DCT

1:18-cv-05368

Khan v. Hemosphere Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-05368, N.D. Ill., 08/07/2018
  • Venue Allegations: Plaintiffs allege venue is proper because Defendants transact business in the district, including offering to sell, selling, and implanting the accused products in Illinois, and advertising through various channels to reach consumers and medical professionals within the district.
  • Core Dispute: Plaintiffs allege that Defendants’ HeRO® Graft, a medical device for hemodialysis access, infringes a patent related to a hybrid arteriovenous shunt.
  • Technical Context: The technology concerns vascular access for hemodialysis patients, a critical life-sustaining procedure for individuals with end-stage renal disease, where reliable and long-lasting access to the bloodstream is a significant clinical challenge.
  • Key Procedural History: The complaint details a chain of commercialization for the accused HeRO Graft, alleging it was manufactured and sold by Hemosphere Inc. from 2008 until its acquisition by Cryolife Inc. in 2012. Cryolife allegedly continued manufacturing and sales until it sold the related assets to Merit Medical Systems Inc. in 2016, which has continued to the present. The complaint also references Defendants' own patents to support allegations of willful infringement. The plaintiffs are proceeding pro se, a factor that may influence case management and procedural dynamics.

Case Timeline

Date Event
2004-03-29 ’344 Patent Priority Date
2008-XX-XX Accused HeRO Graft first sold by Hemosphere Inc.
2012-05-15 Cryolife Inc. acquires Hemosphere Inc.
2014-06-10 ’344 Patent Issue Date
2016-02-04 Merit Medical Systems Inc. acquires HeRO Graft assets from Cryolife
2018-08-07 Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 8,747,344 - Hybrid Arteriovenous Shunt

The Invention Explained

  • Problem Addressed: The patent’s background section describes the high failure rate (nearly 80%) of conventional arteriovenous (AV) grafts used for hemodialysis. This failure is primarily attributed to neointimal hyperplasia, a condition where the vein wall is damaged by the high-pressure arterial blood being returned from the dialysis machine, leading to clotting and obstruction. (’344 Patent, col. 1:30-34, 52-59).
  • The Patented Solution: The invention is a "hybrid" shunt system designed to bypass the vulnerable vein wall. It comprises an arterial graft connected to a venous outflow catheter via a "cuff." The key innovation is that the venous outflow catheter is inserted through a vein but terminates directly in the right atrium of the heart. This configuration deposits the purified, high-pressure blood directly into the heart's larger chamber, avoiding the damaging pressure on the vein wall that causes conventional grafts to fail. (’344 Patent, Abstract; col. 2:24-36; Fig. 1).
  • Technical Importance: This approach seeks to create a more durable and reliable long-term vascular access point, thereby reducing the significant patient morbidity, mortality, and costs associated with access site failure. (’344 Patent, col. 3:9-12).

Key Claims at a Glance

  • The complaint asserts independent claim 13, which is drafted in a means-plus-function format under 35 U.S.C. § 112(f) (formerly para. 6) (Compl. ¶¶ 8-9).
  • The essential elements of claim 13 are:
    • A system for performing hemodialysis on a patient comprising:
      • (a) an arteriovenous shunt means; and
      • (b) a hemodialysis apparatus.
    • The "arteriovenous shunt means" is further defined as comprising:
      • (i) an arterial graft means;
      • (ii) a single lumen venous outflow catheter means for insertion into the right atrium; and
      • (iii) a cuff means to connect the graft means and catheter means.
  • The complaint does not explicitly reserve the right to assert other claims.

III. The Accused Instrumentality

Product Identification

  • The HeRO® (Hemodialysis Reliable Outflow) Graft (Compl. ¶1).

Functionality and Market Context

  • The HeRO Graft is a subcutaneous vascular access device for hemodialysis patients. The complaint alleges that the device consists of three main components: a graft component, a titanium connector, and an outflow component (catheter) (Compl. p. 44). A diagram included in the complaint shows the HeRO Graft's outflow component and graft component being joined by a "Titanium Connector." (Compl. p. 54, Exhibit B, Fig 1). The complaint alleges the HeRO Graft has been sold since 2008, first by Hemosphere Inc., then by Cryolife Inc., and currently by Merit Medical Systems Inc. (Compl. p. 47).

