Mirage IP LLC v. St Jude Medical Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Mirage IP LLC (Texas)
  • Defendant: St. Jude Medical, Inc. (Minnesota)
  • Plaintiff’s Counsel: Ferraiuoli LLC
• Case Identification: 2:17-cv-00383, E.D. Tex., 05/02/2017
• Venue Allegations: Plaintiff alleges venue is proper because Defendant is subject to personal jurisdiction, has regularly conducted business in the district, and certain acts of infringement occurred in the district.
• Core Dispute: Plaintiff alleges that Defendant’s medical guidewires infringe a patent related to guidewire core construction, specifically a core wire with a flexible body and a shapeable tip.
• Technical Context: The technology concerns guidewires used in minimally invasive medical procedures to navigate a patient's vascular system, where a combination of flexibility and steerability at the tip is critical for clinical success.
• Key Procedural History: The complaint does not mention prior litigation, licensing history, or other significant procedural events related to the patent-in-suit.

Case Timeline

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

U.S. Patent No. 6,375,629 - "Core Wire with Shapeable Tip," Issued April 23, 2002

The Invention Explained

• Problem Addressed: The patent addresses a challenge in guidewire design: the need for a guidewire to be highly flexible to navigate tortuous blood vessels, while also having a distal tip that a physician can manually shape for precise steering. The patent notes that materials that are highly flexible (i.e., superelastic) are often not shapeable, as they return to their original configuration after being bent (’629 Patent, col. 1:53-61).
• The Patented Solution: The invention is a core wire for a medical catheter constructed with different material properties along its length. The main (proximal) body is made of a superelastic alloy (like Nitinol), providing excellent flexibility and kink resistance. The very distal tip, however, is subjected to additional processing (such as cold working) to remove its superelasticity, rendering it plastic-like and thus shapeable by a physician before a procedure (’629 Patent, Abstract; col. 2:5-24). This creates a composite device with a flexible shaft and a steerable, shapeable tip.
• Technical Importance: This dual-property design allows for a single guidewire to combine the navigational benefits of a highly flexible superelastic body with the fine-tuned directional control of a custom-shaped tip, a key requirement for complex interventional procedures (’629 Patent, col. 1:26-34).

Key Claims at a Glance

• The complaint asserts infringement of "at least claim 17" (Compl. ¶17, ¶21).
• Independent claim 17 is a means-plus-function claim with 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, but the "at least" language suggests it may do so later.

III. The Accused Instrumentality

Product Identification

• The accused products are the "HydroSteer Guidewires" (Compl. ¶14).

Functionality and Market Context

• The complaint alleges, based on Defendant’s promotional materials, that the Accused Product is a core wire with distinct proximal and distal sections (Compl. ¶14). The proximal section allegedly comprises a "stainless steel proximal core wire" that provides flexibility (Compl. ¶15). The distal section allegedly comprises "Chromium-enriched nitinol" that acts as a shapeable, cold-worked tip (Compl. ¶16). The complaint alleges the product is sold and advertised through a website available in Texas (Compl. ¶7, ¶21). The complaint does not provide further detail on the product's market context or commercial importance.

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

'629 Patent Infringement Allegations

• Identified Points of Contention:
  • Scope Questions: The primary dispute will likely center on the construction of the two "means-plus-function" limitations in claim 17. The scope of these terms is limited to the specific structures disclosed in the patent's specification that perform the claimed functions, and their equivalents.
  • Technical Questions: A key question is whether the accused product's structures are structurally equivalent to those disclosed in the patent. For the "means for flexibility," the court will have to determine whether the alleged "stainless steel" of the accused product is structurally equivalent to the superelastic nitinol alloy described in the patent specification as exhibiting "transformational superelasticity" (’629 Patent, col. 8:42-44). Similarly, for the "means for shapeability," a question is whether the accused "Chromium-enriched nitinol" is structurally equivalent to the "cold-worked" nitinol tip disclosed in the patent, which is described as being in a martensitic phase with "substantially linear elasticity" (’629 Patent, col. 8:57-59). The complaint does not provide evidence to support these asserted equivalencies.

V. Key Claim Terms for Construction

The construction of the two means-plus-function limitations of claim 17 will be central to the case.

• The Term: "means for flexibility in the proximal section"

• Context and Importance: Practitioners may focus on this term because its construction will define the specific structure(s) against which the accused product is compared. Infringement will depend on whether the defendant's alleged "stainless steel" wire is the same as, or an equivalent to, the structure disclosed in the '629 patent.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: A party might argue the function is simply "flexibility," a general mechanical property. However, under § 112(f), the analysis must identify a corresponding structure.
  • Evidence for a Narrower Interpretation: The specification repeatedly links the flexibility of the proximal section to the unique properties of a superelastic alloy like nitinol, which exhibits "transformational superelasticity" through a phase change from austenite to martensite under stress (’629 Patent, col. 7:20-30; col. 8:40-50). This suggests the corresponding structure is a nitinol alloy processed to be superelastic, a much narrower definition than generic "flexibility."

• The Term: "means for shapeability in the distal section, said shapeability means including a cold-worked tip"

• Context and Importance: This term's construction is critical because it defines the patented solution to the non-shapeable tip problem. The dispute will turn on whether the accused product's structure for achieving shapeability is equivalent to the patent's disclosed structure.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: A party might argue the function is simply "shapeability," and the structure is any "cold-worked tip."
  • Evidence for a Narrower Interpretation: The specification describes a specific structural state: a distal tip processed (e.g., by cold-working) to remove superelasticity, resulting in a material that is in a "martensitic phase" and exhibits "only substantially linear elasticity" (’629 Patent, col. 8:55-59; col. 6:34-35). This suggests the corresponding structure is a nitinol alloy tip that has been mechanically altered to suppress its superelastic phase transformation and instead deform plastically.

VI. Other Allegations

• Willful Infringement: The complaint alleges that Defendant had "knowledge of infringement...at least as of the service of the present complaint" (Compl. ¶20). This allegation supports a claim for post-suit willful infringement only and does not allege any pre-suit knowledge of the patent or the alleged infringement.

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

The resolution of this case appears to hinge on the following central questions:

1. A core issue will be one of structural correspondence under § 112(f): Can the accused guidewire's "stainless steel" proximal section be considered legally equivalent to the superelastic nitinol alloy structure disclosed in the '629 patent as the "means for flexibility"? This raises a fundamental question about whether two different materials can be considered structural equivalents for purposes of a means-plus-function claim.

2. A second key issue will be one of technical equivalence: Does the accused product's "Chromium-enriched nitinol" distal tip achieve shapeability through a structure that is the same as or equivalent to the specific "cold-worked" martensitic phase structure disclosed in the patent, which is defined by its "substantially linear elasticity"?

3. An overarching evidentiary question will be whether the plaintiff can substantiate its bare allegations, which are based on unspecified "promotional materials," with sufficient technical evidence to demonstrate that the accused guidewires actually contain the structures corresponding to the functions recited in the means-plus-function claims.