DCT
1:18-cv-01950
Align Technology Inc v. 3Shape As
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Align Technology, Inc. (Delaware)
- Defendant: 3Shape A/S (Denmark), 3Shape TRIOS A/S (Denmark), and 3Shape Inc. (Delaware)
- Plaintiff’s Counsel: Shaw Keller LLP; Paul Hastings LLP
- Case Identification: 1:18-cv-01950, D. Del., 10/19/2020
- Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because Defendants conduct regular business in the district and 3Shape Inc. is a Delaware corporation.
- Core Dispute: Plaintiff alleges that Defendant’s intraoral scanning systems and associated software infringe four patents related to dynamic 3D occlusion mapping, comparing digital dental models over time, and digitally separating teeth models.
- Technical Context: The dispute is in the field of digital dentistry, where intraoral scanners create 3D digital models of a patient's teeth for orthodontic and restorative treatment planning.
- Key Procedural History: The complaint references prior patent infringement actions filed by Align against 3Shape in 2017 in the District of Delaware and the U.S. International Trade Commission (ITC). It cites testimony from the ITC investigation in which a 3Shape executive allegedly acknowledged conducting a "big analysis" of Align's patent portfolio for risk assessment, which may be relevant to the allegations of willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 1997-04-01 | Align Technology, Inc. founded |
| 2000-03-30 | Earliest Priority Date for ’761 Patent |
| 2002-04-16 | ’761 Patent Issued |
| 2002-08-22 | Earliest Priority Date for ’647 Patent and ’661 Patent |
| 2006-07-18 | ’647 Patent Issued |
| 2007-01-02 | ’661 Patent Issued |
| 2008-08-12 | Earliest Priority Date for ’958 Patent |
| 2011-01-01 | 3Shape entered the digital dentistry market (approx. date) |
| 2011-04-29 | Align acquired Cadent Holdings, Inc. |
| 2017-01-01 | Align initiated prior patent litigation against 3Shape (approx. date) |
| 2017-12-26 | ’958 Patent Issued |
| 2020-10-19 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,848,958 - Generating A Dynamic Three-Dimensional Occlusogram
- Patent Identification: U.S. Patent No. 9,848,958, entitled “Generating A Dynamic Three-Dimensional Occlusogram,” issued December 26, 2017.
The Invention Explained
- Problem Addressed: The complaint asserts that prior to the invention, dentists relied on inexact methods like using inked paper to check tooth occlusion (the fit between upper and lower teeth), and then had to "guess how the teeth would fit together during the course of an orthodontic treatment" (Compl. ¶37).
- The Patented Solution: The invention provides for a "dynamic height map or distance field" that generates a virtual, color-coded 3D map indicating the distances between opposing teeth (Compl. ¶38). This "dynamic occlusion map" allows practitioners to visualize the patient's bite throughout a proposed treatment plan, moving beyond static digital models ('958 Patent, Abstract; col. 6:4-10).
- Technical Importance: The technology provides a dynamic and quantitative tool for analyzing a patient's bite, which the complaint suggests is a significant improvement for planning orthodontic and restorative procedures (Compl. ¶38).
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶41).
- Claim 1 recites a non-transitory computing device readable medium with instructions for a method comprising the essential elements of:
- determining a plurality of data sets associated with a set of occlusal information for at least one tooth;
- wherein determining a data set includes calculating an average occlusal distance of at least one triangle of a three dimensional (3D) mesh of the at least one tooth using at least one of a height map and a distance field of the at least one tooth;
- determining a virtual 3D mesh model object of the at least one tooth using the plurality of data sets; and
- displaying the determined virtual 3D mesh model object of the at least one tooth of a patient.
U.S. Patent No. 7,077,647 - Systems and Methods for Treatment Analysis By Teeth Matching
- Patent Identification: U.S. Patent No. 7,077,647, entitled “Systems and Methods for Treatment Analysis By Teeth Matching,” issued July 18, 2006.
The Invention Explained
- Problem Addressed: The complaint states that before this invention, dentists tracked changes in a patient's dentition between visits by relying on "notes and memory," which is described as an "impossible and inexact" process, particularly over long time spans (Compl. ¶59). Conventional analog methods did not allow for precise superimposition of models to track changes (Compl. ¶59).
- The Patented Solution: The invention provides a method to track treatment progress by overlaying and comparing virtual dental models from different points in time to visualize even minor changes (Compl. ¶59). The method involves individually matching teeth between an initial and subsequent digital model and then matching the models as a whole to calculate positional differences ('647 Patent, Abstract; col. 5:14-24).
- Technical Importance: This innovation enables dental practitioners to precisely and objectively track and visualize patient progress over time, which the complaint frames as a significant improvement over conventional methods (Compl. ¶59).
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶62).
- Claim 1 recites a method for determining progress of a dental treatment, comprising the essential elements of:
- providing an initial digital model of a set of dental objects;
- determining planned positions for the set of dental objects;
- providing a subsequent digital model of the dental objects in their moved positions after treatment;
- individually matching each dental object in the subsequent model with a corresponding object in the initial model by identifying and aligning reference points and iteratively minimizing error;
- matching the subsequent digital model as a whole with the initial digital model; and
- calculating one or more positional differences between the moved and planned positions of the dental objects.
