Notice of Pre-AIA or AIA Status
Claims 34 and 36-56 are currently presented for Examination.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/02/2026 has been considered. The submission is in compliance with the provisions of 37 CFR 1.97. Form PTO-1449 is signed and attached hereto.
Response to Amendment
The amendment filed on 07/02/2026 has been entered and considered by the examiner. By the
amendment, claims 34 and 36 are amended, claim 35 is cancelled and claims 55-56 are newly added. Following Applicants arguments and amendments made, Examiner modify the prior art rejections. And, the 101 rejection is withdrawn. See office action
Applicant arguments
Independent claim 34 is patentable over Morton in view of Raby because these references fail to disclose or suggest each and every feature of claim 34 including, "wherein the appliance digital model comprises an anchor configured to be positioned on and along the patient's gingiva and a plurality of arms extending occlusally away from the anchor, each of the arms comprising a proximal portion at the anchor and a distal portion configured to be secured to an orthodontic bracket."
Examiner response
Following Applicants arguments and amendments, the 102 rejection of the claim 34 is Withdrawn. See
updated 103 below that is necessitated by applicant’s amendment. New reference (Peikar) is added.
Applicant arguments
Applicants argue that the Morton for disclosing the consideration of gingival impingement (or lack thereof) in the aligner design process is improper. In addressing dependent claim 44 ("The method of claim 34, further comprising obtaining an analysis result based on the FEA, wherein the analysis result is identification of portions of the orthodontic appliance that may impinge on a patient's gingiva").
Examiner response
Examiner respectfully disagrees. The claims 34 and 56 does not require proving that the appliance actually impinges on the gingiva because the claim says, “portions of orthodontic appliance that may impinges”. It required analysis result identifying portions that may impinge that is the portions presenting a potential interference/collision with the gingiva. Morton teaches FEA of the orthodontic appliance with the patients’ teeth and tissue and region or gap which corresponds to the portion of the orthodontic appliance (See also para 87-94- If an acceptable end position is reached, the motions of the teeth calculated by the finite elements analysis are evaluated to determine whether they are orthodontically acceptable. Finite element analysis begins to find a solution to the composite model and compute the movement of the teeth under the influence of the distorted aligner. A change in the aligner is calculated in the region of the currently selected tooth. See para 110-114- . For example, changes, distortions and the like can be analyzed or determined computationally in terms of probability of occurrence, as well as whether such changes/distortions would be beneficial or detrimental to the desired loading and tooth movement. In one aspect, to compensate for the undesirable force (for example, as shown in FIG. 15B by the arrow), a predetermined relief (for example, but not limited to, 0.1 to 0.3 mm) may be provided such that the contact between the aligner and the tooth that resulted in the undesirable force vector is avoided. There may be a gap or pocket that forms between the tooth and the aligner, for example, as shown in FIG. 16, near the gingival area)
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 56 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Morton et al. (PUB NO: US20100138025A1)
Regarding claim 56
Morton teaches a method for designing an orthodontic appliance for repositioning a tooth of a patient, (see para 002-003-The present invention relates generally to the field of orthodontics, and more particularly to tooth attachments for engaging a dental repositioning appliance, the attachments having improved or optimized design parameters and/or geometries customized to the individual patient and/or for improved application of a desired force system selected to elicit the identified tooth movement. An objective of orthodontics is to move a patient's teeth to positions where function and/or aesthetics are optimized. See para 007-The present invention provides orthodontic systems and related methods for designing and providing improved or more effective tooth moving systems for eliciting a desired tooth movement and/or repositioning teeth into a desired arrangement.) the method comprising:
obtaining an appliance digital model characterizing the orthodontic appliance in a pre- installation configuration; (see para 87- Inputs to the process include an initial aligner shape 20. Using the input data, the process creates a finite element model of the aligner, attachments, teeth and tissue, with the aligner in place on the teeth (step 210). See para 90-91- As was done with the teeth and tissue, a finite element model is created of the polymeric shell aligner (step 330). The model aligner is then computationally manipulated to place it over the modeled teeth in the model jaw to create a composite model of an in-place aligner (step 340).)
obtaining an anatomy digital model characterizing a patient's teeth and gingiva in an original or intermediate arrangement; (see para 79-80- From the data so obtained, a digital data set is derived that represents the initial (that is, pretreatment) arrangement of the patient's teeth and other tissues. The initial digital data set, which may include both raw data from scanning operations and data representing surface models derived from the raw data, is processed to segment the tissue constituents from each other (step 120). Advantageously, digital models of entire teeth are produced, including measured or extrapolated hidden surfaces and root structures as well as surrounding bone and soft tissue. See para 122- In one aspect, the data set associated with the teeth, gingiva and/or other oral tissue, or structures)
performing an FEA to virtually deform the appliance digital model based on the anatomy digital model. (see para 87-Using the input data, the process creates a finite element model of the aligner, attachments, teeth and tissue, with the aligner in place on the teeth (step 210). Next, the process applies a finite element analysis to the composite finite element model of aligner, teeth, tissue, etc. (step 220). See para 91- finite element analysis is begun to find a solution to the composite model and compute the movement of the teeth under the influence of the distorted aligner.)
