DCT
1:21-cv-01804
Alcon Inc v. AMO Development LLC
Key Events
Complaint
I. Executive Summary and Procedural Information
Parties & Counsel:
- Plaintiff: Alcon Inc. (Switzerland), TrueVision Systems, Inc. (Delaware), and Alcon Pharmaceuticals Ltd. (Switzerland)
- Defendant: AMO Development, LLC (Delaware), AMO Manufacturing USA, LLC (Delaware), AMO Sales and Service, Inc. (Delaware), and Johnson & Johnson Surgical Vision, Inc. (Delaware)
- Plaintiff’s Counsel: Shaw Keller LLP; Kirkland & Ellis LLP
Case Identification: Alcon Inc., et al. v. AMO Development, LLC, et al., 1:21-cv-01804, D. Del., 12/23/2021
Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because all Defendant entities are organized under the laws of Delaware.
Core Dispute: Plaintiff alleges that Defendant’s CATALYS® Precision Laser System for cataract surgery infringes patents related to computer-aided image processing and guidance systems that compensate for eye rotation.
Technical Context: The technology at issue involves image-guided surgical systems for femtosecond laser-assisted cataract surgery, which aim to improve accuracy by registering pre-operative diagnostic images with real-time intra-operative views of a patient's eye.
Key Procedural History: The complaint alleges that Plaintiff provided Defendant with actual notice of the asserted patents and infringement allegations via a letter on September 13, 2021, followed by representative claim charts on November 12, 2021.
Case Timeline
| Date | Event |
|---|---|
| 2008-10-22 | ’145 Patent Priority Date |
| 2009-10-20 | ’948 Patent Priority Date |
| 2012-Early | Original CATALYS® System launched in U.S. |
| 2014-12-02 | U.S. Patent No. 8,903,145 Issued |
| 2019-08-06 | U.S. Patent No. 10,368,948 Issued |
| 2020-06-22 | Accused CATALYS® cOS 6.0 software received FDA approval |
| 2020-12-09 | Accused CATALYS® cOS 6.0 software became commercially available |
| 2021-09-13 | Plaintiff sent pre-suit notice letter to Defendant |
| 2021-11-12 | Plaintiff provided claim charts to Defendant |
| 2021-12-23 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,903,145 - "Method and Apparatus for Image Processing for Computer-Aided Eye Surgery"
The Invention Explained
- Problem Addressed: The patent’s background describes the conventional process for intraocular lens (IOL) surgery as a "cumbersome process," noting that manual pre-surgical markings made on the eye with a pen are tedious for the surgeon and can "become fuzzy or may disappear over time," negatively affecting accuracy ( ’145 Patent, col. 1:11-62).
- The Patented Solution: The invention provides a computer-aided method where a pre-operative "reference image" of the eye is acquired and then "enriched" by the surgeon with "context information," such as planned incision locations. During surgery, this reference image is registered with a real-time image of the eye. The system tracks eye movement and overlays the context information on the live view, ensuring it remains at the correct relative position despite eye movement. The system also determines and visually represents the angular displacement between the pre-operative and real-time images. (’145 Patent, Abstract; col. 2:6-18).
- Technical Importance: This technology was designed to replace error-prone manual ink markings with a persistent digital overlay, thereby improving the precision and safety of procedures like toric IOL implantation that depend on accurate angular alignment (’145 Patent, col. 5:7-14).
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶34).
- Claim 1 requires:
- acquiring a reference image of the eye;
- enriching said reference image by inserting additional context information helpful for a surgeon;
- registering the reference image with a real-time image of the eye, which includes determining an angular displacement between the two images; and
- overlaying the context information and a visual representation of the angular displacement over the real-time image based on tracking eye movement, such that the context information stays in the same relative position and the visual representation indicates the amount of angular displacement.
U.S. Patent No. 10,368,948 - "Real-Time Surgical Reference Indicium Apparatus and Methods For Astigmatism Correction"
The Invention Explained
- Problem Addressed: The patent identifies a need for effective surgical reference guides ("indicia") for astigmatism correction procedures. It notes that pre-surgical markings can be inaccurate and that "cyclorotation"—the natural rotation of the eye when a patient moves from a seated (pre-operative) to a supine (operative) position—can cause misalignment between the surgical plan and the actual position of the eye during the procedure (’948 Patent, col. 12:53-62).
- The Patented Solution: The invention is an apparatus that captures a "pre-operative still image" of the patient's eye before cyclorotation occurs. The system's data processor integrates a "virtual indicium" (a digital guide for the surgery) with this pre-operative image. During the procedure, the system produces real-time visualizations and aligns the pre-operative image (with its integrated indicium) to the live view by tracking an identifiable visual feature on the eye. This ensures the surgical guide remains "rotationally accurate" relative to the eye's structures despite any movement or rotation. (’948 Patent, Abstract).
