1:25-cv-00768
Densys Ltd v. Align Technology Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Densys Ltd. (Israel)
- Defendant: Align Technology Inc. (Delaware)
- Plaintiff’s Counsel: Susman Godfrey LLP.; Farnan LLP
- Case Identification: 1:25-cv-00768, D. Del., 06/20/2025
- Venue Allegations: Venue is asserted as proper in the District of Delaware because Defendant is a Delaware corporation and therefore resides in the district.
- Core Dispute: Plaintiff alleges that Defendant’s iTero line of intraoral scanners infringes two patents related to foundational technologies for acquiring and processing three-dimensional dental images.
- Technical Context: The lawsuit concerns digital intraoral scanning, a technology that creates 3D models of a patient's mouth to replace traditional, messy putty-based dental impressions for orthodontic and restorative procedures.
- Key Procedural History: The complaint alleges that one of the patents-in-suit, the ’707 Patent, was previously found to be willfully infringed by Defendant’s competitor, 3Shape, in a separate W.D. Texas litigation that is pending post-trial motions. The complaint also alleges that Defendant had knowledge of Densys and its technology dating back to co-development discussions in the early 2000s, prior to the issuance of the ’707 patent.
Case Timeline
| Date | Event |
|---|---|
| 2000-06-28 | U.S. Patent No. 6,402,707 Priority Date |
| 2000-2001 | Discussions alleged between Densys and Cadent Holdings Inc. |
| 2002-02-14 | Letter alleged from Align's VP of R&D to Densys regarding co-development |
| 2002-06-11 | U.S. Patent No. 6,402,707 Issued |
| 2006-01-11 | U.S. Patent No. 8,665,257 Priority Date |
| 2011-01-01 | Align acquires Cadent Holdings Inc. |
| 2014-03-04 | U.S. Patent No. 8,665,257 Issued |
| 2019-01-01 | Alleged start date of infringement by Accused Products |
| 2025-06-20 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,402,707 - Method and system for real time intra-orally acquiring and registering three-dimensional measurements and images of intra-oral objects and features, Issued June 11, 2002
The Invention Explained
- Problem Addressed: The patent describes the difficulty in accurately combining, or "registering," multiple 3D scans of a patient's mouth into a single, cohesive model (’707 Patent, col. 7:1-7). Errors arise from the movement of the patient, the dentist, and the scanning device, which causes "propagation error" when stitching images together, decreasing the accuracy of the final 3D map (’707 Patent, col. 4:1-5).
- The Patented Solution: The invention proposes establishing an "intra-oral fixed global registration position" inside the patient's mouth at the start of a scan (’707 Patent, Abstract). A mobile scanning wand is then moved to capture different areas. The system records the wand's position relative to this single, unchanging global reference point, not just relative to the last captured frame (’707 Patent, col. 9:6-14). This allows images from multiple, non-contiguous fields of view to be accurately merged into a panoramic 3D model, as they all relate back to the same origin point (’707 Patent, col. 9:19-30).
- Technical Importance: This method provided a potential solution for creating accurate, full-mouth 3D scans in real-time by mitigating the compounding errors that plagued earlier systems.
Key Claims at a Glance
- The complaint asserts independent claims 1 (a method) and 37 (a system).
- Independent Claim 1 requires, in essence:
- Establishing an intra-oral fixed global registration position inside the oral cavity.
- Providing a measuring and imaging device.
- Selecting a field of view of the device at a global position.
- Acquiring a 3D measurement and image while also recording the device's global position relative to the fixed registration position.
- Repeating this process for multiple positions and fields of view.
- Registering the local image data to the global coordinate system to form a composite 3D model.
- The complaint reserves the right to assert additional claims (Compl. ¶32).
U.S. Patent No. 8,665,257 - Three-dimensional modeling of the oral cavity, Issued March 4, 2014
The Invention Explained
- Problem Addressed: The patent identifies a key challenge in optical 3D modeling of teeth: surfaces like enamel often lack distinct features, making it difficult to match corresponding points between different images for triangulation (’257 Patent, col. 2:50-54). Projecting simple patterns like grids can lead to "aliasing," where the system incorrectly matches two different-but-identical-looking points, corrupting the 3D model (’257 Patent, col. 4:1-11).
