DCT

1:03-cv-01952

VAS Cath Inc v. Curators Of University Of Missouri

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:03-cv-01952, D.D.C., 09/22/2003
  • Venue Allegations: Venue is alleged to be proper under 35 U.S.C. § 146, which governs civil actions following a patent interference proceeding, and the general venue statute, 28 U.S.C. § 1391.
  • Core Dispute: Plaintiff seeks reversal of a decision by the USPTO's Board of Patent Appeals and Interferences, arguing its inventors have priority for an invention related to pre-curved dual-lumen catheters, for which the Board awarded priority to Defendant.
  • Technical Context: The technology concerns dual-lumen catheters for long-term hemodialysis, designed with a pre-formed curve to prevent kinking and improve patient comfort when implanted.
  • Key Procedural History: The United States Patent and Trademark Office declared Patent Interference No. 103,988 between Plaintiff's U.S. Patent No. 5,156,592 and a patent application assigned to Defendant. On July 30, 2003, the Board of Patent Appeals and Interferences issued a final decision and judgment against Plaintiff's inventors (Martin et al.). This complaint is a civil action appealing that decision.

Case Timeline

Date Event
1990-01-08 Priority Date for Twardowski '114 Application
1990-04-04 Priority Date for Martin '592 Patent
1992-10-20 Issue Date for U.S. Patent No. 5,156,592
1997-08-19 USPTO Declares Patent Interference No. 103,988
2003-07-30 Board of Patent Appeals and Interferences issues Final Decision
2003-09-22 Complaint Filed

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

U.S. Patent No. 5,156,592 - "PRE-CURVED DUAL LUMEN CATHETER," issued October 20, 1992

The Invention Explained

  • Problem Addressed: The patent describes a problem with soft, flexible catheters used for long-term subclavian vein access in hemodialysis. When such a catheter is implanted using a "tunnel" under the skin, it must bend to enter the vein. This bend can create stresses that cause the catheter to "kink," obstructing blood flow and rendering the device useless (Compl. ¶6; ’592 Patent, col. 3:1-12).
  • The Patented Solution: The invention is a dual-lumen catheter manufactured with a "permanently curved portion" that is pre-formed to accommodate the path from the skin tunnel to the vein ('592 Patent, Abstract; col. 3:24-30). A key structural element is an internal septum separating the two lumens, which is oriented at a right angle to the plane of the curve. This orientation places the septum on the "neutral axis" of the bend, which is alleged to help the catheter resist flattening or kinking forces ('592 Patent, col. 5:7-22).
  • Technical Importance: This design sought to provide a catheter that was soft and flexible enough for long-term patient comfort and biocompatibility, while also being structurally resilient to the mechanical stresses of implantation, thereby increasing the device's reliability and useful life ('592 Patent, col. 2:58-65).

Key Claims at a Glance

  • The complaint does not assert specific claims for infringement but centers on the "Count" of the interference proceeding, which defines the patentable invention in dispute. The Administrative Patent Judge replaced the original Count with "Count 2," which is an alternative combination of claims from the Twardowski '114 application and, by correspondence, the '592 patent (Compl. ¶7).
  • Count 2 provides three alternative definitions of the invention. Count 2A, derived from Twardowski's claims, recites (Compl. ¶7A):
    • A catheter for hemodialysis which comprises a flexible catheter tube defining a plurality of separate lumens
    • said catheter defining an arc angle of generally U-shape in its natural, unstressed configuration
    • whereby said catheter may be implanted with a distal catheter portion residing in a vein... and a proximal catheter portion residing in a surgically created tunnel
  • Count 2B, which corresponds to the subject matter of the '592 patent, recites (Compl. ¶7B):
    • A flexible catheter for prolonged vascular access, the catheter comprising: an elongate flexible and tubular body having a proximal portion, a distal portion and a permanently curved portion linking the proximal and distal portions
    • the curved, the proximal and the distal portions lie naturally in essentially the same plane with the angle contained between the proximal and distal portions being less than 90°
    • a septum extending continuously through said portions and lying substantially at right angles to said plane to divide the tubular body into generally D-shaped intake and outlet lumens
    • intake and outlet tubes coupled to the proximal portion
    • and a tip formed on the distal end... including at least one intake opening... and at least one outlet opening

