DCT

1:03-cv-00019

Boston Scientific Corp v. Kimberly Clark Corp

Log In
Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:03-cv-00019, D.D.C., 01/07/2003
  • Venue Allegations: Venue is alleged to be proper under 35 U.S.C. § 146, which governs civil actions in cases of patent interference.
  • Core Dispute: Plaintiffs seek judicial review of a USPTO Board of Patent Appeals and Interferences decision, alleging the Board erred in awarding priority of invention to Defendants' patents over Plaintiffs' patent application for technology related to multi-lumen endoscopic catheters.
  • Technical Context: The technology involves multi-lumen endoscopic catheters used in procedures such as Endoscopic Retrograde Cholangiopancreatography (ERCP), which are designed to improve procedural efficiency and patient safety.
  • Key Procedural History: This action is a direct appeal under 35 U.S.C. §146 of a Final Decision from the Board of Patent Appeals and Interferences in Patent Interference No. 104,515. In that proceeding, the Board awarded priority of invention to the "Weaver" inventors (Defendants) and determined that their patents were validly claimed, while finding the "Rowland" inventors (Plaintiffs) were not entitled to a patent on their corresponding application claims.

Case Timeline

Date Event
1994-01-31 Priority Date for Weaver Patents (’681, ’028)
1994-05-13 Priority Date for Rowland Application ('834)
1998-08-04 U.S. Patent No. 5,788,681 ('681 Patent) Issues
1998-12-01 U.S. Patent No. 5,843,028 ('028 Patent) Issues
2002-08-28 Board issues Final Decision in Interference No. 104,515
2003-01-07 Complaint Filed

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

No probative visual evidence provided in complaint.

U.S. Patent No. 5,788,681 - "Multi-Lumen Endoscopic Catheter"

Patent Identification: U.S. Patent No. 5,788,681, "Multi-Lumen Endoscopic Catheter," issued August 4, 1998.

The Invention Explained

  • Problem Addressed: The patent describes challenges with prior art single-lumen catheters used in ERCP procedures. Specifically, these catheters required the removal of a guide wire to inject contrast dye, a process that was "awkward and time consuming" and risked misplacing the catheter, necessitating repetition of the procedure. (Compl. ¶12; ’681 Patent, col. 2:8-21, col. 3:25-33).
  • The Patented Solution: The invention is a catheter with at least two independent lumens extending through the catheter body. This design permits a guide wire to remain in place in one lumen while a second lumen is used to inject contrast medium or pass other instruments, thereby avoiding the need to withdraw and reinsert the guide wire. ('681 Patent, Abstract; col. 2:51-68).
  • Technical Importance: This multi-lumen approach was intended to make ERCP procedures safer, faster, and more efficient by allowing simultaneous access for guidance and therapeutic or diagnostic action. ('681 Patent, col. 3:20-47).

Key Claims at a Glance

  • The complaint notes that the Board found Weaver entitled to claims 16-23 of the ’681 Patent (Compl. ¶14(c)).
  • Independent claim 16 includes the following essential elements:
    • A catheter for advancement through an endoscope's accessory channel.
    • A substantially cylindrical, flexible catheter body.
    • At least three independent lumens.
    • A first lumen configured for receiving a wire guide.
    • A second lumen configured for injection of contrast fluid.
    • A third lumen having an electrosurgical instrument, such as a sphinctertome/papillotome, disposed therein.
  • The complaint does not explicitly reserve the right to assert dependent claims, as the dispute centers on entitlement to the claims awarded by the Board.

U.S. Patent No. 5,843,028 - "Multi-Lumen Endoscopic Catheter"

Patent Identification: U.S. Patent No. 5,843,028, "Multi-Lumen Endoscopic Catheter," issued December 1, 1998.

The Invention Explained

  • Problem Addressed: The ’028 Patent, which shares a specification with the ’681 Patent, addresses the same problems of prior art single-lumen catheters, namely the inefficiency and risk associated with needing to exchange a guide wire for a dye injection lumen during endoscopic procedures. (Compl. ¶12; ’028 Patent, col. 2:8-21).
  • The Patented Solution: The solution is a catheter with a plurality of independent lumens, allowing for the simultaneous or sequential use of a guide wire, contrast medium, and/or other surgical instruments without requiring the removal of the guide wire from its established position in the patient's biliary tract. (’028 Patent, Abstract; col. 2:51-68).
  • Technical Importance: The invention's methods aimed to reduce procedure time, patient risk, and the complexity of ERCP, which had previously been "limited to only the most skilled endoscopists." (’028 Patent, col. 2:39-44).

Key Claims at a Glance

  • The complaint notes that the Board found Weaver entitled to claims 7-17 of the ’028 Patent (Compl. ¶14(c)).
  • Independent method claim 11 includes the following essential steps:
    • (a) Selecting a catheter with a first lumen for a wire guide, a second lumen for contrast fluid, and a third lumen for a cutting instrument.
    • (b) Threading the catheter and wire guide through an endoscope into a duct.
    • (c) Infusing contrast medium through the second lumen to visualize the duct.
  • The complaint does not explicitly reserve the right to assert dependent claims.

III. The Accused Instrumentality

The complaint does not allege infringement by a commercial product or service. This action is a statutory appeal of a USPTO patent interference decision, and the central dispute is about which party is entitled to claims for the contested invention, not whether a product infringes those claims.

IV. Analysis of Infringement Allegations

The complaint does not contain allegations of patent infringement or associated claim charts.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for an analysis of claim construction. The dispute centers on the priority of invention for the subject matter as a whole, as defined by the "count" in the underlying interference proceeding, rather than the construction of specific terms for the purpose of an infringement analysis.

VI. Other Allegations

The complaint does not contain allegations of indirect or willful infringement.

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

This case is not a standard patent infringement action but a review of a USPTO priority contest. The central questions for the court are therefore fundamentally different and will likely focus on the following:

  • A primary question is one of priority of invention: Which party—Rowland (Plaintiffs) or Weaver (Defendants)—can produce sufficient evidence to establish an earlier date of invention (i.e., conception coupled with diligence to reduction to practice) for the subject matter defined in the underlying interference count?
  • A related evidentiary issue will be the sufficiency of disclosure: Does the specification of the party ultimately deemed to have priority provide adequate written description and enablement to support the full scope of the invention defined by the interference count as of its priority date? The district court's review under 35 U.S.C. §146 allows for the introduction of new evidence not before the Board, which could be decisive in answering these questions. (Compl. ¶16).