Notice of Pre-AIA or AIA Status
Claims 1-18 and 20-37 are currently presented for Examination.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a) -(d).
The certified copy has been filed in parent Application No. CN202210242424.3 and CN202210243092.0, filed on 03/11/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/01/2023 has been considered. The submission is in compliance with the provisions of 37 CFR 1.97. Form PTO-1449 is signed and attached hereto.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
a design unit, a production unit and an assembly unit (claim 20),
a pre-processing unit and manufacturing unit (claim 37)
The above units do not have corresponding structure found in Specification.
Each of the above generic placeholder is specifically excluded from being interpreted as software per se. See MPEP §2181(II)(B) third to last paragraph.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For the purposes of claim limitations examination, the Examiner will be interpreting the above unit as processing unit in view of instant specification para [0030].
Claim Rejections – 35 USC § 112, First Paragraph
5. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
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.
6. Claim 20 and 37 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) 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. Claim recite the limitations
a. a design unit, a production unit and an assembly unit (claim 20),
b. a pre-processing unit and manufacturing unit (claim 37)
These limitations invoke 35 U.S.C. 112(f) or pre-AlA 35 U.S.C. 112, sixth paragraph, because they use the generic placeholders without reciting sufficient structure to achieve the function or to modify the generic placeholder. The above module does not have corresponding structure found in specification. According to MPEP § 2181(II)(B) "the structure corresponding to a 35 U.S.C. 112(f) claim limitation for a computer-implemented function must include the algorithm needed to transform the general-purpose computer or microprocessor disclosed in the specification.” The specification does not specifically link any algorithms to the above units for performing the claimed function. Thus, the written description fails to disclose the corresponding structure, material, or acts for the claimed function. The written description does not include the structural elements to carry out these specifically claimed functions.
Claim Rejections - 35 USC § 112, Second Paragraph
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.
7. Claim 20 and 37 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AlA), 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 pre-AlA the applicant regards as the invention Claim recite the limitations a. a design unit, a production unit and an assembly unit (claim 20),
b. a pre-processing unit and manufacturing unit (claim 37)
These limitations invoke 35 U.S.C. 112(f) or pre-AlA 35 U.S.C. 112, sixth paragraph, because they use the generic placeholders without reciting sufficient structure to achieve the function or to modify the generic placeholder. The above module does not have corresponding structure found in Specification. In particular, note that “For a computer-implemented 35 U.S.C. 112(f) claim limitation, the specification must disclose an algorithm for performing the claimed specific computer function, or else the claim is indefinite under 35 U.S.C. 112(b)” [MPEP 2181 II.B]. The specification does not specifically link any algorithms to all the different units for performing the claimed function. Thus, the written description fails to disclose the corresponding structure, material, or acts for the claimed function and are indefinite.
Applicant may:
(a) Amend the claims so that the claim limitations will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AlA 35 U.S.C. 112, sixth paragraph; or
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the claimed function, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01 (o) and 2181.
8. Claims 3-4 and 20-37 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.
a. Claims 3-4 and 23-24 recites “target dental arch forma” which is a typo error and could create indefiniteness if not corrected.
b. The claims have numerous issues with antecedent basis. The Examiner suggests amending the claims such that the first recitation of each distinct element uses articles such as “a”/”an”, later recitations referring back to the same distinct element uses articles such as “the”/”said”, to use disambiguating modifiers (e.g., first, second, etc.) when there are multiple distinct elements with the same base term, and that the use of modifiers for each distinct element is kept consistent. Below is a non-exhaustive list of examples of these issues: for claim 21 and 37 are “according to …a target arch expansion parameter”.
c. Claims 20 and 37 recites “a system…” then says: “wherein the method includes…” create ambiguity for mixed statutory class. Appropriate correction is needed.
Claims 22-36 depend on claim 21 and do not cure the aforementioned deficiencies of claim 21, and thus, claims 222-36 are rejected for the reasons set forth above regarding claim 21 as a result.
Claim Rejections - 35 USC §101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. These claims are directed to an abstract idea without significantly more.
(Step 1) Is the claims to a process, machine, manufacture, or composition of matter?
Claims: 1-14 are directed to method or process, that falls on one of statutory category.
(Step 2A) (Prong 1) Is the claim directed to a law of nature, a natural phenomenon, or an abstract
idea? (Judicially recognized exceptions)?
Claim 1 recites:
determining a target arch expansion parameter according to a digital model of an initial dental jaw in an initial dental arch form, wherein the target arch expansion parameter includes a target arch expansion amount and a target arch expansion force; (Determining arch expansion parameters—such as calculating expansion amounts and force—can be performed in the human mind, or with pencil and paper, by an orthodontist evaluating a jaw model. Also, Orthodontist looking at a 3D model on a screen and, through human intuition and mental arithmetic, determines the arch expansion amount and force. Under the broadest reasonable interpretation, these limitations are process steps that cover mental process including an observation, evaluation, judgment or opinion that could be performed in the human mind or with the aid of pencil and paper. [MPEP 2106.04(a)(2) III])
determining a digital model of a target dental jaw in a target dental arch form according to the digital model of the initial dental jaw and the target arch expansion parameter; (claim reciting steps that can be practically performed in the human mind is an abstract idea. An orthodontist can mentally (or with paper/pencil) conceptualize how a jaw should expand based on a parameter. Under the broadest reasonable interpretation, these limitations are process steps that cover mental process including an observation, evaluation, judgment or opinion that could be performed in the human mind or with the aid of pencil and paper. [MPEP 2106.04(a)(2) III])and
designing a digital model of a pre-activated arch expander based on the target arch expansion parameter and the digital model of the target dental jaw, wherein the pre-activated arch expander includes a retaining band and an arch expansion part. (The act of designing—determining geometric parameters based on a target—can be performed in the human mind, by observing a digital model (similar to a plaster cast) and drawing the expansion parts (retaining band, arch expansion part) with pen and paper. Under the broadest reasonable interpretation, these limitations are process steps that cover mental process including an observation, evaluation, judgment or opinion that could be performed in the human mind or with the aid of pencil and paper. [MPEP 2106.04(a)(2) III])
Step 2A, Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
In accordance with Step 2A, Prong 2, the judicial exception is not integrated into a practical application. In particular, claim 1 do not recite the additional elements that integrate the judicial exception into a practical application. Thus, a method designing a pre-activated arch expander is no more than generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.05(h). The claim is directed to an abstract idea.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
In view of Step 2B, the claim as a whole does not amount to significantly more than the recited exception,
i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. . In particular, claim 1 do not recite the additional elements that integrate the judicial exception into a practical application. Thus, a method designing a pre-activated arch expander is no more than generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.05(h). Thus, claim 1 is not patent eligible.
Claim 2 further recites wherein the target arch expansion amount includes one or more of the following parameters corresponding to an adjustment of a jaw from the initial dental arch form to the target dental arch form: the amount of dental arch expansion of the whole of an upper jaw, the amount of dental arch expansion of one side of the upper jaw, the amount of dental arch expansion of the anterior region of the upper jaw, the amount of the dental arch expansion of a posterior region of the upper jaw, the amount of dental arch expansion of the whole of a lower jaw, the amount of dental arch expansion of one side of the lower jaw, the amount of dental arch expansion of the anterior region of the lower jaw, and the amount of the dental arch expansion of a posterior region of the lower jaw. The claim describes determining expansion parameters (amount/force) based on a digital model. Under MPEP 2106.04(a)(2)(III), "mental processes" are those that can be performed in the human mind, or by a human using pen and paper, such as evaluations, calculations, and judgments. Calculating specific dental arch expansion amounts (side-side, anterior-posterior) is a process an orthodontist can mentally or manually perform. Claim therefore, when taken as a whole, still does not integrate the judicial exception into a practical application nor amount to significantly more than the judicial exception. Claim recites unpatentable ineligible subject matter for the same reasoning and analysis as mentioned for claim 1.
Claim 3 further recites wherein the target arch expansion amount is determined by the difference between the widths of the initial dental arch form and the target dental arch forma at a corresponding position. The act of calculating a difference is a basic cognitive process that could, in theory, be done by a human using pen and paper. Claim therefore, when taken as a whole, still does not integrate the judicial exception into a practical application nor amount to significantly more than the judicial exception. Claim recites unpatentable ineligible subject matter for the same reasoning and analysis as mentioned for claim 1.
Claim 4 further recites wherein the difference between the widths of the initial dental arch form and the target dental arch forma at a corresponding position is determined based on measurement of the digital model of the initial dental jaw and analysis of the arch form of the digital model of the initial dental jaw. The claim recites comparing the width of an initial digital model to a target model, which is a calculation and evaluation. An orthodontist can, in theory, perform these measurements (using calipers on a digital screen) and determine the expansion difference mentally or with pen/paper. Claim therefore, when taken as a whole, still does not integrate the judicial exception into a practical application nor amount to significantly more than the judicial exception. Claim recites unpatentable ineligible subject matter for the same reasoning and analysis as mentioned for claim 1.
Claim 5 further recites wherein the target arch expansion force includes the value and the direction of an arch expansion force acting on each tooth of a jaw for adjusting the jaw from the initial dental arch form to the target dental arch form. Determining forces based on an initial vs. final position, can be done with pen-and-paper analysis so it falls under mental process of abstract idea. Claim therefore, when taken as a whole, still does not integrate the judicial exception into a practical application nor amount to significantly more than the judicial exception. Claim recites unpatentable ineligible subject matter for the same reasoning and analysis as mentioned for claim 1.
Claim 6 further recites adjusting at least one of the target arch expansion amount or the target arch expansion force according to the loss of an arch expansion force. An orthodontist observing that an appliance has lost force (arch expansion force loss) and judging that they should adjust the amount or force is a cognitive activity. Under MPEP 2106.04(a)(2)(III), "mental processes" are those that can be performed in the human mind, or by a human using pen and paper, such as evaluations, calculations, and judgments. Claim therefore, when taken as a whole, still does not integrate the judicial exception into a practical application nor amount to significantly more than the judicial exception. Claim recites unpatentable ineligible subject matter for the same reasoning and analysis as mentioned for claim 1.
Claim 7 further recites wherein the step of designing a digital model of a pre- activated arch expander based on the target arch expansion parameter and the digital model of the target dental jaw further includes: determining a target geometric parameter of the pre-activated arch expander based on the digital model of the target dental jaw; searching whether there is a digital model of a preset arch expander that meets a matching requirement from a database according to the target arch expansion parameter and the target geometric parameter; and determining whether a result of the searching is true or false, upon determining that the result of the searching is true: exporting the result of the searching as the digital model of the pre-activated arch expander, exporting a material parameter of the digital model of the pre-activated arch expander at the same time, and ending the step of designing a digital model of a pre-activated arch expander, and upon determining that the result of the searching is false: designing the digital model of the pre-activated arch expander by using a finite element method according to the target geometric parameter and the target arch expansion parameter, and obtaining the digital model of the pre-activated arch expander that meets an arch expansion constraint condition and a material parameter of the digital model of the pre-activated arch expander. The steps of "determining" a geometric parameter, "searching" a database, and "determining" a true/false condition describe mental tasks (observation, evaluation, judgment). Using a "finite element method" (FEM) and applying "arch expansion constraint conditions" involve mathematical algorithms and modeling. So, it falls under the combination of “Mental Process” and “Mathematical Concepts” of abstract idea. The claim is directed to an abstract idea because it does not integrate the idea into a practical application, but rather uses a computer as a tool for automation without improving the computer's functionality. Claim therefore, when taken as a whole, still does not integrate the judicial exception into a practical application nor amount to significantly more than the judicial exception. Claim recites unpatentable ineligible subject matter for the same reasoning and analysis as mentioned for claim 1.
Claim 8 further recites wherein the target geometric parameter includes one or more of the following parameters: number, shape, and fixed position of one or more retaining bands; number of one or more spring coils contained in the arch expansion part; position, diameter, and angle of each spring coil; curvature of an arch wire between adjacent spring coils; and bending angle, length, and curvature of a lingual arm contained in the arch expansion part. The claimed steps (determining number, shape, position, curvature of appliance components) represent steps that can be performed in the human mind, or by a human using a pen and paper. An orthodontist can evaluate a 3D model and, through mental evaluation or manual drafting, determine where to place spring coils, the necessary curvature of an wire, and the length of a lingual arm. Claim therefore, when taken as a whole, still does not integrate the judicial exception into a practical application nor amount to significantly more than the judicial exception. Claim recites unpatentable ineligible subject matter for the same reasoning and analysis as mentioned for claim 1.
Claim 9 further recites wherein the material parameter includes one or more of the following parameters: composition and performance of a material used for manufacturing the arch expansion part; and shape and dimension of a cross-section of an arch wire used for manufacturing the arch expansion part. Obtaining" information such as composition, performance, and shape can be done by observing, recording, or evaluating, which are considered mental processes. Claim therefore, when taken as a whole, still does not integrate the judicial exception into a practical application nor amount to significantly more than the judicial exception. Claim recites unpatentable ineligible subject matter for the same reasoning and analysis as mentioned for claim 1.
