Endobotics LLC v. Hologic Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Endobotics, LLC (Delaware)
  • Defendant: Hologic, Inc. (Delaware)
  • Plaintiff’s Counsel: Law Offices of Scott H. Bernstein LLC
• Case Identification: 1:24-cv-10746, D. Mass., 03/22/2024
• Venue Allegations: Plaintiff alleges venue is proper because Defendant resides in Massachusetts and maintains a regular and established place of business within the district.
• Core Dispute: Plaintiff alleges that Defendant’s "CoolSeal" and "JustRight" lines of surgical instruments infringe three patents related to articulating mechanisms that enhance instrument dexterity.
• Technical Context: The technology concerns manually operated instruments for minimally invasive surgery, designed to provide surgeons with more intuitive control and greater freedom of movement at the tool tip.
• Key Procedural History: The complaint does not mention any prior litigation, inter partes review proceedings, or licensing history related to the patents-in-suit.

Case Timeline

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

U.S. Patent No. 7,147,650 - “Surgical Instrument”

Issued December 12, 2006 (’650 Patent)

The Invention Explained

• Problem Addressed: The patent’s background section identifies a lack of dexterity in conventional endoscopic and laparoscopic instruments, noting that the "fulcrum effect" created by the incision point makes common surgical tasks like suturing and fine dissection challenging to master (’650 Patent, col. 1:9-24).
• The Patented Solution: The invention proposes a surgical instrument with "bendable motion members" at both the proximal (handle) end and the distal (tool) end. These members are mechanically coupled by cables such that a surgeon’s movement of the handle is replicated by the tool, allowing for more intuitive control and manipulation of the instrument’s tip (’650 Patent, Abstract; col. 1:36-45; Fig. 1).
• Technical Importance: This design aimed to overcome the rigid, counter-intuitive motion of traditional laparoscopic tools by creating a more wrist-like articulation at the instrument's tip, controlled directly by the surgeon's hand movements.

Key Claims at a Glance

• The complaint asserts independent claim 60 (’650 Patent, col. 21:60–22:11).
• Essential elements of independent claim 60 include:
  • A surgical instrument with an elongated shaft, a tool at the distal end, and a control handle at the proximal end.
  • The tool is coupled to the shaft via a first movable member, and the handle is coupled via a second movable member.
  • Movement of the handle via the second member causes "attendant movement" of the tool via the first member.
  • At least one of the movable members comprises a "bendable motion member."
  • A "motion member locking mechanism" for releasably locking said movable members, which comprises a locking mechanism for "impeding cable means that extend between said movable members."
• The complaint reserves the right to assert additional claims (Compl. ¶15).

U.S. Patent No. 7,338,513 - “Surgical Instrument”

Issued March 4, 2008 (’513 Patent)

The Invention Explained

• Problem Addressed: Like the ’650 Patent, this patent addresses the limited dexterity of existing minimally invasive surgical instruments (’513 Patent, col. 1:31-41).
• The Patented Solution: The invention builds on the concept of coupled bendable members by adding a "manually rotatable member" (e.g., a knob) adjacent to the handle. This allows the surgeon to manually rotate the instrument shaft and the working tool about their longitudinal axes, independent of the bending or articulation motion (’513 Patent, Abstract; col. 2:5-10). This adds a degree of freedom for tool orientation.
• Technical Importance: The addition of independent axial rotation provides surgeons with more precise control over the orientation of the tool (e.g., the angle of a needle driver's jaws), which is critical for complex tasks like suturing.

Key Claims at a Glance

• The complaint asserts independent claim 1 (’513 Patent, col. 20:50-21:13).
• Essential elements of independent claim 1 include:
  • A surgical instrument with an elongated shaft, a working member (tool) at the distal end, and a control handle at the proximal end.
  • The working member is coupled to the shaft via a distal bendable member, and the handle is coupled via a proximal bendable member.
  • "Actuation means" extending between the members to couple their motion.
  • A "manually rotatable member" arranged adjacent to the control handle for manually rotating the instrument shaft and working member relative to the handle.
• The complaint reserves the right to assert additional claims (Compl. ¶33).

U.S. Patent No. 7,364,582 - “Surgical Instrument”

Issued April 29, 2008 (’582 Patent)

Technology Synopsis

This patent also addresses the dexterity limitations of surgical tools. The described solution is a surgical instrument with proximal and distal bendable members where the "maximum transverse cross-sectional dimension" of the proximal (handle) member is different from that of the distal (tool) member. This dimensional difference is intended to scale the motion between the handle and the tool, potentially amplifying or reducing the tool's movement relative to the surgeon's hand (’582 Patent, Abstract; col. 2:47-53).

Asserted Claims

Independent claim 41 (’582 Patent, col. 20:41-21:2).

