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 .
Restriction
2. Restriction to one of the following inventions is required under 35 U.S.C. 121:
Group I: claims 1-14 and 20, drawn to an orthodontic appliance, classified in CPC A61C 7/08.
Group II: claims 15-19, drawn to a method of making an appliance, classified in CPC A61C 7/002.
3. The inventions are distinct, each from the other because of the following reasons:
Inventions of Groups I and II are related as product and process of manufacturing said product. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case, the appliance as claimed in Group I can be made by another and materially different process, e.g. impression molding.
4. Restriction for examination purposes as indicated is proper because all these inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because at least the following reason(s) apply:
the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries);
the inventions have acquired a separate status in the art in view of their different classification;
the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
the prior art applicable to one invention would not likely be applicable to another invention;
the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
5. Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these 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(a) of the other invention.
6. Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
7. The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined. In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
8. During a telephone conversation with Attorney Raph Younghoon Kim on 11/03/2025, a provisional election was made without traverse to prosecute the invention of Group 1, claims 1-14 and 20. Affirmation of this election must be made by applicant in replying to this Office action.
Claims 15-19 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Specification
9. Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc.
10. The abstract of the disclosure is objected to because it contains legal phraseology “comprising” (line 1), and phrases which can be implied, e.g. "is disclosed” (line 2). Correction is required. See MPEP § 608.01(b).
Drawings
11. The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the features:
- “the appliance body is configured to be coupled to a bone using a bone wire, a bone screw, a bone pin, or any combination thereof” (as recited in claim 10);
- “a clasp, a wire, a bar, or any combination thereof; or a strap, an affixed sleeve, a removable sleeve, a strap, an anterior hinge, a short or long Herbst, a jack screw, a Herbst hinge, or any combination thereof” (as recited in claim 12);
- “a sensor, a light emitting device, or any combination thereof” (as recited in claim 13); and
- “a compliance chip, an electronic or microelectronic device, an electronic accessory to obtain data and communicates the data with another electronic device, or any combination thereof” (as recited in claim 14), must be shown or the features canceled from the claims.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 § 103
12. 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.
13. 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.
14. Claims 1-14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over O’Leary et al. (US 2019/0152152).
Regarding claims 1 and 4, O’Leary et al. discloses an appliance (Figs. 1-18) comprising: an appliance body 100, 200, 300, 400, or 500, etc., including a portion shaped to match a contour of a tooth in an arch (paragraph [0009] “The pocket may define interior walls that conform to one or more of the outer tooth surfaces”).
O’Leary et al. shows the appliance body is configured to couple to the arch to cover portions of a surface of the tooth (see Figs. 1-5). However, O’Leary et al. does not explicitly disclose the appliance covering: about 20% or more and about 99% or less of a surface of the tooth (as recited in claim 1); and up to 99% of an occlusal surface on the tooth or 99% of an anterior occlusal surface on the tooth (as recited in claim 4).
Nonetheless, note that O’Leary et al. discloses various embodiments of the appliance body covering various portions and various amount of surface of the tooth in an arch. For example, O’Leary et al. in the embodiment of Fig. 2A shows the appliance covering the buccal and lingual surfaces of a molar tooth and leaving the occlusal surface portion of the molar uncovered (Fig. 2A; paragraph [0160] “The retainer 200 … cover buccal surfaces and lingual surfaces of all the teeth...The retainer 200 has openings such that it does not cover the occlusal portions of the posterior teeth”). Such coverage is deemed to at least overlap the claimed range of covering about 20% or more and about 99% or less of a surface of the tooth. The same embodiment of Fig. 2A shows the appliance body being configured to cover most of an anterior tooth (Fig. 2A; paragraph [0160] The retainer 200 covers the substantially all of the anterior teeth…”), which is deemed to at least overlap the claimed range of covering about 20% or more and about 99% or less of a surface of the tooth, and up to 99% of an anterior occlusal surface on the tooth.
