DCT
0:17-cv-05094
Niazi Licensing Corp v. Boston Scientific Corp
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Niazi Licensing Corporation (Washington)
- Defendant: Boston Scientific Corp. (Delaware)
- Plaintiff’s Counsel: Madia Law LLC; Boyle Fredrickson, S.C.
- Case Identification: 0:17-cv-05094, D. Minn., 11/13/2017
- Venue Allegations: Venue is based on Defendant having a regular and established place of business, including numerous facilities, within the District of Minnesota.
- Core Dispute: Plaintiff alleges that Defendant’s Acuity brand of telescoping catheter systems infringes a patent related to double catheters used to cannulate the coronary sinus.
- Technical Context: The technology concerns specialized medical devices used in cardiac rhythm management to deliver pacing leads to the heart for therapies such as cardiac resynchronization.
- Key Procedural History: The complaint alleges that the Defendant was aware of the patent-in-suit prior to the filing of the lawsuit, which forms the basis for the willfulness allegation. No other procedural events, such as prior litigation or post-grant proceedings, are mentioned.
Case Timeline
| Date | Event |
|---|---|
| 2000-04-07 | ’268 Patent Priority Date (Provisional App. 60/195,701) |
| 2003-10-28 | ’268 Patent Issue Date |
| 2017-11-13 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,638,268 - "Catheter to cannulate the coronary sinus"
- Patent Identification: U.S. Patent No. 6,638,268, “Catheter to cannulate the coronary sinus,” issued October 28, 2003.
The Invention Explained
- Problem Addressed: The patent addresses the difficulty of placing pacing leads into the coronary sinus, a critical step for certain cardiac therapies. This difficulty is exacerbated in patients with congestive heart failure, whose cardiac anatomy may be altered, making navigation with conventional catheters challenging (ʼ268 Patent, col. 1:59-64; col. 2:1-14).
- The Patented Solution: The invention is a “double catheter” system. It features a relatively stiff, pre-shaped outer catheter that provides torque control and support, and a more pliable, softer inner catheter that slides within the outer one (ʼ268 Patent, col. 3:9-16). This telescoping design allows a physician to extend the softer inner catheter to navigate the tortuous coronary sinus anatomy while the outer catheter provides a stable anchor. The system also includes a mechanism, operated from the handle, to actively change the curvature of the outer catheter’s distal tip (ʼ268 Patent, Abstract; col. 3:55-65).
- Technical Importance: This design sought to improve the success rate and efficiency of placing left ventricular pacing leads, which is a key component of cardiac resynchronization therapy for heart failure patients (ʼ268 Patent, col. 1:31-41).
Key Claims at a Glance
- The complaint asserts infringement of independent Claim 1.
- The essential elements of Claim 1 are:
- An outer, resilient catheter with shape memory and a hook-shaped distal end with at least one curved bend.
- An inner, pliable catheter that is slidably disposed in and longer than the outer catheter, allowing it to be extended or retracted. The inner catheter has a lumen for introducing contrast media and a pacing lead.
- A mechanism operable from the proximal end of the outer catheter for changing the curvature of its distal end.
III. The Accused Instrumentality
Product Identification
- Product Identification: Defendant’s “Acuity” mark catheter, described as a “telescoping catheter system” (Compl. ¶8).
Functionality and Market Context
- Functionality and Market Context: The complaint alleges the Acuity catheter is a double catheter system. Its functionality is described as including an outer, resilient catheter with shape memory and a hook-shaped distal end for cannulation of the coronary sinus (Compl. ¶10). It is also alleged to include an inner, pliable catheter that is slidably disposed within the outer catheter and can be extended or retracted to vary the overall length (Compl. ¶12). The complaint does not provide detail on the market context of the product beyond its use for cannulating the coronary sinus.
