DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/25/2025 has been entered.
Claim Rejections - 35 USC § 112
3. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
4. Claims 1 and 3-20 are rejected under 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 20 each recites:
“wherein the non-elastic deformation comprises a deformation of the orthodontic appliance from an initial shape to a deformed shape, wherein a first portion of the orthodontic appliance configured to be in contact with a first portion of the patient's tooth during use in the initial shape is deformed when the orthodontic appliance is in the deformed shape” (claim 1 lines 10-14; claim 20 lines 13-17).
Such recitation insufficiently defines “non-elastic deformation” that it broadens the scope of “non-elastic deformation” to include “elastic deformation”. That is, the recitation “a deformation… from an initial shape to a deformed shape…” also covers elastic deformation, not just non-elastic deformation. The original disclosure does not have support for such insufficient and broad definition of “non-elastic deformation”. Therefore the recitation is considered to be new matter.
Claims 1 and 20 each recites:
“the dimensions are modified proportionately to the non-elastic deformation of the portion…” (claim 1 lines 16-17; claim 20 lines 19-20, emphasis added).
The original disclosure does not have support for “proportionately”, which therefore is considered to be new matter.
All dependent claims are rejected herein based on dependency.
Claim Rejections - 35 USC § 112(b)
5. 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.
6. Claims 1 and 3-20 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.
Claims 1 (lines 15-19) and claim 20 (lines 18-22) each recites, emphasis added:
“wherein the modified representation of the patient's teeth comprises modified dimensions of the one or more areas of the first representation, wherein the dimensions are modified proportionately to the non-elastic deformation of the portion of the orthodontic appliance corresponding to the one or more areas of the first representation of the patient's teeth,”
The recitation “the non-elastic deformation of the portion” lacks antecedent basis. Note that the claim previously defines antecedent basis for “a non-elastic deformation of the orthodontic positioning appliance” (lines 8-9). There is no antecedent basis for “the non-elastic deformation of the portion”.
The recitations “the dimensions”, “the portion”, and “the orthodontic appliance”, lack sufficient antecedent bases. It is unclear whether such recitations are the same as or different from the previously defined antecedent bases “modified dimensions” (line 15-16), “a first portion” (line 12), and “an orthodontic positioning appliance” (line 6), respectively.
All dependent claims are rejected herein based on dependency.
Claim Rejections - 35 USC § 102/103
7. The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
8. Claims 1, 3-6, and 8-20 are rejected under pre-AIA 35 U.S.C. 102(b) as anticipated by Wen et al. (2006/0234179), or in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Wen et al. in view of Knopp et al. (2005/0106525).
Regarding claim 1, Wen et al. discloses a method, comprising:
receiving, using one or more processors, a first representation of a patient's teeth in a first arrangement (paragraph [0068] “A digital arch model captures the shape information of the subject's tooth models”);
modifying, using the one or more processors, one or more areas of the first representation to create a modified representation of the patient's teeth (paragraph [0021] “The properties of the snap-on aligners may also be simulated and optimized in the design process. The performance of the snap-on aligners can be optimized by varying parameters such as the number, the locations, and the density of the snap-on connectors, and the sizes and locations of the through-holes in the snap-on mechanisms…”);
defining, using the one or more processors, first cavities of an orthodontic positioning appliance using the modified representation of the patient's teeth (paragraph [0036] “appliance may be configured so that its tooth-receiving cavity has a geometry corresponding to an intermediate or end tooth arrangement intended for that appliance...”).
Wen et al. discloses that the modified representation of the patient’s teeth compensates for or overcome a non-elastic deformation 715 (Fig. 7) of the orthodontic positioning appliance due to use of the orthodontic positioning appliance for the patient’s teeth (see Figs. 6-9, see paragraph [0010] “over a period of usage by a subject, an aligner can also become relaxed and open up”; also see paragraph [0017] “practical methods and systems for making dental aligners… and associated receiving connectors on the subject's teeth. The aligners can be attached onto the subject's teeth and assure the dental aligner to be in precise registration as designed throughout the period of wearing by the subject. The aligners may also overcome the aligner relaxation problem due to repeated uses, which is common in prior art dental aligners).
