DCT

3:17-cv-01056

Hologic Inc v. Fujifilm Med Sys USA Inc

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:17-cv-01056, D. Conn., 06/26/2017
  • Venue Allegations: Venue is alleged to be proper in the District of Connecticut because Defendant FUJIFILM USA has its corporate headquarters and a regular and established place of business in Stamford, Connecticut, and has committed acts of infringement in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s ASPIRE Cristalle digital mammography system, when equipped with a Digital Breast Tomosynthesis (DBT) upgrade, infringes five U.S. patents related to tomosynthesis imaging, system mechanics, and image processing.
  • Technical Context: The technology at issue is digital breast tomosynthesis, a 3D imaging technique that acquires images of the breast from multiple angles to create cross-sectional slices, which is designed to improve cancer detection by reducing the effect of overlapping tissue common in standard 2D mammography.
  • Key Procedural History: The complaint alleges that Defendants had pre-suit knowledge of the patents-in-suit, citing references to Hologic’s patents and applications made during the patent prosecution of Fujifilm’s own patents. The complaint also notes that Hologic has provided notice to the public of its patent rights via a virtual patent marking webpage.

Case Timeline

Date Event
2001-10-19 Earliest Priority Date ('940 and '765 Patents)
2002-11-27 Earliest Priority Date ('296, '379, and '684 Patents)
2006-10-17 '684 Patent Issued
2010-03-30 '940 Patent Issued
2010-11-09 '296 Patent Issued
2011-01-01 Hologic's Selenia Dimensions system obtains FDA approval (year only provided)
2011-07-26 '765 Patent Issued
2013-05-28 '379 Patent Issued
2017-01-23 FDA premarket approval for Accused Product's DBT upgrade
2017-06-26 Complaint Filed

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

U.S. Patent No. 7,831,296 - "X-Ray Mammography With Tomosynthesis"

The Invention Explained

  • Problem Addressed: The patent’s background section describes the limitations of conventional 2D mammography, where overlapping structures in the breast can obscure cancers or create false positives, making diagnosis difficult (’296 Patent, col. 1:19-2:46).
  • The Patented Solution: The invention is a "combination mammogram/tomosynthesis system" that, in a single compression of the breast, acquires both a conventional 2D mammogram and a series of low-dose 3D tomosynthesis images taken from multiple angles. The x-ray source moves in an arc while the digital detector moves in coordination, allowing for the reconstruction of 3D slices of the breast tissue, thereby reducing the problem of tissue overlap (’296 Patent, Abstract; col. 3:1-4:54).
  • Technical Importance: This combination approach allows a radiologist to have both a familiar 2D image and a more detailed 3D dataset from a single, brief patient procedure, potentially improving diagnostic accuracy and workflow efficiency (’296 Patent, col. 5:6-6:44).

Key Claims at a Glance

  • The complaint asserts at least independent claim 23 (Compl. ¶19).
  • Essential elements of independent claim 23 include:
    • A system with an x-ray source, a digital imager, and a breast support.
    • A source support for moving the source to different angular positions.
    • A control to energize the source at these positions, where at least one is a "mammogram position" and others are "tomosynthesis positions."
    • The x-ray dose for tomosynthesis positions is less than the dose for the mammogram position.
    • A selectively movable anti-scatter grid that is in the x-ray path for the mammogram position but out of the path for at least some tomosynthesis positions.
    • A processor to form and display both mammogram and tomosynthesis images.
  • The complaint reserves the right to assert dependent claims (Compl. ¶19).

