DCT
5:03-cv-01512
Voda v. Cordis Corp
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Jan K. Voda, M.D. (Oklahoma)
- Defendant: Cordis Corporation (Florida)
- Plaintiff’s Counsel: Kilpatrick Stockton LLP
- Case Identification: 5:03-cv-01512, W.D. Okla., 08/03/2004
- Venue Allegations: Plaintiff alleges venue is proper in the Western District of Oklahoma because a substantial part of the events giving rise to the claims occurred in the district.
- Core Dispute: Plaintiff alleges that Defendant’s XB series of guiding catheters infringes three U.S. patents related to the design and use of angioplasty guide catheters.
- Technical Context: The technology concerns angioplasty guide catheters, which are medical devices used to provide a stable path for deploying other instruments (like balloon catheters) to treat stenotic lesions, or blockages, in coronary arteries.
- Key Procedural History: The complaint alleges that Plaintiff contacted Defendant on March 14, 2002, to provide notice of the patents-in-suit and his belief of infringement, and that subsequent correspondence concluded on June 20, 2002, with Defendant’s refusal to obtain a license. This correspondence forms the basis for the allegation of willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 1991-01-23 | Earliest Priority Date for ’625, ’213, and ’195 Patents |
| 1995-08-29 | U.S. Patent No. 5,445,625 Issues |
| 2000-07-04 | U.S. Patent No. 6,083,213 Issues |
| 2002-03-14 | Plaintiff Voda contacts Defendant Cordis regarding patents |
| 2002-06-20 | Correspondence between parties concludes |
| 2002-11-05 | U.S. Patent No. 6,475,195 Issues |
| 2004-08-03 | First Amended Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 5,445,625 - "Angioplasty Guide Catheter"
- Issued: August 29, 1995
The Invention Explained
- Problem Addressed: The patent describes significant problems with prior art "Judkins-type" catheters when used for angioplasty procedures. These catheters are said to lack adequate "backup support," causing the catheter’s distal tip to be dislodged from the ostium (opening) of the coronary artery when a physician attempts to advance a balloon catheter through a tight blockage. This dislodgement, or "prolapse," complicates the procedure (’625 Patent, col. 2:1-17).
- The Patented Solution: The invention is a guide catheter with a novel distal shape comprising a specific sequence of straight and curved portions. This geometry is designed so that when the catheter is positioned in the cardiovascular system, a portion of it rests in a "substantially contiguous manner against the aortic wall" directly opposite the coronary ostium. This creates a stable, "generally rectilinear axis of support" that extends across the aorta, providing the necessary backup to resist the pushback forces that cause prolapse (’625 Patent, Abstract; col. 8:36-53).
- Technical Importance: The design aimed to provide a more stable platform for angioplasty, potentially increasing the success rate and safety of procedures for treating coronary artery disease (’625 Patent, col. 7:14-24).
Key Claims at a Glance
The complaint does not specify which claims are asserted (Compl. ¶16). For analytical purposes, Claim 1 is examined as a representative independent claim.
- Claim 1: A femoral approach angioplasty guide catheter comprising:
- an elongate flexible tubular member with a first straight proximal portion;
- a second straight portion joined to the first straight portion;
- a tertiary curved portion defining a junction between the first and second straight portions with an obtuse angle of 130° to 150°;
- a secondary curved portion joined to the second straight portion with an arcuate curvature of about 150° to 180°;
- a third straight portion joined to the secondary curved portion;
- a fourth straight portion joined to the third straight portion, defining a terminal distal tip; and
- a primary curved portion at the junction of the third and fourth straight portions, defining an obtuse angle of 140° to 160°.
U.S. Patent No. 6,083,213 - "Angioplasty Guide Catheter"
- Issued: July 4, 2000
The Invention Explained
- Problem Addressed: As a continuation of the application leading to the ’625 Patent, the ’213 Patent addresses the same technical problem: the lack of backup support in conventional Judkins-type catheters, which leads to catheter tip prolapse during angioplasty procedures (’213 Patent, col. 2:1-17).