Claim 10 further recites wherein the material parameter includes a parameter representing that the performance of the material varies with temperature. Claim "recites" a judicial exception, such as a mental process (e.g., observing, evaluating). Claim therefore, when taken as a whole, still does not integrate the judicial exception into a practical application nor amount to significantly more than the judicial exception. Claim recites unpatentable ineligible subject matter for the same reasoning and analysis as mentioned for claim 1.
Claim 11 further recites wherein the matching requirement includes: the deviation between a geometric parameter of the digital model of the preset arch expander and the target geometric parameter is less than a preset first threshold, and the deviation between an actual arch expansion parameter of the digital model of the preset arch expander and the target arch expansion parameter is less than a preset second threshold. The "matching" requirement, without specific technical implementation, describes an evaluation or judgment that a human could practically perform by looking at a model on a screen and comparing it to a target on paper, fulfilling the "mental process" grouping of abstract idea. Claim therefore, when taken as a whole, still does not integrate the judicial exception into a practical application nor amount to significantly more than the judicial exception. Claim recites unpatentable ineligible subject matter for the same reasoning and analysis as mentioned for claim 1.
Claim 12 further recites wherein, the step of designing the digital model of the pre-activated arch expander by using a finite element method according to the target geometric parameter and the target arch expansion parameter and obtaining the digital model of the pre- activated arch expander that meets an arch expansion constraint condition and a material parameter of the digital model of the pre-activated arch expander includes the following steps: generating a finite element model of the initial dental jaw according to the digital model of the initial dental jaw; generating a finite element model of an initial intermediate arch expander according to the target geometric parameter and the target arch expansion parameter, and setting an initial value for a material parameter of the initial intermediate arch expander; performing a finite element calculation on the effect of the finite element model of the intermediate arch expander acting on the finite element model of the initial dental jaw, wherein a result of the finite element calculation includes an actual arch expansion parameter of the intermediate arch expander and a situation about the change of the form of the finite element model of the initial dental jaw; and optimizing the geometric parameter and the material parameter of the finite element model of the intermediate arch expander according to the result of the calculation and repeating the calculation until the result of the calculation meets a preset judgment condition and the arch expansion constraint condition, and exporting the finite element model of the intermediate arch expander as the digital model of the pre-activated arch expander and also exporting a material parameter of the digital model of the pre-activated arch expander. The claim involves creating finite element models, calculating material parameters, setting initial values, and calculating effects. According to MPEP 2106.04(a)(2), "organizing information and manipulating information through mathematical correlations" (e.g., using a computer as a tool to perform calculations) is an abstract idea. The claim describes a process of iterative design ("repeating the calculation"). If the steps of calculating, generating models, and optimizing can be performed in the mind (aided by pen/paper) they are considered mental processes. So, it falls under the combination of “Mental Process” and “Mathematical Concepts” of abstract idea. Claim therefore, when taken as a whole, still does not integrate the judicial exception into a practical application nor amount to significantly more than the judicial exception. Claim recites unpatentable ineligible subject matter for the same reasoning and analysis as mentioned for claim 1.
Claim 13 further recites wherein the arch expansion constraint condition includes one or more of the following conditions: a constraint condition on a contact position between the finite element model of the intermediate arch expander and the finite element model of the initial dental jaw; a biomechanical constraint condition on the displacement of the finite element model of the initial dental jaw under the action of the arch expansion force; and a restriction condition on a tooth root movement of the finite element model of the initial dental jaw. The claim involves creating "finite element models" and applying "biomechanical constraint conditions," which are mathematical formulas, algorithms, and numerical methods for calculating stress-strain behaviors. The claim also involves "observations," "evaluations," "restrictions," and "judgments" on dental movements that could theoretically be performed mentally or with pencil and paper. So, it falls under the combination of “Mental Process” and “Mathematical Concepts” of abstract idea. Claim therefore, when taken as a whole, still does not integrate the judicial exception into a practical application nor amount to significantly more than the judicial exception. Claim recites unpatentable ineligible subject matter for the same reasoning and analysis as mentioned for claim 1.
Claim 14 further recites wherein the step of designing the digital model of the pre-activated arch expander by using a finite element method according to the target geometric parameter and the target arch expansion parameter and obtaining the digital model of the pre-activated arch expander that meets an arch expansion constraint condition and a material parameter of the digital model of the pre-activated arch expander further includes: after the step of optimizing the geometric parameter and the material parameter, adding a digital model of the optimized pre-activated arch expander to the database as a digital model of a new preset arch expander, and storing an actual arch expansion parameter, a geometric parameter, and a material parameter corresponding to the digital model of the new preset arch expander in the database. The steps of designing a digital model, optimizing parameters, and storing parameters (actual expansion, geometric, material) are mental processes that can be performed in the human mind or with pen and paper. The finite element method (FEM) is fundamentally a mathematical technique to solve complex structural mechanics problems. Applying FEM to design and optimize an orthodontic expander is, at its core, a mathematical calculation. The claim, as described, merely uses computer simulation (FEM) to perform a routine design task and stores the resulting data. Simply automating a mental process using a generic computer does not add an inventive concept, making it an ineligible "attempt to patent an abstract idea". Storing the calculated parameters (actual expansion, geometry, material) in a database is merely the output of the mathematical process. Storing data or receiving data in a database is considered insignificant extra-solution activity, which does not convert an abstract idea into a patentable invention. Claim therefore, when taken as a whole, still does not integrate the judicial exception into a practical application nor amount to significantly more than the judicial exception. Claim recites unpatentable ineligible subject matter for the same reasoning and analysis as mentioned for claim 1.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
9. Claim(s) 1-6, 15-18, 20-26 and 29-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (PUB NO: US20180153649A1) in view of Arndt et al. "(PAT NO: USRE35170E).
Regarding claim 1
A method for designing (see abstract-In particular, described herein are methods and apparatuses for forming palatal expanders, including rapid palatal expanders, as well as series of palatal expanders formed as described herein and apparatuses for designing and fabricating them.) comprising:
determining a target arch expansion parameter according to a digital model of an initial dental jaw in an initial dental arch form, wherein the target arch expansion parameter includes a target arch expansion amount and a target arch expansion force; (see para 11-13-For example an apparatus or method for forming a series of expanders may be configured to include: receiving a digital model of the patient's oral cavity in an initial position. A method and apparatuses for forming a series of palatal expanders may include: receiving a digital model of the patient's oral cavity in an initial position, wherein the digital model comprises a digital model of the patient's teeth, gingiva and palate; For example, the increment of change may be one or more of: a rate of expansion between the molars (e.g., of about 0.25 mm per intermediate position or day); an amount of force applied to the patient's oral cavity (e.g., between the molars, of between about 8N to 160N, etc.)
determining a digital model of a target dental jaw in a target dental arch form according to the digital model of the initial dental jaw and the target arch expansion parameter; (see para 11-For example an apparatus or method for forming a series of expanders may be configured to include: receiving a digital model of the patient's oral cavity in an initial position; adjusting the digital model from the initial position to a final position in which the palate is expanded. See para 113- The digital model may adjust from the initial position to a final position in which the palate is expanded 1105.)
and
designing a digital model of a pre-activated arch expander based on the target arch expansion parameter and the digital model of the target dental jaw, (see para 11- generating a palatal expander model corresponding to each intermediate position of a plurality of intermediate positions of the digital model between the initial position and the final position. See para 107- Thus, in any of the methods and apparatuses described herein, the digital model may be used to predict both orthopedic (palate expansion) and orthodontic (dental) movement, and the model may be used to determine a final position setup and to define the movement/velocity of the palatal expansion and/or teeth.)
Wu explicitly does not teach pre-activated arch extender wherein the pre-activated arch expander includes a retaining band and an arch expansion part.
In the related field of invention, Arndt teaches pre-activated arch extender (see col 2 line 34-38-The orthodontic archwire, according to the invention, is a pre-formed wire having a generally "M-shaped" configuration and is comprised of a near-stoichiometric alloy of nickel and titanium which possesses memory-retaining characteristics. See col 2 line 59-60-It is an object of the present invention to provide a removable pre-formed palatal expansion arch)
wherein the pre-activated arch expander includes a retaining band; (see col 5 line 7-11- As appears in FIGS. 2–8, in the installation of arch-wire 1, on a patient's upper first permanent molars 6, 7, a metal band 5 is first fitted on and surrounds each of the molars. In accordance with the present invention, metal bands 5 are provided with lingually-projecting sheaths 4)
wherein the pre-activated arch expander includes an arch expansion part. (See col 3 line 18-22- It is another object of the invention to provide a removable palatal expansion arch which may be removed and adjusted by the clinician or at the manufacturer's laboratory to a different shape by a re-heat treating of the Ni-Ti segment while holding in a newly-formed shape. See col 4 line 31-50-Referring now particularly to FIGS. 1 and 1A of the drawings, illustrated therein is the removable Ni-Ti maxillary palatal expansion arch partially composed of a near-stoichiometric alloy of nickel and titanium extending bilaterally along the palatal concavity uniting end sections made from stainless steel and terminating with lingual sheath inserts. Archwire 1 is preferably made of a near-stoichiometric alloy of nickel and titanium having memory-retaining characteristics, composition of the nickel-titanium alloy is at least 50.5 atomic percent nickel. Another such composition of nickel-titanium alloy is not more than 51.0 atomic percent nickel with the remainder being titanium. As will be observed, archwire 1 is bent to provide a general "M-shape" which provides the counter-forces necessary for moving teeth as will be further described herein. Connected to archwire I is first stainless-steel end 12. The stainless-steel ends 12 and 13 have a pair of unitary length adjustment loops 14 and terminate with lingual sheath inserts 2, 3. The stainless-steel ends 12 and 13 and adjustment loops 14 are united by crimp tubes 15 to the "M-shaped" Ni-Ti archwire 1.)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of customizing a rapid palatal expander as disclosed by Wu to include pre-activated arch extender wherein the pre-activated arch expander includes a retaining band and an arch expansion part as taught by Arndt in the system of Wu for providing an improved removable orthodontic palatal expansion arch having a generally "M"-shaped configuration, the arch having a center segment composed of a near-stoichiometric alloy of nickel and titanium which possesses memory-retaining characteristics to simultaneously expand the bicuspids and expand, rotate, intrude and/or torque the maxillary molars, and end segments composed of an alloy of stainless steel or another biocompatible material configured for securing the archwire to lingual sheaths attached to molar bands. (see abstract, Arndt)
Regarding claim 2
Wu, in view of Arndt, as shown in the rejection above, discloses the limitations of claim 1. Wu further teaches the method according to claim 1, wherein the target arch expansion amount includes one or more of the following parameters corresponding to an adjustment of a jaw from the initial dental arch form to the target dental arch form: the amount of dental arch expansion of the whole of an upper jaw, the amount of dental arch expansion of one side of the upper jaw, the amount of dental arch expansion of the anterior region of the upper jaw, the amount of the dental arch expansion of a posterior region of the upper jaw, the amount of dental arch expansion of the whole of a lower jaw, the amount of dental arch expansion of one side of the lower jaw, the amount of dental arch expansion of the anterior region of the lower jaw, and the amount of the dental arch expansion of a posterior region of the lower jaw. (see para 13-14 - For example any of the methods or apparatuses described herein may be configured to form a series of palatal expanders by: receiving a digital model of the patient's oral cavity in an initial position (the digital model may comprise one or more of: a digital model of the patient's teeth, gingiva, palate, and the patient's lower jaw); Any of the method and apparatuses described herein for forming a series of palatal expanders may be configured to estimate or model the movement of different portions of the palate (e.g., a right side and a left side of the palate. See also para 24- anterior gap formed between the left maxillary portion and the right maxillary portion is larger than a posterior gap. See also para 35)
Regarding claim 3
Wu, in view of Arndt, as shown in the rejection above, discloses the limitations of claim 1. Wu further teaches the method of claim 1, wherein the target arch expansion amount is determined by the difference between the widths of the initial dental arch form and the target dental arch forma at a corresponding position. (See para 13-15- generating a palatal expander model (e.g., digital palatal expander model) corresponding to each of a plurality of intermediate positions of the digital model between the initial position and the final position, wherein the plurality of intermediate positions are based on: a stiffness of the palatal expander and a limit on an increment of change in at least one of the patient's palate and teeth. For example, the increment of change may be one or more of: a rate of expansion between the molars (e.g., of about 0.25 mm per intermediate position or day); Typically, expanders have been described as pre-formed devices having a first molar-engaging region adapted to engage upper molars on a first side of the upper jaw, a second molar-engaging region adapted to engage upper molars on a second side of the upper jaw. Typically, the distance between the molar regions in the series of expanders is sequentially greater. See para 131-132- The distance of movement between molars may be measured (e.g., 8 mm). For example, a method for determining a series of rapid expanders may include taking the prescription from the user (e.g., orthodontics), for example, for 10 mm expansion, and adjusting the expansion model to meet the requirement. The expansion model may be adjusted, for example, by adjust the expansion angle, so that the expansion between molars meets the prescription.)
