DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Responsive to the communication dated 06/10/2026
Claims 1 and 4-22 are pending in the application.
Claims 10-17 are withdrawn from consideration.
Finality
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Response to Arguments - 35 USC § 101
Applicant's arguments filed 06/10/2026 have been fully considered but they are not persuasive.
Applicant argues that a person could not create a model as described in the claims because a it requires “a geometrical near-perfect negative of the tooth surface curvature must be accurate within fractions of a millimeter to ensure custom fit on the patient's tooth”
Examiner responds by explaining that these levels of accuracy are not actually required by the claims, which merely require that the model has a support surface that “geometrically matches at least one contour of the digital impression of the patient's tooth, such that the hollow shell is configured to receive the patient's tooth such that the at least one support surface positionally registers against the patient's tooth;” e.g. that the model and curve of the tooth have the same shape and the model would fit up against the tooth.
Further, performing this design process within a true 3D renderer or other computer system amounts to no more than mere instructions to apply the mental process using a general-purpose computer.
Applicant argues that the amended form of step (D) cannot be performed in the human mind.
Examiner responds by explaining that “computationally creating” a model that could otherwise be created using the human mind amounts to no more than mere instructions to apply the mental process of creating that model using a general purpose computer.
Applicant argues that the abstract idea is integrated into a practical application/provides significantly more because it allows the four components to be integrated into a single unit.
Examiner responds by explaining that, firstly, the difference between the components being designed as separate units versus as a single unit is merely a different in what is depicted in the mental representation; drawing an image of a car with wheels is no more or less of a mental process than drawing an image of a car with its wheels positioned separately.
Further, while the preamble of the independent claims defines them as “A method of manufacturing an orthodontic bracket system” the claims are clearly not directed to an actual manufacturing procedure, with steps A-G performing no manufacturing steps and step H merely producing what was designed in steps A-G. The claims are directed to a specific method of designing an orthodontic system that is produced in a generic manner in a final step, not to a specific manufacturing method.
Further, the simultaneous printing of multiple components that are combined into a single component is merely the printing of a single component. Other than what is being printed, i.e. a single model that has a certain structure, there is no indication that the claimed 3D printing process is anything more than what is generic.
Additionally, as to the applicant’s arguments in regards to Diamond v. Diehr, the claims were not found eligible simply because the claimed process produced a physical product, the key to eligibility was the constant, dynamic interplay between the physical manufacturing device and the control operations that amounted to significantly more than merely performing an initial abstract process and then producing an output based on the result of that abstract process. In contrast, the present claims merely design a particular model through abstract means (steps A-G) and then print that model using generic 3D-printing without any suggestion that a uncommon or unique printing method is being used (step H).
Applicant argues that the abstract idea is integrated into a practical application/ provides significantly more due to a number of alleged improvements.
Examiner responds by addressing each:
Eliminating the thermoforming machine entirely by using 3D printing;
As can be seen from the references used previously to show that the use of 3D printing in dentistry is an example of WURC, the use of 3D printing rather than thermoforming is well-known in the art. See:
Digital workflows in contemporary orthodontics ([Page 14 Col 1 Par 1 – Page 16 Col 2 Par 2])
A Modeling Method of Customized Brackets and Individualized Trays for Orthodontic Treatment ([Abstract])
In-house computer-aided design and 3-dimensional printing of customized orthodontic brackets using hybrid ceramic resin: Is it the time for the orthodontist to take over? ([Abstract, Page 187 Col 2 Par 1 – Page 188 Col 1 Par 1])
Be your own manufacturer: 3D printing intraoral appliances ([Abstract, Page 184 Col 2 Par 1- Page 187 Col 1 Par 1])
Eliminating manual bracket loading into a bonding tray by integrating the bracket directly into the 3D-printed unit; and (4) Achieving a single-unit construction that eliminates assembly steps and human placement error.
This is merely the result of the design of the model, i.e. the abstract idea itself, and therefore cannot integrate the abstract idea into a practical application nor provide significantly more. (MPEP 2106.05(a)(I): An inventive concept "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself." Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016))
Using intraoral scan data to computationally generate a precision-fit placement shell, eliminating impression materials and analog fabrication;
The use of intraoral scanners to generate precise dental appliances is well-known in the art; see:
Digital workflows in contemporary orthodontics ([Page 12 Col 1 Par 12– Page 13 Col 1 Par 1])
A Modeling Method of Customized Brackets and Individualized Trays for Orthodontic Treatment ([Page 1 Col 2 Par 3, Page 5 Col 1 Par 1])
In-house computer-aided design and 3-dimensional printing of customized orthodontic brackets using hybrid ceramic resin: Is it the time for the orthodontist to take over? ([Abstract, Page 187 Col 2 Par 1, Page 188 Col 2 Par 2])
Be your own manufacturer: 3D printing intraoral appliances ([Page 186 Col 2 Par 3])
Clearly, step (H) amounts to no more than insignificant post-solution activity.
Response to Arguments - 35 USC § 103
Applicant's arguments filed 06/10/2026 have been fully considered but they are not persuasive.
Applicant argues that Christensen only teaches the printing of the bonding tray itself and teaches away from also printing the brackets.
Examiner responds by explaining that the passage cited by the applicant as proof that Christensen teaches away from this is actually part of an explanation of the differences between previous systems and the system of Christensen ([Page 14 Col 2 Par 1 (describing previous systems)] “a 3D-printed model can be produced with the virtually placed brackets and a bonding tray can be produced on this model [Figures 7 and 8]. The model is produced with the tie-wing and hook undercuts blocked out to ensure the brackets fit in the bonding tray. The laboratory or clinical staff can then insert the brackets in the bonding tray prior to the bonding session.” [Page 14 Col 2 Par 2 (describing current system) “Our latest and most significant development in labial indirect bonding is to be able to print the bonding tray directly and without the need of a model.”)