U.S. Patent No. 8,452,379 - "X-Ray Mammography With Tomosynthesis"

The Invention Explained

  • Problem Addressed: As a continuation of the '296 Patent, this patent addresses the same problem of diagnostic uncertainty caused by overlapping tissue in conventional 2D mammography (’379 Patent, col. 1:19-2:46).
  • The Patented Solution: The patent describes a "combo x-ray system" that acquires both 2D and 3D images in a single compression. It emphasizes the processing and display of the resulting data, where the conventional 2D mammogram image and the reconstructed 3D tomosynthesis slice images can be displayed "selectively side by side or superimposed" for integrated review (’379 Patent, Abstract; col. 9:55-10:2).
  • Technical Importance: This integrated display of both 2D and 3D image types provides clinicians with a comprehensive diagnostic tool, combining the familiarity of a standard mammogram with the enhanced detail of tomosynthesis slices (’379 Patent, col. 6:38-6:53).

Key Claims at a Glance

  • The complaint asserts at least independent claims 1, 6, and 9 (Compl. ¶32).
  • Essential elements of independent claim 1 include:
    • A system with an x-ray source, digital imager, and compression paddle.
    • A motion control for moving the source relative to the immobilized breast.
    • A processor that derives projection images, where at least one is a "mammogram image" and a multiplicity of others are "tomosynthesis projection images."
    • The processor is further configured to process the tomosynthesis images into "tomosynthesis slice images."
    • A display configured to show the mammogram and slice images "selectively side by side or superimposed."
  • The complaint reserves the right to assert dependent claims (Compl. ¶32).

U.S. Patent No. 7,688,940 - "Mammography System and Method Employing Offset Compression Paddles, Automatic Collimation, and Retractable Anti-Scatter Grid"

  • Technology Synopsis: This invention addresses the mechanical challenges of imaging different breast sizes and views (e.g., mediolateral oblique or MLO) with a fixed-size digital detector. It discloses using smaller, offset compression paddles that can be moved laterally to optimally position the breast, along with automatic adjustment of the x-ray beam (collimation) and a retractable anti-scatter grid to match the paddle's position and imaging mode (’940 Patent, Abstract; col. 2:50-61).
  • Asserted Claims: Independent claims 1 and 22 (Compl. ¶45).
  • Accused Features: The FUJIFILM ASPIRE Cristalle system's mechanical configuration, including its compression paddles, collimation system, and anti-scatter grid functionality (Compl. ¶45).

U.S. Patent No. 7,986,765 - "Mammography System and Method Employing Offset Compression Paddles, Automatic Collimation, and Retractable Anti-Scatter Grid"

  • Technology Synopsis: Belonging to the same family as the '940 Patent, this invention also focuses on the physical apparatus for mammography. It describes a system and method for positioning a breast off-center on the detector using specialized compression paddles and automatically collimating the x-ray beam to match, ensuring optimal image quality and patient comfort, particularly for difficult-to-image anatomies (’765 Patent, Abstract; col. 2:50-61).
  • Asserted Claims: Independent claim 10 (Compl. ¶58).
  • Accused Features: The design and operation of the FUJIFILM ASPIRE Cristalle system's physical imaging components (Compl. ¶58).

U.S. Patent No. 7,123,684 - "Full Field Mammography With Tissue Exposure Control, Tomosynthesis, and Dynamic Field of View Processing"

  • Technology Synopsis: This patent discloses three related technologies for digital mammography. The first is a method for automatically controlling x-ray exposure based on estimates of breast thickness and density. The second is a tomosynthesis system that maintains the focus of an anti-scatter grid on the x-ray source as it moves. The third is a method for dynamically processing the image to define and use a "reduced field of view" that only includes the breast, which improves storage and transmission efficiency (’684 Patent, Abstract; col. 2:36-52).
  • Asserted Claims: Independent claims 11, 29, and 41 (Compl. ¶71).
  • Accused Features: The FUJIFILM ASPIRE Cristalle system's methods for controlling x-ray exposure, performing tomosynthesis, and processing the resulting image data (Compl. ¶71).

III. The Accused Instrumentality

Product Identification

  • The FUJIFILM ASPIRE Cristalle digital mammography system, including its optional software upgrade for "Digital Breast Tomosynthesis (DBT)" (Compl. ¶¶15-16).