Regarding claim 4
Wu, in view of Arndt, as shown in the rejection above, discloses the limitations of claim 1. Wu further teaches the method of claim 3, wherein the difference between the widths of the initial dental arch form and the target dental arch forma at a corresponding position is determined based on measurement of the digital model of the initial dental jaw and analysis of the arch form of the digital model of the initial dental jaw. (See para 13-15- generating a palatal expander model (e.g., digital palatal expander model) corresponding to each of a plurality of intermediate positions of the digital model between the initial position and the final position, wherein the plurality of intermediate positions are based on: a stiffness of the palatal expander and a limit on an increment of change in at least one of the patient's palate and teeth. For example, the increment of change may be one or more of: a rate of expansion between the molars (e.g., of about 0.25 mm per intermediate position or day); Typically, expanders have been described as pre-formed devices having a first molar-engaging region adapted to engage upper molars on a first side of the upper jaw, a second molar-engaging region adapted to engage upper molars on a second side of the upper jaw. See para 120- A digital mode of the patient's oral cavity may be acquired from any appropriate source, such as an intraoral scanner. When acquiring a digital model of patient's oral cavity, the digital model may include upper and lower jaws, including tooth crown, gingiva and maxillary palatal surfaces. see para 123- Thus, the digital model may be constrained to simulate and predict rapid palatal expansion treatment outcome, with both orthopedic and dental movement, which includes orthopedic expansion (e.g., the expansion of the midline suture, and inclination changes of the left and right maxillary halves) and dental movement (e.g., dental movement of tooth inside the bone). The manipulation of the model can be constrained obtained the anatomy of jaw and bone, and/or by measurement and data analysis of real treatment outcome and/or published literature. See para 129-131- The expansion axis may be determined for a particular patient based on landmarks from the oral cavity (e.g., using digital model) and/or additional physiological markings from the patient. The distance of movement between molars may be measured (e.g., 8 mm).)
Regarding claim 5
Wu, in view of Arndt, as shown in the rejection above, discloses the limitations of claim 1. Wu further teaches the method according to claim 1, wherein the target arch expansion force includes the value and the direction of an arch expansion force acting on each tooth of a jaw for adjusting the jaw from the initial dental arch form to the target dental arch form. (See para 12-13-an amount of force applied to the patient's oral cavity…an amount of force applied to the patient's oral cavity (e.g., between the molars, of between about 8N to 160N, etc.); see para 89-the location of applied forces in the patient's mouth (e.g., upper lateral portion of the molars, mid-lateral portion of the molar, lower lateral portion of the molars, gingiva, palate, etc.) and/or portions of the patient's mouth to avoid contact (e.g., gingiva, palate, mid-palate, lateral palate, etc.).)
Regarding claim 6
Wu, in view of Arndt, as shown in the rejection above, discloses the limitations of claim 1. Wu further teaches the method according to claim 1, further comprising: adjusting at least one of the target arch expansion amount or the target arch expansion force according to the loss of an arch expansion force. (See para 161- In any of these methods and apparatuses, the force applied by the expander may be controlled or adjusted based on the treatment stage. For example, the force created from the expander can be controlled and/or adjusted by the treatment stage. At the beginning of treatment, a large force may be needed to open the suture. To achieve a bigger force, the expander can be designed with higher stiffness. For example, by increasing the thickness of the central part of expander (TPA). At the middle of treatment, the force can be reduced, but the expansion velocity can be increased. For example, the thickness of TPA can be reduced to 50%, and the speed can be improved to, e.g., 0.50 mm/day. This may enhance the comfort and ease of insertion/removal, and may provide additional room for the patient's tongue. Closer to the end of the treatment, the expander may be stiffer and the velocity reduced, which may help stabilize the expansion. Thus, in general, the series of expanders may be configured so that the expanders to be worn later in treatment are stiffer (particularly the palatal region) and provide less force between the teeth compared to earlier expanders.)
Regarding claim 15
Wu teaches a method for manufacturing a (see abstract-In particular, described herein are methods and apparatuses for forming palatal expanders, including rapid palatal expanders, as well as series of palatal expanders formed as described herein and apparatuses for designing and fabricating them.) comprising:
designing a digital model of a pre-activated arch expander; (see para 11-For example an apparatus or method for forming a series of expanders may be configured to include: receiving a digital model of the patient's oral cavity in an initial position; adjusting the digital model from the initial position to a final position in which the palate is expanded by morphing the digital model to reflect an orthopedic expansion of the patient's midline suture (and optionally an orthodontic movement of the patient's teeth within the patient's jaw); generating a palatal expander model corresponding to each intermediate position of a plurality of intermediate positions of the digital model between the initial position and the final position)
manufacturing a retaining band and an arch expansion part using the digital model of the pre-activated arch expander and its corresponding material parameter; (see para 16-19- The palatal region of the device may provide force to stretch or expand the mid-palatal region. Although energy-enhancing features may be placed in this region (e.g., springs and thermally active materials), in addition, this region may include on or more adaptations, such as struts, supports, cross-beams, ribs, gaps/windows, attachments, and the like which may distribute the forces applied in a more nuanced manner than previously described. In any of the apparatuses described herein (and methods of fabricating them), the expanders may be formed out of a polymer and/or a metal material, including stainless steel, nickel titanium, copper nickel titanium, etc. The apparatuses and method of forming them may include fabricating one or more of the expanders by direct fabrication techniques. For example, an apparatus (including a series of palatal expanders) may be digitally designed and fabricated by a direct printing (e.g., 3D printing); alternatively, or additionally the fabrication method may include 3D printing of models of the teeth, gingiva and palate that have been digitally configured to form one or more of the series applying the palatal expansion.) and
assembling the retaining band and the arch expansion part on a physical model of a target dental jaw to obtain a pre-activated arch expander matching a target dental arch form, wherein the physical model of the target dental jaw is manufactured from a digital model of the target dental jaw;(See para 105- A customize expander may be generated for each intermediate position and for the final endpoint. In some variations, the final position may be determined as an endpoint for the palatal expansion, and the stages of palatal expanders used to achieve this final configuration may be determined. See para 152- the resulting palatal expander shapes for all of the stages may be used to form the sequence of expanders by direct or indirect fabrication. see para 167-169-The palatal expanders described herein may be fabricated directly, for example by digitally designing the expander and fabricating the digital model using a 3D printer or other direct fabrication technique. Alternatively, or additionally, the palatal expanders described herein may be fabricated indirectly, for example, using a physical model of the patient's dentation (e.g., a ceramic, plastic, plaster, etc. model), onto which materials are applied to form the palatal expander. Indirect fabrication methods may include lamination, in which the palatal expander is formed from laminated layers or portions. Indirect fabrication methods may also include direct fabrication of the model using a direct fabrication technique (e.g., 3D printing, etc.). Hybrid fabrication methods, in which a portion of the expander is directly fabricated, and then combined with additional elements (including layers or supports), with or without the use of a model of the patient's dentition, may also be used. In any of the indirect fabrication techniques described herein, the expander may be formed on a physical model that has been adjusted (e.g., by moving palate) to a desired position on the way to the final expanded position.)
wherein designing a digital model of a pre-activated arch expander includes: determining a target arch expansion parameter according to a digital model of an initial dental jaw in an initial dental arch form, wherein the target arch expansion parameter includes a target arch expansion amount and a target arch expansion force; (see para 11-13-For example an apparatus or method for forming a series of expanders may be configured to include: receiving a digital model of the patient's oral cavity in an initial position. A method and apparatuses for forming a series of palatal expanders may include: receiving a digital model of the patient's oral cavity in an initial position, wherein the digital model comprises a digital model of the patient's teeth, gingiva and palate; For example, the increment of change may be one or more of: a rate of expansion between the molars (e.g., of about 0.25 mm per intermediate position or day); an amount of force applied to the patient's oral cavity (e.g., between the molars, of between about 8N to 160N, etc.)
determining a digital model of a target dental jaw in a target dental arch form according to the digital model of the initial dental jaw and the target arch expansion parameter; (see para 11-For example an apparatus or method for forming a series of expanders may be configured to include: receiving a digital model of the patient's oral cavity in an initial position; adjusting the digital model from the initial position to a final position in which the palate is expanded. See para 113- The digital model may adjust from the initial position to a final position in which the palate is expanded 1105.)
and
designing a digital model of a pre-activated arch expander based on the target arch expansion parameter and the digital model of the target dental jaw, (see para 11- generating a palatal expander model corresponding to each intermediate position of a plurality of intermediate positions of the digital model between the initial position and the final position. See para 107- Thus, in any of the methods and apparatuses described herein, the digital model may be used to predict both orthopedic (palate expansion) and orthodontic (dental) movement, and the model may be used to determine a final position setup and to define the movement/velocity of the palatal expansion and/or teeth.)
Wu explicitly does not teach pre-activated arch extender wherein the pre-activated arch expander includes a retaining band and an arch expansion part.
In the related field of invention, Arndt teaches pre-activated arch extender (see col 2 line 34-38-The orthodontic archwire, according to the invention, is a pre-formed wire having a generally "M-shaped" configuration and is comprised of a near-stoichiometric alloy of nickel and titanium which possesses memory-retaining characteristics. See col 2 line 59-60-It is an object of the present invention to provide a removable pre-formed palatal expansion arch)
wherein the pre-activated arch expander includes a retaining band; (see col 5 line 7-11- As appears in FIGS. 2–8, in the installation of arch-wire 1, on a patient's upper first permanent molars 6, 7, a metal band 5 is first fitted on and surrounds each of the molars. In accordance with the present invention, metal bands 5 are provided with lingually-projecting sheaths 4)
wherein the pre-activated arch expander includes an arch expansion part. (See col 3 line 18-22- It is another object of the invention to provide a removable palatal expansion arch which may be removed and adjusted by the clinician or at the manufacturer's laboratory to a different shape by a re-heat treating of the Ni-Ti segment while holding in a newly-formed shape. See col 4 line 31-50-Referring now particularly to FIGS. 1 and 1A of the drawings, illustrated therein is the removable Ni-Ti maxillary palatal expansion arch partially composed of a near-stoichiometric alloy of nickel and titanium extending bilaterally along the palatal concavity uniting end sections made from stainless steel and terminating with lingual sheath inserts. Archwire 1 is preferably made of a near-stoichiometric alloy of nickel and titanium having memory-retaining characteristics, composition of the nickel-titanium alloy is at least 50.5 atomic percent nickel. Another such composition of nickel-titanium alloy is not more than 51.0 atomic percent nickel with the remainder being titanium. As will be observed, archwire 1 is bent to provide a general "M-shape" which provides the counter-forces necessary for moving teeth as will be further described herein. Connected to archwire I is first stainless-steel end 12. The stainless-steel ends 12 and 13 have a pair of unitary length adjustment loops 14 and terminate with lingual sheath inserts 2, 3. The stainless-steel ends 12 and 13 and adjustment loops 14 are united by crimp tubes 15 to the "M-shaped" Ni-Ti archwire 1.)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of customizing a rapid palatal expander as disclosed by Wu to include pre-activated arch extender wherein the pre-activated arch expander includes a retaining band and an arch expansion part as taught by Arndt in the system of Wu for providing an improved removable orthodontic palatal expansion arch having a generally "M"-shaped configuration, the arch having a center segment composed of a near-stoichiometric alloy of nickel and titanium which possesses memory-retaining characteristics to simultaneously expand the bicuspids and expand, rotate, intrude and/or torque the maxillary molars, and end segments composed of an alloy of stainless steel or another biocompatible material configured for securing the archwire to lingual sheaths attached to molar bands. (see abstract, Arndt)
Regarding claim 16
Wu, in view of Arndt, as shown in the rejection above, discloses the limitations of claim 15. Wu further teaches the method according to claim 15, wherein after the step of assembling the retaining band and the arch expansion part on a physical model of a target dental jaw (see para 169-In any of the indirect fabrication techniques described herein, the expander may be formed on a physical model that has been adjusted (e.g., by moving palate) to a desired position on the way to the final expanded position.)to obtain a pre- activated arch expander matching a target dental arch form, (See para 105- A customize expander may be generated for each intermediate position and for the final endpoint. In some variations, the final position may be determined as an endpoint for the palatal expansion, and the stages of palatal expanders used to achieve this final configuration may be determined. See para 152- the resulting palatal expander shapes for all of the stages may be used to form the sequence of expanders by direct or indirect fabrication.)