Further, Christensen explicitly states the desire to be able to produce appliances (i.e. the brackets) on a 3D printer along with the support structures such as the bonding tray ([Page 16 Col 1 Par 3 – Col 2 Par 1] “Once suitable biocompatible 3D-printing resins become available, it will be possible to produce the appliance on a 3D printer rather than using more expensive 3D milling machines.”) While Christensen does not explicitly teach the bracket being printed alongside the rest of the structures, it is clear that this was only due to the limitations of 3D printed materials at the time.
To this end, Panayi teaches merging the digital model of the orthodontic bracket, the digital model of the placement member, the digital model of the base member and the digital model of the support member into a single printable file and printing it ([Abstract] “Our case report used a novel orthodontic CAD software named UBrackets to design in-house customized orthodontic brackets. Three-dimensional printing was per formed in the orthodontic office using a permanent crown ceramic resin. The complete customized fixed appliance’s design, printing, postprinting, and bonding workflow are also presented.” [Page 190 Col 1 Par 1 – Col 2 Par1] “The virtual brackets were positioned on the virtual printer platform of Preform software in a specific orientation that would facilitate the accurate printing of the brackets, giving attention to the slots (Fig 10). Printing time was performed in 40 minutes with a 50 mm resolution. After printing, the brackets were immersed in Formlab’s Form Wash washing machine containing 91% isopropyl alcohol for 3 minutes to remove the residual resin. The brackets were then removed from the printer’s platform and carefully washed manually with isopropyl alcohol. Dry air was used to remove any residual resin and alcohol. Ultraviolet (UV) light curing was performed in Formlab’s Form Cure unit for 20 minutes.”[Fig. 3] Shows a full printed setup for a tooth including the bracket, supports, placement member, and base)
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Although Panayi teaches printing the entire bracket system on a per-tooth basis, the combination of Panayi with the printed linked whole-arch structure of Christensen would have made printing multiple linked backet systems obvious to one of ordinary skill in the art.
Further, nothing in the claims requires that more than a single bracket system for a single tooth be produced, with language like “digitally merging the digital model of the orthodontic bracket, the digital model of the placement member, the digital model of the base member and the digital model of the support member to create a continuous digital combined model” clearly only requiring a single instance.
Applicant argues that because the printed brackets and trays disclosed in Xing “are printed separately and are never merged into a combined model nor three-dimensionally printed as an integral part.” the use of Xing as a reference is improper.
Examiner explains that while Xing on its own, in isolation from the other references, may not explicitly teach merging the brackets and other elements into a single file and printing them together, this is taught by the combination of Christensen, Panayi, and Xing.
Further, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Claim Objections
Claims 18-22 objected to because of the following informalities:
Claim 18 recites “a physical intraoral scanner configured to digitize the three-dimensional geometry of the patient's tooth;” To avoid potential issues with antecedent basis, it is recommended to amend the claim to instead read “a physical intraoral scanner configured to digitize
Appropriate correction is required.
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, 4-9, and 18-22 are rejected under 35 U.S.C. 101 because they are directed to an abstract idea without significantly more.
Claim 1 (Statutory Category – Process)
Step 2A – Prong 1: Judicial Exception Recited?
Yes, the claim recites a mental process, specifically:
MPEP 2106.04(a)(2)(Ill): “Accordingly, the "mental processes" abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, Judgments, and opinions.”
Further, the MPEP recites “The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation.”
(A) receiving, by one or more computer systems, three- dimensional data representing a digital impression of a patient's tooth; (B) receiving, by the one or more computer systems, a digital model of an orthodontic bracket;
“Receiving” these elements is merely the mental process of creating designs/models featuring them. For example, a person could create an impression of a patient’s tooth by observing it and drawing it with a pen and paper. Similarly, a person could come up for a design for an orthodontic bracket and draw it with a pen and paper.
Doing this with digitally using one or more computer systems amounts to no more than mere instructions to apply the exception.
Should it be found that this is not a mental process, it is also an example of mere data gathering.
(C) positioning, by the one or more computer systems, the digital model of the orthodontic bracket onto the digital impression of the patient's tooth;
(D) computationally creating by the one or more computer systems, a digital model of a placement member comprising a hollow shell including at least one support surface that geometrically matches at least one contour of the digital impression of the patient's tooth, such that the hollow shell is configured to receive the patient's tooth such that the at least one support surface positionally registers against the patient's tooth;
(E) placing, by the one or more computer systems, the at least one support surface of the placement member digital model onto the at least one matching contour of the digital impression of the patient's tooth;
(F) forming, by the one or more computer systems, a digital model of a base member;
(G) forming, by the one or more computer systems, a digital model of a support member, digitally merging the digital model of the orthodontic bracket, the digital model of the placement member, the digital model of the base member and the digital model of the support member to create a continuous digital combined model wherein the digital model of the support member extends between the digital model of the base member and the digital model of the orthodontic bracket and/or between the digital model of the base member and the digital model of the placement member; and
“Creating,” “forming,” “positioning,” and “placing” these model elements merely amounts to drawing them in certain configurations using a pen and paper. For example, a person could reasonably draw a tooth and add an orthodontic bracket to the drawn tooth, then draw a structural placement element that cups the bottom of that tooth, along with a base element and support elements that hold the base, placement, and bracket elements together. “Merging” these elements into a single element merely consists of depicting them as combined.
Doing this digitally using one or more computer systems amounts to no more than mere instructions to apply the exception.
Step 2A – Prong 2: Integrated into a Practical Solution?
Insignificant Extra-Solution Activity (MPEP 2106.05(g)) has found mere data gathering and
post solution activity to be insignificant extra-solution activity.
