DCT

1:20-cv-00842

AMO Development LLC v. Alcon Vision LLC

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Key Events
Amended Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:20-cv-00842, D. Del., 06/17/2021
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware based on Defendants being Delaware corporations that have transacted business and committed acts of infringement in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s LenSx® Laser System for cataract surgery infringes sixteen patents related to image-guided laser ophthalmic surgery, and further alleges copyright infringement based on the alleged theft and incorporation of Plaintiff's software source code and technical documentation into the accused system.
  • Technical Context: The technology relates to femtosecond laser-assisted cataract surgery, which employs advanced imaging like optical coherence tomography (OCT) to guide a laser in performing precise incisions in the eye's lens capsule and crystalline lens, representing a significant technological evolution from manual surgical methods.
  • Key Procedural History: This Second Amended Complaint follows prior pleadings and pre-suit correspondence between the parties. Subsequent to the filing of this complaint, several of the asserted patents have been subject to Inter Partes Review (IPR) proceedings. Notably, IPRs resulted in the cancellation of all asserted claims for U.S. Patents 10,376,356; 10,709,548; 9,233,023; and 9,233,024. Conversely, IPRs confirmed the patentability of all challenged claims for the lead asserted patents, U.S. Patents 8,394,084 and 8,403,921.

Case Timeline

Date Event
2005-01-10 Earliest Priority Date for Palanker Patents ('084, '921)
2007-03-13 Earliest Priority Date for Culbertson Patents ('023, '024)
2010-07-01 Alcon acquires LenSx Lasers, Inc.
2011-01-01 Alcon commercially launches the LenSx Laser System
2013-03-12 U.S. Patent No. 8,394,084 Issues
2013-03-26 U.S. Patent No. 8,403,921 Issues
2013-04-23 U.S. Patent No. 8,425,497 Issues
2013-08-06 U.S. Patent No. 8,500,724 Issues
2014-04-29 U.S. Patent No. 8,709,001 Issues
2015-08-04 U.S. Patent No. 9,095,415 Issues
2015-08-11 U.S. Patent No. 9,101,448 Issues
2015-08-18 U.S. Patent No. 9,107,732 Issues
2015-09-08 U.S. Patent No. 9,125,725 Issues
2016-01-12 U.S. Patent No. 9,233,023 Issues
2016-01-12 U.S. Patent No. 9,233,024 Issues
2016-10-25 U.S. Patent No. 9,474,648 Issues
2017-07-04 U.S. Patent No. 9,693,903 Issues
2017-07-04 U.S. Patent No. 9,693,904 Issues
2019-08-13 U.S. Patent No. 10,376,356 Issues
2020-07-14 U.S. Patent No. 10,709,548 Issues
2021-06-17 Second Amended Complaint Filed

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

U.S. Patent No. 8,394,084 - "Apparatus for patterned plasma-mediated laser trephination of the lens capsule and three dimensional phaco-segmentation"

The Invention Explained

  • Problem Addressed: The patent background describes the challenges of manual cataract surgery, where surgeons must perform a "capsulorhexis"—creating a circular opening in the anterior lens capsule—by hand (Compl. ¶58). This manual process risks unwanted tears, imprecision, and can lead to complications and poor clinical outcomes ('084 Patent, col. 1:40-2:4). Breaking up the hardened lens nucleus using ultrasound (phacoemulsification) also risks damaging delicate eye structures (Compl. ¶58).
  • The Patented Solution: The invention is a system that automates these critical steps using a pulsed laser guided by a three-dimensional imaging assembly, such as Optical Coherence Tomography (OCT) (Compl. ¶61). The imaging assembly creates a "continuous depth profile" of the lens and its capsule, and a controller uses this data to automatically operate a scanning system, directing the laser to create a precise capsulotomy and segment the lens for easier removal ('084 Patent, Abstract; col. 5:1-6:13).
  • Technical Importance: This technology was designed to replace challenging manual surgical steps with an automated, image-guided laser process, thereby increasing the precision, safety, and consistency of cataract surgery (Compl. ¶62).