- The Patented Solution: The patent claims a method of using a catheter whose structure provides superior backup support. The method involves engaging the inner wall of the aorta with a portion of the catheter body opposite the coronary ostium "along a line having a length of about 1.5 cm or greater." This contrasts with the "single point" of contact provided by prior art catheters and creates a more stable foundation for advancing therapeutic devices (’213 Patent, col. 5:35-41, Claim 1).
- Technical Importance: This patent focuses on the functional result of using a properly designed catheter—achieving a broad, stable line of contact against the aortic wall—to improve procedural outcomes (’213 Patent, col. 7:6-24).
Key Claims at a Glance
The complaint does not specify which claims are asserted (Compl. ¶16). For analytical purposes, Claim 1 is examined as a representative independent claim.
- Claim 1: A method for advancing a catheter through the aorta and into a coronary ostium, comprising the steps of:
- providing a catheter including an elongate catheter body having a proximal end, a distal end, and a central lumen adapted to slidably receive a therapeutic catheter;
- advancing the catheter body distal end through the aortic arch; and
- engaging the aorta inner wall with a portion of the catheter body such that when the distal end of the catheter is positioned in the ostium, the catheter body engages the opposite wall of the aorta along a line having a length of about 1.5 cm or greater.
U.S. Patent No. 6,475,195 - "Angioplasty Guide Catheter"
- Issued: November 5, 2002
Technology Synopsis
The ’195 Patent is part of the same patent family and describes an angioplasty guide catheter apparatus with a specific distal shape. The design features a sequence of straight legs and bends intended to create a stable support structure within the aorta by seating a "first substantially straight leg" against the aortic wall opposite the coronary ostium, thereby providing enhanced backup support compared to prior art designs (’195 Patent, Abstract; Background).
Key Claims at a Glance
- Asserted Claims: The complaint does not specify which claims are asserted (Compl. ¶16). Independent claims include 1 (apparatus) and 5 (method).
- Accused Features: The complaint alleges that Defendant's "XB guiding catheter" infringes the ’195 Patent (Compl. ¶16).
III. The Accused Instrumentality
Product Identification
The complaint identifies "at least the XB guiding catheter" as the accused instrumentality (Compl. ¶16).
Functionality and Market Context
The complaint alleges Defendant is in the business of making and selling medical devices, including "guiding catheters for use in coronary angioplasty" (Compl. ¶3). The complaint does not provide technical details regarding the specific structure, materials, or operation of the accused XB guiding catheter. It makes the conclusory allegation that Cordis has "replicated the teachings of the ‘625, ‘213 and ‘195 Patents" (Compl. ¶17).
IV. Analysis of Infringement Allegations
The complaint makes general allegations of infringement without providing a claim chart or detailing how the accused product meets specific claim limitations. The following tables summarize the core claim elements and the corresponding conclusory allegations. No probative visual evidence provided in complaint.
’625 Patent Infringement Allegations
(Based on representative Independent Claim 1)
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a femoral approach angioplasty guide catheter adapted for selective catheterization of a left main coronary artery... | The complaint alleges the XB guiding catheter is a device of this type used for coronary angioplasty. | ¶3, ¶16 | col. 31:30-32 |
| a tertiary curved portion defining a junction of the first straight portion and the second straight portion... an obtuse angle of 130° to 150°... | The complaint's allegation implies the XB guiding catheter possesses a corresponding tertiary curve with this geometry. | ¶16, ¶17 | col. 31:40-45 |
| a secondary curved portion joined to the second straight portion and having an arcuate curvature of about 150° to 180°... | The complaint's allegation implies the XB guiding catheter possesses a corresponding secondary curve with this geometry. | ¶16, ¶17 | col. 31:46-49 |
| a primary curved portion a junction of the third straight portion and the fourth straight portion... an obtuse angle of 140° to 160°... | The complaint's allegation implies the XB guiding catheter possesses a corresponding primary curve with this geometry. | ¶16, ¶17 | col. 31:54-58 |
’213 Patent Infringement Allegations
(Based on representative Independent Claim 1)
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for advancing a catheter through the aorta and into a coronary ostium... | The complaint alleges inducement of the use of the XB catheter, which would constitute performance of such a method. | ¶5 | col. 30:1-3 |
| providing a catheter including an elongate catheter body... | Plaintiff alleges Defendant makes, sells, and induces the use of the XB guiding catheter. | ¶3, ¶5, ¶16 | col. 30:4-8 |
| engaging the aorta inner wall with a portion of the catheter body such that... the catheter body engages the opposite wall of the aorta along a line having a length of about 1.5 cm or greater. | The allegation that the accused product is "covered by" the patent implies that its induced use results in this specific engagement with the aortic wall. | ¶16, ¶17 | col. 30:13-18 |
- Identified Points of Contention:
- Scope Questions: A central dispute for the ’625 and ’195 apparatus patents will likely concern whether the precise geometry of the accused XB catheter falls within the specific angular and dimensional ranges recited in the claims (e.g., "obtuse angle of 130° to 150°").