Data gathering:
(A) receiving, by one or more computer systems, three- dimensional data representing a digital impression of a patient's tooth; (B) receiving, by the one or more computer systems, a digital model of an orthodontic bracket;
When recited at such a high level without any detail as to how this data is “received,” these limitations merely amount to gathering data.
Post-solution activity:
A method of manufacturing an orthodontic bracket system, the method comprising: … (H)three-dimensionally printing, using a three-dimensional printer, and in a single print operation, the digital combined model to form a physical orthodontic bracket system, wherein the physical orthodontic bracket system includes an orthodontic bracket, a placement member, a base member, and a support member as a single integral unit.
Printing the designed model in a generic manner without any details as to how the printing is actually performed amounts to no more than acting on the results of the abstract idea, equivalent to a final step of actually cutting hair after an abstract process, to which the claims are directed, of designing the hairstyle. Therefore, this element is merely insignificant post-solution activity.
Mere Instructions to Apply (MPEP 2106.05(f)) has found that merely applying a judicial exception such as an abstract idea, as by performing it on a computer, does not integrate the claim into a practical solution.
Mere Instructions to Apply:
Mere Instructions To Apply An Exception (MPEP 2106.05(f)) has found that simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. In light of this, the additional generic computer component elements of “one or more computer systems; three- dimensional data representing a digital impression of a patient's tooth; computationally creating, by the one or more computer systems, a digital model; a digital model of an orthodontic bracket; a digital model of a placement member; a digital model of a base member; a digital model of a support member; a continuous digital combined model” are not sufficient to integrate a judicial exception into a practical application nor provide evidence of an inventive concept.
Step 2B: Claim provides an Inventive Concept?
No, as discussed with respect to Step 2A, the additional limitations are Insignificant Extra-Solution Activity or Mere Instructions To Apply An Exception and do not impose any meaningful limits on practicing the abstract idea and therefore the claim does not provide an inventive concept in Step 2B.
Insignificant Extra-Solution Activity (MPEP 2106.05(g)) has found mere data gathering and
post solution activity to be insignificant extra-solution activity.
Data gathering:
(A) receiving, by one or more computer systems, three- dimensional data representing a digital impression of a patient's tooth; (B) receiving, by the one or more computer systems, a digital model of an orthodontic bracket;
When recited at such a high level without any detail as to how this data is “received,” these limitations merely amount to gathering data.
A claim element that amounts to merely gathering data is not indicative of integration into a
practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
Post-solution activity:
A method of manufacturing an orthodontic bracket system, the method comprising: … (H)three-dimensionally printing, using a three-dimensional printer, and in a single print operation, the digital combined model to form a physical orthodontic bracket system, wherein the physical orthodontic bracket system includes an orthodontic bracket, a placement member, a base member, and a support member as a single integral unit.
Printing the designed model in a generic manner without any details as to how the printing is actually performed amounts to no more than acting on the results of the abstract idea, equivalent to a final step of actually cutting hair after an abstract process, to which the claims are directed, of designing the hairstyle. Therefore, this element is merely insignificant post-solution activity.
This element merely acts on the results of the previous abstract steps. A claim element that merely acts on a series of previous abstract steps is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept, as exemplified by ((MPEP 2106.05)(g)(Insignificant application) i. Cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016) and ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.)
Mere Instructions to Apply (MPEP 2106.05(f)) has found that merely applying a judicial exception such as an abstract idea, as by performing it on a computer, does not integrate the claim into a practical solution.
Mere Instructions to Apply:
Mere Instructions To Apply An Exception (MPEP 2106.05(f)) has found that simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. In light of this, the additional generic computer component elements of “one or more computer systems; three- dimensional data representing a digital impression of a patient's tooth; computationally creating, by the one or more computer systems, a digital model; a digital model of an orthodontic bracket; a digital model of a placement member; a digital model of a base member; a digital model of a support member; a continuous digital combined model” are not sufficient to integrate a judicial exception into a practical application nor provide evidence of an inventive concept.
Well-Understood, Routine, Conventional Activity (WURC) has found that claim elements that are understood to be Well-Understood, Routine, Conventional Activity are not indicative of Integration into a Practical Solution nor evidence of an Inventive Concept (MPEP 2106.05(d))
WURC:
A method of manufacturing an orthodontic bracket system, the method comprising: … (H)three-dimensionally printing, using a three-dimensional printer, and in a single print operation, the digital combined model to form a physical orthodontic bracket system,…
Digital workflows in contemporary orthodontics ([Page 14 Col 1 Par 1 – Page 16 Col 2 Par 2])
A Modeling Method of Customized Brackets and Individualized Trays for Orthodontic Treatment ([Abstract])
In-house computer-aided design and 3-dimensional printing of customized orthodontic brackets using hybrid ceramic resin: Is it the time for the orthodontist to take over? ([Abstract, Page 187 Col 2 Par 1 – Page 188 Col 1 Par 1])
Be your own manufacturer: 3D printing intraoral appliances ([Abstract, Page 184 Col 2 Par 1- Page 187 Col 1 Par 1])
The additional elements have been considered both individually and as an ordered combination in the consideration of whether they constitute significantly more, and have been determined not to constitute such.
The claim is ineligible.
Claim 18 The elements of claim 18 are substantially the same as those of claim 1. Therefore, the elements of claim 18 are rejected due to the same reasons as outlined above for claim 1.
As for the elements found in claim 18 but not in claim 1:
receiving, by one or more computer systems, three-dimensional scan data representing a digital impression of a patient's tooth, the three-dimensional scan data being captured by a physical intraoral scanner configured to digitize the three-dimensional geometry of the patient's tooth;
Receiving scan data in a generic manner using a 3D scanner amounts to no more than mere data gathering.