That is, the representation of the patient’s teeth is modified to compensate for or overcome the non-elastic deformation 715 in the aligner appliance (Fig. 7) by adding and implementing connectors 930, 940, on the teeth and complementing through-holes 935, 945, on the aligner appliance (see Fig. 9; paragraph [0068] “The digital arch model further specifies the location of the connectors to be produced on the subject teeth to receive the through-holes”; paragraph [0077] “… connectors 930 and 940 and through-holes 935 and 945 can be produced near the bottom portion 913 to prevent the relaxation or the opening up of the dental aligner 910 near the gingival line”);
Wen et al. further discloses:
the first cavities correspond to the one or more areas of the modified representation and wherein the first cavities are part of a plurality of tooth receiving cavities of the orthodontic positioning appliance configured to move the patient's teeth from the first arrangement toward a second arrangement (paragraph [0068] “A digital dental aligner model is developed based on the digital arch model for moving the subject's teeth at a particular treatment step”);
defining, using the one or more processors, exterior portions of the orthodontic positioning appliance using the modified representation of the patient's teeth (paragraph [0037] “the shell region typically has an inner (e.g., teeth-contacting) surface and an outer surface (opposite to the inner surface));
providing, using the one or more processors, instructions to fabricate the orthodontic positioning appliance based on the defined first cavities and the defined exterior portions; and fabricating the orthodontic positioning appliance using the instructions to fabricate the orthodontic positioning appliance (paragraph [0021] “The properties of the snap-on aligners may also be simulated and optimized in the design process…. can be manufactured by cost-effective processes such as vacuum forming, cutting by a cutter, etching by a laser beam or thermal applier, and CNC based manufacturing”; paragraph [0072] “fabrication techniques can include… stereo lithography, laser machining, molding…”).
Regarding the newly recited limitations, Wen et al. Figs. 6-7 clearly show the non-elastic deformation 715 comprises a deformation of the orthodontic appliance from an initial shape (Fig. 6) to a deformed shape (Fig. 7), wherein a first portion 715 of the orthodontic appliance configured to be in contact with a first portion of the patient's tooth during use in the initial shape (Fig. 6) is deformed when the orthodontic appliance is in the deformed shape (Fig. 7).
Wen et al. further discloses adding and implementing connectors 930, 940, on the teeth (Fig. 9). Such addition of connectors 930, 940, on the teeth is equivalent to the claimed “modified dimensions of the one or more areas of the first representation of the patient’s teeth”. Wen also discloses that the dimensions are modified (i.e. addition of connectors 930, 940) proportionately to the non-elastic deformation of the portion 715 of the orthodontic appliance corresponding to the one or more areas of the first representation of the patient's teeth (see Fig. 9; paragraph [0068] “The digital arch model further specifies the location of the connectors to be produced on the subject teeth to receive the through-holes”; paragraph [0077] “… connectors 930 and 940 and through-holes 935 and 945 can be produced near the bottom portion 913 to prevent the relaxation or the opening up of the dental aligner 910 near the gingival line”);
Under U.S.C. 102(b), note that Wen et al. discloses using a computer to perform the claimed steps of receiving and modifying the representation of the patient’s teeth, and developing a digital dental aligner model as instructions for fabrication. See paragraphs [0066] and [0068] provided herein above. Regarding the recited limitations “using one or more processors”, it is noted that Wen et al.’s disclosed “computer or computerized device” (paragraph 66) includes and use one or more processors to perform the claimed steps, in developing digital arch model modified with added connectors and digital aligner models with complementing through holes (paragraph 68).
