DCT

1:20-cv-00842

AMO Development LLC v. Alcon Vision LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:20-cv-00842, D. Del., 09/28/2020
  • Venue Allegations: Venue is asserted on the basis that all Defendant entities are incorporated in Delaware and have allegedly committed acts of patent infringement in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s LenSx® Laser System for cataract surgery infringes sixteen patents related to methods and systems for performing precise, image-guided ophthalmic procedures using lasers.
  • Technical Context: The technology relates to femtosecond laser-assisted cataract surgery, which utilizes advanced imaging like optical coherence tomography (OCT) to automate critical steps of the procedure, offering a high-precision alternative to manual surgery.
  • Key Procedural History: The complaint alleges Defendant had extensive pre-suit knowledge of the patents, citing Defendant’s citation of the patents-in-suit during its own patent prosecution and Plaintiff’s provision of notice letters with exemplary claim charts to Defendant in March, April, July, and August of 2020. Post-filing, several of the asserted patents have been subject to Inter Partes Review (IPR) proceedings, with some claims being cancelled or disclaimed, which may significantly impact the scope of the case as it proceeds.

Case Timeline

Date Event
2005-01-10 Earliest Priority Date for Palanker Patents ('084, '921, '497, '724, '001, '415, '448, '732, '725, '648, '903, '904)
2007-03-13 Earliest Priority Date for Culbertson Patents ('023, '024, '356, '548)
2011-01-01 Alcon commercially launches the LenSx in the United States
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
2020-03-24 Plaintiff identifies Palanker Patents to Defendant
2020-04-14 Plaintiff provides claim charts for Palanker Patents to Defendant
2020-07-14 U.S. Patent No. 10,709,548 Issues
2020-07-14 Plaintiff identifies Culbertson Patents to Defendant
2020-08-04 Plaintiff provides claim charts for Culbertson Patents to Defendant
2020-09-28 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," issued March 12, 2013

The Invention Explained

  • Problem Addressed: The patent addresses the challenges of manual cataract surgery, which requires significant dexterity and carries risks of complications such as unwanted tears in the lens capsule and damage to surrounding tissues from ultrasonic energy used to break up the lens (’084 Patent, col. 1:17-2:14).
  • The Patented Solution: The invention is a system that automates key steps of cataract surgery using a pulsed laser guided by a three-dimensional optical coherence tomography (OCT) imaging assembly. The system is programmed to automatically scan the patient's eye to create a continuous depth profile, use that data to identify anatomical boundaries like the lens capsule, define treatment regions, and then operate the laser in a precise pattern to create an opening (a capsulotomy) and break up the lens (phaco-segmentation) (’084 Patent, Abstract; col. 6:3-15).
  • Technical Importance: The integration of OCT imaging with automated laser control was designed to improve the precision, consistency, and safety of cataract surgery compared to traditional manual techniques (Compl. ¶¶60-61).

Key Claims at a Glance

  • The complaint asserts claim 1, an independent system claim (Compl. ¶109).
  • The essential elements of claim 1 are:
    • A pulsed laser configured to create dielectric breakdown in lens tissue.
    • 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 the eye with the imaging assembly to generate image data for the depth profile, (ii) identify tissue boundaries from the image data, (iii) identify treatment regions based on the boundaries, and (iv) operate the laser in a pattern to create a capsulotomy.
  • The complaint reserves the right to assert additional claims (Compl. ¶108).

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," issued March 26, 2013

The Invention Explained

  • Problem Addressed: Similar to the ’084 Patent, this invention targets the imprecision and risks inherent in manual cataract surgery, particularly the creation of the anterior capsulotomy (’921 Patent, col. 1:19-2:16).
  • The Patented Solution: The invention is a system that uses a 3D OCT imaging system to acquire data and construct images of the crystalline lens. Based on this image data, a computer control system automatically constructs an "anterior capsulotomy cutting region" defined as an "axially-elongated cutting zone" that transects the anterior capsule. The system then operates the laser assembly to direct a treatment beam in a pattern based on this 3D cutting region to create the capsulotomy (’921 Patent, Abstract; col. 5:55-67).
  • Technical Importance: This technology provided a specific framework for defining the laser cut not as a simple 2D shape, but as a three-dimensional volume, which can enhance the completeness and precision of the capsulotomy incision (Compl. ¶¶60-61).

