DCT
1:21-cv-02291
Iftikhar Khan v. Cryolife Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Nazir Khan, Iftikhar Khan (Illinois)
- Defendant: ARTIVION, Inc. (Georgia)
- Plaintiff’s Counsel: Pro Se
- Case Identification: 1:21-cv-02291, N.D. Ga., 09/01/2022
- Venue Allegations: The complaint does not contain a specific section outlining the basis for venue.
- Core Dispute: Plaintiffs allege that Defendant’s HeRO Graft, a medical device for hemodialysis access, infringes a patent related to a hybrid arteriovenous shunt.
- Technical Context: The technology concerns medical devices designed to provide durable, long-term vascular access for hemodialysis patients, addressing high failure rates associated with conventional methods.
- Key Procedural History: This amended complaint follows a court order. The complaint alleges that the defendant's predecessor had knowledge of the plaintiffs' invention due to the plaintiffs' patent application being cited as prior art during the prosecution of a third-party reissue patent. The complaint also references prior infringement lawsuits filed by the plaintiffs against other entities concerning the same technology.
Case Timeline
| Date | Event |
|---|---|
| 2004-03-29 | Priority Date for '591 and '344 Patents |
| 2005-09-29 | Plaintiffs' patent application publication date |
| 2008-01-01 | HeRO Graft receives FDA clearance (year only provided) |
| 2008-01-01 | Alleged infringing sales by Defendant's predecessor begin (year only provided) |
| 2012-05-15 | Defendant allegedly acquires and begins manufacturing HeRO Graft |
| 2012-10-09 | U.S. Patent 8,282,591 ('591 Patent) issues |
| 2014-06-10 | U.S. Patent 8,747,344 ('344 Patent) issues |
| 2016-05-04 | Defendant allegedly ceases manufacturing and sells HeRO Graft business |
| 2018-08-07 | Plaintiffs file lawsuit against Defendant and others in N.D. Illinois |
| 2021-06-01 | Plaintiffs file lawsuit against Merit Medical Inc. in D. Utah |
| 2022-09-01 | Plaintiffs file Amended Complaint in the present action |
II. Technology and Patent(s)-in-Suit Analysis
- Patent Identification: U.S. Patent No. 8,747,344, "Hybrid Arteriovenous Shunt," issued June 10, 2014.
The Invention Explained
- Problem Addressed: The patent describes that conventional arteriovenous (AV) grafts used for hemodialysis access have a high failure rate, with nearly 80% of failures caused by returning high-pressure blood from a dialysis machine into a patient's vein, which damages the vein walls and leads to obstruction (neointimal hyperplasia) (Compl. ¶2; ’344 Patent, col. 1:29-38).
- The Patented Solution: The invention is a "hybrid" shunt that avoids this problem by using a venous outflow catheter to deposit the purified blood directly into the patient's right atrium. The right atrium is a larger cardiac chamber better suited to handle the high-pressure flow, thereby bypassing the fragile peripheral veins and preventing the damage that leads to graft failure ('344 Patent, Abstract; col. 2:12-18). The system generally consists of an arterial graft, a connecting cuff, and the venous outflow catheter, as depicted in the patent's figures ('344 Patent, FIG. 2).
- Technical Importance: The described solution sought to provide a more durable, long-term vascular access method for hemodialysis, addressing a significant cause of patient morbidity, mortality, and repeat surgical procedures ('344 Patent, col. 1:19-27).
Key Claims at a Glance
- The complaint asserts independent claim 13 (’344 Patent, col. 7:19-43; Compl. ¶5).
- The essential elements of independent claim 13, a system claim, include:
- An arteriovenous shunt means comprising:
- An arterial graft means with a specific diameter for connection to an artery.
- A single lumen venous outflow catheter means with a different diameter, operable for insertion through a vein into the right atrium of the heart.
- A cuff means disposed about both the graft and the catheter to connect them and provide 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 HeRO (Hemodialysis Reliable Outflow) Graft (Compl. ¶3).
Functionality and Market Context
- The HeRO Graft is described as a three-component system for hemodialysis access: an arterial graft component, a metallic connector, and a venous outflow component (catheter) that is placed into the right atrium (Compl. ¶3, ¶6). The complaint includes a product illustration of the HeRO Graft showing these components (Compl., Ex. 4, p. 21). This diagram depicts the "HERO 1002 Arterial Graft Component" and the "HERO 1001 Venous Outflow Component" joined by a "Metallic Connector" (Compl., Ex. 4, p. 21).
- The complaint alleges that the HeRO Graft is a "copied, and unpatend device" that received FDA clearance in 2008 (Compl. ¶3). It further alleges that the Defendant's predecessor sold 5,000 units and that the Defendant continued to manufacture the devices from May 2012 to May 2016 (Compl. ¶9).
