DCT

1:18-cv-01102

West View Research LLC v. Given Imaging Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-01102, D. Del., 07/26/2018
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Given Imaging, Inc. is a Delaware corporation, and because Defendants Given Imaging Ltd. and Medtronic plc are foreign defendants subject to suit in any judicial district.
  • Core Dispute: Plaintiff alleges that Defendants’ PillCam™ capsule endoscopy systems, including ingestible camera capsules and associated data analysis software, infringe six patents related to methods and apparatuses for in-vivo medical diagnosis and data processing.
  • Technical Context: The technology involves ingestible, autonomous probes that capture images within the gastrointestinal tract, which are then processed by software to assist physicians in diagnosing conditions, aiming to improve upon the time-consuming nature of manual review.
  • Key Procedural History: The complaint alleges that Defendants had pre-suit knowledge of the asserted patent family through multiple channels, including a 2009 letter from the inventor, a citation by Defendant Given Imaging Ltd. to one of the patents-in-suit during its own patent prosecution in 2012, and communications from a patent broker in 2016-2017. These allegations form the basis for claims of willful infringement.

Case Timeline

Date Event
1999-03-01 Earliest Priority Date for all Patents-in-Suit
2011-03-29 U.S. Patent No. 7,914,442 Issued
2011-11-29 U.S. Patent No. 8,068,897 Issued
2018-01-09 U.S. Patent No. 9,861,268 Issued
2018-03-13 U.S. Patent No. 9,913,575 Issued
2018-07-24 U.S. Patent No. 10,028,645 Issued
2018-07-24 U.S. Patent No. 10,028,646 Issued
2018-07-26 Complaint Filed

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

U.S. Patent No. 7,914,442 - "Endoscopic smart probe and method"

  • Issued: March 29, 2011

The Invention Explained

  • Problem Addressed: The patent background describes the significant time and cost required for highly skilled physicians to manually review the "several hours worth of data" generated by an endoscopic capsule during its transit through the intestinal tract. This lengthy process creates inefficiencies, costs, and potential for physician fatigue, which could reduce diagnostic accuracy (Compl. ¶79; ’442 Patent, col. 7:10-44).
  • The Patented Solution: The invention proposes an apparatus and method to improve diagnostic efficiency by processing the image data from an ingestible probe. Key aspects include selecting portions of the image data (e.g., contiguous frames) and presenting them alongside "second data," such as reference images of known physiological conditions, on a common display to facilitate comparison and identification of diseases (’442 Patent, Abstract; col. 8:54-68).
  • Technical Importance: This approach sought to automate aspects of the diagnostic process for capsule endoscopy, reducing reliance on exhaustive manual review and potentially enabling less-skilled operators to perform initial screenings (Compl. ¶79).

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 15 (Compl. ¶57).
  • Claim 15, an apparatus claim, includes these essential elements:
    • At least one digital processor.
    • A computer program on a readable medium in communication with the processor.
    • The program is configured to evaluate first data generated by a single sensor of a substantially autonomous intestinal probe with a fixed field of view, while the probe moves through a living being.
    • The program selects at least one portion of contiguous frames of the first data for evaluation based on user input.
    • The program presents the selected portion of first data along with second data to facilitate identification of physiologic conditions.
    • The identification is based at least in part on a comparison of the second data with the first data on a common display device.
  • The complaint reserves the right to assert dependent claims (Compl. ¶57).

U.S. Patent No. 8,068,897 - "Endoscopic smart probe and method"

  • Issued: November 29, 2011

The Invention Explained

  • Problem Addressed: Similar to the ’442 patent, the ’897 patent addresses the inefficiencies of reviewing large volumes of data from capsule endoscopy, and further notes the "significant potential drawback" of physicians reviewing segments at different times, which reduces their ability to correlate findings across the entire data set (’897 Patent, col. 7:51-67).
  • The Patented Solution: The invention describes a method where data from an autonomous probe is received at a "distant location" via a network interface. At this distant location, a computerized device processes the data, divides it into frames, and generates a display of images corresponding to those frames. This allows for remote or centralized analysis, facilitating workflow and rapid evaluation (’897 Patent, Abstract; col. 10:1-12).
  • Technical Importance: The claimed method provides a framework for networked and remote review of capsule endoscopy data, a key step in enabling telemedicine applications and efficient data management in clinical settings (Compl. ¶87).