Accused Features

The complaint alleges the Accused Products infringe by having a proximal bendable member with a maximum cross-sectional dimension that is different than that of the distal bendable member (Compl. ¶61).

III. The Accused Instrumentality

Product Identification

The "Accused Products" include Hologic’s "CoolSeal Portfolio," specifically the CoolSeal Trinity, CoolSeal Reveal, and CoolSeal Mini models, as well as the JustRight surgical instruments (Compl. ¶13). An image in the complaint displays the general appearance of these four product lines (Compl. p. 3).

Functionality and Market Context

The complaint describes the Accused Products as surgical instruments used in minimally invasive procedures (Compl. ¶2). Based on the allegations and visual evidence provided, they are handheld devices with a handle at the proximal end, a long shaft for accessing the surgical site, and a tool at the distal end (Compl. ¶¶18-20). The complaint alleges these instruments incorporate articulating joints and rotational controls to manipulate the tool tip.

IV. Analysis of Infringement Allegations

’650 Patent Infringement Allegations

Identified Points of Contention

• Scope Questions: Claim 60 requires a locking mechanism that functions by "impeding cable means." A central question may be whether the accused latch mechanism, depicted visually in the complaint (Compl. ¶21), operates by directly impeding or blocking the internal control cables, or if it locks the instrument's physical structure through a different principle (e.g., a mechanical stop on the handle).
• Technical Questions: The patent describes a "bendable motion member" as an element that can form a "curved configuration without any sharp breaks or angularity" (’650 Patent, col. 5:4-7). The complaint provides close-up visual evidence of the distal articulating joint (Compl. ¶39). A key question will be whether the accused device's joint, which may be a multi-part pivot, meets the patent's definition of a "bendable motion member."

’513 Patent Infringement Allegations

Identified Points of Contention

• Scope Questions: As with the ’650 Patent, the construction of "distal bendable member" and "proximal bendable member" will be critical. The dispute may turn on whether the accused products’ articulating joints fall within the scope of this term as defined and described in the patent.
• Technical Questions: Claim 1 requires "actuation means" that couple the motion of the proximal member to the distal member. The evidentiary burden will be on the plaintiff to demonstrate that the internal mechanism of the accused products functions in the manner claimed, coupling the bending motion of the two members.

V. Key Claim Terms for Construction

• The Term: "bendable motion member" (from claims in both the ’650 and ’513 Patents)
• Context and Importance: This term appears central to the infringement analysis for all asserted patents. The patents distinguish "bendable" members from traditional "pivotal" joints. The infringement case may depend on whether the accused products' articulating mechanisms, which appear in complaint images to be pivot-based (Compl. ¶39), can be characterized as "bendable."
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The patent defines the term functionally as an element "capable of being constrained... to deviate from a straight line to a curved configuration without any sharp breaks or angularity" (’650 Patent, col. 5:4-7). Plaintiff may argue this performance-based definition is not limited to any specific structure.
  • Evidence for a Narrower Interpretation: The specification explicitly contrasts "pivoted or bendable motion members" (’650 Patent, col. 1:39-40), suggesting they are distinct technologies. The primary disclosed embodiments are unitary structures with a "ribbed construction" or "bellows construction" (’650 Patent, Figs. 5A, 5B), which a defendant could argue limits the term’s scope to such flexible, non-pivoting structures.

VI. Other Allegations

• Indirect Infringement: The complaint alleges inducement of infringement, stating that Defendant provides "instructions or information to explain how to use the Accused Products in an infringing manner," including promotional materials and videos on its websites (Compl. ¶25, ¶46, ¶66). The complaint also pleads contributory infringement (Compl. ¶26, ¶47, ¶67).
• Willful Infringement: Willfulness allegations are based on knowledge of the patents "at least as of the filing of this Complaint" (Compl. ¶31, ¶52, ¶72), which may support a claim for enhanced damages for any post-filing infringement. The complaint does not allege pre-suit knowledge.

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

• A core issue will be one of definitional scope: can the term "bendable motion member," which the patents describe as a unitary structure that forms a curve "without any sharp breaks or angularity," be construed to cover the articulating joints of the Accused Products, which visual evidence in the complaint suggests may be multi-part, pivot-based mechanisms?
• A key evidentiary question will concern the mechanism of action: for the ’650 patent, does the accused products' latching feature (Compl. ¶21) function by "impeding cable means" as required by claim 60, or does it lock the instrument through an alternative mechanical interaction that does not directly act on the control cables?
• A third central question will relate to dimensional differences: for the ’582 patent, the analysis will focus on whether the accused products' proximal and distal articulating members have a "maximum transverse cross-sectional dimension that is different," and whether this structural feature is used to control the positioning of the tool in the manner claimed.