obtaining an analysis result based on the FEA, wherein the analysis result is identification of portions of the orthodontic appliance that may impinge on a patient's gingiva. (See also para 87-94- If an acceptable end position is reached, the motions of the teeth calculated by the finite elements analysis are evaluated to determine whether they are orthodontically acceptable. Finite element analysis begins to find a solution to the composite model and compute the movement of the teeth under the influence of the distorted aligner. A change in the aligner is calculated in the region of the currently selected tooth. See para 110-114- . For example, changes, distortions and the like can be analyzed or determined computationally in terms of probability of occurrence, as well as whether such changes/distortions would be beneficial or detrimental to the desired loading and tooth movement. In one aspect, to compensate for the undesirable force (for example, as shown in FIG. 15B by the arrow), a predetermined relief (for example, but not limited to, 0.1 to 0.3 mm) may be provided such that the contact between the aligner and the tooth that resulted in the undesirable force vector is avoided. There may be a gap or pocket that forms between the tooth and the aligner, for example, as shown in FIG. 16, near the gingival area)
fabricating a physical appliance based on the appliance design model. (see para 004-The Invisalign® System includes designing and/or fabricating multiple, and sometimes all, of the aligners to be worn by the patient before the aligners are administered to the patient and used to reposition the teeth (e.g., at the outset of treatment). Often, designing and planning a customized treatment for a patient makes use of computer-based 3-dimensional planning/design tools, such as software technology available from Align Technology, Inc. See para 107- One feature that can be added is a rim around the gumline, which can be produced by adding a digital model wire at the gumline of the digital model teeth from which the aligner is manufactured.)
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
5. Claim(s) 34, 36-42, 44, 45, 49 and 53-55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morton et al. (PUB NO: US20100138025A1) in view of Peikar et al. "(PUB NO: US20170156823A1)
Regarding claim 34
Morton teaches a method for designing an orthodontic appliance for repositioning a tooth of a patient, (see para 002-003-The present invention relates generally to the field of orthodontics, and more particularly to tooth attachments for engaging a dental repositioning appliance, the attachments having improved or optimized design parameters and/or geometries customized to the individual patient and/or for improved application of a desired force system selected to elicit the identified tooth movement. An objective of orthodontics is to move a patient's teeth to positions where function and/or aesthetics are optimized. See para 007-The present invention provides orthodontic systems and related methods for designing and providing improved or more effective tooth moving systems for eliciting a desired tooth movement and/or repositioning teeth into a desired arrangement.) the method comprising:
obtaining an appliance digital model characterizing the orthodontic appliance in a pre- installation configuration; (see para 87- Inputs to the process include an initial aligner shape 20. Using the input data, the process creates a finite element model of the aligner, attachments, teeth and tissue, with the aligner in place on the teeth (step 210). See para 90-91- As was done with the teeth and tissue, a finite element model is created of the polymeric shell aligner (step 330). The model aligner is then computationally manipulated to place it over the modeled teeth in the model jaw to create a composite model of an in-place aligner (step 340).)
wherein the appliance digital model comprises the anchor configured to be positioned on and along the patient's gingiva (see para 105-109- specification of the shapes and positions of any anchors installed on the teeth or otherwise. One feature that can be added is a rim around the gumline, which can be produced by adding a digital model wire at the gumline of the digital model teeth from which the aligner is manufactured. When an aligner is manufactured by pressure fitting polymeric material over a positive physical model of the digital teeth, the wire along the gumlines causes the aligner to have a rim around it providing additional stiffness along the gumline. Optionally, other features are added to the tooth model data sets to produce desired features in the aligners. Structural features such as attachment recesses or engagement portions)
obtaining an anatomy digital model characterizing a patient's teeth and gingiva in an original or intermediate arrangement; (see para 79-80- From the data so obtained, a digital data set is derived that represents the initial (that is, pretreatment) arrangement of the patient's teeth and other tissues. The initial digital data set, which may include both raw data from scanning operations and data representing surface models derived from the raw data, is processed to segment the tissue constituents from each other (step 120). Advantageously, digital models of entire teeth are produced, including measured or extrapolated hidden surfaces and root structures as well as surrounding bone and soft tissue. See para 122- In one aspect, the data set associated with the teeth, gingiva and/or other oral tissue, or structures)
performing an FEA to virtually deform the appliance digital model based on the anatomy digital model. (see para 87-Using the input data, the process creates a finite element model of the aligner, attachments, teeth and tissue, with the aligner in place on the teeth (step 210). Next, the process applies a finite element analysis to the composite finite element model of aligner, teeth, tissue, etc. (step 220). See para 91- finite element analysis is begun to find a solution to the composite model and compute the movement of the teeth under the influence of the distorted aligner.)
fabricating a physical appliance based on the appliance design model. (see para 004-The Invisalign® System includes designing and/or fabricating multiple, and sometimes all, of the aligners to be worn by the patient before the aligners are administered to the patient and used to reposition the teeth (e.g., at the outset of treatment). Often, designing and planning a customized treatment for a patient makes use of computer-based 3-dimensional planning/design tools, such as software technology available from Align Technology, Inc. See para 107- One feature that can be added is a rim around the gumline, which can be produced by adding a digital model wire at the gumline of the digital model teeth from which the aligner is manufactured.)