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶120).
  • Essential elements of claim 1 include:
    • A pulsed laser configured to create dielectric breakdown in the crystalline lens.
    • A 3D OCT imaging assembly capable of creating a continuous depth profile of the anterior portion of the lens.
    • An optical scanning system to position the laser's focal zone in three dimensions.
    • One or more controllers programmed to automatically: (i) scan tissues to generate image data for the depth profile, (ii) identify tissue boundaries from the data, (iii) identify treatment regions based on the boundaries, and (iv) operate the laser in a pattern to create a capsulotomy.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 8,403,921 - "Method and apparatus for patterned plasma-mediated laser trephination of the lens capsule and three dimensional phaco-segmentation"

The Invention Explained

  • Problem Addressed: The patent addresses the same technical problems as the '084 Patent, namely the imprecision and risks associated with manual capsulorhexis and phacoemulsification in traditional cataract surgery ('921 Patent, col. 1:21-2:45; Compl. ¶58).
  • The Patented Solution: The invention is a system for cataract surgery comprising a laser, a 3D OCT imaging system, an optical scanning system, and a computer control system ('921 Patent, Abstract). The control system is programmed to acquire image data from the lens, construct images, and then construct an "anterior capsulotomy cutting region" based on that data. This region is defined as an "axially-elongated cutting zone transecting the anterior capsule," which guides the laser to create the capsulotomy ('921 Patent, col. 10:1-32).
  • Technical Importance: The invention provides a specific method for defining a three-dimensional, image-guided laser cutting pattern to precisely perform an anterior capsulotomy, a critical step in modern cataract surgery (Compl. ¶¶60-62).

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶143).
  • Essential elements of claim 1 include:
    • A laser assembly for generating a pulsed laser treatment beam.
    • An OCT 3-Dimensional imaging system for imaging the crystalline lens.
    • An optical scanning system for positioning the laser's focal zone.
    • A computer control system programmed to automatically: (a) acquire image data, (b) construct images from the data, (c) construct an anterior capsulotomy cutting region defined as an "axially-elongated cutting zone," and (d) operate the laser to create the capsulotomy based on that region.
  • The complaint does not explicitly reserve the right to assert dependent claims.

Multi-Patent Capsule: U.S. Patent No. 8,425,497

  • Patent Identification: 8,425,497, "Method and apparatus for patterned plasma-mediated laser trephination of the lens capsule and three dimensional phaco-segmentation," issued April 23, 2013 (Compl. ¶16).
  • Technology Synopsis: The patent claims a method of making an incision in eye tissue by acquiring image data, identifying a cutting region, and guiding a pulsed laser to scan at a first depth and then a different second depth to create an incision pattern (Compl. ¶166).
  • Asserted Claims: Claim 1 is asserted (Compl. ¶166).
  • Accused Features: The LenSx system's method of performing laser phacofragmentation by scanning the laser at successive depths within the crystalline lens is accused of infringement (Compl. ¶¶170-173).

(Analysis of the 13 other patents asserted in the complaint would follow in this capsule format).

III. The Accused Instrumentality

Product Identification

  • Alcon's LenSx® Laser System ("LenSx") (Compl. ¶76).

Functionality and Market Context

  • The LenSx is an OCT-guided femtosecond laser system designed for use in cataract surgery (Compl. ¶76). It is alleged to perform several key surgical steps, including creating an anterior capsulotomy (an opening in the lens capsule), fragmenting the lens nucleus, and making corneal incisions (Compl. ¶76). The complaint alleges that Alcon's marketing materials describe the LenSx as using "integrated optical coherence tomography (OCT) – to capture incredibly precise, high-resolution images" which are then used "to plan and perform a surgery to exacting specifications not attainable with traditional surgery" (Compl. ¶96). The system is alleged to directly compete with J&J Vision's own Catalys® Precision Laser System (Compl. ¶78).