A claim element that amounts to merely gathering data is not indicative of integration into a
practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
Moreover, Mere Instructions To Apply An Exception (MPEP 2106.05(f)) has found that simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. In light of this, the additional generic computer component elements of “one or more computer systems; three- dimensional scan data representing a digital impression of a patient's tooth; a physical intraoral scanner configured to digitize the three-dimensional geometry of the patient's tooth; a digital model of an orthodontic bracket; computationally creating, by the one or more computer systems, a digital model of a placement member; a digital model of a base member; a digital model of a support member; a continuous digital combined model” are not sufficient to integrate a judicial exception into a practical application nor provide evidence of an inventive concept.
Claim 4 recites “wherein creating the hollow shell in (D) further comprises: (D)(1) isolating, by the one or more computer systems, a lower portion of the digital impression of the patient's tooth; (D)(2) hollowing, by the one or more computer systems, the isolated lower portion of the digital impression of the patient's tooth to create the hollow shell.”
This merely clarifies aspects of the mental process of forming the model and how it is drawn, and is therefore merely an extension of the mental process, mere data gathering, and mere instructions to apply.
Claim 5 recites “further comprising: (D)(2) forming, by the one or more computer systems, sidewalls of a desired thickness of the hollow shell.”
This merely clarifies aspects of the mental process of forming the model and how it is drawn, and is therefore merely an extension of the mental process, mere data gathering, and mere instructions to apply.
Claim 6 recites “wherein an inner surface of the hollow shell includes the at least one support surface.”
This merely clarifies details about the structure of the drawn model, and is therefore merely an extension of the mental process, mere data gathering, and mere instructions to apply.
Claim 7 recites “wherein the placing of the at least one support surface of the placement member digital model onto the at least one matching contour of the digital impression of the patient's tooth in (E) includes placing the hollow shell onto the lower portion of the digital impression of the patient's tooth.”
This merely clarifies aspects of how the elements are drawn when forming the model and is therefore merely an extension of the mental process, mere data gathering, and mere instructions to apply.
Claim 8 recites “(I) applying a bonding agent to a back side of the orthodontic bracket; (J) placing the placement member onto the patient's tooth; wherein placing the placement member onto the patient's tooth places the back side of the orthodontic bracket onto a front surface of the patient's tooth.”
These limitations merely clarify further steps taken to act on the results of the abstract idea, the claims being directed to the abstract idea itself, and therefore merely amounts to insignificant post-solution activity.
A claim element that merely acts on a series of previous abstract steps is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept, as exemplified by ((MPEP 2106.05)(g)(Insignificant application) i. Cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016) and ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.)
Claim 9 recites “further comprising: (K) disconnecting the support member from the orthodontic bracket.”
This limitation merely clarifies a further step taken to act on the results of the abstract idea, the claims being directed to the abstract idea itself, and therefore merely amounts to insignificant post-solution activity.
A claim element that merely acts on a series of previous abstract steps is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept, as exemplified by ((MPEP 2106.05)(g)(Insignificant application) i. Cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016) and ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.)
Claim 19 recites “wherein creating the hollow shell in (D) further comprises: (D)(1) isolating, by the one or more computer systems, a lower portion of the digital impression of the patient's tooth; (D)(2) hollowing, by the one or more computer systems, the isolated lower portion of the digital impression of the patient's tooth to create the hollow shell; wherein an inner surface of the hollow shell includes the at least one support surface.”
This merely clarifies aspects of the mental process of forming the model and how it is drawn, and is therefore merely an extension of the mental process, mere data gathering, and mere instructions to apply.
Claims 20-22 The elements of claims 19-22 are substantially the same as those of claims 5 and 7-9 (note that claim 22 is the combination of claims 8 and 9). Therefore, the elements of claims 20-22 are rejected due to the same reasons as outlined above for claims 5 and 7-9.
Claim Rejections - 35 USC § 103
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.
(1) Claims 1, 6, 8-9, 18, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Digital workflows in contemporary orthodontics (Hereinafter Christensen) in view of In-house computer-aided design and 3-dimensional printing of customized orthodontic brackets using hybrid ceramic resin: Is it the time for the orthodontist to take over? (Hereinafter Panayi)
Claim 1. Christensen teaches A method of manufacturing an orthodontic bracket system, the method comprising: ([Abstract] “Digital workflows are now increasingly possible in orthodontic practice. Workflows designed to improve the customization of orthodontic appliances are now available through laboratories and orthodontic manufacturing facilities in many parts of the world. These now have the potential to improve certain aspects of patient care.”) (A) receiving, by one or more computer systems, three- dimensional data representing a digital impression of a patient's tooth; ([Page 12 Col 1 Par 1] “Intraoral three-dimensional (3D) data can be collected in many ways…” [Page 12 Col 2 Par 5- Page 13 Col 1 Par 1] “Having acquired the 3D data, they are usually saved in a Standard Triangulation Language (STL) format. The majority of the capturing systems are now “open” which means that we are able to use the STL files in various programs. There are usually several types of subscriptions or contracts available with the chosen scanner provider that will allow the user to export the data set either directly to a laboratory of choice or to other programs with specific functions for data manipulation. It is certainly recommended to research the various devices and subscriptions to ensure that the type of device and the output it produces are applicable to the functions the operator would like to use the data for.” [Figure 2] Shows an example of scanned tooth data)
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(B) receiving, by the one or more computer systems, a digital model of an orthodontic bracket; (C) positioning, by the one or more computer systems, the digital model of the orthodontic bracket onto the digital impression of the patient's tooth; ([Page 14 Col 1 Par 1 -Par 3] “The most frequent use of the 3D dataset so far has been for the production of bonding trays for indirect bonding. So far, we have tried three principal pathways; pressure-formed bonding trays, transparent and nontransparent silicone bonding trays, and direct 3D-printed bonding trays. With the help of commercially available software, we can place the brackets on the 3D model and use tools to help facilitate the most accurate placement of the brackets [Figure 5]. Some software options offer the option to review the aligned brackets and teeth with a full-size wire, giving the clinician an indication of the 3D outcome after alignment of the dentition with the chosen bracket position [Figure 6]. The clinician can then modify the bracket position virtually and improve the predicted outcome… Personally, I find it far simpler to review the bracket positions on the virtual model because of the multiple views we can obtain at the click of a button.” [Figures 3, 5, and 6] Show examples of bracket design systems)
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(D) computationally creating by the one or more computer systems, a digital model of a placement member comprising a hollow shell including at least one support surface that geometrically matches at least one contour of the digital impression of the patient's tooth, such that the hollow shell is configured to receive the patient's tooth such that the at least one support surface positionally registers against the patient's tooth; (E) placing, by the one or more computer systems, the at least one support surface of the placement member digital model onto the at least one matching contour of the digital impression of the patient's tooth; ([Page 14 Col 2 Par 2 – Page 15 Col 1 Par 1] “Our latest and most significant development in labial indirect bonding is to be able to print the bonding tray directly ... With the recently available, flexible biocompatible indirect bonding tray material (NextDent Ortho IBT) developed by NextDent, Eindhoven, NL, we are now able to design the bonding tray using Appliance Designer (3Shape, DK) [Figure 9] and output the design directly to a dental 3D printer [Figure 10].” [Figure 9] Shows the model of the placement member and bracket, which is matched to the contours of the teeth, overlaid on the tooth model.)