Morton does not teach wherein the appliance digital model comprises an anchor anchor, each of the arms comprising a proximal portion at the anchor and a distal portion configured to be secured to an orthodontic bracket;
In the related field of invention, Peikar teaches wherein the appliance digital model comprises an anchor and a plurality of arms extending occlusally away from the anchor, each of the arms comprising a proximal portion at the anchor and a distal portion configured to be secured to an orthodontic bracket; (See para 128-132 and fig 8, 10- Each of the appliances 800 and 1000 in FIGS. 8 and 10 may be configured to be installed on an upper jaw of a patient. Each of the appliances 800 and 1000 includes a plurality of separate arms (arms 806 in FIGS. 8 and 1006 in FIG. 10). The examples shown in FIGS. 8 and 10 include twelve arms 806 or 1006. Each arm 806 (or 1006) has one end extending from or otherwise connected to the bar 802 (or 1002) and a second end on which a male connector element 808 (or 1008) is formed or otherwise connected. Each male connector element 808 is configured to engage with a respective female connector element or bracket, when the appliance 800 (or 1000) is installed on a patient's teeth.)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of tooth attachments for engaging a dental repositioning appliance as disclosed by Morton to include wherein the appliance digital model comprises an anchor and a plurality of arms extending occlusally away from the anchor, each of the arms comprising a proximal portion at the anchor and a distal portion configured to be secured to an orthodontic bracket as taught by Peikar in the system of Morton for repositioning teeth, including orthodontic systems and methods that include or employ one or more appliances that are installed (in a removable or non-removable manner) on a patient's teeth. (see para [0003] and abstract, Peikar)
Regarding claim 36
The combination of Morton and Peikar teaches the method of claim 34. Morton does not teach wherein performing the FEA comprises causing the distal portion of the arm to be positioned at or adjacent to one of the patient's teeth.
However, Peikar further teaches wherein performing the FEA comprises causing the distal portion of the arm to be positioned at or adjacent to one of the patient's teeth. (See para 128-132 and fig 8, 10- Each of the appliances 800 and 1000 in FIGS. 8 and 10 may be configured to be installed on an upper jaw of a patient. Each of the appliances 800 and 1000 includes a plurality of separate arms (arms 806 in FIGS. 8 and 1006 in FIG. 10). The examples shown in FIGS. 8 and 10 include twelve arms 806 or 1006. Each arm 806 (or 1006) has one end extending from or otherwise connected to the bar 802 (or 1002) and a second end on which a male connector element 808 (or 1008) is formed or otherwise connected. Each male connector element 808 is configured to engage with a respective female connector element or bracket, when the appliance 800 (or 1000) is installed on a patient's teeth.)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of tooth attachments for engaging a dental repositioning appliance as disclosed by Morton to include causing the distal portion of the arm to be positioned at or adjacent to one of the patient's teeth as taught by Peikar in the system of Morton for repositioning teeth, including orthodontic systems and methods that include or employ one or more appliances that are installed (in a removable or non-removable manner) on a patient's teeth. (see para [0003] and abstract, Peikar)
Regarding claim 37
The combination of Morton and Peikar teaches the method of claim 34. Morton further teaches wherein the anatomy digital model comprises position data of the tooth to be repositioned by the orthodontic appliance when installed in the patient's mouth. (see para 81-82-Generally, in this step, the position of every tooth is specified. Having both a beginning position and a final position for each tooth, the process next defines a tooth path for the motion of each tooth. In one embodiment, the tooth paths are optimized in the aggregate so that the teeth are moved in the quickest fashion with the least amount of round-tripping to bring the teeth from their initial positions to their desired final positions.)
Regarding claim 38
The combination of Morton and Peikar teaches the method of claim 37. Morton further teaches wherein the data is first position data (see para 81-the position of every tooth is specified.)
and the method further comprises: obtaining a desired digital model characterizing the patient's teeth and gingiva in a desired second configuration, (see para 81-The desired final position of the teeth—that is, the desired and intended end result of the orthodontic treatment or phase of orthodontic treatment—can be received from a clinician in the form of a prescription, can be calculated from basic orthodontic principles, or can be extrapolated computationally from a clinical prescription (step 130). . With a specification of the desired final positions of the teeth and a digital representation of the teeth themselves, the final position and surface geometry of each tooth can be specified (step 140) to form a complete model of the teeth at the desired end of treatment.)
the desired digital model comprising second position data of the tooth, (see para 81-With a specification of the desired final positions of the teeth and a digital representation of the teeth themselves, the final position and surface geometry of each tooth can be specified (step 140) to form a complete model of the teeth at the desired end of treatment. Generally, in this step, the position of every tooth is specified.)
determining displacement data characterizing a displacement between the first position data of the tooth and the second position data of the tooth, (see para 82-Having both a beginning position and a final position for each tooth, the process next defines a tooth path for the motion of each tooth (step 150). The tooth paths are segmented.)
and wherein performing the FEA is based on the displacement data. (see para 87-Inputs to the process include an initial aligner shape 202, various control parameters 204, and a desired end configuration for the teeth at the end of the current treatment path segment 206. Next, the process applies a finite element analysis to the composite finite element model of aligner, teeth, tissue, etc. (step 220). See para 92From the input path information, the input data 404 includes the initial tooth positions for the current path segment, the desired tooth positions at the end of the current path segment, the maximum allowable displacement velocity for each tooth, and the maximum allowable force of each kind for each tooth.)
