DCT
3:17-cv-00185
Niazi Imran v. Biotronik Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Imran Niazi (Wisconsin)
- Defendant: Biotronik, Inc. (Delaware)
- Plaintiff’s Counsel: Boyle Fredrickson, S.C.
- Case Identification: 3:17-cv-00185, W.D. Wis., 03/10/2017
- Venue Allegations: Plaintiff alleges venue is proper because Defendant regularly conducts business in the district, including selling or offering for sale products that allegedly infringe the patent-in-suit.
- Core Dispute: Plaintiff alleges that Defendant’s Selectra brand telescoping catheter system infringes a patent related to double catheters used for cannulating the coronary sinus of a human heart.
- Technical Context: The technology concerns specialized medical catheters designed to navigate the complex and variable anatomy of the coronary sinus, primarily for placing cardiac pacing leads as part of heart failure treatment.
- Key Procedural History: The complaint does not mention any prior litigation, Inter Partes Review (IPR) proceedings, or licensing history related to the patent-in-suit.
Case Timeline
| Date | Event |
|---|---|
| 2000-04-07 | U.S. Patent 6,638,268 Priority Date |
| 2003-10-28 | U.S. Patent 6,638,268 Issued |
| 2017-03-10 | Complaint Filed |
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 describes the difficulty of cannulating the coronary sinus, a critical step for placing pacing leads to treat conditions like congestive heart failure. It notes that the anatomy of the coronary sinus can be highly variable and tortuous, especially in heart failure patients, and that previously available catheters were not well-suited for this purpose, making lead delivery difficult (’268 Patent, col. 1:53-64).
- The Patented Solution: The invention is a "double catheter" system. It combines a relatively stiff, pre-shaped outer catheter providing torque control and support with a more pliable, soft inner catheter that slides within the outer one (’268 Patent, col. 3:10-15). This design allows a physician to adjust the overall length and stiffness of the device, providing the rigidity needed to navigate to the target area and the softness needed to advance safely through tortuous vessels (’268 Patent, col. 3:15-24; Abstract). The outer catheter's curvature can also be adjusted from its proximal end to aid insertion (’268 Patent, Abstract).
- Technical Importance: This telescoping design sought to provide a more adaptable and reliable system for placing pacing leads in the coronary sinus, a key procedure for cardiac resynchronization therapy, which was an area of growing focus at the time (’268 Patent, col. 1:32-41).
Key Claims at a Glance
- The complaint asserts Independent Claim 1 (’268 Patent, col. 6:61–col. 7:8; Compl. ¶7).
- The essential elements of Independent Claim 1 include:
- 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 the outer catheter and is longer than the outer catheter, allowing it to be extended or retracted.
- The inner catheter has an internal 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 the outer catheter's distal end.
III. The Accused Instrumentality
Product Identification
- The accused product is a "telescoping catheter system" sold by Biotronik under the "Selectra" mark (Compl. ¶8).
Functionality and Market Context
- The complaint alleges the Selectra catheter is a medical device for cannulating the coronary sinus (Compl. ¶10). It is described as having an outer, resilient catheter with a curved, hook-shaped distal end, and an inner, pliable catheter that is slidably disposed within the outer catheter (Compl. ¶9-12). The complaint includes a product image that labels an "Outer catheter" and its "Curved bend" (Compl. p. 3). A separate image illustrates that the "Inner catheter" has a "Greater length than outer catheter" (Compl. p. 4). The complaint further alleges the inner catheter contains a lumen for introducing contrast media and a pacing lead (Compl. ¶14), and that the system includes a mechanism for changing the curvature of the outer catheter's distal end (Compl. ¶16). The complaint does not provide details on the product's market position.
