DCT
0:17-cv-05095
Niazi Licensing Corp v. Medtronic Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Niazi Licensing Corporation (Washington)
- Defendant: Medtronic, Inc. (Minnesota)
- Plaintiff’s Counsel: Madia Law LLC; Boyle Fredrickson, S.C.
- Case Identification: Niazi Licensing Corporation v. Medtronic, Inc., 0:17-cv-05095, D. Minn., 11/13/2017
- Venue Allegations: Venue is asserted on the basis that Defendant Medtronic, Inc. is incorporated and headquartered in the District of Minnesota.
- Core Dispute: Plaintiff alleges that Defendant’s "Attain" brand of telescoping catheter systems infringes a patent related to a double catheter assembly for cannulating the coronary sinus of a human heart.
- Technical Context: The technology relates to specialized medical devices used to guide and place pacing leads within the heart's venous system, a critical procedure in cardiac resynchronization therapy for patients with congestive heart failure.
- Key Procedural History: The complaint alleges that the Defendant was aware of the patent-in-suit prior to the lawsuit's filing, which forms the basis for the allegations of willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 2000-04-07 | U.S. Patent 6,638,268 Priority Date |
| 2003-10-28 | U.S. Patent 6,638,268 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," issued October 28, 2003
The Invention Explained
- Problem Addressed: The patent’s background section describes the difficulty of delivering pacing leads into the coronary sinus, particularly in patients with congestive heart failure whose cardiac anatomy may be altered. (’268 Patent, col. 1:56-65). It notes a lack of "presently available preformed catheters that will slip easily into the coronary sinus" to perform this procedure. (’268 Patent, col. 1:43-46).
- The Patented Solution: The invention is a "double catheter" system designed to overcome these challenges. It combines a relatively stiff, pre-shaped outer catheter that provides torque control and support with a softer, more pliable inner catheter that slides within the outer one. (’268 Patent, col. 3:10-18). This telescoping design allows a physician to adjust the device's overall length and flexibility, enabling the stiff outer catheter to provide the necessary support for manipulation while the soft inner catheter navigates the "torturous course of a coronary sinus." (’268 Patent, col. 3:23-25). The system also features a mechanism, such as the cable and torque screw shown in Figure 1, to actively change the curvature of the outer catheter’s tip from its proximal end. (’268 Patent, Abstract; col. 3:55-65).
- Technical Importance: This design sought to create a single, integrated system that could cannulate the coronary sinus, perform an angiogram, provide backup support for lead introduction, and reduce the number of steps and manipulations required for lead placement. (’268 Patent, col. 2:31-41).
Key Claims at a Glance
- The complaint asserts independent Claim 1. (Compl. ¶7).
- 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 slidable within the outer catheter, is longer than the outer catheter to allow for extension and retraction, and 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: The accused products are Medtronic’s telescoping catheter systems sold under the "Attain" mark. (Compl. ¶8). The complaint specifically identifies the "Attain Command catheter" as the outer catheter and the "Attain Select II catheter" as the inner catheter. (Compl. ¶¶10, 12).
- Functionality and Market Context: The complaint alleges the Attain system functions as a double catheter for cannulating the coronary sinus. (Compl. ¶¶9-10). The outer "Attain Command" catheter is alleged to be resilient, possess shape memory, and have a hook-shaped distal end with a curved bend. (Compl. ¶10). A diagram in the complaint illustrates various configurations of the accused outer catheter, highlighting its curved bend. (Compl. p. 3). The inner "Attain Select II" catheter is alleged to be pliable, slidable, and longer than the outer catheter, allowing it to be extended or retracted. (Compl. ¶12). A separate diagram depicts the accused inner catheter. (Compl. p. 4). The complaint further alleges the inner catheter has a lumen for contrast media and pacing leads and that the system includes a mechanism for changing the curvature of the outer catheter's distal end. (Compl. ¶¶14, 16). The complaint does not provide specific details on the product's market positioning.