Regarding claim 39
The combination of Morton and Peikar teaches the method of claim 34. Morton further teaches obtaining a deformed intended appliance digital model from the FEA, (see para 87-Using the input data, the process creates a finite element model of the aligner, attachments, teeth and tissue, with the aligner in place on the teeth (step 210). See para 91-The model aligner is then computationally manipulated to place it over the modeled teeth in the model jaw to create a composite model of an in-place aligner (step 340). Optionally, the forces required to deform the aligner to fit over the teeth, including any hardware attached to the teeth, are computed and used as a figure of merit in measuring the acceptability of the particular aligner configuration. Optionally, the tooth positions used are as estimated from a probabilistic model based on prior treatment steps and other patient information. In a simpler alternative, however, the aligner deformation is modeled by applying enough force to its insides to make it large enough to fit over the teeth, placing the model aligner over the model teeth in the composite model, setting the conditions of the model teeth and tissue to be infinitely rigid, and allowing the model aligner to relax into position over the fixed teeth.)
wherein the deformed intended appliance digital model virtually represents the orthodontic appliance once it has been installed in a patient's mouth with the teeth and gingiva in the original or intermediate arrangement. (see para 91- The model aligner is then computationally manipulated to place it over the modeled teeth in the model jaw to create a composite model of an in-place aligner (step 340). See para 79-82-From the data so obtained, a digital data set is derived that represents the initial (that is, pretreatment) arrangement of the patient's teeth and other tissues. The initial digital data set, which may include both raw data from scanning operations and data representing surface models derived from the raw data, is processed to segment the tissue constituents from each other (step 120). Advantageously, digital models of entire teeth are produced, including measured or extrapolated hidden surfaces and root structures as well as surrounding bone and soft tissue. The tooth paths are segmented. The segments are calculated so that each tooth's motion within a segment stays within threshold limits of linear and rotational translation. In this way, the end points of each path segment can constitute a clinically viable repositioning. See para 87-Other inputs include digital models of the teeth in position in the jaw, models of the jaw tissue, attachment placement and configuration, and specifications of an initial aligner shape and of the aligner material. See para 122- In one aspect, the data set associated with the teeth, gingiva and/or other oral tissue, or structures)
Regarding claim 40
The combination of Morton and Peikar teaches the method of claim 34. Morton further teaches modifying a fixture digital model based on an analysis result of the FEA virtual deformation. (see para 103- For example, if any impossible movements were required (step 620), that is, if the shape calculation process 200 (FIG. 10B) was required to effect a motion for which no rule or adjustment was available, the process 600 proceeds to execute a module that calculates the configuration of a hardware attachment to the subject tooth to which forces can be applied to effect the required motion (step 640). See para 110-Thus, one or more tooth attachments can be selectively added, modified/customized, and included in appliance design and fabrication, with appliance and attachment design and fabrication. See para 87- If an acceptable end position is reached, the motions of the teeth calculated by the finite elements analysis are evaluated to determine whether they are orthodontically acceptable (step 232). If they are not, the process also proceeds to calculate a new candidate aligner shape (step 240). If the motions are orthodontically acceptable and the teeth have reached an acceptable position, the current aligner shape is compared to the previously calculated aligner shapes)
Regarding claim 41
The combination of Morton and Peikar teaches the method of claim 34. Morton further teaches modifying the appliance digital model based on an analysis result of the FEA virtual deformation. (See para 87- If an acceptable end position is reached, the motions of the teeth calculated by the finite elements analysis are evaluated to determine whether they are orthodontically acceptable (step 232). If they are not, the process also proceeds to calculate a new candidate aligner shape (step 240). If the motions are orthodontically acceptable and the teeth have reached an acceptable position, the current aligner shape is compared to the previously calculated aligner shapes. See para 119- Based on the movement vector, and the modeled aligner and/or attachment, the aligner and/or attachment is further modified or reconfigured to factor in the determined movement vector)
Regarding claim 42
The combination of Morton and Peikar teaches the method of claim 34. Morton further teaches wherein modifying the appliance digital model comprises modifying a shape and/or configuration of an anchor and/or arms of the orthodontic appliance and/or a geometry of the pre-installation configuration of the orthodontic appliance. (see para 61-Attachment parameters having values that can be selected/modified according to the present invention include any parameter or feature of an attachment that, if modified, effects a force or torque applied to a patient's tooth, on which it is disposed, during orthodontic treatment. Generally speaking, non-limiting examples of attachment parameters can include or relate to attachment, in whole or in part, geometry, shape, sizing, composition, positioning, and the like. Attachment parameter values can be selected or modified for optimization (e.g., selected movement optimization) and/or patient customization. See para 103-the process 600 proceeds to execute a module that calculates the configuration of a hardware attachment to the subject tooth to which forces can be applied to effect the required motion. See para 110-Thus, one or more tooth attachments can be selectively added, modified/customized, and included in appliance design and fabrication, with appliance and attachment design and fabrication, and incorporation of appliances in a treatment plan as described above.)