- Technical Questions: For the ’213 method patent, a key factual question will be what evidence demonstrates that the use of the XB catheter in a clinical setting necessarily results in it engaging the aortic wall "along a line having a length of about 1.5 cm or greater." This raises issues of how such contact is achieved and measured in a dynamic, in-vivo environment.
V. Key Claim Terms for Construction
The Term: "secondary curved portion... having an arcuate curvature of about 150° to 180°" (’625 Patent, Claim 1).
Context and Importance: This element, in combination with the adjacent straight portions, is critical for defining the structure that allegedly creates the novel, stable contact area against the aortic wall. The definition of this term will be central to determining whether the shape of the accused catheter is literally claimed.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim uses the word "about," which may suggest the numerical range is not rigid. The specification discloses multiple embodiments with different dimensions, which could support an argument that the claims are not limited to a single specific shape (’625 Patent, Figs. 9-13).
- Evidence for a Narrower Interpretation: A party could argue that the term must be construed in light of the stated objective of creating a stable "axis of support" that is functionally distinct from the "single point" contact of the prior art (’625 Patent, col. 5:35-41, Fig. 8D). This could support a narrower construction limited to shapes that achieve this specific functional outcome.
The Term: "engages the... aorta along a line having a length of about 1.5 cm or greater" (’213 Patent, Claim 1).
Context and Importance: This functional language defines the required outcome of the claimed method. The case may turn on whether the use of the accused device achieves this result. Practitioners may focus on this term because infringement depends on the catheter's performance inside the body, not just its static shape.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent contrasts the invention with the "small," "single point" contact of prior art catheters, suggesting "along a line" is meant to require a qualitatively larger area of engagement, not necessarily a perfectly straight or continuous line of contact (’213 Patent, col. 5:35-41).
- Evidence for a Narrower Interpretation: The specification emphasizes the creation of a "substantially contiguous manner [of contact] against the aortic wall for a substantial length (at least about 1.5 centimeters)" (’213 Patent, col. 10:20-23). This language could be used to argue that the engagement must be both substantial in length and largely unbroken.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Defendant is "inducing the use of certain medical products" (Compl. ¶5). However, the infringement count itself does not specify a statutory basis for inducement (e.g., 35 U.S.C. § 271(b)) or plead specific facts showing intent to induce, such as instructions or marketing materials.
- Willful Infringement: The complaint alleges willful infringement based on pre-suit knowledge of the patents (Compl. ¶¶17-18). The factual basis is Defendant's alleged refusal to take a license after being notified of the patents and Plaintiff's infringement allegations in correspondence beginning March 14, 2002 (Compl. ¶¶13-14).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of geometric correspondence: Does the physical shape of the accused XB catheter, with its specific curves, angles, and straight sections, fall within the precise numerical limitations recited in the asserted apparatus claims of the ’625 and ’195 patents?
- A key evidentiary question will be one of in-vivo functionality: For the method claims of the ’213 patent, what clinical or technical evidence can demonstrate that the use of the XB catheter necessarily results in it engaging the aortic wall "along a line" of the required length to provide the claimed backup support?
- A central legal and factual question will be damages and willfulness: Given the allegations of pre-suit notice and a refusal to license, the determination of when infringement began relative to the notice date and whether Defendant’s conduct was egregious will be critical to the potential scope of damages.