U.S. Patent No. 7,156,661 - Systems and Methods for Treatment Analysis By Teeth Matching
- Patent Identification: U.S. Patent No. 7,156,661, entitled “Systems and Methods for Treatment Analysis By Teeth Matching,” issued January 2, 2007 (Compl. ¶19).
Technology Synopsis
- The patent describes a method for improved mapping of dental models taken at different times to track changes in a patient's dentition (Compl. ¶¶78-79). The method involves loading first and second computer models of a jaw and matching them by using a non-moving part of the jaw (e.g., the palate) as a reference region to calculate positional differences between the teeth in the two models (Compl. ¶81).
Asserted Claims
- At least independent claim 1 (Compl. ¶82).
Accused Features
- The 3Shape TRIOS Module and Ortho System software are alleged to practice the claimed method (Compl. ¶82).
U.S. Patent No. 6,371,761 - Flexible Plane For Separating Teeth Models
- Patent Identification: U.S. Patent No. 6,371,761, entitled “Flexible Plane For Separating Teeth Models,” issued April 16, 2002 (Compl. ¶20).
Technology Synopsis
- The patent addresses the problem of digitally separating, or 'cutting,' individual teeth from a 3D dental model. It notes that using a simple flat plane is inadequate because teeth do not have flat sides (Compl. ¶99). The patented solution is a method using a 'flexible plane,' defined by a plurality of adjustable nodes, that can be conformed to the complex contours between teeth to allow for more accurate segmentation (Compl. ¶¶99, 101).
Asserted Claims
- At least independent claim 15 (Compl. ¶102).
Accused Features
- The 3Shape Ortho System software is alleged to practice the claimed method of separating teeth using a flexible, node-based plane (Compl. ¶102).
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are the 3Shape TRIOS and TRIOS 3 intraoral scanning systems, along with associated software products including TRIOS software, TRIOS Module, Ortho System software, and Dental System software (collectively, "3Shape Software") (Compl. ¶27).
Functionality and Market Context
- The accused products are digital dentistry solutions used to obtain digital 3D models of a patient's teeth for dental and orthodontic treatment planning (Compl. ¶6).
- The complaint alleges specific functionalities within the 3Shape Software infringe the patents-in-suit. This includes an "Occlusion map" or "Clearance" feature that uses a color scale to visualize distances between opposing teeth (Compl. ¶¶42-44), a "Patient Monitoring" or "Compare Model Sets" feature that overlays and compares scans taken at different times to measure changes (Compl. ¶¶63-64), and a tooth segmentation tool that uses adjustable splines to separate teeth models (Compl., p. 47).
- The complaint alleges that these products directly compete with Align's own iTero scanners and Invisalign system and characterizes Align as a "leader" in the industry and 3Shape as a "follower" (Compl. ¶¶6, 32). A screenshot from a user manual shows the Accused Instrumentality's color-coded clearance display (Compl. ¶42, p. 13). Another screenshot from a promotional video shows the "difference map" used to provide a "visual overview of changes between two scans" (Compl. ¶63, p. 23).
IV. Analysis of Infringement Allegations
9,848,958 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a non-transitory computing device readable medium having executable instructions which can be executed by a processor to cause a computing device to perform a method, comprising: determining a plurality of data sets associated with a set of occlusal information for at least one tooth of a patient... | 3Shape's software is stored on a non-transitory medium and performs a method of determining data sets related to tooth occlusion. | ¶41 | col. 12:1-5 |
| wherein determining a data set includes calculating an average occlusal distance of at least one triangle of a three dimensional (3D) mesh of the at least one tooth using at least one of a height map and a distance field of the at least one tooth; | The 3Shape software's "Clearance," "Occlusion map," and "Distance map" functions allegedly calculate occlusal distances using height maps or distance fields to generate a color-coded visualization. A user manual screenshot depicts an "Occlusion map function" that visualizes occlusal distances according to a color scale (Compl. ¶44, p. 15). | ¶41 | col. 12:6-12 |
| determining a virtual 3D mesh model object of the at least one tooth using the plurality of data sets; and | The software determines and manipulates a virtual 3D mesh model of the patient's teeth using the calculated occlusal data. | ¶41 | col. 12:13-15 |
| displaying the determined virtual 3D mesh model object of the at least one tooth of a patient. | The software displays the resulting 3D model with color-coding to indicate occlusal distances. A screenshot from the Ortho System user manual shows a color scale next to virtual casts of the upper and lower jaw (Compl. ¶44, p. 15). | ¶41 | col. 12:16-18 |
- Identified Points of Contention:
- Technical Questions: What evidence does the complaint provide that the accused software’s calculation of "clearance" or "distance" performs the specific claimed step of "calculating an average occlusal distance of at least one triangle of a three dimensional (3D) mesh"? The infringement analysis may focus on whether the underlying algorithm of the accused software meets this specific claim limitation.