IV. Analysis of Infringement Allegations
’268 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| an outer, resilient catheter having shape memory and a hook shaped distal end configured for cannulation of the coronary sinus with at least one curved bend; | The Acuity catheter is alleged to include an outer, resilient catheter with shape memory and a hook-shaped distal end with at least one curved bend. | ¶10 | col. 6:62-65 |
| an inner, pliable catheter slidably disposed in the outer catheter and of greater length than the outer catheter so that a distal end portion of the inner catheter can be extended or retracted from a distal end opening of the outer catheter to vary the overall length of the double catheter... | The Acuity catheter is alleged to have an inner, pliable catheter slidable within the outer catheter, allowing it to be extended or retracted. A diagram included in the complaint illustrates this telescoping configuration. | ¶12 | col. 7:1-4 |
| ...the inner catheter having an internal lumen configured for the introduction of contrast media and a pacing lead into the coronary sinus; and | The inner catheter of the accused product is alleged to have a lumen for introducing contrast media and a pacing lead. | ¶14 | col. 7:4-6 |
| a mechanism operable from the proximal end of the outer catheter for changing the curvature of the distal end of the outer catheter. | The Acuity catheter is alleged to include a mechanism, operable from the proximal end, for changing the curvature of the distal end of the outer catheter. The complaint provides no further detail on the structure or operation of this alleged mechanism. | ¶16 | col. 7:7-10 |
- Identified Points of Contention:
- Structural Questions: The complaint alleges, on "information and belief," that the Acuity catheter possesses a "mechanism operable from the proximal end...for changing the curvature" (Compl. ¶¶15-16). The patent specification discloses a specific corresponding structure: a torque screw connected to a pull-wire embedded in the catheter wall (ʼ268 Patent, col. 3:55-65). A central question will be what structure, if any, performs this function in the accused product and whether it is the same as or equivalent to the structure disclosed in the patent. The complaint’s lack of detail on this element suggests it will be a key area of discovery and dispute.
- Scope Questions: The claim requires a "hook shaped distal end." The patent illustrates a specific multi-bend geometry (ʼ268 Patent, Fig. 2; col. 4:8-17). The litigation may raise the question of whether this term is limited to the specific shapes disclosed in the embodiments or if it can be construed more broadly to cover other curved-tip catheter designs.
V. Key Claim Terms for Construction
The Term: "a mechanism operable from the proximal end of the outer catheter for changing the curvature of the distal end of the outer catheter"
Context and Importance: This functional language is critical because infringement will depend on the structure in the accused device that performs this function. Practitioners may focus on this term because its construction will determine whether the claim is limited to the specific pull-wire system disclosed in the patent or could cover a wider range of steering technologies.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language itself is functional and does not recite a specific structure, which a plaintiff may argue supports a construction that is not limited to the disclosed embodiment.
- Evidence for a Narrower Interpretation: The specification discloses a single, specific structure corresponding to this function: "A torque screw 29 is attached to a cable or wire 31 that runs in the wall of outer catheter 11...Rotation of torque screw 29 causes cable 31 to be retracted, which changes the shape of the outer catheter 11" (ʼ268 Patent, col. 3:57-63). A defendant is likely to argue that this detailed disclosure limits the scope of the functional claim language to this structure and its equivalents.
The Term: "hook shaped distal end"
Context and Importance: The definition of "hook shaped" will determine the geometric scope of the patent's protection. The dispute may center on whether the accused Acuity catheter’s shape falls within a proper construction of this term.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term is not explicitly defined in the patent, which may support giving it a plain and ordinary meaning that could encompass a variety of catheters with a curved distal tip.
- Evidence for a Narrower Interpretation: The specification describes the "hook-shaped distal end" as comprising "substantially straight segments spanning three bends" with specific angular ranges (ʼ286 Patent, col. 4:8-17). Figures 1 and 2 depict this specific "question mark shape" (ʼ286 Patent, col. 4:29-32). A defendant may argue these specific descriptions and figures limit the term to a geometry with these particular characteristics.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement by asserting that Defendant "encouraged the end users to use the Infringing Product" (Compl. ¶23). It also alleges contributory infringement by stating that the product "is not a commonly available item with substantial non-infringing uses" and was made or adapted for a known infringing use (Compl. ¶¶25-26).
- Willful Infringement: The complaint alleges willful infringement based on the assertion that "BSC was aware of the '268 patent prior to the filing of this lawsuit" (Compl. ¶21, 27).
VII. Analyst’s Conclusion: Key Questions for the Case
- A primary issue will be one of structural correspondence: Does the accused Acuity catheter contain a "mechanism...for changing the curvature" that is structurally identical or equivalent to the specific pull-wire and torque-screw assembly disclosed in the '268 patent’s specification? The complaint’s conclusory allegation on this point suggests this will be a central evidentiary battleground.
- A second core issue will be one of definitional scope: How narrowly will the term "hook shaped distal end" be construed? The case may turn on whether the term is limited to the specific multi-bend, "question mark" geometry detailed in the patent's embodiments or if it covers a broader range of curved-tip catheter designs, including that of the accused product.