- Technical Importance: The invention provides a dynamic, real-time surgical guide that automatically accounts for eye rotation, a critical factor for achieving accurate outcomes in astigmatism-correcting procedures like limbal relaxing incisions (’948 Patent, col. 2:32-41).
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶54).
- Claim 1 requires an apparatus comprising:
- a data processor configured to receive a pre-operative still image taken prior to cyclorotation;
- a real-time, multidimensional visualization module to produce live visualizations of the surgical site;
- the data processor is further configured to: receive a virtual indicium; integrate the indicium with the pre-operative image to be rotationally accurate; determine movement by tracking an identifiable visual feature; align the pre-operative image and indicium with the live visualization to track movement; and display the live visualization in conjunction with the pre-operative image and indicium.
III. The Accused Instrumentality
Product Identification
- The CATALYS® Precision Laser System integrated with cOS 6.0 software (the "Accused Product") (Compl. ¶13).
Functionality and Market Context
- The Accused Product is a commercial femtosecond laser system used for laser-assisted cataract surgery (Compl. ¶12). The cOS 6.0 software incorporates pre-operative data from a third-party Cassini diagnostic device and uses "iris recognition for automatic cyclorotation compensation" (Compl. ¶14). The system is alleged to perform "biomorphometric intraoperative registration of iris features" and references these live features to the pre-operative data to identify target locations for laser incisions. This process is advertised to avoid problems arising from cyclorotation by adjusting the treatment plan based on the detected rotation of the eye. (Compl. ¶14, ¶15). The complaint includes a screenshot of the Accused Product's user interface, which displays a live intraoperative view of the eye alongside a pre-operative reference image (Compl. ¶17, p. 7).
IV. Analysis of Infringement Allegations
’145 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| acquiring a reference image of the eye | The system acquires a reference image by enabling the "direct importation of preoperative data from the Cassini" device. | ¶36 | col. 2:9-10 |
| enriching said reference image by inserting additional context information helpful for a surgeon | The system enriches the image with context information by using the imported pre-operative data and registered iris features to facilitate "precise laser marking" for incisions. | ¶37 | col. 2:10-13 |
| registering said reference image with a real-time image of the eye... includes determining an angular displacement | The system performs "iris registration for automatic cyclo-rotation compensation" by referencing and adjusting intraoperative iris features to the pre-operative Cassini tomography data. | ¶38 | col. 2:13-18 |
| overlaying the context information and a visual representation of the angular displacement over the real-time image... based on a tracking of the eye movement | The system overlays information that identifies the target incision locations, and this overlay compensates for cyclorotation, thereby tracking eye movement and visually representing the angular displacement. | ¶39 | col. 2:18-24 |
Identified Points of Contention
- Scope Questions: A central question may be whether the automated importation of diagnostic data from a separate device constitutes "enriching said reference image by inserting additional context information" as required by the claim. The defense may argue this limitation requires a more direct, graphical manipulation of the reference image by a user, as depicted in the patent's figures (’145 Patent, Fig. 2).
- Technical Questions: The complaint does not identify a specific, discrete element on the accused system's display that is a "visual representation of the angular displacement." It will be a point of contention whether the system's overall function of adjusting the treatment plan to compensate for rotation meets this limitation, or if the claim requires an explicit visual indicator (e.g., a numerical value or a graphical dial) showing the degree of rotation.
’948 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a data processor configured to receive a pre-operative still image... prior to cyclorotation | The system's processor receives a pre-operative still image by importing data from a Cassini tomography device, which is captured before the patient lies down for surgery and before cyclorotation occurs. | ¶56 | col. 23:54-59 |
| a real-time, multidimensional visualization module... configured to produce... real-time multidimensional visualizations | The Accused Product is a laser surgery system that provides real-time visualization of the surgical site. | ¶57 | col. 23:60-65 |
| wherein the data processor is configured to: receive a virtual indicium | The processor receives a virtual indicium in the form of imported pre-operative data and data for "precise laser marking" that guides the procedure. | ¶59 | col. 24:3-5 |
| integrate the virtual indicium with the pre-operative still image such that the virtual indicium is rotationally accurate | The system facilitates this integration through the "biomorphometric intraoperative registration of iris features" with the pre-operative data. | ¶60 | col. 24:6-9 |
| determine movement... by tracking a position of at least one identifiable visual feature | The system tracks movement by referencing and adjusting "intraoperative iris features" to those from the pre-operative tomography. | ¶61 | col. 24:10-12 |
| align the pre-operative still image including the virtual indicium with the multidimensional visualizations | The system aligns the pre-operative and real-time views to be "rotationally accurate and track the determined movement," thereby compensating for cyclorotation. | ¶62 | col. 24:13-19 |
| display the multidimensional visualizations... in conjunction with the preoperative still image | The user interface of the Accused Product displays the live visualization alongside the pre-operative image and virtual indicium. | ¶63 | col. 24:20-23 |
Identified Points of Contention
- Scope Questions: The definition of "virtual indicium" will be a key issue. The complaint posits that imported pre-operative data and laser guidance plans constitute the claimed indicium. The defense may argue that the term, in the context of the patent, is limited to explicit graphical overlays like lines, arcs, or compass cards, as shown in the patent's figures (’948 Patent, Figs. 8-12), not the underlying data itself.