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(F) forming, by the one or more computer systems, a digital model of a base member;
(G) forming, by the one or more computer systems, a digital model of a support member, digitally merging the digital model of ([Page 14 Col 1 Par 1 - Page 15 Col 1 Par 1] “The most frequent use of the 3D dataset so far has been for the production of bonding trays for indirect bonding. So far, we have tried three principal pathways; pressure-formed bonding trays, transparent and nontransparent silicone bonding trays, and direct 3D-printed bonding trays. … Once the clinician has validated the bracket positions, the bonding trays can be manufactured. This can be achieved Figure 3: The Incognito Treatment Management Portal used in the order and review process of the Incognito customized lingual appliance in several ways; a 3D-printed model can be produced with the virtually placed brackets and a bonding tray can be produced on this model [Figures 7 and 8]. …. Our latest and most significant development in labial indirect bonding is to be able to print the bonding tray directly and without the need of a model. With the recently available, flexible biocompatible indirect bonding tray material (NextDent Ortho IBT) developed by NextDent, Eindhoven, NL, we are now able to design the bonding tray using Appliance Designer (3Shape, DK) [Figure 9] and output the design directly to a dental 3D printer [Figure 10]. At the time of writing this, only the Rapid Shape 3D printer (Rapid Shape GMBH, Germany) has specifications for this material. The material thickness can be selected exactly to the individual clinician’s preference. We chose to cover the entire bracket with 0.5 mm tray material and then digitally add a second layer of 1.5 mm for the incisal/occlusal part of the bracket. By covering the lingual surface, it is easy to get a very clear fit of the tray, and in cases with severe irregularity, we will add extra material on the occlusal aspect of the bonding tray to increase the stiffness of the bonding tray.”[Figure 10] Shows the 3D printed bonding tray. As can be seen from the structure, the final unit includes the main placement member with brackets, a base piece, and support members running between the base and the placement member. See annotated figure below. )
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Christensen does not explicitly teach digitally merging the digital model of the orthodontic bracket, the digital model of the placement member, the digital model of the base member and the digital model of the support member to create a continuous digital combined model; three-dimensionally printing, in a single print operation, the digital combined model to form a physical orthodontic bracket system, wherein the physical orthodontic bracket system includes an orthodontic bracket, a placement member, a base member, and a support member as a single integral unit.
Panayi makes obvious digitally merging the digital model of the orthodontic bracket, the digital model of the placement member, the digital model of the base member and the digital model of the support member to create a continuous digital combined model; three-dimensionally printing, in a single print operation, the digital combined model to form a physical orthodontic bracket system, wherein the physical orthodontic bracket system includes an orthodontic bracket, a placement member, a base member, and a support member as a single integral unit. ([Abstract] “Our case report used a novel orthodontic CAD software named UBrackets to design in-house customized orthodontic brackets. Three-dimensional printing was per formed in the orthodontic office using a permanent crown ceramic resin. The complete customized fixed appliance’s design, printing, postprinting, and bonding workflow are also presented.” [Page 190 Col 1 Par 1 – Col 2 Par1] “The virtual brackets were positioned on the virtual printer platform of Preform software in a specific orientation that would facilitate the accurate printing of the brackets, giving attention to the slots (Fig 10). Printing time was performed in 40 minutes with a 50 mm resolution. After printing, the brackets were immersed in Formlab’s Form Wash washing machine containing 91% isopropyl alcohol for 3 minutes to remove the residual resin. The brackets were then removed from the printer’s platform and carefully washed manually with isopropyl alcohol. Dry air was used to remove any residual resin and alcohol. Ultraviolet (UV) light curing was performed in Formlab’s Form Cure unit for 20 minutes.”[Fig. 3] Shows a full printed setup for a tooth including the bracket, supports, placement member, and base)
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Panayi is analogous art because it is within the field of digital dentistry and the development of dental treatments through the use of 3D printing. It would have been obvious to one of ordinary skill in the art to combine it with Christensen before the effective filing date. One of ordinary skill in the art would have been motivated to make this combination in order to generate more accurate brackets. As noted by Panayi, producing custom-fit orthodontic brackets in an accessible, in-house manner was previously made extremely difficult for a variety of reasons, with the few practical applications being only possible through the use of specialized printing technologies and materials that often were significantly inaccurate and requiring extensive training. ([Page 188 Col 1 Par 2] “At this time, customized orthodontic brackets are only manufactured by external companies offering this service to orthodontists. A few sporadic attempts have recently been made to accomplish customized bracket production in house; however, thus far, these attempts have only been academic, in the form of research involving the applications of emerging technology. Customized brackets were also designed using general-purpose CAD software called Meshmixer (Autodesk, San Raphael, Calif) and printed in cobalt-chromium (CoCr) alloy using a selective laser melting printer.12 