DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
2. The drawings are objected to as failing to comply with 37 CFR 1.84 because:
Figs. 1-6 are black and white photographs that do not transfer well after scanning; the drawings are of insufficient quality that all details are blurry or too dark and are not shown clearly in printed patent or publication. For instance, in Fig. 5 all the numeral characters are very blurry, and at least the elements “auxiliary device 20… comprises first and second hooks 221 and 222… chain 24” (Specification [0165]) are not shown clearly or visible. See 37 CFR 1.84(b)(1).
Fig. 5 shows two views of the invention. Note that each view must have its own Fig. number. Applicant is suggested to use “Fig. 5A” and “Fig. 5B". Amendment to the specification to add the newly numbered view is also required. See 37 CFR 1.84(u).
3. 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 Rejections - 35 USC § 112
4. 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.
5. Claim 1-14 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 1 recites instances of the limitation “the orthodontic aligner” (line 9), and “said orthodontic aligner” (line 10, 12, 14-15, 17-19), which lacks sufficient antecedent basis in the claim. Note that claim 1 defines antecedent basis “at least one orthodontic aligner” (in line 1).
Claim 1 recites “in a position of use” (line 2), then again “in a position of use” (lines 10-11); it is unclear whether these are the same or different elements. Claim 1 further recites “in the position of use” (line 12) which is indefinite because it is unclear whether this limitation in line 12 refers to the position of use in line 2 or in lines 10-11.
Claim 1 recites “said orthodontic aligner, in the position of use, defines, with the supporting arch, a cavity configured to accommodate the auxiliary device, said first and second surfaces belonging to the surface of the supporting arch defining, with said orthodontic aligner, said cavity, only the first tooth, from the first and second teeth, being accommodated entirely in the cavity” (lines 12-16) which is confusing and indefinite.
It is unclear whether the cavity is configured to accommodate just the auxiliary device, or also the first and second surfaces.
The recited limitation “the surface” (line 14) lacks sufficient antecedent basis.
The recitation “said first and second surfaces belonging to the surface of the supporting arch defining, with said orthodontic aligner, said cavity” (lines 13-15) is indefinite because the first and second surfaces are not elements of the orthodontic aligner, therefore it is unclear whether the cavity exists in the aligner without the first and second surfaces.
The recitation “only the first tooth, from the first and second teeth, being accommodated entirely in the cavity” (lines 15-16) is indefinite because it describes the first tooth or a step during using or positioning the aligner. Note that the claim is directed to “a method of manufacturing at least one orthodontic aligner”, not a method of using the aligner. Furthermore, note that the first tooth is not positively claimed. It is unclear whether the cavity exists in the aligner without the first tooth.
Claim 6 recites the limitation “the longitudinal axis” which lacks sufficient antecedent basis in the claim(s).
Claim 10 recites “the occlusal inner surface” (lines 2-3) and “the occlusal surface” (lines 3-4) which lack sufficient antecedent bases in the claim(s).
Claim 11 recites “the outer occlusal surface” (line 3) which lacks antecedent basis.
Claim 12 recites “the eruption” (line 2) which lacks antecedent basis. Claim 12 recites “said tooth” (line 4) which is indefinite because it is not clear whether such “said tooth” is the same as, different from, or part of “at least one tooth” (in line 3).
All other dependent claims are rejected herein based on dependency of the rejected independent claim 1.
Note that all claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors. Applicant is required to review and conform all claims to current U.S. practice.
Claim Rejections - 35 USC § 102
6. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
7. Claims 1-2, 7, 9, and 14, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kuo et al. (US 2020/0237481).
Regarding claim 1, Kuo et al. discloses a method (Fig. 3) for manufacturing at least one orthodontic aligner (Fig. 1) intended to be carried, in a position of use, by a user's dental arch, referred to as a "supporting arch", the supporting arch comprising a first tooth and a second tooth and carrying or being intended to carry an auxiliary device comprising a member connecting a first surface of the first tooth to a second surface of the second tooth (Fig. 1 shows the supporting arch comprising a first tooth and a second tooth each and carrying an auxiliary device, i.e. brackets and wire).
The method comprises:
a) generating a digital three-dimensional model of the supporting arch (Figs. 1 and 3; [0004] “computer-based 3-dimensional planning/design…”);
b) from the digital three-dimensional model of the supporting arch, generating a digital three-dimensional model of the orthodontic aligner configured such that
- said orthodontic aligner can be fixed, in a removable manner, to the supporting arch, in a position of use (Fig. 3; [0024] “appliance can be designed… can be removed by the patient throughout the treatment process”).
- said orthodontic aligner, in the position of use, defines, with the supporting arch, a cavity configured to accommodate the auxiliary device (brackets and wire) said first and second surfaces belonging to the surface of the supporting arch defining, with said orthodontic aligner, said cavity, only the first tooth, from the first and second teeth, being accommodated entirely in the cavity (see Figs. 4-5; [0034] “aligner portion shaped to accommodate braces/bracketed teeth”). Note that Fig. 4B shows each cavity accommodating each tooth, and Figs. 5C-5D shows the cavity accommodate the bracket and the tooth entirely, therefore satisfies “only the first tooth… being accommodated entirely in the cavity” as claimed.
c) manufacturing said orthodontic aligner from the model of the orthodontic aligner; the region of said orthodontic aligner defining said cavity being referred to as the "cavity region" (Figs. 1-5; [0033] “appliance is designed and/or fabricated including a portion or relief in the appliance cavity configured with a volume or geometry to accommodate movement of the bracketed tooth according to the calculated movement”).