the method further comprises: maintaining the pre-activated arch expander in a form that matches an initial dental arch form. (see para 92-The upper surface of the palatal region which is positioned adjacent to the palate when worn by the patient may be contoured to match the actual or predicted shape of the patient's palate)
Regarding claim 17
Wu, in view of Arndt, as shown in the rejection above, discloses the limitations of claim 15. Wu further teaches the method according to claim 16, wherein the step of maintaining the pre-activated arch expander in a form that matches an initial dental arch form includes: applying a deforming force to the pre-activated arch expander while mounting the pre- activated arch expander to a physical model of an initial dental jaw, (see para 11- For example an apparatus or method for forming a series of expanders may be configured to include: receiving a digital model of the patient's oral cavity in an initial position; see para 16- The palatal region of the device may provide force to stretch or expand the mid-palatal region. Although energy-enhancing features may be placed in this region (e.g., springs and thermally active materials), in addition, this region may include on or more adaptations, such as struts, supports, cross-beams, ribs, gaps/windows, attachments, and the like which may distribute the forces applied in a more nuanced manner than previously described. see para 89- As will be described in greater detail below, the shape of the apparatus (e.g., the expander), and therefore the load (e.g., force) applied by the apparatus when worn, may be controlled and selected during the fabrication process. 167-169-The palatal expanders described herein may be fabricated directly, for example by digitally designing the expander and fabricating the digital model using a 3D printer or other direct fabrication technique. Alternatively, or additionally, the palatal expanders described herein may be fabricated indirectly, for example, using a physical model of the patient's dentation (e.g., a ceramic, plastic, plaster, etc. model).)
wherein the physical model of the initial dental jaw is generated based on a digital model of the initial dental jaw; (see para 11- For example an apparatus or method for forming a series of expanders may be configured to include: receiving a digital model of the patient's oral cavity in an initial position; see para 167-169-The palatal expanders described herein may be fabricated directly, for example by digitally designing the expander and fabricating the digital model using a 3D printer or other direct fabrication technique. Alternatively, or additionally, the palatal expanders described herein may be fabricated indirectly, for example, using a physical model of the patient's dentation (e.g., a ceramic, plastic, plaster, etc. model). In any of the indirect fabrication techniques described herein, the expander may be formed on a physical model that has been adjusted (e.g., by moving palate) to a desired position on the way to the final expanded position. The physical model may include attachments (buttons, etc.) for coupling to attachments (e.g., trough-holes, etc.) on the expander, as discussed above.) and
maintaining the pre-activated arch expander in a form that matches the initial dental arch form using a removable transfer template. (see para 103-This expander may act as a template to position the attachment connectors on the teeth, as illustrated in FIGS. 9A, 9B and 10. In FIG. 9A, the attachment connector(s) are included together with the palatal expander 901 which may be used as the placement vehicle (template). The attachment connector 907 may be printed with the expander (including the attachment region), such that one or more tabs 905 (e.g., removable, frangible, severable, etc. tabs) extend from the attachment region having an opening (hole) feature in the palatal expander 901 to an attachment connector. The tab in this example is a small tabs or sliver of material. The tabs will be cut/removed after bonding the attachment connector 707 to the teeth.)
Regarding claim 18
Wu, in view of Arndt, as shown in the rejection above, discloses the limitations of claim 15. Wu further teaches the step of maintaining the pre-activated arch expander in a form that matches an initial dental arch form includes: under the ambient temperature condition outside the transformation temperature range of the manufacturing material, mounting the pre-activated arch expander to a physical model of an initial dental jaw to maintain the pre-activated arch expander in a form that matches the initial dental arch form, , (see para 11- For example an apparatus or method for forming a series of expanders may be configured to include: receiving a digital model of the patient's oral cavity in an initial position; see para 16- The palatal region of the device may provide force to stretch or expand the mid-palatal region. Although energy-enhancing features may be placed in this region (e.g., springs and thermally active materials), in addition, this region may include on or more adaptations, such as struts, supports, cross-beams, ribs, gaps/windows, attachments, and the like which may distribute the forces applied in a more nuanced manner than previously described. see para 89-92- As will be described in greater detail below, the shape of the apparatus (e.g., the expander), and therefore the load (e.g., force) applied by the apparatus when worn, may be controlled and selected during the fabrication process. The upper surface of the palatal region which is positioned adjacent to the palate when worn by the patient may be contoured to match the actual or predicted shape of the patient's palate. See also para 167-169-The palatal expanders described herein may be fabricated directly, for example by digitally designing the expander and fabricating the digital model using a 3D printer or other direct fabrication technique. Alternatively, or additionally, the palatal expanders described herein may be fabricated indirectly, for example, using a physical model of the patient's dentation (e.g., a ceramic, plastic, plaster, etc. model).)
wherein the physical model of the initial dental jaw is generated based on a digital model of the initial dental jaw; (see para 11- For example an apparatus or method for forming a series of expanders may be configured to include: receiving a digital model of the patient's oral cavity in an initial position; see para 167-169-The palatal expanders described herein may be fabricated directly, for example by digitally designing the expander and fabricating the digital model using a 3D printer or other direct fabrication technique. Alternatively, or additionally, the palatal expanders described herein may be fabricated indirectly, for example, using a physical model of the patient's dentation (e.g., a ceramic, plastic, plaster, etc. model). In any of the indirect fabrication techniques described herein, the expander may be formed on a physical model that has been adjusted (e.g., by moving palate) to a desired position on the way to the final expanded position. The physical model may include attachments (buttons, etc.) for coupling to attachments (e.g., trough-holes, etc.) on the expander, as discussed above.)
Wu does not teach wherein: a manufacturing material of the pre-activated arch expander is a material having a shape memory effect and an oral temperature of a human is within a transformation temperature range of the manufacturing material; an ambient temperature condition for the manufacture and the assembly of the pre-activated arch expander is within the transformation temperature range of the manufacturing material;
However, Arndt further teaches the method according to claim 16, wherein: a manufacturing material of the pre-activated arch expander is a material having a shape memory effect and an oral temperature of a human is within a transformation temperature range of the manufacturing material; The orthodontic archwire, according to the invention, is a pre-formed wire having a generally "M-shaped" configuration and is comprised of a near-stoichiometric alloy of nickel and titanium which possesses memory-retaining characteristics. The archwire, due to its memory-retaining characteristics, when stressed, will attempt to return to its pre-formed configuration. The archwire possesses a set mechanical characteristic with low mechanical forces in its martensitic phase at ambient and below-mouth temperatures for ease of insertion and when the archwire is subsequently heated by the mouth to a transition temperature, the archwire attempts to return to the initial configuration. Archwire 1 has inherent temperature and memory-retaining characteristics that are a result of a beginning transition temperature from twelve to twenty degrees centigrade.
an ambient temperature condition for the manufacture and the assembly of the pre-activated arch expander is within the transformation temperature range of the manufacturing material; It is another object of the invention to provide a removable palatal expansion arch which may be removed and adjusted by the clinician or at the manufacturer's laboratory to a different shape by a re-heat treating of the Ni-Ti segment while holding in a newly-formed shape. Another force adjustment feature of this invention is the super flexibility of the Ni-Ti maxillary expansion arch in its martensitic phase at ambient temperatures. The archwire possesses a set mechanical characteristic with low mechanical forces in its martensitic phase at ambient and below-mouth temperatures for ease of insertion and when the archwire is subsequently heated by the mouth to a transition temperature, the archwire attempts to return to the initial configuration set in its austenitic phase and applies a greater sustained force when at mouth temperature during treatment until the desired shape or change in palatal width is achieved by the clinician.)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of customizing a rapid palatal expander as disclosed by Wu to include wherein: a manufacturing material of the pre-activated arch expander is a material having a shape memory effect and an oral temperature of a human is within a transformation temperature range of the manufacturing material; an ambient temperature condition for the manufacture and the assembly of the pre-activated arch expander is within the transformation temperature range of the manufacturing material as taught by Arndt in the system of Wu for providing an improved removable orthodontic palatal expansion arch having a generally "M"-shaped configuration, the arch having a center segment composed of a near-stoichiometric alloy of nickel and titanium which possesses memory-retaining characteristics to simultaneously expand the bicuspids and expand, rotate, intrude and/or torque the maxillary molars, and end segments composed of an alloy of stainless steel or another biocompatible material configured for securing the archwire to lingual sheaths attached to molar bands. (see abstract, Arndt)
Regarding claim 20
Wu further teaches a system for manufacturing a (see abstract-In particular, described herein are methods and apparatuses for forming palatal expanders, including rapid palatal expanders, as well as series of palatal expanders formed as described herein and apparatuses for designing and fabricating them.) comprising:
a design unit configured to design a digital model of a ; (see para 11-For example an apparatus or method for forming a series of expanders may be configured to include: receiving a digital model of the patient's oral cavity in an initial position; adjusting the digital model from the initial position to a final position in which the palate is expanded by morphing the digital model to reflect an orthopedic expansion of the patient's midline suture (and optionally an orthodontic movement of the patient's teeth within the patient's jaw); generating a palatal expander model corresponding to each intermediate position of a plurality of intermediate positions of the digital model between the initial position and the final position. See para 116-FIG. 11F illustrates another example of a method of generating a series of palatal expanders to treat a patient. This method may be performed by a processor (on a computer, tablet, smartphone, etc.) that is configured to execute these steps and may also control fabrication of the resulting series of palatal expanders.)
wherein the method includes: determining a target arch expansion parameter according to a digital model of an initial dental jaw in an initial dental arch form, wherein the target arch expansion parameter includes a target arch expansion amount and a target arch expansion force; (see para 11-13-For example an apparatus or method for forming a series of expanders may be configured to include: receiving a digital model of the patient's oral cavity in an initial position. A method and apparatuses for forming a series of palatal expanders may include: receiving a digital model of the patient's oral cavity in an initial position, wherein the digital model comprises a digital model of the patient's teeth, gingiva and palate; For example, the increment of change may be one or more of: a rate of expansion between the molars (e.g., of about 0.25 mm per intermediate position or day); an amount of force applied to the patient's oral cavity (e.g., between the molars, of between about 8N to 160N, etc.)
determining a digital model of a target dental jaw in a target dental arch form according to the digital model of the initial dental jaw and the target arch expansion parameter; (see para 11-For example an apparatus or method for forming a series of expanders may be configured to include: receiving a digital model of the patient's oral cavity in an initial position; adjusting the digital model from the initial position to a final position in which the palate is expanded. See para 113- The digital model may adjust from the initial position to a final position in which the palate is expanded 1105.)
and
designing a digital model of a pre-activated arch expander based on the target arch expansion parameter and the digital model of the target dental jaw, (see para 11- generating a palatal expander model corresponding to each intermediate position of a plurality of intermediate positions of the digital model between the initial position and the final position. See para 107- Thus, in any of the methods and apparatuses described herein, the digital model may be used to predict both orthopedic (palate expansion) and orthodontic (dental) movement, and the model may be used to determine a final position setup and to define the movement/velocity of the palatal expansion and/or teeth.)
a production unit configured to manufacture a retaining band and an arch expansion part using the digital model of the pre-activated arch expander and its corresponding material parameter; (see para 16-19- The palatal region of the device may provide force to stretch or expand the mid-palatal region. Although energy-enhancing features may be placed in this region (e.g., springs and thermally active materials), in addition, this region may include on or more adaptations, such as struts, supports, cross-beams, ribs, gaps/windows, attachments, and the like which may distribute the forces applied in a more nuanced manner than previously described. In any of the apparatuses described herein (and methods of fabricating them), the expanders may be formed out of a polymer and/or a metal material, including stainless steel, nickel titanium, copper nickel titanium, etc. The apparatuses and method of forming them may include fabricating one or more of the expanders by direct fabrication techniques. For example, an apparatus (including a series of palatal expanders) may be digitally designed and fabricated by a direct printing (e.g., 3D printing); alternatively, or additionally the fabrication method may include 3D printing of models of the teeth, gingiva and palate that have been digitally configured to form one or more of the series applying the palatal expansion. See para 167-Hybrid fabrication methods, in which a portion of the expander is directly fabricated, and then combined with additional elements (including layers or supports), with or without the use of a model of the patient's dentition, may also be used.) and
an assembly unit configured to assemble the retaining band and the arch expansion part on a physical model of a target dental jaw to obtain a pre-activated arch expander matching a target dental arch form, wherein the physical model of the target dental jaw is manufactured from a digital model of the target dental jaw;(See para 105- A customize expander may be generated for each intermediate position and for the final endpoint. In some variations, the final position may be determined as an endpoint for the palatal expansion, and the stages of palatal expanders used to achieve this final configuration may be determined. See para 152- the resulting palatal expander shapes for all of the stages may be used to form the sequence of expanders by direct or indirect fabrication. see para 167-169-The palatal expanders described herein may be fabricated directly, for example by digitally designing the expander and fabricating the digital model using a 3D printer or other direct fabrication technique. Alternatively, or additionally, the palatal expanders described herein may be fabricated indirectly, for example, using a physical model of the patient's dentation (e.g., a ceramic, plastic, plaster, etc. model), onto which materials are applied to form the palatal expander. Indirect fabrication methods may include lamination, in which the palatal expander is formed from laminated layers or portions. Indirect fabrication methods may also include direct fabrication of the model using a direct fabrication technique (e.g., 3D printing, etc.). Hybrid fabrication methods, in which a portion of the expander is directly fabricated, and then combined with additional elements (including layers or supports), with or without the use of a model of the patient's dentition, may also be used. In any of the indirect fabrication techniques described herein, the expander may be formed on a physical model that has been adjusted (e.g., by moving palate) to a desired position on the way to the final expanded position.)
