DCT
2:21-cv-00337
Khan v. Merit Medical Systems Inc
Key Events
Amended Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Nazir Khan, Iftikhar Khan (Illinois)
- Defendant: Merit Medical Systems INC (Utah)
- Plaintiff’s Counsel: Pro Se
- Case Identification: 2:21-cv-00337, D. Utah, 07/28/2021
- Venue Allegations: Venue is asserted based on the defendant, Merit Medical Systems INC., residing in the District of Utah.
- Core Dispute: Plaintiff alleges that Defendant’s HeRo Graft, a vascular access device for hemodialysis, infringes a patent related to a hybrid arteriovenous shunt system.
- Technical Context: The technology concerns medical devices designed to provide long-term, reliable vascular access for hemodialysis patients, a critical area for managing end-stage renal disease.
- Key Procedural History: The complaint notes that a prior lawsuit on the same patent (No. 1:18-cv-05368) was filed in the Northern District of Illinois and subsequently dismissed with prejudice on grounds of improper venue and service, a decision affirmed by the U.S. Court of Appeals for the Federal Circuit. The complaint also references the patent's prosecution history, stating that the invention was distinguished from prior art by, among other things, depositing purified blood directly into the right atrium of the heart.
Case Timeline
| Date | Event |
|---|---|
| 2004-03-29 | U.S. Patent No. 8,747,344 Priority Date |
| 2014-06-10 | U.S. Patent No. 8,747,344 Issue Date |
| 2016-02-04 | Merit Medical Systems INC. allegedly acquires HeRo Graft |
| 2018-08-07 | Plaintiff files prior lawsuit in N.D. Illinois |
| 2020-08-13 | Federal Circuit affirms dismissal of prior lawsuit |
| 2021-07-28 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,747,344 - Hybrid Arteriovenous Shunt, issued June 10, 2014
The Invention Explained
- Problem Addressed: The patent’s background section identifies a primary drawback of conventional arteriovenous (AV) grafts used for hemodialysis: high-pressure blood returning from the dialysis machine damages the patient's veins, leading to frequent clotting, blockages (neointimal hyperplasia), and ultimately, failure of the access site (’344 Patent, col. 1:47-59).
- The Patented Solution: The invention is a "hybrid" shunt system designed to circumvent this problem by avoiding a direct connection to a patient's vein for blood return (’344 Patent, col. 2:11-17). The system uses an arterial graft to draw blood, which is then connected via a special "cuff" to a venous outflow catheter; this catheter is routed through a vein directly into the right atrium of the heart, depositing the purified blood where the high pressure and flow will not damage delicate vessel walls (’344 Patent, Abstract; Fig. 1).
- Technical Importance: This approach seeks to improve the long-term viability (patency) of hemodialysis access sites by eliminating a common point of failure—the graft-to-vein connection—which is a significant source of morbidity for dialysis patients (’344 Patent, col. 5:61-68).
Key Claims at a Glance
- The complaint asserts independent system claim 13 (Compl. p. 11).
- The essential elements of independent claim 13 are:
- An arteriovenous shunt means comprising:
- an arterial graft means with a body, lead end, and terminal end;
- a single lumen venous outflow catheter means with an intake end and a depositing end operable for insertion into the right atrium of the heart;
- a cuff means disposed about the terminal end of the graft and the intake end of the catheter, providing a secure fit;
- A hemodialysis apparatus.
- An arteriovenous shunt means comprising:
- The complaint does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
Product Identification
- The accused product is the "HeRo Graft" (Compl. p. 6).
Functionality and Market Context
- The complaint alleges the HeRo Graft is a device used for hemodialysis that consists of three components: an arterial graft (6 mm diameter), a "metallic connector," and a venous outflow catheter (5 mm diameter) that is placed into the right atrium of the heart (Compl. p. 6).
- The complaint alleges that the function of the accused device is identical to the claimed invention: to create a circuit for hemodialysis where purified blood is returned directly to the right atrium (Compl. pp. 6-7). The complaint notes that Defendant acquired the HeRo Graft from CryoLife Inc. for $18.5 million in 2016 (Compl. p. 3).
