DCT

1:25-cv-00095

CRH Medical Corp v. Mde Medical LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00095, D. Del., 08/06/2025
  • Venue Allegations: Venue is based on Defendants' alleged residence in Delaware as limited liability companies and their purported commission of infringing acts within the judicial district.
  • Core Dispute: Plaintiff alleges that Defendants’ Snyder HemBand ligation banding system infringes three patents related to medical devices for treating hemorrhoids.
  • Technical Context: The technology concerns elastic band ligation devices, which are used to perform a common, minimally invasive medical procedure for treating hemorrhoids by cutting off blood supply to the tissue.
  • Key Procedural History: This is a Second Amended and Supplemental Complaint. The complaint alleges that Defendants actively monitored the prosecution of the '302 Patent, communicated with the USPTO examiner to oppose its issuance, and were aware of the Notice of Allowance before the patent granted. The complaint also includes a count for false patent marking, alleging Defendants continued to mark their product "patent pending" after their own relevant patent applications were abandoned.

Case Timeline

Date Event
2013-08-21 Priority Date for all Asserted Patents
2013 Plaintiff's CRH O'Regan System introduced
2023-01-27 Defendants' Snyder HemBand first sold
2023-11-28 Defendants' patent applications allegedly abandoned
2023-12-01 USPTO issues Notice of Abandonment for Defendants' applications
2024-08-05 Defendants allegedly begin monitoring '302 patent application
2024-11-11 '302 Patent Notice of Allowance issued
2025-01-21 U.S. Patent No. 12,201,302 issues
2025-07-08 U.S. Patent No. 12,349,915 issues
2025-07-08 U.S. Patent No. 12,349,916 issues
2025-08-06 Complaint filed

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

U.S. Patent No. 12,201,302 - "Elastic Band Ligation Device with Anti-Pinch Feature and Method for Treatment of Hemorrhoids"

  • Patent Identification: U.S. Patent No. 12,201,302, "Elastic Band Ligation Device with Anti-Pinch Feature and Method for Treatment of Hemorrhoids," issued January 21, 2025 (Compl. ¶21).

The Invention Explained

  • Problem Addressed: The patent describes a drawback in prior art hemorrhoid ligation devices where the linear and rotational movement of components during use creates a risk of pinching sensitive patient tissue, causing discomfort ('302 Patent, col. 2:27-35).
  • The Patented Solution: The invention is a ligation device with an "anti-pinch feature" designed to mitigate this risk. The solution centers on the geometry of the interface between the internal obturator's tip and the inner wall of the device's tubular member. By defining a specific convergent angle between these two surfaces, the design claims to reduce or eliminate gaps where tissue could become trapped during operation ('302 Patent, col. 2:40-46, col. 7:1-19; Fig. 2B).
  • Technical Importance: The claimed design aims to enhance patient comfort and reduce procedural complications, thereby improving the overall efficacy and patient acceptance of a widely used office-based treatment ('302 Patent, col. 1:13-19).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent Claim 1 (Compl. ¶36).
  • Claim 1 recites a ligation apparatus with three primary components:
    • An inner tubular member with specific portions (tapering, cylindrical) and features (a raised ring, a flange).
    • An outer tubular member that slidably sheaths the inner member, featuring a raised ridge and a flange to engage and disengage with the inner member's raised ring.
    • A single piece obturator plunger inside the inner member, which has a rounded tip, an elongate stem with a rubber seal, and a handle, and is configured to create suction when pulled.

U.S. Patent No. 12,349,915 - "Elastic Band Ligation Device with Anti-Pinch Feature and Method for Treatment of Hemorrhoids"

  • Patent Identification: U.S. Patent No. 12,349,915, "Elastic Band Ligation Device with Anti-Pinch Feature and Method for Treatment of Hemorrhoids," issued July 8, 2025 (Compl. ¶23).

