3Shape As v. Align Technology Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: 3Shape A/S (Denmark)
  • Defendant: Align Technology, Inc. (Delaware)
  • Plaintiff’s Counsel: Buchanan Ingersoll & Rooney PC
• Case Identification: 1:18-cv-00886, D. Del., 08/30/2019
• Venue Allegations: Plaintiff alleges venue is proper because Defendant is a Delaware corporation, conducts regular business in Delaware, and has previously brought patent infringement actions against Plaintiff in the District of Delaware.
• Core Dispute: Plaintiff alleges that Defendant’s iTero Element line of intraoral scanners infringes two patents related to methods for digitally removing unwanted objects from 3D scans and the optical apparatus for performing such scans.
• Technical Context: The lawsuit concerns the technology of intraoral 3D scanners, which are used in dentistry to create digital models of a patient's teeth and gums for designing restorations and orthodontic treatments.
• Key Procedural History: The complaint notes that Defendant previously challenged the validity of U.S. Patent No. 9,629,551 in two inter partes review (IPR) proceedings before the Patent Trial and Appeal Board (PTAB). The PTAB declined to institute trial in both proceedings, determining that Defendant had not presented a prima facie case for the unpatentability of the patent’s claims. While not a final ruling on validity, this procedural history may be raised to suggest the patent has survived prior scrutiny.

Case Timeline

Date	Event
2009-06-17	’042 Patent Priority Date
2011-07-15	’551 Patent Priority Date
2015-08-14	“Video 2” depicting accused product published
2016-12-29	“Video 1” depicting accused product published
2017-04-25	’551 Patent Issue Date
2018-01-01	Defendant’s IPR petitions against ’551 Patent (approx. date)
2019-07-09	’042 Patent Issue Date
2019-08-30	Amended Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 9,629,551 - “Detection of a Movable Object When 3D Scanning a Rigid Object,” issued April 25, 2017

The Invention Explained

• Problem Addressed: When performing a 3D scan of a rigid object like teeth, movable objects such as the patient's tongue, cheeks, or the dentist's instruments can obstruct the view and be captured in the scan data, leading to an inaccurate final 3D model (’551 Patent, col. 1:29-41).
• The Patented Solution: The invention proposes a method to distinguish between the rigid object (teeth) and unwanted movable objects. It involves capturing at least two successive 3D representations of the same location. For each representation, the system determines an "excluded volume"—a region of space where, from the scanner's perspective, no other surface could be present. If a surface from one representation is found to be located within the excluded volume of the other, the system identifies it as a movable object that was only momentarily present and disregards it from the final 3D model (’551 Patent, col. 2:35-61). This process effectively filters out transient artifacts from the scan.
• Technical Importance: This method allows for creating cleaner, more accurate digital dental models from a handheld scanner in a dynamic environment (a patient's mouth) without requiring perfect isolation of the scan area (’551 Patent, col. 1:42-53).

Key Claims at a Glance

• The complaint asserts independent claim 1 and dependent claims 22, 23, and 25 (Compl. ¶26).
• Independent Claim 1 requires a method with the following essential elements:
  • Providing a first 3D representation of at least part of a surface by scanning.
  • Providing a second 3D representation of at least part of the surface by scanning.
  • Determining for the first 3D representation a first excluded volume in space where no surface can be present in both the first and second 3D representations.
  • Determining for the second 3D representation a second excluded volume.
  • If a portion of the surface in the first 3D representation is located in the second excluded volume, that portion is disregarded in the generation of the virtual 3D model.
  • And/or, if a portion of the surface in the second 3D representation is located in the first excluded volume, that portion is disregarded.

U.S. Patent No. 10,349,042 - “Focus Scanning Apparatus,” issued July 9, 2019

The Invention Explained

• Problem Addressed: The patent describes the challenge of obtaining accurate 3D surface geometry using optical scanning, particularly with a handheld device where the distance and orientation to the object are not fixed (’042 Patent, col. 1:40-50).
• The Patented Solution: The patent discloses an intraoral scanner apparatus that operates by "focus scanning." The apparatus uses lighting equipment to generate a probe light, which is transmitted through an optical system toward an object. The key innovation lies in how the light is focused: the system is configured to focus the probe light onto at least two different parts of the object simultaneously, where the light focused on each part has a different "divergence angle" and a "non-parallel" propagation axis (’042 Patent, col. 20:5-12, Abstract). By translating a focus plane along the optical axis and capturing a series of 2D images, the system can analyze the reflected light to produce data for a 3D model (’042 Patent, col. 1:23-28, Fig. 1).
• Technical Importance: This optical configuration provides a method for rapidly acquiring 3D data by analyzing how focus changes across a surface, a technique suitable for compact, handheld scanners that must work in confined spaces like the oral cavity (’042 Patent, col. 1:35-39).

