Mirage IP LLC v. MicroVention Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Mirage IP LLC (Texas)
  • Defendant: MicroVention, Inc. (Delaware)
  • Plaintiff’s Counsel: Ferraiuoli LLC
• Case Identification: 2:17-cv-00380, E.D. Tex., 05/02/2017
• Venue Allegations: Plaintiff alleges venue is proper because Defendant is subject to personal jurisdiction, conducts regular business, and committed alleged acts of infringement in the district.
• Core Dispute: Plaintiff alleges that Defendant’s medical guidewire infringes a patent related to shapeable tips and that its balloon catheter, when used, infringes a method patent for localized intravascular drug delivery.
• Technical Context: The technology relates to advanced guidewires and balloon catheters used in minimally invasive endovascular procedures for treating blockages in blood vessels.
• Key Procedural History: The patents-in-suit descend from extensive patent families, as indicated by the lengthy prosecution histories listed on the face of the patents. No other significant procedural events are mentioned in the complaint.

Case Timeline

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

U.S. Patent No. 6,375,629 - "Core Wire with Shapeable Tip" (issued Apr. 23, 2002)

The Invention Explained

• Problem Addressed: The patent addresses a conflict in the desired properties of a catheter core wire: the main body must be highly flexible and kink-resistant to navigate tortuous blood vessels, while the very distal tip should be manually shapeable by a clinician to facilitate navigation. Materials that are highly flexible, such as superelastic Nitinol, are typically not shapeable, as they return to their original form after being bent. (Compl., Ex. A, ’629 Patent, col. 1:22-61).
• The Patented Solution: The invention is a core wire, typically made from a single piece of superelastic alloy, where the material properties are selectively altered. The main (proximal) body of the wire retains its superelastic properties for flexibility. The distal tip, however, is subjected to additional processing, such as cold working, to remove its superelasticity. This renders the tip plastically deformable, or "shapeable," allowing a surgeon to bend it into a desired curve that it will retain during a procedure. (Compl., Ex. A, ’629 Patent, Abstract; col. 2:5-24).
• Technical Importance: This approach allows a single guidewire to combine the kink-resistance and flexibility of a superelastic alloy with the practical need for a physician-shaped tip, potentially improving navigation and placement accuracy in complex medical procedures. (Compl., Ex. A, ’629 Patent, col. 1:53-61).

Key Claims at a Glance

• The complaint asserts independent claim 17. (Compl. ¶¶ 22, 31).
• Claim 17 is a means-plus-function claim containing the following essential elements:
  • A core wire having proximal and distal sections
  • means for flexibility in the proximal section; and
  • means for shapeability in the distal section, said shapeability means including a cold-worked tip.
• The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 6,958,059 - "Methods and Apparatuses for Drug Delivery to an Intravascular Occlusion" (issued Oct. 25, 2005)

The Invention Explained

• Problem Addressed: When treating a blockage (occlusion) in a blood vessel, therapeutic procedures can dislodge debris (emboli) which may travel downstream and cause further blockages, such as a stroke. The challenge is to deliver a treatment drug directly to the occlusion site while preventing the escape of such debris. (Compl., Ex. B, ’059 Patent, col. 2:23-31).
• The Patented Solution: The patent describes a method where a catheter with an occlusive device (e.g., an inflatable balloon) is advanced past a blood clot. The balloon is then inflated downstream of the clot to block blood flow. A drug-containing fluid is then delivered through the catheter and exits from "at least one hole in a proximal face of the occlusive device." This configuration forces the drug to flow backward (in a distal-to-proximal direction) against the now-stopped blood flow, concentrating the therapeutic agent at the occlusion site while the balloon acts as a barrier to prevent debris from escaping downstream. (Compl., Ex. B, ’059 Patent, Abstract; col. 4:4-16).
• Technical Importance: The method aims to provide a dual-function system that both localizes a high concentration of a therapeutic drug at a target lesion and provides embolic protection during the procedure. (Compl., Ex. B, ’059 Patent, col. 3:15-21).

Key Claims at a Glance

• The complaint asserts independent claim 1. (Compl. ¶¶ 23, 39).
• Claim 1 is a method claim with the following essential steps:
  • 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 occlusion;
  • actuating the occlusive device at a location distal to the occlusion to at least partially block 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, causing the fluid to be delivered in a distal to proximal direction.
• The complaint does not explicitly reserve the right to assert dependent claims.

III. The Accused Instrumentality

Product Identification

The complaint accuses Defendant’s "Traxcess Guidewire" of infringing the ’629 Patent and Defendant's "Scepter C" catheter of being used to infringe the ’059 Patent. (Compl. ¶¶ 19, 23).

