Alcon Inc v. AMO Development LLC

1. Case Identification

• Case #: IPR2021-00817
• Patent #: 8,394,084
• Filed: April 16, 2021
• Petitioner(s): Alcon Inc., Alcon LenSx, Inc., Alcon Vision, LLC, Alcon Laboratories, Inc., and Alcon Research, LLC
• Patent Owner(s): AMO Development, LLC
• Challenged Claims: 1-21

2. Patent Overview

• Title: Laser Surgical System
• Brief Description: The ’084 patent describes an ophthalmological surgical system for performing cataract surgery. The system integrates a pulsed laser for tissue cutting with an Optical Coherence Tomography (OCT) imaging assembly for automatically identifying eye structures and guiding the laser.

3. Grounds for Unpatentability

Ground 1: Obviousness over Swinger, Baikoff, and Li - Claims 1–5, 12–17, and 19 are obvious over Swinger in view of Baikoff and Li.

• Prior Art Relied Upon: Swinger (Patent 6,325,792), Baikoff (a 2004 journal article), and Li (a 2003 journal article). An alternative combination substitutes Yelbuz (a 2002 journal article) for its teachings on 3D imaging.
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Swinger disclosed a computer-controlled, ultrashort-pulsed laser system for performing cataract surgery procedures, including anterior capsulotomy and lens fragmentation. Swinger used older imaging technology like ultrasound or direct visualization. Baikoff taught the use of a more advanced OCT imaging system for pre-surgical diagnostics of the eye’s anterior segment, concluding it was user-friendly, accurate, and useful for planning surgery. Li taught an OCT system that employed a computer algorithm to automatically make measurements based on the boundaries of imaged tissue, overcoming the imprecision of manual measurements.
  • Motivation to Combine: A POSITA would combine Swinger's laser surgery system with Baikoff's superior OCT imaging to improve the accuracy and reproducibility of incisions, a key concern in Swinger. This combination represented a simple substitution of a known, improved imaging modality (OCT) for an older, less precise one (ultrasound) to achieve a predictable result. A POSITA would further incorporate Li's automated measurement algorithms to program Swinger's controller, thereby automating a manual task to improve the speed and accuracy of the overall system.
  • Expectation of Success: Petitioner asserted a high expectation of success, as integrating known imaging and treatment systems was straightforward. Swinger already used imaging to guide its laser, and replacing its ultrasound component with Baikoff's more advanced OCT system would predictably result in more accurate surgical planning and execution.

Ground 2: Obviousness over Freedman and Swinger - Claims 1–5, 12–17, and 19 are obvious over Freedman in view of Swinger.

• Prior Art Relied Upon: Freedman (Patent 6,454,761) and Swinger (Patent 6,325,792).

• Core Argument for this Ground:

  • Prior Art Mapping: Petitioner asserted that Freedman already disclosed the core concept of the ’084 patent: a laser surgery system that uses an integrated OCT imaging assembly to guide a treatment laser for ablating biological tissue. Freedman explicitly mentioned its system could be used for "clearing cataracts." Swinger taught the specific, well-known steps of modern cataract surgery, such as computer-controlled anterior capsulotomy and lens fragmentation, and highlighted the benefits of performing these procedures with laser precision.
  • Motivation to Combine: A POSITA, aware of Freedman's OCT-guided laser system for general tissue ablation, would have been motivated to apply this advanced tool to the specific procedures for cataract surgery as detailed in Swinger. Doing so would be an application of a known technique (Freedman's OCT-guided ablation) to a known method ready for improvement (cataract surgery) to yield the predictable result of greater surgical accuracy. Petitioner argued this was not invention, but rather using a known tool for its intended purpose.
  • Expectation of Success: A POSITA would have had a high expectation of success. Freedman's system was already capable of imaging biological tissue and controlling a laser accordingly. Configuring it to target the cataractous lens and perform the specific cutting patterns described by Swinger would involve routine programming and adaptation.

• Additional Grounds: Petitioner asserted additional obviousness challenges against claims 6–11, 18, and 20–21. These grounds added Hoppeler (a 1992 conference proceeding) to the primary combinations of Swinger/Baikoff/Li and Freedman/Swinger. Hoppeler was cited for its teaching of using a computer-controlled laser to segment a cataractous lens into discrete fragments using various patterns, a known technique to reduce phacoemulsification time during surgery.

4. Key Claim Construction Positions

• "Three-dimensional ... imaging assembly capable of creating a continuous depth profile": Petitioner argued this phrase should be construed to mean an imaging assembly with the hardware capability of scanning in at least two lateral dimensions plus the axial dimension. It does not necessarily require the system to be programmed to acquire and render a full three-dimensional volumetric image. This construction is based on the patent's own disclosure, which illustrates only 2D B-scans, and supports the application of prior art that describes scanning across multiple meridians.
• "Automatically": Petitioner contended this term should be construed as "without user control, but with or without taking into account user input." This construction was proposed to reconcile the term's plain meaning ("without human intervention") with the language of dependent claim 15, which explicitly requires the system to receive user input to identify treatment regions.

5. Arguments Regarding Discretionary Denial

• Petitioner argued extensively that discretionary denial would be inappropriate.
• §325(d) (Same or Substantially the Same Art): Denial was argued to be improper because the primary references, Freedman and Swinger (as a base reference), were never applied or substantively discussed by the Examiner during prosecution. Furthermore, the Examiner failed to consider any of the non-patent literature references (Baikoff, Li, Yelbuz, Hoppeler) relied upon in the petition.
• §314(a) (Fintiv Factors): Petitioner argued against denial based on the parallel Delaware litigation. Key factors cited were: (1) the district court trial was scheduled for February 2023, more than four months after the statutory deadline for a Final Written Decision (FWD); (2) the litigation was in an early stage, with the Markman hearing not yet held and significant discovery remaining; and (3) Petitioner stipulated that, if the IPR is instituted, it will not pursue the same invalidity grounds in the district court.

6. Relief Requested

• Petitioner requested institution of an inter partes review and cancellation of claims 1-21 of the ’084 patent as unpatentable under 35 U.S.C. §103.