Functionality and Market Context

  • The ASPIRE Cristalle is an x-ray breast imaging device. The complaint alleges that on January 23, 2017, Fujifilm announced it had received FDA premarket approval for the DBT upgrade, making tomosynthesis functionality available on the system in the United States (Compl. ¶16). The complaint also notes that Fujifilm subsequently marketed and displayed the system with DBT at medical conferences, indicating commercial activity and availability in the U.S. market (Compl. ¶17).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint references claim chart exhibits that are not attached to the pleading itself. The following tables synthesize the infringement theory based on the narrative allegations for the lead patents.

’296 Patent Infringement Allegations

Claim Element (from Independent Claim 23) Alleged Infringing Functionality Complaint Citation Patent Citation
A combination mammogram/tomosynthesis system comprising: an x-ray source, a flat panel digital x-ray imager, and a breast support... The FUJIFILM ASPIRE Cristalle is alleged to be an x-ray breast imaging device that functions as a combination mammogram and tomosynthesis system. ¶¶15, 19 col. 11:23-27
a source support configured to selectively move the source relative to the breast support between different angular positions... The ASPIRE Cristalle system, with its DBT upgrade, is alleged to perform tomosynthesis, which requires moving the x-ray source to different angular positions. ¶16 col. 11:28-32
...at least one of said angular positions is a mammogram position... but others... are tomosynthesis positions... The accused product is alleged to be a "digital mammography system" with a "Digital Breast Tomosynthesis (DBT)" option, thereby performing both functions. ¶¶15-16 col. 11:36-42
...the x-ray dose for... tomosynthesis positions is less than the x-ray dose for... the mammogram position... The complaint's theory requires that the ASPIRE Cristalle system operates using a lower dose for its tomosynthesis acquisitions than for its standard mammogram acquisition. ¶19 col. 11:43-49
an anti-scatter grid configured to be selectively movable... in said path for the mammogram position but... out of said path for at least some of the tomosynthesis positions... The complaint alleges infringement of this claim, which requires that the ASPIRE Cristalle system includes an anti-scatter grid that is selectively moved or retracted during tomosynthesis. ¶19 col. 11:50-56

’379 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A combo x-ray system for acquiring 2D and 3D images of the breast in a single compression, comprising: an x-ray source, a flat panel digital x-ray imager, and a breast support... The ASPIRE Cristalle system is alleged to be a combo system that acquires both 2D (mammogram) and 3D (tomosynthesis) images. ¶¶15, 32 col. 9:64-10:4
a motion control configured for moving the source relative to a patient's breast while the breast remains immobilized... The accused system's tomosynthesis functionality allegedly includes a motion control for moving the x-ray source. ¶16 col. 10:5-9
a processor configured to... derive therefrom projection images... wherein (i) at least one... is a mammogram image and (ii) each of a multiplicity of the other... is a tomosynthesis projection image... The processor in the ASPIRE Cristalle system allegedly generates both a standard mammogram image and multiple tomosynthesis projection images. ¶¶16, 32 col. 10:13-23
said processor being further configured to process the... tomosynthesis projection images into tomosynthesis slice images... The processor in the accused system allegedly reconstructs the acquired projection images into viewable 3D slices of the breast. ¶¶16, 32 col. 10:24-28
a display configured for displaying said mammogram image and one or more of said tomosynthesis slice images selectively side by side or superimposed. The complaint's infringement theory requires that the ASPIRE Cristalle system's display allows for the concurrent, integrated review of both 2D and 3D images. ¶32 col. 10:33-36

Identified Points of Contention

  • Operational Mode Questions: A primary factual question will be whether the ASPIRE Cristalle system with DBT operates as a "combo" system in the manner claimed—specifically, whether in a single compression it acquires both a distinct, full-dose 2D "mammogram" and a separate series of low-dose 3D "tomosynthesis" images. The defense may argue that it performs only a single tomosynthesis sweep from which a 2D image is mathematically synthesized, which may not meet the claim limitations.
  • Scope Questions: The case will raise questions about the scope of mechanical limitations. For the '296 Patent, does the accused system's anti-scatter grid meet the "selectively movable" limitation? For the '940 and '765 Patents, does the system's hardware for compression and collimation fall within the scope of "offset compression paddles" and "automatic collimation" as defined in those patents?

