/19/2025