DCT

1:22-cv-00309

Fujifilm Sonosite Inc v. Butterfly Network Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: FUJIFILM Sonosite, Inc. v. Butterfly Network, Inc. and BFLY Operations, Inc., 1:22-cv-00309, D. Del., 06/26/2023
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware as Defendants are Delaware corporations.
  • Core Dispute: Plaintiff alleges that Defendant’s portable point-of-care ultrasound (POCUS) systems infringe seven patents related to ultrasound image processing, user interface design, system architecture, and accessory devices.
  • Technical Context: The case concerns the field of point-of-care ultrasound (POCUS), where portable, handheld devices are used for medical imaging at a patient's side, a market Plaintiff claims to have pioneered.
  • Key Procedural History: The complaint, a Second Amended Complaint, alleges that Defendant had pre-suit knowledge of several patents-in-suit. Specifically, it alleges Defendant cited U.S. Patent Nos. 7,867,168 and 8,128,050 to the USPTO during the prosecution of its own patent applications as early as 2014. It further alleges Defendant tested Plaintiff’s M-Turbo product, which was allegedly marked with U.S. Patent Nos. 7,169,108 and 8,861,822. Plaintiff also provided notice of infringement via a letter dated March 9, 2022.

Case Timeline

Date Event
2001-01-15 ’157 Patent Priority Date
2002-02-01 ’108 Patent Priority Date
2004-08-24 ’168 Patent Priority Date
2005-05-31 ’157 Patent Issue Date
2007-01-30 ’108 Patent Issue Date
2008-08-22 ’981 Patent Priority Date
2010-04-07 ’822 Patent Priority Date
2011-01-11 ’168 Patent Issue Date
2011-02-08 ’050 Patent Priority Date
2012-03-06 ’050 Patent Issue Date
2013-01-29 ’981 Patent Issue Date
2014-04-18 ’985 Patent Priority Date
2014-09-30 Earliest date Defendant allegedly knew of ’168 and ’050 Patents
2014-10-14 ’822 Patent Issue Date
2016-06-01 Defendant allegedly submitted IDS citing parent of ’108 Patent
2017-01-10 ’985 Patent Issue Date
2022-03-09 Plaintiff sent letter to Defendant alleging infringement
2023-06-26 Second Amended Complaint Filing Date

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

U.S. Patent No. 6,901,157 - “ULTRASONIC DIAGNOSTIC APPARATUS”

  • Issued: May 31, 2005

The Invention Explained

  • Problem Addressed: The patent describes prior art ultrasound systems as requiring laborious and troublesome manual adjustments of transmission, reception, and image processing parameters for each different body part being scanned (’157 Patent, col. 1:24-33; Compl. ¶19). Existing automated methods for adjusting image gradation were described as indiscriminate and unable to execute a control process proper for each individual body part (’157 Patent, col. 1:41-45; Compl. ¶19).
  • The Patented Solution: The invention proposes an apparatus that automates this process by storing sets of optimized "image processing condition parameters" in a memory unit, with each set corresponding to specific "information of object" (e.g., a body part) (’157 Patent, col. 2:32-41). When an operator inputs information about the object to be inspected, a control unit automatically reads the corresponding parameters from memory and applies them to the image processing unit, thereby streamlining the acquisition of a high-quality diagnostic image (’157 Patent, Fig. 1; Compl. ¶20, ¶22).
  • Technical Importance: This approach aimed to increase the efficiency and consistency of ultrasonic diagnostics by automatically configuring the system with optimal settings for specific anatomical regions, reducing the need for manual operator adjustments (Compl. ¶22).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and dependent claims 2-4 and 6-10 (Compl. ¶57).
  • Independent Claim 1 requires:
    • An ultrasonic transmitting and receiving unit for transmitting and receiving ultrasonic waves.
    • An image processing unit that uses "image processing condition parameters."
    • An information input unit for a user to input "information of object."
    • A parameter memory unit that stores the condition parameters in correspondence with the object information.
    • A control unit that reads the correct parameters from the memory based on the user's input and supplies them to the image processing unit.
    • A display unit to display the resulting image.
  • The complaint does not explicitly reserve the right to assert other dependent claims.