Key Claims at a Glance

  • The complaint asserts independent claim 1 as an example (Compl. ¶82).
  • Claim 1, a method claim, includes these essential elements:
    • Processing data derived from a sensor on a substantially autonomous intestinal probe, where the data was generated while the probe moved through the intestinal tract of a living being.
    • Receiving the data at a location distant from the probe via a network interface.
    • Using a computerized device with a computer program to process at least a portion of the received data at the distant location.
    • Processing includes dividing the data into a plurality of frames.
    • Generating a display with a plurality of images, where at least a portion of the images correspond to one or more frames.
    • Receiving user input as to one or more frames selected for review.
    • Presenting pre-stored data for comparison to the selected frames to facilitate identification of physiologic conditions.
  • The complaint reserves the right to assert other claims (Compl. ¶81).

U.S. Patent No. 9,861,268 - "Methods of processing data obtained from medical device"

  • Issued: January 9, 2018
  • Technology Synopsis: This patent describes a method of processing data from a swallowable probe by generating frames from the data and then using a computer program to automatically analyze the frames to identify a subset of potential interest based on recognizing a "prescribed pattern of pixel intensity or color" (Compl. ¶113, ¶121-123; ’268 Patent, Abstract). The identified subset is then displayed to a user.
  • Asserted Claims: The complaint asserts independent claims 1, 10, and 19 as part of a broader assertion of claims 1-8 and 10-20 (Compl. ¶112-113).
  • Accused Features: The complaint alleges that the "Suspected Blood Indicator (SBI)" and "QuickView" features of the PillCam/RAPID Software infringe the ’268 patent by automatically identifying and displaying frames suspected of containing blood or red areas (Compl. ¶121, ¶123).

U.S. Patent No. 9,913,575 - "Methods of processing data obtained from medical device"

  • Issued: March 13, 2018
  • Technology Synopsis: This patent claims methods for processing data from a medical device by analyzing frames to identify a subset of potential interest based on the recognition of an "artifact" (Compl. ¶136, ¶144-147; ’575 Patent, Abstract). The identified subset is then displayed on a monitor.
  • Asserted Claims: The complaint asserts independent claim 1 as part of a broader assertion of claims 1-8, 10, 17-25, and others (Compl. ¶135-136).
  • Accused Features: The complaint accuses the "Suspected Blood Indicator (SBI)," "QuickView," and "Segment" modes of the PillCam/Rapid and Desktop Software, alleging these features select subsets of images based on recognizing artifacts such as blood, strictures, ulcers, or polyps (Compl. ¶144-147).

U.S. Patent No. 10,028,645 - "Computerized information collection and processing apparatus"

  • Issued: July 24, 2018
  • Technology Synopsis: This patent claims a computerized apparatus comprising two main parts: an ingestible apparatus (the probe) and a non-ingestible apparatus (the analysis workstation). The system is configured to receive image data from the probe and run a computer program to analyze color digital image data, specifically analyzing the intensity of red, green, or blue colors to identify frames of interest (’645 Patent, Abstract; Compl. ¶162, ¶171).
  • Asserted Claims: The complaint asserts independent claim 1 as part of a broader assertion of claims 1-4, 6-10, and others (Compl. ¶161-162).
  • Accused Features: The entire PillCam System (ingestible probe, recorder, and workstation with RAPID software) is accused of infringing. The software's "Suspected Blood Indicator (SBI)" feature is specifically identified as performing the claimed color analysis (Compl. ¶164, ¶171-172).

U.S. Patent No. 10,028,646 - "Computerized information collection and processing apparatus"

  • Issued: July 24, 2018
  • Technology Synopsis: This patent, similar to the ’645 patent, claims a complete system with an ingestible probe and a second, non-ingestible computerized apparatus. The key claimed function is the processing of image data to generate frames and then using a program to identify a portion of those frames based on an analysis of color intensity, with the identified portion then being marked for display (’646 Patent, Abstract; Compl. ¶193, ¶204).
  • Asserted Claims: The complaint asserts independent claim 1 as part of a broader assertion of claims 1-10, 13-16, and others (Compl. ¶192-193).
  • Accused Features: The complaint accuses the complete PillCam System. The "Suspected Blood Indicator (SBI)" feature is alleged to perform the claimed function of identifying and marking frames based on red color data for preview (Compl. ¶195, ¶204).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are collectively referred to as the "PillCam Systems" or "PillCam Technologies" (Compl. ¶26.q-r). This includes various models of ingestible endoscopic capsules (e.g., PillCam SB 3, PillCam COLON 2), data recorders (Recorder 2, Recorder 3), and associated software suites (PillCam/RAPID Software, Desktop Software, Web Software) (Compl. ¶26).

