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 .
Election/Restrictions
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Restriction Groups:
Group I, claims 1-2, drawn to a retainer.
Group II, claims 3-5, drawn to a method of manufacturing a retainer.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of claim 1, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Schumacher (US 2019/0069974 A1).
Regarding claim 1, Schumacher discloses a retainer (retainer 1 [Figs. 1-7, 0069]) comprising:
a body (arc 3 [Fig. 1, 0070]) formed of a shape memory alloy material (the retainer 1 is formed of nitinol; nitinol sheet 20 is the base material [Fig. 7, 0072, 0080]) and formed as a single integrated configuration (“in the course of preparing the retainer from the metal sheet a single continuous piece is obtained” [0037]), the body having a first surface (machining surface 13 [Figs. 5-7, 0078, 0080]) in close contact with each tooth along a tooth arrangement (“The surface with which the retainer 1 abuts the tooth surface 17 corresponds to the machining surface 13 of the retainer 1” [Figs 5 and 6, 0078]),
wherein the body comprises:
a curved protrusion part (tips 6 [Figs. 1, 2, and 4, 0070]) that protrudes toward an interdental space so that the curved protrusion part is inserted into the interdental space (“The second category describes ”tips” 6 which form the points of the arc 3, which enter into the interdental spaces” [0070]), the curved protrusion part being in close contact with inner tooth surfaces of a plurality of teeth forming the interdental space (the tips 6 are inserted into the dental space and the overall largest measured perpendicular distance between the retainer and the tooth surface is 10µm [0074]); and
a plurality of support parts (shallow waves 5 [Figs. 1, 2, and 4, 0070]) in close contact with tooth surfaces of each tooth outside the interdental space (“shallow waves 5 are therefore correspondingly adapted to an individual tooth shape of a patient” [0070]; the overall largest measured perpendicular distance between the retainer and the tooth surface is 10µm [0074]), and
the body is manufactured by being laser cut from a base material of the shape memory alloy material on the basis of 3D scanning data of the tooth arrangement and then a width between distal ends thereof being modified so as to correct at least a shape error caused by the laser cutting. Though this final limitation is shared between Group I and Group II, the manufacturing process by which the retainer is formed is not a patentable limitation of the claim for the retainer itself. See MPEP 2113(I).
During a telephone conversation with Belinda Lee on July 21, 2025, a provisional election was made without traverse to prosecute the invention of Group II, claims 3-5. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-2 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character not mentioned in the description: 4.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference character mentioned in the description: 3.
It should be noted that the above objections are likely related. Reference character ‘3’ is used in the description to denote a burr. Reference character ‘4’ is used in Fig. 9 to denote a part that appears to be a burr in the appropriate step in the schematic. Applicant should select either 3 or 4 to denote this part, and ensure that the specification and drawings are consistent.
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. 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.
Specification
The disclosure is objected to because of the following informalities:
“there is are problems” should be corrected to --there are problems-- in [PG Pub: 0006].
“twisted three strands” should be corrected to --twisted strands-- in [PG Pub: 0007].
“body 110” should be corrected to --body 100—in [PG Pub: 0072].
References to Fig. 11 in [PG Pub: 0136 and 0137] are unclear in the context of what is being discussed in these paragraphs. References should instead be made to Figs. 10 and/or 12, as these figures illustrate the elements discussed in these paragraphs.
“body forming part 100” should be corrected to --body forming part 100’-- in [PG Pub: 0165].
“body forming body 100’” should be corrected to --body forming part 100’-- in [PG Pub: 0173].
It is stated that “the body 100 may be fixed to the tooth arrangement by being elastically deformed and being in close contact with the body 100” in [PG Pub: 0213 and 0220]. This sentence as written, currently reads that the body 100 is in close contact with itself, and it is unclear what is meant to be conveyed.
Appropriate correction is required.
Claim Objections
Claim 3 objected to because of the following informalities:
“the scanning data” should be corrected to --the three-dimensional scanning data--.
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 3-5 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.
Regarding claim 3, the recitation “the body forming part expands and is fixed such that a width between distal ends thereof is widened or is reduced and fixed such that the width between the distal ends thereof is narrowed” contains grammatical errors that render the limitation unclear as to whether the body forming part is being widened and/or narrowed. This claim is being interpreted as two separate clauses, and can be corrected to --the body forming part expands and is fixed such that a width between distal ends thereof is widened, or is reduced and is fixed such that the width between the distal ends thereof is narrowed--.
Regarding claim 5, the limitation of “vertical width of the interdental space” is unclear and is not distinctly defined in the specification, and thus, renders claim 5 indefinite. The term vertical width is understood to mean a distance in the vertical direction and as claim 5 is currently written, changes to vertical width of the interdental space is indefinite, as it is unclear how a distance in the vertical direction of the interdental space may change. However, in the specification, it is discussed that the width of the interdental space may change as one moves from the lower end to the upper end of the space [PG Pub: 0093-0095]. Thus, claim 5 will be interpreted as, and can be corrected to --the body forming part is cut so that changes in vertical curve of tooth surfaces of each tooth and changes in the width of the interdental space along the vertical direction are reflected to the body forming part--.