U.S. Patent No. 9,538,985 - “HAND-HELD MEDICAL IMAGING SYSTEM WITH IMPROVED USER INTERFACE FOR DEPLOYING ON-SCREEN GRAPHICAL TOOLS AND ASSOCIATED APPARATUSES AND METHODS”

  • Issued: January 10, 2017

The Invention Explained

  • Problem Addressed: The patent addresses the ergonomic challenges of operating portable ultrasound systems, where a user must hold a transducer wand in one hand while simultaneously operating the base unit with the other (’985 Patent, col. 2:65-3:2; Compl. ¶32). This problem was exacerbated by systems that required keyboards or trackballs, which limited true portability and one-handed operation of the base unit (’985 Patent, col. 3:2-5; Compl. ¶33).
  • The Patented Solution: The invention discloses a handheld ultrasound system with a touchscreen user interface organized into distinct areas. This includes a "first control area" with graphical tools (like calipers or markers) and a "second control area" that is specifically designed to be accessible by the thumb of the hand holding the device (’985 Patent, col. 8:11-17). This second area allows the user to select attributes of a chosen tool (e.g., selecting a specific anatomical icon) with their thumb, facilitating simultaneous operation of the transducer and the handheld base unit (Compl. ¶35). The specification provides an example of a thumbwheel with soft buttons as this second control area (’985 Patent, Fig. 3C; Compl. ¶34).
  • Technical Importance: This user interface design improves the usability of handheld ultrasound systems, allowing a single operator to more efficiently and accurately identify, mark, and measure features in an ultrasound image while actively scanning a patient (Compl. ¶35, ¶40).

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶84).
  • Independent Claim 1 requires:
    • A portable ultrasound system with a hand-held base unit that includes a touchscreen display and a processor.
    • A "first control area" on the display with selectable graphical tools.
    • A "second control area" on the display that is "accessible by a hand of the user that is holding the portable ultrasound system."
    • The second control area includes controls that can be "selectively activated by a thumb of the user to select an attribute of a selected graphical tool."
    • An "active image area" where the ultrasound image is displayed and the selected graphical tool can be overlaid.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 7,867,168 - “ULTRASONIC TRANSDUCER HAVING DISTRIBUTED WEIGHT PROPERTIES”

  • Issued: January 11, 2011 (Compl. ¶41)
  • Technology Synopsis: The patent describes an ultrasound system architecture where the battery power source is physically distributed between the handheld transducer assembly and a separate main processing unit (Compl. ¶42). These two components are connected by a digital data cable that carries information between them.
  • Asserted Claims: Independent claim 1 and dependent claims 4 and 5 are asserted (Compl. ¶113).
  • Accused Features: The complaint alleges that the combination of the Butterfly iQ/iQ+ probe (containing some power source/circuitry) and the connected mobile device (acting as the main processing unit with its own battery) infringes by creating a system with a distributed battery power source (Compl. ¶42, ¶116).

U.S. Patent No. 7,169,108 - “CW BEAM FORMER IN AN ASIC”

  • Issued: January 30, 2007 (Compl. ¶44)
  • Technology Synopsis: The patent is directed to an ultrasound system Application Specific Integrated Circuit (US-ASIC). The claimed US-ASIC integrates multiple key functional components onto a single chip, including at least one beam former, a transducer controller, and one or more digital signal processors (Compl. ¶45).
  • Asserted Claims: Independent claim 1 and dependent claims 2-4 are asserted (Compl. ¶140).
  • Accused Features: The complaint alleges that the Accused Products, specifically the iQ and iQ+ probes, contain a US-ASIC that integrates the claimed functional elements (Compl. ¶142-143).

U.S. Patent No. 8,861,822 - “SYSTEMS AND METHODS FOR ENHANCED IMAGING OF OBJECTS WITHIN AN IMAGE”

  • Issued: October 14, 2014 (Compl. ¶47)
  • Technology Synopsis: The patent discloses a method for improving the visibility of an interventional instrument (e.g., a needle) within surrounding tissue. It establishes two different "ultrasound imaging signatures": one optimized for high-quality tissue imaging and another for high-quality instrument imaging. The system generates a frame using each signature, detects the instrument in the second frame, creates a mask around the instrument, and then blends pixels from both frames to create a final composite image showing both tissue and instrument clearly (Compl. ¶48).
  • Asserted Claims: Independent claim 1 and dependent claims 2-5 are asserted (Compl. ¶158).
  • Accused Features: The complaint accuses the "Needle Viz" imaging tool offered on the Butterfly Mobile Application, which is alleged to produce an ultrasound image that includes an image of an interventional instrument (Compl. ¶160). A screenshot in the complaint shows that "Needle Viz" is offered as part of a paid "Procedural Tools" subscription package (Compl. p. 67).