Alternatively, under U.S.C. 103(a), Wen et al. discloses computer or computerized device to perform the claimed steps, but is not explicit in using one or more processors as claimed. Knopp et al. explicitly discloses a computer-implemented method and system of using one or more processors 52 (see Knopp et al. Fig. 1D) to receive and modify a representation of the patient teeth in order to design and fabricate dental aligner appliances for orthodontic treatments (Knopp et al. Fig. 1A-1D; paragraph [0062] “The methods … generally rely on manipulating an initial digital data set (IDDS) at a computer or workstation having a suitable graphical user interface (GUI) and software appropriate for viewing and modifying the image”; paragraph [0066] “Data processing system 50 typically includes at least one processor 52…). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to execute Wen et al.’s method using one or more processors as taught by Knopp et al. to be well known suitable data processing and software system in order to effectively computer-aided-design and computer-aided-manufacture the dental aligner appliance.
Claims 3-6 and 8-19:
Per claims 3-4, Wen et al. discloses using the instructions to form a mold of the patient's teeth, and forming a sheet of polymeric material over the mold to fabricate the orthodontic positioning appliance (paragraph [0067] “After the aligner-making material is heated… pressed on the subject's dental arch model… cause… material to relax and fittingly form around the surface the subject's dental arch model”; [0068] “arch model includes registration marks that can be copied onto the sheet 310 of aligner-making material”)
As to claim 5, Wen et al. discloses fabrication through stereolithography (paragraph [0072] “fabrication techniques can include… stereo lithography”), which is a form of 3D printing that directly fabricates the orthodontic positioning appliance as claimed.
As to claim 6, Wen et al. discloses fabrication through stereolithography (paragraph [0072] “fabrication techniques can include… stereo lithography”). Such stereolithography fabrication is a form of 3D printing selectively cures a liquid photopolymer resin, layer by layer, creating solid, three-dimensional objects from CAD designs. Therefore, Wen et al.’s disclosed stereolithographic fabrication selectively hardens polymeric material used to form the orthodontic positioning appliance using the instructions to fabricate the orthodontic positioning appliance, as claimed.
As to claims 8-9, Wen et al. discloses at least one of the first cavities is a molar tooth receiving cavity configured to receive a molar 810 of the patient's teeth (Fig. 8); wherein the molar is shown having the molar has a first width near the gingival margin of the molar (best pointed to by reference numeral 913 or below 945 in Fig. 9); and a second width (best pointed to by reference numeral 911 in Fig. 9) away from the gingival margin of the molar; and the second width 911 is greater than the first width 913 near the gingival margin (Fig. 9).
As to claims 10-11, Wen et al. discloses the non-elastic deformation is due to internal strain due to installation, removal, or some combination thereof, of the appliance; and that the non-elastic deformation is associated with material creep, stress relaxation, or some combination thereof, of a polymeric material used to form the orthodontic positioning appliance (paragraph [0017] “aligner relaxation problem due to repeated uses, which is common in prior art dental aligners”; paragraph [0074] “FIG. 7 shows the side view of the aligner 710 that has been worn on the subject's tooth 720 after a period of usage such as a few days or a week. The lower part 715 of the dental aligner 710 is relaxed and opened up, which prevents the dental aligner 710 to exert proper stress on the bottom of the tooth”).
As to claim 12, Wen et al. discloses modifying one or more areas of the first representation to create the modified representation of the patient's teeth comprises decreasing a width of an internal cavity (through-hole 330) of the orthodontic positioning appliance near an opening of the internal cavity 330 (Figs. 1B, 1D; paragraph [0043] “the through-hole may have a wide opening that tapers in to a smaller diameter as it passes from the inner surface to the outer surface of the aligner”; paragraph [0049] “FIG. 1B shows a through-hole that with a large opening at the inner surface 101, which gradually tapers into a narrower opening”. That is, Web et al. discloses modifying one or more areas of the first representation to create the connector/through-holes mechanism comprising decreasing a width (smaller diameter) of an internal cavity (though-hole) of the aligner near an opening of the internal cavity through-hole (paragraphs [0042]-[0049]).