V. Key Claim Terms for Construction

The Term: "mammogram position" (’296 Patent, Claim 23)

  • Context and Importance: This term is critical because the claim requires the system to operate at both a "mammogram position" and "tomosynthesis positions," with different x-ray dose characteristics for each. The infringement analysis depends on whether the accused device performs two distinct types of acquisitions (a 2D mammogram and a 3D tomosynthesis sweep) or a single, unified acquisition.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim defines the term as a position "that is the same or similar to a position for a conventional mammogram" (’296 Patent, col. 11:38-40). This could be argued to encompass any image taken at or near a 0° angle, regardless of how it is generated or its dose level.
    • Evidence for a Narrower Interpretation: The claim explicitly links the "mammogram position" to an x-ray dose that is "similar to a dose used for a conventional mammogram," while the "tomosynthesis positions" use a dose that is "less than" that amount (’296 Patent, col. 11:43-49). This suggests the term is not just about the angle, but requires a specific, higher-dose imaging event distinct from the lower-dose tomosynthesis sweep.

The Term: "selectively movable" (referring to the anti-scatter grid) (’296 Patent, Claim 23)

  • Context and Importance: Infringement of claim 23 requires that the anti-scatter grid is "in said path for the mammogram position but... out of said path for at least some of the tomosynthesis positions." Practitioners may focus on this term because it implies a specific mechanical action. The dispute will center on whether the accused product's grid is physically retracted or if it remains stationary.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party might argue "out of said path" could be met functionally, for example if the grid remains stationary but its scattering effect is computationally corrected for or otherwise rendered irrelevant during tomosynthesis, though this interpretation may be difficult to support.
    • Evidence for a Narrower Interpretation: The related '940 and '765 Patents in the same family are titled with "Retractable Anti-Scatter Grid," and the '940 patent specification explicitly describes a motor to "selectively withdraw" the grid (’940 Patent, col. 4:37-41). This strongly suggests "movable" requires physical displacement.

VI. Other Allegations

Indirect Infringement

  • The complaint alleges that Defendants induce infringement by providing customers with operating manuals, training, and technical support that instruct them to use the ASPIRE Cristalle system in an infringing manner (Compl. ¶¶ 21-22, 34-35, 47-48, 60-61, 73-74). It also alleges contributory infringement on the basis that the accused product contains non-staple features especially made or adapted for infringing the patents (Compl. ¶¶ 23-25, 36-38, 49-51, 62-64, 75-77).

Willful Infringement

  • The complaint alleges that Defendants had knowledge of the patents-in-suit prior to the lawsuit. The basis for this allegation is Defendants' citation of Hologic's patents and/or their parent applications during the prosecution of Fujifilm's own U.S. patents (Compl. ¶¶ 26, 39, 52, 65, 78). This alleged pre-suit knowledge forms the basis of the claim for willful and deliberate infringement.

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

  • A key evidentiary question will be one of operational functionality: Does the accused ASPIRE Cristalle system, in a single breast compression, actually acquire a distinct, higher-dose 2D "mammogram" image in addition to a series of separate, lower-dose 3D "tomosynthesis" images, or does its "combo" mode rely on a different process, such as synthesizing a 2D image from the 3D tomosynthesis dataset?
  • A central issue of claim construction will be one of mechanical implementation: Can the claim terms "selectively movable" (for the anti-scatter grid) and "offset compression paddles" be met by the specific hardware design of the accused system, or is there a fundamental mismatch between the patented mechanics and the accused device's structure and operation?
  • A critical question for damages will be one of pre-suit knowledge: Do the patent prosecution records cited in the complaint establish that Defendants knew of Hologic's specific patent rights and proceeded to infringe despite a substantial and unjustified risk, thereby supporting the claim for willful infringement?