IV. Analysis of Infringement Allegations
U.S. Patent No. 6,638,268 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 Selectra catheter includes an outer, resilient catheter with shape memory and a hook-shaped distal end with a curved bend for cannulation of the coronary sinus, as depicted in a product image. | ¶¶9-10 | col. 2:18-21 |
| 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... | The Selectra catheter includes an inner, pliable catheter slidably disposed in the outer catheter. It is longer than the outer catheter, allowing it to be extended or retracted from the distal end. | ¶¶11-12 | col. 2:21-25 |
| 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 Selectra catheter has a lumen configured for introducing contrast media and a pacing lead. | ¶¶13-14 | col. 2:25-28 |
| a mechanism operable from the proximal end of the outer catheter for changing the curvature of the distal end of the outer catheter | The Selectra catheter is alleged, upon information and belief, to include a mechanism operable from its proximal end for changing the curvature of the outer catheter's distal end. | ¶¶15-16 | col. 2:28-31 |
- Identified Points of Contention:
- Technical Questions: The complaint's allegation regarding the "mechanism...for changing the curvature" is stated "upon information and belief" and lacks any specific factual support, such as images or product descriptions detailing how this mechanism operates (Compl. ¶16). A primary point of contention will be whether the accused Selectra catheter actually incorporates such a feature and, if so, how it functions. The plaintiff will bear the burden of proving this element through discovery.
- Scope Questions: The interpretation of "mechanism... for changing the curvature" may become a central issue. The patent discloses embodiments including a cable-and-pulley system operated by a torque screw (’268 Patent, col. 4:55-64) and a telescoping system where inserting an obturator changes the outer catheter's shape (’268 Patent, col. 6:6-18). The case may turn on whether the term is construed broadly to cover any means of altering curvature or is limited to structures similar to those explicitly described in the specification.
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 term defines a key functional feature of the invention that distinguishes it from a simple, static pre-curved catheter. The infringement analysis for this limitation is currently supported only by a conclusory allegation in the complaint (Compl. ¶15-16). Practitioners may focus on this term because its construction will dictate the type of evidence required to prove infringement and could be dispositive if the accused product achieves variable curvature through a method outside the construed scope of the claim.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim uses the general term "mechanism" without specifying a particular structure. A plaintiff may argue this term should be given its plain and ordinary meaning, covering any structure that performs the stated function of changing the distal end's curvature from the proximal end.
- Evidence for a Narrower Interpretation: A defendant may argue that the scope of "mechanism" is informed or limited by the embodiments disclosed in the specification. These include a specific mechanical system with a "torque screw 29... attached to a cable or wire 31" that retracts to change the catheter's shape (’268 Patent, col. 4:55-64) and a "three-part telescoping embodiment" where the insertion of an obturator alters the curvature (’268 Patent, col. 6:6-18). A defendant could argue these examples define the scope of the claimed "mechanism."
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement, stating that Biotronik "encouraged the end users to use the Infringing Product" (Compl. ¶23). It also alleges contributory infringement, stating that the product is not a "commonly available item with substantial non-infringing uses" and was adapted for an infringing use (Compl. ¶25-26). These allegations are not supported by specific facts, such as references to user manuals or marketing materials.
- Willful Infringement: The complaint alleges willful infringement based on the assertion that "Biotronik was aware of the ‘268 patent prior to being put on notice by Niazi" (Compl. ¶21, ¶27). No specific facts are provided to support this allegation of pre-suit knowledge.
VII. Analyst’s Conclusion: Key Questions for the Case
The resolution of this dispute will likely depend on the answers to two central questions:
A key evidentiary question will be one of technical proof: Can the Plaintiff, through discovery, produce evidence that the accused Selectra catheter contains the specific "mechanism operable from the proximal end... for changing the curvature" required by Claim 1? The complaint's conclusory allegation for this element suggests this may be a focal point of discovery and dispute.
A core issue will be one of claim scope: How will the court construe the term "mechanism"? Whether this term is given a broad functional definition or is limited to structures analogous to the cable-and-pulley or telescoping obturator systems described in the patent will be critical in determining whether the accused product infringes.