7,077,647 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| providing an initial digital model of a set of dental objects; | The "Compare Scans" and "Compare Model Sets" features load an initial digital model of a patient's dentition. | ¶62 | col. 4:1-2 |
| determining planned positions for the set of dental objects; | The complaint alleges the accused software practices this step as part of the overall method for determining treatment progress. | ¶62 | col. 4:3-4 |
| providing a subsequent digital model of the set of dental objects in their moved positions after at least some of them have been moved by the dental treatment; | The "Compare Scans" and "Compare Model Sets" features load a subsequent digital model captured after the patient's teeth have moved. | ¶62 | col. 4:5-8 |
| individually matching each of the dental objects in the subsequent digital model with a dental object in the initial digital model to determine corresponding dental objects... | The software provides tools to align the upper and lower jaws of the two model sets, using user-selected points as references to match the models. A user manual screenshot shows options for "Surface 1-point" and "Surface 3-point" alignment (Compl. ¶64, p. 27). | ¶62 | col. 4:9-20 |
| matching the subsequent digital model as a whole with the initial digital model; | The alignment process matches the overall digital models. | ¶62 | col. 4:21-22 |
| and calculating one or more positional differences between the moved and planned positions of at least some of the corresponding dental objects. | The software's "difference map" calculates and displays a "visual overview of changes between two scans," which allegedly represents the positional differences. | ¶62 | col. 4:23-27 |
- Identified Points of Contention:
- Scope Questions: A central question may be whether the accused functionality meets the "determining planned positions" and "calculating... positional differences between the moved and planned positions" limitations. The complaint's evidence shows the accused software comparing two actual historical scans to monitor progress, which raises the question of whether comparing a current scan to a prior actual scan (rather than a future, planned position) falls within the scope of the claim.
V. Key Claim Terms for Construction
For the ’958 Patent
- The Term: "average occlusal distance"
- Context and Importance: This term is central to the infringement analysis for the ’958 patent. Its construction will determine whether the accused software's general distance/clearance calculation is sufficient to infringe, or if a more specific mathematical operation is required. Practitioners may focus on this term because the complaint alleges infringement based on the software's output (a color-coded map) without detailing the underlying algorithm (Compl. ¶¶ 41-44).
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent specification does not appear to provide an explicit, limiting definition for this term, which may suggest it should be given its plain and ordinary meaning to one of skill in the art.
- Evidence for a Narrower Interpretation: The term is used in the context of a "triangle of a three dimensional (3D) mesh," which may suggest that the "average" is a specific mathematical calculation performed on the vertices of that discrete geometric element, rather than a more general distance measurement.
For the ’647 Patent
- The Term: "planned positions"
- Context and Importance: This term is critical because the primary evidence in the complaint shows the accused software comparing two actual scans from different times, not comparing an actual scan to a future, pre-determined treatment goal. The viability of the infringement claim for the ’647 patent may depend on whether "planned positions" can be construed to include the positions from a prior scan used as a baseline.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party could argue that a prior scan represents the "plan" at that point in time, and any deviation from it is a deviation from the plan.
- Evidence for a Narrower Interpretation: The patent is titled "Systems and Methods for Treatment Analysis" and discusses determining the "progress of a dental treatment" ('647 Patent, col. 4:1). The claim language calculates differences between "moved" and "planned" positions, which suggests a comparison between an actual state and a target or goal state, consistent with a forward-looking treatment plan.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that 3Shape induces infringement by providing customers with products and instructing them on how to use the allegedly infringing features through user manuals, training videos, and marketing materials (Compl. ¶¶ 47, 49, 67, 69).
- Willful Infringement: The complaint alleges willful infringement based on both pre-suit and post-suit knowledge. It claims 3Shape had pre-suit knowledge of Align's patents from prior business dealings, citations in 3Shape's own patent prosecution, and an FDA 510(k) submission identifying Align's products as substantially equivalent (Compl. ¶¶ 33, 52). Crucially, the complaint cites testimony from a prior ITC investigation where a 3Shape executive allegedly stated that the company performed a "big analysis" of Align's patent portfolio as part of a risk assessment, during which "internal concerns at 3Shape were raised about Align's patents" (Compl. ¶¶ 53, 73).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "planned positions" in the ’647 patent, which implies a forward-looking treatment goal, be construed to cover the accused software’s function of comparing a current dental model to a past dental model to track historical changes?
- A key evidentiary question will be one of technical implementation: for the ’958 patent, does the accused software’s "Occlusion map" function perform the specific calculation of an "average occlusal distance of at least one triangle" as required by the claim, or is there a fundamental mismatch in the underlying algorithm?
- A central question for damages will be willfulness: given the complaint’s specific allegations of a pre-suit internal "big analysis" of Align's patent portfolio cited from prior litigation testimony, the court will likely examine whether 3Shape acted with the requisite knowledge and intent to support a finding of willful infringement.