Key Claims at a Glance

  • The complaint asserts claim 1, an independent system claim (Compl. ¶132).
  • The essential elements of claim 1 are:
    • A laser assembly for generating a pulsed laser treatment beam.
    • An OCT 3D imaging system for imaging the crystalline lens.
    • An optical scanning system for positioning the laser beam.
    • A computer control system programmed to automatically: (a) acquire image data, (b) construct images from the data, (c) construct an "anterior capsulotomy cutting region" comprising an "axially-elongated cutting zone," and (d) operate the laser to create the capsulotomy based on that region.
  • The complaint reserves the right to assert additional claims (Compl. ¶131).

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

  • Patent Identification: U.S. Patent No. US8425497B2, "Method and apparatus for patterned plasma-mediated laser trephination of the lens capsule and three dimensional phaco-segmentation," issued April 23, 2013 (Compl. ¶18).
  • Technology Synopsis: This patent claims a method of making an incision in eye tissue. The method involves operating an imaging system to acquire image data of the crystalline lens, using a control system to identify a cutting region based on that data, and then generating and scanning a pulsed laser beam in a pattern at multiple depths to segment the lens into pieces for removal (Compl. ¶155).
  • Asserted Claims: Claim 1 (independent method claim) (Compl. ¶155).
  • Accused Features: The accused features are the operations of the LenSx system when performing laser phacofragmentation, which allegedly involves acquiring image data, defining a cutting region, and scanning a laser at different depths to segment the lens (Compl. ¶¶157-162).

Multi-Patent Capsule: U.S. Patent No. 8,500,724

  • Patent Identification: U.S. Patent No. US8500724B2, "Method and apparatus for patterned plasma-mediated laser trephination of the lens capsule and three dimensional phaco-segmentation," issued August 6, 2013 (Compl. ¶19).
  • Technology Synopsis: This patent claims a method for laser cataract surgery that protects the retina. The method involves generating an image of the lens, determining a targeted treatment region that transects the anterior capsule but not the posterior capsule, and then directing a laser in a two-part pattern: first to create a light-scattering region, and subsequently to cut lens tissue anterior to that region for removal (Compl. ¶174).
  • Asserted Claims: Claim 1 (independent method claim) (Compl. ¶174).
  • Accused Features: The accused features are the operations of the LenSx system, which allegedly generate an image, define a treatment zone that avoids the posterior capsule, and direct a laser in patterns to create incisions for lens fragmentation (Compl. ¶¶175-179).

Note: The complaint continues with similar allegations for an additional twelve patents-in-suit (U.S. Patent Nos. US8709001B2; US9095415B2; US9101448B2; US9107732B2; US9125725B2; US9233023B2; US9233024B2; US9474648B2; US9693903B2; US9693904B2; US10376356B2; and US10709548B2), which are not detailed individually in this report.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is the Alcon LenSx® Laser System ("LenSx") (Compl. ¶1).

Functionality and Market Context

  • The LenSx is an OCT-guided laser system designed to perform anterior capsulotomy, lens fragmentation, and corneal incisions during cataract surgery (Compl. ¶71). The system's user interface allows surgeons to select among different programs, including "Capsule" and "Lens" for cataract procedures (Compl. p. 15, figure). The complaint alleges the system utilizes a 3D spectral domain OCT imaging assembly to generate a "circle scan" or "line scan," which provides a depth profile of the eye's anterior structures (Compl. ¶¶112, 114, 135). Based on this imaging data, a computer controller automatically identifies tissue boundaries and directs a femtosecond laser in a pre-programmed, three-dimensional pattern to create incisions (Compl. ¶¶111, 113, 115). The complaint positions the LenSx as a direct competitor to the Plaintiff's Catalys® Precision Laser System in a highly specialized market (Compl. ¶73).