Regarding claim 44
The combination of Morton and Peikar teaches the method of claim 34. Morton further teaches obtaining an analysis result based on the FEA, wherein the analysis result is identification of portions of the orthodontic appliance that may impinge on a patient's gingiva. (See also para 87- If an acceptable end position is reached, the motions of the teeth calculated by the finite elements analysis are evaluated to determine whether they are orthodontically acceptable. See para 91- finite element analysis is begun to find a solution to the composite model and compute the movement of the teeth under the influence of the distorted aligner. See para 110-114- . For example, changes, distortions and the like can be analyzed or determined computationally in terms of probability of occurrence, as well as whether such changes/distortions would be beneficial or detrimental to the desired loading and tooth movement. In one aspect, to compensate for the undesirable force (for example, as shown in FIG. 15B by the arrow), a predetermined relief (for example, but not limited to, 0.1 to 0.3 mm) may be provided such that the contact between the aligner and the tooth that resulted in the undesirable force vector is avoided. There may be a gap or pocket that forms between the tooth and the aligner, for example, as shown in FIG. 16, near the gingival area)
Regarding claim 45
The combination of Morton and Peikar teaches the method of claim 34. Morton further teaches obtaining an analysis result based on the FEA, wherein the analysis result is a local distance between a portion of the appliance digital model and a portion of the . (See para 80- Advantageously, digital models of entire teeth are produced, including measured or extrapolated hidden surfaces and root structures as well as surrounding bone and soft tissue. See para 87-the motions of the teeth calculated by the finite elements analysis are evaluated to determine whether they are orthodontically acceptable. See para 148-If the movement is more than a specified threshold, the tooth is identified as requiring an attachment. see para 151-152-In addition, the constraint thresholds should be satisfied, such as the distance to the gingival curve.)
Morton does not teach lingual surface of the patient’s gingiva.
However, Peikar further teaches lingual surface of the patient’s gingiva. (see para 117- FIG. 7 shows a representation of an OTA image of an upper and a lower jaw of a patient, on which examples of female connector elements 700 are attached to the lingual surface of the teeth, on the upper and lower arches)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of tooth attachments for engaging a dental repositioning appliance as disclosed by Morton to include lingual surface of the patient’s gingiva as taught by Peikar in the system of Morton for repositioning teeth, including orthodontic systems and methods that include or employ one or more appliances that are installed (in a removable or non-removable manner) on a patient's teeth. (see para [0003] and abstract, Peikar)
Regarding claim 49
The combination of Morton and Peikar teaches the method of claim 34. Morton further teaches obtaining an analysis result based on the FEA, wherein the analysis result is a local distance between a portion of the appliance digital model and a portion of the . (See para 80- Advantageously, digital models of entire teeth are produced, including measured or extrapolated hidden surfaces and root structures as well as surrounding bone and soft tissue. See para 87-the motions of the teeth calculated by the finite elements analysis are evaluated to determine whether they are orthodontically acceptable. See para 148-If the movement is more than a specified threshold, the tooth is identified as requiring an attachment. see para 151-152-In addition, the constraint thresholds should be satisfied, such as the distance to the gingival curve.)
Morton does not teach lingual surface of the patient’s gingiva.
However, Peikar further teaches lingual surface of the patient’s gingiva. (see para 117- FIG. 7 shows a representation of an OTA image of an upper and a lower jaw of a patient, on which examples of female connector elements 700 are attached to the lingual surface of the teeth, on the upper and lower arches)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of tooth attachments for engaging a dental repositioning appliance as disclosed by Morton to include lingual surface of the patient’s gingiva as taught by Peikar in the system of Morton for repositioning teeth, including orthodontic systems and methods that include or employ one or more appliances that are installed (in a removable or non-removable manner) on a patient's teeth. (see para [0003] and abstract, Peikar)
Regarding claim 53
The combination of Morton and Peikar teaches the method of claim 34. Morton further teaches wherein the FEA virtual deformation models the real-world behavior of an orthodontic appliance fabricated based on the appliance digital model when the orthodontic appliance is installed in a patient's mouth with the teeth in the original or intermediate arrangement. (see para 53-55-FIG. 1A shows one exemplary adjustment appliance 10 which is worn by the patient in order to achieve an incremental repositioning of individual teeth in the jaw 11. As set forth in the prior applications, an appliance can be designed and/or provided as part of a set or plurality of appliances and treatment can be administered according to a treatment plan. In such an embodiment, each appliance may be configured so that one or more tooth-receiving cavities has a geometry corresponding to an intermediate or final tooth arrangement intended for the appliance. See para 76-It will be recognized that appliance design and fabrication is not limited to any particular method and can include various computer and non-computer-based methodologies. See para 86-91-Having calculated appliance definitions, the process 100 can proceed to the manufacturing step (step 180) in which appliances defined by the process are manufactured, or electronic or printed information is produced that can be used by a manual or automated process to define appliance configurations or changes to appliance configurations. Optionally, the forces required to deform the aligner to fit over the teeth, including any hardware attached to the teeth, are computed and used as a figure of merit in measuring the acceptability of the particular aligner configuration. finite element analysis is begun to find a solution to the composite model and compute the movement of the teeth under the influence of the distorted aligner.)