As to claim 2, Kuo discloses that in step a), a digital three-dimensional model of the auxiliary device is generated; in step b), the model of the auxiliary device is positioned on the model of the supporting arch, and then the digital three-dimensional model of the orthodontic aligner is generated using the model of the supporting arch on which the model of the auxiliary device was positioned (Figs. 10-11; [0054]-[0057]).
As to claim 7, Kuo et al. discloses the auxiliary device (i.e. bracket/wire) comprises a first and second hooks (brackets) which are intended to be rigidly fixed to the first and second surfaces and to which the member (i.e. archwire) is fixed, the member/archwire being designed so as to exert a tension between said first and second hooks/brackets (Fig. 1; [0025]-[0026]).
As to claim 9, Kuo et al. discloses that digital three-dimensional model of the orthodontic aligner is shaped such that, in the position of use, the orthodontic aligner modifies the position and/or the orientation of at least a third tooth other than the first and second teeth (see Figs. 1 and 4A-4B showing at least three teeth are bracketed and wired and the aligner are position over the bracketed/wired teeth
As to claim 14, Kuo discloses the method is implemented to manufacture a plurality of orthodontic aligners intended to be worn successively in the context of orthodontic treatment of a malocclusion ([0024] “The patient's teeth can be progressively repositioned from an initial tooth arrangement to a target tooth arrangement by placing a series of incremental position adjustment appliances over the patient's teeth”).
Claim Rejections - 35 USC § 103
8. 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.
9. Claims 3-6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kuo et al. (US 2020/0237481).
As to claim 3, Kuo et al. does not disclose that specifically the second tooth is held in position by the orthodontic aligner. Nonetheless, note that Kuo discloses that the aligner is “configured to retain or move teeth” ([0028]), or “retention of tooth/teeth positioning, prevention of a particular movement… of a tooth” ([0046]). Therefore, it would have been obvious to one having ordinary skill in the art to design the orthodontic aligner to hold, i.e. retain, the second tooth in position according to the prescribed treatment plan.
As to claims 4-5, Kuo et al. discloses that the aligner includes active portion that contacts the tooth to apply force (see [0052]) and/or allows for a tooth rotate on itself about an axis that passes through its center and is perpendicular to its occlusal face (see Fig. 6A). Therefore, depending on the treatment plan as needed by the patient and their dental malocclusion, it would have been obvious to one having ordinary skill in the art to design and configure the orthodontic aligner to not be contact with the first tooth and is in contact with more than 10% of the surface of the second tooth as active portion to elicit movement, and/or to allows the first tooth to rotate on itself, about an axis that passes through its center and is perpendicular to its occlusal face, over an angular sector of greater than 20° according the prescribed treatment plan.
As to claims 6 and 8, Kuo et al. discloses the cavity may have various lengths and volumes, e.g. to cover one tooth only (see Fig. 4B) or to cover multiple teeth (Fig. 4A), indicating that such length and volume of the cavity are of optimizable variables. Therefore, the claimed ranges that the cavity has a length greater than 10 mm and a volume greater than 80 mm3 would have been obvious to one having ordinary skill in art at the time the invention was made since it has been held that discovering optimum or workable ranges is well within the skill of an artisan via routine experimentation in order to improve upon what is already generally known. See MPEP §§ 2144.05.
10. Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Kuo et al. in view of Lewkowitz-Shpuntoff (US 2025/0032223)
As to claims 10-13, Kuo et al. fails to disclose the orthodontic aligner is configured to have the claimed features.
Per claims 10 and 12, Lewkowitz-Shpuntoff discloses an aligner (Fig. 11F) having a cavity accommodating teeth 711, 712, 713, and auxiliary device 741, wherein there is an occlusal free space extending between the occlusal inner surface of the orthodontic aligner and the occlusal surface of the supporting arch/tooth 712, and the auxiliary device 741 being accommodated in the occlusal free space (see Fig. 11F; [0092]). The aligner as shown in Fig. 11 is configured to guide the eruption of at least one tooth 712 (see Figs. 11A-11H), wherein in Fig. 11F the occlusal surface of tooth 712 is not spaced from the occlusal inner surface of the aligner (i.e. no point is spaced apart by more than 1mm). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Kuo et al. by including a cavity with an occlusal free space as taught by Lewkowitz-Shpuntoff in order to effectively guide the eruption of a tooth.
Per claim 11 and 13, Lewkowitz-Shpuntoff discloses an aligner (Fig. 9) that in the position of use and in an occlusion position, the outer occlusal surface of the cavity region is in contact with the teeth of the dental arch antagonist to the supporting arch and is deformable under the effect of the masticatory forces (see Figs. 9b-9d; [0085] “distributing the bite force and preventing traumatic occlusion while eating). Note that Figs. 9b and 9c show the cavity region 542 having a plane occlusal outer surface. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Kuo et al. by including the outer occlusal surface of the cavity being in contact with the teeth of the dental arch antagonist to the supporting arch and having a plane occlusal outer surface as taught by Lewkowits-Shpuntoff in order to effectively distribute the masticatory force while eating.
Conclusion
11. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner HAO D. MAI whose telephone number is (571)270-3002. The examiner can normally be reached on Mon-Fri 8:00-4:30. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eric Rosen can be reached on (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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/HAO D MAI/
Examiner, Art Unit 3772
Prosecution Insights