III. The Accused Instrumentality

This action is not a standard patent infringement suit and does not identify a commercially sold accused product. The dispute centers on priority of invention between Plaintiff's '592 patent and Defendant's Twardowski '114 application for the subject matter defined by the interference Count (Compl. ¶¶3, 5). The complaint alleges that the Board of Patent Appeals and Interferences erred in its decision, which found that Defendant's inventors (Twardowski et al.) had priority for the invention, and seeks a judgment from the court that Plaintiff's inventors (Martin et al.) are the true first inventors (Compl. ¶23; Prayer for Relief ¶C).

IV. Analysis of Infringement Allegations

No infringement allegations are made in the complaint. This section is not applicable.

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

The complaint explicitly identifies the construction of a term from the interference Count as a central issue in the dispute.

  • The Term: "generally U-shaped"
  • Context and Importance: This term appears in Count 2A, which is a copy of a claim from the Defendant's application (Compl. ¶7A). The Plaintiff alleges that the Board "erroneously interpreted" this term and, based on that erroneous interpretation, held that Plaintiff's inventors had not established a reduction to practice of the invention (Compl. ¶19). The definition of this term is therefore critical to determining whether the work done by Plaintiff's inventors falls within the scope of the contested invention, which is a key element of the priority dispute.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The '592 patent, which corresponds to the subject matter of the Count, does not use the term "U-shaped" in its independent claims. Instead, it describes the geometry as a "permanently curved portion" where the angle between the proximal and distal portions is "less than 90°" and preferably in the range of "0°-20°" ('592 Patent, col. 6:45-48; col. 7:22-25). A party could argue that this language defines a broad class of curved shapes, not limited to a symmetrical "U."
    • Evidence for a Narrower Interpretation: The '592 patent's figures, such as Figure 1 and Figure 5, depict a catheter with a distinct, semi-circular curve that could be described as U-shaped. A party could argue that the term "generally U-shaped" should be construed in light of these embodiments and its plain meaning to require a shape that resembles the letter 'U,' rather than any gentle curve or J-shape.

VI. Other Allegations

This complaint appeals a decision from a USPTO interference proceeding. The primary allegations are not of infringement but of legal and factual error by the Board of Patent Appeals and Interferences. The complaint alleges the Board erred by:

  • Refusing to find claims unpatentable: Allegedly refusing to hold claims 19-37 and 19-38 of the Twardowski application unpatentable under 35 U.S.C. § 135(b) and § 112, respectively (Compl. ¶¶14, 16).
  • Ignoring newly discovered prior art: Allegedly declining to exercise its authority to consider a Canadian patent ('122 patent) as prior art against the Twardowski application claims (Compl. ¶¶17-18).
  • Erroneous claim construction: Misinterpreting the term "generally U-shaped" from the interference Count (Compl. ¶19).
  • Erroneous holdings on priority: Incorrectly holding that Plaintiff's inventors were not entitled to establish a constructive reduction to practice based on an earlier-filed application and that Plaintiff's SC-400 product was not an actual reduction to practice of the invention (Compl. ¶¶21, 23).

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

This case presents a district court review of a complex patent interference proceeding. The outcome will likely depend on the court's de novo review of the evidence and its interpretation of patent law principles concerning priority of invention. The central questions for the court appear to be:

  • A core issue will be one of definitional scope: Did the Board of Patent Appeals and Interferences correctly construe the term "generally U-shaped"? The court's interpretation of this term will directly impact whether the evidence of Plaintiff's prior work constitutes a reduction to practice of the contested invention.
  • A second key question will be one of entitlement to priority: Based on a proper construction of the invention and a review of the evidence, which party—Plaintiff's inventors (Martin et al.) or Defendant's inventors (Twardowski et al.)—was the first to invent the subject matter, either through an actual reduction to practice or by filing a patent application that adequately described the invention?
  • Finally, the court will need to address a procedural and substantive patentability question: Did the Board err in refusing to consider certain prior art or in declining to find the claims of the Defendant's application unpatentable on other grounds presented during the interference?