As to claim 13, Wen et al. discloses the modified representation of the patient's teeth corresponds to a complement of the non-elastic deformation (paragraph [0056] “A connector may be any appropriate shape for engaging with through-holes in the aligner…The connector may be shaped or sized to complement or conform to the through-holes as described above.
As to claims 14-16, Wen et al. discloses at least one of the plurality of tooth receiving cavities comprises an upper portion 912 shaped to match a contour of an occlusal surface of the patient's tooth 920, a lower portion 911 having a proximal end 911 beginning at the upper portion 912 and a distal end 913 terminating near the patient's gingival margin when the orthodontic positioning appliance is worn by the patient (Fig. 9); wherein the lower portion 911/913 of the at least one of the plurality of tooth receiving cavities is shaped to apply a desired force or torque to the patient's tooth (paragraph [0017] “The snap-on dental aligner therefore can ensure that the aligner produces the correct force to achieve a desirable movement in the subject's teeth”).
As to claims 17-19, Wen et al. discloses the first arrangement comprises a current arrangement of the patient’s teeth, and scanning the patient's teeth to obtain a representation of a current arrangement of the patient's teeth (paragraph [007] “ first determine a three-dimensional mental image of the subject's physical orthodontic structure… which may be assisted through the use of x-rays and/or models”). Wen et al. discloses identifying a plurality of stages of a treatment plan to move the patient's teeth from the current arrangement toward a target arrangement, wherein the plurality of stages define a plurality of intermediate arrangements between the current arrangement and the target arrangement; and wherein the first arrangement is the current arrangement or one of the plurality of intermediate arrangements (paragraph [0034] “An orthodontic treatment usually includes plurality of treatment steps. One or more dental aligners can be worn on the subject's teeth at each treatment step. The orthodontist first determines the initial configurations of the subject's teeth and decides target final configurations for the subject's teeth at the end of the treatment. One or more dental aligners can then be produced so that a subject wearing the dental aligners will gradually have his or her teeth repositioned”).
Regarding claim 20, Wen et al. discloses a system comprising:
a computer system to implement a computer-implemented method as detailed above with respect to claim 1. That is, Wen et al. discloses a computer-implemented method of designing and manufacturing an orthodontic shell-typed aligner system as claimed, in which the model of the patient’s teeth 920 are modified to add attachments (connectors 930, 940) which complement the aligner’s though-holes 935, 945 (Fig. 9). Such connector/through-hole mechanism in the modified representation (Fig. 9) is to overcome/compensate for a non-elastic deformation (known problem of the aligner relaxes and opens up at lower portion 715 as shown in Fig. 7) of the aligner due to usage of the aligner. See Wen et al. Figs. 6-9; paragraphs [0066]-[0077]].
Under U.S.C. 102(b), note that Wen et al. discloses using a computer to perform the claimed steps of receiving and modifying the representation of the patient’s teeth, and developing a digital dental aligner model as instructions for fabrication. See paragraphs [0066] and [0068] provided herein above. Particularly, Wen et al. discloses: “computer to store the desired positions of the through-holes on the aligner. In some variations, the computer may be used to control the process of making the guide holes…” (paragraph [0066], emphasis added). The noted emphasis on a computer to store data and control the process indicate that the disclosed computer would include one or more processors, memory coupled to the one or more processors, wherein the memory is configured to store computer-executable instructions that, when executed by the one or more processors, cause the system to implement a computer-implemented method as detailed above with respect to claim 1. Wen et al. also discloses a fabrication machine configured to fabricate the orthodontic positioning appliance based on the instructions to fabricate the orthodontic positioning appliance (paragraphs [0071]- [0072] “aligner components are fabricated by CNC based manufacturing in accordance with a digital dental aligner model”; paragraph [0072] “fabrication techniques can include stereo lithography”).
