DCT
1:21-cv-02291
Iftikhar Khan v. Cryolife Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Nazir Khan and Iftikhar Khan (Illinois), acting pro se
- Defendant: Cryolife Inc and Hemosphere (jurisdictions not specified)
- Plaintiff’s Counsel: Pro Se
- Case Identification: 1:21-cv-02291, N.D. Ga., 06/01/2021
- Venue Allegations: The complaint does not specify the basis for venue in the Northern District of Georgia.
- Core Dispute: Plaintiffs allege that Defendants’ HeRo Graft, a medical device for hemodialysis access, infringes a patent related to a hybrid arteriovenous shunt system.
- Technical Context: The technology concerns surgically implanted devices that provide long-term vascular access for patients with chronic renal failure who require routine hemodialysis.
- Key Procedural History: The complaint discloses a prior lawsuit filed by the same plaintiffs in the Northern District of Illinois in 2018, which was dismissed with prejudice on grounds of improper venue and service. That dismissal was affirmed by the U.S. Court of Appeals for the Federal Circuit in 2020.
Case Timeline
| Date | Event |
|---|---|
| 2004-03-29 | ’344 Patent Priority Date |
| 2008-12-01 | Hemosphere Inc. allegedly begins selling the accused HeRo graft |
| 2012-05-15 | Cryolife Inc. acquires the HeRo graft from Hemosphere Inc. |
| 2014-06-10 | U.S. Patent No. 8,747,344 Issues |
| 2018-08-07 | Plaintiffs file prior infringement lawsuit in N.D. Illinois |
| 2020-08-13 | Federal Circuit affirms dismissal of prior lawsuit |
| 2021-06-01 | 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 (’344 Patent)
The Invention Explained
- Problem Addressed: The patent’s background section describes that conventional arteriovenous (AV) grafts for hemodialysis suffer from a high failure rate—nearly 80%—due to damage to vein walls caused by high-pressure blood returning from the dialysis machine, leading to complications like neointimal hyperplasia and clotting (’344 Patent, col. 1:30-44).
- The Patented Solution: The invention proposes a "hybrid" shunt system that avoids direct anastomosis to a vein. It uses a flexible arterial graft connected to a venous outflow catheter, which is inserted through a vein and terminates directly in the patient's right atrium. This configuration is designed to deposit the purified, high-pressure blood into the heart, bypassing and thus protecting the more fragile vein walls from damage (’344 Patent, Abstract; col. 2:12-20). A key component is a cuff that connects the arterial graft to the venous catheter (’344 Patent, Fig. 1).
- Technical Importance: This approach seeks to improve the long-term patency and reduce the infection and clotting risks associated with traditional hemodialysis access methods (’344 Patent, col. 2:15-20).
Key Claims at a Glance
- The complaint asserts independent claim 13 (’344 Patent, col. 7:20-40).
- The essential elements of claim 13, presented as a "means-plus-function" claim, are:
- An arteriovenous shunt means comprising:
- an arterial graft means for subcutaneous connection to an artery.
- a single lumen venous outflow catheter means for insertion through a vein into the right atrium of the heart.
- a cuff means comprising an inlet and an outlet, wherein the cuff is "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 other claims.
III. The Accused Instrumentality
Product Identification
- The "HeRo Graft" vascular access device (Compl. ¶12).
Functionality and Market Context
- The complaint describes the HeRo Graft as a device with three primary components: an arterial graft, a "metallic connector," and a venous outflow catheter that is placed into the right atrium of the heart (Compl. ¶12). A photograph included in the complaint shows these three components assembled for implantation (Compl. p. 19). The device's alleged function is identical to that of the claimed invention: to create a subcutaneous circuit for hemodialysis by taking blood from an artery and returning purified blood to the right atrium (Compl. ¶13). The complaint alleges Hemosphere began selling the device in December 2008 and that Cryolife acquired it on May 15, 2012 (Compl. ¶4).
IV. Analysis of Infringement Allegations
The complaint alleges literal infringement of claim 13 under the framework for means-plus-function claims (35 U.S.C. § 112, para. 6), arguing that the accused device's connector is structurally equivalent to the patent's claimed "cuff means" (Compl. ¶¶18-19, 21).