Functionality and Market Context

• The "Traxcess Guidewire" is alleged to comprise a core wire with distinct proximal and distal sections. The complaint alleges the proximal section is made of stainless steel to provide flexibility, while the distal section is made of "Chromium-enriched nitinol" and features a "cold-worked tip" to provide shapeability. (Compl. ¶¶ 19-21).
• The "Scepter C" is identified as a catheter that, when used, performs the steps of the asserted method claim from the ’059 Patent. The complaint alleges that Defendant itself performs these steps "at least during internal testing." (Compl. ¶¶ 23, 39). The accused instrumentality is alleged to have a balloon that can be inflated to occlude a vessel and a lumen for delivering fluid. (Compl. ¶¶ 24-26).
• The complaint does not provide specific details on the market context or commercial importance of the products beyond identifying them as commercialized by Defendant. (Compl. ¶¶ 13, 18, 23).
• No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

’629 Patent Infringement Allegations

• Identified Points of Contention:
  • Scope Questions: Claim 17 is a means-plus-function claim, meaning its scope is limited to the structures disclosed in the patent specification and their equivalents. A primary question for the court will be one of structural equivalence. The ’629 Patent specification appears to describe a single, monolithic Nitinol wire that is differentially processed to create a superelastic proximal section and a non-superelastic distal tip (col. 2:11-24). The complaint alleges the accused product uses two different materials: a "stainless steel proximal core wire" and a "nitinol at distal section" (Compl. ¶¶ 20-21). The case may turn on whether this composite construction is structurally equivalent to the patent's disclosed monolithic structure for performing the claimed functions.
  • Technical Questions: Does the alleged "stainless steel proximal core wire" (Compl. ¶20) perform the function of providing flexibility in a way that is equivalent to the "transformational superelasticity" explicitly described and claimed as the basis for flexibility in the patent? (col. 7:48-54).

’059 Patent Infringement Allegations

• Identified Points of Contention:
  • Scope Questions: The interpretation of the phrase "at least one hole in a proximal face of the occlusive device" will be critical. The court will need to determine if this requires the fluid exit port to be located on the structure of the balloon itself, as some embodiments in the patent suggest (e.g., Fig. 12, element 450), or if it can be read more broadly to include a port on the catheter shaft immediately adjacent to the proximal end of the balloon.
  • Technical Questions: What is the actual physical structure of the accused Scepter C catheter? The complaint's allegation that the delivery hole is at the "tip of the Accused Instrumentality" (Compl. ¶26) is ambiguous and will require factual evidence to determine if it meets the specific limitation of being "in a proximal face of the occlusive device."

V. Key Claim Terms for Construction

Term from ’629 Patent: "means for flexibility in the proximal section" / "means for shapeability in the distal section"

• Context and Importance: These are means-plus-function limitations under 35 U.S.C. § 112(f). Their scope is not defined by the words alone, but by the corresponding structure described in the patent's specification and its equivalents. The infringement analysis will depend on whether the accused guidewire's alleged two-material construction (stainless steel and nitinol) is equivalent to the structure disclosed in the patent.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A party could argue that the patent's overall objective is a flexible body and a shapeable tip, and that any combination of materials achieving this functional result should be considered equivalent.
  • Evidence for a Narrower Interpretation: The specification consistently describes the invention as starting with a single "elongate body of NiTi alloy" and then applying different treatments to its sections. (col. 2:11-24). Language describing the process as "remov[ing] superelasticity from this end" of the "core wire that results" suggests a unitary, monolithic structure rather than a composite of different metals. (col. 2:18-22).

Term from ’059 Patent: "at least one hole in a proximal face of the occlusive device"

• Context and Importance: This term defines the precise location of drug delivery, which is central to the claimed method of creating a localized, reverse-flow treatment zone. Infringement hinges on whether the accused Scepter C catheter has a port in this exact location. Practitioners may focus on this term because it appears to be a key point of novelty.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A party might argue that the "proximal face" could encompass the entire forward-facing surface of the catheter's distal tip assembly, including the portion of the catheter shaft to which the balloon is mounted.
  • Evidence for a Narrower Interpretation: The specification provides strong evidence for a narrower reading. Claim 5, which depends from claim 1, recites "delivering a drug-containing fluid through a plurality of holes in a proximal face of the balloon." (’059 Patent, col. 20:20-22). This suggests the "occlusive device" in claim 1 is the balloon, and the "face" is the surface of the balloon itself. Figure 12 further illustrates this, showing holes (450) directly on the proximal surface of the balloon (422).

VI. Other Allegations

• Indirect Infringement: The complaint focuses on allegations of direct infringement. For the ’059 method patent, the specific factual basis for infringement is Defendant's own "internal testing" activities. (Compl. ¶¶ 23, 39). The complaint does not plead specific facts to support a claim for either induced or contributory infringement, such as alleging that Defendant's instructions for use direct clinicians to perform the patented method.
• Willful Infringement: The complaint alleges that Defendant had knowledge of the patents "at least as of the service of the present complaint." (Compl. ¶¶ 30, 38). This allegation may support a claim for enhanced damages based on post-filing conduct but does not establish the pre-suit knowledge typically required to prove pre-filing willful infringement.

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

• A core issue for the ’629 patent will be one of structural equivalence under § 112(f): Is the accused guidewire's alleged composite construction, using separate stainless steel and nitinol components, legally equivalent to the ’629 patent’s disclosed structure of a single, differentially-treated nitinol wire?
• A dispositive question for the ’059 patent will be one of claim construction and factual proof: Can the phrase "a hole in a proximal face of the occlusive device" be construed to read on a port located on the catheter shaft adjacent to the balloon, and does the evidence show the accused Scepter C catheter is in fact constructed this way?