Nevertheless, printing CoCr brackets using powder bed fusion technology did not result in accurate printing, especially for parts that require high printing resolution, such as the bracket slots. Using nonorthodontic CAD software to design customized orthodontic brackets proved difficult, demanding excellent knowledge of CAD software.”) To this end Panayi presents a method for orthodontic bracket 3D printing that is easier to use for orthodontists while allowing for printing on common commercial 3D printers ([Page 188 Col 1 Par 2 – Col 2 Par 1] “Using nonorthodontic CAD software to design customized orthodontic brackets proved difficult, demanding excellent knowledge of CAD software. For that reason, new orthodontic CAD software for the in-house design of customized brackets was developed by Deltaface (Coruo, Limoges, France).12 The software, named UBrackets, enables the orthodontist to design customized brackets in compliance with the concept of orthodontic treatment with the end in mind. Briefly, the bracket customization design involves importing the dental arches in 3D stereolithography (SLA) format, the orientation of the dental arches, creating virtual dental models, the segmentation of the teeth (Fig 1), defining the local axes of the roots, and finally performing a digital setup of the teeth (Fig 2). … UBrackets can be used to design customized orthodontic brackets in 2 ways… The second way of designing customized brackets involves the full printing of the brackets in an in-house model using a permanent crown ceramic resin manufactured by Formlabs (Somerville, Mass) (Fig 3).” [Page 191 Col 1 Par 1] “Customized labial orthodontic brackets were designed using UBrackets CAD software and printed with Formlabs 3B printer using Formlabs permanent crown resin. Designing took approximately 15 minutes to perform, whereas the printing and postprinting procedure took 1.5 hours.”) Overall, one of ordinary skill in the art would have recognized that combining Panayi with Christensen would result in a system that was simpler to operate and allowed for easier printing of the entire structure.
Claim 6. Christensen teaches wherein an inner surface of the hollow shell includes the at least one support surface. ([Figure 9] Shows the design of the placement member. As can be seen, the inner surface of the member matches the contour of the teeth. This is equivalent to the claimed support contour.)
Claim 8. Christensen teaches further comprising: (I) applying a bonding agent to a back side of the orthodontic bracket; (J) placing the placement member onto the patient's tooth; wherein placing the placement member onto the patient's tooth places the back side of the orthodontic bracket onto a front surface of the patient's tooth. ([Figure 10] Shows the bonding process. The ‘light curing’ referred to in the caption describes curing the bonding agent that had been applied to the back of the brackets before being placed on the front side of the teeth.)
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Claim 9. Christensen teaches further comprising: (K) disconnecting the support member from the orthodontic bracket. ([Figure 10] Shows the system in place in the mouth after bonding and describes bending the support system (i.e. the placement member, support members, and base member) away and removing it. As can be seen from (c), the support structures including the support members are still attached at the time of bonding.)
Claims 18 and 22. The elements of claims 18 and 22 are substantially the same as those of claims 1 and 8-9 (note that claim 22 is the combination of claims 8 and 9). Therefore, the elements of claims 18 and 22 are rejected due to the same reasons as outlined above for claims 1 and 8-9. Further, Christensen makes obvious the additional elements of claim 18, particularly “the three-dimensional scan data being captured by a physical intraoral scanner configured to digitize the three-dimensional geometry of the patient's tooth;” ([Page 12 Col 1 Par 1] “Intraoral three-dimensional (3D) data can be collected in many ways…” [Page 12 Col 2 Par 3- Page 13 Col 1 Par 1] “Several of the intraoral scanners are now able to produce study and working models in color,[2] increasing the diagnostic and treatment planning options. Clinicians have a wide variety of devices to choose from. The purpose of this paper is not to advocate a certain device. It is intended simply to illustrate some of the possible workflows with digital data capture. Our preferred choice is the Trios® 3 intraoral scanner (3Shape, Copenhagen, Denmark).Having acquired the 3D data, they are usually saved in a Standard Triangulation Language (STL) format. The majority of the capturing systems are now “open” which means that we are able to use the STL files in various programs. There are usually several types of subscriptions or contracts available with the chosen scanner provider that will allow the user to export the data set either directly to a laboratory of choice or to other programs with specific functions for data manipulation. It is certainly recommended to research the various devices and subscriptions to ensure that the type of device and the output it produces are applicable to the functions the operator would like to use the data for.” [Figure 2] Shows an example of scanned tooth data)
(2) Claims 4-5, 7, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Digital workflows in contemporary orthodontics (Hereinafter Christensen) in view of In-house computer-aided design and 3-dimensional printing of customized orthodontic brackets using hybrid ceramic resin: Is it the time for the orthodontist to take over? (Hereinafter Panayi) in further view of A Modeling Method of Customized Brackets and Individualized Trays for Orthodontic Treatment (Hereinafter Xing)
Claim 4. Christensen teaches wherein creating the hollow shell in (D) further comprises: (D)(1) isolating, by the one or more computer systems, a lower portion of the digital impression of the patient's tooth; ([Figure 9] Shows the design of the placement member. Note how it only covers the bottom of the tooth.)