IV. Analysis of Infringement Allegations

8,394,084 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a pulsed laser configured to produce a treatment beam which creates dielectric breakdown in a focal zone of the treatment beam within one or more tissue structures of a cataractous crystalline lens The LenSx is an ophthalmic surgical laser that uses focused femtosecond laser pulses to create incisions and separate tissue within the lens capsule and crystalline lens, which allegedly achieves photodisruption through dielectric breakdown (Compl. ¶122). ¶122 col. 5:1-5
a three-dimensional, optical coherence tomography imaging assembly capable of creating a continuous depth profile of the anterior portion of the cataractous crystalline lens...by detecting remitted illumination light from locations distributed throughout a volume of the cataractous crystalline lens, and generating signals based upon the remitted light The LenSx is alleged to include a 3D spectral domain OCT imaging assembly that scans a light source throughout the anterior chamber of the eye (Compl. ¶123). The complaint includes a diagram from Alcon illustrating a "circle scan" that allegedly provides the claimed continuous depth profile (Compl. ¶123, p. 44). ¶123 col. 5:1-14
an optical scanning system configured to position a focal zone of the treatment beam to a targeted location in three dimensions in the crystalline lens The LenSx allegedly includes a computer-controlled scanning system that directs the focused laser beam throughout a three-dimensional pattern to position the focal zone and produce an incision (Compl. ¶124). ¶124 col. 5:8-12
one or more controllers operatively coupled to the laser, optical system, and imaging assembly, and programmed to automatically: i. scan tissues...to generate image data signals to create a continuous depth profile... ii. identify one or more boundaries...based at least in part on the image data; iii. identify one or more treatment regions based upon the boundaries; and iv. operate the optical scanning system with the pulsed laser...to create a capsulotomy... The LenSx allegedly includes computer monitors and controllers that are programmed to automatically perform these steps (Compl. ¶¶125-128). The complaint alleges the computer uses the OCT image data to auto-find the anterior and posterior surfaces of the lens capsule, identifying boundaries (Compl. ¶126). This identification is shown in a screenshot of the LenSx user interface, which displays the OCT image with horizontal lines indicating the depth of the anterior capsule (Compl. ¶126, p. 46). The controller then allegedly uses these boundaries to define treatment regions and operate the laser to create a capsulotomy (Compl. ¶¶127-128). ¶¶125-128 col. 5:13-17

8,403,921 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a laser assembly for generating a pulsed laser treatment beam that creates dielectric breakdown in a focal zone...so as to effect a cataract surgery procedure The LenSx is alleged to be an ophthalmic surgical laser using focused femtosecond laser pulses to create incisions in the lens capsule and crystalline lens, which achieves photodisruption via dielectric breakdown (Compl. ¶145). ¶145 col. 9:1-12
an optical coherence tomography (OCT) 3-Dimensional imaging system configured for imaging tissue of a cataractous crystalline lens of the patient The LenSx allegedly uses a 3D spectral domain OCT imaging assembly to generate a "circle scan" which provides an image of the cataractous crystalline lens (Compl. ¶146). A diagram from Alcon is included to illustrate this circle scan and the resulting depth profile image (Compl. ¶146, p. 57). ¶146 col. 9:13-17
an optical scanning system configured for positioning the focal zone of the treatment beam to targeted locations of the crystalline lens The LenSx is alleged to use a computer-controlled scanning system to direct the laser beam in a three-dimensional pattern to a targeted location (Compl. ¶147). ¶147 col. 9:18-21
a computer control system...programmed to automatically: a) acquire image data... b) construct one or more images... c) construct an anterior capsulotomy cutting region...comprising an anterior cutting boundary axially spaced from a posterior cutting boundary so as to define an axially-elongated cutting zone transecting the anterior capsule; and d) operate the optical scanning system...to create an anterior capsulotomy... The LenSx allegedly includes a computer control system that automatically performs these steps (Compl. ¶¶148-151). The complaint alleges the system acquires image data and constructs an image (Compl. ¶¶148-149). It further alleges that the system constructs the claimed "axially-elongated cutting zone" by programming cuts from at least 100 microns below to 100 microns above the anterior capsule, creating a "cylindrical incision" by scanning successive circles at different depths (Compl. ¶150). The system then allegedly operates the laser based on this pattern to create the anterior capsulotomy (Compl. ¶151). ¶¶148-151 col. 9:22-37

Identified Points of Contention

  • Scope Questions: A central point of contention may be the proper construction of the claim term "continuous depth profile" in the ’084 Patent. The infringement allegation rests on the theory that the accused LenSx "circle scan" meets this limitation (Compl. ¶123). The dispute may focus on whether discrete circular scans at different depths constitute a "continuous" profile as contemplated by the patent. Similarly, for the ’921 Patent, a dispute may arise over whether the "cylindrical incision" allegedly created by the LenSx by stacking circular laser patterns (Compl. ¶150) meets the claim requirement of an "axially-elongated cutting zone."
  • Technical Questions: An evidentiary question may concern the degree of automation in the accused LenSx system. Claim 1 of the ’084 Patent requires a controller "programmed to automatically" perform a four-step process of scanning, identifying boundaries, identifying treatment regions, and operating the laser. The analysis may question what level of user input or confirmation, if any, is involved in the accused system's workflow and whether that workflow meets the "automatically" limitation for each required step.