Regarding claim 54
The combination of Morton and Peikar teaches the method of claim 34. Morton further teaches wherein the anatomy digital model includes securing portions in the positions of a patient's teeth. (see para 79-81- a digital data set is derived that represents the initial (that is, pretreatment) arrangement of the patient's teeth and other tissues. The initial digital data set, which may include both raw data from scanning operations and data representing surface models derived from the raw data, is processed to segment the tissue constituents from each other (step 120). In particular, in this step, data structures that digitally represent individual tooth crowns are produced. Generally, in this step, the position of every tooth is specified. See also para 89-91- boundary conditions specifying the immovable boundaries of the model elements. In one implementation, the model elements include only models of the teeth, a model of a highly viscous embedding substrate fluid, and boundary conditions that define, in effect, a rigid container in which the modeled fluid is held. In a simpler alternative, however, the aligner deformation is modeled by applying enough force to its insides to make it large enough to fit over the teeth, placing the model aligner over the model teeth in the composite model, setting the conditions of the model teeth and tissue to be infinitely rigid, and allowing the model aligner to relax into position over the fixed teeth. The surfaces of the aligner and the teeth are modeled to interact without friction at this stage, so that the aligner model achieves the correct initial configuration over the model teeth)
Regarding claim 55
The combination of Morton and Peikar teaches the method of claim 34. Morton further teaches revising the appliance digital model based on the FEA, and wherein fabrication of the physical appliance is based on the revised appliance digital model. (see para 87- Using the input data, the process creates a finite element model of the aligner, attachments, teeth and tissue, with the aligner in place on the teeth (step 210). Next, the process applies a finite element analysis to the composite finite element model of aligner, teeth, tissue, etc. (step 220). The analysis runs until an exit condition is reached, at which time the process evaluates whether the teeth have reached the desired end position for the current path segment, or a position sufficiently close to the desired end position (step 230). If an acceptable end position is not reached by the teeth, the process calculates a new candidate aligner shape (step 240). See para 120- Thereafter, the modified or optimized dental appliance may be manufactured through rapid prototyping (e.g., sterolithography) or other suitable techniques to attain the desired tooth movement.)
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
6. Claims 43, 46-48 and 50-52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morton et al. (PUB NO: US20100138025A1) in view of Peikar et al. "(PUB NO: US20170156823A1)and further in view of Raby et al. "(PUB NO: US20170367792A1)
Regarding claim 43
The combination of Morton and Peikar teaches the method of claim 34. Morton further teaches obtaining an analysis result based on the FEA, (see para 63-As noted above, appliances or aligners accomplish tooth movement by applying a series or system of forces (force system) comprised of forces, the moment of a force, and the moment of a couple to a tooth to elicit a biological response of the periodontal tissues and bone structures which surround the tooth. See also para 87- If an acceptable end position is reached, the motions of the teeth calculated by the finite elements analysis are evaluated to determine whether they are orthodontically acceptable. See para 91- finite element analysis is begun to find a solution to the composite model and compute the movement of the teeth under the influence of the distorted aligner)
The Morton and Peikar does not teach wherein the analysis result is a measure of strain in the appliance digital model
However, Raby further teaches wherein the analysis result is a measure of strain in the appliance digital model. (See para 89-90- In some examples, determining dimensions and shapes of the removable dental appliance includes selecting, with computer 70, the dimensions and shapes of the removable dental appliance according to a set of predefined design constraints. The set of predesigned design constraints may include one or more factors, including, but not limited to, a maximum localized force applied to one or more of the surrounded teeth, a maximum rotational force applied to one or more of the surrounded teeth, a maximum translational force applied to one or more of the surrounded teeth, a maximum total force applied to one or more of the surrounded teeth, and a maximum strain applied to the removable dental appliance when worn by the patient when the surrounded teeth are in their initial positions. Computer 70 may use finite element analysis (FEA) techniques to analyze forces on a patient's teeth as well as the removable dental appliance during the determination of the dimensions and shapes of the removable dental appliance. For example, computer 70 may apply FEA to a solid model of the patient's teeth as the modeled teeth move from their initial positions to their final positions representing a treatment including an ordered set of removable dental appliances. Computer 70 may use FEA select appropriate of the removable dental appliance to apply the desired forces on the teeth.)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of tooth attachments for engaging a dental repositioning appliance as disclosed by Morton to include herein the analysis result is a measure of strain in the appliance digital model as taught by Raby in the system of Morton and Peikar for selection of proper appliances for the particular patient, placement of appliances in the mouth, and adjustment of appliances throughout treatment. Another motivation is to visualize the patient's dentition to diagnose and assist in orthodontic treatment planning at any stage of treatment that can be used in manufacturing appliances, such as brackets, that are customized to the patient. (see para [0003] and abstract, Raby)
Regarding claim 46
The combination of Morton and Peikar teaches the method of claim 45. Morton further teaches changing a (See para 122-In one aspect, the data set associated with the teeth, gingiva and/or other oral tissue, or structures may be intentionally altered through, for example, addition, partial or total subtraction, uniform or non-uniform scaling, Boolean or non-Boolean algorithm, or geometric operations, or one or more combinations thereof, for the configuration, modeling and/or manufacturing of the dental appliance that may be optimized for the desired or intended treatment goal. See para 110-For example, changes, distortions and the like can be analyzed or determined computationally in terms of probability of occurrence, as well as whether such changes/distortions would be beneficial or detrimental to the desired loading and tooth movement. See para 115-Referring to FIG. 16, the optimization of the aligner shape geometry to address the formed gap or pocket)
Morton explicitly does not say thickness of a gingiva.