Functionality and Market Context

  • The PillCam system allows for minimally invasive visualization of the gastrointestinal tract (Compl. ¶46-47). A patient swallows a vitamin-sized capsule containing a camera, which captures and wirelessly transmits images to an external data recorder worn by the patient (Compl. ¶60, ¶85). The recorder is later returned to a clinician, who downloads the raw image data to a computer workstation (Compl. ¶64, ¶88). The accused RAPID software then processes the hours of raw data, transforms it into a viewable video, and provides tools for analysis, such as the "Suspected Blood Indicator (SBI)" which automatically marks frames suspected of containing blood (Compl. ¶50, ¶52, ¶60). The complaint presents a screenshot from a user manual showing the PillCam software interface, which is used to process the data downloaded from the recorder (Compl. p. 22).

IV. Analysis of Infringement Allegations

7,914,442 Patent Infringement Allegations

Claim Element (from Independent Claim 15) Alleged Infringing Functionality Complaint Citation Patent Citation
An apparatus adapted to evaluate first data generated by a single sensor of a substantially autonomous intestinal probe... The PillCam System, including the RAPID software, is an apparatus that evaluates data from the single-sensor PillCam SB capsules, which are described as autonomous intestinal probes. ¶60 col. 101:15-18
...the first data previously generated by said single sensor with a substantially fixed field of view, while said probe moved substantially autonomously through the intestinal tract of a living being... The PillCam probe's CMOS sensor has a fixed field of view. The probe moves autonomously through the intestinal tract via peristalsis. The data is generated during this transit. ¶64, ¶65 col. 101:18-24
...wherein said program is configured to...select at least one portion of contiguous frames of said first data for evaluation based at least in part on user input... The RAPID software allows a user to select portions of the compiled video for review. The complaint shows a user interface with a video timeline and thumbnails, which a user can select to view specific frames or sequences of frames. ¶66 col. 101:28-31
...and present said selected at least one portion of said first data along with second data in order to facilitate identification of one or more physiologic conditions of said living being... The RAPID software's "Atlas" function allows a user to view the captured video frame(s) from the patient alongside a database of pre-stored reference images of various diseases and conditions (the "second data"). ¶67 col. 101:31-35
...said identification based at least in part on comparison of said second data with said selected at least one portion of said first data on a common display device. The complaint includes a screenshot of the RAPID Atlas feature displaying the patient's current image and the reference "Atlas Images" side-by-side on the same screen, facilitating direct visual comparison by the physician. ¶68, p. 33 col. 101:35-39
  • Identified Points of Contention:
    • Scope Questions: A central question may be the scope of "second data." The complaint alleges this is met by the RAPID Atlas's library of reference images (Compl. ¶67). A dispute could arise over whether this library of generic medical images constitutes the "second data" contemplated by the patent, or if the term requires data more specific to the patient or procedure.
    • Technical Questions: The claim requires selection of "contiguous frames." The accused software allows users to select individual thumbnails or ranges of video (Compl. ¶66, p. 29). The factual question will be whether this user interaction constitutes the selection of "contiguous frames" as required by the claim language.

8,068,897 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of processing data derived from a sensor disposed on a substantially autonomous intestinal probe... The PillCam System processes data from the ingestible PillCam probe, which contains an image sensor and moves autonomously through the intestinal tract. ¶84-85 col. 100:50-54
...receiving said data at a location distant from said probe via a network interface... Data is recorded by a device worn by the patient and later downloaded to a workstation at a physician's office or other networked location. The complaint alleges the USB port used for download is a "standardized network interface." ¶87-88, ¶93 col. 100:55-56
...using a computerized device...to process at least a portion of said received data at said distant location, said processing comprising: dividing at least said portion of said received data into a plurality of frames... The PillCam workstation (a PC) runs the RAPID software, which processes the downloaded data. This processing includes transforming the raw image data into a sequence of individual frames for video playback. A user manual screenshot illustrates various multi-frame views (e.g., Dual, Quad, Mosaic) created by the software. ¶94-95, p. 55 col. 100:57-65
...generating a display comprising a plurality of images, at least a portion of said plurality of images corresponding to one or more of said frames... The RAPID software generates a user interface displaying the video images. The complaint provides a screenshot of the main viewing screen showing the current video image, a linear representation of all frames, and selectable thumbnails. ¶96, p. 56 col. 100:66-col. 101:2
...receiving user input as to one or more of said frames being selected for review... The system allows a user to select thumbnails for review, add comments, or use functions like the "Atlas" for comparison, all of which constitute user input regarding specific frames. ¶97-98 col. 101:3-4
...presenting pre-stored data for use in comparison to at least one of said selected frames...to facilitate identification of one or more physiologic conditions... The RAPID software's "Atlas" functionality presents pre-stored "textbook" images and videos of various diseases for side-by-side comparison with the patient's selected video frames. ¶98, p. 59 col. 101:5-9
  • Identified Points of Contention:
    • Scope Questions: The definition of "location distant from said probe" may be a key point of dispute. The complaint suggests this can be a networked computer in a different room from where the data is downloaded (Compl. ¶87). Defendants may argue for a construction requiring a greater degree of separation than is typical in a single clinical setting.
    • Technical Questions: A factual question may arise over whether a USB connection, as alleged in the complaint (Compl. ¶92-93), qualifies as a "network interface" in the context of the patent. While technically a bus, its use for data transfer between distinct devices (recorder and workstation) may support the plaintiff's theory.

