DCT
2:17-cv-00379
Mirage IP LLC v. Cook Medical Tech LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Mirage IP LLC (Texas)
- Defendant: Cook Medical Technologies LLC (Indiana)
- Plaintiff’s Counsel: Ferraiuoli LLC
- Case Identification: 2:17-cv-00379, E.D. Tex., 05/02/2017
- Venue Allegations: Plaintiff alleges venue is proper in the Eastern District of Texas because Defendant is subject to personal jurisdiction, conducts regular business in the district, and certain alleged acts of infringement occurred there.
- Core Dispute: Plaintiff alleges that Defendant’s "HiWire Nitinol Core Wire Guide" infringes a patent related to medical guidewire technology featuring a shapeable distal tip.
- Technical Context: The technology pertains to core wires for medical catheters, which are essential tools for minimally invasive procedures such as angioplasty, requiring a combination of flexibility to navigate blood vessels and tip-shapeability for physician control.
- Key Procedural History: The complaint notes that the patent-in-suit was issued after a full and fair examination and that Plaintiff is the current owner with rights to recover for past infringement. No other procedural history, such as prior litigation or administrative challenges, is mentioned.
Case Timeline
| Date | Event |
|---|---|
| 1998-02-19 | U.S. Patent No. 6,375,629 Priority Date |
| 2002-04-23 | U.S. Patent No. 6,375,629 Issue Date |
| 2017-05-02 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,375,629 - "Core Wire with Shapeable Tip"
- Patent Identification: U.S. Patent No. 6,375,629, "Core Wire with Shapeable Tip", issued April 23, 2002.
The Invention Explained
- Problem Addressed: The patent describes a challenge in medical guidewire design: the need for a device that is flexible enough to navigate tortuous vascular pathways without kinking, while also having a distal tip that a physician can manually shape to steer the wire. Previously known guidewires made from superelastic materials (like Nitinol) were difficult to permanently shape at the tip because their superelasticity caused them to return to their original form. (’629 Patent, col. 1:24-36, 1:53-62).
- The Patented Solution: The invention is a core wire constructed with distinct proximal and distal sections. The proximal section retains its superelastic properties, providing the necessary flexibility for navigation. The distal section, however, is subjected to additional processing, such as cold working, which removes its superelasticity. This makes the tip plastically deformable, or "shapeable," by a physician before a procedure. (’629 Patent, Abstract; col. 2:5-24). This process is described as creating a martensitic phase in the distal tip, which exhibits linear elasticity, unlike the superelastic austenitic phase of the proximal section (’629 Patent, col. 6:25-35; col. 7:55-62).
- Technical Importance: This dual-characteristic design allows a single guidewire to combine the navigational advantages of a highly flexible, kink-resistant body with the procedural advantages of a physician-shapeable tip. (’629 Patent, col. 1:56-62).
Key Claims at a Glance
- The complaint asserts at least independent claim 17. (Compl. ¶16, ¶20).
- 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 other claims.
III. The Accused Instrumentality
Product Identification
- The complaint identifies the "HiWire Nitinol Core Wire Guide" as the Accused Product. (Compl. ¶13).
Functionality and Market Context
- The complaint alleges, based on Defendant's promotional materials, that the Accused Product is a core wire guide comprising a core wire with proximal and distal sections. (Compl. ¶13). It is alleged to have a "stainless steel proximal core wire" providing flexibility and a "Chromium-enriched nitinol" distal tip that is shapeable and cold-worked. (Compl. ¶14-15). The complaint asserts the product is sold and advertised through a website available in Texas. (Compl. ¶20, fn. 2). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
Claim Chart Summary
- The complaint’s allegations for claim 17 are summarized below.
| Claim Element (from Independent Claim 17) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A core wire having proximal and distal sections | The Accused Product comprises a core wire having proximal and distal sections. | ¶13 | col. 5:10-14 |
| means for flexibility in the proximal section; | The Accused Product comprises means (e.g., stainless steel proximal core wire at proximal end of the core wire) for flexibility. | ¶14 | col. 7:45-54 |
| and means for shapeability in the distal section, said shapeability means including a cold-worked tip. | The Accused Product comprises means for shapeability in the distal section...including a cold-worked tip (e.g., Chromium-enriched nitinol at distal section of the core wire). | ¶15 | col. 6:25-35 |
Identified Points of Contention
- Scope Questions (Means-Plus-Function): As claim 17 is written in means-plus-function format, the scope of its terms is limited to the structures disclosed in the specification and their equivalents.