The combination of Christensen and Panayi does not explicitly teach (D)(2) hollowing, by the one or more computer systems, the isolated lower portion of the digital impression of the patient's tooth to create the hollow shell.
Xing makes obvious (D)(2) hollowing, by the one or more computer systems, the isolated lower portion of the digital impression of the patient's tooth to create the hollow shell. ([Page 4 Col 1 Par 1] “As shown in Fig. 7, the initial tray MPretray is obtained, but it is obvious that interference is existed with tooth and bracket. It is the presence of the interference that provides possibility to build the functional surface of tray, namely we remove the interference regions to realize tray positioning. On the other hand, in order to implementation of the bracket laying and the tray removing, we adopt isometric extrude method to build model MSlot and MWing based on the contour CSlot and CWing, then cut off the contact sections between tray and them. The tray modeling process above by Boolean operation can be expressed as: MTray=MPretray-MTooth-MBracket-MSlot-MWing.” [Figure 7] Shows the process described in Par 1 of forming the inner geometry of the shell by subtracting or “hollowing” out the shape of the tooth impression.)
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Xing is analogous art because it is within the field of orthodontic treatment development using 3D printing. It would have been obvious to one of ordinary skill in the art to combine it with Christensen and Panayi before the effective filing date. One of ordinary skill in the art would have been motivated to make this combination in order to make the printing process faster and more inexpensive. As noted by Xing, previous methods for designing and producing orthodontic treatments using 3D printing have suffered from lengthy processes and high-accuracy (and therefore cost) demands to produce workable pieces. ([Page 1 Col 1 Par 2 – Col 2 Par 1] “In recent years, advances in computer-aided design and computer-aided manufacturing (CAD/CAM) provide new possibilities in orthodontics. CAD/CAM has enabled visual treatment option [4-5], customized bracket design [6-7], indirect bonding system design [8-9] and so on. Wiechmann et al. [7] proposed a method for designing the personalized bracket with uniform thickness base according to the tooth surface form. However, this method is time-consuming and based on a mass of manual interactions. Ciuffolo et al. [8] introduced a method of tray preparation for indirect bracket bonding. Although this method improves the bonding accuracy, the bracket can easily get loose or even fall when the tray removed. Dirac [9] developed a combined tray including labial side and lingual part, but it requires high manufacturing accuracy which leads to high cost. Regardless of whether the brackets or the trays are researched in the world, there are imbalance problems among reasonability, efficiency, and cost and so on. In addition, additive manufacturing (AM) technology is a high-end procedure in which a solid object is produced from a digital model [10]. It has many characteristics, such as cost saving, processing cycle time reduction, etc. The rapid development of AM provides reliable support for model manufacturing after digital design [11-12].”) To this end, Xing presents a method for orthodontic treatment design and production that is significantly more efficient and accurate without requiring high-cost techniques. ([Page 1 Col 2 Par 2] “This paper presents a new automatic modeling method of brackets and trays for orthodontic treatment, including two aspects: firstly, custom brackets are designed in accordance with tooth surface morphology; secondly, individual trays are built quickly by isometric extrude operation and Boolean operation. What’s more, the efficiency of modeling and the bracket bonding accuracy are analyzed respectively.” [Page 5 Col 1 Par 1 - Col 2 Par 1] “TABLE II shows the statistical result of the deviation before and after bonding. In the process of traditional orthodontic treatment, the accuracy value of bracket bonded is usually about 0.16 mm. Thus, the result of error analysis demonstrates that the bonded bracket has higher position precision, and can meet the requirements of Orthodontics. This paper proposes an automatic modeling method of customized brackets and individualized trays by CAD/CAM technology. The experimental results show that the design method has higher efficiency and bonding precision, so it can help the clinician to place the brackets accurately in short time. The modeling method provides a new way for the design of orthodontic device. In the next step, we will complete the manufacture of brackets and trays based on 3D printing technology, and apply them for clinical orthodontic treatment. According to the results of clinical trials, we will further analyze and optimize the design process.”) Overall, one of ordinary skill in the art would have recognized that combining Xing with Christensen and Panayi would result in a system that is significantly more precise without requiring significant additional costs.
Claim 5. Christensen teaches further comprising: (D)(3) forming, by the one or more computer systems, sidewalls of a desired thickness of the hollow shell. ([Figure 9] Shows the model of the placement member. As can be seen, there are sidewalls of a certain thickness. [Page 14 Col 2 Par 2 – Page 15 Col 1 Par 1] “The material thickness can be selected exactly to the individual clinician’s preference. We chose to cover the entire bracket with 0.5 mm tray material and then digitally add a second layer of 1.5 mm for the incisal/occlusal part of the bracket. By covering the lingual surface, it is easy to get a very clear fit of the tray, and in cases with severe irregularity, we will add extra material on the occlusal aspect of the bonding tray to increase the stiffness of the bonding tray.”)
Claim 7. Christensen teaches wherein the placing of the at least one support surface of the placement member digital model onto the at least one matching contour of the digital impression of the patient's tooth in (E) includes placing the hollow shell onto the lower portion of the digital impression of the patient's tooth. ([Figure 9] Shows the design of the placement member. As can be seen, the inner surface of the member matches the contour of the teeth. Further, only the lower portion of the teeth are covered.)
Claim 19. Christensen teaches wherein creating the hollow shell in (D) further comprises: (D)(1) isolating, by the one or more computer systems, a lower portion of the digital impression of the patient's tooth; ([Figure 9] Shows the design of the placement member. Note how it only covers the bottom of the tooth.) ([Figure 9] Shows the design of the placement member. As can be seen, the inner surface of the member matches the contour of the teeth. This is equivalent to the claimed support contour.)