U.S. Patent No. 8,360,981 - “ULTRASONIC DIAGNOSTIC APPARATUS”

  • Issued: January 29, 2013 (Compl. ¶50)
  • Technology Synopsis: This patent describes an ultrasonic apparatus that uses an "impulse drive type" display. A key feature is that the ratio of the "blanking period" (when the display is off) to the "image display period" within one field period is variable and can be adjusted by a control unit based on factors like the selected body part or frame rate (Compl. ¶51).
  • Asserted Claims: Independent claim 1 and dependent claim 3 are asserted (Compl. ¶190).
  • Accused Features: The complaint alleges that the Accused Products, which use a mobile device to display real-time ultrasound images, constitute an apparatus that includes the claimed impulse drive display with a variable blank period ratio (Compl. ¶192, ¶194).

U.S. Patent No. 8,128,050 - “ULTRASOUND SCANNER SUPPORT DEVICES”

  • Issued: March 6, 2012 (Compl. ¶53)
  • Technology Synopsis: The patent claims a physical support device for an ultrasound scanner. The device includes a body with a recess for a scanner connector and a "peripheral channel" for wrapping the connecting cable. A key limitation is that this channel must have a curve at each directional change with a radius of at least approximately 0.25 inches, intended to prevent kinking or damage to the cable (Compl. ¶54).
  • Asserted Claims: Independent claims 1, 5, 7, 9, 10, and 12 are asserted (Compl. ¶218).
  • Accused Features: The complaint accuses the "Butterfly Hard Case" of infringing the ’050 patent (Compl. ¶219).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are the Butterfly "iQ" and "iQ+" ultrasound probes, the "Butterfly Hard Case," and the "Butterfly Mobile Application" software, which operate together as a system (Compl. ¶11).

Functionality and Market Context

The Butterfly system is a portable, point-of-care ultrasound (POCUS) product. It consists of a handheld probe (iQ or iQ+) that connects via a cable to a general-purpose mobile device, such as a smartphone or tablet (Compl. ¶11, ¶59). The Butterfly Mobile Application, which must be downloaded and installed on the mobile device, processes the ultrasound signals from the probe and displays real-time medical images on the device's screen (Compl. ¶11, ¶64). The complaint alleges the system is "closed," meaning the probe can only be used with Defendant's software, and that use requires an annual subscription or "Membership Plan" (Compl. ¶63, ¶90). The complaint includes a screenshot of Defendant's website requiring customers to select a "Membership plan" to enable features like "Diagnostic Tools" and "Procedural Tools" (Compl. p. 23).

IV. Analysis of Infringement Allegations

’157 Patent Infringement Allegations

The complaint alleges that the combination of the Butterfly probe, a compatible mobile device, and the Butterfly Mobile Application collectively meets the elements of an "ultrasonic diagnostic apparatus" as claimed (Compl. ¶59). The infringement theory suggests that the probe acts as the "transmitting and receiving unit," while the mobile device's processor and the mobile application software perform the functions of the "image processing unit," "parameter memory unit," and "control unit" (Compl. ¶16, ¶59-60). The application's user interface, which allows users to select exam presets, is alleged to be the "information input unit," and the mobile device's screen serves as the "display unit" (Compl. ¶16, ¶59).

’985 Patent Infringement Allegations

The complaint alleges that the Accused Products, specifically the mobile device running the Butterfly Mobile Application, constitute the claimed "portable ultrasound system" with a "hand-held base unit" (Compl. ¶86). The infringement theory posits that the app's graphical user interface on the mobile device's touchscreen provides the claimed control areas (Compl. ¶29, ¶87). It alleges the interface has a "first control area" with graphical tools (e.g., markers, calipers) and a distinct "second control area" with controls that are accessible and activatable by the thumb of the hand holding the device for selecting attributes of those tools, thereby enabling the claimed ergonomic, one-handed operation (Compl. ¶29, ¶86).

Identified Points of Contention

  • Scope Questions: A central question for the '157 Patent may be whether software-based "presets" in a mobile application constitute the "information of object" and whether the software functions map onto the distinctly claimed hardware "units" (e.g., "parameter memory unit", "control unit") described in the patent. For the ’985 patent, a key question may be whether a designated software region on a standard touchscreen satisfies the specific ergonomic limitations of a "second control area accessible by a hand...holding the portable ultrasound system" and "activated by a thumb," or if the claim requires a more purpose-built hardware or software feature.
  • Technical Questions: For the '157 Patent, the analysis may turn on how the Accused Product's software architecture stores and retrieves imaging parameters corresponding to user-selected presets. For the ’985 patent, the analysis may depend on evidence of how users actually hold and interact with the mobile device when using the accused application, and whether the user interface is functionally designed for the specific one-handed, thumb-driven operation required by the claim.