- The Patented Solution: The invention discloses a system that projects a "structured illumination" pattern composed of a stored, two-dimensional array of random patterns onto the intraoral scene (’257 Patent, Abstract). Because the patterns are random, each point is distinguishable, preventing aliasing. A camera captures an image of the scene with the projected pattern, and a processor then creates a 3D model by triangulating the captured pattern against a stored reference image of the same pattern projected onto a surface of known geometry, like a plane (’257 Patent, col. 5:1-9, col. 10:43-52).
- Technical Importance: This approach allows for the creation of accurate 3D models using compact hardware (potentially a single camera) and without the need for prominent natural features on the object being scanned.
Key Claims at a Glance
- The complaint asserts independent claim 1 (a system).
- Independent Claim 1 requires, in essence:
- A pattern generator for creating an array of random patterns.
- A projectable medium with a memory for storing the array.
- A projector for projecting the stored array onto the intra-oral scene.
- An acquiring unit (camera) for capturing images of the projected array.
- Various calculators and software for pattern-matching, calculating parallax between a reference image and the captured image, and constructing a 3D model.
- The complaint reserves the right to assert additional claims (Compl. ¶47).
III. The Accused Instrumentality
Product Identification
The accused products are Align’s “iTero” branded three-dimensional intraoral scanners, including but not limited to the iTero Element 5D, iTero Element 5D Plus, iTero Element 2, iTero Element Flex, and iTero Lumina Pro, among others (Compl. ¶22). These scanners and their associated software and hardware are collectively referred to as the "Accused Products" (Compl. ¶22).
Functionality and Market Context
The iTero Scanners are used by dental professionals to create digital 3D models of a patient's teeth and gums (Compl. ¶16). The complaint alleges these scanners form a complete intraoral scanning system that works with Align software and hardware components (Compl. ¶22). The complaint further alleges that the Accused Products are commercially important and generate substantial revenue, including through "convoyed sales" of Align's orthodontic aligner treatments (Compl. ¶23). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint references preliminary claim charts (Exhibits 3 and 4) that were not provided with the filing. The following analysis is based on the narrative infringement allegations.
’707 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| (a) establishing an intra-oral fixed global registration position inside the oral cavity of the dental patient... | The iTero Scanners are alleged to establish a reference framework to enable real-time acquisition and registration of 3D measurements from multiple locations within the mouth. | ¶32 | col. 9:6-14 |
| (b) providing a measuring and imaging device for measuring and imaging the intra-oral objects and features... | The iTero scanner wand itself is alleged to be the claimed measuring and imaging device. | ¶32 | col. 15:6-14 |
| (d) acquiring at least one three-dimensional measurement and image... and, recording said global position of said measuring and imaging device relative to said intra-oral fixed global registration position... | The iTero system is alleged to capture 3D data and simultaneously record the scanner's position relative to its established coordinate system. | ¶32 | col. 20:31-39 |
| (e) repeating step (c) and step (d) for a plurality of said global positions and a plurality of the fields of view... | The operator's action of moving the iTero scanner around the patient's mouth to capture a full scan is alleged to meet this limitation. | ¶32 | col. 21:26-34 |
| (f) registering local coordinate space pixel positions... with corresponding global coordinate space pixel positions... | The iTero software is alleged to process and stitch together the multiple captured images into a single, cohesive 3D model based on the recorded positional data. | ¶32 | col. 21:46-56 |
’257 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a pattern generator for generating a two-dimensional array of a plurality of random... patterns; | The iTero Lumina series scanners are alleged to contain a component that generates a structured light pattern for projection. | ¶47 | col. 12:3-6 |
| a projectable medium that contains a memory for storing said array...; a projector for projecting said array from said memory onto the intra-oral scene... | The Accused Products are alleged to store and project a pre-defined light pattern onto the patient's teeth during scanning. | ¶47 | col. 11:59-64 |
| an acquiring unit with at least one camera for acquiring images of said array projected on the intra-oral scene... | The scanner's optical sensor is alleged to be the camera that captures the image of the teeth illuminated by the projected pattern. | ¶47 | col. 12:1-3 |
| a pattern-matching software... a parallax calculator... a modeling software for constructing a three-dimensional model... | The iTero system's software and processors are alleged to perform the necessary calculations—including matching the captured pattern to a reference and calculating depth—to construct the final 3D model. | ¶47 | col. 12:6-19 |
Identified Points of Contention
- Scope Questions: A primary question for the ’707 patent will be whether the iTero system’s method for registering scans constitutes an "intra-oral fixed global registration position." The court may need to determine if this term requires a single, physically-anchored reference point established at the outset, or if it can read on systems that use continuous frame-to-frame surface matching to maintain global coordinates.