As such, O’Leary et al. clearly discloses the appliance having a customized coverage of the surface of each posterior or anterior tooth based on the patient’s specific treatment plan (paragraphs [0121]-[0125] “devices can include custom coverage for each of the posterior, anterior, and palatal regions…”). O’Leary et al. thereby effectively indicates that the percentage ranges of a surface or portion of a tooth covered by the appliance is of optimizable variables. Therefore, such claimed ranges of coverages of about 20% or more and about 99% or less of a surface of the tooth (as recited in claim 1), and up to 99% of an anterior occlusal surface on the tooth (as recited in claim 4), 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 an 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.
As to claim 2, O’Leary et al. discloses the arch is a mandibular arch or a maxillary arch (paragraph [0009] “The unitary body may be configured to mate with the patient’s upper or lower dental arch”).
As to claim 3, O’Leary et al. in the embodiment of Figs. 2A-2D shows the appliance body 200 being configured to cover only a portion of an occlusal surface on the tooth (Figs. 2A; paragraph [0160]).
As to claim 4, Fig. 2A shows the appliance body 200 being configured to cover up to 99% of an anterior occlusal surface on the tooth (paragraph [0160] “retainer 200 covers substantially all of the anterior teeth”).
As to claim 5, O’Leary et al. in the embodiment of Figs. 8A-8D shows the appliance body 800 has an opening to allow a tooth to tooth contact on an anterior occlusal surface through the opening (Fig. 8A).
As to claim 6, appliance body 800 is shown being configured to cover only a portion of an incisor surface, a canine surface, a posterior occlusal surface, or any combination thereof (Fig. 8A; paragraph [0166]).
As to claim 7, the appliance body 800 is shown configured to cover only a portion of a molar surface or a premolar surface (Fig. 8A).
As to claim 8, Fig. 2A shows the appliance body 200 configured to cover a plurality of teeth.
As to claim 9, O’Leary et al. discloses the appliance body is configured to perform palatal expansion or maxillary expansion (Figs. 11A-11D, paragraph [0169] “allows the doctors to have the option to use a rapid palate expander post treatment of arch expansion”).
As to claim 10, O’Leary et al. discloses the appliance body is configured to be coupled to a bone using a bone wire, a bone screw, a bone pin, or any combination thereof (Fig. 17B; paragraph [0177] “retainer 1750 includes a thicker posterior base, along with an embedded stiffening element (e.g., wire). The wire can be made out of a shape memory material such as a nickel titanium alloy”).
As to claim 11, O’Leary et al. does not disclose the specifically claimed range of thickness from about 0.5 mm to about 5 mm. Nonetheless, note that O’Leary et al. discloses the appliance may include various thicknesses to facilitate forces applied based on the treatment requirement (paragraphs [0006]-[0007], [0026]-[0027], [0166] “thickness can the increased regionally to increase the force applied to the teeth…”), thereby effectively indicates that the appliance’s thickness is of optimizable variable. Therefore, such claimed range of thickness from about 0.5 mm to about 5 mm 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 an 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.
As to claim 12, O’Leary et al. discloses the appliance further comprising a clasp, a wire, a bar, or any combination thereof (paragraph [0024] “body may include a protrusion, tab, hook…, slot…”; paragraph [0166] “retainer 800 includes a bar…”).
As to claims 13-14, O’Leary et al. discloses the appliance further comprising a sensor, a compliance chip, or an electronic accessory to obtain data and communicates the data with another electronic device (paragraph [0151] “one or more sensors or chips that are configured to track… patient compliance…, GPS, health, one or more biomarkers, etc.”).
As to claim 20, O’Leary et al. discloses a kit comprising at least one of the appliance according to claim 1 as detailed above and instructions for using the appliance (paragraph [0189] “instructions from the physical may be used… the apparatus… shipped… directly to the patient…”). Note that instructions for using the appliance (i.e. physician’s instructions or prescriptions for the orthodontic treatment, e.g. how and when and for how long to wear the appliance, etc.) being included in the kit would have been obvious and well known as with any prescribed orthodontic treatment to ensure proper compliance of the treatment.
Conclusion
15. 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