The Invention Explained

  • Problem Addressed: Similar to the ’302 Patent, this patent addresses the problem of prior art devices creating a risk of pinching sensitive tissue during hemorrhoid ligation procedures ('915 Patent, col. 2:40-47).
  • The Patented Solution: The patent discloses a ligation apparatus with a similar overall structure, including an inner member, a slidable outer member, and an internal plunger for creating suction. The claims of this patent distinguish themselves by reciting "at least one protrusion" on the inner and outer members for engagement, rather than the "flange" specified in the ’302 Patent, suggesting a different mechanical interaction ('915 Patent, Claim 1; Abstract).
  • Technical Importance: This patent describes a potential alternative mechanical configuration for an anti-pinch ligation device, aiming to achieve the same goal of improved patient comfort and safety ('915 Patent, col. 1:25-28).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent Claim 1 (Compl. ¶66).
  • Claim 1 recites a ligation apparatus comprising:
    • An inner elongate member with a raised ring and "at least one protrusion."
    • An outer elongate member that slidably sheaths the inner member, also featuring "at least one protrusion" configured to disengage a raised ridge from the inner member's ring.
    • A single piece obturator plunger disposed within the inner member and configured to create suction.

U.S. Patent No. 12,349,916 - "Elastic Band Ligation Device with Anti-Pinch Feature and Method for Treatment of Hemorrhoids"

  • Patent Identification: U.S. Patent No. 12,349,916, "Elastic Band Ligation Device with Anti-Pinch Feature and Method for Treatment of Hemorrhoids," issued July 8, 2025 (Compl. ¶25).
  • Technology Synopsis: This patent, part of the same family as the '302 and '915 patents, is also directed to solving the problem of tissue pinching in hemorrhoid ligation devices ('916 Patent, Abstract). It discloses a multi-component apparatus comprising inner and outer tubular members and an internal plunger, with the claims specifying a particular combination of geometric features—including tapering portions, a conical frustrum, flanges, and rings—to enable suction-based ligation safely ('916 Patent, Claim 1).
  • Asserted Claims: Independent Claim 1 is asserted (Compl. ¶75).
  • Accused Features: The complaint alleges that the Defendants' Snyder HemBand product embodies the complete ligation apparatus recited in the claims (Compl. ¶¶72, 74).

III. The Accused Instrumentality

Product Identification

The Snyder HemBand (Compl. ¶12).

Functionality and Market Context

The Snyder HemBand is described as a ligation banding system and a "rubber band applicator that allows a physician to place a rubber band at the base of the hemorrhoid" (Compl. ¶14). The complaint alleges the product is an "exact copy" of Plaintiff's CRH O'Regan System and is sold across the U.S. through distributors and online as a direct competitor (Compl. ¶¶12, 13, 15).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

U.S. Patent No. 12,201,302 Infringement Allegations

The complaint references a preliminary claim chart in Exhibit D that was not provided with the filed complaint (Compl. ¶36). The narrative infringement theory asserts that the Snyder HemBand is a ligation apparatus that satisfies all elements of at least Claim 1 of the ’302 Patent (Compl. ¶35). The complaint alleges the accused product contains the claimed inner tubular member, the slidable outer tubular member, and the single-piece obturator plunger configured to create suction force as recited in the claim (Compl. ¶37).

  • Identified Points of Contention:
    • Scope Questions: Do the specific mechanical structures of the Snyder HemBand meet the definitions of the "raised ring," "raised ridge," and "flange" elements as recited in Claim 1? The construction of these terms will be central to determining literal infringement.
    • Technical Questions: Does the accused product’s plunger mechanism operate as a "single piece obturator plunger" that, when actuated, creates "sufficient suction force" as required by Claim 1(C)(iv)? The complaint lacks specific technical details about how the accused device generates suction.

U.S. Patent No. 12,349,915 Infringement Allegations

The complaint alleges that the Snyder HemBand infringes at least Claim 1 of the ’915 Patent and references a detailed claim chart in Exhibit I, which was not included with the complaint (Compl. ¶66). The core allegation is that the accused product is a ligation apparatus containing the three main components of Claim 1: an inner elongate member, an outer elongate member, and a single-piece obturator plunger (Compl. ¶¶65, 67).

