DCT
0:17-cv-01969
Qxmedical LLC v. Vascular Solutions LLC
Key Events
Amended Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: QXMédical, LLC (Delaware)
- Defendant: Vascular Solutions, LLC (Minnesota), Teleflex Life Sciences Limited (Malta), Arrow International, Inc. (Pennsylvania), and Teleflex LLC (Delaware)
- Plaintiff’s Counsel: Anthony Ostlund Baer & Louwagie PA.
- Case Identification: 0:17-cv-01969, D. Minn., 04/24/2020
- Venue Allegations: Plaintiff alleges venue is proper in the District of Minnesota because Defendant Vascular Solutions, LLC is a Minnesota resident, the Defendants have systematic contacts with the state, and the claims arise from those contacts.
- Core Dispute: Plaintiff seeks a declaratory judgment that its "Boosting Catheter" product does not infringe six patents owned by Defendants related to coaxial guide catheters used in interventional cardiology.
- Technical Context: The technology involves specialized catheters designed to provide additional "backup support" during procedures like stenting, preventing the primary guide catheter from being dislodged from a coronary artery.
- Key Procedural History: The dispute arose from pre-suit correspondence in 2017, where Defendants' counsel accused Plaintiff's product of infringing the patents-in-suit and alleged that the product was a "blatant and obvious" copy of Defendants' patented GuideLiner catheter product. This correspondence forms the basis for the "actual controversy" required for a declaratory judgment action. The patents-in-suit have been subject to multiple Inter Partes Review (IPR) proceedings, resulting in the cancellation and modification of numerous claims, including some originally asserted in this case family.
Case Timeline
| Date | Event |
|---|---|
| 2006-05-03 | Earliest Priority Date for all Patents-in-Suit |
| 2011-11-01 | U.S. Patent No. 8,048,032 Issues |
| 2012-03-27 | U.S. Patent No. 8,142,413 Issues |
| 2015-02-17 | U.S. Patent No. RE45,380 Reissues |
| 2015-10-20 | U.S. Patent No. RE45,760 Reissues |
| 2015-10-27 | U.S. Patent No. RE45,776 Reissues |
| 2016-08-23 | U.S. Patent No. RE46,116 Reissues |
| 2017-04-12 | Defendants' counsel sends letter to Plaintiff asserting likely infringement |
| 2017-04-18 | Plaintiff responds to Defendants, denying infringement |
| 2017-05-30 | Defendants' counsel sends second letter asserting infringement of four reissue patents |
| 2020-04-24 | Complaint for Declaratory Judgment Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,048,032 - Coaxial Guide Catheter for Interventional Cardiology Procedures (Issued Nov. 1, 2011)
The Invention Explained
- Problem Addressed: During interventional cardiology procedures, such as placing a stent, physicians advance instruments through a primary guide catheter that is seated in the opening (ostium) of a coronary artery. The backward force created when pushing these instruments through tough arterial lesions can dislodge the guide catheter, making the procedure difficult or impossible (’032 Patent, col. 1:35-40).
- The Patented Solution: The invention is a secondary, inner "coaxial guide catheter" designed to be delivered through a standard guide catheter. This inner catheter extends deeper into the coronary artery to provide enhanced anchoring, or "backup support." It is comprised of a flexible distal tip to allow for safe, "atraumatic" placement within the artery, and a more rigid proximal portion that acts as a rail, providing the stiffness needed to resist dislodgement forces (’032 Patent, col. 2:54-64, Abstract).
- Technical Importance: The technology aimed to provide the benefits of "deep seating" a catheter for superior support without the risks of arterial damage associated with using conventional, uniformly stiff guide catheters for that purpose (’032 Patent, col. 2:25-34).
Key Claims at a Glance
- The complaint asserts non-infringement of independent claims 1 and 11 (Compl. ¶14).
- Claim 1 Elements:
- A device for use with a standard guide catheter.
- A flexible tip portion defining a tubular structure with a circular cross-section and a specific length and diameter for insertion through the guide catheter.
- The flexible tip portion defines a coaxial lumen for interventional cardiology devices to pass through.
- A substantially rigid portion proximal to the flexible tip, defining a rail structure without a lumen.
- The rigid portion is more rigid than the flexible tip portion.
- The total length of the device is longer than the guide catheter, allowing the rigid portion to extend proximally out of the guide catheter's hemostatic valve.
- The complaint does not explicitly reserve the right to assert dependent claims but seeks a declaration of non-infringement on "any of the VSI Patents" (Compl. Prayer for Relief ¶1).
U.S. Patent No. 8,142,413 - Coaxial Guide Catheter for Interventional Cardiology Procedures (Issued Mar. 27, 2012)
The Invention Explained
- Problem Addressed: This patent, a divisional of the '032 Patent, addresses the same technical problem of providing adequate backup support to prevent guide catheter dislodgement during interventional cardiology procedures (’413 Patent, col. 1:40-45).