- Technical Questions: It raises the question of how the accused system's "iris recognition" and "biomorphometric intraoperative registration" functions technically operate and whether this process meets the claim limitation of "tracking a position of at least one identifiable visual feature."
V. Key Claim Terms for Construction
Patent: ’145 Patent
- The Term: "enriching said reference image by inserting additional context information"
- Context and Importance: This term is critical because Plaintiff's infringement theory relies on the automated importation of diagnostic data satisfying this "enriching" step. The court's construction will determine whether a largely automated data transfer process falls within the scope of a claim limitation that the patent specification illustrates with more user-driven, graphical manipulation.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification lists "surgery planning data" as an example of context information, and the overall goal is to provide a "tool which can assist" the surgeon in planning and execution. This language may support an argument that any method of incorporating planning data, including automated import, constitutes "enriching." (’145 Patent, col. 2:65-66, col. 3:10-13).
- Evidence for a Narrower Interpretation: The specification describes a "surgery planner" that allows a surgeon to use a "graphical manipulation tool" to "insert context information... into the reference image." This and accompanying figures suggest a more interactive, manual process of graphically modifying the image, potentially narrowing the term's scope. (’145 Patent, col. 5:35-42; Fig. 2).
Patent: ’948 Patent
- The Term: "virtual indicium"
- Context and Importance: The infringement case for the ’948 patent hinges on whether the pre-operative data and resulting laser treatment plan in the Accused Product can be classified as a "virtual indicium." Practitioners may focus on this term because if it is construed narrowly to mean only an explicit graphical overlay, Plaintiff's infringement argument could be weakened.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent's summary states the invention provides "effective reference indicia including data for making at least one ocular relaxing incision," suggesting that "data" itself can be part of the indicium. The term is not explicitly defined, allowing for an argument that it should be given its plain and ordinary meaning of a guide or indicator. (’948 Patent, col. 2:34-37).
- Evidence for a Narrower Interpretation: The detailed description and figures exclusively show embodiments where the "virtual indicium" is a graphical overlay, such as a "compass card," cross-hairs, and arcs representing incision paths. This could support an argument that the term is implicitly limited to such graphical representations. (’948 Patent, Figs. 8-12; col. 18:7-13).
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement for both patents. Inducement is based on allegations that Defendant encourages its customers to use the Accused Product in an infringing manner through marketing, user manuals, and training (Compl. ¶42, ¶66). Contributory infringement is based on allegations that the Accused Product is especially made for the infringing use in cataract surgery and is not a staple article of commerce with substantial non-infringing uses (Compl. ¶44).
- Willful Infringement: Plaintiff alleges willful infringement based on Defendant's continued infringement after receiving actual notice via a letter dated September 13, 2021 (Compl. ¶43, ¶67).
VII. Analyst’s Conclusion: Key Questions for the Case
This case will likely focus on the interplay between claim language rooted in user-driven graphical interfaces and the functionality of a modern, highly automated surgical system. The central questions for the court appear to be:
- A core issue will be one of definitional scope: does the automated importation and application of diagnostic data in the accused system meet the ’145 Patent’s requirement of a surgeon "enriching" a reference image with "context information," a step the patent specification illustrates as a manual, graphical planning process?
- A second key issue will be one of technical classification: can the underlying data and laser guidance plan used by the accused system be properly classified as a "virtual indicium" under the ’948 Patent, or is that term limited by the patent's embodiments to explicit graphical overlays displayed to the user?
- An evidentiary question of functional interpretation will arise for the ’145 Patent: does the accused system's overall function of compensating for cyclorotation satisfy the claim requirement of displaying a "visual representation of the angular displacement," or must Plaintiff prove the existence of a discrete visual element on the user interface that performs this specific function?