Key Claims at a Glance

• The complaint asserts independent claims 1, 17, 19, and 21 (Compl. ¶91).
• Independent Claim 1 requires an intraoral scanner with:
  • A color image sensor with an array of sensor elements.
  • Lighting equipment to generate a probe light.
  • An optical system with a beam splitter, at least one lens, and a tip for insertion into the oral cavity.
  • The scanner operates by translating a focus plane along an optical axis to capture 2D images.
  • The lens is configured to focus the probe light onto at least two different parts of the object.
  • The probe light focused on a first part of the object has a first divergence angle and first propagation axis.
  • The probe light focused on a second part of the object has a second divergence angle and second propagation axis.
  • The first and second propagation axes are non-parallel.
  • The scanner transmits reflected light back to the color image sensor, which produces data for the 3D geometry from the series of 2D images.
• Independent Claim 19 recites a method of providing data using a scanner with similar hardware, focusing on the steps of inserting the tip, generating a probe light, and transmitting/reflecting light that is non-telecentrically focused.

III. The Accused Instrumentality

Product Identification

• The "iTero Element Scanner," "iTero Element 2 Scanner," and "iTero Element Flex Scanner," which are handheld intraoral 3D scanners (Compl. ¶8).

Functionality and Market Context

• The complaint alleges the accused scanners are engineered to "simultaneously process the scan," "stitch[] together images," and, critically, "detect[] and remove[] soft tissues [i.e., movable objects]" (Compl. ¶¶29, 52). This functionality is alleged to be part of an effort to "eliminate extra process steps during intraoral scanning" (Compl. ¶29).
• The complaint cites marketing materials stating the scanners capture 6,000 frames per second and use "parallel confocal imaging technology" to achieve accurate scans (Compl. ¶¶38, 114). The scanners are also alleged to use color scanning to distinguish between different structures, such as gingiva and teeth (Compl. ¶31).
• The complaint includes a still image from a promotional video showing the accused scanner being used, with an inset highlighting the digital removal of a lip from the 3D model (Compl. ¶47, p. 9). This visual is offered as direct evidence of the accused "soft tissue" removal feature.

IV. Analysis of Infringement Allegations

’551 Patent Infringement Allegations

Claim Element (from Independent Claim 1) -	Alleged Infringing Functionality -	Complaint Citation	Patent Citation
a method for detecting a movable object in a location, when scanning a rigid object...comprises: providing a first 3D representation of at least part of a surface by scanning at least part of the location; [and] providing a second 3D representation...	The accused scanners capture thousands of frames per second, providing multiple overlapping 3D representations of the patient's mouth in a short time. -	¶¶37-39	col. 3:41-47
determining for the first 3D representation a first excluded volume in space where no surface can be present in both the first 3D representation and the second 3D representation...	The scanners allegedly use "parallel confocal sampling" which "would necessarily calculate excluded volume data" based on the distances from the scanner to the tooth surface for each successive overlapping scan. -	¶41	col. 4:26-34
if a portion of the surface in the first 3D representation is located in space in the second excluded volume, the portion of the surface in the first 3D representation is disregarded in the generation of the virtual 3D model...	The scanners are marketed as being able to "detect[] and remove[] soft tissues," which are alleged to be movable objects. A promotional video allegedly shows surfaces associated with a lip being disregarded from the 3D model.	¶¶29, 44, 47	col. 2:49-61

Identified Points of Contention (’551 Patent)

• Technical Question: The complaint's theory hinges on the allegation that the accused scanners' "parallel confocal sampling" technology "necessarily" calculates "excluded volume data" as claimed in the patent (Compl. ¶41). A central question will be whether the accused method for removing soft tissue actually operates by defining and comparing such "excluded volumes," or if it uses an alternative technique (e.g., color-based segmentation, AI-based object recognition) that does not map onto the claim elements.
• Scope Question: A video still depicts the accused product detecting and removing a patient's lip from the 3D model (Compl. ¶46, p. 8). The case may turn on whether the accused functionality that performs this removal is technically equivalent to the claimed method of comparing successive scans and their corresponding "excluded volumes."

’042 Patent Infringement Allegations

Claim Element (from Independent Claim 1) -	Alleged Infringing Functionality -	Complaint Citation	Patent Citation
An intraoral scanner for providing data for 3D geometry...comprising: a color image sensor comprising an array of sensor elements; -	The accused scanners comprise a color image sensor. A webpage allegedly states, "Color scanning gives you a significant leap forward in visualization." -	¶¶93, 111	col. 22:40-42
lighting equipment configured to generate a probe light; -	The accused scanners are alleged on information and belief to comprise lighting equipment that generates a probe light. -	¶94	col. 22:43-44
an optical system comprising a beam splitter, at least one lens, and a tip configured to be inserted into the oral cavity... -	On information and belief, the scanners comprise these optical components. An image on a webpage is cited to show the tip inserted into an oral cavity. -	¶¶95, 113	col. 37:23-31
wherein the intraoral scanner is configured to operate by translating a focus plane along an optical axis... -	The accused scanners allegedly operate by translating a focus plane, citing a webpage stating they use "parallel confocal imaging technology." -	¶¶96, 114	col. 38:50-52
wherein the at least one lens is configured such that the intraoral scanner transmits...the probe light...onto at least two different parts of the object...wherein the first propagation axis and the second propagation axis are non-parallel...	The complaint alleges on information and belief that the lens system is configured to focus light with non-parallel propagation axes, largely tracking the claim language. -	¶97	col. 38:32-44