  • Identified Points of Contention:
    • Scope Questions: Claim 1 of the ’915 Patent requires "at least one protrusion" on both the inner and outer members for mechanical engagement. A key question for the court will be whether the accused product contains structures that meet the definition of "protrusion" and whether that term carries a different scope than the term "flange" used in the related '302 and '916 patents.
    • Technical Questions: What evidence supports the allegation that the Snyder HemBand's plunger creates suction specifically "at the first inner opening of the inner elongate member," as required by Claim 1(C)(iv)?

V. Key Claim Terms for Construction

Terms from the ’302 Patent

  • The Term: "single piece obturator plunger" (Claim 1(C))
  • Context and Importance: The interpretation of "single piece" will be critical. If construed to mean monolithically formed as one indivisible unit, it could provide a non-infringement argument for a device where the obturator tip and plunger stem are manufactured separately and later assembled. Practitioners may focus on this term because the functionality may be identical regardless of the manufacturing method.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the plunger as "integrally formed with an obturator," which could support a functional interpretation where the components act as a single unit, even if assembled ('302 Patent, col. 6:21-22).
    • Evidence for a Narrower Interpretation: The plain language of the claim is "single piece." An argument for a narrower construction would be that this language was chosen to mean a unitary, non-assembled structure. The patent's figures appear to depict a continuous component from the handle to the rounded tip ('302 Patent, Fig. 1).

Terms from the ’915 Patent

  • The Term: "protrusion" (Claim 1(A)(iv) and 1(B)(ii)(b))
  • Context and Importance: The patent family uses different terms for engagement features ("flange" in '302, "protrusion" in '915). The definition of "protrusion" is therefore important for determining infringement of the ’915 Patent specifically, and it raises the question of whether the patentee intended a different scope for this term.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: "Protrusion" is a general term not explicitly defined in the patent. It could be argued to encompass a wide range of structures that extend from a surface, including a flange, tab, or nub.
    • Evidence for a Narrower Interpretation: The doctrine of claim differentiation between related patents may suggest that the patentee's choice of "protrusion" instead of "flange" was deliberate and intended to claim a different structure. However, the specification does not provide a clear basis for such a distinction.

VI. Other Allegations

  • Willful Infringement: The complaint includes a count for willful infringement of the '302 Patent (Compl., Count II). The allegations are based on purported pre-suit knowledge derived from Plaintiff's virtual patent marking and, more significantly, on alleged pre-issuance conduct (Compl. ¶¶42, 43). The complaint claims that Defendants actively monitored the prosecution of the patent application, contacted the USPTO examiner in an attempt to prevent issuance, and knew of the Notice of Allowance, suggesting a deliberate disregard of Plaintiff's rights (Compl. ¶¶43-45).
  • False Marking: The complaint asserts a claim for false patent marking (Compl., Count III). It alleges that Defendants mark the Snyder HemBand packaging with the phrase “patent pending” with an intent to deceive the public, despite their corresponding U.S. patent applications having been abandoned since November 2023 (Compl. ¶¶50, 51, 57).

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

  • A central issue of claim construction will be the differentiation of claim terms across the patent family: did the patentee intend a meaningful distinction between a "flange" (as claimed in the '302 and '916 Patents) and a "protrusion" (as claimed in the '915 Patent), and does the accused Snyder HemBand product possess structures that meet these potentially distinct definitions?
  • The willfulness claim will present a key factual question regarding pre-issuance conduct: does the evidence show that Defendants' alleged monitoring of the '302 Patent's prosecution and communication with the USPTO constitutes the kind of objective recklessness required for a finding of willful infringement, or was it permissible competitive analysis?
  • A key evidentiary question will be one of structural and functional correspondence: beyond the allegation that the accused product is a "copy," what technical evidence will be presented to prove that the Snyder HemBand’s components—particularly its plunger and engagement mechanisms—perform the specific functions in the precise manner required by the asserted independent claims?