Alternatively, under U.S.C. 103(a), Wen et al. discloses computer or computerized device, but is not explicit as to the one or more processors, memory coupled to the processor, configured to store software instructions to execute the method as claimed. Knopp et al. explicitly discloses a computer-implemented method and system of using one or more processors 52, memory 60 coupled to the processor 52 (see Knopp et al. Fig. 1D, paragraphs [0066]-[00071]), configured to store software instruction to execute the method of receiving and modifying a representation of the patient teeth in order to design and fabricate dental aligner appliances for orthodontic treatments (Knopp et al. Fig. 1A-1D; paragraph [0062] “The methods … generally rely on manipulating an initial digital data set (IDDS) at a computer or workstation having a suitable graphical user interface (GUI) and software appropriate for viewing and modifying the image”; paragraph [0066] “Data processing system 50 typically includes at least one processor 52…”; paragraph [0069]-[0070] “software modules… RAM 60 for storage of instructions and data during program execution…).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to execute Wen et al.’s method using one or more processors as taught by Knopp et al. to be well known suitable data processing and software system in order to effectively computer-aided-design and computer-aided-manufacture the dental aligner appliance.
9. Claim 7 is rejected under pre-AIA 35 U.S.C. 103(a) as obvious over Wen et al. in view of Knopp et al., and further in view of DeSimone et al. (2006/0078841).
Wen/Knopp discloses the invention substantially as claimed according to claim 1 as detailed above. Particularly per claim 7, Wen et al. discloses the non-elastic deformation comprises a deformation at lower part 715 (see Fig. 7) of the aligner appliance due to use of the aligner for the patient’s teeth (Fig. 7; paragraph [0074]).
However, Wen/Knopp fails to disclose the non-elastic deformation comprises a deformation between 0% and 30% of an initial appliance dimension. Nonetheless, note that Wen et al. shows the lower part 715 has a non-elastic deformation (i.e. “relaxed and opened up” at 715 as shown in Fig. 7) that makes the appliance at lower part 715 being larger than, or at least more than 0% of an initial appliance dimension, which overlaps with the claimed range of between 0% and 30% of an initial appliance dimension.
DeSimone et al. discloses an orthodontic shell-typed aligner appliance (Fig. 1) having stress relaxation over time of not more than 50% (see abstract), or preferably not more than 30% (paragraph [0015] “polymeric materials…preferably have stress relaxation over time of not more than 30%), indicating that such claimed range of deformation percentage is of result effective variable. As such, in view of Wen/Knopp and DeSimone, such claimed range of deformation of between 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.
Response to Arguments
10. Applicant’s arguments regarding the claim amendments have been fully considered but they are not persuasive. The claim amendments fail to overcome Wen et al.
Regarding the newly recited limitations in the amended claims 1 and 20,, Wen et al. Figs. 6-7 clearly show the non-elastic deformation 715 comprises a deformation of the orthodontic appliance from an initial shape (Fig. 6) to a deformed shape (Fig. 7), wherein a first portion 715 of the orthodontic appliance configured to be in contact with a first portion of the patient's tooth during use in the initial shape (Fig. 6) is deformed when the orthodontic appliance is in the deformed shape (Fig. 7).
Wen further discloses adding and implementing connectors 930, 940, on the teeth (Fig. 9). Such addition of connectors 930, 940, on the teeth is equivalent to the claimed “modified dimensions of the one or more areas of the first representation of the patient’s teeth”. Wen also discloses that the dimensions are modified (i.e. addition of connectors 930, 940) proportionately to the non-elastic deformation of the portion 715 of the orthodontic appliance corresponding to the one or more areas of the first representation of the patient's teeth (see Fig. 9; paragraph [0068] “The digital arch model further specifies the location of the connectors to be produced on the subject teeth to receive the through-holes”; paragraph [0077] “… connectors 930 and 940 and through-holes 935 and 945 can be produced near the bottom portion 913 to prevent the relaxation or the opening up of the dental aligner 910 near the gingival line”);
Conclusion
11. 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
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