IV. Analysis of Infringement Allegations
The complaint alleges infringement of Claim 13 under 35 U.S.C. § 112, paragraph 6 (now § 112(f)), asserting that the accused device is a "means plus function" equivalent to the claimed invention (Compl. p. 11). The central dispute concerns the "cuff means" element. The complaint includes a diagram comparing the claimed invention with the accused device. Exhibit A, Fig. 1 shows the patented cuff as an external component disposed around the graft and catheter, while Exhibit A, Fig. 3 shows the accused HeRO Graft's connector (Compl. pp. 18, 20).
’344 Patent Infringement Allegations
| Claim Element (from Independent Claim 13) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| an arterial graft means comprising a body, a lead end and a terminal end... | The HeRo Graft includes an arterial graft component, alleged to be 6 mm in diameter. | p. 6 | col. 4:30-34 |
| a-single lumen venous outflow catheter means comprising an intake end and depositing end, wherein said depositing end is operable for insertion...into the right atrium of the heart... | The HeRo Graft includes a venous outflow catheter, alleged to be 5 mm in diameter, that deposits blood into the right atrium. | p. 6 | col. 4:46-53 |
| a cuff means comprising an inlet and an outlet, wherein...said cuff is disposed about said terminal end of said subcutaneous graft; and...about said intake end of said venous outflow catheter... | The HeRo Graft contains a "metallic connector" that connects the arterial graft and the venous outflow catheter. The complaint alleges this is a structural equivalent that performs an identical function. | p. 6, 12 | col. 4:60-64 |
| a hemodialysis apparatus. | The HeRo Graft is used in conjunction with a dialysis machine to perform hemodialysis. | pp. 6-7 | col. 5:45-56 |
Identified Points of Contention
- Scope Questions: A primary issue is whether the accused HeRo Graft's internal "metallic connector" is a structural equivalent to the claimed "cuff means" under 35 U.S.C. § 112(f). The claim language specifies the cuff is "disposed about" the graft and catheter, which suggests an external configuration, whereas the complaint describes the accused connector as being "disposed within the lumen" (Compl. p. 12).
- Technical Questions: The analysis will question whether the structural difference between an external cuff and an internal connector is "insubstantial." The complaint provides a diagram of the claimed invention, which depicts an external cuff connecting the graft and catheter (Compl. p. 18, Ex. A, Fig. 1). Evidence regarding how each structure achieves the connection and maintains blood flow will be central to determining equivalence.
V. Key Claim Terms for Construction
- The Term: "cuff means"
- Context and Importance: This term is explicitly identified by the Plaintiff as a means-plus-function limitation under 35 U.S.C. § 112(f) (Compl. p. 11). Its construction will define the scope of the claimed invention. The infringement case hinges on whether the accused "metallic connector" is the same as or an equivalent to the structure disclosed in the '344 patent that corresponds to this function.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party might argue that the recited function—"connecting the graft and the venous outflow catheter" and providing a "secure fit"—is the key aspect, and any structure that achieves this function in a similar way could be considered an equivalent (’344 Patent, claim 13; col. 4:60-64).
- Evidence for a Narrower Interpretation: The specification's primary embodiment and Figure 1 clearly depict the "cuff" (13) as an external sleeve that fits over or around the ends of the graft (11) and catheter (12) (’344 Patent, Fig. 1). The claim language itself requires the cuff to be "disposed about" the other components, which may be construed to mean "surrounding" or "encircling," potentially excluding an internal connector.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement under 35 U.S.C. § 271(b), stating that Merit Medical sold the components of the HeRo Graft to hospitals with the intent that physicians would assemble and implant them into patients, thereby performing the claimed method (Compl. p. 14, Claim III).
- Willful Infringement: Willfulness is alleged based on "Intentional copying" (Compl. p. 14, Claim IV). The complaint asserts that Defendant was aware of the patented concept of depositing blood into the right atrium and chose to copy it for the HeRo Graft, distinguishing it from prior art associated with the Defendant (Compl. p. 15).
VII. Analyst’s Conclusion: Key Questions for the Case
This case appears to present two central questions for judicial determination:
A core issue will be one of claim scope under 35 U.S.C. § 112(f): Can the term "cuff means," which is described in the patent and depicted in its figures as an external sleeve "disposed about" the graft and catheter, be construed to cover the accused HeRo Graft's internal "metallic connector"?
A key evidentiary question will be one of structural equivalence: Assuming the function is identical, is the structural difference between an external cuff and an internal connector "insubstantial"? The resolution will likely depend on a detailed technical comparison of how each structure connects the components, affects blood flow, and contributes to the overall function of the shunt.