V. Key Claim Terms for Construction

The Term: "continuous depth profile" (’084 Patent, Claim 1)

  • Context and Importance: This term is critical because the infringement theory hinges on the allegation that the accused LenSx system's "circle scan," generated by its OCT imaging assembly, creates such a profile (Compl. ¶123). The construction of "continuous" will be determinative of whether the accused device's imaging function meets this element.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the imaging assembly as being used for "3D patterning" and providing information about the "axial location" of the lens capsule ('084 Patent, col. 5:5-11). This suggests the purpose is to map the lens in 3D space, which may support a broader reading that encompasses any method, including a series of scans, that achieves this result.
    • Evidence for a Narrower Interpretation: The detailed description mentions creating a "three-dimensional topographical map" by directing a "plurality of parallel line scans across the anterior surface of the lens" ('084 Patent, col. 12:4-6). This specific embodiment of using parallel line scans could be used to argue for a narrower definition that does not read on the accused "circle scan" methodology.

The Term: "axially-elongated cutting zone" (’921 Patent, Claim 1)

  • Context and Importance: This term defines the geometry of the computer-generated treatment plan that guides the laser. The complaint alleges that the LenSx system creates a "cylindrical incision" by stacking circular scans at different depths, and that this constitutes an "axially-elongated cutting zone" (Compl. ¶¶150-151). Whether this interpretation is correct will be a central issue.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent's abstract describes creating "three dimensional phaco-segmentation," and the specification discusses creating a "three dimensional cutting pattern" ('921 Patent, col. 10:20-21). This language suggests the invention is not limited to a specific geometry but encompasses various 3D shapes that achieve the surgical goal.
    • Evidence for a Narrower Interpretation: The patent describes a specific purpose: to create an anterior capsulotomy "transecting the anterior capsule" ('921 Patent, Claim 1). A defendant may argue that the term "zone" implies a single, contiguous volumetric shape planned by the controller, rather than a construct built from a series of discrete 2D patterns executed sequentially.

VI. Other Allegations

Indirect Infringement

  • The complaint alleges active inducement, stating Alcon encourages its customers to use the LenSx in an infringing manner through marketing, user manuals, and providing consumables like the "LenSx SoftFit Patient Interface" (Compl. ¶¶131, 154). It also alleges contributory infringement on the basis that the LenSx, when used for its FDA-approved indications of anterior capsulotomy and lens fragmentation, has no substantial non-infringing use (Compl. ¶¶133, 156).

Willful Infringement

  • The complaint alleges willful infringement based on extensive pre-suit knowledge. The allegations point to Alcon's citation of the parent patent applications in its own patent filings (Compl. ¶¶85-87), Alcon's awareness of industry publications describing the technology (Compl. ¶89), a 2013 press release announcing the issuance of the '084 patent (Compl. ¶91), and direct notice letters from J&J Vision that included exemplary claim charts (Compl. ¶¶93-94).

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

  • A core issue will be one of definitional scope: can the term "continuous depth profile" ('084 Patent), which the specification illustrates with "parallel line scans," be construed to cover the stacked "circle scan" method allegedly used by the accused system? Similarly, does creating a "cylindrical incision" via sequential circular scans meet the definition of constructing an "axially-elongated cutting zone" ('921 Patent)?
  • A key evidentiary question will be one of pre-suit knowledge and intent: the complaint provides an extensive timeline alleging Alcon's awareness of the patented technology years before the lawsuit, including through citations in its own patent prosecution. The case will likely feature a significant dispute over whether this alleged knowledge rises to the level of willfulness required for enhanced damages.
  • A third major issue is the impact of parallel validity challenges: The cancellation of all asserted claims in four of the asserted patents via IPR proceedings significantly narrows the scope of the dispute. Conversely, the confirmation of the asserted claims of the lead '084 and '921 patents in IPRs strengthens their presumption of validity and may focus the litigation on the infringement questions surrounding those specific patents.