However, Raby further teaches thickness of a gingiva. (See para 73-Similarly, an increase in the width (i.e., occlusal gingival thickness) of the active band 112 of removable dental appliance 100 will result in an increase in the radius of the couple, which will increase the applied force during appliance deformation.)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of tooth attachments for engaging a dental repositioning appliance as disclosed by Morton to include thickness of a gingiva as taught by Raby in the system of Morton and Peikar for selection of proper appliances for the particular patient, placement of appliances in the mouth, and adjustment of appliances throughout treatment. Another motivation is to visualize the patient's dentition to diagnose and assist in orthodontic treatment planning at any stage of treatment that can be used in manufacturing appliances, such as brackets, that are customized to the patient. (see para [0003] and abstract, Raby)
Regarding claim 47
The combination of Morton and Peikar teaches the method of claim 45. Morton further teaches increasing . (See para 122-In one aspect, the data set associated with the teeth, gingiva and/or other oral tissue, or structures may be intentionally altered through, for example, addition, partial or total subtraction, uniform or non-uniform scaling, Boolean or non-Boolean algorithm, or geometric operations, or one or more combinations thereof, for the configuration, modeling and/or manufacturing of the dental appliance that may be optimized for the desired or intended treatment goal. See para 110-For example, changes, distortions and the like can be analyzed or determined computationally in terms of probability of occurrence, as well as whether such changes/distortions would be beneficial or detrimental to the desired loading and tooth movement. See para 115-Referring to FIG. 16, the optimization of the aligner shape geometry to address the formed gap or pocket)
Morton explicitly does not say thickness of a gingiva.
However, Raby further teaches thickness of a gingiva. (See para 73-Similarly, an increase in the width (i.e., occlusal gingival thickness) of the active band 112 of removable dental appliance 100 will result in an increase in the radius of the couple, which will increase the applied force during appliance deformation.)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of tooth attachments for engaging a dental repositioning appliance as disclosed by Morton to include thickness of a gingiva as taught by Raby in the system of Morton and Peikar for selection of proper appliances for the particular patient, placement of appliances in the mouth, and adjustment of appliances throughout treatment. Another motivation is to visualize the patient's dentition to diagnose and assist in orthodontic treatment planning at any stage of treatment that can be used in manufacturing appliances, such as brackets, that are customized to the patient. (see para [0003] and abstract, Raby)
Regarding claim 48
The combination of Morton and Peikar teaches the method of claim 45. Morton further teaches decreasing a (See para 122-In one aspect, the data set associated with the teeth, gingiva and/or other oral tissue, or structures may be intentionally altered through, for example, addition, partial or total subtraction, uniform or non-uniform scaling, Boolean or non-Boolean algorithm, or geometric operations, or one or more combinations thereof, for the configuration, modeling and/or manufacturing of the dental appliance that may be optimized for the desired or intended treatment goal. See para 110-For example, changes, distortions and the like can be analyzed or determined computationally in terms of probability of occurrence, as well as whether such changes/distortions would be beneficial or detrimental to the desired loading and tooth movement. See para 115-Referring to FIG. 16, the optimization of the aligner shape geometry to address the formed gap or pocket)
Morton explicitly does not say thickness of a gingiva.
However, Raby further teaches thickness of a gingiva. (See para 73-Similarly, an increase in the width (i.e., occlusal gingival thickness) of the active band 112 of removable dental appliance 100 will result in an increase in the radius of the couple, which will increase the applied force during appliance deformation.)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of tooth attachments for engaging a dental repositioning appliance as disclosed by Morton to include thickness of a gingiva as taught by Raby in the system of Morton and Peikar for selection of proper appliances for the particular patient, placement of appliances in the mouth, and adjustment of appliances throughout treatment. Another motivation is to visualize the patient's dentition to diagnose and assist in orthodontic treatment planning at any stage of treatment that can be used in manufacturing appliances, such as brackets, that are customized to the patient. (see para [0003] and abstract, Raby)
Regarding claim 50
The combination of Morton and Peikar teaches the method of claim 49. Morton further teaches changing a (See para 122-In one aspect, the data set associated with the teeth, gingiva and/or other oral tissue, or structures may be intentionally altered through, for example, addition, partial or total subtraction, uniform or non-uniform scaling, Boolean or non-Boolean algorithm, or geometric operations, or one or more combinations thereof, for the configuration, modeling and/or manufacturing of the dental appliance that may be optimized for the desired or intended treatment goal. See para 110-For example, changes, distortions and the like can be analyzed or determined computationally in terms of probability of occurrence, as well as whether such changes/distortions would be beneficial or detrimental to the desired loading and tooth movement. See para 115-Referring to FIG. 16, the optimization of the aligner shape geometry to address the formed gap or pocket)
Morton explicitly does not say thickness of a gingiva.