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 system for cataract surgery on an eye... The LenSx is marketed and indicated for use in patients undergoing cataract surgery. ¶110 col. 1:17-19
a pulsed laser configured to produce a treatment beam which creates dielectric breakdown in a focal zone... within one or more tissue structures of a cataractous crystalline lens; The LenSx uses focused femtosecond laser pulses to create incisions and separate tissue via photodisruption, which is alleged to be achieved through dielectric breakdown. ¶111 col. 5:1-4
a three-dimensional, optical coherence tomography imaging assembly capable of creating a continuous depth profile of the anterior portion of the cataractous crystalline lens... The LenSx includes a 3D spectral domain OCT imaging assembly that scans the eye to generate what Alcon calls a "circle scan," which allegedly provides a continuous depth profile. ¶112 col. 5:5-14
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 uses a computer-controlled scanning system to direct the focused laser beam throughout a three-dimensional pattern to produce an incision. ¶113 col. 5:15-32
one or more controllers... programmed to automatically: i. scan tissues of the patient’s eye with the imaging assembly so as to generate image data signals to create a continuous depth profile... The LenSx has a computer that allegedly monitors and controls the system to automatically scan eye tissues with the OCT assembly to generate a continuous depth profile. The complaint includes a screenshot from Alcon's materials depicting such a profile. ¶114 col. 6:3-7
ii. identify one or more boundaries of the one or more tissue structures of the cataractous crystalline lens based at least in part on the image data; The LenSx computer allegedly auto-finds the anterior and posterior surfaces of the lens capsule and generates horizontal lines on the OCT image to indicate the depth of the anterior capsule. ¶115 col. 6:8-10
iii. identify one or more treatment regions based upon the boundaries; The LenSx uses its OCT-based imaging to assist in localizing specific target locations, which is alleged to satisfy this element. ¶116 col. 6:11-12
iv. operate the optical scanning system with the pulsed laser to produce a treatment beam directed in a pattern... so as to create a capsulotomy... The LenSx system is allegedly computer-controlled to direct the laser in a 3D pattern to perform a capsulotomy, with a 50 kHz repetition rate and maximum pulse energy of 15 microjoules. ¶117 col. 6:13-15

8,403,921 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A system for cataract surgery on an eye of a patient... The LenSx is a system indicated for use in patients undergoing cataract surgery. ¶133 col. 1:19-21
a laser assembly for generating a pulsed laser treatment beam that creates dielectric breakdown... The LenSx includes an ophthalmic surgical laser using focused femtosecond pulses to create photodisruption, which is alleged to be achieved through dielectric breakdown. ¶134 col. 5:16-29
an optical coherence tomography (OCT) 3-Dimensional imaging system configured for imaging tissue of a cataractous crystalline lens of the patient; The LenSx uses a 3D spectral domain OCT imaging assembly that generates a "circle scan" which allegedly provides an image of the cataractous crystalline lens. ¶135 col. 5:30-34
an optical scanning system configured for positioning the focal zone of the treatment beam to targeted locations of the crystalline lens; The LenSx has a computer-controlled scanning system that directs the focused laser beam throughout a 3D pattern to produce an incision. ¶136 col. 5:35-39
a computer control system... programmed to automatically: a) acquire image data from locations distributed throughout a volume of the cataractous crystalline lens... The LenSx computer controls the system and uses its OCT imaging assembly to scan the anterior chamber of the eye, allegedly acquiring image data throughout a volume of the lens. An illustrative diagram shows the scanning of the eye with the OCT system. ¶137, p. 39 col. 5:40-49
b) construct one or more images of the patient’s eye tissues from the image data... The LenSx uses its OCT imaging assembly to generate what Alcon refers to as a circle scan, which provides an image of at least a portion of the crystalline lens. ¶138 col. 5:50-54
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; The LenSx uses its OCT imaging to localize target locations and its anterior capsulotomy pattern is allegedly programmed to cut from below to above the anterior capsule, creating what Alcon describes as a "cylindrical incision." This is alleged to be an axially-elongated cutting zone. ¶139 col. 5:55-62
d) operate the optical scanning system and laser assembly to direct a treatment beam in a pattern based on the anterior capsulotomy cutting region... The LenSx computer-controlled scanning system directs the laser in a pattern based on the created capsulotomy region to create the anterior capsulotomy. ¶140 col. 5:63-67