V. Key Claim Terms for Construction

For the ’157 Patent

  • The Term: "information of object" (from Claim 1)
  • Context and Importance: The definition of this term is critical for determining whether a user's selection of a pre-defined imaging mode (e.g., "Cardiac," "Lung") in the accused app meets this limitation. Practitioners may focus on whether this term requires specific anatomical identification or if it can be construed more broadly to cover any user input that selects a corresponding set of stored parameters.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language itself is broad, simply requiring "information of object concerned with the object to be inspected" without specifying the type or granularity of that information.
    • Evidence for a Narrower Interpretation: The specification provides examples of the "information of object" as "one of the body parts such as liver, heart and so on" (’157 Patent, col. 4:38-39), which may support an interpretation requiring the input to relate to a specific anatomical part rather than a general imaging mode.

For the ’985 Patent

  • The Term: "a second control area that is accessible by a hand of the user that is holding the portable ultrasound system" (from Claim 1)
  • Context and Importance: This term is central to the patent's purported ergonomic innovation. The dispute will likely center on whether any software-defined region on a touchscreen can be considered "accessible" in the claimed manner, or if it implies a specific design optimized for thumb use while gripping the device.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim does not require a physical or mechanically distinct control, only a "control area," which could be read to cover a designated region of a touchscreen interface.
    • Evidence for a Narrower Interpretation: The specification describes the problem being solved as the difficulty of using one hand to hold the device and the other to operate it (’985 Patent, col. 2:65-3:2). A disclosed embodiment shows a physical "thumbwheel 357" with "soft button controls" as an example of this second control area (’985 Patent, col. 4:31-33; Compl. ¶34), which may suggest the claimed "area" must be similarly optimized for and located within easy reach of the thumb of the holding hand.

VI. Other Allegations

Indirect Infringement

The complaint alleges both induced and contributory infringement for all asserted patents. The factual basis for inducement includes Defendant's alleged provision of training, user manuals, and promotional materials that instruct customers on how to use the Accused Products in an infringing manner (e.g., Compl. ¶72-73). The allegations also lean heavily on the "closed system" nature of the products, where Defendant allegedly requires customers to download its specific application, purchase a subscription, and use the probe and app together, thereby controlling the customers' infringing acts (Compl. ¶63). A screenshot shows Defendant's sales portal, which restricts who is eligible to purchase the device (Compl. p. 21).

Willful Infringement

Willfulness is alleged for all asserted patents. The complaint alleges pre-suit knowledge based on several grounds: (1) Defendant's citation of the ’168 and ’050 patents to the USPTO during prosecution of its own applications, dating back to 2014 (Compl. ¶12); (2) Defendant's alleged acquisition and testing of Plaintiff's M-Turbo product, which was purportedly marked with the ’108 and ’822 patent numbers (Compl. ¶13, ¶145-146, ¶172-173); and (3) a notice letter sent by Plaintiff on March 9, 2022 (Compl. ¶82). The complaint includes a photograph allegedly showing Defendant's employees demonstrating Plaintiff's M-Turbo product at a trade show (Compl. p. 5).

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

  • A core issue will be one of system definition: For patents originally drafted with integrated hardware in mind (e.g., the ’157 Patent’s "control unit"), how will the claims be applied to a disaggregated system comprising a hardware probe, a third-party mobile device, and separately downloaded application software? The court’s approach to claim construction for these "means-plus-function"-style limitations in a modern software context will be critical.
  • A second key question will be one of ergonomic scope for the '985 patent: Can a software-defined control area on a generic touchscreen satisfy a claim limitation requiring that it be "accessible by a hand of the user that is holding the portable ultrasound system" and activated by the thumb, or does this require a more specific physical or functional design tailored for such one-handed operation?
  • A significant factual dispute will likely concern willfulness and the extent of pre-suit knowledge. Plaintiff’s allegations that Defendant cited specific patents-in-suit during its own patent prosecution and publicly tested Plaintiff's marked products provide a concrete basis for willfulness claims that will depend heavily on the evidence presented.