Wu explicitly does not teach pre-activated arch extender wherein the pre-activated arch expander includes a retaining band and an arch expansion part.
In the related field of invention, Arndt teaches pre-activated arch extender (see col 2 line 34-38-The orthodontic archwire, according to the invention, is a pre-formed wire having a generally "M-shaped" configuration and is comprised of a near-stoichiometric alloy of nickel and titanium which possesses memory-retaining characteristics. See col 2 line 59-60-It is an object of the present invention to provide a removable pre-formed palatal expansion arch)
wherein the pre-activated arch expander includes a retaining band; (see col 5 line 7-11- As appears in FIGS. 2–8, in the installation of arch-wire 1, on a patient's upper first permanent molars 6, 7, a metal band 5 is first fitted on and surrounds each of the molars. In accordance with the present invention, metal bands 5 are provided with lingually-projecting sheaths 4)
wherein the pre-activated arch expander includes an arch expansion part. (See col 3 line 18-22- It is another object of the invention to provide a removable palatal expansion arch which may be removed and adjusted by the clinician or at the manufacturer's laboratory to a different shape by a re-heat treating of the Ni-Ti segment while holding in a newly-formed shape. See col 4 line 31-50-Referring now particularly to FIGS. 1 and 1A of the drawings, illustrated therein is the removable Ni-Ti maxillary palatal expansion arch partially composed of a near-stoichiometric alloy of nickel and titanium extending bilaterally along the palatal concavity uniting end sections made from stainless steel and terminating with lingual sheath inserts. Archwire 1 is preferably made of a near-stoichiometric alloy of nickel and titanium having memory-retaining characteristics, composition of the nickel-titanium alloy is at least 50.5 atomic percent nickel. Another such composition of nickel-titanium alloy is not more than 51.0 atomic percent nickel with the remainder being titanium. As will be observed, archwire 1 is bent to provide a general "M-shape" which provides the counter-forces necessary for moving teeth as will be further described herein. Connected to archwire I is first stainless-steel end 12. The stainless-steel ends 12 and 13 have a pair of unitary length adjustment loops 14 and terminate with lingual sheath inserts 2, 3. The stainless-steel ends 12 and 13 and adjustment loops 14 are united by crimp tubes 15 to the "M-shaped" Ni-Ti archwire 1.)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of customizing a rapid palatal expander as disclosed by Wu to include pre-activated arch extender wherein the pre-activated arch expander includes a retaining band and an arch expansion part as taught by Arndt in the system of Wu for providing an improved removable orthodontic palatal expansion arch having a generally "M"-shaped configuration, the arch having a center segment composed of a near-stoichiometric alloy of nickel and titanium which possesses memory-retaining characteristics to simultaneously expand the bicuspids and expand, rotate, intrude and/or torque the maxillary molars, and end segments composed of an alloy of stainless steel or another biocompatible material configured for securing the archwire to lingual sheaths attached to molar bands. (see abstract, Arndt)
Regarding claim 21
Wu teaches a method for manufacturing a (see abstract-In particular, described herein are methods and apparatuses for forming palatal expanders, including rapid palatal expanders, as well as series of palatal expanders formed as described herein and apparatuses for designing and fabricating them.) comprising:
determining a target arch expansion parameter according to a digital model of an initial dental jaw in an initial dental arch form; (see para 11-13-For example an apparatus or method for forming a series of expanders may be configured to include: receiving a digital model of the patient's oral cavity in an initial position. A method and apparatuses for forming a series of palatal expanders may include: receiving a digital model of the patient's oral cavity in an initial position, wherein the digital model comprises a digital model of the patient's teeth, gingiva and palate; For example, the increment of change may be one or more of: a rate of expansion between the molars (e.g., of about 0.25 mm per intermediate position or day); an amount of force applied to the patient's oral cavity (e.g., between the molars, of between about 8N to 160N, etc.)
determining a target arch expansion force according to the initial dental arch form and the target arch expansion amount; (See para 89- As will be described in greater detail below, the shape of the apparatus (e.g., the expander), and therefore the load (e.g., force) applied by the apparatus when worn, may be controlled and selected during the fabrication process. Designing an accurate and effective series of palatal expanders should ideally accurately model the palatal expansion to include both linear translation (e.g., in an xy plane). Thus, the expander(s) in a series of expanders may be accurately and in some cases automatically, configured so that they achieve the desired palatal expansion within predetermined (or user/physician/technician) adjustable parameters such applied expansion force (e.g., between x and y N, less than y N, etc., where x is about 5, 6, 7, 8, 9, 10. 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, etc. and y is about 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, etc. and is less than x), the location of applied forces in the patient's mouth. See para 106- n general, palatal expanders customized to a particular patient may be based on manipulation of a digital model of the patient's oral cavity that includes both orthopedic (e.g., palatal expansion) and optionally orthodontic (e.g., tooth movement within the jaw) movements to create a series of expanders.)
determining a digital model of a target dental jaw in a target dental arch form according to the digital model of the initial dental jaw and the target arch expansion parameter; (see para 11-For example an apparatus or method for forming a series of expanders may be configured to include: receiving a digital model of the patient's oral cavity in an initial position; adjusting the digital model from the initial position to a final position in which the palate is expanded. See para 113- The digital model may adjust from the initial position to a final position in which the palate is expanded 1105.)
determining a geometric parameter and a material parameter of a pre-activated arch expander according to the digital model of the target dental jaw and the target arch expansion force, (see para 89- In addition, the palatal expanders may also be digitally modeled, including modeling both the shape (dimensions, including thickness, curvature, attachment points, etc.) and the material(s) used. Thus, the expander(s) in a series of expanders may be accurately and, in some cases, automatically, configured so that they achieve the desired palatal expansion within predetermined (or user/physician/technician) adjustable parameters such applied expansion force. see para 40- The user interface may also allow the user to select parameters such as the number and location of attachments, the size (e.g., width, thicknesses, etc.) of the palatal region of the palatal expander, the separation between the palatal expander and all or portions of the patient's palate when the apparatus is worn, the force (e.g., maximum force) applied by the palatal expander, the presence and/or extent of any detachment region (e.g., on the buccal side), etc. see para 157-The methods and apparatuses described herein may allow one or more of these techniques (or others) to be modeled and selected automatically or by a user, and may allow adjustment for other parameters to keep the stiffness and/or force and/or rate of movement constraints on the devices within predetermined or settable parameter ranges.))
and selecting a manufacturing material according to the material parameter, (see para 116-A user interface may interactively allow control of the design of the series of palatal expanders. For example, a user interface may allow the user to select the material from which the palatal expander is going to be formed, and therefore the material properties of the apparatus 3005.)
manufacturing the pre-activated arch expander on a physical model of the target dental jaw according to the geometric parameter, wherein the physical model of the target dental jaw is generated based on the digital model of the target dental jaw. (See para 11- For example an apparatus or method for forming a series of expanders may be configured to include: receiving a digital model of the patient's oral cavity in an initial position; see para 167-171-The palatal expanders described herein may be fabricated directly, for example by digitally designing the expander and fabricating the digital model using a 3D printer or other direct fabrication technique. Alternatively, or additionally, the palatal expanders described herein may be fabricated indirectly, for example, using a physical model of the patient's dentation (e.g., a ceramic, plastic, plaster, etc. model). In any of the indirect fabrication techniques described herein, the expander may be formed on a physical model that has been adjusted (e.g., by moving palate) to a desired position on the way to the final expanded position. The physical model may include attachments (buttons, etc.) for coupling to attachments (e.g., trough-holes, etc.) on the expander, as discussed above. Any of the expanders described herein may be formed by one or more lamination processes in which multiple layers are sequentially or simultaneously attached together to form the expander. A lamination method may generally include using thermoplastic layers of various thicknesses and combining them to form various layers.)
Wu explicitly does not teach pre-activated arch extender wherein the pre-activated arch expander includes a retaining band and an arch expansion part.
In the related field of invention, Arndt teaches pre-activated arch extender (see col 2 line 34-38-The orthodontic archwire, according to the invention, is a pre-formed wire having a generally "M-shaped" configuration and is comprised of a near-stoichiometric alloy of nickel and titanium which possesses memory-retaining characteristics. See col 2 line 59-60-It is an object of the present invention to provide a removable pre-formed palatal expansion arch)
wherein the pre-activated arch expander includes a retaining band; (see col 5 line 7-11- As appears in FIGS. 2–8, in the installation of arch-wire 1, on a patient's upper first permanent molars 6, 7, a metal band 5 is first fitted on and surrounds each of the molars. In accordance with the present invention, metal bands 5 are provided with lingually-projecting sheaths 4)
wherein the pre-activated arch expander includes an arch expansion part. (See col 3 line 18-22- It is another object of the invention to provide a removable palatal expansion arch which may be removed and adjusted by the clinician or at the manufacturer's laboratory to a different shape by a re-heat treating of the Ni-Ti segment while holding in a newly-formed shape. See col 4 line 31-50-Referring now particularly to FIGS. 1 and 1A of the drawings, illustrated therein is the removable Ni-Ti maxillary palatal expansion arch partially composed of a near-stoichiometric alloy of nickel and titanium extending bilaterally along the palatal concavity uniting end sections made from stainless steel and terminating with lingual sheath inserts. Archwire 1 is preferably made of a near-stoichiometric alloy of nickel and titanium having memory-retaining characteristics, composition of the nickel-titanium alloy is at least 50.5 atomic percent nickel. Another such composition of nickel-titanium alloy is not more than 51.0 atomic percent nickel with the remainder being titanium. As will be observed, archwire 1 is bent to provide a general "M-shape" which provides the counter-forces necessary for moving teeth as will be further described herein. Connected to archwire I is first stainless-steel end 12. The stainless-steel ends 12 and 13 have a pair of unitary length adjustment loops 14 and terminate with lingual sheath inserts 2, 3. The stainless-steel ends 12 and 13 and adjustment loops 14 are united by crimp tubes 15 to the "M-shaped" Ni-Ti archwire 1.)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of customizing a rapid palatal expander as disclosed by Wu to include pre-activated arch extender wherein the pre-activated arch expander includes a retaining band and an arch expansion part as taught by Arndt in the system of Wu for providing an improved removable orthodontic palatal expansion arch having a generally "M"-shaped configuration, the arch having a center segment composed of a near-stoichiometric alloy of nickel and titanium which possesses memory-retaining characteristics to simultaneously expand the bicuspids and expand, rotate, intrude and/or torque the maxillary molars, and end segments composed of an alloy of stainless steel or another biocompatible material configured for securing the archwire to lingual sheaths attached to molar bands. (see abstract, Arndt)
Regarding claim 26
Wu, in view of Arndt, as shown in the rejection above, discloses the limitations of claim 1. Wu further teaches the method according to claim 1, wherein the target arch expansion force is determined based on the initial dental arch form and the target arch expansion amount according to the principle of oral orthodontic mechanics. (See para 107-110-Thus, in any of the methods and apparatuses described herein, the digital model may be used to predict both orthopedic (palate expansion) and orthodontic (dental) movement, and the model may be used to determine a final position setup and to define the movement/velocity of the palatal expansion and/or teeth. When configured to operate semi-automatically the apparatus may operate interactively with a user, such as a dental technician, physician, dentist, orthodontist, etc., so that the at least some of the design parameters and decisions may be guided by the user, who may be provided immediate feedback, including visual feedback and modeled feedback on the forces acting on the simulated expander and patient's dentation. see para 156- In general, a rapid palatal expander designer may be designed by the methods and apparatuses described herein based on biomechanics and biological knowledge, as discussed above.)
Regarding claim 29
Wu, in view of Arndt, as shown in the rejection above, discloses the limitations of claim 21. Wu further teaches the method according to claim 21, further comprising: adjusting the target arch expansion amount and/or the target arch expansion force according to one or more of a patient's age, developmental status, and type of malocclusion. (See para 162-In addition, the patient's age may influence the design parameters for the expanders. When the patient is young (e.g., <7 years) old, the force needed to open suture and expansion may be smaller. So the stiffness of expander can also be reduced. For adult patients (who may also use surgical techniques to open suture in addition to the expanders described herein), the expansion force may be much bigger than for younger patients. The expander may also be stiffer.)
Regarding claim 31
Wu, in view of Arndt, as shown in the rejection above, discloses the limitations of claim 21. Wu further teaches the method according to claim 21, further comprising: adjusting the digital model of the target dental jaw according to the loss of an arch expansion force. (See para 161- In any of these methods and apparatuses, the force applied by the expander may be controlled or adjusted based on the treatment stage. For example, the force created from the expander can be controlled and/or adjusted by the treatment stage. At the beginning of treatment, a large force may be needed to open the suture. To achieve a bigger force, the expander can be designed with higher stiffness. For example, by increasing the thickness of the central part of expander (TPA). At the middle of treatment, the force can be reduced, but the expansion velocity can be increased. For example, the thickness of TPA can be reduced to 50%, and the speed can be improved to, e.g., 0.50 mm/day. This may enhance the comfort and ease of insertion/removal, and may provide additional room for the patient's tongue. Closer to the end of the treatment, the expander may be stiffer and the velocity reduced, which may help stabilize the expansion. Thus, in general, the series of expanders may be configured so that the expanders to be worn later in treatment are stiffer (particularly the palatal region) and provide less force between the teeth compared to earlier expanders.)