Identified Points of Contention

  • Scope Questions: For the ’084 Patent, a potential issue is whether the separate controller steps of "identify... boundaries" and "identify... treatment regions" are distinct, identifiable operations in the accused LenSx system, or if these functions are conflated in a way that might avoid literal infringement of the claim's sequence. For the ’921 Patent, a central question may be one of scope: does the LenSx’s creation of a "cylindrical incision" by stacking 2D circular scans meet the definition of an "axially-elongated cutting zone," or does that term require a different, pre-defined volumetric shape?
  • Technical Questions: A key technical question for both patents is how the LenSx system translates the OCT image data into a laser scanning pattern. The complaint alleges this process is automated and meets the claim limitations, but the specific algorithms and operational logic used by the LenSx controller will be a central factual issue for the court.

V. Key Claim Terms for Construction

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

  • Context and Importance: This term is foundational to the automated process claimed in the ’084 Patent, as the profile serves as the input data for all subsequent controller steps. Practitioners may focus on this term because the nature of the accused product's "circle scan" (Compl. ¶112) raises the question of whether a scan along a single circle constitutes a "continuous" profile of the lens's anterior "portion."
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent does not explicitly define "continuous," which may support giving the term its plain and ordinary meaning. The term "profile" may suggest that a representative cross-section, rather than a full volumetric map, is sufficient (’084 Patent, col. 5:9).
    • Evidence for a Narrower Interpretation: Language in the specification describing the detection of light from locations "distributed throughout a volume" of the lens could be argued to require a more comprehensive data set than a single circular scan to create the profile (’084 Patent, col. 5:9-12).

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

  • Context and Importance: The definition of this term is critical to the infringement analysis for the ’921 Patent, as it describes the three-dimensional nature of the computer-generated surgical plan. The dispute will likely center on whether the LenSx's process of building a "cylindrical incision" from stacked 2D scans (Compl. ¶139) meets the definition of this "zone."
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes creating an incision with an axial extent to ensure the capsule is fully transected, a result that could arguably be achieved by stacking circular cuts (’921 Patent, col. 3:19-27). The term "zone" itself implies a region or volume.
    • Evidence for a Narrower Interpretation: Embodiments described in the patent, such as the use of multi-focal lenses to create simultaneous focal points at different depths, could suggest that an "axially-elongated cutting zone" requires something more than the sequential stacking of 2D patterns (’921 Patent, Fig. 7A-7D; col. 9:15-32).

VI. Other Allegations

Indirect Infringement

  • The complaint alleges both induced and contributory infringement. Inducement is primarily based on allegations that Alcon encourages its customers to infringe by marketing the LenSx for its FDA-approved indications and providing instructions, manuals, and support that direct the infringing use (Compl. ¶¶120, 143). Contributory infringement is based on the allegation that the LenSx is a material part of the invention especially adapted for infringing use and has no substantial non-infringing use when operated in its "Capsule" and "Lens" modes (Compl. ¶¶122, 145).

Willful Infringement

  • The complaint makes extensive allegations to support willfulness based on pre-suit knowledge. It alleges that Alcon has tracked the asserted patent families since at least 2008 through its own patent prosecution activities (Compl. ¶¶81-83, 88), was aware of the technology through industry publications and press releases prior to the patents issuing (Compl. ¶¶85-87), and received direct notice of infringement via letters and exemplary claim charts from the Plaintiff in the months preceding the lawsuit (Compl. ¶¶89-90).

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

  • A core issue will be one of definitional scope: can the term "axially-elongated cutting zone," which suggests a pre-defined three-dimensional volume, be construed to cover the accused "cylindrical incision" which is allegedly formed by stacking multiple two-dimensional circular laser patterns?
  • A key evidentiary question will be one of operational equivalence: does the accused LenSx system's software perform the discrete, sequential steps of (1) identifying boundaries and then (2) identifying treatment regions as recited in claim 1 of the '084 Patent, or is there a technical variance in its operational logic that places it outside the literal scope of the claim?
  • A central issue for damages will be willfulness: given the detailed allegations of Defendant's long-term awareness of the technology and patents, including citations in its own patent filings and receipt of pre-suit notice letters, the court will need to determine if Defendant's alleged infringement was willful, which could expose it to enhanced damages.