The combination of Christensen and Panayi does not explicitly teach (D)(2) hollowing, by the one or more computer systems, the isolated lower portion of the digital impression of the patient's tooth to create the hollow shell.
Xing makes obvious (D)(2) hollowing, by the one or more computer systems, the isolated lower portion of the digital impression of the patient's tooth to create the hollow shell. ([Page 4 Col 1 Par 1] “As shown in Fig. 7, the initial tray MPretray is obtained, but it is obvious that interference is existed with tooth and bracket. It is the presence of the interference that provides possibility to build the functional surface of tray, namely we remove the interference regions to realize tray positioning. On the other hand, in order to implementation of the bracket laying and the tray removing, we adopt isometric extrude method to build model MSlot and MWing based on the contour CSlot and CWing, then cut off the contact sections between tray and them. The tray modeling process above by Boolean operation can be expressed as: MTray=MPretray-MTooth-MBracket-MSlot-MWing.” [Figure 7] Shows the process described in Par 1 of forming the inner geometry of the shell by subtracting or “hollowing” out the shape of the tooth impression.)
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Xing is analogous art because it is within the field of orthodontic treatment development using 3D printing. It would have been obvious to one of ordinary skill in the art to combine it with Christensen and Panayi before the effective filing date. One of ordinary skill in the art would have been motivated to make this combination in order to make the printing process faster and more inexpensive. As noted by Xing, previous methods for designing and producing orthodontic treatments using 3D printing have suffered from lengthy processes and high-accuracy (and therefore cost) demands to produce workable pieces. ([Page 1 Col 1 Par 2 – Col 2 Par 1] “In recent years, advances in computer-aided design and computer-aided manufacturing (CAD/CAM) provide new possibilities in orthodontics. CAD/CAM has enabled visual treatment option [4-5], customized bracket design [6-7], indirect bonding system design [8-9] and so on. Wiechmann et al. [7] proposed a method for designing the personalized bracket with uniform thickness base according to the tooth surface form. However, this method is time-consuming and based on a mass of manual interactions. Ciuffolo et al. [8] introduced a method of tray preparation for indirect bracket bonding. Although this method improves the bonding accuracy, the bracket can easily get loose or even fall when the tray removed. Dirac [9] developed a combined tray including labial side and lingual part, but it requires high manufacturing accuracy which leads to high cost. Regardless of whether the brackets or the trays are researched in the world, there are imbalance problems among reasonability, efficiency, and cost and so on. In addition, additive manufacturing (AM) technology is a high-end procedure in which a solid object is produced from a digital model [10]. It has many characteristics, such as cost saving, processing cycle time reduction, etc. The rapid development of AM provides reliable support for model manufacturing after digital design [11-12].”) To this end, Xing presents a method for orthodontic treatment design and production that is significantly more efficient and accurate without requiring high-cost techniques. ([Page 1 Col 2 Par 2] “This paper presents a new automatic modeling method of brackets and trays for orthodontic treatment, including two aspects: firstly, custom brackets are designed in accordance with tooth surface morphology; secondly, individual trays are built quickly by isometric extrude operation and Boolean operation. What’s more, the efficiency of modeling and the bracket bonding accuracy are analyzed respectively.” [Page 5 Col 1 Par 1 - Col 2 Par 1] “TABLE II shows the statistical result of the deviation before and after bonding. In the process of traditional orthodontic treatment, the accuracy value of bracket bonded is usually about 0.16 mm. Thus, the result of error analysis demonstrates that the bonded bracket has higher position precision, and can meet the requirements of Orthodontics. This paper proposes an automatic modeling method of customized brackets and individualized trays by CAD/CAM technology. The experimental results show that the design method has higher efficiency and bonding precision, so it can help the clinician to place the brackets accurately in short time. The modeling method provides a new way for the design of orthodontic device. In the next step, we will complete the manufacture of brackets and trays based on 3D printing technology, and apply them for clinical orthodontic treatment. According to the results of clinical trials, we will further analyze and optimize the design process.”) Overall, one of ordinary skill in the art would have recognized that combining Xing with Christensen and Panayi would result in a system that is significantly more precise without requiring significant additional costs.
Claims 20-21. The elements of claims 20-21 are substantially the same as those of claims 5 and 7. Therefore, the elements of claims 20-21 are rejected due to the same reasons as outlined above for claims 5 and 7. Further, Christensen makes obvious the additional elements of claim 18, as inherited by claims 20-21, particularly “the three-dimensional scan data being captured by a physical intraoral scanner configured to digitize the three-dimensional geometry of the patient's tooth;” ([Page 12 Col 1 Par 1] “Intraoral three-dimensional (3D) data can be collected in many ways…” [Page 12 Col 2 Par 3- Page 13 Col 1 Par 1] “Several of the intraoral scanners are now able to produce study and working models in color,[2] increasing the diagnostic and treatment planning options. Clinicians have a wide variety of devices to choose from. The purpose of this paper is not to advocate a certain device. It is intended simply to illustrate some of the possible workflows with digital data capture. Our preferred choice is the Trios® 3 intraoral scanner (3Shape, Copenhagen, Denmark).Having acquired the 3D data, they are usually saved in a Standard Triangulation Language (STL) format. The majority of the capturing systems are now “open” which means that we are able to use the STL files in various programs. There are usually several types of subscriptions or contracts available with the chosen scanner provider that will allow the user to export the data set either directly to a laboratory of choice or to other programs with specific functions for data manipulation. It is certainly recommended to research the various devices and subscriptions to ensure that the type of device and the output it produces are applicable to the functions the operator would like to use the data for.” [Figure 2] Shows an example of scanned tooth data)
Conclusion
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/M.P.M./Examiner, Art Unit 2187
/EMERSON C PUENTE/Supervisory Patent Examiner, Art Unit 2187
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