Identified Points of Contention (’042 Patent)

• Technical Question: The infringement allegations for the specific optical configuration (e.g., "non-parallel propagation axis") are made "upon information and belief" and closely track the claim language without providing significant independent technical detail from public sources (Compl. ¶¶97, 103, 115). A key point of contention will be whether discovery reveals that the internal optics of the iTero scanners actually operate in the specific manner claimed by the patent.
• Scope Question: The core of the infringement dispute for claim 1 will likely focus on the meaning of "a first propagation axis and the second propagation axis are non-parallel." The interpretation of this phrase will be critical in determining whether the accused optical system falls within the scope of the claims.

V. Key Claim Terms for Construction

For the ’551 Patent

• The Term: "excluded volume"
• Context and Importance: This term is the central mechanism of the invention. The definition of what constitutes an "excluded volume" and how it is "determined" will be dispositive for infringement. Defendant’s method of soft tissue removal must involve determining such a volume to infringe.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The claim defines the term functionally as a "volume in space where no surface can be present in both the first 3D representation and the second 3D representation" (’551 Patent, claim 1). This functional language may support an interpretation not strictly tied to a specific calculation method.
  • Evidence for a Narrower Interpretation: The specification links the concept to the "scan volume," which is defined by the "focusing optics in the 3D scanner and the distance to the surface which is captured" (’551 Patent, col. 4:26-34). This could support a narrower construction requiring the volume to be defined by the physical and optical properties of the scanner itself, rather than by a more abstract software algorithm.

For the ’042 Patent

• The Term: "the first propagation axis and the second propagation axis are non-parallel"
• Context and Importance: This limitation defines the unique optical geometry that distinguishes the claimed invention. Proving that the accused scanner's optics meet this geometric constraint is essential for Plaintiff's case. Practitioners may focus on this term because the complaint's allegations for this element are not supported by detailed public-facing evidence.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The claim language itself is relatively general. The term "propagation axis" could be interpreted broadly as the general path of a light beam, which may support finding that any two non-identical light paths are "non-parallel."
  • Evidence for a Narrower Interpretation: The patent specification links this feature to a specific embodiment where the probe light is focused onto two different parts of the object with "a first divergence angle" and "a second divergence angle" (’042 Patent, claim 1). This context suggests the "non-parallel" axes may be a direct consequence of creating these distinct divergence angles, potentially narrowing the term's meaning to optical systems that operate in this specific way.

VI. Other Allegations

• Indirect Infringement: The complaint alleges inducement of infringement for both patents, stating Defendant trains customers on the use of the accused scanners and provides product information and marketing materials that encourage infringing use (Compl. ¶¶68-70, 126-128). It also alleges contributory infringement, asserting the scanners are a material part of the inventions, are especially adapted for infringing use, and are not staple articles of commerce (Compl. ¶¶77-79, 135-137).
• Willful Infringement: Willfulness is alleged for both patents. For the ’551 patent, the allegation is supported by Defendant’s prior, unsuccessful IPR challenges, which allegedly establish pre-suit knowledge of the patent and its infringement (Compl. ¶¶23-25, 82). For the ’042 patent, the allegation is based on more general claims of knowledge (Compl. ¶¶90, 140).

VII. Analyst’s Conclusion: Key Questions for the Case

• A central technical question will be one of operational equivalence: Does Align's "soft tissue removal" feature, as implemented in the iTero scanners, function by generating and comparing "excluded volumes" from successive 3D scans as required by the ’551 patent? Or does it rely on a different technological approach, such as simple color-based image processing, that falls outside the claim scope?
• A key issue combining claim construction and evidence will define the dispute over the ’042 patent: What is the specific technical meaning of focusing probe light along "non-parallel propagation axes"? The case will likely require expert testimony and reverse engineering of the accused devices to determine if their internal optical architecture embodies this specific geometry as claimed.
• A significant procedural question will be the impact of prior patent challenges: How will the court view the PTAB’s non-institution decisions for the ’551 patent? While not binding on the district court, 3Shape may argue these decisions demonstrate the patent’s strength and support its claim for willful infringement, a characterization Align will likely contest.