Regarding claim 37
Wu teaches a system for manufacturing a (see abstract-In particular, described herein are methods and apparatuses for forming palatal expanders, including rapid palatal expanders, as well as series of palatal expanders formed as described herein and apparatuses for designing and fabricating them.) comprising:
pre-processing unit configured to obtain information about a jaw in an initial dental arch form and generate a digital model of an initial dental jaw;(see para 12-A method and apparatuses for forming a series of palatal expanders may include: receiving a digital model of the patient's oral cavity in an initial position, wherein the digital model comprises a digital model of the patient's teeth, gingiva and palate; see para 34-Any of these methods may include receiving the digital model of the patient's upper jaw, either directly (e.g., from an intraoral scanner) or indirectly, e.g., by scanning a model or cast of the patient's teeth.)
a manufacturing unit configured to manufacture a ; (see para 11-For example an apparatus or method for forming a series of expanders may be configured to include: receiving a digital model of the patient's oral cavity in an initial position; adjusting the digital model from the initial position to a final position in which the palate is expanded by morphing the digital model to reflect an orthopedic expansion of the patient's midline suture (and optionally an orthodontic movement of the patient's teeth within the patient's jaw); generating a palatal expander model corresponding to each intermediate position of a plurality of intermediate positions of the digital model between the initial position and the final position. See para 116-FIG. 11F illustrates another example of a method of generating a series of palatal expanders to treat a patient. This method may be performed by a processor (on a computer, tablet, smartphone, etc.) that is configured to execute these steps and may also control fabrication of the resulting series of palatal expanders.)
wherein the method includes: determining a target arch expansion parameter according to a digital model of an initial dental jaw in an initial dental arch form; (see para 11-13-For example an apparatus or method for forming a series of expanders may be configured to include: receiving a digital model of the patient's oral cavity in an initial position. A method and apparatuses for forming a series of palatal expanders may include: receiving a digital model of the patient's oral cavity in an initial position, wherein the digital model comprises a digital model of the patient's teeth, gingiva and palate; For example, the increment of change may be one or more of: a rate of expansion between the molars (e.g., of about 0.25 mm per intermediate position or day); an amount of force applied to the patient's oral cavity (e.g., between the molars, of between about 8N to 160N, etc.)
determining a target arch expansion force according to the initial dental arch form and the target arch expansion amount; (See para 89- As will be described in greater detail below, the shape of the apparatus (e.g., the expander), and therefore the load (e.g., force) applied by the apparatus when worn, may be controlled and selected during the fabrication process. Designing an accurate and effective series of palatal expanders should ideally accurately model the palatal expansion to include both linear translation (e.g., in an xy plane). Thus, the expander(s) in a series of expanders may be accurately and in some cases automatically, configured so that they achieve the desired palatal expansion within predetermined (or user/physician/technician) adjustable parameters such applied expansion force (e.g., between x and y N, less than y N, etc., where x is about 5, 6, 7, 8, 9, 10. 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, etc. and y is about 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, etc. and is less than x), the location of applied forces in the patient's mouth. See para 106- n general, palatal expanders customized to a particular patient may be based on manipulation of a digital model of the patient's oral cavity that includes both orthopedic (e.g., palatal expansion) and optionally orthodontic (e.g., tooth movement within the jaw) movements to create a series of expanders.)
determining a digital model of a target dental jaw in a target dental arch form according to the digital model of the initial dental jaw and the target arch expansion parameter; (see para 11-For example an apparatus or method for forming a series of expanders may be configured to include: receiving a digital model of the patient's oral cavity in an initial position; adjusting the digital model from the initial position to a final position in which the palate is expanded. See para 113- The digital model may adjust from the initial position to a final position in which the palate is expanded 1105.)
determining a geometric parameter and a material parameter of a pre-activated arch expander according to the digital model of the target dental jaw and the target arch expansion force, (see para 89- In addition, the palatal expanders may also be digitally modeled, including modeling both the shape (dimensions, including thickness, curvature, attachment points, etc.) and the material(s) used. Thus, the expander(s) in a series of expanders may be accurately and, in some cases, automatically, configured so that they achieve the desired palatal expansion within predetermined (or user/physician/technician) adjustable parameters such applied expansion force. see para 40- The user interface may also allow the user to select parameters such as the number and location of attachments, the size (e.g., width, thicknesses, etc.) of the palatal region of the palatal expander, the separation between the palatal expander and all or portions of the patient's palate when the apparatus is worn, the force (e.g., maximum force) applied by the palatal expander, the presence and/or extent of any detachment region (e.g., on the buccal side), etc. see para 157-The methods and apparatuses described herein may allow one or more of these techniques (or others) to be modeled and selected automatically or by a user, and may allow adjustment for other parameters to keep the stiffness and/or force and/or rate of movement constraints on the devices within predetermined or settable parameter ranges.))
and selecting a manufacturing material according to the material parameter, (see para 116-A user interface may interactively allow control of the design of the series of palatal expanders. For example, a user interface may allow the user to select the material from which the palatal expander is going to be formed, and therefore the material properties of the apparatus 3005.)
manufacturing the pre-activated arch expander on a physical model of the target dental jaw according to the geometric parameter, wherein the physical model of the target dental jaw is generated based on the digital model of the target dental jaw. (See para 11- For example an apparatus or method for forming a series of expanders may be configured to include: receiving a digital model of the patient's oral cavity in an initial position; see para 167-171-The palatal expanders described herein may be fabricated directly, for example by digitally designing the expander and fabricating the digital model using a 3D printer or other direct fabrication technique. Alternatively, or additionally, the palatal expanders described herein may be fabricated indirectly, for example, using a physical model of the patient's dentation (e.g., a ceramic, plastic, plaster, etc. model). In any of the indirect fabrication techniques described herein, the expander may be formed on a physical model that has been adjusted (e.g., by moving palate) to a desired position on the way to the final expanded position. The physical model may include attachments (buttons, etc.) for coupling to attachments (e.g., trough-holes, etc.) on the expander, as discussed above. Any of the expanders described herein may be formed by one or more lamination processes in which multiple layers are sequentially or simultaneously attached together to form the expander. A lamination method may generally include using thermoplastic layers of various thicknesses and combining them to form various layers.)
Wu explicitly does not teach pre-activated arch extender wherein the pre-activated arch expander includes a retaining band and an arch expansion part.
In the related field of invention, Arndt teaches pre-activated arch extender (see col 2 line 34-38-The orthodontic archwire, according to the invention, is a pre-formed wire having a generally "M-shaped" configuration and is comprised of a near-stoichiometric alloy of nickel and titanium which possesses memory-retaining characteristics. See col 2 line 59-60-It is an object of the present invention to provide a removable pre-formed palatal expansion arch)
wherein the pre-activated arch expander includes a retaining band; (see col 5 line 7-11- As appears in FIGS. 2–8, in the installation of arch-wire 1, on a patient's upper first permanent molars 6, 7, a metal band 5 is first fitted on and surrounds each of the molars. In accordance with the present invention, metal bands 5 are provided with lingually-projecting sheaths 4)
wherein the pre-activated arch expander includes an arch expansion part. (See col 3 line 18-22- It is another object of the invention to provide a removable palatal expansion arch which may be removed and adjusted by the clinician or at the manufacturer's laboratory to a different shape by a re-heat treating of the Ni-Ti segment while holding in a newly-formed shape. See col 4 line 31-50-Referring now particularly to FIGS. 1 and 1A of the drawings, illustrated therein is the removable Ni-Ti maxillary palatal expansion arch partially composed of a near-stoichiometric alloy of nickel and titanium extending bilaterally along the palatal concavity uniting end sections made from stainless steel and terminating with lingual sheath inserts. Archwire 1 is preferably made of a near-stoichiometric alloy of nickel and titanium having memory-retaining characteristics, composition of the nickel-titanium alloy is at least 50.5 atomic percent nickel. Another such composition of nickel-titanium alloy is not more than 51.0 atomic percent nickel with the remainder being titanium. As will be observed, archwire 1 is bent to provide a general "M-shape" which provides the counter-forces necessary for moving teeth as will be further described herein. Connected to archwire I is first stainless-steel end 12. The stainless-steel ends 12 and 13 have a pair of unitary length adjustment loops 14 and terminate with lingual sheath inserts 2, 3. The stainless-steel ends 12 and 13 and adjustment loops 14 are united by crimp tubes 15 to the "M-shaped" Ni-Ti archwire 1.)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of customizing a rapid palatal expander as disclosed by Wu to include pre-activated arch extender wherein the pre-activated arch expander includes a retaining band and an arch expansion part as taught by Arndt in the system of Wu for providing an improved removable orthodontic palatal expansion arch having a generally "M"-shaped configuration, the arch having a center segment composed of a near-stoichiometric alloy of nickel and titanium which possesses memory-retaining characteristics to simultaneously expand the bicuspids and expand, rotate, intrude and/or torque the maxillary molars, and end segments composed of an alloy of stainless steel or another biocompatible material configured for securing the archwire to lingual sheaths attached to molar bands. (see abstract, Arndt)
10. Claim(s) 7-14 and 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (PUB NO: US20180153649A1) in view of Arndt et al. "(PAT NO: USRE35170E) and further in view of Lai et al. (PUB NO: US20030059736A1)
Regarding claim 7
Wu, in view of Arndt, as shown in the rejection above, discloses the limitations of claim 1. Wu further teaches the method according to claim 1, wherein the step of designing a digital model of a pre- activated arch expander based on the target arch expansion parameter and the digital model of the target dental jaw further includes: (see para 107-The method and apparatus may determine a final position of the palate and/or teeth to be achieved by the series of expanders, including staging orthopedic and orthodontic movement to achieve the final position. This modeling may then be used to design a customized rapid palatal expander for a specific patient. Thus, in any of the methods and apparatuses described herein, the digital model may be used to predict both orthopedic (palate expansion) and orthodontic (dental) movement, and the model may be used to determine a final position setup and to define the movement/velocity of the palatal expansion and/or teeth)
determining a target geometric parameter of the pre-activated arch expander based on the digital model of the target dental jaw; (see para 40-The user interface may also allow the user to select parameters such as the number and location of attachments, the size (e.g., width, thicknesses, etc.) of the palatal region of the palatal expander, the separation between the palatal expander and all or portions of the patient's palate when the apparatus is worn, the force (e.g., maximum force) applied by the palatal expander, the presence and/or extent of any detachment region (e.g., on the buccal side), etc.)
upon determining that the result of the searching is true: exporting the result of the searching as the digital model of the pre-activated arch expander, (see para 29-Generating a series of palatal expanders may comprise generating a plurality of data files, wherein each data file in the plurality of data files corresponds to one of the palatal expanders of the series of palatal expanders. Generating the series of palatal expanders may comprise directly fabricating the series of palatal expanders from the plurality of data files, e.g., by 3D printing or related techniques.)
exporting a material parameter of the digital model of the pre-activated arch expander at the same time, (see para 116-a user interface may allow the user to select the material from which the palatal expander is going to be formed, and therefore the material properties of the apparatus 3005. See para 89-In addition, the palatal expanders may also be digitally modeled, including modeling both the shape (dimensions, including thickness, curvature, attachment points, etc.) and the material(s) used. Thus, the expander(s) in a series of expanders may be accurately and in some cases automatically, configured so that they achieve the desired palatal expansion within predetermined (or user/physician/technician) adjustable parameters)
and ending the step of designing a digital model of a pre-activated arch expander, (see para 139-Finally the palatal expander shape maybe determined 3059, and finished.)
and obtaining the digital model of the pre-activated arch expander that meets an arch expansion constraint condition and a material parameter of the digital model of the pre-activated arch expander. (See para 13- the plurality of intermediate positions is based on: a stiffness of the palatal expander and a limit on an increment of change in at least one of the patient's palate and teeth. For example, the increment of change may be one or more of: a rate of expansion between the molars (e.g., of about 0.25 mm per intermediate position or day); an amount of force applied to the patient's oral cavity (e.g., between the molars, of between about 8N to 160N, etc.); a rate of dental movement of the patient's teeth. See para 86- These methods may limit the force and/or rate of movement delivered by each palatal expander in a sequence of expanders. see para 157- The methods and apparatuses described herein may allow one or more of these techniques (or others) to be modeled and selected automatically or by a user, and may allow adjustment for other parameters to keep the stiffness and/or force and/or rate of movement constraints on the devices within predetermined or settable parameter ranges.)
and a material parameter of the digital model of the pre-activated arch expander. (see para 116-a user interface may allow the user to select the material from which the palatal expander is going to be formed, and therefore the material properties of the apparatus 3005. See para 89-In addition, the palatal expanders may also be digitally modeled, including modeling both the shape (dimensions, including thickness, curvature, attachment points, etc.) and the material(s) used. Thus, the expander(s) in a series of expanders may be accurately and, in some cases, automatically, configured so that they achieve the desired palatal expansion within predetermined (or user/physician/technician) adjustable parameters)
The combination of Wu and Arndt does not teach searching whether there is a digital model of a preset arch expander that meets a matching requirement from a database according to the target arch expansion parameter and the target geometric parameter; and determining whether a result of the searching is true or false. and upon determining that the result of the searching is false: designing the digital model of the pre-activated arch expander by using a finite element method according to the target geometric parameter and the target arch expansion parameter.