Regarding claims 4 and 5, these claims are rejected under 35 U.S.C. 112(b) by virtue of their dependence on claim 3.
Claim Rejections - 35 USC § 103
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.
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 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (WO 2020122565 A1) in view of Li (CN 109396294 B).
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Annotated Figure 1. Figs. 2 and 3 disclosed by Kim, modified to show elements of the retainer body and results of additional processing.
Regarding claim 3, Kim discloses a method for manufacturing a retainer (adhesive retainer 100 [Fig. 2, 0024, steps of manufacturing outlined in abstract]) provided with a body (body portion 110 [Figs. 2-4, 0025]) which comprises a curved protrusion part (curved protrusion 111 [Figs. 2 and 5, 0031]) that protrudes so as to be inserted into an interdental space so that the body is in close contact with tooth surfaces of a plurality of teeth forming a tooth arrangement (“The curved protrusion (111) refers to an area where a part of the body portion (110) protrudes so as to be in close contact with the depression formed in the gap between adjacent teeth” [0032]) and which comprises a support part (body portion 110 has an “attachment area” where it is attached to each tooth [0034, 0036]; areas of attachment of body portion 110 to teeth can be seen in [Figs. 3 and 4]; see Annotated Figure 1) that is in close contact with tooth surfaces of each tooth outside the interdental space (“the body portion (110) is laser-cut with a slope of each tooth surface to maximize the attachment area with the tooth surface” [0034]; body portion 110 is seen in close contact with teeth in Figs. 3 and 4), the method comprising:
a three-dimensional scanning data acquisition process in which three-dimensional scanning data of the tooth arrangement (“3D scanning data includes tooth alignment, tooth surface curvature for each tooth, tooth shape, interdental shape, tooth surface inclination, etc.” [0028]) are acquired by using a three-dimensional scanning apparatus (“data obtained by using a 3D scanner” [0028]);
a data processing process in which processing line data defining a laser cutting shape (a “cutting shape” is input into a laser cutter [0029, 0057-0058]) for manufacturing the body are generated on the basis of the scanning data of the tooth arrangement (the scanning data is input into the laser cutter [0029] and the cutting shape is corrected for sharp edges and grooves before cutting [0057-0058]);
a laser cutting process in which a body forming part configuring the body is manufactured by laser cutting a base material formed of a shape memory alloy material (“body portion (110) can be manufactured by laser cutting a shape memory alloy plate based on three-dimensional scanning data” [0026]) on the basis of the generated processing line data (the three-dimensional scanning data is input directly into the laser cutter and processed via computer software to correct for any sharp edges before cutting [0028, 0057-0058]).
Kim does not expressly disclose a width modification process in which the body forming part expands and is fixed such that a width between distal ends thereof is widened or is reduced and fixed such that the width between the distal ends thereof is narrowed, and then is thermally treated, thereby manufacturing the body in which a modified width between distal ends is maintained.
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Annotated Figure 2. Fig. 1 disclosed by Li, modified to show elements of device used for width modification of an archwire.
Li discloses a method for bending an orthodontic archwire [abstract], and a device for the method [Figs. 1 and 2; see Annotated Figure 2]. This method involves importing a design for an archwire body into a laser cutting machine (Step 1 [0010]; Further, “As a preferred embodiment, in step 1, the cutting machine uses laser cutting” [0019]), laser cutting a groove into a thin plate (cutting the groove is part of Step 1 [0010]), placing a wire made of shape memory alloy into the groove (Step 2 [0011]; titanium alloys are used [0006, 0040]), applying at least one pressure plate over the thin plate (Step 3 [0012]), and heat treating this set-up to preserve the shape of the wire (Step 4 [0013]).
Thus, Li teaches a width modification process (Steps 1-4 for bending archwire [0010-0013]) in which the body forming part expands and is fixed such that a width between distal ends thereof is widened or is reduced and fixed such that the width between the distal ends thereof is narrowed (Steps 2 and 3 [0011-0012]; the wire is bent and inserted into the groove, which will involve either widening or narrowing the width between the distal ends, depending on the starting bend of the wire; regarding Step 3, the pressure plates will fix the wire in place), and then is thermally treated (Step 4 [0013]), thereby manufacturing the body in which a modified width between distal ends is maintained (the bent shape is maintained through the “heat preservation” process [0013, heating process detailed in 0040]).
It is obvious to combine prior art elements according to known methods to yield predictable results. See MPEP 2143(A). The MPEP states the prior art must: (1) teach each claimed element (a method or apparatus that will be modified), (2) show that one of ordinary skill in the art could have combined the elements by known methods and that the combination does not change the function of the elements, and (3) show that one of ordinary skill would have recognized that applying the known technique to the base device would yield predictable results. See MPEP 2143(A).