V. Key Claim Terms for Construction

  • Term (from ’442 Patent): "second data"

    • Context and Importance: The infringement allegation for the ’442 patent hinges on the accused "RAPID Atlas" feature meeting this limitation. The definition of "second data" will determine whether a pre-stored library of generic, non-patient-specific medical images falls within the scope of the claim.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claims do not specify the source or nature of the "second data" beyond its use for comparison to identify physiologic conditions. The specification discusses using pre-stored data for comparison without limiting it to patient-specific data, which may support a broad interpretation that includes a reference atlas (’442 Patent, col. 91:35-43).
      • Evidence for a Narrower Interpretation: The specification also discusses comparing data from different portions of the same patient's examination, which could suggest that "second data" is intended to be other data from the same subject (’442 Patent, col. 7:51-67). Defendants may argue that the term implies a more direct relationship to the "first data" than a generic image library.

  • Term (from ’897 Patent): "location distant from said probe"

    • Context and Importance: This term is central to the novelty of the claimed method, which involves remote or networked data processing. Infringement depends on whether the accused clinical workflow—downloading data from a recorder to a workstation in an office—constitutes processing at a "distant location."
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent does not define a specific physical distance. The specification's focus on separating the data acquisition (by the probe in the patient) from the data processing (on a computer) may support an interpretation where any physically separate processing device is "distant" (’897 Patent, col. 10:1-12).
      • Evidence for a Narrower Interpretation: The specification mentions scenarios like a "centralized location" for analysis, which could imply a location that is organizationally or geographically separate, such as a remote reading center, rather than merely a computer in the same facility (’897 Patent, col. 48:35-42).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendants induce infringement by providing customers with detailed materials—including user manuals, instructional videos, software download portals, and technical support—that instruct and encourage them to use the PillCam systems in a manner that directly infringes the patents-in-suit (Compl. ¶29, ¶48, ¶72-76). The complaint further alleges contributory infringement, stating the accused software and hardware components are not staple articles of commerce and are specifically designed to be used in an infringing manner (Compl. ¶77-78).
  • Willful Infringement: The complaint alleges that Defendants' infringement has been willful. The basis for this allegation is purported pre-suit knowledge of the patent family from at least three sources: a letter sent by the inventor to Defendants in January 2009; Defendant Given Imaging Ltd.'s citation to the ’442 patent during the prosecution of its own patent in June 2012; and communications from a patent broker in late 2016 or early 2017 (Compl. ¶55, ¶70-71).

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

  • A core issue will be one of definitional scope: can terms like "second data" (’442 patent) and "location distant" (’897 patent) be construed broadly enough to read on the accused system's use of a generic image atlas and a standard clinical workflow where data is downloaded to a local workstation? The outcome of claim construction for these terms may be dispositive for the lead patents.
  • A second key question will be one of technical implementation: do the automated features of the accused software, such as the "Suspected Blood Indicator," perform the specific, multi-step algorithmic analysis of "artifacts" or "pixel intensity patterns" required by the claims of the later-issued patents (e.g., ’268, ’575), or do they operate as simpler color filters that fall outside the claimed methods?
  • A third pivotal issue will be the impact of alleged pre-suit knowledge: the complaint provides multiple, distinct factual allegations of pre-suit notice dating back to 2009. How the court and jury evaluate this evidence will be critical to the question of willfulness and the potential for enhanced damages.