In the related field of invention, Lai teaches searching whether there is a digital model of a preset arch expander that meets a matching requirement from a database according to the target arch expansion parameter and the target geometric parameter; (see para 27-the program 100 at the block 114 may instead be arranged to make the initial prescription and appliance selections automatically by comparing the pretreatment model entered at the blocks 106, 108, and/or 110 to treatment data stored in the memory system 16. This treatment data, for example, may be in the form of a look up table or other data structure containing past pre-treatment models and the corresponding orthodontic treatment strategies which were used to successfully treat the patients from whom the past pre-treatment models were derived. Thus, the current patient's pre-treatment model may be used as an address into the memory system 16 in order to read out the treatment strategy corresponding to this address. Extrapolation can be used in the case where a patient's pre-treatment model is not an exact match with the stored pre-treatment models.)
and determining whether a result of the searching is true or false, (see para 27-Extrapolation can be used in the case where a patient's pre-treatment model is not an exact match with the stored pre-treatment models. See para 41- If, as indicated by a block 136, the treatment strategy requires modification because the stresses, strains, forces, friction, and/or moments displayed at the block 132 are excessive or are outside desired ranges or because the force levels become ineffective, the treatment strategy is changed and the processing of the blocks 114-136 is repeated using the modified treatment strategy.)
and upon determining that the result of the searching is false: designing the digital model of the pre-activated arch expander by using a finite element method according to the target geometric parameter and the target arch expansion parameter, (see para 14-performing a finite element analysis based on the proposed orthodontic treatment and a movement of the patient's teeth between the first and second positions; e) selecting a new set of orthodontic appliances if the finite element analysis indicates that the proposed orthodontic treatment produces undesired effects; and, f) repeating d) and e). see para 33-These finite element analysis programs are general purpose finite element analysis programs that can be used by the program 100 to determine the stresses, strains, forces, friction, and moments on the selected orthodontic appliances and on the patient's teeth, PDL (periodontic ligament structure), and bone.)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of customizing a rapid palatal expander as disclosed by Wu and Arndt to include searching whether there is a digital model of a preset arch expander that meets a matching requirement from a database according to the target arch expansion parameter and the target geometric parameter; and determining whether a result of the searching is true or false. and upon determining that the result of the searching is false: designing the digital model of the pre-activated arch expander by using a finite element method according to the target geometric parameter and the target arch expansion parameter as taught by Lai in the system of Wu and Arndt in order to use the finite element analysis to design and/or select orthodontic appliances and further study the interaction between orthodontic appliances and teeth in order to develop an effective orthodontic treatment strategy. (see para 12, Lai)
Regarding claim 8
Wu, in view of Arndt and Lai, as shown in the rejection above, discloses the limitations of claim 7. Wu further teaches the method according to claim 7, wherein the target geometric parameter includes one or more of the following parameters: number, shape, and fixed position of one or more retaining bands; number of one or more spring coils contained in the arch expansion part; position, diameter, and angle of each spring coil; curvature of an arch wire between adjacent spring coils; and bending angle, length, and curvature of a lingual arm contained in the arch expansion part. (see para 89-In addition, the palatal expanders may also be digitally modeled, including modeling both the shape (dimensions, including thickness, curvature, attachment points, etc.) and the material(s) used.)
Regarding claim 9
Wu, in view of Arndt and Lai, as shown in the rejection above, discloses the limitations of claim 7. Wu further teaches the method according to claim 7, wherein the material parameter includes one or more of the following parameters: composition and performance of a material used for manufacturing the arch expansion part; and shape and dimension of a cross-section of an arch wire used for manufacturing the arch expansion part. (See para 18- the expanders may be formed out of a polymer and/or a metal material, including stainless steel, nickel titanium, copper nickel titanium, etc. see para 116-119 and see fig 11F- For example, a user interface may allow the user to select the material from which the palatal expander is going to be formed, and therefore the material properties of the apparatus 3005. material properties (e.g., stiffness))
Regarding claim 10
Wu, in view of Arndt and Lai, as shown in the rejection above, discloses the limitations of claim 7. Wu further teaches the method according to claim 7, wherein the material parameter includes a parameter representing that the performance of the material varies with temperature. (see para 169-For example, an expander may be formed of an acrylic material that is applied in a sheet over a physical model, formed (e.g., thermoformed, set) and then cut and/or trimmed. In various examples provided herein, the material may form (including set) by temperature and/or light or other appropriate means. For example, an expander may be formed of a thermoplastic curable polymer.)
Regarding claim 11
Wu, in view of Arndt and Lai, as shown in the rejection above, discloses the limitations of claim 7. Wu explicitly does not teach the deviation between a geometric parameter of the digital model of the preset arch expander and the target geometric parameter is less than a preset first threshold, and the deviation between an actual arch expansion parameter of the digital model of the preset arch expander and the target arch expansion parameter is less than a preset second threshold.
However, Lai further teaches the method according to claim 7, wherein the matching requirement includes: the deviation between a geometric parameter of the digital model of the preset arch expander and the target geometric parameter is less than a preset first threshold, and the deviation between an actual arch expansion parameter of the digital model of the preset arch expander and the target arch expansion parameter is less than a preset second threshold. (See para 34- The appliance material properties may be stored in a data base of the memory system 16 and may be automatically accessed from the data base based upon the appliances selected at the block 114. The material properties for appliances may require entry each time that the treating orthodontist changes appliances during treatment. For examples, archwires of different thicknesses and/or metals may be changed one or more times during treatment. Also, the archwires may be bent into different geometries one or more times during treatment. See para 41-43- If, as indicated by a block 136, the treatment strategy requires modification because the stresses, strains, forces, friction, and/or moments displayed at the block 132 are excessive or are outside desired ranges or because the force levels become ineffective, the treatment strategy is changed and the processing of the blocks 114-136 is repeated using the modified treatment strategy. For example, the blocks 134 and 136 may be executed manually or they may be executed automatically by comparing the calculated stresses, strains, forces, friction, and/or moments to acceptable or desired ranges and by selecting appliances targeted to bring any errant stresses, strains, forces, friction, and/or moments within the desired and/or acceptable ranges.)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of customizing a rapid palatal expander as disclosed by Wu and Arndt to include the deviation between a geometric parameter of the digital model of the preset arch expander and the target geometric parameter is less than a preset first threshold, and the deviation between an actual arch expansion parameter of the digital model of the preset arch expander and the target arch expansion parameter is less than a preset second threshold as taught by Lai in the system of Wu and Arndt in order to use the finite element analysis to design and/or select orthodontic appliances and further study the interaction between orthodontic appliances and teeth in order to develop an effective orthodontic treatment strategy. (see para 12, Lai)
Regarding claim 12
Wu, in view of Arndt and Lai, as shown in the rejection above, discloses the limitations of claim 7 “wherein, the step of designing the digital model of the pre-activated arch expander by using a finite element method according to the target geometric parameter and the target arch expansion parameter and obtaining the digital model of the pre- activated arch expander that meets an arch expansion constraint condition and a material parameter of the digital model of the pre-activated arch expander” (see claim 7) includes the following steps:
(see para 89-In addition, the palatal expanders may also be digitally modeled, including modeling both the shape (dimensions, including thickness, curvature, attachment points, etc.) and the material(s) used. Thus, the expander(s) in a series of expanders may be accurately and in some cases automatically, configured so that they achieve the desired palatal expansion within predetermined (or user/physician/technician) adjustable parameters such applied expansion force. see para 105-A customize expander may be generated for each intermediate position and for the final endpoint (including a maintenance device to be worn for a period of time, e.g., 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, etc.) after expansion of the palate. The methods and apparatuses described herein may be configured to design each expander, including the stiffness and/or shape of the expander (and in particular the palatal region, referred to herein as the IPA or interpalatal arch) by modeling both the orthopedic movement of the arch and the orthodontic movement of teeth in the jaw bone, and applying constraints on the movements of the palate, teeth and/or gingiva in the jaw, including constrains (e.g., limits) on one or more of: the rate of movement of the two sides of the palate, the rate of expansion between the teeth (e.g., molars on opposite side of the patient's upper jaw), an amount of force applied to the patient's oral cavity, a rate of dental movement of the patient's teeth, and a rate of change of an angle between a left and a right portion of the palate)
setting an initial value for a material parameter of the initial intermediate arch expander; (see para 116-The method (or a processor configured to perform the method) may then prepare for planning the stages of the palatal expanders 3003. A user interface may interactively allow control of the design of the series of palatal expanders. For example, a user interface may allow the user to select the material from which the palatal expander is going to be formed, and therefore the material properties of the apparatus 3005.)
and exporting the finite element model of the intermediate arch expander as the digital model of the pre-activated arch expander and also exporting a material parameter of the digital model of the pre-activated arch expander. (see para 89- In addition, the palatal expanders may also be digitally modeled, including modeling both the shape (dimensions, including thickness, curvature, attachment points, etc.) and the material(s) used. see para 111-In general any of the methods and apparatuses configured to perform these methods described herein may be performed by a dedicated apparatus, which may include digital inputs (digital file inputs and user inputs, such as keyboards, etc.), one or more processors, at least one visual output (e.g., screen, printer, etc.) and one or more digital outputs, including a digital file output for use in fabrication, such as direct (e.g., 3D printing) fabrication. See para 167- . Alternatively or additionally, the palatal expanders described herein may be fabricated indirectly, for example, using a physical model of the patient's dentation (e.g., a ceramic, plastic, plaster, etc. model), onto which materials are applied to form the palatal expander.)
Wu does not teach generating a finite element model of the initial dental jaw according to the digital model of the initial dental jaw; generating a finite element model of an initial intermediate arch expander according to the target geometric parameter and the target arch expansion parameter, and performing a finite element calculation on the effect of the finite element model of the intermediate arch expander acting on the finite element model of the initial dental jaw, wherein a result of the finite element calculation includes an actual arch expansion parameter of the intermediate arch expander and a situation about the change of the form of the finite element model of the initial dental jaw; and optimizing the geometric parameter and the material parameter of the finite element model of the intermediate arch expander according to the result of the calculation and repeating the calculation until the result of the calculation meets a preset judgment condition and the arch expansion constraint condition.
In the related field of invention, Lai further teaches generating a finite element model of the initial dental jaw according to the digital model of the initial dental jaw; (see para 14- creating a first model based upon first positions of a patient's teeth; b) creating a second model based upon second positions of the patient's teeth, wherein the second positions represent desired positions of the patient's teeth; c) selecting a proposed set of orthodontic appliances according to a proposed orthodontic treatment; d) performing a finite element analysis based on the proposed orthodontic treatment and a movement of the patient's teeth between the first and second positions;)
generating a finite element model of an initial intermediate arch expander (see para 39-40- The finite element analysis is re-run at this point in order to determine the stresses, strains, forces, friction, and moments that will be exerted on the appliances, teeth, the PDL for each tooth, and the bone by the deforming of the archwires as determined during execution of the block 126. If intermediate positions are included in the proposed orthodontic treatment, it may be necessary at the block 128 to finish execution of the finite element analysis at each intermediate position between the final and original positions for processing by a block 130.)
performing a finite element calculation on the effect of the finite element model of the intermediate arch expander acting on the finite element model of the initial dental jaw, wherein a result of the finite element calculation includes an actual arch expansion parameter of the intermediate arch expander and a situation about the change of the form of the finite element model of the initial dental jaw; (see para 39-40- The finite element analysis is re-run at this point in order to determine the stresses, strains, forces, friction, and moments that will be exerted on the appliances, teeth, the PDL for each tooth, and the bone by the deforming of the archwires as determined during execution of the block 126.
optimizing the geometric parameter and the material parameter of the finite element model of the intermediate arch expander according to the result of the calculation and repeating the calculation until the result of the calculation meets a preset judgment condition and the arch expansion constraint condition, (see para 41- At a block 132, the teeth and appliances are displayed along with the stresses, strains, forces, friction, and moments determined by the finite element analysis. This display is examined at a block 134. If, as indicated by a block 136, the treatment strategy requires modification because the stresses, strains, forces, friction, and/or moments displayed at the block 132 are excessive or are outside desired ranges or because the force levels become ineffective, the treatment strategy is changed and the processing of the blocks 114-136 is repeated using the modified treatment strategy. The treatment strategy may require modification, for example, in the case where the stress on an appliance or tooth or bone is excessive or insufficient or in the case where the strain on a ligament is excessive or insufficient.)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of customizing a rapid palatal expander as disclosed by Wu and Arndt to include generating a finite element model of the initial dental jaw according to the digital model of the initial dental jaw; generating a finite element model of an initial intermediate arch expander according to the target geometric parameter and the target arch expansion parameter, and performing a finite element calculation on the effect of the finite element model of the intermediate arch expander acting on the finite element model of the initial dental jaw, wherein a result of the finite element calculation includes an actual arch expansion parameter of the intermediate arch expander and a situation about the change of the form of the finite element model of the initial dental jaw; and optimizing the geometric parameter and the material parameter of the finite element model of the intermediate arch expander according to the result of the calculation and repeating the calculation until the result of the calculation meets a preset judgment condition and the arch expansion constraint condition as taught by Lai in the system of Wu and Arndt in order to use the finite element analysis to design and/or select orthodontic appliances and further study the interaction between orthodontic appliances and teeth in order to develop an effective orthodontic treatment strategy. (see para 12, Lai)
Regarding claim 13
Wu, in view of Arndt and Lai, as shown in the rejection above, discloses the limitations of claim 12. Wu does not teach wherein the arch expansion constraint condition includes one or more of the following conditions: a constraint condition on a contact position between the finite element model of the intermediate arch expander and the finite element model of the initial dental jaw; a biomechanical constraint condition on the displacement of the finite element model of the initial dental jaw under the action of the arch expansion force; and a restriction condition on a tooth root movement of the finite element model of the initial dental jaw.