- Technical Questions: For the ’257 patent, a key factual dispute may be whether the pattern projected by the iTero scanners is "random" as that term is used in the patent. Analysis will likely focus on the specific characteristics of the projected light pattern and whether the accused system's reconstruction algorithm functions by triangulating a captured pattern against a stored reference, as the claim requires.
V. Key Claim Terms for Construction
The Term: "intra-oral fixed global registration position" (’707 Patent, Claim 1)
Context and Importance
This term is the central inventive concept of the ’707 patent. The outcome of the infringement analysis for this patent will likely depend entirely on whether the iTero system is found to use such a position. Practitioners may focus on this term to distinguish the patented method from other registration techniques like iterative closest point (ICP) or surface-based matching.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The specification states the position is "definable in terms of global coordinate space" and associated with a "fixed global reference coordinate system," which could suggest it is a conceptual point in a coordinate system rather than a physical object (col. 9:11-14).
- Evidence for a Narrower Interpretation: The preferred embodiment describes an "intra-oral fixed global registration device" (34 in FIG. 1) that is "temporarily fixed" to an intra-oral object (col. 14:38-51). This suggests the position is established by a tangible, non-moving physical component placed in the mouth.
The Term: "random" (referring to the patterns) (’257 Patent, Claim 1)
Context and Importance
The "random" nature of the projected patterns is the patent's stated solution to the problem of aliasing. Whether the pattern used by the iTero scanners meets the definition of "random" will be critical.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The patent contrasts its invention with simple, repeating patterns (like grids) and emphasizes that its patterns are "probabilistically unique" such that the chance of a pattern appearing more than once is "extremely low" (col. 8:24-44). This could support a construction where "random" means non-systematic, complex, or aperiodic.
- Evidence for a Narrower Interpretation: The patent repeatedly notes that the random patterns are generated and then "saved in a projectable medium" (e.g., a slide) for later, reproducible projection (col. 5:1-9). This distinguishes the invention from physically-generated, non-reproducible random patterns like laser speckle. A narrower construction might require the pattern to be both random in appearance and stored/reproducible.
VI. Other Allegations
Indirect Infringement
The complaint alleges that Align induces infringement by providing customers with training materials, product manuals, user guides, and other marketing information that instruct and encourage them to operate the iTero Scanners in a manner that infringes the patents-in-suit (Compl. ¶¶37, 52).
Willful Infringement
The complaint alleges willfulness based on both pre- and post-suit knowledge. Pre-suit knowledge is alleged based on: (1) Align's alleged co-development discussions with Densys in the early 2000s; (2) the jury verdict of willful infringement against Align's competitor (3Shape) on the ’707 patent; and (3) over 100 citations to the ’707 patent in Align's own patent portfolio (Compl. ¶¶24-26). The filing of the lawsuit itself is asserted to provide knowledge for any ongoing infringement (Compl. ¶27).
VII. Analyst’s Conclusion: Key Questions for the Case
This case will likely center on fundamental questions of technology and intent. The key issues for the court to resolve appear to be:
A core issue will be one of technical operation: Does the accused iTero system’s software register sequential scans by referencing a single, "intra-oral fixed global registration position" established at the beginning of the procedure, as taught in the ’707 patent, or does it use an alternative algorithm, such as continuous surface-based matching between frames?
A second key evidentiary question will be one of definitional scope: Does the structured light pattern projected by the accused iTero scanners qualify as "random" within the meaning of the ’257 patent, and does the system’s 3D reconstruction algorithm operate by triangulating this pattern against a stored reference, as claimed?
Finally, the case raises a significant question of culpability: Given the prior litigation involving the ’707 patent and the alleged history of direct communications and patent citations, what did Align know about the patents-in-suit and when? Did its actions constitute the type of "egregious" conduct that would justify an award of enhanced damages for willful infringement?