- The interpretation of "means for flexibility" will be a central issue. The patent specification repeatedly describes this function as being performed by a superelastic material, such as a NiTi alloy, in the proximal section. (’629 Patent, col. 6:55-60). The complaint alleges the accused structure is "stainless steel." (Compl. ¶14). This raises the question of whether a standard stainless steel structure is structurally equivalent to the disclosed superelastic NiTi alloy for performing the claimed function.
- Similarly, for "means for shapeability," the corresponding structure in the patent is a distal tip of a NiTi alloy that has been cold-worked to remove its superelasticity and induce a martensitic phase. (’629 Patent, col. 6:25-35). A key question is whether the accused "Chromium-enriched nitinol" tip is structurally equivalent to this disclosed configuration.
- Technical Questions: The complaint's allegations appear to be based on "promotional materials." (Compl. ¶13-15). A primary technical question will be what evidence exists to demonstrate that the accused "Chromium-enriched nitinol" tip is, in fact, a "cold-worked tip" from which superelasticity has been removed, as required by the claim.
V. Key Claim Terms for Construction
The Term: "means for flexibility in the proximal section"
- Context and Importance: Practitioners may focus on this term because it is a means-plus-function limitation whose scope will be critical to the infringement analysis. The outcome will depend on whether the accused "stainless steel" structure is found to be an equivalent to the structure disclosed in the patent.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party could argue that the term should not be limited to superelastic alloys, pointing to general statements that the core wire can be made of materials "such as stainless steel." (’629 Patent, col. 5:9-10).
- Evidence for a Narrower Interpretation: The structure disclosed in the specification as performing the function of flexibility is a proximal section made of a superelastic material (specifically, a NiTi alloy) that exhibits "transformational superelasticity." (’629 Patent, col. 7:45-54). An argument could be made that this specific mechanism of flexibility defines the scope of the claim.
The Term: "means for shapeability in the distal section, said shapeability means including a cold-worked tip"
- Context and Importance: This limitation captures the core of the invention. Its construction will determine if the accused product's tip infringes. The dispute will likely focus on the structural requirements of a "cold-worked tip" and its equivalents.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party may argue that this covers any guidewire tip that is rendered shapeable through a mechanical process, with the patent's specific roller-based cold-working method being merely an example.
- Evidence for a Narrower Interpretation: The specification explicitly discloses a structure where a superelastic alloy is processed (e.g., via rolling or drawing) to create a "cold worked martensite phase" that has "substantially linear elasticity." (’629 Patent, col. 6:25-35, col. 7:58-62). The scope may be narrowly construed to cover only this structure and its close equivalents.
VI. Other Allegations
Willful Infringement
- The complaint requests "enhanced damages" but alleges Defendant's knowledge of infringement began only "at least as of the service of the present complaint." (Compl. ¶19; Prayer for Relief ¶5). These allegations could potentially support a claim for willful infringement only for conduct occurring after the lawsuit was filed, not for any pre-suit activities.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim construction and equivalence: can the "means for flexibility" limitation, which the patent specification links to a superelastic NiTi alloy structure, be construed to cover the accused product's alleged "stainless steel" proximal section? This raises a fundamental question of structural equivalence under 35 U.S.C. § 112(f).
- A key evidentiary question will be one of factual proof: beyond the high-level allegations sourced from "promotional materials," what technical evidence can Plaintiff produce to demonstrate that the Defendant's "Chromium-enriched nitinol" tip is, in fact, a "cold-worked tip" from which superelasticity has been removed, as structurally defined and required by the patent?