- The Patented Solution: The patent claims a method of providing backup support using a coaxial guide catheter system. The method involves inserting a standard guide catheter, positioning its distal end in a branch artery, and then inserting the claimed coaxial guide catheter (with its flexible tip and more rigid proximal portion) through the standard catheter to achieve a deeper, more stable position within the target artery (’413 Patent, col. 10:28-65).
- Technical Importance: The claimed method provides clinicians with a specific procedural framework for using a coaxial catheter system to overcome the challenges of crossing tough lesions in coronary arteries (’413 Patent, col. 2:50-56).
Key Claims at a Glance
- The complaint asserts non-infringement of independent claim 1 (Compl. ¶14).
- Claim 1 Elements (Method):
- Inserting a standard guide catheter into a first artery.
- Positioning the distal end of the standard guide catheter in a branch artery.
- Inserting a flexible tip portion of a coaxial guide catheter into the standard guide catheter.
- Further inserting a substantially rigid portion (proximal to the flexible tip) into the standard guide catheter.
- Advancing a distal portion of the flexible tip beyond the standard guide catheter's distal end and into the second artery.
- Inserting an interventional cardiology device through the standard guide catheter alongside the substantially rigid portion and through the lumen of the flexible tip portion.
- The complaint seeks a declaration of non-infringement on "any of the VSI Patents" (Compl. Prayer for Relief ¶1).
Multi-Patent Capsule: U.S. Patent No. RE45,380
- Patent Identification: U.S. Reissued Patent No. RE45,380, Coaxial Guide Catheter for Interventional Cardiology Procedures, issued Feb. 17, 2015.
- Technology Synopsis: This reissue patent relates to the same coaxial guide catheter technology, describing a system comprising a standard guide catheter and an inner device with a flexible tip and a more rigid proximal "rail structure." The claims focus on the structural and relational characteristics of this inner device.
- Asserted Claims: The complaint asserts non-infringement of independent claim 25 (Compl. ¶14).
- Accused Features: The entirety of the Plaintiff's Boosting Catheter product is accused, with the specific dispute centered on whether the product contains the claimed "substantially rigid portion" (Compl. ¶14, 18).
Multi-Patent Capsule: U.S. Patent No. RE45,760
- Patent Identification: U.S. Reissued Patent No. RE45,760, Coaxial Guide Catheter for Interventional Cardiology Procedures, issued Oct. 20, 2015.
- Technology Synopsis: This patent, also part of the same family, claims a coaxial guide catheter system. The claims specify different structural configurations and features of the inner catheter's rigid portion, which acts as a support rail.
- Asserted Claims: The complaint asserts non-infringement of independent claims 25, 48, 51, and 53 (Compl. ¶14).
- Accused Features: The Plaintiff's Boosting Catheter is accused, with the dispute focused on the absence of the claimed "substantially rigid segment" (Compl. ¶14, 21).
Multi-Patent Capsule: U.S. Patent No. RE45,776
- Patent Identification: U.S. Reissued Patent No. RE45,776, Coaxial Guide Catheter for Interventional Cardiology Procedures, issued Oct. 27, 2015.
- Technology Synopsis: Continuing the same theme, this patent claims a coaxial guide catheter system with particular emphasis on the properties and construction of the inner catheter's components, including its rigid support segment.
- Asserted Claims: The complaint asserts non-infringement of independent claims 25, 52, and 53 (Compl. ¶14).
- Accused Features: The Plaintiff's Boosting Catheter is accused, with the dispute focused on the absence of the claimed "substantially rigid segment" (Compl. ¶14, 24).
Multi-Patent Capsule: U.S. Patent No. RE46,116
- Patent Identification: U.S. Reissued Patent No. RE46,116, Coaxial Guide Catheter for Interventional Cardiology Procedures, issued Aug. 23, 2016.
- Technology Synopsis: This patent also claims a coaxial guide catheter system. Its claims further define the structural features of the inner catheter, including the "substantially rigid segment" that provides backup support.
- Asserted Claims: The complaint asserts non-infringement of independent claims 25, 43, 51, and 52 (Compl. ¶14).
- Accused Features: The Plaintiff's Boosting Catheter is accused, with the dispute focused on the absence of the claimed "substantially rigid segment" (Compl. ¶14, 27).
III. The Accused Instrumentality
Product Identification
Plaintiff's "Boosting Catheter" (Compl. ¶9).