IV. Analysis of Infringement Allegations

The complaint alleges infringement of claim 13, a means-plus-function claim, arguing that the accused HeRO Graft performs the identical function using an equivalent structure (Compl. p. 46).

’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... The HeRO Graft includes the "He®RO Graft Component," an arterial graft. ¶9; p. 44 col. 3:30-46
(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 the "He®RO outflow component," a catheter that is placed into the right atrium. A diagram illustrates this placement. ¶10; p. 53 col. 3:47-60
(iii) a cuff means comprising an inlet and an outlet... wherein... the cuff provides a secure fit for said arterial graft... and said venous outflow catheter... The HeRO Graft uses a "titanium connector" to connect the graft component and the outflow component. The complaint alleges this is an "insubstantial" change and structurally equivalent. p. 44 col. 3:60-68
b. a hemodialysis apparatus. The HeRO Graft is used in conjunction with a dialysis machine (hemodialysis apparatus) for cleaning a patient's blood. ¶9 col. 2:51
  • Identified Points of Contention:
    • Scope Questions: The central dispute appears to be one of structural equivalence under 35 U.S.C. § 112(f). The analysis will likely focus on whether the accused HeRO Graft’s internal "titanium connector" (Compl. p. 54, Exhibit B, Fig 1) is structurally equivalent to the "cuff means" disclosed in the patent, which is described and depicted as an external component placed "over a cuff" (Compl. p. 51, Exhibit A, Fig 1; ’344 Patent, col. 3:60-62).
    • Technical Questions: Does the complaint provide sufficient evidence that the internal connector of the HeRO Graft performs the identical function of providing a secure connection in substantially the same way, with substantially the same result, as the external cuff disclosed in the patent specification?

V. Key Claim Terms for Construction

  • The Term: "cuff means" (within the "arteriovenous shunt means" of claim 13).
  • Context and Importance: As claim 13 is a means-plus-function claim, the infringement analysis will require the court to first identify the claimed function and then determine whether the accused device's structure is identical or equivalent to the corresponding structure disclosed in the specification. The definition of the "cuff means" is therefore case-dispositive. Practitioners may focus on this term because the complaint explicitly identifies the connector as the key structural difference between the patented invention and the accused device (Compl. p. 44).
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language requires a "cuff means" that connects the graft and catheter and "provides a secure fit" (’344 Patent, cl. 13). An argument could be made that any structure performing this connection function, regardless of its specific configuration (internal vs. external), falls within the scope.
    • Evidence for a Narrower Interpretation: The specification explicitly describes the connection as being made "by surgical anastomosis over a cuff 13" (’344 Patent, col. 3:61-62). Furthermore, the only embodiment depicted in the patent's figures (e.g., Fig. 1) shows an external cuff surrounding the junction of the graft and catheter. This disclosure of a specific external structure may be used to argue for a narrower construction that excludes internal connectors as equivalents.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges contributory infringement, asserting that Defendants sell a venous outflow catheter that is a component of the infringing system (Compl. ¶10). It also alleges induced infringement based on the sale of the HeRO Graft by each corporate defendant in the chain of commerce and through advertising on the internet (Compl. ¶11). Direct infringement is alleged against a long list of physicians and hospitals for implanting the devices (Compl. ¶12).
  • Willful Infringement: Willfulness is alleged based on Defendants' knowledge of their own patents (U.S. 6,582,409 and RE44,639), which allegedly require positioning a catheter in a vein, not the right atrium. The complaint argues that by making and selling a device (the HeRO Graft) that deposits blood into the right atrium, Defendants knew they were practicing the distinct invention of the ’344 Patent and were therefore liable for willful infringement (Compl. ¶13, p. 49).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A core issue will be one of structural equivalence: can the accused HeRO Graft's internal "titanium connector" be deemed an equivalent structure to the "cuff means" disclosed in the ’344 Patent, which the specification and figures depict as an external component, under the framework of 35 U.S.C. § 112(f)?
  • A key evidentiary question will be one of scienter for willfulness: does the content of Defendants’ own patent portfolio provide sufficient evidence that they had pre-suit knowledge of the ’344 Patent and its specific teachings, thereby supporting a claim of deliberate or reckless infringement?
  • A central procedural question will be the viability of the litigation strategy: given the pro se status of the Plaintiffs, a significant challenge will be managing a complex patent case against multiple corporate defendants and hundreds of individual medical professional and hospital defendants named in the complaint.