IV. Analysis of Infringement Allegations
'344 Patent Infringement Allegations
| Claim Element (from Independent Claim 13) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a. an arteriovenous shunt means comprising: i. an arterial graft means comprising a body... operable for subcutaneous connection to an artery... | The HeRO Graft includes an arterial graft component. An illustrative diagram is provided in the complaint. | ¶6; Ex. 4 | col. 4:30-45 |
| ii. 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 component that is directed into the right atrium of the heart. | ¶6; Ex. 4 | col. 4:46-59 |
| iii. a cuff means... disposed about said terminal end of said subcutaneous graft; and... disposed about said intake end of said venous outflow catheter... wherein the cuff provides a secure fit... | The HeRO Graft utilizes an "indisposed metallic connector" that connects the graft and venous outflow catheter. The complaint alleges this performs an identical function to the claimed cuff and that the structural difference is "insubstantial" under 35 U.S.C. § 112(f). | ¶4; ¶6 | col. 4:60-65 |
| b. a hemodialysis apparatus. | The HeRO Graft is used in conjunction with a standard dialysis machine to perform hemodialysis. | ¶6 | col. 2:51 |
- Identified Points of Contention:
- Scope Questions: The primary point of contention identified in the complaint is the "cuff means" limitation. The complaint alleges the patented invention uses a cuff "disposed about" the components, while the accused HeRO Graft uses a "metallic connector [that] is indisposed" (Compl. ¶4). The central legal and factual question will be whether the scope of "cuff means," as construed under 35 U.S.C. § 112(f) (means-plus-function), covers the accused connector.
- Technical Questions: The infringement analysis will turn on whether the accused "metallic connector" performs the identical function as the claimed "cuff means"—which the complaint defines as transmitting blood from the graft to the catheter (Compl. ¶4)—and whether its structure is equivalent to the cuff structure disclosed in the patent (e.g., a Teflon or Dacron cuff over which a surgical anastomosis is performed) ('344 Patent, col. 4:65; Abstract).
V. Key Claim Terms for Construction
- The Term: "a cuff means"
- Context and Importance: This term is the focal point of the infringement dispute, as the complaint acknowledges a structural difference at this point of connection between the patented invention and the accused product (Compl. ¶4). The plaintiffs' case hinges on this term being interpreted as a means-plus-function limitation under 35 U.S.C. § 112(f) and the accused "indisposed metallic connector" being found to be a structural equivalent.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: Plaintiffs may argue that the use of the word "means" creates a presumption that § 112(f) applies. The specification describes the function as connecting the venous outflow catheter to the graft ('344 Patent, col. 4:60-62), a function the accused connector also performs. Plaintiffs' argument for infringement relies on the function being identical and the structural difference being "insubstantial" (Compl. ¶4).
- Evidence for a Narrower Interpretation: A defendant may argue that the claim itself recites sufficient structure—"disposed about said terminal end of said... graft; and... disposed about said intake end of said... catheter"—to take the term outside the scope of § 112(f). Even if it is a means-plus-function term, the specification discloses a specific structure: a cuff made of "Teflon® or Dacron®" over which a "surgical anastomosis" is performed ('344 Patent, col. 4:65; Abstract). A defendant could argue its "indisposed metallic connector" is not an equivalent to this disclosed structure.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement under 35 U.S.C. § 271(b). The factual basis is the allegation that the Defendant supplied the three components of the HeRO Graft to hospitals and surgeons, who then directly infringed by assembling and implanting the device into patients (Compl. ¶9, ¶11).
- Willful Infringement: The complaint alleges willful infringement based on pre-suit knowledge of the plaintiffs' patents. It is alleged that the Defendant (or its predecessors) knew of the plaintiffs' pending patent application as early as September 29, 2005, because the application was cited in a reissue patent (US RE44,639 E) for technology that the Defendant's predecessor was the assignee of (Compl. ¶11). This, combined with continued manufacturing after the '344 patent issued, is alleged to constitute "reckless disregard" (Compl. ¶12).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim construction and equivalence: Does the claim term "cuff means," which the patent describes as being "disposed about" the components, read on the accused HeRO Graft's "indisposed metallic connector"? This will likely involve a detailed analysis under 35 U.S.C. § 112(f) to determine if the term is a means-plus-function limitation and, if so, whether the different structures are legally equivalent.
- A second central question will be one of scienter for willfulness: Can the plaintiffs prove that the defendant possessed the requisite knowledge and intent for willful infringement based on the citation of their published patent application in an unrelated third-party reissue proceeding, and does the defendant's subsequent conduct rise to the level of egregious misconduct warranting enhanced damages?