’344 Patent Infringement Allegations
| Claim Element (from Independent Claim 13) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| an arterial graft means... | The HeRo Graft includes an arterial graft, which the complaint states is 6 mm in diameter (Compl. ¶12). | ¶12 | col. 4:30-34 |
| a-single lumen venous outflow catheter means... operable for insertion through a vein into the right atrium of the heart... | The HeRo Graft includes a venous outflow catheter that "goes into the right atrium of the heart" (Compl. ¶12). | ¶12 | col. 4:46-59 |
| a cuff means... wherein: 1. said cuff is disposed about said terminal end of said subcutaneous graft; and 2. said cuff is disposed 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 (Compl. ¶12). | ¶12 | col. 4:60-64 |
| a hemodialysis apparatus. | The complaint alleges the HeRo Graft is used as part of a hemodialysis system (Compl. ¶13). | ¶13 | col. 5:46-52 |
- Identified Points of Contention:
- Scope Questions: The central dispute appears to be whether the accused "metallic connector," which is allegedly "disposed in" the graft and catheter, is a structural equivalent to the claimed "cuff means," which the claim requires to be "disposed about" the graft and catheter. This raises the question of whether the claim term "disposed about" mandates a specific external structural configuration that is absent in the accused device.
- Technical Questions: The complaint explicitly notes the structural difference in the connector's placement—"in" versus "about" (Compl. ¶12). A key technical question will be what structural characteristics, beyond the function of connecting the two components, are disclosed in the ’344 Patent for the "cuff means." The patent's Figure 1 shows the cuff (13) as an external component fitting over the graft (11) and catheter (12) (Compl., p. 20; ’344 Patent, Fig. 1). The complaint includes a diagram of the accused HeRo device that shows a connector linking the graft and catheter, seemingly internally (Compl., Ex. A, Fig. 3, p. 18).
V. Key Claim Terms for Construction
- The Term: "cuff means"
- Context and Importance: This term is the lynchpin of the infringement case. As a means-plus-function limitation, its scope is defined by the corresponding structure described in the specification and its equivalents. The dispute will center on whether the accused device's "metallic connector" is an equivalent to the structure disclosed for the "cuff means." Practitioners may focus on this term because the complaint admits a structural difference in placement ("disposed in" vs. "disposed about") but argues for functional identity (Compl. ¶12).
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party could argue that the primary structure disclosed is any component that performs the function of securely connecting the graft and catheter to transmit blood. The specification states, "The single lumen venous outflow catheter is connected to the graft by surgical anastomosis over a cuff 13" (’344 Patent, col. 4:60-62), potentially focusing on the connecting function over the precise physical arrangement.
- Evidence for a Narrower Interpretation: The claim language itself requires the cuff to be "disposed about" both the graft and the catheter (’344 Patent, col. 7:32-35). This language, combined with the depiction in Figure 1 where the cuff (13) clearly encircles the other components, suggests a specific external structure. A party may argue this explicit language and depiction limit the scope of equivalents to structures that are similarly arranged externally.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement by stating that Defendants sold the component parts of the HeRo Graft to hospitals, enabling physicians to assemble and implant the allegedly infringing device into patients (Compl. ¶27).
- Willful Infringement: The complaint alleges "intentional copying and willful infringement," asserting that Defendants' own assigned patents describe devices where the catheter remains in the vein. The pleading suggests that by manufacturing a device where the catheter terminates in the right atrium, Defendants willfully copied the novel aspect of the Plaintiffs’ invention (Compl. ¶28).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of structural equivalence: Under the means-plus-function framework, is the accused HeRo Graft's internal "metallic connector" an equivalent to the patent's disclosed external "cuff"? The resolution may depend on whether the claim limitation "disposed about" is interpreted as a strict structural requirement or merely as descriptive of one embodiment of a connector.
- A key evidentiary question will be one of functional identity: While the complaint alleges the function of the two connectors is identical—transmitting blood—the analysis may examine whether the different structural arrangements ("in" versus "about") result in any insubstantial differences in the way that function is performed, which could defeat a finding of § 112(f) equivalence.
- A threshold procedural question is whether this action is barred by the preclusive effect of the prior lawsuit's dismissal "with prejudice" on venue grounds, a topic raised by the complaint itself but not reconciled with the current filing in a new forum.