In this case, Kim discloses a method for producing an orthodontic retainer utilizing three-dimensional patient scanning data, and laser cutting manufacturing of the retainer. However, Kim does not expressly disclose the claimed width modification process. Li teaches a width modification process for bending orthodontic archwires utilizing a design for the desired bending of the archwire. This design is input into a laser cutter, which manufactures a custom plate for the bending method described above. One of ordinary skill in the art could have combined the retainer manufacturing method disclosed by Kim with the width modification process taught by Li. Specifically, following the steps disclosed by Kim, the processing line data could be modified to the desired width and input into the laser cutter. Then, Steps 1-4 disclosed by Li could be utilized to modify the width of the retainer. The method disclosed by Li could easily follow the method disclosed by Kim, and the addition of the width modification would be simple, as the disclosure of Kim includes the production of the line data needed to begin Step 1 of Li.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the retainer manufacturing method disclosed by Kim by adding the width modification process taught by Li. Further, because both references utilize orthodontic appliances made of shape memory alloys, and because the method of Kim provides scanning data that can be used in the method of Li, one of ordinary skill in the art would have yielded predictable results with this combination.
Regarding claim 5, Kim discloses that the method is further comprising an additional processing process (“additional processing” [0042-0046]) which is performed after the laser cutting process (“the [reflection of the tooth surface] slope can be formed through separate additional processing after laser cutting” [0042]; see Annotated Figure 1) and in which the body forming part is cut so that changes in vertical curve of tooth surfaces of each tooth and in vertical width of the interdental space are reflected to the body forming part (the additional processing is intended to shape the front and back surfaces of body portion 110 to include the slope of each tooth surface [0093]; the additional processing “may include milling” [0046]).
Allowable Subject Matter
Claim 4 would be allowable if rewritten to overcome the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The nearest prior art reference regarding claim 4 is Li (CN 109396294 B). Li discloses the width modification described above wherein a groove is laser cut into a plate using archwire design data (Step 1 [0010]), an archwire made of shape memory alloy is bent and placed into the plate (Step 1 [0011]), then fixed by a pressure plate (Step 3 [0012]), and thermally treated such that the archwire maintains its bent shape (Step 4 [0013]).
Li discloses that the plate is provided grooves via laser cutting, which would make the plate the analogous element to the claimed base material. However, while the plate is laser cut to form the grooves, this laser cutting step (Step 1 [0010]) is not what produces the initial archwire. Rather, the archwire is brought in during a following step (Step 2 [0011]) and is a separate part from the plate. Thus, Li does not disclose that in the laser cutting process, a portion cut from the base material is removed, and cutting spaces are formed on opposite sides with respect to the body forming part.
Further, because Li does not disclose cutting spaces in the plate, Li also does not disclose a fixing process in which a first side surface of the body forming part and an inner facing surface of the base material facing each other through a first side cutting space are brought into close contact with each other so as to remove the first side cutting space in the cutting spaces of the opposite sides, thereby fixing the body forming part to the base material while the body forming part is in a state in which the width between the distal ends thereof is modified. Rather, the fixing process disclosed by Li involves placing the wire into the grooves on the plate and applying at least one pressure plate (Step 3 [0012]).
Other relevant references involving shape modification methods for orthodontic appliances made of shape memory alloy include Hansen (US 2014/0154637 A1) and Lee (US 2018/0206941 A1). These references and their relevance will be discussed briefly.
Hansen discloses a method for modifying the shape of archwires to ease archwire insertion into orthodontic brackets [abstract]. This method involves placing archwires made of shape memory alloy into plate fixtures with a desired shape of the archwire being cut into channels on the fixtures (archwires 912 and 914, fixtures 900 and 902, channels 904 and 906 [0083-0086, Figs. 13a-b and 14a-b]). Once the archwires are placed into the channels, the shape memory alloys are conditioned to maintain their new desired shape [0085]. However, similarly to Li, Hansen does not disclose that the archwires are cut from the base material (i.e., plates 900 and 902). Further, Hansen does not disclose a fixing process including closing a space to move the surface of the archwires to contact a surface of the fixing plates.
Lee discloses a kit for modifying the shape of orthodontic archwire [abstract]. The kit includes a jig, which fixes an archwire made of shape memory alloy into a desired configuration while it undergoes thermal treatment to maintain its new shape (jig base 10 with plurality of jigs 20 [Figs. 1 and 5, abstract, 0052]). However, the kit disclosed by Lee includes fastening of the archwire onto the top of a fixing stage (jig base 10) using fasteners (fixing screws 30 [0055, Fig. 1]), rather than inserting the archwire into a base material comprising spaces. Thus, Lee does not disclose a base material that has been laser cut, nor spaces into which the archwire is inserted.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARISSA RAE BOSS whose telephone number is (571)270-0274. The examiner can normally be reached 8:00am-5:00pm.
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, Ibrahime Abraham can be reached at (571)270-5569. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARISSA RAE BOSS/Examiner, Art Unit 3761
/TOPAZ L. ELLIOTT/Primary Examiner, Art Unit 3761
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