However, Raby further teaches thickness of a gingiva. (See para 73-Similarly, an increase in the width (i.e., occlusal gingival thickness) of the active band 112 of removable dental appliance 100 will result in an increase in the radius of the couple, which will increase the applied force during appliance deformation.)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of tooth attachments for engaging a dental repositioning appliance as disclosed by Morton to include thickness of a gingiva as taught by Raby in the system of Morton and Peikar for selection of proper appliances for the particular patient, placement of appliances in the mouth, and adjustment of appliances throughout treatment. Another motivation is to visualize the patient's dentition to diagnose and assist in orthodontic treatment planning at any stage of treatment that can be used in manufacturing appliances, such as brackets, that are customized to the patient. (see para [0003] and abstract, Raby)
Regarding claim 51
The combination of Morton and Peikar teaches the method of claim 49. Morton further teaches increasing . (See para 122-In one aspect, the data set associated with the teeth, gingiva and/or other oral tissue, or structures may be intentionally altered through, for example, addition, partial or total subtraction, uniform or non-uniform scaling, Boolean or non-Boolean algorithm, or geometric operations, or one or more combinations thereof, for the configuration, modeling and/or manufacturing of the dental appliance that may be optimized for the desired or intended treatment goal. See para 110-For example, changes, distortions and the like can be analyzed or determined computationally in terms of probability of occurrence, as well as whether such changes/distortions would be beneficial or detrimental to the desired loading and tooth movement. See para 115-Referring to FIG. 16, the optimization of the aligner shape geometry to address the formed gap or pocket)
Morton explicitly does not say thickness of a gingiva.
However, Raby further teaches thickness of a gingiva. (See para 73-Similarly, an increase in the width (i.e., occlusal gingival thickness) of the active band 112 of removable dental appliance 100 will result in an increase in the radius of the couple, which will increase the applied force during appliance deformation.)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of tooth attachments for engaging a dental repositioning appliance as disclosed by Morton to include thickness of a gingiva as taught by Raby in the system of Morton and Peikar for selection of proper appliances for the particular patient, placement of appliances in the mouth, and adjustment of appliances throughout treatment. Another motivation is to visualize the patient's dentition to diagnose and assist in orthodontic treatment planning at any stage of treatment that can be used in manufacturing appliances, such as brackets, that are customized to the patient. (see para [0003] and abstract, Raby)
Regarding claim 52
The combination of Morton and Peikar teaches the method of claim 49. Morton further teaches decreasing a (See para 122-In one aspect, the data set associated with the teeth, gingiva and/or other oral tissue, or structures may be intentionally altered through, for example, addition, partial or total subtraction, uniform or non-uniform scaling, Boolean or non-Boolean algorithm, or geometric operations, or one or more combinations thereof, for the configuration, modeling and/or manufacturing of the dental appliance that may be optimized for the desired or intended treatment goal. See para 110-For example, changes, distortions and the like can be analyzed or determined computationally in terms of probability of occurrence, as well as whether such changes/distortions would be beneficial or detrimental to the desired loading and tooth movement. See para 115-Referring to FIG. 16, the optimization of the aligner shape geometry to address the formed gap or pocket)
Morton explicitly does not say thickness of a gingiva.
However, Raby further teaches thickness of a gingiva. (See para 73-Similarly, an increase in the width (i.e., occlusal gingival thickness) of the active band 112 of removable dental appliance 100 will result in an increase in the radius of the couple, which will increase the applied force during appliance deformation.)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of tooth attachments for engaging a dental repositioning appliance as disclosed by Morton to include thickness of a gingiva as taught by Raby in the system of Morton and Peikar for selection of proper appliances for the particular patient, placement of appliances in the mouth, and adjustment of appliances throughout treatment. Another motivation is to visualize the patient's dentition to diagnose and assist in orthodontic treatment planning at any stage of treatment that can be used in manufacturing appliances, such as brackets, that are customized to the patient. (see para [0003] and abstract, Raby)
Conclusion
7. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Matov et al. US 20200214800 A1
ii. Discussing the method of generating an orthodontic model. The method include: generating an initial model of a patient dentition; generating a target model of the patient dentition; defining a plurality of caps and a plurality of links, wherein each link connects two of the plurality of caps; generating a relaxed model of a dental appliance from the plurality of caps and the plurality of links; generating a deformed model of a dental appliance from the plurality of caps and plurality of links; and determining a plurality of movements, wherein the plurality of moments transform the relaxed model to the deformed model and wherein the moments are configured to direct the patient dentition from the initial model to the target model.
Domroese et al. US 20220047358 A1
ii. Discussing the removable dental appliance that includes an appliance body configured to at least partially surround a plurality of teeth of a dental arch of a patient. The appliance body includes a shell shaped to engage a tooth in an initial position and a gingival ridge extending from a mesial interproximal region along a gingival edge of the shell to a distal interproximal region. The gingival ridge is configured to engage a lingual or labial surface of the tooth below a height of contour of the tooth to enable the appliance body to apply a force vector at a contact point on the tooth to cause movement of the tooth toward a desired position of the tooth when the removable dental appliance is worn by the patient.
8. All claims 34 and 36-56 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PURSOTTAM GIRI whose telephone number is (469)295-9101. The examiner can normally be reached 7:30-5:30 PM, Monday to Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RENEE CHAVEZ can be reached at 5712701104. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PURSOTTAM GIRI/
Examiner, Art Unit 2186
/RENEE D CHAVEZ/Supervisory Patent Examiner, Art Unit 2186
Prosecution Insights