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 accused Attain catheter includes an outer, resilient "Attain Command catheter" with shape memory and a hook-shaped distal end with at least one curved bend, configured for cannulation of the coronary sinus. | ¶¶9-10 | col. 9:60-64 |
| 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... to vary the overall length of the double catheter... | The accused Attain catheter includes an inner, pliable "Attain Select II catheter" slidably disposed in the outer catheter. It is longer than the outer catheter, allowing its distal end to be extended or retracted to vary the double catheter's overall length. | ¶¶11-12 | col. 9:65 - 10:2 |
| ...the inner catheter having an internal lumen configured for the introduction of contrast media and a pacing lead into the coronary sinus | The inner catheter of the accused Attain catheter includes a lumen configured for the introduction of contrast media and a pacing lead into the coronary sinus. | ¶¶13-14 | col. 10:2-4 |
| a mechanism operable from the proximal end of the outer catheter for changing the curvature of the distal end of the outer catheter | The accused Attain catheter includes a mechanism operable from the proximal end of the outer catheter for changing the curvature of the distal end of the outer catheter. | ¶¶15-16 | col. 10:5-8 |
- Identified Points of Contention:
- Scope Questions: The complaint’s allegations map directly onto the elements of Claim 1. A potential point of contention may arise over the scope of the term "hook shaped distal end". The patent specification describes specific multi-bend geometries, including a "question mark shape" with defined angle ranges for its curves. (’268 Patent, col. 4:8-17, col. 4:29-32). The litigation may therefore raise the question of whether the shape of the accused Attain Command catheter falls within the scope of the term as construed in light of these specific embodiments.
- Technical Questions: The complaint alleges the existence of a "mechanism... for changing the curvature" but provides no technical detail on its structure or operation. (’268 Patent, col. 10:5-8; Compl. ¶16). The patent discloses a specific cable-and-spool mechanism to perform this function. (’268 Patent, col. 3:55-65). A central technical question will be what evidence demonstrates that the accused product's deflection mechanism functions in a manner covered by the claim, either literally or under the doctrine of equivalents.
V. Key Claim Terms for Construction
The Term: "hook shaped distal end"
- Context and Importance: This term is fundamental to the structural definition of the outer catheter. Its construction will be critical in determining whether the specific geometry of the accused Attain Command catheter infringes the claim. Practitioners may focus on this term because the patent's specification provides more detailed geometric descriptions than the claim language itself.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The plain language of Claim 1 requires only a "hook shaped" end with "at least one curved bend", without specifying angles or the number of bends, which may support a construction covering a wide variety of curved-tip catheters. (’268 Patent, col. 9:62-64).
- Evidence for a Narrower Interpretation: The specification describes a preferred embodiment as having a distal end with "substantially straight segments spanning three bends" and characterizes one configuration as a "question mark shape." (’268 Patent, col. 4:8-17, 4:29-32). This disclosure of a specific, complex geometry could be used to argue for a narrower construction that limits the claim scope to such multi-bend configurations.
The Term: "mechanism operable from the proximal end... for changing the curvature"
- Context and Importance: This functional limitation is a key feature of the claimed invention. As the complaint does not describe how the accused mechanism works, the construction of this term will define the universe of structures that can meet this element, which will be central to the infringement analysis.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim uses the general term "mechanism" without reciting any specific components like a "cable," "wire," or "screw." (’268 Patent, col. 10:5-8). This may support a broad functional interpretation covering any structure at the proximal end that causes the distal tip to change its curvature.
- Evidence for a Narrower Interpretation: The only embodiment disclosed in the specification for performing this function is a "torque screw" connected to a "cable or wire" that runs through the catheter wall to the distal end. (’268 Patent, col. 3:55-65, Fig. 1). An argument may be made that the scope of "mechanism" should be tethered to this disclosed structure and its equivalents, potentially excluding technologically dissimilar deflection systems.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement. (Compl. ¶20). The inducement claim is based on the allegation that Medtronic "encouraged the end users to use the Infringing Product." (Compl. ¶23). The contributory infringement claim is based on allegations that Medtronic knew the product was adapted for an infringing use and that it is not a staple article of commerce with substantial non-infringing uses. (Compl. ¶¶25-26).
- Willful Infringement: The complaint alleges that Medtronic has willfully infringed the ’268 patent based on the assertion that "Medtronic was aware of the ‘268 patent prior to the filing of this lawsuit." (Compl. ¶21). Plaintiff seeks enhanced damages and a finding that the case is exceptional, entitling it to attorneys' fees. (Compl. ¶¶27-29).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "hook shaped distal end," as used in Claim 1, be construed broadly to cover catheters with a simple curve, or is its meaning limited by the more complex, multi-bend "question mark shape" embodiments detailed in the patent's specification? The resolution of this question will be pivotal in determining if the accused "Attain" catheter's geometry meets this limitation.
- A key evidentiary question will be one of structural and functional correspondence: does the accused product's mechanism for changing the catheter's curvature operate in a way that is covered by the claims? The case will likely require a detailed technical comparison between the unspecified mechanism in the Attain system and the patent's disclosed cable-and-spool embodiment to determine literal infringement or infringement under the doctrine of equivalents.
- A central factual dispute will revolve around pre-suit knowledge and intent: what evidence will establish that Medtronic was aware of the ’268 patent prior to the suit, as alleged, and what actions, if any, did it take in response to that knowledge? The answers will be determinative for the plaintiff's claims of willful infringement and its request for enhanced damages.