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 12/23/2022
Claims 1-17 are pending in the application.
Claims 10-17 are withdrawn from consideration. See the Election/Restrictions section below.
Information Disclosure Statement
The IDS dated 12/23/2022 has been reviewed. See attached.
Drawings
The drawings dated 12/23/2022 have been reviewed. They are accepted.
Abstract
The abstract dated 12/23/2022 has been reviewed. It has 97 words, and contains no legal phraseology. It is accepted.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-9, drawn to a method of manufacturing an orthodontic bracket system for placement of a bracket and an attached bracket, classified in B29C64/00.
II. Claims 10-17, drawn to a bracket placement jig and bracket system, classified in A61C 7/146.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case the product as claimed could be made by another materially different process such as injection molding.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
Inventions I and II would require a different field of search (e.g. searching different classes/subclasses or electronic resources, or employing different search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Saul Acherman on 27 February 2025 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-9. Affirmation of this election must be made by applicant in replying to this Office action. Claims 10-17 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 1-9 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, 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) forming, by the one or more computer systems, a digital model of a placement member including at least one support contour that matches at least one contour of the digital model of the patient's tooth;
(E) placing, by the one or more computer systems, the at least one support contour 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, the digital model of the support member extending 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
“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.
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, 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) printing, using a three-dimensional printer, 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 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 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; a digital impression of a patient's tooth; 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;” 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, 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) printing, using a three-dimensional printer, 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 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 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; a digital impression of a patient's tooth; 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;” 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) printing, using a three-dimensional printer, 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 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 unit.
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 2 recites “wherein the printing of 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 includes combining 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.”
This limitation amounts to merely storing multiple pieces of data into the same container, which is a form of storing data in memory. With this in mind, storing data in a generic manner is explicitly recognized by the courts as an example of mere instructions to apply the exception. (MPEP 2106.05(f)(2): Whether the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or 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.)
Further the courts have also recognized storing and retrieving data in memory as an example of well-understood, routine conventional activity (MPEP2106.05(d)(II)(iv) Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93;)
Claim 3 recites “wherein the forming of the digital model of the placement member in (D) further comprises: (D)(1) forming a digital shell, by the one or more computer systems.”
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 4 recites “wherein forming a digital shell in (D)(1) further comprises: (D)(2) isolating, by the one or more computer systems, a lower portion of the digital impression of the patient's tooth; (D)(3) hollowing, by the one or more computer systems, the isolated lower portion of the digital impression of the patient's tooth to form the digital 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)(3) forming, by the one or more computer systems, sidewalls of a desired thickness of the digital 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 digital shell includes the at least one support contour.”
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 contour 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 digital 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 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 1-3, and 6-9 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, 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) forming, by the one or more computer systems, a digital model of a placement member including at least one support contour that matches at least one contour of the digital model of the patient's tooth
(E) placing, by the one or more computer systems, the at least one support contour 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, the digital model of the support member extending 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
(H) printing, using a three-dimensional printer, the digital model of the
([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 printing, using a three-dimensional printer, the digital model of the orthodontic bracket.
Panayi makes obvious printing, using a three-dimensional printer, the digital model of the orthodontic bracket. ([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’sForm Cure unit for 20 minutes.”)
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 2. Christensen teaches wherein the printing of the digital model of the ([Figure 9] shows the digital model of the placement model. [Figure 10] shows the final model after printing, including the supports and base. Due to presence of these supports and base printed in the same material and connected to the placement member, it would be obvious to one of ordinary skill in the art that the last version of the file that was printed included these structures)
Panayi makes obvious wherein the printing of the digital model of the orthodontic bracket includes combining the digital model of the orthodontic bracket, the digital model of the base member, and the digital model of the support member into a single printable file. ([Fig. 10] Shows a preview of the printable file. As can be seen, each bracket includes supports and a base.)
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Claim 3. Christensen teaches wherein the forming of the digital model of the placement member in (D) further comprises: (D)(1) forming a digital shell, by the one or more computer systems. ([Figure 9] Shows the design of the placement member. [Examiner’s note: based on the specification [Par 41] “[0041] For example, in some embodiments, as shown in FIG. 3A, a placement member 202 may include a shell member 204 including sidewalls 206 defining an inner volume 208. In some embodiments, the sidewalls 206 and inner volume 208 of each shell member 204 are contoured to generally match the contours and shape of a corresponding portion of a tooth T that the shell member 204 may be designed to engage.” and Fig. 6C of the drawings, the way the model of the placement member fits around the bottom of the digital impression of the teeth is interpreted as being equivalent to this forming of the shell])
Claim 6. Christensen teaches wherein an inner surface of the digital shell includes the at least one support contour. ([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 7. Christensen teaches wherein the placing of the at least one support contour 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 digital 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 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.)
(2) Claims 4-5 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 forming a digital shell in (D)(1) further comprises: (D)(2) 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)(3) hollowing, by the one or more computer systems, the isolated lower portion of the digital impression of the patient's tooth to form the digital shell.
Xing makes obvious (D)(3) hollowing, by the one or more computer systems, the isolated lower portion of the digital impression of the patient's tooth to form the digital 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 digital 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.”)
Conclusion
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/M.P.M./Examiner, Art Unit 2187
/EMERSON C PUENTE/Supervisory Patent Examiner, Art Unit 2187