Mirage IP LLC v. Oscor Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Mirage IP LLC (Texas)
  • Defendant: Oscor Inc. (Florida)
  • Plaintiff’s Counsel: Ferraiuoli LLC
• Case Identification: 2:17-cv-00381, E.D. Tex., 05/02/2017
• Venue Allegations: Plaintiff alleges venue is proper because Defendant is subject to personal jurisdiction in the district and has regularly conducted business there.
• Core Dispute: Plaintiff alleges that Defendant’s "VENOS" occlusion balloon catheter, when used, infringes a patent related to methods for delivering drugs to an intravascular occlusion.
• Technical Context: The technology lies in the medical device field, specifically concerning catheter-based systems designed to treat blockages in blood vessels while minimizing downstream complications.
• Key Procedural History: The complaint does not mention any prior litigation, inter partes review (IPR) proceedings, or licensing history related to the patent-in-suit.

Case Timeline

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

• Patent Identification: U.S. Patent No. 6,958,059, "Methods and Apparatuses for Drug Delivery to an Intravascular Occlusion," issued October 25, 2005 (’059 Patent, cover; Compl. ¶8).

The Invention Explained

• Problem Addressed: The patent describes the clinical challenge of treating intravascular occlusions (blockages in blood vessels). It notes that conventional treatments like angioplasty risk dislodging plaque or thrombi, which can travel downstream and cause serious complications such as a stroke (’059 Patent, col. 2:4-32).
• The Patented Solution: The invention claims a method where a catheter with an occlusive device, such as an inflatable balloon, is advanced past the blockage. The device is then actuated (e.g., inflated) to block blood flow distal to the occlusion. A therapeutic fluid is then delivered through the catheter lumen and exits through a hole located on the "proximal face" of the occlusive device. This configuration is intended to cause the fluid to flow in a "distal to proximal direction" (i.e., against the normal direction of blood flow), thereby localizing the drug at the site of the occlusion (’059 Patent, Abstract; col. 4:4-16).
• Technical Importance: This approach seeks to enhance treatment safety and efficacy by creating an isolated treatment zone, concentrating the therapeutic agent on the blockage while simultaneously preventing dislodged particles from escaping into the bloodstream (’059 Patent, col. 3:1-4).

Key Claims at a Glance

• The complaint asserts at least independent claim 1 (Compl. ¶12, 16, 20).
• The essential elements of independent claim 1 are:
  • delivering a catheter having a proximal end, a distal end, a lumen, and an occlusive device on the distal end into a blood vessel near an intravascular occlusion;
  • actuating the occlusive device at a location distal to the occlusion to at least partially occlude blood flow; and
  • delivering a drug-containing fluid through the lumen and out through at least one hole in a "proximal face" of the occlusive device, such that the fluid is delivered in a "distal to proximal direction." (’059 Patent, col. 19:13-26).

III. The Accused Instrumentality

Product Identification

• The "VENOS" occlusion balloon catheter (Compl. ¶12).

Functionality and Market Context

• The complaint alleges that the Accused Instrumentality is an occlusion balloon catheter that, when used, performs the steps of the patented method (Compl. ¶12). The alleged infringing use involves delivering the catheter, inflating its balloon distal to an occlusion to block blood flow, and then delivering a fluid through the catheter's lumen out a hole at its tip to treat the occlusion (Compl. ¶13-15). The complaint bases its infringement allegations on Defendant's "internal testing" of the device (Compl. ¶12). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

’059 Patent Infringement Allegations

• Identified Points of Contention:
  • Technical Questions: A primary evidentiary question is whether Plaintiff can prove that Defendant's "internal testing" involves every step of the claimed method. Specifically, the complaint alleges the delivery of a "drug-containing fluid," and it will be a point of contention what evidence supports this specific allegation (Compl. ¶15). Further, the complaint alleges a "distal to proximal direction" of fluid delivery, raising the question of what evidence demonstrates this specific flow dynamic occurs with the accused device (Compl. ¶15).
  • Scope Questions: The complaint's infringement theory is based on Defendant's own direct use of the method, specifically during "internal testing" (Compl. ¶12). The case may raise the question of whether such testing activities, performed to ensure regulatory compliance, constitute an infringing "use" under 35 U.S.C. § 271.

V. Key Claim Terms for Construction

• The Term: "a proximal face of the occlusive device" (’059 Patent, col. 19:24).
• Context and Importance: This term is critical as it defines the precise location of the fluid-delivery hole relative to the occlusion balloon. The interpretation of whether the hole must be a structural feature of the balloon itself or can simply be located on the catheter body adjacent to the balloon will be central to the infringement analysis. Practitioners may focus on this term because it is a specific structural limitation that enables the "distal to proximal" flow direction, a key feature of the claimed invention.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A party arguing for a broader definition may point to figures like FIG. 8A, which illustrates a catheter (200) delivering fluid (234) at a location proximal to the balloon (12), without the exit port being explicitly shown as part of the balloon structure itself (’059 Patent, FIG. 8A). The description states the drug is delivered through the lumen of an aspiration catheter, which is distinct from the guidewire carrying the balloon, suggesting the hole is not necessarily integral to the occlusive device (’059 Patent, col. 13:35-43).
  • Evidence for a Narrower Interpretation: A party arguing for a narrower definition may cite the plain language of Claim 1, which requires the hole to be "in a proximal face of the occlusive device" (’059 Patent, col. 19:24). The specification provides further support, stating that "the drug-containing fluid is delivered through a plurality of holes in a proximal face of an occlusive balloon," directly linking the holes to the balloon structure (’059 Patent, col. 4:14-16).

VI. Other Allegations

• Indirect Infringement: The complaint includes a conclusory allegation of indirect infringement but does not plead specific facts to support either inducement or contributory infringement, such as knowledge of infringement by third parties or intent to cause infringing acts (Compl. ¶18). The factual allegations focus on Defendant's own alleged direct infringement (Compl. ¶20).
• Willful Infringement: The complaint alleges that Defendant has had knowledge of infringement "at least as of the service of the present complaint," which may support a claim for post-filing willful infringement but does not allege pre-suit knowledge (Compl. ¶19).

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

• A core issue will be one of evidentiary sufficiency: Can Plaintiff produce sufficient evidence to demonstrate that Defendant's alleged "internal testing" activities meet every limitation of the asserted method claim? This will require specific proof of the delivery of a "drug-containing fluid" and the resulting "distal to proximal" flow, as these elements are currently alleged upon information and belief.
• The case will also turn on a key question of claim construction: How the court construes the term "a proximal face of the occlusive device" will be critical. The dispute will likely focus on whether this term requires the fluid exit port to be structurally integral to the balloon itself, or if it can be interpreted more broadly to cover the catheter tip area immediately preceding the balloon.