However, Lai further teaches the method according to claim 12, wherein the arch expansion constraint condition includes one or more of the following conditions: a constraint condition on a contact position between the finite element model of the intermediate arch expander and the finite element model of the initial dental jaw; a biomechanical constraint condition on the displacement of the finite element model of the initial dental jaw under the action of the arch expansion force; and a restriction condition on a tooth root movement of the finite element model of the initial dental jaw. (See para 34-41- Also, the program 100 at the block 124 meshes all components (teeth and appliances) except for the target surfaces of the contact pairs if the contact surfaces are assumed to be rigid. Moreover, contact pairs are defined at the block 124. A contact pair includes the surfaces of two appliances that contact each other. For example, the archwire and each bracket form corresponding contact pairs, the archwire and each of the ligatures that holds the archwire to a corresponding bracket form other corresponding contact pair, and the brackets and ligatures form still other corresponding contact pairs. By convention, one of the appliances of a contact pair forms a contact surface and the other of the appliances of the contact pair forms a target surface. For self-ligating brackets, the archwire and the caps or clips form yet other corresponding contact pairs. All such contact pairs are defined at the block 124 by identifying and quantifying the areas of the contact surfaces of the contact pairs. The finite element analysis is re-run at this point in order to determine the stresses, strains, forces, friction, and moments that will be exerted on the appliances, teeth, the PDL for each tooth, and the bone by the deforming of the archwires as determined during execution of the block 126. If, as indicated by a block 136, the treatment strategy requires modification because the stresses, strains, forces, friction, and/or moments displayed at the block 132 are excessive or are outside desired ranges)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of customizing a rapid palatal expander as disclosed by Wu and Arndt to include wherein the arch expansion constraint condition includes one or more of the following conditions: a constraint condition on a contact position between the finite element model of the intermediate arch expander and the finite element model of the initial dental jaw; a biomechanical constraint condition on the displacement of the finite element model of the initial dental jaw under the action of the arch expansion force; and a restriction condition on a tooth root movement of the finite element model of the initial dental jaw as taught by Lai in the system of Wu and Arndt in order to use the finite element analysis to design and/or select orthodontic appliances and further study the interaction between orthodontic appliances and teeth in order to develop an effective orthodontic treatment strategy. (see para 12, Lai)
Regarding claim 14
Wu, in view of Arndt and Lai, as shown in the rejection above, discloses the limitations of claim 12. wherein the step of designing the digital model of the pre-activated arch expander by using a finite element method according to the target geometric parameter and the target arch expansion parameter and obtaining the digital model of the pre-activated arch expander that meets an arch expansion constraint condition and a material parameter of the digital model of the pre-activated arch expander (see claim 12) further includes
after the step of optimizing the geometric parameter and the material parameter, (see para 40- The user interface may also allow the user to select parameters such as the number and location of attachments, the size (e.g., width, thicknesses, etc.) of the palatal region of the palatal expander, the separation between the palatal expander and all or portions of the patient's palate when the apparatus is worn, the force (e.g., maximum force) applied by the palatal expander, the presence and/or extent of any detachment region (e.g., on the buccal side), etc. see para 157-The methods and apparatuses described herein may allow one or more of these techniques (or others) to be modeled and selected automatically or by a user, and may allow adjustment for other parameters to keep the stiffness and/or force and/or rate of movement constraints on the devices within predetermined or settable parameter ranges.)
adding a digital model of the optimized pre-activated arch expander (see para 29-Generating a series of palatal expanders may comprise generating a plurality of data files, wherein each data file in the plurality of data files corresponds to one of the palatal expanders of the series of palatal expanders. See para 119-Once the entire sequence is generated, the processor may then fabricate, or transmit the electronic file(s) describing each stage, for fabrication. Any appropriate fabrication technique may be used, including 3D printing.)
and an actual arch expansion parameter, a geometric parameter, and a material parameter corresponding to the digital model of the new preset arch expander (see para 89-In addition, the palatal expanders may also be digitally modeled, including modeling both the shape (dimensions, including thickness, curvature, attachment points, etc.) and the material(s) used. Thus, the expander(s) in a series of expanders may be accurately and, in some cases, automatically, configured so that they achieve the desired palatal expansion within predetermined (or user/physician/technician) adjustable parameters such applied expansion force)
Wu does not teach the database as a digital model of a new preset arch expander, storing….. in the database.
However, Lai further teaches the database as a digital model of a new preset arch expander, storing…. in the database. (See para 27-This treatment data, for example, may be in the form of a look up table or other data structure containing past pre-treatment models and the corresponding orthodontic treatment strategies which were used to successfully treat the patients from whom the past pre-treatment models were derived. Thus, the current patient's pre-treatment model may be used as an address into the memory system 16 in order to read out the treatment strategy corresponding to this address).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of customizing a rapid palatal expander as disclosed by Wu and Arndt to include the database as a digital model of a new preset arch expander, storing…... in the database as taught by Lai in the system of Wu and Arndt in order to use the finite element analysis to design and/or select orthodontic appliances and further study the interaction between orthodontic appliances and teeth in order to develop an effective orthodontic treatment strategy. (see para 12, Lai)
Regarding claim 27
Wu, in view of Arndt and Lai, as shown in the rejection above, discloses the limitations of claim 21. Wu further teaches wherein the target arch expansion force is determined based on the initial dental arch form and the target arch expansion amount(see para 114-the method or apparatus may determine each stage (each intermediate position) based on a stiffness of the palatal expander and a limit on an one or more of the rate of movement of the patient's teeth when the palatal expander corresponding to that stage is worn, and/or a limit on the force(s) applied by the palatal expander to the patient's oral cavity or regions of the oral cavity. See para 119- The processor may then use the initial position and the proposed final position and may apply the constraints defined to the processor to generate the sequential stages corresponding to individual palatal expanders. For example, for each stage, the processor may set the palatal expander configuration (e.g., the position of the tooth engagement regions that attach over the molars of the right and left maxillary halves, and the size and thickness of the palatal region, etc.) to generate a maximum amount of force and/or movement (e.g., 0.25 mm, etc.) at each stage based on the material properties (e.g., stiffness) of the palatal expander)
Wu does not teach wherein the target arch expansion force is determined by retrieving a similar historical case from a database to obtain a corresponding treatment regimen and determined based on the initial dental arch form and the target arch expansion amount
However, Lai further teaches wherein the target arch expansion force is determined by retrieving a similar historical case from a database to obtain a corresponding treatment regimen and determined based on the initial dental arch form and the target arch expansion amount. (See para 27-29-comparing the pretreatment model entered at the blocks 106, 108, and/or 110 to treatment data stored in the memory system 16. This treatment data, for example, may be in the form of a look up table or other data structure containing past pre-treatment models and the corresponding orthodontic treatment strategies which were used to successfully treat the patients from whom the past pre-treatment models were derived. Thus, the current patient's pre-treatment model may be used as an address into the memory system 16 in order to read out the treatment strategy corresponding to this address. Intermediate positions of the patient's teeth may also be entered and stored at the block 116. One or more such intermediate positions of the patient's teeth are optionally employed where the orthodontist's proposed treatment strategy includes the re-positioning of the patient's teeth in stages, where each stage may involve the replacement or modification of selected appliances such as force modules and/or archwires, where each stage involves the employment of different force levels, where the orthodontist intends to use appliances whose geometries or properties change over time and may need to be replaced during treatment, and/or the like.)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of customizing a rapid palatal expander as disclosed by Wu and Arndt to include wherein the target arch expansion force is determined by retrieving a similar historical case from a database to obtain a corresponding treatment regimen and determined based on the initial dental arch form and the target arch expansion amount as taught by Lai in the system of Wu and Arndt in order to use the finite element analysis to design and/or select orthodontic appliances and further study the interaction between orthodontic appliances and teeth in order to develop an effective orthodontic treatment strategy. (see para 12, Lai)
Regarding claim 28
Wu, in view of Arndt and Lai, as shown in the rejection above, discloses the limitations of claim 21. Wu further teaches the method according to claim 21, wherein the target arch expansion force is determined based on a relationship between an arch expansion amount and an arch expansion force, (See para 89- As will be described in greater detail below, the shape of the apparatus (e.g., the expander), and therefore the load (e.g., force) applied by the apparatus when worn, may be controlled and selected during the fabrication process. Designing an accurate and effective series of palatal expanders should ideally accurately model the palatal expansion to include both linear translation (e.g., in an xy plane). Thus, the expander(s) in a series of expanders may be accurately and in some cases automatically, configured so that they achieve the desired palatal expansion within predetermined (or user/physician/technician) adjustable parameters such applied expansion force (e.g., between x and y N, less than y N, etc., where x is about 5, 6, 7, 8, 9, 10. 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, etc. and y is about 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, etc. and is less than x), the location of applied forces in the patient's mouth. See para 106- n general, palatal expanders customized to a particular patient may be based on manipulation of a digital model of the patient's oral cavity that includes both orthopedic (e.g., palatal expansion) and optionally orthodontic (e.g., tooth movement within the jaw) movements to create a series of expanders.)
Wu does not teach wherein the relationship is obtained statistically from an experimental measurement and/or a clinical treatment result.
However, Lai further teaches wherein the relationship is obtained statistically from an experimental measurement and/or a clinical treatment result. (See para 27- comparing the pretreatment model entered at the blocks 106, 108, and/or 110 to treatment data stored in the memory system 16. This treatment data, for example, may be in the form of a look up table or other data structure containing past pre-treatment models and the corresponding orthodontic treatment strategies which were used to successfully treat the patients from whom the past pre-treatment models were derived. See para 43- For example, the blocks 134 and 136 may be executed manually or they may be executed automatically by comparing the calculated stresses, strains, forces, friction, and/or moments to acceptable or desired ranges and by selecting appliances targeted to bring any errant stresses, strains, forces, friction, and/or moments within the desired and/or acceptable ranges.)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of customizing a rapid palatal expander as disclosed by Wu and Arndt to include wherein the relationship is obtained statistically from an experimental measurement and/or a clinical treatment result as taught by Lai in the system of Wu and Arndt in order to use the finite element analysis to design and/or select orthodontic appliances and further study the interaction between orthodontic appliances and teeth in order to develop an effective orthodontic treatment strategy. (see para 12, Lai)
Regarding claim 22
Claim 22 is rejected for the same reasons as Claim 2, as they share the same elements.
Regarding claim 23
Claim 23 is rejected for the same reasons as Claim 3, as they share the same elements.
Regarding claim 24
Claim 24 is rejected for the same reasons as Claim 4, as they share the same elements.
Regarding claim 25
Claim 25 is rejected for the same reasons as Claim 5, as they share the same elements
Regarding claim 30
Claim 30 is rejected for the same reasons as Claim 6, as they share the same elements.
Regarding claim 32
Claim 32 is rejected for the same reasons as Claim 8, as they share the same elements.
Regarding claim 33
Claim 33 is rejected for the same reasons as Claim 9, as they share the same elements.
Regarding claim 34
Claim 34 is rejected for the same reasons as Claim 16, as they share the same elements.
Regarding claim 35
Claim 35 is rejected for the same reasons as Claim 17, as they share the same elements.
Regarding claim 36
Claim 36 is rejected for the same reasons as Claim 18, as they share the same elements.
Conclusion
11. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Shanjani et al. US20190262101A1
i. Discussing the intraoral appliances that allow the application of sometimes complex force systems to different areas of a patient's teeth, palate, and/or other portions of a dentition.
12. All claims 1-18 and 20-37 are rejected.
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/PURSOTTAM GIRI/
Examiner, Art Unit 2186
/RENEE D CHAVEZ/Supervisory Patent Examiner, Art Unit 2186
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