Functionality and Market Context
The complaint describes the Boosting Catheter as a product used by physicians "in combination with a guiding catheter to help deliver an interventional device (e.g., a stent) to the coronary and peripheral vasculature of a patient" (Compl. ¶9). The complaint does not provide further technical details on the product's construction or mechanism of action, other than to assert that it lacks the "substantially rigid portion" or "segment" recited in the patents-in-suit (Compl. ¶14). Defendants' pre-suit correspondence alleges the product is a copy of its "patented GuideLiner catheter product" (Compl. ¶13).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
U.S. Patent No. 8,048,032 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a flexible tip portion defining a tubular structure having a circular cross-section... | The complaint does not provide sufficient detail for analysis of this element, but implies the Boosting Catheter is a device used with a guide catheter. | ¶9 | col. 10:30-38 |
| ...defining a coaxial lumen having a cross-sectional inner diameter through which interventional cardiology devices are insertable... | The complaint states the Boosting Catheter is used to help deliver interventional devices, which suggests it possesses a lumen for this purpose. | ¶9 | col. 10:36-38 |
| a substantially rigid portion proximal of and operably connected to... the flexible tip portion and defining a rail structure without a lumen... | Plaintiff explicitly denies that the Boosting Catheter has this element. | ¶14 | col. 10:39-42 |
| ...and more rigid along a longitudinal axis than, the flexible tip portion... | Plaintiff explicitly denies that the Boosting Catheter has the "substantially rigid portion," and therefore implicitly denies this comparative rigidity feature. | ¶14 | col. 10:40-41 |
| ...a total length of the device... that is longer than the length of the continuous lumen of the guide catheter... | The complaint does not provide sufficient detail for analysis of this element. | ¶14 | col. 10:44-48 |
U.S. Patent No. 8,142,413 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| inserting the standard guide catheter into a first artery... | This is a method step performed by a user; the complaint describes the Boosting Catheter as a product used in such procedures. | ¶9 | col. 10:37-40 |
| inserting a flexible tip portion of a coaxial guide catheter... into the continuous lumen of the standard guide catheter... | This is a method step performed by a user; the complaint describes the Boosting Catheter as being used "in combination with a guiding catheter." | ¶9 | col. 10:43-48 |
| further inserting a substantially rigid portion that is proximal of... the flexible tip portion, into the continuous lumen of the standard guide catheter... | Plaintiff's denial that its product has a "substantially rigid portion" is the basis for its assertion of non-infringement of this method claim. | ¶14 | col. 10:48-52 |
| inserting the interventional cardiology device... alongside of the substantially rigid portion and... through a lumen of the flexible tip portion... | Plaintiff's denial that its product has a "substantially rigid portion" is the basis for its assertion of non-infringement of this method claim. | ¶14 | col. 11:2-7 |
Identified Points of Contention
- Scope Questions: The central dispute, as framed by the complaint, is definitional. A court will need to determine the scope of the term "substantially rigid portion" (and its variant "substantially rigid segment"). The key question is whether this term requires a specific structure, such as the solid metal "rail structure without a lumen" described in claim 1 of the '032 patent, or if it can be construed more broadly to cover other structures that are merely "more rigid" than the catheter's flexible tip.
- Technical Questions: A primary factual question for the court will be whether the physical construction of the Plaintiff's Boosting Catheter includes a component that meets the legally construed definition of "substantially rigid portion." As the complaint provides no technical details of the accused product, this will depend entirely on evidence developed during discovery.
V. Key Claim Terms for Construction
- The Term: "substantially rigid portion" / "substantially rigid segment"
- Context and Importance: This term is the lynchpin of the dispute as articulated in the complaint (Compl. ¶14). Plaintiff's entire declaratory judgment action rests on the assertion that its product lacks a structure meeting this limitation. The scope given to this term will likely be dispositive of infringement for all six patents-in-suit.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claims often define the term relatively, stating the portion is "more rigid along a longitudinal axis than, the flexible tip portion" ('032 Patent, col. 10:40-41). This language may support an interpretation where "substantially rigid" is not an absolute property but is defined in comparison to another part of the same device, potentially capturing a wider range of materials and constructions.
- Evidence for a Narrower Interpretation: The specification discloses specific, highly rigid embodiments for this element, such as a "stainless steel or Nitinol tube" or "hypotube" (’032 Patent, col. 4:47-49; col. 6:37-39). Furthermore, claim 1 of the '032 patent explicitly recites the rigid portion as "defining a rail structure without a lumen." This specific description of a solid rail could be used to argue that the term requires a non-hollow, metallic structure, which would be a significantly narrower construction.
VI. Other Allegations
The complaint does not contain allegations of indirect or willful infringement, as it is a request for a declaratory judgment of non-infringement filed by the accused infringer.
VII. Analyst’s Conclusion: Key Questions for the Case
This case appears to center on a classic patent dispute involving claim construction and factual application. The key questions for the court will likely be:
- A core issue will be one of definitional scope: Does the term "substantially rigid portion," as used across the patent family, require a solid, metallic "rail structure" as described in specific embodiments and claims, or is it a relative term that can encompass any structure that is simply more rigid than the device's flexible tip? The outcome of this claim construction will define the infringement landscape.
- A key evidentiary question will be one of technical structure: As a matter of fact, what is the physical construction and material composition of the Plaintiff's Boosting Catheter? The resolution of the case will depend on whether that physical structure falls within the court's final construction of the critical "substantially rigid portion" limitation.